By Zeba Siddiqui
MUMBAI Sun Pharmaceutical Industries Ltd does not expect pressure on generic drug prices in the United States to abate anytime soon, its managing director said on Thursday, signalling a challenging year ahead in the company's largest market.Dilip Shanghvi's comments followed publication of Sun Pharma's second-quarter results in which profit more than doubled from a year earlier, driven by higher sales in nearly all its markets.The United States began an investigation into generic drug prices last year and the possibility of another U.S. probe hit Indian pharmaceutical stocks last week. Sun, the world's fifth biggest generic drug maker, did not comment on this on Thursday, but said it believed pricing pressures would continue. Like most of its Indian rivals, Sun has had a tough year in the United States due to few regulatory approvals to launch new products, and regulatory restrictions over its Halol drug factory in Gujarat that caused supply constraints.
Sun has now completed an overhaul of that facility and is awaiting an FDA re-inspection, Shanghvi told analysts on a conference call. But he said he was not sure if the plant would win regulatory clearance in the next five months. "Looking at the experience of some other sites, it may take more than three months post-reinspection to get clearance," Shanghvi said. Analysts are waiting for Sun's tildrakizumab, an experimental psoriasis drug that showed positive results in late-stage trials, to be put forward for U.S. approval. Shanghvi said the company is also considering testing the same compound in other disease areas.
Sun reported that July-September profit rose to 22.35 billion rupees ($335.8 million) from 10.29 billion rupees a year earlier. Analysts expected an average profit of 16.46 billion rupees, according to Thomson Reuters I/B/E/S.Sales in its largest market, the United States, rose 9 percent, while those in India rose 11 percent. In emerging markets, Sun's sales rose 22 percent, the company said in a statement.
"The synergies from the Ranbaxy acquisition are gaining momentum and we are on track to achieve the targeted benefits," Shanghvi said.Sun has earlier said it expects to reap $300 million in synergies by fiscal 2018 from its purchase of rival Ranbaxy Laboratories last year.($1 = 66.5600 rupees) (Reporting by Zeba Siddiqui in Mumbai; Editing by Keith Weir and Jane Merriman)
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