House Passes Patent Term Extension Bill

In 2001, The Medicines Company failed to file a patent term extension application for its anticoagulant drug Angiomax® (bivalirudin) within the 60-day time limit set forth under 35 U.S.C. § 156(d)(1); the application was filed one day late. Since that time, there have been efforts to remedy this deficiency by legislation (including H.R. 5120; S. 1785; and provisions of S. 1145, the patent "reform" act; as well as an earlier "stand alone" version of the bill introduced as H.R. 1178 earlier in this Congress). Last Monday, the House finally passed a bill containing the necessary provisions.
The bill, H.R. 6344, sets forth the changes in patent term extension law in Section 4:

The details can be read here.

Conference & CLE Calendar

Source: http://patentdocs.typepad.com/
July 1, 2008 - Prior Art & Obviousness 2008: The PTO and CAFC Perspective on Patent Law Sections 102 & 103 (Practising Law Institute) - New York, NY
July 9, 2008 - Quanta v. LG: What You Should Know (ALI-ABA) - 12:00-1:00 PM (EST) webcast
July 9-11, 2008 - Fundamentals of Patent Prosecution 2008: A Boot Camp for Claim Drafting & Amendment Writing (Practising Law Institute) - San Francisco, CA
July 16, 2008 - Patent Claim Construction Workshop (Law Seminars International) - Seattle, WA
July 24-25, 2008 - Advanced Patent Prosecution Workshop 2008: Claim Drafting & Amendment Writing (Practising Law Institute) - New York, NY
August 11-12, 2008 - Advanced Patent Prosecution Workshop 2008: Claim Drafting & Amendment Writing (Practising Law Institute) - San Francisco, CA
August 10-15, 2008 - Advanced Courses (Patent Resources Group) - Washington, DC
September 11, 2008 - Developments in Pharmaceutical and Biotech Patent Law (Practising Law Institute) - New York, NY
September 11-12, 2008 - Current Issues in Complex IP Licensing (Law Seminars International) - Philadelphia, PA
September 15-16, 2008 - Biotech Patents*** (American Conference Institute)
September 22-23, 2008 - USPTO Boot Camp: Patent Edition*** (American Conference Institute) - Alexandria, VA
September 22-23, 2008 - FDA Boot Camp*** (American Conference Institute)
September 22-23, 2008 - Patent Litigation 2008 (Practising Law Institute) - San Francisco, CA
October 6-7, 2008 - Patent Litigation 2008 (Practising Law Institute) - McLean, VA
October 15, 2008 - Developments in Pharmaceutical and Biotech Patent Law (Practising Law Institute) - San Francisco, CA
October 15-17, 2008 - Maximizing Pharmaceutical Patent Lifecycles*** (American Conference Institute) - New York, NY
October 23-24, 2008 - Patent Litigation 2008 (Practising Law Institute) - Chicago, IL
November 10-11, 2008 - Patent Litigation 2008 (Practising Law Institute) - Atlanta, GA
November 17-18, 2008 - Patent Litigation 2008 (Practising Law Institute) - New York, NY
***Patent Docs is a media sponsor of this conference or CLE

Court Report

Eli Lilly and Company et al. v. APP Pharmaceuticals LLC

1:08-cv-00384; filed June 25, 2008 in the District Court of Delaware

Infringement of U.S. Patent No. 5,344,932 ("N-(pyrrolo(2,3-d)pyrimidin-3-ylacyl)-Glutamic Acid Derivatives," issued September 6, 1994), licensed to Eli Lilly, following a paragraph IV certification as part of APP's filing of an ANDA to manufacture a generic version of Lilly's Alimta® (pemetrexed for injection, used to treat malignant pleural mesothelioma and locally advanced or metastatic non-small cell lung cancer). View the complaint here.

Dey LP et al. v. Sepracor Inc.

1:08-cv-00372; filed June 20, 2008 in the District Court of Delaware

Declaratory judgment of non-infringement and invalidity of U.S. Patent No. 6,451,289 ("Albuterol Formulations," issued on September 17, 2002) in conjunction with Dey's filing of an ANDA to manufacture a generic version of Sepracor's Xopenex® (levalbuterol hydrochloride inhalation solution, used to treat bronchospasm caused by asthma and chronic obstructive pulmonary disease). View the complaint here.

Hoffman-La Roche Inc. v. Apotex Inc. et al.

2:08-cv-03065; filed June 16, 2008 in the District Court of Delaware

Infringement of U.S. Patent No. 4,927,814 ("Diphosphonate Derivatives, Pharmaceutical Compositions and Methods of Use," issued May 22, 1990) following a paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of Roche's Boniva® (150 mg once-monthly tablets) (ibandronate sodium, used to treat post-menopausal osteoporosis). View the complaint here.

GlaxoSmithKline Responds to FDA on Cervarix and Plans to Submit Final Study Data for Approval

GlaxoSmithKline today provided the following update regarding its application to the U.S. Food and Drug Administration (FDA) for approval of CERVARIX(R), its vaccine to prevent cervical cancer.

The whole story can be read here.

New Drug Application for Inhaled Treprostinil Submitted to the U.S. Food and Drug Administration

United Therapeutics Corporation and its wholly-owned subsidiary, Lung Rx, Inc., announced today the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of an inhaled formulation of treprostinil (ITRE) for the treatment of pulmonary arterial hypertension (PAH), a chronic, life-threatening disease. The submission starts a 60-day period during which the FDA will examine the application for completeness. If the FDA accepts the ITRE NDA for review, then it is expected to be subject to the standard 10- to 12-month review period before an action letter is issued.

The whole story can be read here.

Labopharm Receives Response from FDA Regarding its Once-Daily Tramadol Product

Labopharm Inc. today announced that the Company has received a response from the U.S. Food and Drug Administration (FDA) regarding its most recent appeal of the decision in the Agency's Approvable Letter for its once-daily tramadol formulation through the Formal Dispute Resolution process.

The details can be read here.

AstraZeneca Submits for New Dosage Strengths of Atacand Plus

June 30, 2008 - AstraZeneca today announced a European decentralized procedure (DCP) submission seeking approval for two new dose strengths of Atacand Plus, for those hypertensive patients not optimally controlled by monotherapy. The reference member state for the procedure is Sweden, and the submission incorporates data from three studies.

The new strengths of the fixed dose combination Atacand Plus, comprised of candesartan cilexetil and hydrochlorothiazide (HCT) in doses of 32/12.5mg or 32/25mg, will offer a second line hypertension indication for hypertensive patients who are not optimally controlled. The clinical studies in this submission show that Atacand Plus at these doses is more effective in reducing blood pressure than their monotherapy components taken alone. In addition, the fixed dose of Atacand Plus 32/25mg was more effective than 32/12.5mg in hypertensive patients who had inadequate blood pressure control with candesartan monotherapy.

The details can be read here.

Indevus Receives Approvable Letter from FDA for Nebido

Indevus Pharmaceuticals, Inc. today announced that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for NEBIDO(R) related to a New Drug Application (NDA) submitted to the FDA in August 2007. The letter, received on June 27, 2008, indicated that the application may be approved if the Company is able to adequately respond to certain clinical deficiencies related to the product. The letter generally confirmed the Company's previously-announced indications from the FDA based on telephone discussions.

The details can be read here.

Ceftobiprole, a New Anti-MRSA Broad-spectrum Antibiotic, Receives Its First Marketing Authorization by Health Canada

June 30, 2008 - Basilea Pharmaceutica Ltd. announces that ceftobiprole (ZEFTERA(TM)), the first-in-class anti-MRSA broad-spectrum cephalosporin, has obtained regulatory approval from Health Canada authorizing the marketing of ceftobiprole for the treatment of complicated skin and soft tissue infections including diabetic foot infections. In addition, Basilea announces further organizational changes in preparation of product commercialization.

The details can be read here.

Bavarian Nordic Files Patent Infringement Suit Against Oxford BioMedica

Bavarian Nordic has filed a patent infringement suit against Oxford BioMedica plc, Biomedica, Inc., and Oxford BioMedica Ltd., in the United States District Court of the Southern District of California.

Bavarian Nordic owns several United States patents relating to an attenuated strain of the company's core technology, MVA-BN(R), which is the basis for its innovative smallpox vaccine, IMVAMUNE(R). MVA-BN(R) also holds promise as a vector for delivering recombinant vaccines.

Bavarian Nordic asserts three patents as a basis for its infringement action, which are U.S. Patent No. 6,761,893, U.S. Patent No. 6,913,752 and U.S. Patent No. 7,335,364.

The details can be read here.

Par Pharmaceutical Receives Final Approval to Market Generic Marinol CIII (Dronabinol) Capsules

Par Pharmaceutical Companies, Inc. today announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for dronabinol, a generic version of Solvay Pharmaceutical's Marinol(R), a CIII controlled substance. This product is approved to treat nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments and is available in 2.5mg, 5 mg and 10 mg strengths. Annual U.S. sales of Marinol are approximately $190 million, according to IMS Health data. Par will begin shipping all strengths of dronabinol soft gel capsules to the trade immediately.

The details can be read here.

Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Elavil

Caraco Pharmaceutical Laboratories, Ltd., announced today that the US Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Applications (ANDAs) for Amitriptyline Hydrochloride USP Tablets, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg.

Amitriptyline Hydrochloride is an antidepressant. Its use is indicated to treat symptoms of depression. According to IMS Data, for the twelve months ended March, 2008, Amitriptyline Hydrochloride USP Tablets had annual generic sales of approximately $16 million. It is marketed under the brand name of Elavil(R), a registered trademark of AstraZeneca.

The details can be read here.

Watson Launches Generic Marinol Capsules

Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, announced today that, under a supply agreement with Solvay Pharmaceuticals, Inc., Watson has launched the authorized generic version of dronabinol in the 2.5, 5 and 10 mg once daily dosage strengths. Dronabinol is the generic version of Solvay Pharmaceuticals' MARINOL(R) (dronabinol) CIII Capsules, indicated to treat nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. Dronabinol is also indicated to treat anorexia associated with weight loss in patients with acquired immunodeficiency syndrome (AIDS). For the 12-months ending December 2007, Solvay reported MARINOL(R) sales of 105 million.

The details can be read here.

Axentis Pharma acquires cystic fibrosis patent rights from Austrian firm

The rights to key patents for an innovative screening tool for treatments for cystic fibrosis were transferred to Swiss biotech company Axentis Pharma AG. The company has acquired the rights from an Austrian firm that has made a vital contribution to the development of new approaches to treating the disease.

