Dr Reddy's Labs Ties up with US-based Cutis Pharma for API & Drug Research

Wednesday, Apr 06, 2016

Dr Reddy’s Laboratories Ltd has entered into API (active pharmaceutical ingredient) supply and joint development agreements with the US-based Cutis Pharma to advance several programs in Cutis Pharma’s R&D portfolio, including RM-02, RM-03, and RM-06, toward FDA approval.

Cutis Pharma, a specialty pharmaceutical company that has historically developed and distributed kits used by pharmacists to safely create compounded medications, has aggressively invested in its R&D pipeline, recently announcing the opening of a manufacturing centre at its Wilmington, Massachusetts (USA), facility and completion of validation activities supporting its first NDA filing of the company’s lead pipeline drug, RM-01, next year. The partnership with Dr Reddy’s Laboratories will allow for the acceleration of three additional drugs, RM-02, RM-03 and RM-06, towards FDA approval.

“This partnership has significant strategic benefits for both parties. Dr Reddy’s Laboratories breadth of expertise and international infrastructure provide great synergy to Cutis Pharma’s own R&D and commercial organisations and will be a significant catalyst in our plans to fast-track the development of three of our programs towards new drug application (NDA) filings,” commented Neal Muni, chief executive officer of Cutis Pharma.

Deepak Sapra, vice president & global head, CPS business of Dr Reddy’s Laboratories, said, “We continuously engage in research to find innovative solutions that address the unmet needs of patients and to create a robust healthcare ecosystem. The partnership with Cutis Pharma will further enhance and strengthen their R&D portfolio in bringing good health to millions in the country.”

Muni added, “By leveraging the strengths of both parties, we look forward to expediting the development of three of our key R&D portfolio assets and maximizing commercial value of these programs in the US as well as select international markets.”

Cutis Pharma Inc is a privately held, specialty pharmaceutical company focusing on the development and commercialisation of value-added proprietary pharmaceutical products and technologies in the prescription compounding sector of the health care industry. The product line and development efforts are focused on providing optimised, more efficient alternatives for the preparation of compounded prescriptions, by offering FIRST unit-of-use prescription compounding kits. Use of these branded compounding kits benefits all key stakeholders, including physicians, pharmacists and patients.


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