Palatin Technologies Profile
Palatin Technologies, Inc., a biopharmaceutical company, engages in developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor (MCr) system.
The company's product candidates are targeted, receptor-specific therapeutics for the treatment of diseases with significant unmet medical need and commercial potential.
The company's new product development activities in inflammation disease indications focus primarily on development of MCr peptides for ocular conditions, but also include conditions in the gut and kidney. Utilizing peptides, which are agonists at MC1r, and in some instances agonists at additional melanocortin receptors, the company is developing products to treat inflammatory and autoimmune diseases, such as dry eye disease (also known as keratoconjunctivitis sicca), uveitis, diabetic retinopathy, and inflammatory bowel disease. The company is also developing peptides that are active at more than one melanocortin receptor and small molecule MCr agonists.
The company's U.S. Food and Drug Administration (FDA) approved melanocortin receptor agonist, Vyleesi (bremelanotide injection), is an as needed therapy used in anticipation of sexual activity and self-administered in the thigh or abdomen via a single-use subcutaneous auto-injector by premenopausal women with hypoactive sexual desire disorder (HSDD). Vyleesi is the first FDA-approved melanocortin agent and the first and only FDA-approved as-needed treatment for premenopausal women with HSDD.
Melanocortin Receptor Programs
The company is designing and developing potent and highly selective MC1r agonist peptides and agonist peptides specific for more than one melanocortin receptor for the treatment of a variety of inflammatory and autoimmune indications. The company's agonist peptides regulate certain inflammatory cytokines, and modulate the activities of immune cells, such as monocytes and T cells, to reduce immune response, and may utilize mechanisms engaged by the endogenous melanocortin system in regulation of the immune system and resolution of inflammatory responses.
The company has conducted preclinical animal studies with MC1r selective and multiple MCr selective peptide drug candidates for selected inflammatory disease and autoimmune indications.
PL9643 for Dry Eye Disease and Anti-Inflammatory Ocular Indications: PL9643, a peptide melanocortin agonist active at multiple MCrs, including MC1r and MC5r, is the company's lead clinical development candidate for anti-inflammatory ocular indications, including dry eye disease, which is also known as keratoconjunctivitis sicca.
The company has developed a PL9643 ophthalmic solution (topical eye drops) in a single use delivery device, and a Phase 3 pivotal clinical trial (MELODY-1) designed to support a New Drug Application (NDA) has completed patient enrollment, with top line results expected by December 31, 2023. The company's Phase 2 clinical trial demonstrated improvements in both the signs and symptoms of dry eye disease in moderate to severe patients after just two weeks of treatment, with no adverse safety signals and tolerability. The company held an end-of-Phase 2 meeting with the FDA in June 2021, which included all aspects of the PL9643 development plan, including study design, endpoints, interim assessment, and patient population for the Phase 3 program. If results of the MELODY-1 clinical trial are positive, the company will initiate a second Phase 3 clinical trial.
Oral PL8177 for Inflammatory Bowel Diseases: PL8177, a selective MC1r agonist peptide, is the company's lead clinical development candidate for inflammatory bowel diseases, including ulcerative colitis. The company has completed subcutaneous dosing of human subjects in a Phase 1 single and multiple ascending dose clinical safety study, and a human microdose pharmacokinetic study to evaluate a polymer-encapsulated, delayed-release, oral formulation of PL8177.
For ulcerative colitis and other inflammatory bowel diseases the company administers PL8177 in its oral formulation to deliver PL8177 to the interior wall of the diseased bowel. PL8177 activates MC1r present on the interior wall of the bowel in ulcerative colitis and other inflammatory bowel diseases.
A Phase 2 study in ulcerative colitis using the company's polymer-encapsulated, delayed-release, oral formulation of PL8177 initiated patent enrollment in September 2022, and is ongoing.
Diabetic Nephropathy Proof-of-Concept Study: A Phase 2 proof-of-concept study is enrolling patients in a study for diabetic nephropathy.
Melanocortin Peptides for Diabetic Retinopathy: The company conducted preclinical studies with melanocortin peptides in diabetic retinopathy models and has selected a peptide candidate for further development work. The company is working on a formulation for intravitreal and subcutaneous administration. If results support advancing the program, the company will conduct required safety studies and manufacture drug product under Good Manufacturing Practices (GMP) regulations needed to file an Investigational New Drug application (IND) and initiating clinical studies.
Ocular Research Programs: The company is conducting research in several additional ocular areas, including both front of the eye and back of the eye indications, exploring use of its compounds to treat additional indications.
Vyleesi for Hypoactive Sexual Desire Disorder (HSDD): Vyleesi, the registered trademark for bremelanotide injection, was approved by the FDA in June 2019 for the treatment of premenopausal women with acquired, generalized HSDD. AMAG Pharmaceuticals, Inc. (AMAG), which had exclusively licensed Vyleesi for North America, initiated sales and marketing efforts for Vyleesi in the United States in August 2019, with a national launch in September 2019. In July 2020, the company and AMAG entered into a termination agreement, pursuant to which the license agreement was terminated, it regained all North America rights for Vyleesi, and AMAG made a payment to the company at closing and a payment to the company in the first quarter of 2021. The company assumed Vyleesi manufacturing agreements, and AMAG transferred information, data and assets related exclusively to Vyleesi, including existing inventory.
