BASEL, Switzerland & MAPLE GROVE, Minn.—Roche and Upsher-Smith Laboratories Inc., via its wholly owned U.K. subsidiary Proximagen Ltd., have announced the beginning of a worldwide agreement to further develop a novel, oral small-molecule inhibitor of Vascular Adhesion Protein 1 (VAP-1), a cell-adhesion molecule that could be an effective approach in treating inflammatory diseases. The inhibitor is presently in Phase 2 clinical development.
"This agreement will allow our companies to fully explore the significant and far-reaching potential of this novel VAP-1 inhibitor. Roche’s deep expertise in drug development and proven success in commercialization will allow us to fully explore the unique attributes of this important molecule and the therapeutic benefits it may provide in the future,” Dr. William Pullman, chief scientific officer and Biotech Research Institute Division President for Upsher-Smith, commented in a statement regarding the deal. “We are pleased to work with Roche on this compound as we share their commitment to patients."
Per the terms of the agreement, Roche has been granted a worldwide exclusive license for the development and commercialization of the VAP-1 inhibitor. Roche and Proximagen will conduct additional Phase 2 studies in a novel collaboration model to further define the therapeutic potential of this compound, and based on the results, Roche will assume responsibility for its late-stage development and worldwide commercialization. Though no specific financial details were disclosed, Roche will make an upfront payment to Proximagen, as well as downstream development, regulatory and sales milestones. Proximagen also stands to receive tiered royalties on net sales of a potential future product that contains this molecule. The deal is subject to the expiration or early termination of the applicable U.S. Hart-Scott-Rodino waiting period.
“This agreement is a novel partnering model where regulatory responsibility and trial sponsorship will only transition upon the success of additional clinical studies,” Dr. Sophie Kornowski-Bonnet, head of Roche Partnering, added in a press release. “A dedicated and very experienced team located at the Roche Innovation Center New York, will drive the development most efficiently from our side.”
In other recent news for Roche, the company announced that the European Commission has approved Cotellic (cobimetinib) for use in combination with Zelboraft (vemurafenib) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. This approval is based on data from Roche's Phase 3 coBRIM study, which demonstrated that patients with previously untreated BRAF V600 mutation-positive advanced melanoma who were treated with Cotellic in combination with Zelboraf lived a median of one year (12.3 months) without their disease worsening or death, compared to 7.2 months with Zelboraf alone. Cotellic inhibits some mutated forms of MEK while Zelboraf inhibits certain mutated forms of BRAF, both of which are proteins in a cell signaling pathway that play a role in controlling cancer cell growth and survival. The combination of these compounds is believed to reduce cancer cell growth longer than Zelboraf alone.
SOURCE: Roche press release