Zacks_Analysts's Blog Posts on People And Picks

Positive Results on Forest/Gedeon Drug - Analyst Blog

Thu, 09 Feb 2012 18:33:00

Forest Laboratories, Inc. (FRX) and partner Gedeon Richter recently presented positive top-line results on their antipsychotic candidate, cariprazine (RGH-188). Preliminary top-line results were presented from a phase III study that was conducted in patients with acute mania associated with bipolar I disorder.
Results from the five-week multi-center, double-blind, placebo-controlled, parallel-group study showed that patients in the cariprazine arm experienced significant symptom improvement compared to patients in the placebo arm. The improvement was observed as early as the fifth day of treatment and at each subsequent time point studied.
Cariprazine, a novel, orally active D2/D3 antagonist, was generally well tolerated. However, discontinuations due to adverse events were higher in the cariprazine arms compared to placebo. Forest Labs intends to analyze the data further. Results from this study were similar to those reported by the company from two other studies conducted with cariprazine.
Cariprazine is being studied for other indications as well, including schizophrenia, bipolar depression, and as an adjunct treatment in major depressive disorder (MDD). Forest Labs plans to file for approval of cariprazine in the second half of 2012.
Cariprazine became a part of Forest Labs' pipeline with its 2004 collaboration and licensing agreement with Gedeon Richter. Forest Labs gained development and exclusive US rights to cariprazine and related compounds. Other players in the antipsychotic market include Bristol-Myers Squibb (BMY) and Eli Lilly (LLY) among others.
We are pleased to see Forest Labs' progress with its pipeline. The pipeline needs to deliver given the patent cliff being faced by the company. ...

Bristol-Myers, SNY Win Plavix Damages - Analyst Blog

Thu, 09 Feb 2012 18:20:00

Apotex recently settled its dispute regarding the blockbuster blood thinner Plavix with Bristol-Myers Squibb Company (BMY) and partner Sanofi (SNY). The patent related dispute, which started in 2002, was resolved after Apotex paid Bristol-Myers and Sanofi approximately $444.2 million as damages.
Apotex parted with the amount following the decision of an US appeals court in October 2011 which upheld the intellectual property rights related to Plavix. Apotex made further payments to the tune of $1.26 million (post-judgment interest) and $0.9 million (legal cost). The payments by Apotex were welcomed by both Bristol-Myers and Sanofi as the at-risk launch of a generic version of Plavix by Apotex in 2006 resulted in significant loss of revenues.
Plavix is scheduled to go off patent in the US within a few months (May 17, 2012). The US genericization of Plavix, which contributed $7.1 billion to Bristol-Myers’ total revenue in 2011, is expected to substantially hit 2012 earnings and revenues. Management expects 2012 revenue to decline from 2011 levels. Bristol-Myers expects to generate just $2.7 billion in sales from Plavix in 2012.
Bristol-Myers is trying to combat the threat of genericization hanging over many of its key drugs by inking deals and acquisitions and introducing new products. Many new products were launched/ approved in 2011.
Key product approvals at Bristol-Myers in 2011 include EU approval of Eliquis (apixaban) for preventing venous thromboembolic events in adults who have undergone elective hip or knee replacement surgery; US approval of Erbitux in combination with platinum-based chemotherapy and 5-fluorouracil as a first-line therapy in patients suffering from recurrent locoregional or metastatic head and ...

Update on VPHM's Industrial Facility - Analyst Blog

Thu, 09 Feb 2012 18:06:00

ViroPharma Inc. (VPHM) recently announced that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Cinryze’s industrial scale manufacturing facility.
The regulatory body made three comments related to a portion of the cleaning validation for industrial scale manufacturing, of which only one requires additional unplanned activity. ViroPharma does not expect this activity to take much time to complete.
The FDA also said that it has not finished reviewing the company’s January 2012 updated responses to observations specific to the September 2011 inspection of the Amsterdam facility.
We note that ViroPharma undertook an expansion of the production capacity for Cinryze in 2009. In early 2010, the company submitted the Cinryze industrial scale manufacturing Prior Approval Supplement (PAS) to the FDA. In October 2010, the regulatory body issued a CRL, asking for additional information on observations from the pre-approval inspection and review of the technical processes. In October 2011, ViroPharma submitted its response to the CRL.
The company expects the regulatory approval of the facility to increase its supply by 100,000 - 120,000 doses, for up to 160,000 doses annually, or $640 million worth of product. We believe that successfully building an industrial-scale facility is an important catalyst for ViroPharma shares, as future growth of Cinryze sales rely on added production capacity.
Cinryze is one of the leading products at ViroPharma. The company markets the drug worldwide in the intravenous form as a treatment for routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema (...