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BMS/ Gilead's Atripla for HIV approved in EU

The EU commission grants marketing authorisation for Bristol-Myers Squibb and partner Gilead Sciences' combined HIV triple therapy pill, Atripla, the first of its kind on the market

The EU commission has granted marketing authorisation for US-based pharmaceutical company Bristol-Myers Squibbís (BMS) and partner Gilead Sciences' combined HIV triple therapy pill, Atripla (efavirenz/ emtricitabine/ tenofovir).

Atripla was developed in a joint venture between BMS and Gilead Sciences and is the first combined triple therapy combined pill of its kind for use in the treatment of HIV and AIDS. The once daily pill was designed to simplify current HIV treatment regimes, which can involve many different types of pills taken at different times of the day.

Each film-coated tablet contains 600 mg efavirenz, 200 mg emtricitabine and 245 mg tenofovir. Atripla is formally approved for marketing in the 27 member states of the EU, as well as Norway and Iceland.

The approval states that Atripla will be used in the treatment of HIV-1 infections in adults with HIV-1 RNA concentration levels of less than 50 copies/ ml on their current combination antiretroviral therapy for more than three months.

Patients must not have experienced virological failure on any prior antiretroviral therapy and must be known not to have harboured virus strains with mutations conferring significant resistance to any of the three components contained in Atripla prior to initiation of their first antiretroviral treatment regimen.

The EU marketing authorisation application for Atripla was filed by a three-way joint venture based in Ireland called Bristol-Myers Squibb Gilead Sciences And Merck Sharp & Dohme Ltd.

The FDA approved Atripla in the US in July 2006. Gilead reported sales of the drug were USD 212.4m in Q2 FY07, an increase of 12 per cent from USD 190.2m in Q1 FY07. Sales of Atripla commenced in the US in Q3 2006.

Friedman, Billings and Ramsey analysts said in April 2007 that Atripla's US patient pool would be enough to push it to near-blockbuster levels. In 2007, the drugís first full year on that market, the analysts expected sales of about USD 822m.

Avista buys BMS' medical imaging business unit for USD 525m
In other news, BMS and Avista Capital Partners have signed a definitive agreement for Avista to acquire Bristol-Myers Squibb Medical Imaging (BMS MI) for approximately USD 525m in cash.

BMS MI is a leading supplier of medical imaging products for nuclear and ultrasound cardiovascular diagnostic imaging procedures.

The transaction should complete by the end of January 2008, subject to customary regulatory approvals, at which time BMS MI will operate as an independent company under a new name.

Don Kiepert, the founder and former Chairman, CEO, and President of Point Therapeutics, will become the chief executive officer of the company upon completion of the transaction.

BMS MI will be Avista's sixth investment in the healthcare industry. On 13 December 2007, Avista agreed to acquire from Boston Scientific its Fluid Management and Venous Access businesses. Also this year, Avista made healthcare investments in BioReliance and VWR International, while in 2006 the company revealed investments in Nycomed and MedServe.

While at DLJ Merchant Banking Partners, the Avista partners were involved in numerous healthcare transactions including Accellent, Charles River Laboratories, Focus Diagnostics, KCI, NextPharma, Prometheus Labs, and Warner Chilcott.

JP Morgan Securities served as financial advisor for BMS in the BMS MI transaction, while and Cravath, Swaine & Moore LLP served as legal counsel for the company. Weil, Gotshal & Manges served as legal counsel for Avista Capital Partners.

18th December 2007

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