MUMBAI (NewsRise) -- Sun Pharmaceutical Industries said its new ophthalmic drug for dry eye disease met its primary endpoint in a phase three study, giving a shot in the arm for India's largest drug maker that aims to strengthen its specialty pharmaceutical products.
The company, backed by billionaire Dilip Shanghvi, last year got exclusive global rights for the drug Seciera through the acquisition of Ocular Technologies. Sun bought Ocular from Auven Therapeutics, a private equity firm focused on drug development, for an initial payment of $40 million. The company is developing the drug to sell in the U.S., Europe, and Japan, as well as in several emerging markets.
Sun's shift in focus to specialty drugs comes at a time when generic drugs are facing stiff competition and pricing pressure in the U.S., the largest pharmaceutical market in the world.
Specialty medicines currently account for about 25% of global medical spending.
In the 12 weeks of study, Seciera showed statistically significant improvement in the primary end point, Sun said in a statement on late Wednesday. Shanghvi, the managing director of Sun, said the company will now discuss the results with the U.S. Federal Drug Administration and agree on the next steps of the program.
Sun had late last year launched its first branded ophthalmic drug BromSite in the U.S. after receiving the FDA approval in April. Sun had received the rights to BromSite from InSite Vision, an U.S. based ophthalmic drug maker, which it acquired in 2015.
"A key strategic imperative for our ophthalmic business is to participate in the rapidly growing, underserved, and dynamic dry eye market, which is expected to reach $5 billion by 2020," said Jerry St. Peter, vice president and head of Sun Ophthalmics.
Analysts are bullish about the prospects of the company's specialty drug portfolio, if it manages to win the regulatory approval for Seciera. With barely two drugs available in the U.S. dry eye care market- Allergan's Restasis approved in 2002 and Shire's Xiidra, which own the approval in July 2016- they say Sun can easily win market share.
"The product has the prospect to achieving sales in excess of $500 million in the U.S.," Nomura said in a report. "Seciera is a better formulation compared to Restasis, which has sales of $1 billion, and can quickly take share."
Still, concerns linger around whether the product will receive regulatory approval, since the company wasn't able to meet the symptom score in the phase two study, and hasn't confirmed whether the last phase met the parameter.
"Many experts believe that the FDA may look for both reduction in signs and symptoms in pivotal clinical trial while approving a product for dry eye," Nomura said. "FDA feedback is crucial in ascertaining approvability and timeline for launch."
Sun is also among companies being investigated by the U.S. federal department for alleged price collusion. Sun has denied any wrong doing. The company is also reeling under increased scrutiny from the FDA, after the U.S. regulator flagged a series of safety lapses and quality control issues at some of its manufacturing plants. The scrutiny led to fewer approvals to launch new products until earlier this year.
Shares of Sun Pharmaceutical gained 0.89% in Mumbai trading, while the benchmark BSE Sensex closed 0.92% higher.
--Dhanya Ann Thoppil