Sepracor Inc. said it has entered into an agreement to acquire Oryx Pharmaceuticals Inc., an affiliate of the Arrow Group. Oryx is a specialty pharmaceutical company that in-licenses and markets branded prescription pharmaceutical products to physician specialists and hospitals within Canada and is focused in the cardiovascular, central nervous system (CNS) disorders, pain and infectious disease therapeutic areas.
The company's portfolio consists of 14 specialized products, including Niaspan, Advicor, Angiomax, Naprelan, Cubicin, Trileptal and Restoril and is projected to achieve 2008 revenues of approximately Cdn $20 million.
Under the terms of the agreement, Oryx's shareholders will receive US $50 million (approximately 2.5 times projected 2008 sales) and may become entitled to receive subsequent payments up to $20 million upon accomplishment of various regulatory milestones. The transaction is expected to close on June 1, 2008, subject to customary closing conditions.
"The acquisition of Oryx fulfills a long-standing corporate objective of developing a commercial footprint in the strategically important Canadian pharmaceutical market. Given the growth in our research and development pipeline and the planned submissions of products such as Lunesta, Brovana and eslicarbazepine for marketing approval in Canada, this acquisition should enable us to fully leverage Sepracor's current and future product opportunities in this market in addition to the Oryx portfolio," said Adrian Adams, president and chief executive officer, Sepracor. "We are also delighted to be taking on board an experienced management team and commercial infrastructure that has demonstrated excellent regulatory and product launch successes over recent times."
"I am extremely proud of the team at Oryx and all that we accomplished in the past," said Douglas Reynolds, president, Oryx Pharmaceuticals Inc. "We are very excited to become part of such a growing and dynamic company as Sepracor and to building upon what is already a strong commercial footprint within Canada."
(Source:www.pharmabiz.com)
Tuesday, May 6, 2008
Lev Pharmaceuticals Announces Cinryze Complete Response Submission Accepted for Review by FDA
May 6, 2008 - Lev Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Lev's complete response submission for Cinryze(TM) (C1 inhibitor), the Company's lead product candidate. Lev is seeking marketing approval for Cinryze(TM) for both the acute and prophylactic treatment of hereditary angioedema (HAE), also known as C1 inhibitor deficiency.
In addition, the FDA has designated Lev's complete response as a Class 2 resubmission, establishing an October 14, 2008 target action date to complete its review of the biologics license application (BLA) for Cinryze(TM). Lev submitted its complete response to FDA on April 14, 2008.
"As expected, the FDA has determined our response to be a Class 2 resubmission, and we look forward to further advancing our application through the FDA's review process," said Joshua Schein, chief executive officer of Lev.
The FDA issued a complete response letter (or "approvable" letter) on January 30, 2008 requesting information with respect to chemistry, manufacturing, and controls (CMC), as well as additional analyses of existing efficacy data from the Cinryze(TM) trials. No additional safety information and no additional clinical trials have been requested to date.
On May 2, 2008, the Blood Products Advisory Committee (BPAC) to the FDA voted unanimously that there is sufficient evidence of the safety and efficacy for the approval of Cinryze(TM) (C1 inhibitor) for the prophylactic treatment of HAE. The data from Lev's acute treatment trial was not presented before the BPAC and is currently under active review at FDA.
In addition, the FDA has designated Lev's complete response as a Class 2 resubmission, establishing an October 14, 2008 target action date to complete its review of the biologics license application (BLA) for Cinryze(TM). Lev submitted its complete response to FDA on April 14, 2008.
"As expected, the FDA has determined our response to be a Class 2 resubmission, and we look forward to further advancing our application through the FDA's review process," said Joshua Schein, chief executive officer of Lev.
The FDA issued a complete response letter (or "approvable" letter) on January 30, 2008 requesting information with respect to chemistry, manufacturing, and controls (CMC), as well as additional analyses of existing efficacy data from the Cinryze(TM) trials. No additional safety information and no additional clinical trials have been requested to date.
