Cosette Pharmaceuticals, Inc.

Dry Eye Disease (DED): PL9643 MELODY-2 & MELODY-3 Phase 3 Pivotal Clinical Studies FDA Confirms Protocols and Endpoints Targeting Enrollment Start in 4Q Calendar Year 2024 Topline Results Anticipated 4Q Calendar Year 2025 Potential Collaboration/Funding Discussions Ongoing Obesity: Phase 2 Clinical Study with Melanocortin-4 Receptor (MC4R) Agonist + Glucagon Like Peptide-1 (GLP-1) Patient Dosing Commenced 3Q Calendar Year 2024 Topline Results Expected 1Q Calendar Year 2025 Male Sexual Dysfunction: Development and Clinical Program with Bremelanotide Co-Formulated with a PDE5i for the Treatment of Erectile Dysfunction (ED) in Patients That Do Not Respond to PDE5i Monotherapy Pharmacokinetics Study Expected to Start 1Q Calendar Year 2025 Patient Recruitment in Phase 3 Study Anticipated in 2H Calendar Year 2025 Ulcerative Colitis (UC): Oral PL8177 Phase 2 Clinical Study in Active UC Patients Interim Analysis Readout Expected in 4Q Calendar Year 2024 Topline Results Anticipated 1Q Calendar Year 2025 Potential Collaboration Discussions Ongoing CRANBURY, N.J. , Sept. 9, 2024 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, today provided an update on its clinical programs, strategic priorities, and anticipated milestones. "We continue to execute on the clinical development front and expect several key milestones from multiple programs over the next twelve months," said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin. "Patient dosing has commenced in our Phase 2 clinical study of an MC4R agonist plus a GLP-1 in obese patients. Our clinical program evaluating bremelanotide co-formulated with a PDE5i for the treatment of ED in patients who do not respond to PDE5i monotherapy is expected to begin in the first half of calendar year 2025. An interim analysis readout on our Phase 2 clinical trial of PL8177 in patients with UC is expected later this calendar year. Additionally, as a result of a positive Type C meeting with the FDA and agreement on PL9643 for DED Phase 3 trial protocols and endpoints, we anticipate the initiation of pivotal clinical studies MELODY-2 and MELODY-3 in the fourth quarter of this calendar year." Dr. Spana further commented, "We are focused on the continued development of melanocortin receptor system treatments for obesity and male sexual dysfunction. We are actively engaging in discussions with potential partners and companies that have the financial and operational resources to progress PL9643 for DED, our other ocular programs, and our ulcerative colitis program, through development, approval, and into commercialization. Program Updates and Anticipated Milestones Ocular Programs (melanocortin receptor agonists): Phase 3 PL9643 clinical program for the treatment of dry eye disease (DED): Potential collaboration/funding discussions ongoing MELODY-2 & MELODY-3 Phase 3 pivotal clinical studies Concluded a positive Type C meeting with the FDA and reached an agreement on sign and symptom endpoints on the remaining two Phase 3 pivotal trial protocols Targeting 4Q calendar year 2024 to begin patient enrollment Topline results anticipated 4Q calendar year 2025 Potential NDA submission 1H calendar year 2026 Successful Phase 3 MELODY-1 pivotal study successfully completed Statistical significance (p<0.025) met for co-primary symptom endpoint of pain Statistical significance (p,0.05) met for 7 of 11 secondary symptom endpoints at the 12-week treatment period Statistical significance (p<0.05) met for rapid onset of efficacy and multiple symptom endpoints, including the co-primary pain endpoint at the 2-week treatment period and continued to improve over the 12-week treatment period Statistical significance (p<0.05) met for multiple sign endpoints, including 4 fluorescein staining endpoints at the 2-week treatment period Corneal fluorescein staining is used to measure corneal epithelial damage and reductions in corneal fluorescein staining with treatments like PL9643 indicate improvement in corneal health Excellent safety and tolerability profile Obesity Program: Phase 2 clinical study for the co-administration of melanocortin agonist bremelanotide (MC4R) with tirzepatide (GLP-1) in obese patients for the treatment of obesity: Initiated 2Q of calendar year 2024 Patient dosing commenced 3Q calendar year 2024 Topline results expected 1H calendar year 2025 The study is designed to enroll up to 60 patients at four trial sites in the United States with the Primary endpoint of the trial to demonstrate the