Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced that its wholly owned subsidiary has entered into an exclusive licensing agreement with Mimetogen Pharmaceuticals, a clinical stage biotechnology company, to develop and commercialize tavilermide (MIM-D3), a topical formulation of a novel small molecule TrkA agonist for the treatment of dry eye disease.
Under the terms of the agreement, Allergan will make an upfront payment of $50 million to Mimetogen and will fund phase 3 development of tavilermide. Mimetogen will additionally be entitled to receive potential milestone payments and royalties based on commercialization of the product.
Tavilermide is a small cyclic peptidomimetic of NGF, a naturally occurring protein in the eye responsible for the maintenance of corneal nerves and epithelium. Tavilermide is differentiated from other investigational therapies in dry eye disease because it induces the production of mucin, a naturally occurring component of the tear film, and works upstream prior to inflammation.
"Allergan is committed to leading in the development of novel therapies in eye care and dry eye disease," said David Nicholson, Executive Vice President and President, Global Brands Research and Development at Allergan. "Tavilermide brings a novel approach to treating the signs and symptoms of dry eye disease by enhancing the ocular tear film. If approved, tavilermide would provide another exciting new treatment option for patients suffering with dry eye and further strengthen our dry eye portfolio and pipeline."
"Mimetogen is excited to work together with Allergan, the recognized leader in developing effective therapies to treat dry eye disease," noted Garth Cumberlidge, PhD, Mimetogen President & CEO. "I am very proud of our Mimetogen colleagues who have worked very hard to develop tavilermide, and look forward to working with Allergan to advance this important development program for patients."
In a previously announced Phase 2 trial (Study Designation MIM-725) tavilermide demonstrated significant improvements in both signs and symptoms with 1% tavilermide versus placebo, together with strong safety, comfort and tolerability profiles. Tavilermide is currently being evaluated in two multi-center Phase 3 clinical studies in the United States for the treatment of dry eye disease.
"Dry eye disease continues to be an area where novel therapies are needed to improve the treatment of the disease, including the underlying cause of dry eye, for patients," said Rajesh K. Rajpal, MD, Medical Director and Founder, See Clearly Vision Group, Mclean, VA and Clinical Faculty, Georgetown University, Washington, DC. "Tavilermide has shown the ability to improve patient-reported blurriness and poor vision with a positive comfort and tolerability profile in recent clinical studies. This development program is encouraging for the ophthalmology community seeking new therapies to better address this important area of patient treatment."
Dry Eye Disease
Dry eye disease can be caused by advanced age, contact lens wear, certain medications, eye diseases, other medical conditions or environmental factors. One type of dry eye is caused by decreased tear production due to inflammation. Without enough tears, the film protecting the eye can break down, creating dry spots on the cornea. Chronic dry eye is estimated to affect 25 million patients in the U.S.
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines and biologic products for patients around the world.
Allergan markets a portfolio of best-in-class products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women's health, urology, cardiovascular and anti-infective therapeutic categories, and operates the world's third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. Allergan is an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally.
With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.
For more information, visit Allergan's website at www.allergan.com.
About Mimetogen Pharmaceuticals
Mimetogen Pharmaceuticals, Inc. is a private company focused on developing the use of peptidomimetics as a novel approach to treating ophthalmic diseases with high unmet medical needs. The underlying technology, originally licensed from McGill University and the Lady Davis Institute for Medical Research in Montreal, has been developed with the support of VIMAC Milestone Medica, Ora, Medwell Capital, MSBi Valorisation, and iNovia Capital.
Allergan Forward-Looking Statements
Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's business. These factors include, among others, the risks associated with acquisition transactions; the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Quarterly Report on Form 10-Q for the quarter ended June 30, 2015 (such periodic public filings having been filed under the "Allergan plc" or "Actavis plc" names) and from time to time in Allergan's other investor communications . Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.
 Market Scope®, 2011 Report on the Global Market for Dry Eye Products; 2011, 1-148.