PHARMACY

Mylan launches generic Risperdal M-Tab

BY Alaric DeArment

PITTSBURGH — Generic drug maker Mylan has launched a version of a drug used to treat schizophrenia, the company said Friday.

Mylan announced the launch of risperidone orally disintegrating tablets in the 0.5-mg, 1-mg, 2-mg, 3-mg and 4-mg strengths.

The drug is a generic version of Johnson & Johnson’s Risperdal M-Tab. Various versions of risperidone orally disintegrating tablets had sales of about $61 million in 2010, according to IMS Health.

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Study: Antiretroviral therapy cuts HIV transmission risk by 96%

BY Alaric DeArment

WASHINGTON — Patients with HIV who immediately started antiretroviral therapy significantly reduced the risk of spreading the virus to an uninfected partner, compared with those who delayed therapy, according to results of a multinational study. The study also found that antiretroviral therapy reduced the risk of transmission by 96%.

The six-year “HPTN 052” ”study, conducted by the HIV Prevention Trials Network at 13 sites in the Americas, Asia and Africa, enrolled 1,763 couples in which one partner was HIV-positive and the other was HIV-negative — also known as serodiscordant couples — 97% of which were heterosexual. The infected partner had to have a CD4 cell count of 350 to 550 per cubic millimeter at level, at which he or she did or did not yet require HIV treatment. Researchers then divided couples into two groups, one in which the infected partner immediately started therapy, and another in which the partner delayed therapy until after his or her CD4 count began decreasing.

Among the 877 couples in the delayed-treatment group, there were 27 cases of the uninfected partner contracting HIV, but in the immediate-treatment group, only one infection occurred.

“This is excellent news,” principle study investigator and associate vice chancellor for global health and director of the Institute of Global Health and Infectious Diseases at the University of North Carolina at Chapel Hill Myron Cohen said. “The study was designed to evaluate the benefit to the sexual partner as well as the benefit to the HIV-infected person. This is the first randomized clinical trial to definitively indicate that an HIV-infected individual can reduce sexual transmission of HIV to an uninfected partner by beginning antiretroviral therapy sooner.”

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GPhA expresses support of Congressional Affordable Medicines Caucus

BY Alaric DeArment

WASHINGTON — A new congressional caucus will look for ways to educate the public and members of Congress on how to reduce the country’s healthcare costs with affordable medicines.

Reps. Jo Ann Emerson, R-Mo., and Peter Welch, D-Vt., will serve as chairwoman and chairman for the Congressional Affordable Medicines Caucus, whose formation was announced Thursday.

The Generic Pharmaceuticals Association, the main lobby for the generic drug industry, expressed support for the new caucus and its goals, which include increasing generic drug utilization in Medicare and Medicaid and ensuring that the Food and Drug Administration’s Office of Generic Drugs has enough resources.

The GPhA said Medicare and Medicaid didn’t do enough to take advantage of generic drugs, and according to the Centers for Medicare and Medicaid Services, an increase in generic utilization of 2% by Medicaid would save the program more than $1.3 billion, while a 5% increase would save it nearly $3.4 billion. At the same time, the Office of Generic Drugs has a backlog of more than 2,000 approval applications for generic drugs, including as many as 365 new generic versions of branded drugs.

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