Allergan said today it will develop and commercialize the Phase III dry eye disease treatment tavilermide (MIM-D3) through an exclusive licensing agreement with Mimetogen Pharmaceuticals. The deal will generate at least $50 million-plus for Mimetogen.
Tavilermide is a small cyclic peptidomimetic of NGF, a naturally occurring protein in the eye responsible for maintaining corneal nerves and epithelium. Tavilermide is designed to induce production of mucin, a naturally occurring component of the tear film, and works upstream prior to inflammation.
Tavilermide is Mimetogen’s lead dry eye compound, now under study in two multicenter Phase III studies in the U.S.
Last year, Mimetogen announced positive results from a second Phase II study (MIM-725) showing significant improvements in both signs and symptoms with 1% tavilermide versus placebo, together with strong safety, comfort, and tolerability profiles. A first Phase II study (MIM-724) also generated promising results.
“Tavilermide brings a novel approach to treating the signs and symptoms of dry eye disease by enhancing the ocular tear film,” David Nicholson, evp and president, global brands research and development at Allergan, said in a statement. “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.”
Allergan agreed to pay Mimetogen $50 million upfront, as well as fund Phase III development of tavilermide. Mimetogen will also be eligible for payments tied to achieving milestones payments and royalties based on commercialization of the dry eye treatment.
The deal comes more than a year after the August 2014 termination of an exclusive licensing agreement for tavilermide between Mimetogen and Bausch+Lomb, which was acquired in 2013 by Valeant Pharmaceuticals International for $8.7 billion.
The licensing agreement fits with Allergan’s focus on eye care as one of eight therapeutic areas. Allergan’s other seven therapeutic areas are the central nervous system, medical aesthetics, gastroenterology, women's health, urology, cardiovascular, and anti-infective therapeutics.
Allergan announced the Mimetogen deal the same day it released third-quarter results. Allergan finished the quarter with net income of $5.232 billion compared with a net loss of $1.043 billion in Q3 2014, on net revenue that nearly doubled, rising 90% to $4.089 billion.
The company said its results were impacted by amortization and acquisition-related expenses, including license agreements, impairments, acquisition accounting valuation related expenses and severance associated with acquired businesses—mainly the acquisition of Allergan Inc. on March 17, 2015 and research and development (R&D) expenses resulting from the acquisition of R&D assets from Merck & Co. and Naurex.
Privately held Mimetogen focuses on developing the use of peptidomimetics as a novel approach to treating ophthalmic diseases with high unmet medical needs.
Mimetogen’s underlying technology was originally developed at McGill University and the Lady Davis Institute for Medical Research in Montreal. The company has won financing from investors that include VIMAC Milestone Medica, Ora, Medwell Capital, MSBi Valorisation, and iNovia Capital.