"2019 was pivotal for Palatin - we had a major achievement with the FDA approval of Vyleesi® for the treatment of HSDD in premenopausal women, which resulted in the receipt of a $60 million milestone payment," said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin. "The FDA approval was also significant for premenopausal women, as they now have a safe and effective as-needed treatment option available to them. Our enhanced cash position, which was $92 million at December 31, 2019, puts us in an excellent position to advance our pipeline programs. We have two Phase 2 clinical studies starting in the first half of calendar year 2020: a dry eye disease study with data expected in the fourth quarter of calendar year 2020 and an ulcerative colitis trial with data expected in mid-calendar year 2021."
On January 9, 2020 AMAG Pharmaceuticals, Inc. ("AMAG") announced that, as a result of a strategic review, it will divest Vyleesi, which it exclusively licensed from Palatin for North America, and another female healthcare product, Intrarosa®. AMAG stated that it has received preliminary expressions of interest in these assets.
Under the Vyleesi license agreement, AMAG has a contractual obligation to use commercially reasonable efforts to commercialize Vyleesi. If AMAG materially breaches this obligation and fails to cure such breach, Palatin could potentially have the right to terminate the license agreement and require AMAG to assign and transfer its Vyleesi rights to Palatin. In the event AMAG assigns its Vyleesi license, the assignee must expressly agree to be bound by the Vyleesi license agreement between AMAG and Palatin.
Dr. Spana further commented, "AMAG's planned divestiture of Vyleesi is based on its change in strategy and the early commercial stage of Vyleesi and is not a result of the launch performance to date. We have a good relationship with AMAG and understand its decision in the context of its overall strategy. That said, we will diligently protect our rights as the Vyleesi licensor and take appropriate steps to safeguard that the significant value of Vyleesi remains intact and continues to grow. We will also be opportunistic and flexible as the divestiture process advances, with the objective that the next owner of the North American rights to Vylessi is committed to the robust commercialization of the product."
Overview of Programs and Calendar Year 2020 Outlook
Hypoactive Sexual Desire Disorder (HSDD) / Vyleesi® (bremelanotide injection)
Vyleesi is the first as needed treatment approved for premenopausal women with acquired, generalized HSDD. AMAG Pharmaceuticals, Palatin's North American licensee, launched Vyleesi nationally in September through select specialty pharmacies with its established women's health sales force of approximately 125 sales representatives. While AMAG has not yet released prescription numbers for the quarter ended December 31, 2019, AMAG has stated publicly that the "Vyleesi launch is off to a strong start."
Palatin is advancing discussions on Vyleesi collaborations for territories outside the currently licensed territories of North America, China, and Korea, and anticipates executing multiple agreements during calendar year 2020. Vyleesi is licensed to Fosun Pharma in China and Kwangdong Pharmaceuticals in South Korea. Both companies are advancing Vyleesi through the regulatory process in their respective territories, which includes the conduct of certain clinical studies in those territories prior to filing for market approval.
Anti-Inflammatory / Autoimmune Programs
Melanocortin agonist products are under development for the treatment of inflammatory and autoimmune diseases such as dry eye disease, uveitis, diabetic retinopathy and inflammatory bowel diseases (ulcerative colitis).
An investigational new drug application (IND) for PL9643 in dry eye disease (DED) was filed with the US Food and Drug Administration (FDA) in December 2019. A Phase 2 clinical study is expected to commence in the first quarter of calendar year 2020, with data readout anticipated in the fourth quarter of calendar year 2020.
A Phase 2 proof-of-concept clinical study with an oral formulation of PL8177 in ulcerative colitis patients is anticipated to commence mid-calendar year 2020, with data readout mid-calendar year 2021.
Palatin continues its assessment and development work related to the treatment of patients with diabetic retinopathy and non-infectious uveitis (NIU) (FDA granted orphan drug designation for PL8177 in NIU), with the objective of commencing clinical trials in calendar year 2021.
Natriuretic Peptide Receptor ("NPR") System Program
Palatin has designed and is developing potential drug candidates that are selective agonists for one or more different natriuretic peptide receptors, including natriuretic peptide receptor-A ("NPR-A"), natriuretic peptide receptor B ("NPR-B"), and natriuretic peptide receptor C ("NPR-C").
PL3994, an NPR-A agonist, will be evaluated in a Phase 2a clinical study in heart failure patients with preserved ejection fraction. The proposed study is part of a collaboration with two major academic medical centers and is supported by an American Heart Association grant. The study is anticipated to start patient enrollment in 2020.
PL3994 has potential utility in the treatment of a number of cardiovascular diseases, including genetic and orphan diseases resulting from a deficiency of endogenous active NPR-A, and PL5028, a dual NPR-A and NPR-C agonist in development for cardiovascular diseases, has potential for reducing cardiac hypertrophy and fibrosis, among other indications.
Genetic Obesity Program
The Company's melanocortin receptor 4 ("MC4r") peptide PL8905 and orally active small molecule PL9610 are currently under investigation for the treatment of rare genetic metabolic and obesity disorders. These programs are under internal evaluation for orphan designation, potential development and licensing.
Corporate
Cash and cash equivalents at December 31, 2019 amounted to $92 million. The Company has no outstanding debt.
