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Keeping an eye on DARPins
IRVINE, Calif.—A pharmaceutical alliance got a boost today as Allergan, Inc. and Molecular Partners AG announced that they have entered into two separate agreements for the discovery, development and commercialization of proprietary therapeutic DARPin products for therapies for serious ophthalmic diseases. The agreements are the latest expansion of the companies' relationship. Molecular Partners will receive a total of $62.5 million in upfront payments between the two agreements, with the possibility of receiving additional success-based payments, including a potential total of $1.4 billion in aggregate development, regulatory and sales milestones as well as tiered royalties in the low double digits based on future product sales.
"With Allergan we have found the ideal partner to generate a strong pipeline of DARPin-based drug candidates with the goal to treat retinal and other severe ocular diseases," Christian Zahnd, Ph.D., CEO of Molecular Partners, said in a press release. "This significant expansion of our agreement together with the fast progress in the ongoing phase IIb development of AGN-150998 / MP0112 is a great validation of the DARPin approach."
MP0260 is a small therapeutic protein with dual activity that inhibits all relevant forms of vascular endothelial growth factor A (VEGF-A) and platelet-derived growth factor B (PDGF-B). Preclinical models have shown the compound to demonstrate high efficacy and long intravitreal pharmacokinetics, and it is currently being investigated as a treatment for wet AMD.
The first deal consists of an exclusive license agreement for designing, developing and commercializing a dual anti-VEGF-A/PDGF-B DARPin (MP0260) and related backups, indicated for the treatment of exudative age-related macular degeneration (AMD) and related conditions. Per the terms of the agreement, the companies will collaborate on development of MP0260 through the human proof-of-concept stage, after which Molecular Partners has the option to co-fund Allergan's subsequent development costs in exchange for a sizeable increase in its share of royalties.
The second agreement establishes an exclusive discovery alliance in which Molecular Partners and Allergan will collaborate on the design and development of DARPins against selected targets implicated in several serious eye diseases. Allergan has the right to exercise three options to exclusively license ophthalmology compounds from the collaboration during the research phase. For each option that is executed, Molecular Partners is eligible for an option exercise fee, and Allergan will be take over sole responsibility for all downstream development, manufacturing and commercialization.
"This is an important step forward in our strategy to build on strong partnerships with the leaders in a therapeutic area" Patrick Amstutz, Ph.D., chief business officer of Molecular Partners, said in a statement. "DARPins are potent biologics which may address significant unmet medical needs in large patient populations in various disease areas."
Molecular Partners' DARPins are a new class of protein drugs that offer increased potency and target specificity. The proteins are capable of being selected to bind to any target molecule with significant specificity, offering potential in agonistic, antagonistic or inhibitory drug compounds. DARPin candidates can also be engineered to include additional enhancement of certain pharmacokinetic properties, adaptation to carry different effector functions or multiple binding specificities.
"As a leader in ophthalmology, Allergan is committed to developing new treatments for serious eye diseases like AMD," said Scott M. Whitcup, M.D., executive vice president of research and development and chief scientific officer of Allergan, in a statement. "We look forward to further developing a novel therapy that blocks both VEGF and PDGF, as a potential way to improve vision in patients with wet AMD."