This morning, Pozen (POZN) initiated phase III studies on PA-325/40, a fixed-dose combination of 325mg enteric coated aspirin and 40mg of immediate release omeprazole. The phase III program will consist of two pivotal trials conducted under a Special Protocol Assessment (SPA) agreed upon with the U.S. FDA, and one long-term safety study. The two pivotal programs will enroll approximately 500 patients per study at over 100 sites around the U.S. The primary endpoint of the pivotal studies is the cumulative incidence of gastric ulcers over the six-month treatment period for PA32540 versus 325 mg of enteric-coated aspirin. The long-term study will enroll approximately 400 patients and assess safety over a period of one year. Pozen is developing PA-325/40 for use in the secondary prevention of heart attacks and strokes in patients at risk for associated gastric ulcers. Aspirin is the No. 1 recommended agent for at-risk ...

Recently, AstraZeneca plc (AZN) announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its blood clot preventer Brilinta (ticagrelor). Brilinta is an oral reversible P2Y12 adenosine diphosphate receptor antagonist for arterial thrombosis aimed to compete with the blockbuster drug Plavix which is co-developed by Bristol-Myers Squibb (BMY) and Sanofi-Aventis (SNY). On Oct 26, 2009, AstraZeneca filed for approval of the drug with the European Medicines Agency (EMEA) and is awaiting validation of the application.   AstraZeneca is seeking an FDA approval of Brilinta primarily on the basis of data from PLATO (a study of Platelet Inhibition and Patient Outcomes), a late-stage 18,624 patient trial, that showed that Brilinta was more effective than Plavix in treating patients with acute coronary syndrome (ACS) in 43 countries. Brilinta treatment resulted in a reduction of cardiovascular events (CV death, MI or ...

Bristol-Myers Squibb Co. (BMY) intends to split its 83.1% holding in the Nutritional segment which operates under its subsidiary Mead Johnson and develops infant formulas such as Enfamil and other nutritional products. The move is aimed to enable the company to concentrate on its core biopharmaceutical business. The transaction is expected to be accretive to earnings beginning in 2010.  Under the terms of the deal, Bristol-Myers shareholders can exchange some, none or all of their shares of the company for shares of Mead Johnson common stock tax-free and at a discount. On completion, the exchange offer would enable Bristol-Myers to dispose of its entire holding interest in Mead Johnson.  For every $1 of Bristol-Myers stock exchanged, stockholders will get approximately $1.11 worth of Mead shares. The offer is set to expire on Dec 14, unless extended or terminated. Bristol-Myers owns 170 million shares of Mead Johnson. ...

Bristol-Myers Squibb Co. (BMY) yesterday announced the completion of the $2.4 billion acquisition of Medarex, Inc.  Following the completion of the deal, Medarex has become a wholly-owned subsidiary of Bristol-Myers. The deal was funded by Bristol-Myers from available cash.   The merger became effective on Sept 1. Consequently, the acquired entity will not trade on the Nasdaq Stock Market from Sept 2.   As a reminder, Bristol-Myers initiated a cash tender offer to buy all outstanding shares of common stock of Medarex for $16.00 per share on July 28. The period expired on Aug 26 and the subsequent offering period ended on Aug 31. Approximately 90.7% of Medarex’s outstanding shares were tendered in favor of Bristol’s cash tender offer.   Bristol-Myers acquired the remaining outstanding shares of Medarex common stock through a “short form merger". The shares were converted into the right to receive $16.00 per share, in ...

AstraZeneca (AZN) recently said that results from a phase III head-to-head trial showed that its Brilinta (ticagrelor) achieved greater efficacy in the primary endpoint, reduction of cardiovascular events, compared to Sanofi-Aventis/Bristol-Myers’ (SNY/BMY) Plavix (clopidogrel).

Brilinta significantly reduced the mortality rate from cardiovascular events, myocardial infarctions and strokes without increasing major bleeding, which is a side-effect of Plavix. However, the frequently reported side-effects of Brilinta included slower heart rhythms and dyspnoea.

Brilinta is an investigational oral anti-platelet treatment being developed for acute coronary syndrome (ACS). Results from the 18,624 patient PLATO (A Study of Platelet Inhibition and Patient Outcomes) trial were presented at the European Society of Cardiology congress and published in the New England Journal of Medicine (NEJM).