The core element of the platform technology involves human proteins which despite offering sufficient functionality are subjected to enzymatic digestion in untreated cells due to genetic mutations in their structure.

The details can be read here.

Cipla Patents Salt and Complex of Blockbuster Drug Substances in India

Mumbai-based Cipla has lately obtained patents for new form of two blockbuster drug substances, namely, esomeprazole and alendronate. In past, Cipla has constantly accused foreign MNCs for ever-greening of patent monopoly and strongly opposed patenting of so-called trivial improvements but in general practicing the same in India.

The whole story can be read here.

Vanda's insomnia drug tasimelteon shows positive result in phase 3 trial

Vanda Pharmaceuticals Inc. announced positive top-line results from a phase III trial showing that investigational drug candidate, tasimelteon (VEC-162), a novel melatonin agonist, met the primary endpoint of the trial and significantly improved sleep in adult patients with chronic insomnia.

We are excited that the results of this phase III chronic insomnia study demonstrate the clinical utility of tasimelteon and the ability of the compound to treat sleep disorders over a period of four weeks. The mechanism of action of tasimelteon as a circadian regulator gives Vanda the opportunity to explore its use for the treatment of circadian rhythm sleep disorders as well as chronic primary insomnia, stated Paolo Baroldi, MD, PhD, Vanda's chief medical officer.

The details can be read here.

Panacea Biotec net dips by 12.6% for 2007-08, dividend at 100%

Panacea Biotec, a Rs 850 crore second largest vaccine producer in India, has suffered setback during the year ended March 2008 on account of lower vaccine sales and rupee appreciation. The company's net profit declined by 12.6 per cent to Rs 128.98 crore from Rs 147.64 crore in the previous year. Its net sales also moved down marginally by 0.1 per cent to Rs 841.34 crore from Rs 842.36 crore. With fall in profits, its earning per share nosedived to Rs 19.51 from Rs 23.84 in the last year.

The board of directors has recommended equity dividend of 100 per cent (Re 1 per share) for the year 2007-08, aggregating Rs 6.68 crore. The equity capital increased to Rs 66.8 crore as at the end of March 2008 from Rs 65.8 crore with the of allotment of 10.12 lakh equity of Re 1 each at a premium of Rs 356.57 per share upon conversion of 82 Zero coupon FCCBs aggregating US $8.2 million.

The vaccines sales have declined by four per cent to Rs 647.24 crore from Rs 674.41 crore in 2006-07. However, its formulations sales improved by 18.1 per cent Rs 200.85 crore from Rs 170.02 crore.

Rajesh Jain, joint managing director, said, "The financial year 2007-08 was full of challenges and exciting achievements, Panacea Biotec achieved new milestones by filing 143 patent applications internationally this year, taking the tally to 828 patent applications so far. The company also achieved WHO pre-qualification for its two innovative combination vaccines Easyfour (DPT-Hib) and Ecovac-4 (DPT-HepB). The company has also become market leader in the private Indian combination vaccine market, with 45 per cent market share. The formulations segment of the company registered 18 per cent growth which is higher than industry growth of 14 per cent as per ORG IMS. The company has become number one in the field of organ transplantation. Despite over 10 per cent increase in rupee against US$, we have been able to match the top line with last year.

Centocor, Inc. Submits BLA to FDA for Golimumab in the Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

Centocor, Inc. announced today that a Biologics License Application (BLA) has been submitted to the U.S. Food and Drug Administration (FDA) requesting the approval of golimumab (CNTO 148) as a monthly subcutaneous treatment for adults with active forms of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. Golimumab, Centocor's next-generation human anti-TNF-alpha monoclonal antibody, is being studied as an every four week subcutaneous injection and is also being studied as an intravenous (IV) infusion therapy. In February 2008, Centocor submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) requesting the approval of golimumab as a monthly subcutaneous treatment for the same indications.

The whole story can be read here.

Schering-Plough and Merck Announce Withdrawal of Loratadine/Montelukast NDA and Termination of Respiratory Joint Venture

Schering-Plough Corp. and Merck & Co., Inc. announce the withdrawal of the New Drug Application (NDA) for the loratadine/montelukast combination tablet.

The companies also terminated the Schering-Plough/Merck Pharmaceuticals respiratory joint venture, which was formed in May 2000 to develop and market a fixed-combination product that would combine loratadine and montelukast. This action has no impact on the business of the Merck/Schering-Plough cholesterol joint venture.

The U.S. Food and Drug Administration (FDA) issued on April 25, 2008 a not-approvable letter for the proposed fixed-dose combination of loratadine and montelukast.

As a result of the termination of the respiratory joint venture, Schering- Plough expects to receive payments totaling $105 million from Merck as specified in the joint venture agreements which Schering-Plough will recognize over the remaining three quarters of 2008.

HIV/AIDS Update - Zidovudine Oral Solution USP, 50 mg/5 mL Generic Product Approval

On June 26, 2008, FDA granted approval for a generic Zidovudine Oral Solution USP, 50 mg/5 mL formulation manufactured by Cipla Limited of of Mumbai, India. The is a full approval, meaning that this generic zidovudine formulation can be marketed in the United States. The application was reviewed under the expedited review provisions of the President's Emergency Plan for AIDS Relief (PEPFAR).

The details can be read here.

Barr Announces Favorable Ruling in Mirapex Patent Challenge

The whole case can be read here.

Barr Pharmaceuticals, Inc. today announced that U.S. District Court for Delaware has ruled in favor of its subsidiary, Barr Laboratories, Inc., in the challenge of the patent listed by Boehringer Ingelheim Pharmaceuticals, Inc. in connection with Boehringer Ingelheim's Mirapex(R) Tablets (pramipexole dihydrochloride) 0.125mg, 0.25mg, 0.5mg, 1mg & 1.5mg.

In his ruling, District Court Judge Joseph J. Farnan, Jr. found that the patent claims at issue in the litigation were invalid on the grounds of nonstatutory double patenting.

Barr's Abbreviated New Drug Application (ANDA) for a generic Mirapex product received final approval from the U.S. Food and Drug Administration (FDA) in February 2008. Barr believes that it is the first company to file an ANDA with a paragraph IV certification for Mirapex Tablets, 0.125mg, 0.25mg, 0.5mg, 1mg & 1.5mg.

"We are very pleased with the Court's favorable decision regarding the patent on Mirapex, and are currently reviewing the opinion in the case and evaluating our options," said Bruce L. Downey, Barr's Chairman and CEO.

Barr filed its ANDA for generic Mirapex Tablets, 0.25mg containing a paragraph IV certification with the FDA in May 2005 and in June 2005 amended its application to include the tablet strengths 0.125mg, 0.5mg, 1mg, and 1.5mg. Following receipt of the notice from the FDA of the application's acceptance for filing, Barr notified the New Drug Application (NDA) holder and patent owner. On September 26, 2005, Boehringer Ingelheim filed suit in the U.S. District Court in Delaware to prevent Barr from proceeding with the commercialization of its product, formally initiating the patent challenge process under the Hatch-Waxman Act. In March 2008, the patent infringement case was heard in front of Judge Farnan.

Mirapex (pramipexole dihydrochloride) had annualized sales of approximately $381 million for the twelve months ended April 2008, based on IMS sales data.


Source:www.pharmalive.com

South Korean court rules against Pfizer in patent dispute

A South Korean court has reportedly ruled against Pfizer Inc. in a patent suit over the blockbuster cholesterol-reducing drug Lipitor.

A South Korean court on Thursday upheld an earlier ruling that Pfizer's Lipitor patent was invalid and that the generic made by five South Korean pharmaceutical companies did not breach the patent.

The details can be read here.

Committee for Medicinal Products for Human Use Post-authorisation Summary of Positive Opinion for Tracleer

LONDON, June 26, 2008-On 26 June 2008 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion** to recommend the variation to the terms of the marketing authorisation for the medicinal product Tracleer. The Marketing Authorisation Holder for this medicinal product is Actelion Registration Ltd.

The CHMP adopted a new indication as follows:

"Some improvements have also been shown in patients with PAH WHO functional class II.".

Detailed conditions for the use of this product will be described in the updated Summary of Product Characteristics (SPC) which will be published in the revised European Public Assessment Report (EPAR) and will be available in all official European Union languages after the variation to the marketing authorisation has been granted by the European Commission.

For information, the full indications for Tracleer will be as follows***:

"Treatment of pulmonary arterial hypertension (PAH) to improve exercise capacity and symptoms in patients with WHO functional class III.

Efficacy has been shown in:

Primary (idiopathic and familial) PAH PAH secondary to scleroderma without significant interstitial pulmonary disease PAH associated with congenital systemic-to-pulmonary shunts and Eisenmenger’s physiology.

Some improvements have also been shown in patients with PAH WHO functional class II

Tracleer is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease (see section 5.1)."

Committee for Medicinal Products for Human Use Post-Authorisation Summary of Positive Opinion for Cymbalta

On 26 June 2008 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion** to recommend the variation to the terms of the marketing authorisation for the medicinal product Cymbalta. The Marketing Authorisation Holder for this medicinal product is Eli Lilly Nederland B.V.

The CHMP adopted a new indication as follows: ‘‘Treatment of generalised anxiety disorder’’.

Detailed conditions for the use of this product will be described in the updated Summary of Product Characteristics (SPC) which will be published in the revised European Public Assessment Report (EPAR) and will be available in all official European Union languages after the variation to the marketing authorisation has been granted by the European Commission.

For information, the full indications for Cymbalta will be as follows***: ‘‘Treatment of major depressive episodes.

Treatment of diabetic peripheral neuropathic pain in adults.

Treatment of generalised anxiety disorder’’.

European Approval for Roche's Pegasys Personalises Treatment for a Subgroup of Hepatitis C Patients

26 June 2008-Roche announced today that the European Commission has approved a shortened, 16-week course of treatment with Pegasys (peginterferon alfa-2a (40 KD)) plus Copegus (ribavirin) for certain hepatitis C patients.

The four-month treatment course will be for patients with particular strains of chronic hepatitis C (genotype 2 or 3) who have low virus levels before starting treatment, and who show a rapid virological response by clearing the virus from the blood within the first 4 weeks of treatment. This shorter treatment duration with Pegasys/Copegus will provide patients with the full benefits of therapy while reducing unnecessary drug exposure.

