– Vyleesi® for Premenopausal Women with Hypoactive Sexual Desire Disorder (HSDD) – AMAG to Divest Asset
– Dry Eye Disease Phase 2 Study to Commence Q1 2020 – Data Q4 2020
– Approximately $92 Million in Cash and Cash Equivalents at December 31, 2019
Jan 21, 2020, 07:30 ET
CRANBURY, N.J., Jan. 21, 2020 /PRNewswire/ — Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing targeted, receptor-specific therapeutics for the treatment of diseases with significant unmet medical need and commercial potential, today provided a corporate update and outlook for calendar year 2020.
“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.
Cash and cash equivalents at December 31, 2019 amounted to $92 million. The Company has no outstanding debt.
About Palatin Technologies
Palatin Technologies, Inc. is a biopharmaceutical company developing targeted, receptor-specific therapeutics for the treatment of diseases and conditions with significant unmet medical need and commercial potential. Palatin’s strategy is to develop products and then form marketing collaborations with industry leaders in order to maximize their commercial potential. For additional information regarding Palatin, please visit Palatin’s website at www.Palatin.com.
Statements in this press release that are not historical facts, including statements about future expectations of Palatin Technologies, Inc., such as statements about clinical trial results, potential actions by regulatory agencies including the FDA, regulatory plans, development programs, proposed indications for product candidates, AMAG’s plans to divest Vyleesi and Intrarosa, Palatin’s ongoing relationship with AMAG and ability to protect its rights as the Vyleesi licensor, and market potential for product candidates, are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995. Palatin intends that such forward-looking statements be subject to the safe harbors created thereby. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause Palatin’s actual results to be materially different from its historical results or from any results expressed or implied by such forward-looking statements. Palatin’s actual results may differ materially from those discussed in the forward-looking statements for reasons including, but not limited to, transfer of marketing and sale of Vyleesi in North America to another pharmaceutical company, sales of Vyleesi in the United States and elsewhere in the world, results of clinical trials, regulatory actions by the FDA and other regulatory and the need for regulatory approvals, Palatin’s ability to fund development of its technology and establish and successfully complete clinical trials, the length of time and cost required to complete clinical trials and submit applications for regulatory approvals, products developed by competing pharmaceutical, biopharmaceutical and biotechnology companies, commercial acceptance of Palatin’s products, and other factors discussed in Palatin’s periodic filings with the Securities and Exchange Commission. Palatin is not responsible for updating for events that occur after the date of this press release.
Vyleesi® is a registered trademark of AMAG Pharmaceuticals, Inc. in North America and of Palatin Technologies, Inc. elsewhere in the world.
SOURCE Palatin Technologies, Inc.