News (Updated December 4, 2011)

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UPDATE 2-Mylan's HIV/AIDS therapy gets tentative nod

Thu, Dec 1 2011

* Drug combination can be used as second-line treatment option

* Eligible to purchase in certain developing countries

* Shares hit one-month high

Dec 1 (Reuters) - Generic drugmaker Mylan Inc said U.S. health regulators gave a tentative approval to its drug combination to prevent HIV/AIDS.

The combination of the drugs Atazanavir Sulfate and Ritonavir, an antiretroviral (ARV), is a second-line treatment option for HIV/AIDS and can also be used along with other ARVs, the company said.

Atazanavir and Ritonavir are the generic versions of Bristol-Myers Squibb's Reyataz and Abbott Laboratories' Norvir, respectively.

The drug combination works by blocking the activity of human immunodeficiency viruses causing AIDS in the body. However, it cannot treat the disease.

"This 'combo' helps to facilitate treatment compliance for HIV/AIDS patients by providing a convenient, once-a-day dosing option, while reducing the cost of treatment for patients," Mylan president Heather Bresch said in a statement.

According to the United Nations, at the end of 2008, 33.4 million people were living with HIV, with an additional 2.7 million getting infected with the disease each year.

The U.S. Food and Drug Administration approved Mylan's therapy on Thursday -- on World AIDS Day -- through the President's Emergency Plan for AIDS Relief.

It will be eligible for purchase in certain developing countries, Mylan said.

Shares of Canonsburg, Pennsylvania-based Mylan were up 1.28 percent at $19.78 in afternoon trading on Nasdaq. They touched a one-month high of $19.96 earlier in the day.


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