This is good news for eligible patients as previously, all patients with genotype 2 or 3 hepatitis C (HCV) received 24 weeks of Pegasys/Copegus therapy, regardless of their baseline virus levels and response while on treatment.

The details can be read here.

EMEA Recommends New Warnings and Contraindications for Ergot-derived Dopamine Agonists

June 26, 2008-The European Medicines Agency has recommended updating the product information for ergot-derived dopamine agonists with new warnings and contraindications in relation to the risk of fibrosis.

The whole story can be read here.

EMEA Recommends a New Warning for Epoetins for Their Use in Cancer Patients

June 26, 2008-The European Medicines Agency (EMEA) has recommended updating the product information for epoetin-containing medicines with a new warning for their use in cancer patients stating that blood transfusion should be the preferred method of correcting anaemia in patients suffering cancer. Epoetin-containing medicines are indicated in patients with chronic renal failure and for the treatment of anaemia in symptomatic patients with non-myeloid tumours receiving chemotherapy.

The whole story can be read here.

Cystic Fibrosis - Axentis Pharma Takes Over Patents and Continues Development of Innovative Platform Technology

The rights to key patents for an innovative screening tool for treatments for cystic fibrosis were transferred today to Swiss biotech company Axentis Pharma AG. The company has acquired the rights from an Austrian firm that has made a vital contribution to the development of new approaches to treating the disease. The core element of the platform technology involves human proteins which - despite offering sufficient functionality - are subjected to enzymatic digestion in untreated cells due to genetic mutations in their structure.

The details can be read here.

Akorn-Strides, LLC Announces FDA Approvals for Famotidine Injection USP Single-Dose Vials and multiple dose vials

Jun 26, 2008 - Akorn-Strides, LLC today announced the approvals of two ANDAs for Famotidine Injection USP, 20 mg/2mL Single-Dose Vials and 40 mg/4mL & 200 mg/20mL Multiple-Dose Vials. Akorn-Strides, LLC is a Joint Venture that was formed in 2005 by Akorn, Inc. (NASDAQ: AKRX) and Strides Arcolab Limited (NSE: STAR)(BSE: 532531). The primary mission for the Joint Venture is to develop liquid, lyophilized and dry powder formulations of generic injectable products targeting several therapeutic markets with a major focus on anti-infectives, analgesics and CNS medicines.

Famotidine Injection is indicated for the short term treatment of duodenal and gastric ulcers and gastroesophageal reflux disease (GERD). Famotidine Injection is therapeutically equivalent to the brand product Pepcid Injection of Merck. Recent IMS data estimates an annual market size of approximately $8 million.

The details can be read here.

Sun Pharma raises fresh concerns for sale of Taro's Irish facility

Sun Pharmaceutical Industries has raised fresh concerns regarding sale of Irish facility of Taro. The company had sent a strong worded letter to Dr Barrie Levitt, chairman of Taro Pharmaceutical Industries Ltd and said that without Sun Pharma's consent Taro can't sale this facility. The letter also pointed out that the improper termination of the merger agreement does not give Taro the right to sell Taro Ireland without its consent. Any action of this nature will force Sun to hold each of Taro's directors personally accountable. Further, any potential buyer would also be entering into such a transaction at its own, risk, and Sun reserves all its rights against Taro, its directors, and any potential buyer.

The company objected the move in response to Levitt's letter of June 19 to Taro's shareholders, his letter of June 15, to Sun Pharma and the Initiating Motion filed by Taro in the Tel-Aviv District Court on the same day.

Dilip Shanghvi, chairman and managing director of Sun, said in its letter that Taro has been unable to address its substantive objections to the proposed sale of Irish subsidiary (Taro Ireland). Instead, Taro has tried to deflect attention from the logic of our reasoning by accusing us of breaching our duty of good faith to Taro and its other shareholders.

We made public our grave concerns about the proposed sale, not because we were trying to improperly interfere with Taro's business, as your lawsuit claims, but because, as a shareholder and potential owner of Taro - whose efforts to consummate the transaction we signed in 2007 you have no alternative means on alerting other shareholders to the unseemly circumstances of the proposed sale.

Sun pointed out that the company has no intention of interfering with Taro's business. Indeed this would be contrary to our own interests. We do, however, seek full disclosure of the facts relating to the proposed sale of taro Ireland, as well as managements' justifications for what would appear to a rational onlooker to be a disposition of valuable asset at an inopportune time, and on terms highly unfavourable to Taro.

Regarding mishandling of assets, Sun said that its primary objection lies in what it believe to be the Taro's board's mishandling of Taro Ireland. Earlier, Taro said that, Taro Ireland has been costing $8 lakh per month to maintain, and the sale of facility will enhance Taro's cash flows. This is yet another example of an ill-considered approach by the same management that led Taro to the brink of insolvency in 2006-07, requiring Sun to invest nearly $60 million to rescue the company. Selling the assets now may increase Taro's short-term cash flow and improve the company's performance this year. However, such sale would mean falling to realize a potentially substantial return on the investment of almost $5- million which Taro has made in Taro Ireland over the years.

Pursuant to our merger agreement of May 18, 2007, Taro agreed, as is customary in such transactions, to conduct its business in the ordinary course until the closing of the transaction. A sale of Taro Ireland, which is a significant asset, cannot by any stretch the imagination be considered an action in the ordinary course, and as such, Taro was required to obtain Sun's consent to the proposed sale in 2007.

Sun pointed out that the Taro should provide full disclosure regarding the total investment made in Taro Ireland to date, including capitalized losses; the present asset base of Taro Ireland; its financials for the last five years and Taro Ireland's products which have been, or are in the process of being, approved by the Irish and other authorities. The present price is lower than Taro Ireland's existing asset value. Taro has neither been able to reconcile the valuation used in the proposed sale nor provide evidence that this is the best offer available.

Further, Sun's letter pointed out that in addition to the undervaluation and risky form of consideration being proposed, one of the potential buyers has a close relationship with Taro's senior management. The only rational reason we can imagine for a sale so economically and strategically unfavourable to Taro and is shareholders is that it forms part of your concerted effort to discourage Sun from exercising its right to acquire Taro.

Clavis Pharma Receives US Orphan Drug Designation for Elacyt

June 25, 2008-Clavis Pharma today announced that the US Food & Drug Administration (FDA) has granted orphan drug designation to ELACYT(TM) for the treatment of Acute Myeloid Leukaemia (AML). Within haematology, Clavis Pharma is currently conducting a Phase II study with ELACYT in patients undergoing second salvage therapy for AML, and a Phase I study with ELACYT in combination with idarubicin, in patients undergoing first salvage treatment (patients with refractory /relapsed AML).
"We are pleased to receive this orphan drug designation for ELACYT, in addition to the European Commission designation received last year" says Geir Christian Melen, CEO of Clavis Pharma. "Patients with AML need better agents as current treatment options are highly unsatisfactory. This designation is an important milestone in Clavis Pharma's strategy to achieve marketing approval for ELACYT as swiftly as possible."

The US Orphan Drug Act provides incentives to encourage the development of drugs for rare disease conditions affecting fewer than 200,000 persons in the United States of America (USA). The designation allows for amongst others a possible exemption from the FDA-user fee and assistance in clinical trial protocol design. If ELACYT receives marketing approval for AML in the USA, the designation will entitle Clavis Pharma to exclusive marketing rights for AML for seven years following the approval.

It should be noted that orphan drug designation does not limit a drug to less common diseases. The drug may as well, in parallel or afterwards, be developed for more common diseases.

Targanta's Oritavancin MAA Accepted for Review by EMEA

Targanta Therapeutics Corporation today announced that the European Medicines Agency (EMEA) has accepted for review its Marketing Authorization Application (MAA) for oritavancin, Targanta's novel semi-synthetic lipoglycopeptide antibiotic candidate with potent bactericidal (killing) activity against a broad spectrum of gram-positive bacteria. Targanta is seeking approval of intravenous oritavancin in the European Union for the treatment of complicated skin and soft tissue infections (cSSTI) caused by gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). Targanta announced the submission of its MAA for oritavancin to EMEA on June 9, 2008.

The details can be read here.

FDA Approves Kinrix - New Combination Vaccine for Children

GlaxoSmithKline announced today that the U.S. Food and Drug Administration (FDA) has approved KINRIX(TM) [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine], the first combination vaccine to offer protection against diphtheria, tetanus, pertussis and polio diseases in one shot.

"Children 4 to 6 years-old can receive five or more vaccinations in a single visit, which can be stressful for parents and vaccinators," said William P. Hitchcock, MD, Assistant Clinical Professor of Pediatrics, School of Medicine. "By reducing the number of shots given in one visit, combination vaccines like KINRIX may make it easier for kids to meet school vaccination requirements and CDC recommendations."

The details can be read here.

Pharming Acquires Licences to Key Fibrinogen Patents

June 25, 2008. Biotech company Pharming Group NV announced today that it has acquired an exclusive sub-license to key patents and technology on recombinant fibrinogen from GTC Biotherapeutics Inc ("GTC"). These rights enable Pharming to accelerate pharmaceutical development of recombinant human fibrinogen (rhFIB) and stimulate medical device development through its biomaterials program.

The details can be read here.

Ranbaxy Gains Tentative Approval to Manufacture and Market Valganciclovir Hydrochloride Tablets

Ranbaxy Laboratories Limited (RLL), announced today that the company has received tentative approval from the U.S. Food and Drug Administration to manufacture and market Valganciclovir Hydrochloride Tablets, 450 mg. Total annual market sales for Valganciclovir HCl Tablets were $239 million (IMS - MAT: March 2008).

Ranbaxy believes that it has First-to-File status on Valganciclovir tablets, thereby providing a potential of 180-days of marketing exclusivity, offering a significant opportunity in the future.

The details can be read here.

Federal Circuit Refuses to Rehear Caraco v. Forest

We previously reported that on April 1, in a 2-1 decision in Caraco v. Forest, the Federal Circuit held that an ANDA applicant may in some circumstances bring a declaratory judgment action for noninfringement even if the patentee has granted the applicant a covenant not to sue. Today, the Federal Circuit denied Forest's petition for rehearing or rehearing en banc, without opinion.

The Caraco v. Forest decision expanded declaratory judgment jurisdiction for ANDA applicants that have not been sued on an Orange Book-listed patent. Indeed, several ANDA applicants have filed DJ complaints since the decision.

