PHARMACY

Investigational antidepressant garners positive results in late-stage clinical trial

BY Alaric DeArment

NEW YORK — Patients taking an investigative antidepressant undergoing late-stage clinical development showed “significant” improvement, according to study results released Monday.

Forest Labs and Pierre Fabre Medicament announced results of a phase-3 trial of levomilnacipran in adults with major depressive disorder. Results showed a statistically significant improvement in patients treated with the drug, compared with those taking placebo.

“Depressed patients often struggle to find the right antidepressant, and the need for new medications is high,” Forest Research Institute SVP research and development Marco Taglietti said. “These positive phase-3 results are very encouraging and support the continued research of levomilnacipran in adult patients with major depressive disorder.”

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Ranbaxy to produce, market antiretrovirals under licensing agreement with Gilead

BY Allison Cerra

GURGAON, India — Ranbaxy will produce and market three HIV/AIDS drugs that currently are in late-stage clinical development by Gilead under a new licensing agreement between the drug makers.

Under the agreement, Ranbaxy said it would produce and market the following drugs in India and other developing nations after gaining necessary regulatory approval: elvitegravir, an investigational integrase inhibitor; cobicistat, an investigational antiretroviral boosting agent; and the “Quad,” a once-daily, single-tablet combination of four separate Gilead medicines. Ranbaxy and Gilead first teamed up in 2006 to market tenofovir and emtricitabine in India and many other developing nations.

“We appreciate Gilead’s initiatives for the treatment of HIV/AIDS in the developing world, through partnerships," Ranbaxy’s global pharmaceutical business president Rajiv Gulati said. "We are pleased to extend our partnership with Gilead for the in-licensed new antiretrovirals that will enhance our capability to provide quality affordable medicines for the treatment of HIV/AIDS in the developing countries.”

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Matrix expands licensing agreement with Gilead for HIV/AIDS therapies

BY Allison Cerra

PITTSBURGH — Mylan subsidiary Matrix Labs has expanded its licensing agreement with Gilead Sciences.

Under the new terms, Mylan said that Matrix has the rights to produce and market generic versions of three Gilead HIV/AIDS therapies — elvitegravir, an investigational integrase inhibitor; cobicistat, an investigational antiretroviral boosting agent; and the “quad,” a once-daily, single-tablet combination of four separate Gilead medicines — if and when the drugs receive regulatory approval.

“Every patient living with HIV/AIDS has a right to treatment,” Mylan president Heather Bresch said. “Matrix has made a significant contribution to dramatically lowering the cost of HIV/AIDS medicines, and we are now focused on expanding access to high-quality treatment to more people who need it. We are pleased to expand our collaboration with Gilead as it will enable more individuals living with HIV/AIDS in resource-limited countries to access the newest innovative medicines.”

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