India's Sun Pharma wants Halol reinspected by U.S. FDA as soon as April

Mumbai-based Sun Pharmaceutical Industries wants the U.S. FDA to reinspect its troubled Halol plant between April and June as it makes progress on answering complaints that were first noted in September 2014 and some of which were highlighted again in a December 2015 warning letter.

However, on the Feb. 12 financial third quarter earnings call for the top drugmaker in India and fifth largest global generics maker, Managing Director Dilip Shanghvi said he believed the company has turned the corner on the plant now banned from exports to the U.S. after extensive remediation.

"As all of you are aware, in December 2015, we received a warning letter from U.S. FDA for the Halol facility. We've undertaken some incremental remedial measures to address this and we are progressing well on the implementation of these measures," he said.

Sun Managing Director Dilip Shanghvi

"We understand that investors need clarity on the timeline of the Halol resolution, while it is difficult to predict such timelines, we expect to put in a request for re-inspection of this facility, sometime in quarter one of FY2017."

That would be the first quarter of the company's financial year, which starts on April 1, but Shanghvi cautioned in response to an analyst query that the reinspection is a company request and the exact timing is up to the U.S. FDA.

"I'd say that we should be able to request (the U.S.) FDA for inspecting the facility in first quarter. We can't influence their decision to inspect. So, I don't know when they will inspect. We also don't know how long it will take for them to recertify the facility, those are things which are not in our hand."

The troubles at the plant, which provides about 15% of the company's product sales in the U.S., has crimped operations and led the company to move production of a generic copy of Gleevec/Glivec for the U.S. market to another facility.

An analyst on the call asked about the launch of the generic of the Novartis ($NVS) cancer drug nearly two weeks in--noting U.S. sales fell 11% in the third quarter ended Dec. 31 even as net profit reached INR14.17 billion rupees ($208 million) driven by higher active pharmaceutical ingredient sales.

Shanghvi offered an upbeat assessment.

"During the (third) quarter, we received the final approval of generic Gleevec from the US FDA," Shanghvi said. "We have launched our generic version in the U.S. on February 1, 2016. We expect this product to be a key contributor to our revenue and profits in the exclusivity period."

But he did note that the end of the 180-day exclusivity period should see hard competition, but also noted the drug "is not a typical generic product, because it's a product which is essentially distributed through specialty pharmacy."

"And Novartis would have special pricing arrangement with many of the peers. So it is not something that I would classify as a typical generic product. So, I would expect that the pick-up will be gradual. However, we are seeing reasonable traction with the product in the early days, and we are quite happy with the way in which the product is progressing."

However, reports suggest it remains behind on epilepsy drug Elepsia XR, developed in-house through Sun Pharma Advanced Research.

The Ranbaxy Laboratories unit also came in for attention with Shanghvi suggesting an ongoing review to cut costs and focus on key products would see further changes to the portfolio. Sun too is looking at rationalizing products and ventures including a 2011 pact with Merck ($MRK) on generics. However, Merck and Sun will continue a marketing pact for sitagliptin and tildrakizumab in India.

"The synergy benefits of the Ranbaxy acquisition have begun to reflect in our financials," he said. "We remain committed in allocating required resources for enhancing our specialty and complex generics pipeline."

- here's the release

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