It would not be surprising if Forest now appealed to the Supreme Court. However, given that the Court recently decided a declaratory judgment case, MedImmune v. Genentech, and that the Federal Circuit appeared to follow that decision in Caraco v. Forest, Supreme Court review seems unlikely.

Orchid gets Canadian nod for piperacillin/tazobactam injection

The Chennai-based pharma major, Orchid Chemicals & Pharmaceuticals Ltd (Orchid) has received approval from the Canadian TPD (Therapeutic Products Directorate) for its ANDS (Abbreviated New Drug Submission) for piperacillin and tazobactam for injection.

Orchid is the largest manufacturer-exporter of cephalosporin bulk actives in India and produces antibiotics like cephalosporins, high-end betalactams, monobactams and carbapenems, also non-antibiotic products for central nervous system, cardiovascular, gastro-intestinal, pain management and osteoporosis therapeutic categories.

Emisphere, Nordisk pact to develop oral formulation of GLP-1 receptor agonists for diabetes

Emisphere Technologies, Inc. and Novo Nordisk A/S have entered into an exclusive development and license agreement to develop and commercialize oral formulations of Novo Nordisk's proprietary GLP-1 receptor agonists, which have the potential of treating type II diabetes, using Emisphere's eligen technology.

The agreement includes at least $87 million in product development and sales milestone payments to Emisphere, of which $10 million will be the minimum first year payment, as well as royalties on sales. The agreement also provides Novo Nordisk with the option to develop oral formulations of Novo Nordisk compounds other than GLP-1 receptor agonists using Emisphere's proprietary carrier technology. Further financial details of the agreement were not made public.

The details can be read here.

Sirion Therapeutics Announces FDA Approval of Durezol for Treatment of Postoperative Ocular Inflammation and Pain

Sirion Therapeutics, Inc., a privately held ophthalmic-focused biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved its new drug application for Durezol(TM) (difluprednate ophthalmic emulsion) 0.05%, a topical steroid for the treatment of postoperative ocular inflammation and pain. The approval came after a six month priority review.

The details can be read here.

New Aptivus (tipranavir) Oral Solution Approved for Treatment-Experienced Pediatric and Adolescent HIV Patients

Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) granted approval of Aptivus(R) (tipranavir) capsules/oral solution with dosing information for treatment-experienced pediatric patients between the ages of 2-18 infected with HIV-1. The oral solution formulation, which is a new dosage form of APTIVUS, was also approved for treatment-experienced adults. The oral solution formulation will be available in the U.S. beginning in mid-September. The FDA granted full (traditional) approval to APTIVUS capsules for treatment-experienced adults in October 2007.

The details can be read here.

FDA Approves PrandiMet, a Replaglinide and Metformin Fixed-Dose Combination Tablet for Treatment of Type 2 Diabetes

Jun 24, 2008 - Sciele Pharma, Inc. (NASDAQ:SCRX) and Novo Nordisk Inc. today announced that the U.S. Food and Drug Administration (FDA) approved PrandiMet(TM) (repaglinide and metformin HCl) tablets, the first and only fixed-dose combination of the fast-acting secretagogue replaglinide (also known as Prandin(R)) and insulin sensitizer, metformin, for the treatment of type 2 diabetes. Under a previously announced agreement, Sciele Pharma will exclusively market PrandiMet(TM) to physicians in the U.S. Sciele Pharma anticipates that PrandiMet(TM) will be available to physicians and patients in the U.S. in the second half of 2008.

PrandiMet(TM) has been approved to lower the blood glucose in adult patients with type 2 diabetes whose hyperglycemia cannot be controlled satisfactorily by meglitinide and/or metformin.

The whole story can be read here.

Barr and Bayer Sign Supply and Licensing Agreements for Launch of Generic Yasmin and Yaz Oral Contraceptives

Barr Pharmaceuticals, Inc. today announced that its wholly owned subsidiary, Barr Laboratories, Inc. has entered into supply and licensing agreements with Bayer for generic versions of Bayer's Yasmin(R) (drospirenone and ethinyl estradiol) and Yaz(R) (drospirenone and ethinyl estradiol) oral contraceptive products. Under terms of these agreements, Bayer will supply Barr with the generic products for launch prior to the expiration of the patents protecting these products and Barr will have sole responsibility to market, sell and distribute the products in the U.S. under the Barr Laboratories label.

The details can be read here.

Teva Introduces Ramipril Capsules

June 24, 2008 – Teva Pharmaceuticals is pleased to announce the introduction and availability of Ramipril Capsules. This product is AB rated and bioequivalent to Altace®* Capsules. Ramipril Capsules are available in 2.5 mg, 5 mg, and 10 mg strengths, in bottle sizes of 100.

“Generic pharmaceuticals are playing an increasingly important role in healthcare cost containment,” states John Denman, V.P. Sales and Marketing. “Teva Pharmaceuticals continues to lead the way with timely new product launches.”

US FDA committee recommends Centocor's ustekinumab for psoriasis

Centocor, Inc. announced that the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) of the US Food and Drug Administration (FDA) has unanimously recommended the approval of ustekinumab, a new subcutaneous, investigational biologic therapy for the treatment of adult patients with moderate to severe plaque psoriasis.

Ustekinumab is a new human monoclonal antibody with a novel mechanism of action that targets the cytokines interleukin-12 (IL-12) and interleukin-23 (IL-23), naturally occurring proteins that are important in the body's regulation of immune responses and that are also believed to play an important role in psoriasis.

The details can be read here.

Jerini to Submit Complete Response to the FDA for Icatibant in the Treatment of HAE

June 23, 2008 - Jerini AG (FSE:JI4) announced today that following last week's communication with the US Food and Drug Administration (FDA), the company will submit a complete response to the FDA's not approvable letter for Icatibant in the treatment of acute attacks of hereditary angioedema (HAE). Jerini's complete response, to be submitted in the next three to four months, will provide the agency with information relating to Icatibant's efficacy in the treatment of HAE.

The details can be read here.

Warner Chilcott Announces Approval of Doryx Delayed-Release 150 mg Tablets

Warner Chilcott Limited (Nasdaq:WCRX) announced today that the Food and Drug Administration (FDA) has approved a 150 mg strength of DORYX(r) (doxycycline hyclate) Delayed-Release Tablets.

The whole story can be read here.

U.S. FDA Licenses Sanofi Pasteur's New Pediatric Combination Vaccine, Pentacel

Sanofi Pasteur, the vaccines division of the sanofi-aventis Group, announced today that the U.S. Food and Drug Administration (FDA) has licensed Pentacel(R), Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine. Pentacel(R) vaccine is indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis, and invasive disease due to Haemophilus influenzae type b (Hib). Pentacel(R) vaccine is approved for use in infants and children 6 weeks through 4 years of age (prior to fifth birthday).

The details can be read here.

FDA Approves Velcade (Bortezomib) for Injection for Patients with Previously Untreated Multiple Myeloma

Millennium Pharmaceuticals, The Takeda Oncology Company, and Takeda Pharmaceutical Company Limited today announced that the U.S. Food and Drug Administration (FDA) approved VELCADE for patients with previously untreated multiple myeloma (MM). The Company's co-development partner, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) also has filed a corresponding application with the European Medicines Evaluation Agency (EMEA).

The details can be read here.

Notice of Launching of Anti-Hypertension Drug 'Avapro'

June 23, 2008 - Dainippon Sumitomo Pharma Co., Ltd. launches AVAPRO® tablet 50 mg / 100 mg, anti-hypertension drug (generic name: irbesartan) as of July 1, 2008.

AVAPRO® is a long-acting ARB (angiotensin II receptor antagonist) with a long half-life in blood and a 24-hour-lasting blood pressure-lowering effect, having high anti-hypertensive effect in mild to severe hypertension.

Irbesartan was discovered by sanofi-aventis , co-developed by sanofi-aventis and Bristol Myers Squibb and was launched in 1997 overseas. This drug is currently sold in 86 countries under the brand name of AVAPRO and APROVEL. Based on the large-scale clinical trials, IDNT and IRMA2, which are often cited in the major international guidelines, this drug is also recognized as the only one ARB with evidence for its renoprotective effect in hypertensive type 2 diabetic patients covering both early-stage and overt nephropathy at 300mg/day, and is highly regarded as one of the top ARB brands.

Lupin Enters Into Marketing Alliance with ASCEND Therapeutics for Suprax 400 mg Tablets in the U.S.

Lupin Pharmaceuticals, a subsidiary of Lupin Ltd., announced today that the Company has entered into a promotion agreement for Suprax(R) 400 mg Tablets with ASCEND Therapeutics, Inc.

Under the terms of the alliance, ASCEND Therapeutics will initiate promotion of the product in the U.S. in the month of June 2008. ASCEND has a 50-person Women's Health sales force which will detail the product primarily to Obstetricians and Gynecologists (OB/GYNs). Lupin will continue to promote the product to Pediatricians and Family Practitioners.

The details can be read here.

Pfizer to Pay $975,000 for Alleged Clean Air Violations at Connecticut Facility

The pharmaceutical company Pfizer Inc. has agreed to pay a $975,000 civil penalty to resolve alleged violations of the Clean Air Act at its former manufacturing plant in Groton, Conn., the Justice Department and Environmental Protection Agency (EPA) announced today. Today's settlement is the first of its type in federal court under regulations that are designed to control the emissions of hazardous air pollutants from pharmaceutical manufacturing operations.

The details can be read here

Alchemia Patents Granted for Generic Fondaparinux

June 23, 2008 - Alchemia Ltd. (ASX:ACL) announces the granting of the first two patents in the "Synthetic Heparin Oligosaccharide" family of patents. Australian patent 2002331426 and divisional patent 2007203325 were recently sealed by IP Australia. A further two divisional applications (2008200567 and 2008200616) have completed the examination process and have been accepted to grant. Both of these are expected to be sealed in the next few months. These patents are currently being examined in other major markets.

The details can be read here.

Taro Receives Final FDA Approval for RX Cetirizine Hydrochloride Syrup ANDA

June 23, 2008 - Taro Pharmaceutical Industries Ltd. (Pink Sheets: TAROF, "Taro", the "Company") reported today that it has received final approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for prescription Cetirizine Hydrochloride Syrup, 1 mg / 1 mL ("cetirizine syrup"). Taro had received tentative approval for this ANDA in October 2007. The Company plans to market the product through its U.S. affiliate, Taro Pharmaceuticals U.S.A., Inc.

