July 11, 2008-- Momenta Pharmaceuticals, Inc. (Nasdaq: MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Abbreviated New Drug Application (ANDA) for a generic version of Copaxone (glatiramer acetate injection), submitted by Sandoz Inc., Momenta’s development and commercialization partner for this product.
The details can be read here.
Friday, July 11, 2008
Akorn-Strides, LLC Announces the First Commercial Product Launch for the Joint Venture, Rifampin for Injection
Jul 11, 2008 - Akorn-Strides, LLC today announced the first commercial product launch for the Joint Venture, Rifampin for Injection USP, 600 mg/vial. Rifampin is used in the treatment of all forms of tuberculosis in conjunction with Isoniazid and Ethambutol.
To date, the company has filed for 18 ANDAs and received nine ANDA approvals. Five additional products are under development and expected to be filed in the next 12 months. The Joint Venture expects to generate immediate revenue from this product launch and from several other new product launches in the second half of 2008. The approximate annual IMS market value of the nine approved products is $192 million.
The details can be read here.
To date, the company has filed for 18 ANDAs and received nine ANDA approvals. Five additional products are under development and expected to be filed in the next 12 months. The Joint Venture expects to generate immediate revenue from this product launch and from several other new product launches in the second half of 2008. The approximate annual IMS market value of the nine approved products is $192 million.
The details can be read here.
Thursday, July 10, 2008
Panacea gets WHO prequalification for pentavalent vaccine
Panacea Biotec, a leading vaccine manufacturing company, has received WHO prequalification for its fully liquid innovative combination pentavalent vaccine, EasyFive against five deadly infectious diseases (DTwP + Hep B+ Hib) of early childhood. This feat comes close on heels of Panacea Biotec's pre-qualification by WHO for two other combination vaccines, EasyFour (DTP + Hib) and Ecovac (DTP + Hep B) in January this year.
In a notification, WHO has advised the UN procuring agencies regarding the acceptability of these vaccines worldwide. Panacea Biotec is already a pre-qualified supplier of OPV and hepatitis-B vaccines to UN agendas, a company press release said.
This makes Panacea Biotec as the first Indian company & one of three companies in the world to have been pre-qualified by WHO for a pentavalent vaccine. Pentavalent vaccines are used by UN agencies (UNICEF, PAHO etc.) to vaccinate & save precious lives of millions of children in the developing world.
Panacea Biotec has been playing an important role in immunization through its novel and innovative, world's first fully liquid vaccine with brands such as, 'Easy Four' & 'Easy Five', for over 3 years. It has partnered with WHO & UNICEF' with a mission of supporting the cause of maximising coverage of vaccines under the Expanded Program on Immunization (EPI) for more than a decade.
Developing countries would need a combination vaccine to the tune of around 300 Mb doses annually. The combined demand of all combination paediatric vaccines worldwide was valued at USD 600 million in 2005 and estimated to grow up to USD 1.6 billion by 2012. Pentavalent vaccine market is estimated to cross a mark of $1 billion out of which UN agencies arc likely to procure this vaccine worth more than Rs 1,500 crore (>$ 350Mio), by 2009 itself The WHO prequalification fox Easy Five makes Panacea Biotec a strong contender in this important market segment.
"India is responding to globalization faster than people think. Encouraging innovation from India to develop vaccines for the developing countries is good for the world and will help to reduce the overall costs of healthcare, a cause dose to our heart", said Rajesh Jain speaking on the occasion.
Panacea Biotec inaugurated its ultra modern, green field construction, vaccine production plant at Baddi, HP., with over Rs.100 crore (approx. USD 25 million) investment in September 2007, having capacity of more than I billion doses per annum, to cater to domestic and global.
In a notification, WHO has advised the UN procuring agencies regarding the acceptability of these vaccines worldwide. Panacea Biotec is already a pre-qualified supplier of OPV and hepatitis-B vaccines to UN agendas, a company press release said.
This makes Panacea Biotec as the first Indian company & one of three companies in the world to have been pre-qualified by WHO for a pentavalent vaccine. Pentavalent vaccines are used by UN agencies (UNICEF, PAHO etc.) to vaccinate & save precious lives of millions of children in the developing world.
