Dr. Reddy’s, CutisPharma announce API supply, joint development partnerships
WILMINGTON, Mass. — Dr. Reddy’s Laboratories and specialty pharmaceutical company CutisPharma announced Tuesday agreements for active pharmaceutical ingredient (API) supply and joint development as a way to advance several of CutisPharma’s research and development programs.
“This partnership has significant strategic benefits for both parties,” CutisPharma CEO Dr. Neal Muni said. “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.”
CutisPharma recently opened a new manufacturing center at its headquarters and the partnership will see the acceleration of three drugs in its pipeline toward approval by the Food and Drug Administration.
“We continuously engage in research to find innovative solutions that address the unmet needs of patients and to create a robust healthcare ecosystem,” Dr. Reddy’s VP and global head of CPS business Deepak Sapra said. “The partnership with CutisPharma will further enhance and strengthen their R&D portfolio in bringing good health to millions in the country.”
Diplomat announces availability of Lilly’s Taltz
BY DSN STAFF
FLINT, Mich. — Diplomat Pharmacy announced Tuesday that it had been selected as part of Eli Lilly and Co.’s limited-distribution network for its recently approved plaque psoriasis treatment Taltz (ixekizumab).
"Psoriasis is a serious chronic disease that can have debilitating symptoms," Diplomat president Gary Kadlec said. “Taltz enables patients an important treatment option.”
Information about Diplomat’s psoriasis program can be found here.
ANI gets FDA approval for oxycodone, launches hydrocortisone rectal cream
SILVER SPRING, Md. and BAUDETTE, Minn. — ANI Pharmaceuticals on Tuesday announced the Food and Drug Administration approval for one new generic and the launch of another.
The company received FDA approval for its generic of oxycodone HCl capsules. The drug will be available in 5-mg dosage strength, and it saw annual sales of $7.5 million for the 12 months ended February 2016, according to IMS Health. The drug is indicated to manage moderate to severe acute and chronic pain when opioid use is appropriate.
“When launched, this will be our third commercial Schedule II narcotic product,” ANI president and CEO Arthur Przybyl said. “In addition, we have received a target action date of January 2, 2017 from the FDA for another Schedule II narcotic product. We remain hopeful that we will obtain three additional Schedule II narcotic product approvals within the next 12 months.”
The company also announced the launch of its hydrocortisone retal cream 1% and 2.5%. The cream is indicated for relief of corticosteroid dermatoses. The two products saw annual sales of about $84 million for the 12 months ended February 2016, according to IMS Health.
“We are excited to add these niche topical products to our growing generic portfolio,” Przybyl said.
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