Taro's cetirizine syrup is bioequivalent to McNeil Consumer Healthcare's Zyrtec(R) Syrup. Cetirizine syrup is a prescription medication used for the relief of symptoms associated with perennial allergic rhinitis in children 6 to 23 months of age, and for chronic urticaria (hives) in children 6 months to 5 years of age. According to industry sources, annual U.S. sales of cetirizine syrup products were approximately $150 million.

Merck Provides Update on U.S. Regulatory Status of MK-0524A (ER niacin/laropiprant) and MK-0524B (ER niacin/laropiprant/simvastatin)

Jun 20, 2008 - Merck & Co., Inc. today provided an update on the regulatory status in the United States of its investigational medicines MK-0524A (ER niacin/ laropiprant) and MK-0524B (ER niacin/laropiprant/simvastatin) for the treatment of primary hypercholesterolemia or mixed dyslipidemia.

Merck recently met with the U.S. Food and Drug Administration (FDA) to discuss the Not Approvable action letter it received on April 28 in response to its New Drug Application (NDA) for MK-0524A. At the meeting, the FDA stated that additional efficacy and safety data were required and suggested that the Company wait for the results of the HPS2-THRIVE (Treatment of HDL to Reduce the Incidence of Vascular Events) cardiovascular outcomes study, which is expected to be completed in January 2013.

The details can be read here.

FDA Approves GlaxoSmithKline's Avodart in Combination with Tamsulosin for the Treatment of Symptomatic Enlarged Prostate

GlaxoSmithKline today announced that the U.S. Food and Drug Administration (FDA) has approved AVODART (dutasteride) in combination with tamsulosin for the treatment of symptomatic enlarged prostate, a disease that affects half of all men over 50 years old. The new indication reflects emerging research showing the combination of the two medicines treats the symptoms of enlarged prostate more effectively than either medicine alone.

The details can be read here.

FDA Announces Tentative Approval: Fixed Dose Combination of Generic Lamivudine/Stavudine Tablets for Pediatric Dosing

On June 19, 2008, FDA granted tentative approval to fixed dose combination lamivudine/stavudine tablets, 30mg/6mg & 60mg/12mg for oral suspension for pediatric use, manufactured by Cipla Limited of Mumbai, India. The application was reviewed under expedited review provisions for the President's Emergency Plan for AIDS Relief.

Lamivudine and stavudine are anti-viral drugs indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. Combination products such as this one can decrease pill burden and could result in improved dosing compliance for HIV infected individuals.

FDA's tentative approval of this product means that although existing patents and/or exclusivity prevent marketing of this product in the United States, the product has been shown to meet all of FDA's safety, efficacy, and manufacturing quality standards required for marketing in the U.S., and thus qualifies for consideration for purchase under PEPFAR.

As with all generic applications, FDA conducts an on-site inspection of each manufacturing facility and of the facilities performing the bioequivalence studies prior to granting approval or tentative approval to these applications to evaluate the ability of the manufacturer to produce a quality product and to assess the quality of the bioequivalence data supporting the application.

Glenmark Generics Gets US FDA Approval For Trandolapril Tabs

Friday, Glenmark Generics, a subsidiary of Glenmark Pharmaceuticals got ANDA approval from US FDA for Trandolapril tablets USP of 1 mg, 2 mg and 4 mg strengths. The company said that it would commence marketing and distribution of these products in US market immediately.

Trandolapril is an angiotensin-converting enzyme used to treat high blood pressure and is generic equivalent of Mavik tablets marketed by Abbott Laboratories. Total sales for Trandolapril tablets exceed $23 million in the twelve months period ending March 2008 as per IMS data.

(source: www.rttnews.com)

Merck Applies to Extend Use of Erbitux for First-Line Head and Neck Cancer in Europe

June 19, 2008 – Merck KGaA announced today that it has submitted an application to the European Medicines Agency (EMEA) to broaden the use of the targeted therapy Erbitux® (cetuximab) to include first-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN).

The submitted label would extend the use of Erbitux for treatment of patients with recurrent and/or metastatic squamous cell cancer of the head and neck in combination with platinum-based chemotherapy.

The details can be read here.

AVANIR Announces Grant of New Zenvia Patent

Jun 19, 2008 - AVANIR Pharmaceuticals today announced that the European Patent Office (EPO) has granted AVANIR a new patent, extending the period of commercial exclusivity for its lead drug candidate Zenvia(TM) (dextromethorphan/quinidine) into 2023.

EPO patent number 1.539.166 titled "Pharmaceutical Compositions Comprising Dextromethorphan and Quinidine for the Treatment of Neurological Disorders" will be published in the European Patent Bulletin on July 2, 2008 and will be effective on that date. The new European patent expands the available Zenvia dose ranges under prior patent protection and encompasses the Company's current clinical development programs in pseudobulbar affect (PBA) and diabetic peripheral neuropathic (DPN) pain, as well as other neurologic conditions.

The details can be read here.

Weitz & Luxenberg Files Seroquel Diabetes Lawsuit Against AstraZeneca

Weitz & Luxenberg, PC, one of the leading plaintiffs' litigation law firms in America, filed a lawsuit today against pharmaceutical giant AstraZeneca on behalf of a New York City Fire Department Emergency Medical Technician whose diabetes was allegedly caused by AstraZeneca's drug Seroquel. The plaintiff, EMT Ernest Armstead, was one of the many brave responders on the morning of September 11, 2001. He was severely injured when the World Trade Center's North Tower collapsed as he was helping victims at the foot of the buildings.

The whole story can be read here.

Roxane Laboratories, Inc. Announces the Launch of Ramipril Capsules

Roxane Laboratories, Inc. announced today the approval of its Abbreviated New Drug Application (ANDA) for Ramipril Capsules, 1.25mg, 2.5mg, 5mg and 10mg by the U.S. Food and Drug Administration. The 1.25mg, 2.5mg, 5mg and 10mg strengths will be available in various packaging configurations. Roxane Laboratories Ramipril Capsules are available for immediate shipment to wholesalers and pharmacies nationwide.

The details can be read here.

Perrigo Announces Approval for Rx Cetirizine Syrup

Perrigo Company today announced that it has received final approval from the U.S. Food and Drug Administration to manufacture and market Cetirizine Hydrochloride Syrup (Rx only), 1mg/mL. The product is comparable to McNeil Consumer Healthcare's Zyrtec(R) Syrup, 1mg/mL, indicated for the relief of symptoms associated with seasonal allergic rhinitis.

The details can be read here.

Enbrel (etanercept) Application for the Treatment of Pediatric Psoriasis to be Discussed at FDA Dermatologic and Ophthalmic Drugs Advisory Committee

June 18, 2008--Amgen announced that the supplemental Biologics License Application (sBLA) for ENBREL for the treatment of pediatric patients with chronic moderate to severe plaque psoriasis who have tried another therapy will be discussed today at a meeting of the DODAC. Moderate to severe plaque psoriasis is a serious, chronic inflammatory disease that can have both physical and psychosocial impact. According to a study published in the British Journal of Dermatology, chronic psoriasis can have as much of an impact on a child's physical, psychological and social functioning as other serious childhood diseases such as asthma, epilepsy and diabetes.

The whole story can be read here.

China Sky One Medical, Inc. Obtains SFDA Approval to Produce Four New Drugs

China Sky One Medical, Inc. (''China Sky One'' or ''the Company''), a China-based manufacturer, marketer and distributor of pharmaceutical, medicinal and diagnostic kit products, announced today that it has obtained approval from the State Food and Drug Administration (SFDA) in the People's Republic of China for four new drugs: Tobramycin Eye Drops, Compound Zinc Sulfate Eye Drops, Ofloxacin Suppositories and Ofloxacin Gels.

The details can be read here.

CSL Receives Approval from the Australian Therapeutic Goods Administration (TGA) to Register PanvaxR

Australia, June 17, 2008- CSL Limited announced today that it has received approval from the Australian Therapeutic Goods Administration (TGA) to register Panvax®, CSL’s avian influenza vaccine. Developed by CSL in collaboration with the Australian government, Panvax is intended for use in the prevention of influenza caused by a pandemic strain of avian influenza virus.

The details can be read here

Ranbaxy and Pfizer Settle Lipitor Litigation Worldwide

June 18, 2008 -- Ranbaxy Laboratories Limited (Ranbaxy), announced today that it has entered into an agreement with Pfizer Inc. to settle most of the patent litigation worldwide involving Atorvastatin (Lipitor), the world's most-prescribed cholesterol-lowering medicine. This decision will allow for an earlier introduction of a generic formulation that will benefit patients and many healthcare systems throughout the world. Lipitor is the world's largest selling drug with worldwide sales in 2007 of $12.7 billion.

The agreement pertains solely to Ranbaxy and its affiliates and does not cover legal challenges to the Lipitor patents involving other generic manufacturers. However, as Ranbaxy was the first generic challenger to the listed Lipitor patents, it retains the right to the marketing exclusivity of 180 days in the United States. Under the terms of the agreement, Ranbaxy will have a license to sell generic versions of Atorvastatin and the fixed-dose combination of Atorvastatin-Amlodipine besylate in the United States effective Nov. 30, 2011.

Welcoming the development, Malvinder Mohan Singh, CEO and MD, Ranbaxy Laboratories Ltd., said, "This comprehensively settles outstanding issues between Ranbaxy and Pfizer bringing to closure a number of ongoing patent disputes. It also provides certainty and visibility to the launch of Ranbaxy's Generic Atorvastatin, with 180-day market exclusivity in the US and an early entry in other markets. This will make the worlds largest selling drug more accessible to patients who will gain from the timely availability of an affordable quality option."

Ranbaxy will also have a license to sell Atorvastatin on varying dates in an additional 7 countries, including: Canada, Belgium, Netherlands, Germany, Sweden, Italy and Australia. Ranbaxy and Pfizer have also resolved their disputes regarding Atorvastatin in Malaysia, Brunei, Peru and Vietnam.

In addition, the lawsuits between Pfizer and Ranbaxy regarding Atorvastatin will be dismissed in select countries and the lawsuits between Pfizer and Ranbaxy regarding the fixed dose combination product containing Atorvastatin and amlodipine will be dismissed in the U.S. and Ranbaxy will no longer contest the validity of Pfizer's patents in such countries. Such patent challenges by Ranbaxy regarding Lipitor have been underway in numerous markets since 2003.

The Atorvastatin patents involved in this agreement are the basic compound patent, which expires in the United States in 2010; the enantiomer patent, which expires in the United States in 2011; and various process and crystalline form patents, which expire in 2016 and 2017; and the combination patent for fixed-dose combination product which expires in 2018.