The data on Brilinta look compelling and could help the product gain market share from Plavix once launched. Sanofi-Aventis recorded 2.6 billion Euros from Plavix sales last year,

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Yesterday, Bristol-Myers Squibb Co. (BMY) announced that its cash tender offer to purchase all outstanding shares of common stock of Medarex Inc. (MEDX) expired on Aug. 26.  The tender offer was not extended, unlike the previous instance when the offer originally scheduled to close on August 24 was extended by two days.   The cash tender offer saw 87.7% of Medarex shares outstanding, or a total of 119 million shares, being tendered. With an objective of acquiring the remaining Medarex stock, Bristol announced a subsequent offering period from yesterday until August 31, 2009, unless extended.   The Bristol management believes that the completion of the deal would be hastened if more than 90% Medarex shares are tendered. Even if the new tender offer fails to attain this goal, the deal is expected to close by year end.   In July 2009, Bristol-Myers announced that it would pay ...

Bristol Myers Squibb Co. (BMY) yesterday announced the approval of a broader label for its rheumatoid arthritis drug Orencia by the U.S. Food and Drug Administration (FDA).   The agency approved an addition to the label that supports the use of Orencia (abatacept) in patients suffering from moderate to severe rheumatoid arthritis, duration of which is less than or equal to two years. The drug that recorded global sales of $129 million in 2008 is designed to reduce symptoms of rheumatoid arthritis. However, it should not be administered along with tumor necrosis factor (TNF) antagonists and is not recommended for use in tandem with other biologic rheumatoid arthritis therapies.   As a reminder, the drug was initially approved by the FDA in late 2005 and made commercially available in the U.S. in February 2006. At that time its label indicated the usage of the drug for patients with ...

Yesterday, Bristol-Myers Squibb Co. (BMY) extended its cash tender offer to purchase all outstanding shares of Medarex Inc. (MEDX) by two days to Aug. 26. Bristol-Myers offered to buy Medarex for $16 per share, or $2.1 billion in July. However, less than 9% of Medarex's outstanding shares have been tendered till now. Last week, antitrust regulators approved the deal.

With the acquisition of Medarex, Bristol-Myers will get the UltiMAb Human Antibody Development System, which produces high affinity, human antibodies for use in a broad range of therapeutic areas, including immunology and oncology. It will also obtain Medarex’s next-generation Antibody-Drug Conjugate (ADC) technology, which is a novel and proprietary platform that could open new fields in cancer treatment.

Medarex’s has seven antibodies in clinical trials under its sole funding and is developing three other antibodies under partnership contracts. Importantly, Bristol-Myers will acquire full ownership and rights to ipilimumab,

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Bristol-Myers Squibb Co. (BMY) yesterday announced that the regulatory review period for its cash tender offer to acquire Medarex Inc. (MEDX) has expired. On July 28, 2009, Bristol-Myers had initiated an offer to buy all outstanding shares of common stock of Medarex for $16 per share. The clearance of the review, necessary under the anti-trust law, allows the $2.1 billion deal to proceed.   With the Medarex acquisition, Bristol-Myers will acquire the UltiMAb Human Antibody Development System, which produces high affinity, fully human antibodies for use in a broad range of therapeutic areas, including immunology and oncology. Bristol-Myers will also acquire Medarex’s next-generation Antibody-Drug Conjugate (ADC) technology, which is a novel and proprietary platform that could open new fields in oncology drug development.   Medarex’ pipeline includes seven antibodies in clinical trials under its sole sponsorship and three other antibodies which are being co-developed with other partners. ...

At last, the uncertainty regarding Sanofi-Aventis' (SNY) Lantus (generic name insulin glargine) seems to be over. Today, the company released a statement by a board of experts regarding the potential link of Lantus with increased cancer risk. They have come to the conclusion that all the four cases had significant methodological limitations and shortcomings, thus making the results inconclusive.

As a reminder, in the month of June, a study by the European Association for the Study of Diabetes observed that Lantus (generic name insulin glargine) increases the risk of cancer in diabetics taking the drug. The study, carried out on 127,000 patients in four European countries found that out of every 100 patients using Lantus for about 1 1/2 years, one additional person developed cancer.

But the FDA was not convinced with the study as patients were not studied long enough to substantiate the risk. Accordingly, it planned to review the

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