Panacea Biotec has been playing an important role in immunization through its novel and innovative, world's first fully liquid vaccine with brands such as, 'Easy Four' & 'Easy Five', for over 3 years. It has partnered with WHO & UNICEF' with a mission of supporting the cause of maximising coverage of vaccines under the Expanded Program on Immunization (EPI) for more than a decade.
Developing countries would need a combination vaccine to the tune of around 300 Mb doses annually. The combined demand of all combination paediatric vaccines worldwide was valued at USD 600 million in 2005 and estimated to grow up to USD 1.6 billion by 2012. Pentavalent vaccine market is estimated to cross a mark of $1 billion out of which UN agencies arc likely to procure this vaccine worth more than Rs 1,500 crore (>$ 350Mio), by 2009 itself The WHO prequalification fox Easy Five makes Panacea Biotec a strong contender in this important market segment.
"India is responding to globalization faster than people think. Encouraging innovation from India to develop vaccines for the developing countries is good for the world and will help to reduce the overall costs of healthcare, a cause dose to our heart", said Rajesh Jain speaking on the occasion.
Panacea Biotec inaugurated its ultra modern, green field construction, vaccine production plant at Baddi, HP., with over Rs.100 crore (approx. USD 25 million) investment in September 2007, having capacity of more than I billion doses per annum, to cater to domestic and global.
Patent Granted for ProBioGen's Avian Cell Line AGE1.CR
July 10, 2008 - ProBioGen AG, a leading biotechnology company in cell engineering and production of biopharmaceuticals, has been granted patent protection for AGE1.CR, a proprietary duck cell line developed for the production of human and animal vaccines and proteins.
The granted patent as parent, ProBioGen also claims the use of a duck cell line that is infected with Modified Vaccinia Ankara (MVA) and that replicates MVA.
The details can be read here.
The granted patent as parent, ProBioGen also claims the use of a duck cell line that is infected with Modified Vaccinia Ankara (MVA) and that replicates MVA.
The details can be read here.
Angiotech Wins Before the UK House of Lords
Angiotech Pharmaceuticals, Inc. , a global specialty pharmaceutical and medical device company, announced that yesterday, the highest court of the United Kingdom, the House of Lords, confirmed in a precedent-setting decision the validity of one of Angiotech's patents related to its paclitaxel stent inventions. As Lord Neuberger of Abbotsbury, commented, "The decision represents a significant development in the United Kingdom patent law".
"We are pleased that the House of Lords entered final judgment in Angiotech's favor and view this outcome as further proof of the continued strength of our paclitaxel stent patent portfolio throughout the world," said Dr. Bill Hunter, President and CEO of Angiotech. "We remain committed to vigorously protecting our proprietary technologies and defending our intellectual property, and reaching supportive conclusion on this decision reaffirms this commitment," added Dr. Hunter.
The patent at issue was granted to Angiotech Pharmaceuticals Inc. by the European Patent Office (the "EPO") on June 25, 1997. At the EPO, five different companies opposed the patent. After over nine years of legal battles their challenge proved unsuccessful and the validity of the patent was maintained. On February 1, 2005, Angiotech commenced suit against Conor Medsystems Inc. ("Conor") in the Netherlands. Conor responded by commencing proceedings in the UK to revoke the patent. Conor argued that, as of July 1993 (the priority date), the claims in the patent lacked inventive step (i.e., were obvious) under UK law.
Both the UK trial court and the UK Court of Appeal decided that the patent was invalid in view of several publications. Within the same time frame several courts in the Netherlands, following the approach of the EPO and concluded that Angiotech's claimed invention was inventive and not obvious in view of the same publications. Angiotech appealed the UK lower court decisions to the House of Lords seeking to resolve these inconsistent outcomes.
In his lead opinion upholding the validity of Angiotech's patent, Lord Hoffmann did not agree with the reasoning that the UK lower courts used in justifying revocation and instead agreed with the opinion of the Dutch Court. The House of Lords' unanimous decision reflects an important development in bringing uniformity to the interpretation of the European Patent Convention among the national courts of Europe and the European Patent Office.
