2018 Highlights and Recent Events
Vyleesi (bremelanotide)
Vyleesi™, the trade name for bremelanotide - Under development for Hypoactive Sexual Desire Disorder ("HSDD"):
In June 2018, our exclusive North American Licensee for Vyleesi, AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) ("AMAG"), was notified by the U.S. Food and Drug Administration ("FDA") of acceptance for the filing of the New Drug Application ("NDA") on Vyleesi, with an FDA PDUFA (Prescription Drug User Fee Act) goal date for completion of the FDA review of the NDA of March 23, 2019.
FDA's acceptance of the NDA triggered a $20 million milestone payment to Palatin, less expenses paid by AMAG.
Palatin is entitled to receive up to $60 million upon regulatory approval by the FDA.
If approved, Vyleesi would become the first and only on-demand pharmacologic option indicated for the treatment of HSDD in premenopausal women in the U.S.
Entered into a collaboration and license agreement with Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. ("Fosun"), a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd in September 2017 for exclusive rights to develop and commercialize Vyleesi in the territories of mainland China, Taiwan, Hong Kong S.A.R. and Macau S.A.R.
Received $4,500,000 in October 2017, consisting of an upfront payment of $5,000,000 less $500,000, which was withheld in accordance with tax withholding requirements in China.
Entered into a license agreement with Kwangdong Pharmaceutical Co., Ltd. ("Kwangdong") in November 2017 for exclusive rights to develop and commercialize Vyleesi in the Republic of Korea.
Received $417,500 in December 2017, consisting of an upfront payment of $500,000 less $82,500 which was withheld in accordance with tax withholding requirements in the Republic of Korea.
PL-8177 / PL-8331
Melanocortin Receptor 1 (MC1r) Agonists under development for the treatment of inflammatory and autoimmune diseases such as dry eye, uveitis, diabetic retinopathy and inflammatory bowel diseases:
Completed subcutaneous dosing of human subjects with PL-8177 in a Phase 1 single and multiple ascending dose clinical safety study, with data expected in the fourth quarter of calendar 2018.
May 2018 – Presented positive preclinical data on PL-8331 at TIDES: Oligonucleotide and Peptide Therapeutics 2018 Meeting.
April 2018 – Presented preclinical oral formulation data on PL-8177, an investigational MC1r agonist for Inflammatory Bowel Diseases at the 2018 Keystone Symposia on "The Resolution of Inflammation in Health and Disease."
Zurück
