Joint development agreement will accelerate NDA filing and worldwide commercialization.
WILMINGTON, Mass. (April 5, 2016) – CutisPharma, a specialty pharmaceutical company that has historically developed and distributed kits used by pharmacists to safely create compounded medications, announced today that it is entering into Active Pharmaceutical Ingredient (API) supply and joint development agreements with Dr. Reddy’s Laboratories Ltd. to advance several programs in CutisPharma’s R&D portfolio, including RM-02, RM-03, and RM-06, toward FDA approval.
“This partnership has significant strategic benefits for both parties,” said Neal Muni, MD, MSPH, Chief Executive Officer of CutisPharma. “Dr. Reddy’s Laboratories breadth of expertise and international infrastructure provide great synergy to CutisPharma’s own R&D and commercial organizations 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.”
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 CutisPharma will further enhance and strengthen their R&D portfolio in bringing good health to millions in the country.”
“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 United States as well as select international markets.” Muni said.
CutisPharma has aggressively invested in its research and development pipeline, recently announcing the opening of a state-of-the-art manufacturing center at its Wilmington, Mass., 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.
CutisPharma, Inc., based in Wilmington, Mass., is a privately held, specialty pharmaceutical company focusing on the development and commercialization 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 optimized, 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.
About Dr. Reddy’s Laboratories
Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses – Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. The Company’s major therapeutic areas of focus are gastro-intestinal, cardiovascular, diabetology, oncology, pain management and anti-infectives. Dr. Reddy’s operates in markets across the globe. For more information, log on to: www.drreddys.com
Greg Turner, Ball Consulting Group, LLC