The Committe for Medicinal Products for Human Use recommended the approval of byetta as an add-on therapy for the treatment of type 2 diabetes

Amylin Pharmaceuticals announced that the Committee for Medicinal Products for Human use (CHMP) for the European Medicines Agency (EMA) recommended the approval of Amylin's Byetta (exenatide twice-daily) as an add-on therapy to basal insulin, with or without metformin and/or Actos (pioglitazone), for the treatment of type 2 diabetes in adults who have not achieved adequate glycemic control with these agents.

The European Commission will review the marketing application submitted for Byetta in addition to the recommendation made by the CHMP and make the decision

Par Pharmaceuticals completed acquisition of Edict Pharmaceuticals

Par Pharmaceuticals announced completion of Edict Pharmaceuticals, an Indian developer and manufacturer o f generic pharmaceuticals. Par Pharmaceutical acquired Edict for $20.5M at closing. In addition, the company also made a $4.4M repayment of certain pre-close indebtedness.

Edict Pharmaceuticals currently has 11 abbreviated New Drug Application with the US FDA.

Myland and Pfizer entered into a settlement agreement with Intelliject and Sanofi-Aventis

Mylan and Pfizer entered into a settlement agreement with Intelliject and Sanofi-Aventis in regard to Epinephrine auto-injector.  Under the terms of the agreement, Intelliject and Sanofi-Aventis may launch e-cue (epinephrine auto-injector) no earlier than Nov 15, 2012.  The launch will depend on the final approval from the US FDA in regard to the New Drug Application submitted by Intelliject for its epinephrine auto-injector that will be manufactured and marketed by Sanofi-Aventis.

Meridian (a subsidiary of Pfizer) currently manufactures the EpiPen Auto-Injector which is currently being marketed and distributed by Mylan Specialty in the US.

EpiPen Auto Injector contains epinephrine that has been approved for the emergency treatment of life-threatning allergic reactions caused by allergies, exercise or unknown triggers and for people who are at  increased risk for these reaction.  These pens can be self-administered as emergency supportive therapy only.  Patients will still need to go to emergency center for medical treatment.

Gilead's shares dived with the results of the ELECTRON study

Gilead released data for Genotype 1 Null Responder Hepatitis C patients in the ELECTRON study evaluating the company GS-7977 in combination with ribavirin for the treatment of hepatitis C.

The results showed that majority of hepatitis C genotype 1 patients with a prior null response to an interferon-containing regimen enrolled in the ongoing ELECTRON study had viral relapse within four weeks after completing the 12 weeks regimen of GS-7977 and ribavirin.  The result is quite disappointing because the effect of the treatment could not be sustained.

GSP-7977 is formerly known as

rVIIa-FP of CSL Behring received orphan drug designation

CSL Behring announced that the FDA has given orphan drug designation to the company's rVIIa-FP for the treatment and prophylaxis of bleeding episodes in patients with congenital hemophilia and inhibitors to coagulation factor VIII or IX.

The company said clinical development of rVIIa-FP will soon be initiated.  The clinical program intends to show that extended half-life rVIIa-FP will lead to fewer dose requirement while providing adequate therapeutic response in patients with hemophilia A and B with inhibitors.

The agent has also been given orphan drug designation by the European Commission in MAy 2011.

rVII-a-FP was developed using the company's albumin fusion technology to increase the the half life of the agent.

Ariad's ponatinib received patent covrering the compound until 2026

Ariad announced that the US Patent and Trademark Office has issued the US Patent No 8,114,874 titled "Substituted Acetylenic Imidazol [1,2-B] Pyridazine Compounds as Kinase Inhibitors" covering the company's ponatinib.  The patent is expected to last until December 22, 2026.  O

Ponatinib is an investigational pan-BCR-ABL inhibitor that was discovered by scientists at Ariad.  BCR-ABL is abnormal tyrosine kinase that is often expressed in patients with chronic myeloid leukemia and Philadelphia chromosomve positive acute lymphoblastic

Merck established joint venture with Supera Farma

Merck announced that it has established a joint venture with Supera Farma in Brazil to market and distribute and sell a portfolio of innovative pharmaceutical and branded generic products from Merck, Cristalia and Eurofarma solely in the retail sector.

Supera Farma Laboratorios is co-owned by Cristalia and Eurofarma.

The move will allow Merck to gain additional local expertise, and expanded portfolio of products as well as a strong distribution network to increase wider access to medicines for Brazilian.  The joint venture will have its own dedicated sales force separated from the three parent companies. However, the joint venture will utilize the parent companies' infrastructure for activities such as sales force training.

Merck will own approximately 51% of the joint venture while Cristalia and Eurofarma will have 49% of the share.

BioSante announced approval of Bio-T-Gel in the US

So the company finally wrote a press release in regard to the approval of the company's Bio-T-Gel for the treatment of male hypogonadism or low testosterone levels.

After numerous recent setbacks, the company finally has some good news going on.

