Mylan, Pfizer settle drug dispute
PITTSBURGH Generic drug manufacturer Mylan and pharmaceutical giant Pfizer have settled a dispute over Mylan’s attempt to manufacture a generic version of an antifungal drug.
Mylan announced Wednesday that it had entered a license agreement with Pfizer concerning Mylan subsidiary Matrix Labs’ voriconazole tablets in the 50-mg and 200-mg strengths, a generic version of Pfizer’s Vfend. Matrix had filed a regulatory approval application with the Food and Drug Administration; as the first company to file the application, Mylan will have the right to market its version in direct competition with Pfizer’s product for six months once the patent expires. Under the agreement, Mylan will have the right to market voriconazole tablets in the U.S. in first quarter 2011.
Vfend, used to treat yeast and other fungal infections, had sales of $164 million during the 12-month period ending June 30, according to IMS Health data.
Merck KGaA acquires BGIP
DARMSTADT, Germany Drug maker Merck KGaA has acquired an Indian bioscience company based in the city of Bangalore, Merck announced Tuesday.
The German drug maker – a separate company from U.S.-based Merck & Co. – announced the acquisition of Bangalore Genei (India) Private, having purchased it from Sanmar Group through its Indian subsidiary, Merck Specialties Private.
Merck said the acquisition would make it one of the leading bioscience companies in India, though it did not disclose financial terms of the deal. BGIP develops proteonomic and genomic research products, having generated $4.45 million in revenues during the 2008-2009 fiscal year.
CDC reports continued short supply of H1N1, seasonal flu vaccines
ATLANTA H1N1 flu vaccine continues to be in short supply, reported an executive with the Centers for Disease Control and Prevention during a press conference Thursday afternoon, and the majority of seasonal flu vaccines already have been dispensed.
Approximately 82% of this year’s allotment for seasonal flu vaccine has been dispensed so far. “Manufacturers expect us to have 114 million doses by the end of the year,” reported Anne Schuchat, director of the National Center for Immunization and Respiratory Diseases at CDC. “We’ll see if we make that prediction they have made for us.”
As to H1N1 vaccine, there currently are 41.6 million on hand that are available for the states to order. “We believe that will be somewhat less than what manufacturers expected to reach at this point,” Schuchat said. “41.6 million is more than we had before, but not as much as we hoped to have by today.”
Immunization efforts for this supply continue to be focused on high-priority populations — pregnant women, healthcare workers, children up to age 24, seniors with chronic conditions and parents of children under 6 years. However, that focus may shift from high-priority groups to the general population soon, Schuchat suggested. “As the supply increases, we do think that access and convenience and ease of getting vaccinated will improve,” she said.
From April through Oct. 17, the CDC estimated approximately 22 million people have become ill from pandemic influenza (H1N1), including as many as 153,000 possible hospitalizations. The CDC gave a median estimate of 3,900 people dead in the first six months of the pandemic from this virus, with the estimates ranging from 2,500 up through 6,100 people having died so far.
“We’ve been talking a lot about this pandemic being a younger person’s disease, that it’s disproportionately affecting children and young adults and relatively sparing the elderly, very different from seasonal flu,” Schuchat said.
So, in children under 18 years, the CDC estimated 8 million children have been ill with influenza, 36,000 hospitalized and 540 children have died from this pandemic influenza. For adults 18 to 64 years, the CDC estimated 12 million cases, 53,000 hospitalizations and 2,900 deaths. For people 65 years and over, the CDC estimated about 2 million cases, 9,000 hospitalizations and about 440 deaths.