On May 2, 2008, the Blood Products Advisory Committee (BPAC) to the FDA voted unanimously that there is sufficient evidence of the safety and efficacy for the approval of Cinryze(TM) (C1 inhibitor) for the prophylactic treatment of HAE. The data from Lev's acute treatment trial was not presented before the BPAC and is currently under active review at FDA.
AstraZeneca Submits sNDA for Seroquel XR for the Treatment of Major Depressive Disorder
May 6, 2008-AstraZeneca today announced submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for once-daily SEROQUEL XR™ (quetiapine fumarate) Extended-Release Tablets to seek approval for the treatment of major depressive disorder (MDD) as monotherapy, adjunct therapy, and maintenance therapy in adult patients.
The details can be read here.
The details can be read here.
Breakthrough Instrument to Test Inhalable Drug Delivery Devices
May 6, 2008 - Cambridge Consultants has announced that it is developing a low-cost, portable instrument that has the potential to revolutionise the way certain drug delivery devices are tested. Through the innovative use of technology, the new device can mirror the performance and level of data provided by current laboratory laser diffraction measurement machines, for an estimated one-hundredth of the cost when integrated into a high volume device. The device measures the droplet size distribution in an airstream, a technique used in testing respiratory drug delivery devices.
The details can be read here.
The details can be read here.
New Formulation of Medication for Thalassaemia Patients
May 6, 2008--A new treatment option – Ferriprox Oral Solution - is now available to patients suffering from thalassaemia major, a rare genetic disease with only 50 percent of the patients surviving the age of 35 years1. Thalassaemia patients require blood transfusions to survive, which leads to damaging iron accumulation in the tissues, especially the heart. Ferriprox (deferiprone) is an iron chelator that effectively removes the excess iron from the body caused by blood transfusions. A liquid formulation of Ferriprox is now available in the UK, Germany, Denmark, Norway and Sweden.
The details can be read here.
The details can be read here.
EPO Announces Symbicort European COPD Use Patent Decision
May 6, 2008-AstraZeneca today announced that the European Patent Office (EPO) Technical Board of Appeal has made a final ruling that the European Combination patent covering the use of Symbicort® (formoterol and budesonide) for the treatment of chronic obstructive pulmonary disease (COPD) (EP1014993B) has been revoked, following an appeal from generic manufacturers Norton Healthcare and Generics UK.
The EPB1014993 is one of two patents covering the Symbicort® combination (formoterol and budesonide) in the use of treatment for COPD in the United Kingdom, Austria, Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Spain, Sweden, Switzerland, the Netherlands, Finland, Portugal, Liechtenstein, Luxemburg, Monaco, Cyprus, Latvia, Romania and Slovenia. The original patent expiration for this patent was 2018. The second of the two patents (EPB1210943) is currently under separate opposition.
“Symbicort is a strong brand and constitutes an important part of our growth potential for the coming years in Europe, where we have data exclusivity protection until August 2010,” said David Brennan, Chief Executive Officer of AstraZeneca.
AstraZeneca will continue to defend and enforce its remaining intellectual property rights protecting Symbicort®. This portfolio includes patents and applications for processes, formulations, delivery devices (M3 Turbuhaler) and use ‘as needed’ (Symbicort SMART®), with expiration dates up to 2019. In addition to these patents, Symbicort® retains data exclusivity until August 2010 in some European markets. On October 18, 2007 the EPO Technical Board of Appeal made a final ruling that the European Combination patent for Symbicort (EPB 0613371) was revoked.
Worldwide sales of Symbicort® reached $1.58 billion in 2007, with Europe accounting for $1.34 billion. SYMBICORT® is a trade mark of the AstraZeneca group of companies.
(Source: www.pharmalive.com)
The EPB1014993 is one of two patents covering the Symbicort® combination (formoterol and budesonide) in the use of treatment for COPD in the United Kingdom, Austria, Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Spain, Sweden, Switzerland, the Netherlands, Finland, Portugal, Liechtenstein, Luxemburg, Monaco, Cyprus, Latvia, Romania and Slovenia. The original patent expiration for this patent was 2018. The second of the two patents (EPB1210943) is currently under separate opposition.
