Daiichi Sankyo's atrial fibrillation-treating edoxaban posted promising results in Phase III, matching the stroke-prevention prowess of warfarin with a better safety profile, but the drug may struggle to carve out market share in a cluttered space.
The good news for Daiichi Sankyo: Its new anticoagulant drug matched the old standard-issue drug warfarin at preventing stroke and blood clots. And as far as safety goes, edoxaban beat warfarin by a significant stretch. That's an entree into the warfarin-alternative market, expected to grow to $10 billion over the next several years.
The manufacturing problems Japan's Daiichi Sankyo acquired when it took control of generic drugmaker Ranbaxy Laboratories have been one booby trap after another: warning letters, import bans, a consent decree and a $500 million settlement with U.S. authorities.
After agreeing to pay $500 million to U.S. authorities in May, Japan's Daiichi Sankyo let it be known it was taking "available legal remedies" against certain shareholders that it says misrepresented critical information about the regulatory problems facing Ranbaxy Laboratories prior to acquisition.
The Hatch-Waxman Act shook up the generic drugs business in 1984, and almost 30 years later, it's safe to say the law had its desired effect. About 84% of the 4 billion prescriptions written each year are for generic drugs, saving patients and government programs billions of dollars a year. In other words, generic drugs are big business. And with a slew of blockbuster brands now off patent, it's a big business with growing pains.
The company said today that Glenn Gormley has been named corporate president and chairman of Daiichi Sankyo Inc. He takes over the president role from John Gargiulo, who's out as of yesterday. The company did not give a reason for the departure of Gargiulo, who had been president, CEO and head of Daiichi's commercial division.
ArQule watched its shares scrape the bottom last fall when it pulled the plug on a late-stage lung cancer drug, but rumors that the Woburn, MA, company is primed to release data that could revive tivantinib sent its stock price up as much as 19% on Friday.
Ranbaxy Laboratories calls its plant in Mohali, India, an ultra-modern facility, but FDA inspectors found rampant problems during visits last year. They found toilets without running water and discovered a drug tablet that appeared to have a human hair sticking from it. Others had oil spots on them. And plant managers were not getting to the root cause of the problems.
While many Big Pharma players have only recently discovered the potential of doing business in Russia, India's generic drugmaker Ranbaxy Laboratories has been there for two decades. Ranbaxy has established itself by selling the low-price copycat drugs it has made its fortunes on, but is now looking at moving up the value chain.
The European Society of Cardiology meeting in Amsterdam produced some notable data for a slate of closely-watched heart drugs over the long weekend.