Bristol-Myers Squibb and Pfizer to file apixaban In Europe; J&J unit submits palmitate for schizophrenia

US drug majors Bristol-Myers Squibb and Pfizer are planning to submit a European application for regulatory approval of apixaban for the prevention of venous thromboembolism (VTE) after orthopedic surgery in the first half of 2010.

The filing will be supported by ADVANCE-2 and ADVANCE-3, two clinical trials that evaluated apixaban versus the European dosing regimen of enoxaparin for prevention of VTE in patients undergoing orthopedic surgery. Results of ADVANCE-2 were first presented in July 2009 at the 22nd Congress of the International Society on Thrombosis and Haemostasis in Boston. The ADVANCE-3 data will be submitted for publication and presentation in 2010.

Apixaban is a novel, oral, highly selective Factor Xa inhibitor, a new class of agents being studied for the potential to prevent and treat blood clots in the veins and arteries.
The two firms entered into a collaboration in 2007. The terms of the apixaban deal included an upfront payment of $250 million by Pfizer to B-MS, with Pfizer funding 60% of all planned development costs effective January 1, 2007 going forward, and B-MS. 40%. The latter also became eligible for additional payments of up to $750 million based on development and regulatory milestones. The companies will jointly develop the clinical and marketing strategy of apixaban, and will share commercialization expenses and profits/losses equally on a global basis.

Other companies developing or selling new blood-clotting drugs include AstraZeneca, Eli Lilly, Bayer and Johnson & Johnson, and analysts have estimated that the market for such therapies could reach a global value of $20 billion. Shares of B-MS rose nearly 1% at $25.30 each in after-hours trading after closing down 0.08% at $25.14 on Friday on the New York Stock Exchange, while Pfizer was largely unchanged.

Meantime, Janssen-Cilag, a business unit of US health care giant Johson & Johnson, has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) for paliperidone palmitate for the treatment of schizophrenia. Paliperidone palmitate, a once-monthly atypical antipsychotic injection, utilizes Ireland-headquartered Elan's Drug Technologies NanoCrystal technology. The application of the NanoCrystal technology has allowed for a ready-to-use one month duration intramuscular injectable formulation to be developed.

The US Food and Drug Administration cleared the drug earlier this year, Elan said in a statement.