The whole Judgement can be read here.
"We are pleased that the House of Lords entered final judgment in Angiotech's favor and view this outcome as further proof of the continued strength of our paclitaxel stent patent portfolio throughout the world," said Dr. Bill Hunter, President and CEO of Angiotech. "We remain committed to vigorously protecting our proprietary technologies and defending our intellectual property, and reaching supportive conclusion on this decision reaffirms this commitment," added Dr. Hunter.
The patent at issue was granted to Angiotech Pharmaceuticals Inc. by the European Patent Office (the "EPO") on June 25, 1997. At the EPO, five different companies opposed the patent. After over nine years of legal battles their challenge proved unsuccessful and the validity of the patent was maintained. On February 1, 2005, Angiotech commenced suit against Conor Medsystems Inc. ("Conor") in the Netherlands. Conor responded by commencing proceedings in the UK to revoke the patent. Conor argued that, as of July 1993 (the priority date), the claims in the patent lacked inventive step (i.e., were obvious) under UK law.
Both the UK trial court and the UK Court of Appeal decided that the patent was invalid in view of several publications. Within the same time frame several courts in the Netherlands, following the approach of the EPO and concluded that Angiotech's claimed invention was inventive and not obvious in view of the same publications. Angiotech appealed the UK lower court decisions to the House of Lords seeking to resolve these inconsistent outcomes.
In his lead opinion upholding the validity of Angiotech's patent, Lord Hoffmann did not agree with the reasoning that the UK lower courts used in justifying revocation and instead agreed with the opinion of the Dutch Court. The House of Lords' unanimous decision reflects an important development in bringing uniformity to the interpretation of the European Patent Convention among the national courts of Europe and the European Patent Office.
The whole Judgement can be read here.
Actavis generic prostate cancer drug Bicalutamide first to market in UK, Germany, France
Actavis Group, the international generic pharmaceuticals company, today announced the launch of Bicalutamide tablets in the United Kingdom, Germany and France. Bicalutamide Actavis is the first generic version of the oncology drug to be made available in the three markets.
The details can be read here.
The details can be read here.
Wednesday, July 9, 2008
Pfizer Forgoes Fees To Close Accupril Suit
A Pfizer Inc. subsidiary has ended its decade-old dispute with Teva Pharmaceuticals USA Inc. over the hypertension drug Accupril by dropping attorneys' fees and willful infringement claims in exchange for Teva dropping its appeal of a finding that the generics maker infringed Pfizer's patent.
The details can be read here.
The details can be read here.
Apotex's Acular LS ANDA infringes Roche's '493 Patent- Fed. Circuit
A federal appeals court has affirmed a ruling that Apotex’s application for a generic version of the anti-inflammatory eye treatment Acular infringed a patent (US5110493) held by Roche Palo Alto LLC and licensed to Allergan LLC, finding the Canadian drugmaker had failed to prove that the reverse doctrine of equivalents was applicable in the case.
The whole Judgement (2008) can be read here.
Roche’s patent covers drug formulations for treating eye inflammation and covers products sold as ACULAR and ACULAR LS. The two formulations differ in their proportion of various drugs such as an ammonium preservative and a surfactant.
Hoping to sell generic versions, Apotex filed two ANDAs with the FDA – one for each formulation. In response, Roche filed two separate infringement actions against Apotex (the ACULAR and ACULAR LS cases respectively). In 2007 the CAFC put a final nail in the ACULAR case by affirming the district court’s holding that the patent was not invalid and not unenforceable (infringement had already been decided). This appeal involves ACULAR LS.
The whole story about this case in detail can be read here.
The whole Judgement (2008) can be read here.
Roche’s patent covers drug formulations for treating eye inflammation and covers products sold as ACULAR and ACULAR LS. The two formulations differ in their proportion of various drugs such as an ammonium preservative and a surfactant.