Vyleesi faces competition primarily from Addyi (flibanserin) for the treatment of HSDD in pre-menopausal women and is marketed by Sprout Pharmaceuticals, Inc.
Vyleesi is distributed nationally through a home delivery specialty pharmacy. The company also focuses its Vyleesi marketing efforts towards healthcare professionals, who play a significant role in increasing HSDD and Vyleesi awareness among their patients. As the commercial potential of Vyleesi is demonstrated, the company is exploring licensing marketing and distribution rights for the United States to a marketing partner.
The company has a license agreement with Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. (Fosun) for exclusive rights to commercialize Vyleesi in China. The company has a license agreement with Kwangdong Pharmaceutical Co., Ltd. (Kwangdong) for exclusive rights to commercialize Vyleesi in Korea.
The company retains worldwide rights for Vyleesi for HSDD and all other indications outside Korea and China. The company is seeking potential partners for marketing and commercialization rights for Vyleesi for HSDD outside the licensed territories, including entering into a license agreement for marketing and commercialization rights for Vyleesi in the United States.
Strategy
The company's strategy is to develop products and then form marketing collaborations with industry leaders to maximize product commercial potential. The key elements of the company's strategy include maximizing revenue from Vyleesi by marketing Vyleesi in the United States, supporting its existing licensees for China and Korea, and licensing Vyleesi for the United States and additional regions; maintaining a team to create, develop and commercialize MCr products addressing unmet medical needs; entering into strategic alliances and partnerships with pharmaceutical companies to facilitate the development, manufacture, marketing, sale, and distribution of product candidates that it is developing; and completing development and seeking regulatory approval of certain of its other product candidates.
Patents and Proprietary Information
The company owns a number of issued United States patents and has pending United States patent applications, many with issued or pending counterpart patents in selected foreign countries.
The company owns four issued United States patents and pending patent applications in the United States for methods of treating female sexual dysfunction (FSD) with Vyleesi, with related patents issued or pending in selected countries in Europe and Asia and in Australia and New Zealand. Issued patents and pending applications in the United States and elsewhere in the world have a presumptive term, if a patent is issued, until 2033.
The company owns two issued United States patents claiming the Vyleesi drug substance. One patent has expired, and the other patent, which would have otherwise expired in 2020, has been granted a five-year extension, the maximum period as compensation for patent term lost during drug development and the FDA regulatory review process, pursuant to the Drug Price Competition and Patent Term Restoration Act of 1984, or the Hatch-Waxman Amendments. This patent expires in June 2025. In addition, the claims of the outstanding patent covering Vyleesi may not provide meaningful protection. Further, third parties may challenge the validity or scope of any issued patent, and under the Hatch-Waxman Amendments, potentially receive approval of a competing generic version of its product or products even before a court rules on the validity or infringement of its patents.
The company has filed patent applications under the Patent Cooperation Treaty claiming PL9643 and other peptides in development for ocular and inflammatory disease indications and has entered national stage prosecution in the United States, European Patent Office, Eurasian Patent Office, and broadly throughout the world. If one or more patents are granted, the patents will have a presumptive term until 2041. Until one or more product candidates covered by a claim of one of these patent applications are developed for commercialization, which may never occur, the company cannot evaluate the duration of any potential patent term extension under the Hatch-Waxman Amendments.
The company owns five issued patents in the United States, and issued patents in Australia, Belgium, Brazil, Canada, China, France, Germany, Ireland, Israel, Japan, Korea, Mexico, New Zealand, Russia, South Africa, Sweden, Switzerland and the United Kingdom claiming highly selective MC1r agonist peptides, including for the treatment of inflammation-related diseases and disorders and related indications. The presumptive term of the issued patents and pending patent applications is until 2030. Until one or more product candidates covered by a claim of one of these patent applications are developed for commercialization, which may never occur, the company cannot evaluate the duration of any potential patent term extension under the Hatch-Waxman Amendments.
The company has additional issued United States patents on melanocortin receptor specific peptides and small molecules, including patents on an alternative class of melanocortin receptor-specific peptides for the treatment of sexual dysfunction and other indications, and on natriuretic peptide receptor agonist compounds, but it is not actively developing any product candidate covered by a claim of any of these patents.
Trademarks and Trade Names
Palatin Technologies and Vyleesi are registered trademarks of the company, and Palatin and the Palatin logo are trademarks of the company.
Research and Development
For the year ended June 30, 2023, the company's research and development expenses were $22,630,577.
U.S. Governmental Regulation of Pharmaceutical Products
The products the company is developing are subject to federal regulation in the United States, principally by the FDA under the Federal Food, Drug, and Cosmetic Act, and by state and local governments, as well as ministries of health and other authorities in foreign governments.
History
Palatin Technologies, Inc. was founded in 1986. The company was incorporated under the laws of the state of Delaware in 1986.
