PHARMACY

HIV-prevention vaccine candidate shows promise in human trials

BY Sandra Levy

A series of HIV-prevention vaccine regimens have been evaluated in a study of uninfected human volunteers in five countries, and the results appear promising.

The study, published in The Lancet, was conducted by a team of researchers led by Beth Israel Deaconess Medical Center’s Dr. Dan H. Barouch, director of the Center for Virology and Vaccine Research in collaboration with Janssen Vaccines & Prevention and other partners.

Barouch and his colleagues tested the same vaccine for its ability to protect rhesus monkeys challenged with an HIV-like virus from infection. The vaccines induced robust and comparable immune responses in humans and monkeys and protected monkeys against the acquisition of infection.

“This study demonstrates that the mosaic Ad26/Ad26 plus gp140 vaccine candidate induced robust and comparable immune responses in human and monkeys,” said Barouch, who also is a professor of medicine at Harvard Medical School. “Moreover, the vaccine provided 67% protection against viral challenge in monkeys.”

Intended to provide broad protection from the many strains of HIV that are prevalent worldwide, the “mosaic” vaccine contains a patchwork of genetic sequences found among various HIV strains. Known as APPROACH, the phase 1/2a trial tested seven different Ad26/Env HIV vaccine regimens for their safety, tolerability and the ability to elicit immune responses in 393 healthy adult volunteers in Rwanda, South Africa, Thailand, Uganda and the United States. All vaccine regimens were well-tolerated and induced robust immune responses in the participants.

“Based on these data, the mosaic Ad26/Env HIV-1 vaccine has been advanced into a phase 2b clinical efficacy study to determine whether this vaccine will prevent HIV infection in humans in southern Africa,” Barouch said. “We expect results in 2021. This is only the 5th HIV vaccine concept that will be tested for efficacy in humans in the 35-plus year history of the global HIV epidemic.”

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PHARMACY

Teva launches generic Uceris

BY Sandra Levy

Teva Pharmaceuticals Industries has introduced the generic version of Salix Pharmaceuticals’ Uceris (budesonide) extended-release tablets in a 9 mg dosage strength.

Budesonide extended-release tablets are a glucocorticosteroid indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis.

“The launch of generic budesonide extended-release tablets signals an important addition to Teva’s portfolio,” said Teva executive vice president and head of North America Commercial Brendan O’Grady. “We continue to be focused on bringing affordable generic treatment options to our customers, including those living with chronic, life-long conditions like ulcerative colitis.”

Uceris has a market value of approximately $196 million in the United States, according to IMS data as of May 2018.

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PHARMACY

Lupin receives FDA nod for generic Plaquenil tablets  

BY Sandra Levy

Lupin has received the green light from the Food and Drug Administration for a generic version of Concordia Pharmaceuticals’ Plaquenil tablets, 200 mg. (hydroxychloroquine sulfate tablets, 200 mg).

The product is indicated for the treatment of uncomplicated malaria due to P. falciparum, P. malariae, P. ovale and P. vivax; the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported; the treatment of chronic discoid lupus erythematosus and systemic lupus erythematosus in adults; and the treatment of acute and chronic rheumatoid arthritis in adults.

The product’s market size for the 12 months ended April 2018 was $215.3 million, according to IQVIA data.

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