Today, Novartis had the pleasure of hiking its 2013 forecast for the second time this year. And once again, it has Diovan to thank--or, to put a finer point on it, Novartis has Ranbaxy Laboratories to thank. The ongoing bumbling at the Indian generics maker means there's still no copycat version of Diovan to drain away sales of the blockbuster blood-pressure drug.
Novartis pharma chief David Epstein isn't worried about Japanese sales of the blood pressure drug Diovan. He's "much more worried" about the Swiss drugmaker's reputation, now that its Diovan marketing and research are under investigation in Japan. And top-level Novartis managers in Japan are already feeling the effects of that concern.
Novartis' troubles in Japan just keep growing. Now, a government panel is zeroing in on its Diovan advertising. Officials say that the promos may have broken Japanese law--and that could lead to fines and jail terms, Bloomberg reports.
Swiss drugmaker Novartis has repeatedly apologized after learning that a company employee was affiliated with a study in Japan of blockbuster Diovan as a statistician without revealing his ties to the Swiss healthcare giant. But authorities are not satisfied with apologies and intend to go on-site next week for a closer look.
Ranbaxy's misfortunes continue to translate into Novartis' good fortune. For a year, the revenues of the Swiss drugmaker have benefited from the fact that a generic of its top selling hypertension drug Diovan has yet to hit the market. And now the FDA has banned Ranbaxy's manufacturing plant from exporting the drug to the U.S.
Former Novartis employees did work on Diovan trials in Japan and didn't disclose their relationships with the company in the studies, the company says. But Novartis also said an independent investigation found no evidence clinical trial data was manipulated.
Why exactly a generic version of Novartis' blood-pressure drug Diovan has yet to hit the market is a bit of a mystery, but one thing is clear: The company is benefiting from the delay.
Ranbaxy Laboratories may be dealing with more regulatory issues for its plant in Mohali, and they may be interfering with it getting generic Diovan to market.
Ranbaxy Laboratories had the 6-month exclusive right to produce a generic of Novartis' blockbuster hypertension fighter Diovan. But the patent loss came and went months ago, and Ranbaxy's generic remains missing in action.
Ranbaxy Laboratories has been through a boatload of turmoil this year, but the CEO of India's largest generic drugmaker comes off as unfazed. In fact, he is touting big plans in the U.S. for the company.