Hoping to sell generic versions, Apotex filed two ANDAs with the FDA – one for each formulation. In response, Roche filed two separate infringement actions against Apotex (the ACULAR and ACULAR LS cases respectively). In 2007 the CAFC put a final nail in the ACULAR case by affirming the district court’s holding that the patent was not invalid and not unenforceable (infringement had already been decided). This appeal involves ACULAR LS.
The whole story about this case in detail can be read here.
Teva's glatiramer acetate 40mg fails in phase 3 trial
Teva Pharmaceutical Industries Ltd. announced top-line results from a phase III study designed to assess the efficacy, safety and tolerability of glatiramer acetate (GA) 40mg as compared to the approved Copaxone 20mg in the treatment of relapsing-remitting multiple sclerosis (RRMS). The 40mg dose did not demonstrate increased efficacy in reducing the relapse rate; however, the higher dose maintained the favourable safety and tolerability profile of Copaxone 20mg.
The details can be read here.
The details can be read here.
FDA Revises Process for Responding to Drug Applications
July 9, 2008-The U.S. Food and Drug Administration today announced that it is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted.
Under new regulations that govern the drug approval process, FDA's Center for Drug Evaluation and Research (CDER) will no longer issue "approvable" or "not approvable" letters when a drug application is not approved. Instead, CDER will issue a "complete response" letter at the end of the review period to let a drug company know of the agency's decision on the application.
"These new regulations will help the FDA adopt a more consistent and neutral way of conveying information to a company when we cannot approve a drug application in its present form," said Janet Woodcock, M.D., director of the agency's Center for Drug Evaluation and Research (CDER). "Thorough and timely review of drug applications is a priority of the FDA, and these new processes will make our communications with sponsors of applications more consistent."
Taking the place of "approvable" and "not approvable" letters, a "complete response" letter will be issued to let a company know that the review period for a drug is complete and that the application is not yet ready for approval. The letter will describe specific deficiencies and, when possible, will outline recommended actions the applicant might take to get the application ready for approval.
Currently, when assessing new drug applications, the FDA can respond to a sponsor in one of three types of letters: an "approval" letter, meaning the drug has met agency standards for safety and efficacy and the drug can be marketed for sale in the United States; an "approvable" letter, which generally indicates that the drug can probably be approved at a later date provided that the applicant provides certain additional information or makes specified changes (such as to labeling); or a "not approvable" letter, meaning the application has deficiencies generally requiring the submission of substantial additional data before the application can be approved.
"Complete response" letters are already used to respond to companies that submit biologic license applications. The process for drugs and biologics will be consistent under the new regulations.
The revision should not affect the overall time it takes the FDA to review new or generic drug applications or biologic license applications. These changes, which will become effective on Aug. 11, 2008, are not expected to directly affect consumers.
In July 2004, the FDA issued a proposed rule on these topics. At that time the agency asked for comments on the proposal. Today's final rule addresses comments submitted to the agency.
For more information, see:
Link to the Complete Response Final Rulehttp://www.fda.gov/cder/regulatory/complete_response_FR/default.htm
Link to the drug approval process pagehttp://www.fda.gov/fdac/special/testtubetopatient/default.htm
Under new regulations that govern the drug approval process, FDA's Center for Drug Evaluation and Research (CDER) will no longer issue "approvable" or "not approvable" letters when a drug application is not approved. Instead, CDER will issue a "complete response" letter at the end of the review period to let a drug company know of the agency's decision on the application.
"These new regulations will help the FDA adopt a more consistent and neutral way of conveying information to a company when we cannot approve a drug application in its present form," said Janet Woodcock, M.D., director of the agency's Center for Drug Evaluation and Research (CDER). "Thorough and timely review of drug applications is a priority of the FDA, and these new processes will make our communications with sponsors of applications more consistent."
Taking the place of "approvable" and "not approvable" letters, a "complete response" letter will be issued to let a company know that the review period for a drug is complete and that the application is not yet ready for approval. The letter will describe specific deficiencies and, when possible, will outline recommended actions the applicant might take to get the application ready for approval.
