Tuesday, January 21, 2020 8:03:32 AM
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.
Recent PTN News
- Palatin Provides Update on Clinical Programs, Strategic Priorities, and Anticipated Milestones • PR Newswire (US) • 09/09/2024 11:30:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/06/2024 08:35:29 PM
- FDA Confirms Acceptability of Palatin's Remaining Phase 3 Pivotal Clinical Trials for PL9643 in Dry Eye Disease (DED) • PR Newswire (US) • 08/28/2024 11:30:00 AM
- First Patient Dosed in Phase 2 Clinical Study of Palatin's Bremelanotide Co-Administered with Tirzepatide (GLP-1) for the Treatment of Obesity • PR Newswire (US) • 08/22/2024 11:30:00 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/02/2024 09:01:24 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/31/2024 08:31:03 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/31/2024 08:31:01 PM
- Form S-1 - General form for registration of securities under the Securities Act of 1933 • Edgar (US Regulatory) • 07/25/2024 08:46:11 PM
- Form 4/A - Statement of changes in beneficial ownership of securities: [Amend] • Edgar (US Regulatory) • 07/17/2024 03:14:36 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/16/2024 08:32:10 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/16/2024 08:32:05 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/16/2024 08:31:58 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/16/2024 08:31:50 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/16/2024 08:31:43 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/16/2024 08:31:40 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/16/2024 08:31:20 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/16/2024 08:31:16 PM
- Palatin Announces Exercise of Warrants for Approximately $6.1 Million Gross Proceeds • PR Newswire (US) • 06/21/2024 12:00:00 PM
- Palatin Announces the Initiation of a Phase 2 Clinical Study of Bremelanotide Co-Administered with a PDE5i for the Treatment of Erectile Dysfunction (ED) • PR Newswire (US) • 06/20/2024 11:30:00 AM
- Palatin Initiates Phase 2 Clinical Study of Bremelanotide for the Treatment of Obesity • PR Newswire (US) • 06/12/2024 11:30:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/15/2024 12:40:59 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/15/2024 12:04:24 PM
- Palatin Reports Third Quarter Fiscal Year 2024 Financial Results and Provides Corporate Update • PR Newswire (US) • 05/15/2024 11:30:00 AM
- Palatin to Report Third Quarter Fiscal Year 2024 Results; Teleconference and Webcast to be held on May 15, 2024 • PR Newswire (US) • 05/09/2024 11:30:00 AM
- Palatin Announces FDA Clearance of IND Application for the Co-Administration of Bremelanotide with Tirzepatide (GLP-1) for the Treatment of Obesity • PR Newswire (US) • 05/02/2024 11:30:00 AM
VHAI - Vocodia Partners with Leading Political Super PACs to Revolutionize Fundraising Efforts • VHAI • Sep 19, 2024 11:48 AM
Dear Cashmere Group Holding Co. AKA Swifty Global Signs Binding Letter of Intent to be Acquired by Signing Day Sports • DRCR • Sep 19, 2024 10:26 AM
HealthLynked Launches Virtual Urgent Care Through Partnership with Lyric Health. • HLYK • Sep 19, 2024 8:00 AM
Element79 Gold Corp. Appoints Kevin Arias as Advisor to the Board of Directors, Strengthening Strategic Leadership • ELMGF • Sep 18, 2024 10:29 AM
Mawson Finland Limited Further Expands the Known Mineralized Zones at Rajapalot: Palokas step-out drills 7 metres @ 9.1 g/t gold & 706 ppm cobalt • MFL • Sep 17, 2024 9:02 AM
PickleJar Announces Integration With OptCulture to Deliver Holistic Fan Experiences at Venue Point of Sale • PKLE • Sep 17, 2024 8:00 AM