PHARMACY

Matrix obtains license agreement for HIV treatment

BY Allison Cerra

PITTSBURGH — A Mylan subsidiary has inked a nonexclusive license agreement with Tibotec Pharmaceuticals to manufacture, market and distribute a generic version of an HIV treatment.

Pending the regulatory approval of TMC278 (rilpivirine hydrochloride), Matrix Labs will have the right to manufacture once-daily 25-mg TMC278 as a single-agent medicine and a fixed-dose combination product, Mylan said. Matrix also will be able to market the drug in sub-Saharan Africa, certain developing countries and India.

Prior to the signing of license agreements, TMC278 was submitted for regulatory approval in the United States, Europe, Canada, Switzerland, Australia, Russia and South Korea. Upon approval, it is expected that TMC278, in combination with other antiretroviral medicinal products, will be indicated for the treatment of HIV-1 infection in treatment-naive adult patients.

"This agreement represents additional recognition for Mylan’s Matrix in the antiretroviral market, in which Matrix is a leader," Mylan president Heather Bresch said. "It also marks a significant step toward the future access of this important new product being developed by Tibotec Pharmaceuticals for patients living with HIV/AIDS. By obtaining this license at this time, we can now begin our research-and-development phase for our formulation to ensure that a generic version will be available in developing countries as quickly as possible. This was an important step in ensuring that novel ARV treatments available in more fortunate countries are accessible to patients in need all over the world."

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PHARMACY

Q4, full-year earnings up for Novartis

BY Alaric DeArment

BASEL, Switzerland — Swiss drug maker Novartis posted sales of $14.2 billion for fourth quarter 2010 and $50.6 billion for the year as a whole, according to an earnings report released Thursday.

That compared with sales of $12.9 billion and $44.3 billion during fourth quarter 2009 and 2009 as a whole, respectively. Profits for the year were nearly $10 billion, an 18% increase from $8.4 billion in 2009, though profits for the quarter decreased by 2%, from fourth quarter 2009’s $2.32 billion to $2.27 billion in fourth quarter 2010.

“Novartis achieved excellent results in 2010 as all divisions contributed to above-market growth,” Novartis CEO Joseph Jimenez said. “I am proud that Novartis continues to lead the industry in innovation, with 13 key product approvals and 16 major filings in pharmaceuticals in 2010, including our breakthrough multiple sclerosis therapy, Gilenya, which has been launched in the United States.”

Sandoz, the company’s generics arm, had sales of $8.5 billion, a 14% increase over 2009’s sales of $7.5 billion. This included strong growth in retail sales of generics and biosimilars, and the launch of a generic version of Sanofi-Aventis’ blood-thinning drug Lovenox (enoxaparin), as well as launches of generic versions of Astellas Pharma’s organ-transplant drug Prograf (tacrolimus) and Merck’s cardiovascular drug Cozaar (losartan).

In addition, the company expected to complete its $12.9 billion acquisition of eye care company Alcon this year.

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Amylin trims losses in Q4, full-year results

BY Alaric DeArment

SAN DIEGO — Amylin Pharmaceuticals continued to experience losses in sales and profits during fourth quarter 2010 and for the year as a whole, but losses were lower than in 2009, according to financial results released by the drug maker Wednesday.

The company reported revenues of $174.2 million for the quarter and $668.8 million for the year. This compared with $185.5 million in fourth quarter 2009 and $758.4 million for 2009 as a whole. This translated into $11.9 million in losses for fourth quarter 2010 and $135.5 million for 2010, compared with $44.7 million in losses for fourth quarter 2009 and $169.3 million for 2009 as a whole.

Better news came for the company’s individual products. Amylin received a $10 million milestone payment from Eli Lilly in connection with the launch in Japan of the diabetes drug Byetta (exenatide), which the two market under a collaborative agreement.

Lilly also received approval of Byetta in Canada, while a retrospective clinical study found that the drug outperformed most other treatments in patients with Type 2 diabetes. The Food and Drug Administration also approved the design of a clinical trial of Bydureon, a long-acting version of Byetta.

In addition, the company plans to complete its submission of a regulatory approval application for the biotech drug metreleptin in patients with diabetes and hypertriglyceridemia by the end of the year.

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