The agreement also covers the fixed-dose combination of Atorvastatin-Amlodipine besylate (presently marketed under the brand Caduet, which also contains crystalline Form I Atorvastatin), a fixed-dose combination product indicated for patients suffering from both high blood pressure and high levels of cholesterol. The patent for the fixed-dose combination expires in 2018. The settlement also resolves additional patent litigation between the companies involving the branded drugs Accupril (in the U.S.) and Viagra (in Ecuador) and all patent litigation with Ranbaxy relating to generic formulation of Quinapril hydrochloride in the United States and Sildenafil in Ecuador.

Litigation between Ranbaxy and Pfizer relating to Lipitor will continue in five other European countries -- Finland, Spain, Portugal, Denmark and Romania.

(Source: www.pharmalive.com)

Pfizer, Ranbaxy Delay Generic Lipitor for 20 Months

June 18 www.Bloomberg.com reported -- Pfizer Inc. and India's Ranbaxy Laboratories Ltd. agreed to keep copies of the cholesterol pill Lipitor off the U.S. market an extra 20 months, a move that may generate an added $12 billion for the U.S. drugmaker.

Under a lawsuit settlement, Ranbaxy won't sell generic versions of Lipitor, the world's best-selling drug, until November 2011, New York-based Pfizer said today in a statement. Analysts had projected Ranbaxy would enter the market in March 2010, when the main patent expires, while Pfizer was using litigation to delay competition until 2016.

The deal buys Pfizer Chief Executive Officer Jeffrey Kindler more time to find new drugs to replace as much as $12 billion a year at risk when Lipitor copies become available. Investors have been skeptical that Kindler, a former lawyer, can offset the losses with a plan that includes increasing sales of current products, cost cutting and speeding new drugs to market. Since Kindler took command in July 2006, Pfizer, the world's biggest drugmaker, has lost 32 percent of its value.

The settlement ``removes the risk inherent in litigation'' for both companies, said David Reid, Pfizer's acting general counsel. Pfizer had sued Gurgaon, India-based Ranbaxy in federal court to keep Lipitor copies off the market for eight years.

Caduet, a Pfizer drug that combines Lipitor and the company's blood pressure medicine Norvasc, also will be available in generic form in 2011 under the deal. Caduet last year generated $568 million in global sales. In addition to the U.S. cases over Lipitor and Caduet, the agreement settles Lipitor lawsuits in 11 countries.

Shares Rise

Pfizer rose 3.4 percent to $18.33 at 7:53 a.m. in early trading today, after falling 5 cents yesterday to $17.72 on the New York Stock Exchange. Ranbaxy shares rose for the fourth straight day by 15.65 rupees, or 2.7 percent, to close at 597.5 rupees a share in Mumbai trading today, their highest value since January 7, 2005.

Pfizer and Ranbaxy have been fighting in U.S. courts since 2003 over Ranbaxy's bid to sell generic Lipitor. Pfizer sued Ranbaxy again in March, this time over patents expiring in 2016 related to the process of making atorvastatin, the active ingredient in Lipitor. Pfizer has another patent on Lipitor that expires in 2017.

Pfizer was also asking the U.S. Patent and Trademark Office to reissue a patent expiring in June 2011 that was invalidated by an appeals court. In the first round of the review, the patent office rejected that request.

Sale of Ranbaxy

Daiichi Sankyo Co., Japan's third largest drugmaker, said on June 11 it would buy control of Ranbaxy for as much as $4.6 billion. On June 13, Ranbaxy's shares rose to a three-year high after the Business Standard in India reported Pfizer may make a hostile bid for the Indian generic-drug maker.

``We're not intending to buy the company,'' Pfizer's Reid said in an interview yesterday.

Pfizer has faced a string of setbacks since 2006, when the company halted testing on the experimental cholesterol pill torcetrapib, which had been positioned to replace Lipitor. Last year, the company stopped selling its inhaled insulin Exubera, projected to have $1 billion in annual revenue, and sales of its smoking pill Chantix have fallen almost a third after it was tied to suicides in January.

Roopesh Patel, an analyst at UBS Securities LLC in New York, said Lipitor could drop as much as 70 percent beginning in March 2010, when generics were expected to be available.

Patent Upheld

A U.S. appeals court had upheld the patent expiring in 2010. Other litigation, pending in federal court in Wilmington, Delaware, could have kept the Lipitor copies off the market until 2016 and Caduet generics until 2018.

Ranbaxy was the first to challenge the Lipitor patents, which would give it the right to have the only approved generic version on the market for six months.

Ranbaxy Chief Executive Officer Malvinder Mohan Singh said the agreement ``provides certainty and visibility'' to his company's efforts to sell generic Lipitor. Singh said the 2010 proposal ``depended on successfully crossing the hurdles posed by Pfizer's other patents that expire in the next eight years.''

Teva Pharmaceutical Industries Ltd., the world's biggest generic-drug maker, also is challenging the Lipitor patents in a case pending in Delaware. Teva was first sued by Pfizer over Lipitor in June 2007 and, typically, patent suits in Delaware take three or more years to be completed, including appeals.

Under the settlement, Ranbaxy will be able to enter the market at set dates in seven other countries, mostly around September 2011, depending on the expirations of patents and other regulatory periods in those areas. The seven countries are Canada, Belgium, Netherlands, Germany, Sweden, Italy and Australia.

Other Countries

Ranbaxy will continue to sell generic Lipitor in Malaysia, Brunei, Peru and Vietnam. Litigation remains in Finland, Spain, Portugal, Denmark and Romania.

The agreement also settles lawsuit over the Viagra impotence drug pending in Ecuador, and one over the blood pressure medicine Accupril pending in New Jersey.

In the Accupril case, Ranbaxy and partner Teva began selling copies of the drug in December 2004 before they were ordered to stop by a court. Pfizer was seeking compensation for the lost sales. Terms of the agreement over Accupril are confidential and the patent has expired, said Pfizer spokesman Chris Loder.

The Lipitor case is Pfizer Inc. v. Ranbaxy Laboratories Ltd., 08cv164, U.S. District Court District of Delaware (Wilmington). The Caduet cases are Pfizer v. Ranbaxy, 08cv162 and 07cv138, also in Wilmington. The Accupril suit is Pfizer Inc. v. Teva Pharmaceuticals USA Inc., 05cv620, U.S. District Court in the Newark, New Jersey.

Norvasc patent ruling favors Pfizer in US court of Appeals for federal circuit

June 17, 2008. United states court of Appeals for Federal Circuit has affirmed the District court's (January 2008) decision in favour of pfizer w.r.t to Norvasc.

A federal appeals court has rejected Synthon IP's challenge of a trial court's decision that two patents Synthon asserted against Pfizer Inc. in a case over the blockbuster blood pressure drug Norvasc are unenforceable due to inequitable conduct.

The federal circuits decision can be read here.

The district court decision can be read here.

In a related case, Pfizer earlier defeated Synthon's efforts to launch a generic version of Norvasc. See Pfizer, Inc. v. Synthon Holdings BV, No. 1:05CV39 (M.D.N.C. 2006).




Earlier at drugresearcher.com it was reported as below:

Synthon originally accused Pfizer of patent infringement of manufacturing processes to produce the hypertension drug, asserting that it infringed patents issued to the company in 2003 and 2005.
The patents related to processes in the drug manufacture, as well as the production of amlodipine besylate, the active ingredient in Norvasc. However, Pfizer maintained that it had not only published the process Synthon was referring to, but had also been using it for 15 years.

The court sided with Pfizer in stating that not only did its method of producing Norvasc not infringe on Synthon's patent, but also that the Dutch firm had obtained the patent by fraudulent means by not disclosing its use of Pfizer's published materials to the US Patent and Trademark Office.

"It's very difficult to meet standards for establishing inequitable conduct," said Alan Waxman, Pfizer's general counsel.

"But in this case it is clear that Synthon improperly used Pfizer's own published material to obtain a patent that it then tried to enforce against us."

Pfizer said it intends to seek attorney's fees from Synthon, who still have the option to appeal against the ruling.

Back in September last year, the company reported that it had successfully defended the patent challenge by Synthon, in a ruling which also prohibited the generics manufacturer from launching a generic version of Norvasc until September this year when the US patent protection for the drug expires.

Norvasc is a widely prescribed mediation for the treatment of hypertension, and in 2006 brought in revenues of $4.71bn for the company. Pfizer has also taken steps to defend the franchise from generic competition by combining Norvasc with its blockbuster drug Lipitor (astorvastatin calcium) for patients with high cholesterol as well as hypertension. The product, Caduet (amlodipine besylate/astorvastatin calcium), achieved revenues of $370m for the year, up 95 per cent from $185m in 2005.

During Norvasc's development in the 1980s, Pfizer originally used amlodipine maleate in its tablet formulation, but decided to switch to amlodipine besylate due to chemical instability observed in the original formulation and the fact that it was sticking to the tabletting machinery.

This was an unprecedented move at the time, as in order to facilitate the scaling up of manufacturing operations, Pfizer had to completely abandon its maleate formulation, which had already reached Phase III clinical studies. Developing the besylate formulation would have required repeated testing to gain approval from the US Food and Drug Administration (FDA) and risked substantially delaying Norvasc's commercial launch.

In the end, however, the move paid off, and Pfizer's formulation scientists were able to produce large commercial batches of amlodipine besylate tablets by direct compression on high-speed tablet presses without disruption, which had proved difficult with the maleate salt of amlodipine.

In 2004 Norvasc held 65.7 per cent of the market for calcium blockers, with Bayer's Adalat (nifedipine) its closest rival with 12.3 per cent.

Ipca gets US FDA marketing nod for metoclopramide tabs

The Mumbai based leading pharmaceutical company Ipca Laboratories has received US FDA marketing approval for metoclopramide tablets DSP 5mg and 10mg. Ipca is marketing this product in alliance with Ranbaxy Pharmaceutical Ltd, a US subsidiary of Ranbaxy Laboratories.

The total annual market sales for metoclopramide tablets in US were US $27 millions. This is the sixth such product approval received under the alliance from US FDA.

The details can be read here.