safety and increased efficacy of co-administration of bremelanotide with tirzepatide on reducing body weight Patients will be treated with tirzepatide-only for four weeks, have eligibility confirmed, then randomized to one of four treatment regimens Patients will undergo multiple assessments of safety and efficacy to help profile the effectiveness of bremelanotide in treating general obesity as a stand-alone treatment or in conjunction with GLP-1/GIP therapy Additional trial information, including inclusion and exclusion criteria, can be found at via the identifier NCT06565611 Novel MC4R selective long-acting agonist: Initiation of investigational new drug (IND) enabling activities expected 4Q of calendar year 2024 Filing of IND anticipated 2H of calendar year 2025 Male Sexual Dysfunction Program: Initiated a development and clinical program for the evaluation of bremelanotide co-formulated with PDE5 inhibitor (PDE5i), for the treatment of erectile dysfunction (ED) in patients that do not respond to PDE5i monotherapy: Pharmacokinetics study initiation expected to start 1Q of calendar year 2025 Patient recruitment in Phase 3 clinical study anticipated 2H calendar year 2025 Topline results targeted for 1H calendar year 2026 Approximately 35% of men with ED have an inadequate response to PDE5i treatments and represent a large underserved market Palatin previously conducted clinical trials showing the synergistic effects of combining bremelanotide with a PDE5i as a treatment for ED Ulcerative Colitis Program (melanocortin receptor agonist): Phase 2 PL8177 oral formulation for the treatment of ulcerative colitis (UC): Potential collaboration discussions ongoing Interim analysis expected in 4Q calendar year 2024 Topline results anticipated 1Q calendar year 2025 Additional trial information, including inclusion and exclusion criteria, can be found at via the identifier NCT05466890 Diabetic Nephropathy Program (melanocortin receptor agonist): Phase 2 bremelanotide BREAKOUT study (BMT 701) in patients with diabetic kidney disease: Topline results expected in the fourth quarter of calendar year 2024 Additional trial information, including inclusion and exclusion criteria, can be found at via the identifier NCT05709444 Vyleesi® (bremelanotide injection) / Hypoactive Sexual Desire Disorder: Asset sale to Cosette Pharmaceuticals for up to $171 million closed in December 2023: $12 million upfront, plus potential sales-based milestones of up to $159 million based on annual net sales ranging from $15 million to $200 million Palatin retained rights and use of bremelanotide for obesity and male erectile dysfunction indications About Melanocortin Receptor Agonists The melanocortin receptor ("MCR") system has effects on inflammation, immune system responses, metabolism, food intake, and sexual function. There are five melanocortin receptors, MC1R through MC5R. Modulation of these receptors, through use of receptor-specific agonists, which activate receptor function, or receptor-specific antagonists, which block receptor function, can have medically significant pharmacological effects. Many tissues and immune cells located in the eye (and other places, for example the gut and kidney) express melanocortin receptors, empowering our opportunity to directly activate natural pathways to resolve disease inflammation. About Palatin Palatin is a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor systems, with targeted, receptor-specific product candidates for the treatment of diseases with significant unmet medical need and commercial potential. Palatin's strategy is to develop products and then form marketing collaborations with industry leaders to maximize their commercial potential. For additional information regarding Palatin, please visit Palatin's website at and follow Palatin on Twitter at @PalatinTech. Forward-looking Statements Statements in this press release that are not historical facts, including statements about future expectations of Palatin Technologies, Inc., such as statements about Palatin products in development, clinical trial results, potential actions by regulatory agencies including the FDA, regulatory plans, development programs, proposed indications for product candidates, 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, 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 events that occur after the date of this press release. Palatin Technologies® is a registered trademark of Palatin Technologies, Inc. SOURCE Palatin Technologies, Inc.

