Vertex reports Q1 earnings
CAMBRIDGE, Mass. Vertex Pharmaceuticals ended first quarter 2009 with $869 million in cash, cash equivalents and marketable securities, the company announced Thursday.
The company is conducting a phase 3 study of telaprevir, a protease inhibitor for treating hepatitis C in patients who have not received treatment or for whom other treatments have failed. In March, Vertex started a phase 2a trial of VX-809, a compound designed to treat cystic fibrosis, and it also plans to start trials for the investigational CF drug VX-770 in the United States and Europe.
“With our strong performance in the first quarter, we are well-positioned to drive forward key programs in hepatitis C and cystic fibrosis and to deliver on our 2009 financial projections outlined earlier this year,” Vertex president Matt Emmens said. “Our top priority is to execute on the telaprevir phase 3 program and to prepare for [a new drug application] filing for telaprevir in the second half of 2010.”
FDA approves hypertension generic
ROCKVILLE, Md. The Food and Drug Administration has approved a generic version of Abbott’s Oretic, agency records show.
The FDA approved Ipca Labs’ hydrochlorothiazide capsules in the 12.5 mg strength. The drug is used to treat hypertension.
Oretic was originally approved in 1959, and its active pharmaceutical ingredient is used in a number of hypertension drugs.
Biogen Idec receives FDA approval for multiple sclerosis, Crohn’s disease treatment
CAMBRIDGE, Mass. The Food and Drug Administration has given approval to a drug for treating multiple sclerosis and Crohn’s disease.
Biogen Idec announced Thursday that the FDA had approved Tysabri (natalizumab), which already has approval in more than 40 countries as a treatment for moderate to severe Crohn’s disease and relapsing forms of multiple sclerosis. Biogen Idec co-markets the drug with Ireland-based Elan Corp.
Biogen Idec will use a high titer process for which it received approval in the European Union in December to manufacture the drug in higher quantities at its plant in Research Triangle Park, N.C.
“Developing this high titer process is another example of our world-class expertise and leadership in biologics manufacturing,” Biogen Idec COO Bob Hamm said. “We expect this new process to result in about a four-fold increase in yield.”