Genzyme Files Applications for Approval of Mozobil in the United States and Europe

Genzyme Corporation announced today that it has submitted marketing applications in both the United States and the European Union for Mozobil(TM) (plerixafor), a product candidate intended to enhance mobilization of hematopoietic stem cells for collection and subsequent autologous transplantation in patients with lymphoma and multiple myeloma. The company has requested priority review of its U.S. application and, if granted, Mozobil could be approved by the end of this year. European approval is expected in 2009. Additional global applications in up to 60 countries are expected to follow.

The details can be read here.

Cipher's Revised NDA for CIP-Tramadol ER Accepted for Review by FDA

Cipher Pharmaceuticals Inc. today announced that its revised New Drug Application (NDA) for CIP-Tramadol ER, its extended-release formulation of tramadol, has been accepted for review by the U.S. Food and Drug Administration (FDA). Cipher expects the review to be completed by October 2008.

In May 2007, the Company received an approvable letter from the FDA pertaining to its original NDA for CIP-TRAMADOL ER. Cipher's revised NDA includes data from additional pharmacokinetic studies conducted by the Company comparing CIP-TRAMADOL ER to Ultram(R) ER. It is possible that the submission could trigger patent infringement litigation and a stay of up to 30 months under the Hatch-Waxman Act.

Allergan Receives U.S. FDA Approval for Trivaris (triamcinolone acetonide injectable suspension) 80 mg/mL

June 17, 2008 - Allergan, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Trivaris(TM) (triamcinolone acetonide injectable suspension) 80 mg/mL, a synthetic glucocorticoid corticosteroid with anti-inflammatory action. Delivered via intravitreal injection, the ophthalmic indications for TRIVARIS(TM) include sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. These are inflammatory conditions that can result in vision loss.

"Retinal diseases are currently the leading cause of blindness in developed countries and represent a significant unmet need in eye care," said Scott Whitcup, M.D., Allergan's Executive Vice President, Research and Development. "TRIVARIS(TM) marks the first approval for Allergan resulting from our strategic focus on the development of therapies for back-of-the-eye diseases, and we remain committed to bringing forth innovative new treatments for patients suffering from retinal diseases."

The important safety information can be read here.

Humira Subcutaneous Injection 40mg Syringe 0.8mL Now Available for the Treatment of Rheumatoid Arthritis

On June 17, 2008, Abbott Japan Co., Ltd. and Eisai Co., Ltd. announced that HUMIRA(R) subcutaneous injection 40mg Syringe 0.8mL (referred to as HUMIRA hereinafter) will be available for the treatment of rheumatoid arthritis from June 18, 2008.

HUMIRA received approval for manufacturing and distribution in Japan on April 16, 2008, and was listed in the National Health Insurance drug price list on June 13, 2008. After its launch, Abbott and Eisai will take a one-brand, one-channel and two-promotion scheme to ensure provision of information on proper use of HUMIRA. Both Abbott and Eisai will provide specialist medical representatives (MRs), and Abbott will cooperate with Eisai's hospital MRs. The two companies will conduct postmarketing surveillance in patients receiving HUMIRA during a certain period of time after launching to promote the effective and safe use of HUMIRA.

The details can be read here.

Cephalon Announces Issuance of Patent for Amrix

Cephalon, Inc. announced today that the U.S. Patent and Trademark Office has issued a pharmaceutical formulation patent for Amrix(R) (Cyclobenzaprine Hydrochloride Extended-Release Capsules). U.S. Patent No. 7,387,793 was issued to Eurand Inc., the developer of Amrix, and expires on February 26, 2025. Last year, Cephalon acquired an exclusive license from Eurand to market AMRIX in North America. The issued claims cover Eurand's proprietary Diffucaps(R) technology used to formulate AMRIX as an extended-release capsule containing the muscle relaxant cyclobenzaprine. The AMRIX formulation allows, for the first time, a full day of cyclobenzaprine in a single dose medication for the treatment of acute painful musculoskeletal conditions.

The details can be read here.

Depomed Announces Allowance of Additional U.S. Patent Covering Gabapentin GR

June 17, 2008 - Depomed, Inc. (NASDAQ:DEPO) announced today that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for U.S. patent application number 10/280,309.

Paul B. Simboli, Depomed's director of Intellectual Property, noted that the patent contains claims directed to methods for treating neuropathic pain and claims related to methods for delivering compounds via specific dosage form technologies.

The whole story can be read here.

NPS Pharmaceuticals Notified of ANDA Filings for Cinacalcet HCl

June 16, 2008 - NPS Pharmaceuticals, Inc. (NASDAQ: NPSP) today reported the receipt of Paragraph IV Certification Notice Letters related to certain drug manufacturers' Abbreviated New Drug Applications (ANDA) submitted to the U.S. Food and Drug Administration (FDA) requesting approval to market and sell generic versions of Sensipar(R) (cinacalcet HCl), a drug licensed to Amgen by NPS.

Under NPS's licensing agreement with Amgen, Amgen is responsible for all development and commercial activities involving Sensipar(R), as well as enforcing applicable patent rights, in the licensed territories and NPS is entitled to receive from Amgen royalty payments on sales of Sensipar(R), as well as certain milestones payments. In 2004 and 2007, NPS partially monetized its rights to receive payments from Amgen through the issuance of Series A and Series B notes, which are non-recourse to NPS. After repayment of this debt, Sensipar(R) royalties will return to NPS.

The details can be read here.

Glenmark Pharma to expand product portfolio in Brazil

The Mumbai-based Glenmark Pharmaceuticals Ltd is planning to expand its product portfolio in Brazil with 22 products in pipeline to be launched by next year, as the market is reporting higher growth along with a potential to serve the Latin American market as a whole.

Glenmark Pharma, one of the select Indian companies having wholly owned subsidiary Glenmark Farmaceutica Ltda (GFL) in Brazil, is currently marketing 28 of its products in therapeutic areas like derma, respiratory, gynaecology, endocrinology and oncology. The company will explore the potential of the region for strategic development in future, informed the company spokesperson.

The details can be read here.

Zydus Cadila launches venlafaxine tablets in US

The Ahmedabad leading Pharmaceutical company Zydus Cadila has announced the first day launch of venlafaxine hydrochloride tablets upon receiving the final approval from the US FDA.

The company is marketing the products in the strength of 25, 37.5, 50, 100 mg in the US market. the sales of venlafaxine hydrochloride an anti- depressant was estimated at US $194 million in 2007 as per NDC.

FDA Documents: Enbrel (etanercept) for the Treatment of Pediatric Plaque Psoriasis

June 16, 2008 - The FDA has released documents, ahead of Wednesday's meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee, regarding Amgen, Inc. drug Enbrel.

The whole document can be read here.

Court Report

About Court Report: Every week (http://patentdocs.typepad.com/) report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.

As reported by Sherri Oslick in their site i.e. patent docs, following are the details of new cases filed. More details can be obtained from http://patentdocs.typepad.com/

Sepracor Inc. et al. v. Sandoz, Inc.
4:08-cv-00089; filed June 12, 2008 in the Eastern District of North Carolina

View the complaint here.


Nycomed GmbH et al. v. Teva Pharmaceuticals USA, Inc. et al.
2:08-cv-02877; filed June 11, 2008 in the District Court of New Jersey

View the complaint here.


Takeda Pharmaceutical Co. Ltd. et al. v. Barr Pharmaceuticals Inc. et al.
1:08-cv-00339; filed June 9, 2008 in the District Court of Delaware
View the complaint here.


Ethypharm S.A. v. Barr Laboratories Inc. et al.
1:08-cv-00344; filed June 9, 2008 in the District Court of Delaware

View the complaint here.


Janssen, L.P. et al. v. Sandoz, Inc.
3:08-cv-02892; filed June 9, 2008 in the District Court of New Jersey
View the complaint here.


Cytologic, Inc., et al. v. Biopheresis Gmbh et al.
1:08-cv-00978; filed June 6, 2008 in the District Court of the District of Columbia
View the complaint here.


Medicis Pharmaceutical Corp. v. Perrigo Israel Pharmaceuticals, Ltd. et al.
1:08-cv-00539; filed June 6, 2008 in the Western District of Michigan
View the complaint here.


Eli Lilly and Company et al. v. Teva Parenteral Medicines Inc.
1:08-cv-00335; filed June 5, 2008 in the District Court of Delaware

View the complaint here.


Forest Laboratories Inc. et al. v. Apotex Inc. et al.
1:08-cv-00336; filed June 5, 2008 in the District Court of Delaware

View the complaint here.


King Pharmaceuticals, Inc. et al. v. Lupin Ltd. et al.
1:08-cv-01468; filed June 5, 2008 in the District Court of Maryland

King Pharmaceuticals, Inc. et al. v. Sandoz Inc.
3:08-cv-02802; filed June 5, 2008 in the District Court of New Jersey

View the Lupin complaint here.


Daiichi Sankyo Co., Ltd. et al. v. Matrix Laboratories, Ltd. et al.
2:08-cv-02752; filed June 3, 2008 in the District Court of New Jersey

View the complaint here.


Centocor Inc. v. Genentech Inc. et al.
2:08-cv-03573; filed May 30, 2008 in the Central District of California

View the complaint here.

Novartis Vaccines and Diagnostics S.r.l. Withdraws Its Marketing Authorisation Application for the Pre-pandemic Vaccine Aflunov

LONDON, June 16, 2008-The European Medicines Agency (EMEA) has been formally notified by Novartis Vaccines and Diagnostics S.r.l. of its decision to withdraw the application for a centralised marketing authorisation for the pre-pandemic vaccine Aflunov (A/VietNam/1194/2004 (H5N1) virus surface inactivated antigen).

Aflunov was expected to be used for active pre-pandemic immunisation against H5N1 subtype of the influenza A virus.

The details can be read here.

U.S. FDA Approves Requip XL, the First and Only Oral Once-Daily Non-Ergot Dopamine Agonist for Parkinson's Disease

June 13, 2008 -- GlaxoSmithKline today announced the approval of Requip(R) XL(TM) (ropinirole extended-release tablets) in the U.S. for the treatment of the signs and symptoms of idiopathic Parkinson's disease. Requip XL is the first and only oral once-daily non-ergot dopamine agonist indicated for Parkinson's disease. The product should be available in pharmacies in mid-July 2008.

The details can be read here.

FDA Approves Cymbalta for the Management of Fibromyalgia

The U.S. Food and Drug Administration (FDA) has approved Cymbalta(R) (duloxetine HCl) for the management of fibromyalgia, a chronic widespread pain disorder, Eli Lilly and Company announced today. Cymbalta is the first serotonin- norepinephrine reuptake inhibitor with proven efficacy for reducing pain in patients with fibromyalgia. The fibromyalgia indication represents the second FDA-approved use for Cymbalta for a pain disorder, demonstrating the medication's analgesic effect.