The companies will jointly control Cosette, with a focus on accelerating innovation and growth. Since Avista's initial investment in Cosette in December 2018, Cosette has launched new products through research and development efforts, acquisitions, and licensing deals. This includes the acquisition of Ambien and Ambien CR in the United States from Sanofi US. The company reports that these initiatives have led to significant EBITDA growth and free cash flow generation, positioning Cosette for future opportunities. Apurva Saraf, president and CEO of Cosette, said: “This partnership is a testament to the remarkable transformation our business has achieved over the past four years, driven by an unwavering commitment to strategic business development and operational excellence. I am immensely proud of the entire Cosette team for their dedication in delivering this robust growth. “We have successfully diversified our portfolio with branded products such as Clomid, Ambien, and Benicar, along with innovative, patent-protected drugs like Vyleesi and Intrarosa. With our strong R&D and business development pipeline, we are well positioned to drive substantial growth in partnership with Avista and Hamilton Lane." Financial strength and future opportunities for Cosette Pharmaceuticals The companies indicate that this transaction will enhance Cosette's balance sheet and support growth through investments in R&D and strategic acquisitions. The goal is to build a durable, high-growth, branded pharmaceutical company. As part of the transaction, Cosette has also secured a new term loan financing with Hayfin Capital Management and a new revolving credit facility provided by UBS Investment Bank, Capital One, National Association, and Santander Corporate & Investment Bank, who acted as joint lead arrangers and joint bookrunners for the financing. googletag.cmd.push(function () { googletag.display('text-ad1'); }); David Burgstahler, managing partner and CEO of Avista, added: “We value Avista's long-term relationship with Hamilton Lane and look forward to collaborating with them as a strategic partner to drive growth and value at Cosette. Our collective expertise will prove invaluable as Cosette evaluates larger M&A opportunities as part of the company's growth strategy.” Cosette Pharmaceuticals has made significant contributions to the pharmaceutical industry, particularly in the realm of specialty pharmaceuticals. The company has a strong focus on developing and commercializing branded and generic products that address unmet medical needs. With a diverse portfolio that includes notable products, Cosette has demonstrated a commitment to innovation and patient care. It says its strategic approach to research and development, coupled with targeted acquisitions and licensing deals, has enabled them to introduce groundbreaking therapies and expand their market presence, positively impacting patient outcomes and advancing healthcare solutions.

Cosette Pharmaceuticals Acquires Ambien® and Ambien CR® (Zolpidem Tartrate) Tabs from Sanofi US in the US Market Seamless Transition Ensures Continued Supply for Patients Who Depend on Ambien® Acquisition Builds on Cosette’s Leading Expertise in Carving Out Critical Drugs from Global Pharma Companies BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Cosette Pharmaceuticals, Inc. (“Cosette”), a US-based specialty pharmaceutical company, has completed the acquisition of Ambien® and Ambien CR® in the United States from Sanofi US. This press release features multimedia. View the full release here: Ambien (Photo: Business Wire) “We are excited at the addition of Ambien to our portfolio,” stated Apurva Saraf, President and CEO of Cosette. “We continue to leverage our demonstrated, best-in-class capabilities in executing complex carve-outs and integrating diverse products. This acquisition not only strengthens our product portfolio but also reaffirms our commitment to ensuring high-quality products continue to remain available to patients worldwide." According to IQVIA®, U.S. annual sales for Ambien® and Ambien® CR for the 12 months ended April 2024 were $39 million. Cosette has a history of successfully acquiring or carving-out and integrating products from companies across Japan, Europe, and the USA. Our strategic approach and deep industry expertise help us make divestiture and product transition seamless, ensuring uninterrupted access to critical medicines for millions of patients. Patients and providers can learn more about Ambien® and Ambien CR®, including Important Safety Information, at About Cosette Pharmaceuticals: Cosette Pharmaceuticals, Inc. (“Cosette”) is a US-based, fully integrated pharmaceutical company with a fast-growing portfolio of branded pharmaceuticals consisting of products in women’s health, cardiology and dermatology. Cosette has a long history in quality manufacturing of complex dosage forms including topical creams, ointments, oral liquids/solutions and suppositories. Cosette has corporate and manufacturing facilities in New Jersey and North Carolina and is supported by 300+ dedicated employees across all functional areas. Cosette is backed by Avista Capital Partners, a healthcare focused private equity firm. Visit and follow us on LinkedIn.