The drug-pricing battle continues, but this time, Gilead Sciences' Sovaldi isn't at the center. That dubious honor goes to Vertex Pharmaceuticals' cystic fibrosis treatment Kalydeco. According to a lawsuit filed by three CF patients, Arkansas Medicaid officials are locking them out of Kalydeco treatment.
With all hands on deck at Vertex focused on the development of a crucial combo drug for cystic fibrosis, the Boston-based biotech has outlicensed an influenza drug to J&J in exchange for a $30 million upfront.
Startup Alkeus is being sued by Irish drugmaker Alkermes for trademark infringement. According to the Boston Business Journal, the 25-year-old Alkermes filed the lawsuit on May 27, alleging that the smaller company's name could easily be mistaken for that of the more established developer of central nervous system disorder drugs.
With Gilead's Sovaldi elbowing Vertex's Incivek aside, Vertex is calling it quits on a once-ambitious R&D effort to keep a niche for itself in hepatitis C. The market, though, didn't blink, rewarding the biotech with a spike in its share price after Vertex cited some early success with a combination therapy for cystic fibrosis.
Even after out-licensing a pair of hepatitis C therapeutic candidates to Vertex, which was bidding on finding a contender as a new wave of transformational drugs approached the market, South San Francisco-based Alios BioPharma stubbornly maintained a very low profile.
Vertex Pharmaceuticals' piecemeal approach to the world's cystic fibrosis sufferers took a hit as Kalydeco failed to meet its primary endpoint in a Phase III trial on patients with one form of the disease, sending the company's shares down as much as 6% premarket on Thursday morning before an eventual rebound.
In drug development, everything's a gamble, if you're doing something new and shooting at a big target. But there has to be a reasonable assumption that if safety issues aren't being glossed over and the efficacy data hold up, these top drugs can change standards of care and grab market share. So here's my pick of the likely big winners >>
While pedestrian investors wait on press releases, conference calls and trial results before acting on biotech stocks, some of the world's largest hedge funds have figured out how to speed up the process of publicity: Ask the FDA.
Biotech companies have set out to keep U.S. tax credits pinned to costs of developing drugs for rare or "orphan" diseases, seeking to escape the mammoth budgetary ax of Congress on Capitol Hill.
The FDA placed a partial clinical hold on U.S. development of a 200 mg dose of VX-135 after three patients in a European study showed signs of liver toxicity after taking 400 mg doses of the compound, Vertex spokesman Zach Barber confirmed via email.