Photocure gets regulatory marketing approval for Hexvix in Chile

Photocure ASA, a Norwegian specialty pharma firm that develops and sells pharmaceuticals and medical devices based on proprietary photodynamic technology, has announced that its cancer drug Hexvix® has received Marketing Authorization in Chile.

Furthermore, Photocure's partner and exclusive distributor, Genotests SpA has gained official regulatory approval from Chile's Instituto de Salud Pública.

In 2020, Photocure had signed an exclusive marketing and distribution contract with Genotests, a company focusing on marketing genetic tests for cancer and targeting cancer professionals, to market and distribute Hexvix in Chile.

Under its partnership, Photocure will produce Hexvix and provide regulatory, training, and promotional materials to Genotests, while the later will cover all costs associated with acquiring regulatory approval and commercializing Hexvix in Chile.

Dan Schneider, President and CEO of Photocure, stated that “the importance of bringing this vital treatment to bladder cancer patients in the region is demonstrated by the fast-track classification by the Chilean regulatory authority and the expedited approval”.

“The company expects Hexvix to be available to patients in Chile in the fourth quarter supported by Genotests' dedication and great execution on this program”.

“The agreement marks Photocure's first foray into the South American continent. It aligns with the company’s aim of spreading the availability of Hexvix into new markets so that patients and urologists can benefit from the advantages of BLC®”.

Oscar Varas, Founder & Owner of Genotests, said that “bringing this eccentric product to Chile is significant. Annually, there are about 1,500 new cases of bladder cancer in the country, approximately 5,000 TURBT* procedures, and around 11,000 surveillance cystoscopies”.

“They are delighted to expand on the firm’s existing network and engage with capital equipment vendors to bring blue light cystoscopy along with Hexvix to the Chilean urology community at the earliest”.

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