On August 6, 2019 Palatin Technologies, Inc. (NYSE American: PTN) reported that it will be presenting at Canaccord Genuity’s 39th Annual Growth Conference on Wednesday, August 7, 2019, at 10:30 am ET. The conference will be held at the InterContinental Hotel in Boston, MA (Press release, Palatin Technologies, AUG 6, 2019, View Source [SID1234538234]).
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Carl Spana, Ph.D., President and Chief Executive Officer of Palatin Technologies, will provide an update on Palatin’s corporate and development programs, including:
Hypoactive Sexual Desire Disorder / Vyleesi (bremelanotide injection)
On June 21, 2019, the U.S. Food and Drug Administration (FDA) granted marketing approval of AMAG Pharmaceuticals, Inc’s New Drug Application (NDA) for Vyleesi, a melanocortin receptor agonist developed by Palatin, indicated for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. The Vyleesi autoinjector is the first treatment for this patient population that can be self-administered as needed in anticipation of sexual activity.
The FDA’s approval of the NDA triggered a $60 million milestone payment to Palatin (received July 2019) under its North American license agreement with AMAG.
AMAG is expected to launch Vyleesi nationally in September 2019.
Discussions with multiple parties on potential commercial partnerships for territories outside North America, China and South Korea are advancing.
Melanocortin Anti-Inflammatory / Autoimmune Programs under development for the treatment of inflammatory and autoimmune diseases such as dry eye, uveitis, diabetic retinopathy and inflammatory bowel diseases (ulcerative colitis)
A Phase 2 proof-of-concept clinical study for PL-8177 with a systemic formulation in NIU patients is anticipated to commence in the first quarter of calendar year 2020.
A Phase 2 proof-of-concept clinical study for PL-8177 with an oral formulation in ulcerative colitis patients is anticipated to commence in the first quarter of calendar year 2020.
A Phase 2 clinical study for PL-9643 in dry eye disease is currently anticipated to commence in the first quarter of calendar year 2020. A recently completed Type B pre-IND (Investigational New Drug) meeting with the FDA established the development pathway for activities, including CMC, non-clinical studies and clinical studies, required for an NDA (New Drug Application) submission.
Cash and cash equivalents at June 30, 2019, on a pro forma basis, which includes the $60 million milestone payment by exclusive North American licensee, AMAG Pharmaceuticals, Inc., is approximately $102 million dollars.