Tarsus Pharmaceuticals and LianBio Announce Strategic Collaboration for Development and Commercialization of TP-03 in Greater China
Irvine, California; Shanghai; and Princeton, New Jersey – March 29, 2021 – Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), a late-stage clinical biopharmaceutical company, and LianBio, a biopharmaceutical company focused on bringing transformative medicines to patients in China and key Asian markets, today announced a strategic partnership to jointly develop and commercialize TP-03 in Greater China (mainland China, Hong Kong, Macau, and Taiwan). TP-03 is an investigational first-in-class therapy for the treatment of Demodex blepharitis and meibomian gland dysfunction (MGD), two ophthalmic conditions with significant unmet medical needs.
As part of the strategic partnership, LianTuo Bio will obtain exclusive rights to develop and commercialize TP-03 in Greater China. Tarsus will receive a $15 million upfront payment, as well as up to $185 million in development and commercialization milestone payments, including $10 million by June 30, 2021, and $45 million within the next 12 months contingent upon anticipated near-term clinical milestones. Based on TP-03 sales in Greater China, Tarsus is also eligible for low-double-digit tiered royalties and will acquire a minority equity stake in LianTuo Bio’s ophthalmology business, which will vest to Tarsus upon the achievement of specified development and commercialization milestones. Tarsus plans to allocate this non-dilutive capital toward the development of TP-03 for the treatment of Demodex blepharitis and meibomian gland dysfunction, as well as other promising pipeline candidates, including TP-04 and TP-05, which address significant unmet medical needs in conditions such as rosacea, Lyme disease, and malaria.
“We are delighted to partner with LianTuo Bio to make TP-03 available to patients in China. Through this collaboration, we continue to advance our company mission—starting with eye care—to deliver transformative therapies to patients in need,” said Dr. Bobak Azamian, CEO of Tarsus. “With its experienced team and growing product pipeline, we believe LianTuo Bio is well positioned to successfully commercialize TP-03 in Greater China. As a global company, we look forward to entering China, the world’s second-largest healthcare market, to provide treatment for the many patients urgently in need of therapy for Demodex blepharitis and meibomian gland dysfunction.”
“It is estimated that there are over 100 million patients in China with Demodex blepharitis and meibomian gland dysfunction. Meanwhile, the four Phase 2 clinical trials of TP-03 continue to generate compelling data. Based on this, we have targeted TP-03 and selected it as the cornerstone product for LianTuo Bio’s ophthalmology business,” said Mr. Konstantin Poukalov, Managing Director at Perceptive Advisors and Executive Chairman of LianTuo Bio. “We will continue to focus on innovative medicines that improve the quality of life for patients with unmet medical needs, thereby strengthening LianTuo Bio’s product pipeline. Through our collaboration with Tarsus, we will further expand into new therapeutic areas in Greater China where medical needs remain significantly underserved.”
TP-03 (0.25% lotilaner ophthalmic solution) is a novel investigational drug for the treatment and eradication of Demodex mites. TP-03 is a potent, non-competitive antagonist of insect and arachnid γ-aminobutyric acid (GABA)-gated chloride channels (GABA-Cl). Its high lipophilicity facilitates absorption into the sebum within hair follicles where the mites reside. Tarsus has completed four Phase 2 clinical trials of TP-03 for the treatment of Demodex blepharitis, all of which met their respective endpoints with no significant adverse events and no treatment discontinuations. TP-03 is currently being evaluated in the pivotal Phase 2b/3 Saturn-1 clinical trial. If approved, TP-03 could provide treatment for millions of patients worldwide suffering from Demodex blepharitis.
Blepharitis is a common ocular condition characterized by inflammation, redness, and irritation of the eyelid margins. Demodex blepharitis is caused by infestation with Demodex mites, the most common ectoparasites in humans. In the United States, approximately 45% of blepharitis cases are attributed to Demodex mites, affecting an estimated 9 million patients. However, one published study estimates that at least 45 million people visit ophthalmology clinics annually, and internal research by Tarsus indicates that approximately 58% of ophthalmology clinic patients present with waxy, cylindrical dandruff-like collarettes at the base of the eyelashes, which are pathological hallmarks of Demodex infestation. Based on these two data points, the actual number of patients with Demodex blepharitis may be as high as approximately 25 million. Currently, there are no FDA-approved treatments for Demodex blepharitis.
The lipids secreted by the meibomian glands in the eyelids constitute the outermost layer of the tear film. One of the hallmark features of meibomian gland dysfunction (MGD) is the extensive obstruction of these glands, which alters tear film composition and leads to ocular irritation, inflammation, and a spectrum of ocular surface diseases. MGD is one of the primary causes of dry eye disease, and currently, there are no approved treatments available. The clinical manifestations of MGD have been shown to correlate with infestation by a species of demodex mite, specifically Demodex folliculorum. TP-03 is currently under investigation as a potential therapy aimed at alleviating key aspects of MGD by eradicating Demodex folliculorum.
Tarsus Pharmaceuticals is a biopharmaceutical company focused on late-stage clinical development. Starting with eye care, the company leverages established science and novel technologies to deliver transformative therapies for patients. Tarsus is advancing its product pipeline to address high unmet medical needs across multiple therapeutic areas, including eye care, dermatology, and infectious disease prevention. The company’s lead candidate, TP-03, is a novel therapeutic agent for the treatment of Demodex blepharitis and is currently in Phase 2b/3 clinical trials. TP-03 is also being developed for the treatment of meibomian gland dysfunction.
LianBio’s mission is to deliver optimal science-driven breakthrough therapies to patients in China and other key Asian markets through efficient product development, enabled by strategic collaborations with leading global biopharmaceutical companies. By partnering with world-class collaborators across diverse therapeutic areas and geographies, LianBio has built a disease-relevant product pipeline that leverages translational mechanisms and precision therapies to improve patient outcomes.
Statements in this press release regarding future expectations, plans, and prospects, as well as any other statements that are not historical facts, may constitute “forward-looking statements.” These statements include, but are not limited to, those concerning: Tarsus’s receipt of payments and the achievement and timing of significant milestones under contractual terms; LianTuo Bio’s ability to commercialize TP-03 in the Greater China region; the market size for TP-03; Tarsus’s planned and anticipated revenues from candidate products, including TP-03; and future events, the timing, objectives, and results of clinical studies, as well as expected regulatory and development milestones. Words such as “believe,” “consider,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “hope,” their negatives, or similar expressions—including but not limited to the terms listed above—are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Due to a number of important factors, actual results may differ materially from those indicated in such forward-looking statements. Actual results are discussed from time to time in filings made by Tarsus with the U.S. Securities and Exchange Commission (SEC). Copies of these filings are posted on its website and are available free of charge from Tarsus. However, new risk factors and uncertainties may arise from time to time, and it is not possible to predict all such risk factors and uncertainties. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. Any forward-looking statements contained in this press release are based on the current expectations of Tarsus’s management team, are effective as of the date of this press release, and Tarsus assumes no obligation to update any forward-looking statements due to new information, future events, or otherwise.