Currently, when assessing new drug applications, the FDA can respond to a sponsor in one of three types of letters: an "approval" letter, meaning the drug has met agency standards for safety and efficacy and the drug can be marketed for sale in the United States; an "approvable" letter, which generally indicates that the drug can probably be approved at a later date provided that the applicant provides certain additional information or makes specified changes (such as to labeling); or a "not approvable" letter, meaning the application has deficiencies generally requiring the submission of substantial additional data before the application can be approved.
"Complete response" letters are already used to respond to companies that submit biologic license applications. The process for drugs and biologics will be consistent under the new regulations.
The revision should not affect the overall time it takes the FDA to review new or generic drug applications or biologic license applications. These changes, which will become effective on Aug. 11, 2008, are not expected to directly affect consumers.
In July 2004, the FDA issued a proposed rule on these topics. At that time the agency asked for comments on the proposal. Today's final rule addresses comments submitted to the agency.
For more information, see:
Link to the Complete Response Final Rulehttp://www.fda.gov/cder/regulatory/complete_response_FR/default.htm
Link to the drug approval process pagehttp://www.fda.gov/fdac/special/testtubetopatient/default.htm
Mundipharma Submits New Analgesic Targin for European Approval
July 9, 2008-Mundipharma announced today that Targin, an oral prolonged-release oxycodone / naloxone combination tablet, has been submitted for regulatory approval in Europe.
Targin(r) is a combination of a strong opioid receptor agonist, oxycodone, and a locally acting opioid receptor antagonist, naloxone. The oxycodone provides the analgesic effect, while the naloxone, exerting its effect only in the gut (before being eliminated by the liver), prevents the onset of opioid induced constipation (OIC) through blockade of the opioid receptors found in the gut.
The details can be read here.
Targin(r) is a combination of a strong opioid receptor agonist, oxycodone, and a locally acting opioid receptor antagonist, naloxone. The oxycodone provides the analgesic effect, while the naloxone, exerting its effect only in the gut (before being eliminated by the liver), prevents the onset of opioid induced constipation (OIC) through blockade of the opioid receptors found in the gut.
The details can be read here.
European Commission Announces Marketing Authorisation for 50mg Once Weekly Enbrel for Patients With Moderate-to-Severe Psoriasis
The European Commission announced today a new 50 mg Enbrel(R) (etanercept) once weekly dosage regimen as an alternative to the currently approved 25 mg Enbrel(R) twice weekly regimen for the treatment of patients with moderate-to-severe plaque psoriasis. Based on the outcome of the extensive European 318 study in adult patients with moderate-to-severe plaque psoriasis, the European Commission issued the marketing authorisation for the European Union for a once weekly 50mg Enbrel(R) dosing.
The details can be read here.
The details can be read here.
Aloxi (palonosetron HCL) Injection Available for Prevention of Postoperative Nausea and Vomiting
Eisai Co., Ltd. and its U.S. subsidiary Eisai Inc. (Headquarters: New Jersey, United States, Chairman & CEO: Hajime Shimizu) and its partner Helsinn Healthcare SA (Headquarters: Switzerland, CEO: Riccardo Braglia) announced the availability of ALOXI® (palonosetron hydrochloride) injection 0.075 mg for the prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. The introduction of ALOXI for PONV represents the first launch with an additional indication of an MGI PHARMA, INC. product since Eisai acquired the organization in January 2008.
The details can be read here
The details can be read here
Par Pharmaceutical to Launch meclizine HCL Tablets
Par Pharmaceutical Companies, Inc. today announced that it will commence shipment of 12.5mg and 25mg meclizine HCl tablets immediately. At this time, Par believes it is the exclusive supplier of the AB-rated generic product.
The details can be read here.
The details can be read here.
Panacea Biotec receives US Patent for ‘Thank God’ TM
Panacea Biotec, India’s leading research based Health Management Company involved in research, manufacturing and marketing of branded pharmaceutical formulations, vaccines and natural products has been granted a patent from US Patent & Trademark Office for their product Thank GodTM (Euphorbia Prostrata) for effective management of hemorrhoids & piles (Patent No. 7,371,412 B2). With this, the company is looking forward to launch this product in high potential markets of US and EU. As per current industry trends, the total potential of anti-hemorrhoids & piles market in US & EU is between USD 500-600 million.
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