“Symbicort is a strong brand and constitutes an important part of our growth potential for the coming years in Europe, where we have data exclusivity protection until August 2010,” said David Brennan, Chief Executive Officer of AstraZeneca.
AstraZeneca will continue to defend and enforce its remaining intellectual property rights protecting Symbicort®. This portfolio includes patents and applications for processes, formulations, delivery devices (M3 Turbuhaler) and use ‘as needed’ (Symbicort SMART®), with expiration dates up to 2019. In addition to these patents, Symbicort® retains data exclusivity until August 2010 in some European markets. On October 18, 2007 the EPO Technical Board of Appeal made a final ruling that the European Combination patent for Symbicort (EPB 0613371) was revoked.
Worldwide sales of Symbicort® reached $1.58 billion in 2007, with Europe accounting for $1.34 billion. SYMBICORT® is a trade mark of the AstraZeneca group of companies.
(Source: www.pharmalive.com)
Patent Claims Allowed Covering Samaritan's Alzheimer's Memory Recovery Drug in Australia
May 6, 2008 - Samaritan Pharmaceuticals, a biopharmaceutical company committed to commercializing new innovative therapeutic drugs, has received notification that the claims in the patent application for "Neuroprotective Spirostenol Pharmaceutical Compositions" covering Caprospinol (SP-233) have been allowed by the Australian Patent Office.
The hallmark of Alzheimer's disease is plaque formation in areas of the brain that control memory and thinking skills. Plaque can cause swelling and bumps on nerve cells, making it hard or even impossible for the cells to communicate. While the cause of Alzheimer's disease still remains unknown, a growing number of researchers are indicating that plaque formation and accumulation may play a role.
The details can be read here
The hallmark of Alzheimer's disease is plaque formation in areas of the brain that control memory and thinking skills. Plaque can cause swelling and bumps on nerve cells, making it hard or even impossible for the cells to communicate. While the cause of Alzheimer's disease still remains unknown, a growing number of researchers are indicating that plaque formation and accumulation may play a role.
The details can be read here
Valeant Pharmaceuticals Announces Temporary Stay in Efudex Case
May 5, 2008 - Valeant Pharmaceuticals (NYSE:VRX) today announced that Spear Pharmaceuticals has agreed not to market, sell or ship a generic fluorouracil cream 5% pursuant to a stay in Valeant's legal case against the Food and Drug Administration (FDA). The stay will remain in place until May 14, 2008, or until a further order of the Court is issued.
The details can be read here.
The details can be read here.
Fougera First-to-Market With Calcipotriene Topical Solution 0.005% (Rx) (Scalp Solution)
Today, Fougera, a division of Nycomed US Inc., announced it has received FDA approval to bring to market the first generic Calcipotriene Topical Solution 0.005% (Rx) (Scalp Solution). The generic formulation compares to Dovonex(R) by Warner-Chilcott.
Fougera's Calcipotriene Topical Solution is indicated for the topical treatment of chronic, moderately severe psoriasis of the scalp (see product package insert for full prescribing information). It is available in a 60 mL bottle.
"Fougera has received more FDA approvals for topical products during the past seven years than any other generic company. Today's announcement that we are first-to-market with Calcipotriene Topical Solution is another example of our ongoing commitment to provide safe, effective and affordable options to health care providers and their patients," stated David Klaum, Senior Vice President, Commercial Business Operations.
Fougera's Calcipotriene Topical Solution is indicated for the topical treatment of chronic, moderately severe psoriasis of the scalp (see product package insert for full prescribing information). It is available in a 60 mL bottle.
"Fougera has received more FDA approvals for topical products during the past seven years than any other generic company. Today's announcement that we are first-to-market with Calcipotriene Topical Solution is another example of our ongoing commitment to provide safe, effective and affordable options to health care providers and their patients," stated David Klaum, Senior Vice President, Commercial Business Operations.
Roxane Laboratories, Inc. Announces the Launch of Ropinirole Hydrochloride Tablets
Roxane Laboratories, Inc. announced today the approval of its Abbreviated New Drug Application (ANDA) for Ropinirole Hydrochloride Tablets, 0.25mg, 0.5mg, 1mg, 2mg, 3mg, 4mg, 5mg by the USFDA. The product is available in Bottles of 100 and is available for immediate shipment to wholesalers and pharmacies nationwide.