"The approval of Cymbalta is important because it provides physicians and patients with a new treatment option shown to help reduce pain and improve functioning in this difficult-to-treat disorder," said Madelaine Wohlreich, M.D., medical advisor and research physician at Lilly.

The cause of fibromyalgia remains unknown; however, scientists believe it may be related to some combination of changes in brain and spinal cord chemistry,(i) genetics(ii) and stress(iii). Some researchers believe fibromyalgia is a disorder of increased sensitivity to pain. Although the way Cymbalta works in people is not fully known, medical experts believe it increases the activity of two naturally occurring substances called serotonin and norepinephrine. These substances aid communication in many areas of the brain and spinal cord that affect emotion. Research also suggests that these substances are part of the body's natural pain-suppressing system.

"The FDA approval of Cymbalta for the management of fibromyalgia is another important step in the efforts to ensure that people with fibromyalgia will have the availability of effective medications to help reduce the chronic, widespread pain of this life-altering disorder," said Lynne Matallana, president of the National Fibromyalgia Association and a fibromyalgia patient.

Fibromyalgia is estimated to affect 2 percent of the U.S. population - approximately 5 million people - the majority of those diagnosed being women.(iv),(v) The disorder is characterized by chronic widespread pain and tenderness. Some patients may have additional symptoms.(i) Although there is no known cure for fibromyalgia, some physicians recommend a comprehensive care plan that can include education, medication, and lifestyle changes to help manage the symptoms of the disorder.(i)

"In fibromyalgia, there is no one-size-fits-all approach to managing the disorder," said Dan Clauw, M.D., professor of medicine in the Division of Rheumatology and director of the Chronic Pain and Fatigue Research Center at the .

The approval marks the fourth disorder that the FDA has approved for Cymbalta. In addition to fibromyalgia, Cymbalta is approved for the management of diabetic peripheral neuropathic pain (DPNP) and the treatment of major depressive disorder and generalized anxiety disorder, all in adults age 18 years and older.

Source:www.pharmalive.com

Golimumab and Actemra Will Be Two of the Most Successful Emerging Novel Agents in the Rheumatoid Arthritis Drug Treatment Market

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that Centocor/Schering-Plough/Mitsubishi Tanabe/Janssen's golimumab and Roche/Chugai's Actemra will be two of the most successful emerging novel agents in the rheumatoid arthritis drug market over the next decade in the United States, France, Germany, Italy, Spain, United Kingdom and Japan.

The whole story can be read here.

Fontus Pharmaceuticals Acquires Nephrology and Endocrinology Drug from Roche Laboratories Inc.

Fontus Pharmaceuticals, Inc., a specialty pharmaceutical company focused on nephrology and endocrinology, announced today that it has acquired ROCALTROL(R) (calcitriol) from Roche Laboratories Inc. ROCALTROL is a vitamin D analog prescribed by nephrologists for the management of hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (CRF) and by endocrinologists for the management of hypocalcemia in patients with post-surgical hypoparathyroidism, idiopathic hypoparathyroidism and pseudohypoparathyroidism.

The details can be read here.

Mylan Announces Final FDA Approval for Generic Version of Antidepressant Effexor

Mylan Inc. today announced that its subsidiary, Mylan Pharmaceuticals Inc., has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Venlafaxine Hydrochloride (HCl) Tablets 25 mg (base), 37.5 mg (base), 50 mg (base), 75 mg (base) and 100 mg (base).

Venlafaxine HCl Tablets, indicated for the treatment of major depressive disorder, are the generic version of Wyeth's Effexor(R) Tablets, which had annual U.S. sales of approximately $188 million for the 12 months ending March 31, 2008.

Mylan Announces Tentative FDA Approval for Generic Version of Antihypertensive Avalide Tablets

Mylan Inc. today announced that its subsidiary, Mylan Pharmaceuticals Inc., has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Irbesartan and Hydrochlorothiazide Tablets, 150 mg/12.5 mg and 300 mg/12.5 mg.

Irbesartan and Hydrochlorothiazide Tablets, indicated for the treatment of hypertension, are the generic version of Sanofi Aventis' Avalide(R) Tablets, which had U.S. sales of approximately $288 million for the 12 months ending March 31, 2008, according to IMS Health.

Currently, Mylan has 92 ANDAs pending FDA approval, 20 of which are potential first-to-file opportunities.

Lupin Receives USFDA Approval for Escitalopram Oxalate Tablets

Lupin Pharmaceuticals, Inc. (LPI) announced today that it has received tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Escitalopram Oxalate Tablets 10 mg and 20 mg from the U.S. Food and Drug Administration (USFDA).
Lupin's Escitalopram tablets are the AB-rated generic equivalent of Forest Laboratories' Lexapro(R) tablets, indicated for the treatment of major depressive disorder. The brand product had annual sales of approximately $2.6 billion for the twelve months ended March 2008, based on IMS Health sales data.

Commenting on the approval, Vinita Gupta, President and Managing Director of Lupin Pharmaceuticals, Inc. said, "We are pleased to receive this tentative approval and look forward to bringing Escitalopram tablets to the US market as an affordable generic alternative post patent expiry."

The product will be introduced in the market through LPI's strong network of national wholesalers and drug stores post patent expiry in March 2012. This will strengthen Lupin's presence in the Selective Serotonin Reuptake Inhibitor (SSRI) segment.

source:www.pharmalive.com

Abraxis to Appeal Jury Ruling on Elan Patent Infringement Claim

Jun 13, 2008 - Abraxis BioScience, Inc. (NASDAQ:ABII), a fully integrated, global biotechnology company, today announced that it intends to appeal the jury ruling in the U.S. District Court for the District of Delaware that Abraxis has infringed upon a patent owned by Elan. In the suit, Elan claimed that Abraxis infringed upon two of Elan's patents, 5,834,025 and 5,399,363, asserting ABRAXANE(R) (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) uses technology protected by Elan-owned patents. Elan withdrew its claim that Abraxis infringed on its 025 patent. The jury ruled that Abraxis has infringed upon Elan's 363 patent, which runs until 2011, and awarded Elan $55 million in damages for sales of Abraxane(R) to date. The company said it is disappointed by the jury ruling in this complex patent litigation and feels confident as it proceeds to appeal in this matter. Abraxis will pursue post-trial motions and appeal the judgment of the District Court.

ChemGenex acquires omacetaxine's global rights

ChemGenex Pharmaceuticals will gain full commercial control of omacetaxine mepesuccinate (formerly known as Ceflatonin) through an arrangement with its European partner Stragen Pharma to transfer the ownership of Intellectual Property (IP) and commercial rights currently held by Stragen.

Omacetaxine is ChemGenex's lead product in clinical development and is in the final stages of a phase 2/3 clinical trial in chronic myeloid leukaemia (CML) patients with the T315I mutation for whom there are currently no effective drug treatments.

The details can be read here.

Ranbaxy Rises to 3-Year High on Report Pfizer May Bid

June 13 (Bloomberg) -- Ranbaxy Laboratories Ltd., India's biggest drugmaker, rose to its highest price in more than three years after the Business Standard reported that Pfizer Inc. may try to top Daiichi Sankyo Co.'s takeover bid.

Pfizer, the world's largest drugmaker, may make a hostile bid for the 65 percent of Ranbaxy that isn't held by the founding Singh family, the Standard said today. Neither Pfizer nor Daiichi would comment. A spokesman for Ranbaxy said the agreement with Daiichi Sankyo, announced June 11, ``is sealed.''

The whole story can be read here.

Sanofi-Aventis Sues Sun Pharmaceutical

June 12 -- Sanofi-Aventis SA, France's largest drugmaker, sued Indian rival Sun Pharmaceutical Industries Ltd., alleging infringement of a U.S. patent for Uroxatral, used to treat an enlarged prostate gland.

The whole story can be read here.

Teva: The 800-pound gorilla of generics

"Analysts estimate the worldwide market for generics will increase from $75 billion to $125 billion by 2012," says Michael Shulman.

In his ChangeWave Biotech Investor he states, "The key question for us is: Who is going to make the most money from these expirations? And the 800-pound gorilla in this market is our long-time holding, Teva Pharmaceuticals.

"Teva is the largest and best generics company in the world with $9.4 billion in sales in 2007 and the gap between it and its competitors is growing. Teva has 331 products on the market, 65% more than its closest competitor.

"More importantly, based on its business model of a mix of proprietary and generic drugs, the company's operating margins are 10 points higher than competitors and that gap is widening. In fact, in the United States, the number of prescriptions filled with Teva generics is 50% more than its closest competitor.

The details can be read here.

Phase 3 study shows alogliptin reduces blood sugar

Results from five pivotal phase III studies of alogliptin were announced at the American Diabetes Association (ADA) 68th Scientific Sessions by Takeda Global Research & Development Center, Inc. Alogliptin, which has been shown to be a highly selective inhibitor of dipeptidyl peptidase-4 (DPP-4), is currently under investigation as an oral treatment for type 2 diabetes.

Alogliptin administered once daily demonstrated statistically significant reductions in haemoglobin A1c(HbA1c) versus placebo as a monotherapy and as an add-on therapy with the major classes of type 2 diabetes medications: metformin, thiazolidinediones, insulin and sulfonylureas.

The details can be read here.

Jubilant recognises Waters India as outstanding partner

Waters India has been recognized as the outstanding sourcing partner for the year 2008 by Jubilant Organosys. The company was selected from among 300 vendors in the category of machinery and equipment.

The company is engaged in providing the latest separations science, laboratory information management and mass spectrometry technology supported by high commitment by for efficient and prompt service and applications support.

Jubilant recognizes Waters as a valued partner, stated Shyam Bang, executive director of Jubilant Organosys.

As a response to receiving this 'Outstanding Partner' award, KV Venugopalan, president, Waters India, pointed out the company's mission is to strive for customer success through innovative solutions and superior service support.

Jubilant Organosys Ltd. is an integrated pharmaceutical industry player, one of the largest custom research and manufacturing services (CRAMS) and drug discovery and development services companies out of India.

Waters technology breakthroughs and laboratory solutions provide a platform for customer success. With revenue of $1.47 billion in 2007 and 5,000 employees, the company is driving scientific discovery and operational excellence for customers worldwide.