In an effort to get itself into a place where it can again ship from its FDA-approved plants in India, Ranbaxy Laboratories says it is taking a hard look at how it runs its API operations.
Japanese drugmaker Daiichi Sankyo, which owns controlling interest in the Indian generics company Ranbaxy Laboratories, is having to rethink its strategy now that Ranbaxy's key API plant has been banned from shipping to the U.S. and its analytics lab came in for harsh criticism from the FDA.
Japan's Daiichi Sankyo believed it was making a solid move when it bought controlling interest in Ranbaxy Laboratories for $4.6 billion in 2008. Instead it has seen its finances burdened by Ranbaxy's non-stop regulatory issues, leading some to wonder if Daiichi might get fed up and bail out. But executives today said they don't intend to do that, at least not for now. Instead Daiichi will take "drastic" steps to turn the operations around.
Massachusetts biotech ArQule has gotten word from its data monitoring committee that its Phase III trial of tivantinib is doing fine despite a dosing reduction that once threatened to derail its development, stoking hopes that the company can finally get its liver cancer treatment across the goal line and sending shares up nearly 30%.
Japan's Daiichi Sankyo, which has controlling ownership of India's troubled Ranbaxy Laboratories, is helping Ranbaxy deal with all of its FDA regulatory issues. According to The Hindu Business Line, the assurances were made Thursday in talks between Daiichi Sankyo CEO George Nakayama and Commerce & Industry Minister Anand Sharma.
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.