Milestones could reach $375 million, and Allergan will take over from Phase III.
Allergan is paying $45 million up front to license Molecular Partners’ MP0112, a Phase II treatment for retinal diseases. Molecular Partners is further entitled to receive about $375 million in development, regulatory, and sales milestones. In addition, the company will receive tiered double-digit royalties.
Under the agreement, Allergan obtains exclusive global rights for MP0112 for ophthalmic indications. The parties will work together during Phase IIb development, and Allergan will be responsible for Phase III development and commercialization activities.
Data on MP0112 from two separate Phase I/IIa trials in wet age-related macular degeneration (AMD) and diabetic macular edema (DME) showed that the drug is well tolerated and has a potentially long-lasting effect on vision gain after a single injection. For most patients in the cohorts treated with the higher dose of the investigational compound, the potential beneficial effect on visual acuity lasted for approximately 16 weeks, Molecular Partners reports.
MP0112, a protein therapeutic, is the lead candidate in Molecular Partners’ pipeline, which is based on DARPin® technology. The platform reportedly combines the desired properties of antibody therapeutics with those of small molecules. DARPins have superior potencies, are robust, low-cost in their development, safe, and can penetrate tissue easily, according to Molecular Partners.
Pools of high-affinity (low pM) DARPins can be directly identified from large naïve libraries (1,012 individual members) by ribosomal display, retaining a high sequence diversity, the company explains. Typically, no affinity maturation and lead optimization are needed.
Enriched pools of binders are screened for the DARPins with the best functional properties. Lead candidates can typically be identified within a few months, Molecular Partners states. Lead DARPins are routinely optimized for their pharmacokinetic behavior and screened for potential T-cell epitopes.
Besides MP0112, Molecular Partners has additional compounds in preclinical development and late-stage research in oncology, inflammation, and other therapeutic areas. In January 2008, Centocor Research & Development inked a deal to use DARPin technology to treat inflammatory diseases. In May 2009, Molecular Partners said that it achieved all research milestones under this collaboration. Roche signed on Molecular Partners in February 2007 for R&D on undisclosed targets. In November 2006, Schering Plough inked a cancer therapeutic and diagnostic deal with Molecular Partners.
Commenting on the deal with Allergan, Christian Zahnd, Ph.D., CEO of Molecular Partners, says, “This is a transformational deal for Molecular Partners, and Allergan is the ideal partner for MP0112 to build the most value out of our lead product. Further, this agreement strengthens our ability to execute on the progression of our substantial internal systemic pipeline.”
Allergan has several eyecare products on the market. It has four compounds in multiple Phase II and III trials covering DME, ocular surface disease, retinal diseases, and glaucoma. It also has a preclinical candidate for AMD.
“This agreement aligns with Allergan’s strategy to become a leader in developing new treatments for retinal disease,” says Scott M. Whitcup, M.D., evp, CSO of Allergan. “The goal of this program is to develop a potentially more effective treatment for diseases like neovascular age-related macular degeneration with the possibility for less frequent intravitreal injections.”