Paratek Announces License Grant to Almirall for SEYSARA® (sarecycline) for Greater China Region
Almirall LLC today announced the publication of long-term safety data from a 40 week, Phase 3 open-label extension study of Seysara® in patients 9 years of age and older. Seysara® is a novel tetracycline-derived oral antibiotic developed specifically for the treatment of acne and was approved by the FDA in October of 2018. Since its launch in January of this year, Seysara® has been prescribed for more than 60,000 patients2.
Thursday was a bad day on Wall Street, as major benchmarks fell sharply after worries about other financial markets took their toll on stocks. A substantial jump in bond yields has taken the 10-year Treasury to 3.2%, and some investors fear that higher rates could raise financing costs for companies, taking away some of their incentive to invest in further growth. However, even with the downward pressure on the overall market, some stocks had good showings. Barnes & Noble (NYSE:BKS), Paratek Pharmaceuticals (NASDAQ:PRTK), and Hortonworks (NASDAQ:HDP) were among the best performers on the day. Here's why they did so well.
Paratek Pharmaceuticals felt double the love from the FDA this week, as two of its antibiotics won back-to-back approvals—one for Paratek itself, and the other for deal partner Allergan's dermatology buyer Almirall.
US regulators have approved Paratek’s Seysara for the treatment of acne in patients aged nine years or older.
FDA Approves SEYSARA (Sarecycline) for Inflammatory Lesions of Acne Vulgaris
EXTON, Pa., Sept. 21, 2018 /PRNewswire/ -- Almirall, S.A. (ALM) announced today the finalization of their acquisition of products from Allergan's Medical Dermatology unit in the United States: Aczone® (dapsone), Tazorac® (tazarotene), Azelex® (azelaic acid) and Cordran® Tape (flurandrenolide). In addition, sarecycline, a New Chemical Entity (NCE) currently under FDA review for approval in the treatment of acne is part of the transaction.
Spain’s Almirall has acquired Allergan’s US dermatology portfolio in a deal worth up to $650 million. This includes an upfront cash payment of $550 million and a potential earn-out of up to $100 million payable in 2022 based on the performance of the portfolio.
Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK), a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry, today announced that a meeting of the Antimicrobial Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has been scheduled for August 8, 2018 to review the Company's New Drug Applications (NDAs) for once-daily, oral and intravenous omadacycline. Omadacycline is under review for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).
Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK), a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon its expertise in novel tetracycline chemistry, today announced recent progress across its product pipeline. Paratek has initiated the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration for the indications of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP) and is on track to submit the final components during the first quarter of 2018. Rolling submission allows completed portions of an NDA to be reviewed by the FDA on an ongoing basis. The FDA had previously granted omadacycline Qualified Infectious Disease Product designation and Fast Track designation, which provides for a Priority Review of the NDA, once accepted.