Roxane Laboratories' Ropinirole Hydrochloride Tablets are AB rated to REQUIP(R) (ropinirole hydrochloride) Tablets. Annual sales of Ropinirole Hydrochloride Tablets, 0.25mg, 0.5mg, 1mg, 2mg, 3mg, 4mg, 5mg are approximately $499 Million(1).
Roxane Laboratories' Ropinirole Hydrochloride Tablets are indicated for the treatment of moderate-to-severe primary Restless Leg Syndrome (RLS).
The most commonly reported side effects in people taking ropinirole for RLS are nausea, vomiting, dizziness, and drowsiness or sleepiness. You should be careful until you know if ropinirole affects your ability to remain alert while doing normal daily activities, and you should watch for the development of significant daytime sleepiness or episodes of falling asleep. It is possible that you could fall asleep while doing normal activities such as driving a car, doing physical tasks, or using hazardous machinery while taking ropinirole. Your chances of falling asleep while doing normal daily activities while taking ropinirole are greater if you are taking other medicines that cause drowsiness. Hallucinations (unreal sounds, visions, or sensations) have also been reported in patients taking ropinirole, however, this was uncommon in patients taking ropinirole for RLS.
This is not a complete list of side effects and should not take the place of discussions with your healthcare providers.
Roxane Laboratories' Ropinirole Hydrochloride Tablets are AB rated to REQUIP(R) (ropinirole hydrochloride) Tablets. Annual sales of Ropinirole Hydrochloride Tablets, 0.25mg, 0.5mg, 1mg, 2mg, 3mg, 4mg, 5mg are approximately $499 Million(1).
Roxane Laboratories' Ropinirole Hydrochloride Tablets are indicated for the treatment of moderate-to-severe primary Restless Leg Syndrome (RLS).
The most commonly reported side effects in people taking ropinirole for RLS are nausea, vomiting, dizziness, and drowsiness or sleepiness. You should be careful until you know if ropinirole affects your ability to remain alert while doing normal daily activities, and you should watch for the development of significant daytime sleepiness or episodes of falling asleep. It is possible that you could fall asleep while doing normal activities such as driving a car, doing physical tasks, or using hazardous machinery while taking ropinirole. Your chances of falling asleep while doing normal daily activities while taking ropinirole are greater if you are taking other medicines that cause drowsiness. Hallucinations (unreal sounds, visions, or sensations) have also been reported in patients taking ropinirole, however, this was uncommon in patients taking ropinirole for RLS.
This is not a complete list of side effects and should not take the place of discussions with your healthcare providers.
Monday, May 5, 2008
GSK Pharma signs licensing agreement with Astellas for Mycamine
GlaxoSmithKline (GSK) Pharma has announced a collaboration agreement with Japan based Astellas Pharma Inc. for exclusive rights for the latter's injectible anti-fungal agent Micafungin (brand name Mycamine) in the Indian market.
Micafungin, an original research product of Astellas was initially approved by Japanese Agency in 2002, by the US FDA in 2005 followed by other countries.
The details can be read here.
Micafungin, an original research product of Astellas was initially approved by Japanese Agency in 2002, by the US FDA in 2005 followed by other countries.
The details can be read here.
Glenmark introduces Onabet topical antifungal cream in India
Glenmark Pharmaceuticals Ltd. (GPL), one of India's leading research-led, integrated pharmaceutical companies has launched its topical antifungal cream Onabet (sertaconazole nitrate 2% cream) in the Indian market.
Onabet, a benzothiophene imidazole agent has a broad spectrum of coverage against dermatophytes, yeasts including candida, other filamentous fungi and bacteria associated with cutaneous fungal infections.
Cutaneous fungal infections like tinea (commonly known as ringworm) and candidal skin infections affect millions of people across the world. In some cases complete cure is not achieved due to increasing pathogenicity of many fungal micro-organisms and decreasing sensitivity to traditional antifungal agents. Incomplete treatment of cutaneous fungal infections may further lead to relapse thereby producing significant morbidity.
