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Dr.Reddy's says scouting for in-licensing opportunities to expand specialty portfolio

“While we develop novel agents ourselves, we continue to seek licensing and development opportunities with third parties to further expand our product pipeline,” the drug maker in its annual report filed before Securities Exchange Commission (SEC) said.

June 20, 2017 / 09:44 PM IST
 
 
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Dr.Reddy’s on Tuesday said it is scouting for in-licensing opportunities as it plans to expand its proprietary or specialty portfolio, in addition to its in-house drug development programme.

“While we develop novel agents ourselves, we continue to seek licensing and development opportunities with third parties to further expand our product pipeline,” the drug maker said in its annual report filed before Securities Exchange Commission (SEC).

“Our goal is to balance the development of our own product candidates with in-licensing of promising compounds that complement our product offering,” the company added.

Dr.Reddy’s said along with in-licensing opportunities, the company is ready to pursue out-licensing and joint development of some of its lead compounds with companies looking to enhance their own product portfolio.

The company has a pipeline of 16 products under development as on March 31.

In January and February 2016, Dr.Reddy’s received US FDA approval for its New Drug Applications (NDA) for two products including the dermatology product Sernivo and the neurology product Zembrace.

Both products were launched in the US market during FY17. The company also received a tentative approval for its dermatology product called Zenavod.

The company said NDA for DFN-06 used in treatment of moderate plaque psoriasis was submitted in January 2017. Another drug candidate called Xeglyze - the pediatric version to treatment of lice acquired from Australian firm Hatchtech - is pending for approval.

Dr.Reddy’s submitted its NDA for Xeglyze in September 2015. The company said it has received a complete response letter (CRL) from the US FDA in August 2016 and will file its response in July 2017.

The company said its migraine drug DFN-02 completed its phase-3 trial and the submission of NDA is planned for 2018.

While the company’s anti-psoriasis drug in-licensed from Xenoport is getting into phase2b/3, its blood cancer biologic drug in-licensed from Eisai is under phase-3 trial. The company said it expects to file the biologics license application in 2019.

Along with biosimilars, Dr Reddy’s is betting big on proprietary products, focusing on two therapeutics areas, dermatology and neurology in US market.

The proprietary products division targets unmet patient needs utilising previously approved active ingredients through product improvement and repurposed drugs.

The company spent about Rs 1,960 crore or 13.9 percent of its Rs.14,081 revenues on research and development (R&D).

The company expects its biosimilar and proprietary business to contribute in the range of USD 300 to 500 million in the next five years.

first published: Jun 20, 2017 09:44 pm

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