Another Ranbaxy Mystery: What Happened To Valsartan?
This article was originally published in PharmAsia News
Executive Summary
Ranbaxy’s valsartan application may have been held back after FDA detected lapses at the company’s new manufacturing site in Mohali, India, according to sources, but the beleaguered company has a plan to move forward.
MUMBAI – For over eight months, the first-filer status of Ranbaxy Laboratories Ltd.’s valsartan has been shrouded in mystery. If all had gone well, Ranbaxy was to launch the generic of Novartis AG blockbuster Diovan in the U.S. by Sept. 22, 2012, one day after patent expiry, but the Indian company has yet to receive approval from U.S. FDA.
Despite building suspense and apprehension, senior Ranbaxy officials have informed investors over quarterly earnings calls that the company believes its 180-day exclusivity on the drug is intact and a launch will occur as soon as the regulatory approval is in place. Analysts have generally remained positive about a launch or monetization of valsartan, expecting upside from the windfall opportunity (Also see "Past A Bumpy Road, Ranbaxy Eyes Smooth Path If Exclusive Launches Materialize" - Scrip, 19 Mar, 2013.).
However, the mystery continues to deepen. Ranbaxy’s valsartan application appears to be stuck in a logjam after an FDA inspection detected manufacturing lapses at Ranbaxy’s newly commissioned Mohali site in the northern state of Punjab. Ranbaxy declined to comment on queries from PharmAsia News.
A senior industry source, who requested not to be identified, said a U.S. FDA inspection conducted a few months ago revealed violations at the site, and the agency issued a Form 483 highlighting the deviations. FDA officials were at the Mohali site as part of their function to approve Ranbaxy’s valsartan application. But since the lapses were observed, all finished products from the Mohali site are feared to be blocked.
FDA did not respond to inquiries about this story.
Earlier this week, Ranbaxy paid $500 million to settle criminal and civil allegations in the U.S. involving data fraud and drug manufacturing violations (Also see "Ranbaxy Agrees To Pay $500 Million To Resolve Manufacturing Violations At Indian Sites" - Scrip, 13 May, 2013.).
Future Risks
With products from Mohali potentially blocked, another consultant for regulatory affairs said that the company may face the danger of losing its first-filer exclusivity on Roche’s Valcyte (valganciclovir), a drug used for the prevention of cytomegalovirus infections, unless the approval for Mohali is restored within a short time.
In terms of valsartan, Ranbaxy is not waiting for Mohali. It is learned that Ranbaxy has moved its valsartan application to the company’s Ohm Labs site in New Jersey, and the FDA is in the process of reviewing the new application. If valsartan data generated from Ohm Labs is found compliant with regulatory requirements, Ranbaxy may be lucky a second time around in salvaging gains from the U.S. market.
Ranbaxy implemented a similar strategy to get a generic version of Pfizer Inc. blockbuster Lipitor (atorvastatin) approved in 2011 (Also see "Ranbaxy Bags Atorvastatin Approval From U.S. FDA In A Nail-Biting Finish" - Scrip, 1 Dec, 2011.).
After approval, Ranbaxy moved manufacturing of atorvastatin to Mohali from Ohm Labs in April 2012, but later shifted production of the product back to New Jersey. In November 2012, Ranbaxy announced a voluntary recall of atorvastatin after tiny glass particles were found in certain batches. The company also chose to stop manufacturing atorvastatin until it investigated the cause and remediated the problem.
On March 26, Ranbaxy said it had resumed supply of atorvastatin to the U.S. market. Although Ranbaxy did not disclose where atorvastatin is now manufactured, the source said it likely could not be supplied from Mohali until all pending issues are rectified and a site approval is issued by FDA.
The sprawling Mohali site was approved by FDA in late 2011 and kindled hopes of a renewed push for Ranbaxy exports to the U.S. (Also see "Shot In The Arm: U.S. FDA Approves Ranbaxy's Finished Dose Unit At Mohali; Company May Shore Up Product Filings" - Scrip, 29 Nov, 2011.). The company had hoped to overcome controversies surrounding its two other India sites, Paonta Sahib and Dewas, which were under investigation by FDA for good manufacturing practices violations and data fabrication.
For now however, the company is faced with the grim reality that its three manufacturing sites in India are blocked by FDA.
And the windfall Ranbaxy had expected for valsartan has instead gone to Novartis. Every month of generic delay has meant roughly $100 million in extra sales for Diovan, Novartis CFO Jon Symonds said on the company’s most recent quarterly call.