The fungicidal mechanism in Onabet reduces the chances of relapse by offering better penetration and long term residency within the skin. The substantial anti-inflammatory action further provides rapid symptomatic relief in cases of fungal infections with inflammation and pruritis. The active ingredient in Onabet, sertaconazole nitrate, has been approved by US FDA and is marketed in over 24 countries worldwide.
Glenmark Pharmaceuticals Ltd. has been rendering its services to the medical fraternity and patients of superficial fungal infections through time tested antifungal preparations like Candid and Candid B. With the launch of Onabet, Glenmark further strengthens its antifungal management armamentarium.
Onabet, a benzothiophene imidazole agent has a broad spectrum of coverage against dermatophytes, yeasts including candida, other filamentous fungi and bacteria associated with cutaneous fungal infections.
Cutaneous fungal infections like tinea (commonly known as ringworm) and candidal skin infections affect millions of people across the world. In some cases complete cure is not achieved due to increasing pathogenicity of many fungal micro-organisms and decreasing sensitivity to traditional antifungal agents. Incomplete treatment of cutaneous fungal infections may further lead to relapse thereby producing significant morbidity.
The fungicidal mechanism in Onabet reduces the chances of relapse by offering better penetration and long term residency within the skin. The substantial anti-inflammatory action further provides rapid symptomatic relief in cases of fungal infections with inflammation and pruritis. The active ingredient in Onabet, sertaconazole nitrate, has been approved by US FDA and is marketed in over 24 countries worldwide.
Glenmark Pharmaceuticals Ltd. has been rendering its services to the medical fraternity and patients of superficial fungal infections through time tested antifungal preparations like Candid and Candid B. With the launch of Onabet, Glenmark further strengthens its antifungal management armamentarium.
Suven's clinical candidate SUVN-502 secures European product patent
The Hyderabad-based Suven Life Sciences Ltd has received product patent, EP 1581492 for its clinical candidate SUVN-502 from the European Patent Office (EPO), which is valid until June 2023.
Commenting on the development Venkat Jasti, CEO of Suven Life Sciences, said, "We are very pleased by the grant of this patent for our clinical candidate SUVN-502 which is being developed for CNS disorders in the treatment of cognitive impairment associated with neuro-degenerative disorders like Alzheimer's disease (AD), Attention Deficit Hyperactivity Disorder (ADHD), memory impairment associated with aging and schizophrenia etc, the unmet medical needs".
He added that the potential market opportunity for these indications is more than $18 billion globally. Granting of this patent to our clinical candidate SUVN-502 is more timely and relevant now that the candidate is entering into clinical trials. Securing patent protection for our discoveries enhanced the value of our technologies and products substantially.
With the latest one, Suven has four European product patents and all of them have been validated in all the 37 member countries of Europe including major markets like Germany, Switzerland, Denmark, Spain, France, United Kingdom, Italy, Netherlands, Poland, Sweden and Finland. The company stated that EP 1581492 is an exclusive intellectual property (IP) of Suven and was achieved through the internal discovery research efforts.
In addition to this Suven has obtained product patents from USA (4), India (4), Australia (2), Eurasia (2), Korea (2), Mexico (2), New Zeeland (2), and Singapore (2). The granted claims of all these patents include the class of selective 5-HT compounds discovered by Suven and are being developed for the treatment of debilitating central nervous system (CNS) disorders such as Alzheimer's disease, ADHD, depression, Huntington's disease, MCI, memory impairments associated with aging, Parkinson's disease, Schizophrenia, vascular dementia and obesity.
Commenting on the development Venkat Jasti, CEO of Suven Life Sciences, said, "We are very pleased by the grant of this patent for our clinical candidate SUVN-502 which is being developed for CNS disorders in the treatment of cognitive impairment associated with neuro-degenerative disorders like Alzheimer's disease (AD), Attention Deficit Hyperactivity Disorder (ADHD), memory impairment associated with aging and schizophrenia etc, the unmet medical needs".