Bio-T-Gel was developed originally by BioSante who later licensed the compound to Teva for late stage clinical development.

BioSante in return will receive royalties as well as certain milestone payments upon commercialization of Bio-T-Gel.

Tevas released full year financial results

Yesterday was Watson's day...today it's Teva!

Teva Pharmaceutical released its fourth quarter and full year financial earnings ending on December 31, 2011 today.

With strong earnings, the company's stock was up by 4% since market opens. Teva is being traded in the NASDAQ as TEVA

The company recorded a net revenue of $5.7B in its fourth quarter which was an increase of $1.3B compared to the same quarter of last year. The company

Mylan intends to change Dey Pharma to Mylan Specialty

Mylan announced that it plans to change Dey Pharma to Mylan Specialty.

The company's CEO said "the name change to Mylan Specialty is an important milestone and a natural steep in our company's evolution."  Mylan Specialty President said the name change provides the company opportunity to "fully maximized the power of Mylan brand, its reputation

CPP-115 received orphan drug designation in the EU

Catalyst Pharmaceuticals Partners announced that the European Commission has granted the company's CPP-115, a novel GABA aminotransferase inhibitor, an orphan drug designation for the treatment of West Syndrome (infantile spasms).  Previously, the European Medicines Agency Committee on Orphan Medicinal Products has recommended the orphan drug designation

Zioptan has been approved and will be available in the US in March

The FDA announced that it has approved Zioptan (tafluprost ophthalmic solution) to be used in the reduction of elevated eye pressure in patients with open angle glaucoma. The medication has already been appoved for the management of higher-than-normal eye pressure.

The approval was based on the efficacy and safety results from five controlled clinical studies evaluating the agent in approximately 905 patients. The agent was tested in preservative-free formulations and preservative-containing formulations.  The results in the studies showed that

Watson released its positive fourth quarter earnings

Watson released its fourth quarter and full year financial results with positive earnings.

The company had a net revenue of 1.5B in the fourth quarter ending on December 31, 2011 which was an increase from $952.7M from the same quarter of last year.  The company net income from the fourth quarter of 2011 was $225M which was an increase of 93% from the same quarter of last year.

The the full year, the net revenue was $4.6B which was an increase from $3.6B from the full year of 2010. The full year net income has also increased to $603.8M from $425.4M from last year.


As of December 31, 2011, the company had $6.698B in total assets and approximately 3.1B in total liabilities

Watson has also provided additional estimate for 2012:

• Total global generics segment revenue will be between 3.9B and 4.1B
• Total global brands segment revenue will be between $500 and $525M
• Total ANDA distribution segment revenue will be between $85M and $900M
• Adjusted non-GAAP earnings for 2012 will be between $5.5 and $5.8 per diluted share
• Adjusted EBITDA for 2012 will be between $1.3 and 1.375B

With strong earnings, the company's stock has increased approximately 3.52% today.

Sunesis received notice of allowance covering vosaroxin from the US Patent and Trademark Office

Sunesis announced that the US Patent and Trademark Office has issued a notice of allowance for US Patent Application No. 12/982,785 claiming certain compositions related to the company's vosaroxin.  Sunesis will have exclusive rights to certain Active Pharmaceutical Ingredient compositions of vosaroxin as well as the final products that are related to the compositions.  The patent's exclusivity is expected to last until Mid 203 in the US.

Vosaroxin is currently being studied in the pivotal trial in patients with first relapsed or refractory acute myeloid leukemia. The trial is a multinational, randomized, double-blind, placebo-controlled trial evaluating vosaroxin in combination with cytarabine in 14 countries including the US, Canada, Europe, Australia and New Zealand. More information about the Valor trial can be found at : www.valortrial.com

Vosaroxin is an anti-cancer quinolone derivative. It intercalates DNA and inhibits topoisomerase II. As a result, it will lead to  replication-dependent, site-selective DNA damage, G2 arrest and apoptosis.

Valeant acquired Eyetech

So it doesn't matter if the ISTA deal doesn't work out, Valeant has agreed to acquire Eyetech, a privately-owned ophthalmic biotechnology company dedicated to the treatment of sight-threatening disease of the retina.  Eyetech currently has one product in the market which is Macugen (pegaptanib sodium injection) for the treatment of neovascular age-related macular degeneration.  Macugen is a selective VEGF-165 inhibitor and can be administered once every six-week by intravitreal injection.

Eyetech markets and sells Macugen in the US while Pfizer markets and sells Macugen outside of the US.

Columbia lab transferred its new drug application to Watson

Columbia Lab announced that it has transferred the new drug application for progesterone vaginal gel 8% seeking approval for its use to reduce risk of preterm birth in women with a singleton gestation and a short uterine cervical length in the mid-trimester of pregnancy to Watson.

Watson said it will work with the FDA to support the review of the NDA.  The expected decision data has been set to be on Feb 26, 2012.