Photocure announces regulatory approval of Hexvix in Chile

Photocure ASA, the Bladder Cancer Company, announces that the Marketing Authorization for Hexvix® in Chile has been granted. Photocure’s partner and exclusive distributor, Genotests SpA, received the official regulatory approval by the Instituto de Salud Pública de Chile on August 12th.

Now that the product is approved, Genotests will prepare for the commercialization.

In August 2020, Photocure entered into an agreement with Genotests, a privately held company specializing in the marketing of genetic tests for cancer and targeting cancer specialists, to exclusively market and distribute Hexvix in Chile. Under the terms of the agreement, Genotests will fund all costs to secure regulatory approval and commercialize Hexvix in Chile. Photocure will manufacture the product and support Genotests with regulatory activities, training, and promotional materials.

“The fast track designation by the Chilean regulatory authority and the expedited approval shows the significance of bringing this important solution to bladder cancer patients in the region,” said Dan Schneider, President and CEO of Photocure. “With Genotests’ dedication and strong execution on this initiative, we expect that Hexvix will become accessible to patients in Chile in the fourth quarter of this year. This partnership represents Photocure’s first step into the South American continent, and supports our strategy of expanding the availability of Hexvix into new territories to ensure that patients and urologists have access to the benefits of using blue light cystoscopy (BLC®). The procedure with Hexvix, or Cysview, is recommended in guidelines for the management of bladder cancer around the world.”

“It is a privilege to bring this fantastic product to Chile” said Oscar Varas, founder and owner of Genotests. “There are approximately 1,500 new bladder cancer cases annually in our country, an estimated 5,000 TURBT* procedures and nearly 11,000 surveillance cystoscopies. We look forward to building on our established network and to collaborate with providers of capital equipment to launch blue light cystoscopy with Hexvix into the Chilean urology community as soon as possible.” BioSpace