He added that the potential market opportunity for these indications is more than $18 billion globally. Granting of this patent to our clinical candidate SUVN-502 is more timely and relevant now that the candidate is entering into clinical trials. Securing patent protection for our discoveries enhanced the value of our technologies and products substantially.
With the latest one, Suven has four European product patents and all of them have been validated in all the 37 member countries of Europe including major markets like Germany, Switzerland, Denmark, Spain, France, United Kingdom, Italy, Netherlands, Poland, Sweden and Finland. The company stated that EP 1581492 is an exclusive intellectual property (IP) of Suven and was achieved through the internal discovery research efforts.
In addition to this Suven has obtained product patents from USA (4), India (4), Australia (2), Eurasia (2), Korea (2), Mexico (2), New Zeeland (2), and Singapore (2). The granted claims of all these patents include the class of selective 5-HT compounds discovered by Suven and are being developed for the treatment of debilitating central nervous system (CNS) disorders such as Alzheimer's disease, ADHD, depression, Huntington's disease, MCI, memory impairments associated with aging, Parkinson's disease, Schizophrenia, vascular dementia and obesity.
Canadian Regulatory Authority Has Accepted New Drug Submission for Alitretinoin for Review
Basilea Pharmaceutica Ltd. (SWX:BSLN) announces that the Therapeutic Products Directorate (TPD) of Health Canada has accepted for review the New Drug Submission of oral alitretinoin for the treatment of severe refractory chronic hand eczema.
Marketing applications for the use of alitretinoin in the treatment of severe chronic refractory hand eczema are also under regulatory review in several EU member states and in Switzerland.
(Source: www.pharmalive.com)
Marketing applications for the use of alitretinoin in the treatment of severe chronic refractory hand eczema are also under regulatory review in several EU member states and in Switzerland.
(Source: www.pharmalive.com)
European Regulatory Agency Supports Opaxio Brand Name for Cell Therapeutics' Lung Cancer Drug
Cell Therapeutics, Inc. (CTI) today announced that it received a positive opinion from the European Medicines Agency (EMEA) for the brand name Opaxio(TM) (paclitaxel poliglumex), which replaces Xyotax(TM) as the brand name.
"We are pleased the EMEA has provided a favorable review of the OPAXIO brand name, which tested well in market research. This is a key step toward commercialization as we prepare for the potential introduction of this novel biologically enhanced chemotherapeutic in Europe, to establish OPAXIO as the global brand name for paclitaxel poliglumex," noted Jim Fong, Vice President of Commercial Operations at CTI.
In April, the EMEA accepted for review CTI's Marketing Authorization Application (MAA) for OPAXIO (paclitaxel poliglumex, CT-2103) for first-line treatment of patients with non-small cell lung cancer (NSCLC) with ECOG (Eastern Cooperative Oncology Group) performance status 2 (PS2). The EMEA's review process generally takes 15 to 18 months; if the MAA is approved by the EMEA at the end of its review, CTI will be authorized to begin selling OPAXIO in the European Union.
Lung cancer remains the biggest cancer killer in Europe. The incidence of lung cancer in Europe is more than 13 percent of all cancers, and in 2000 resulted in nearly 350,000 deaths.
"We are pleased the EMEA has provided a favorable review of the OPAXIO brand name, which tested well in market research. This is a key step toward commercialization as we prepare for the potential introduction of this novel biologically enhanced chemotherapeutic in Europe, to establish OPAXIO as the global brand name for paclitaxel poliglumex," noted Jim Fong, Vice President of Commercial Operations at CTI.
In April, the EMEA accepted for review CTI's Marketing Authorization Application (MAA) for OPAXIO (paclitaxel poliglumex, CT-2103) for first-line treatment of patients with non-small cell lung cancer (NSCLC) with ECOG (Eastern Cooperative Oncology Group) performance status 2 (PS2). The EMEA's review process generally takes 15 to 18 months; if the MAA is approved by the EMEA at the end of its review, CTI will be authorized to begin selling OPAXIO in the European Union.
Lung cancer remains the biggest cancer killer in Europe. The incidence of lung cancer in Europe is more than 13 percent of all cancers, and in 2000 resulted in nearly 350,000 deaths.
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