The long-delayed and highly anticipated launch of generic Diovan is on the way, which is a bummer for Novartis and a huge boost for Indian drugmaker Ranbaxy Laboratories. It is also validation for the decision by Sun Pharmaceutical's owner, billionaire Dilip Shanghvi, who struck a $3.2 billion deal to buy Ranbaxy despite its years of FDA entanglements over quality issues.
With its $3.2 billion buyout of Ranbaxy Laboratories, Sun Pharmaceutical is not only buying a business in need of serious manufacturing improvements, but one that is bleeding money as FDA bans keep it from launching exclusive generics for blockbusters like Novartis' Diovan and AstraZeneca's Nexium.
The inability of Ranbaxy Laboratories to get its generic of heart drug Diovan to market for 18 months has been a boon for Novartis. Not so much for consumers.
Sun Pharmaceutical execs acknowledge it will be no easy task to repair Ranbaxy Laboratories' damaged reputation with the FDA and the public. But Sun managing director Dilip Shanghvi and his lieutenants came in with a laundry list of actions to be taken quickly to jump-start the process, sources tell Reuters.
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.
Given that Indian drugmaker Ranbaxy Laboratories is under FDA sanctions for its manufacturing misses, a quarterly loss of $25.5 million may not sound so bad. But the January ban of a key API plant stands to make the current quarter worse, and competitors are looking for every opportunity to take even more business away.
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.
Ranbaxy Laboratories had a compliance program and plenty of warning signs that there were problems at its plants before the FDA and Department of Justice got involved in an investigation that led to serious actions and a $500 million fine. It just didn't have the culture or the buy-in at all levels to fix them.
What is a generic drugmaker going to do when the FDA finds flies filling its analytics laboratory and shuts down a yet another plant key to serving the U.S. market? Start looking for other markets. That is what analysts say India's generics leader Ranbaxy Laboratories is faced with now that it has only one FDA-approved facility to work with and its critical API plant is banned from supplying it.
Novartis' blockbuster Diovan has enjoyed nearly 18 months of sales unscathed by generics since its patent expired in September 2012, as regulatory entanglements have kept Ranbaxy Laboratories from producing its copycat version. Now the Indian drugmaker has a plan to finally get it to market and claim its 6 months of exclusivity.