Urogen reports positive Phase III urinary tract cancer drug results

Pharmaceutical laboratory Photo: Shutterstock

The company hopes to obtain FDA approval and launch its drug this year.

In a Phase III trial of Israeli company Urogen Pharma's (Nasdaq: URGN) drug for treatments of upper urinary tract cancer, 58% of the patients responded fully to treatment, meaning that no cancer was found after the treatment. All of the patients in whom no cancer was found were still fully free of cancer after six months. The company's product is designed as a drug alternative to endoscopic surgery (which usually must be repeated when the disease recurs) or removal of a kidney.

Urogen's trial was conducted on 60 patients without a control group, meaning that the company obtained the results at the end of treatment for each patient. The product was submitted for approval by the US Food and Drug Administration (FDA) on a rolling submission track, in which the company submits the results to the FDA as soon as they are received. Urogen therefore announced last week that it expected approval of its product in 2019, and was preparing to set up a marketing system for the product, thereby hinting that the results so far were as the company had planned.

The trial was a relatively small one, but in recent years, the FDA has approved drugs for treatment of serious diseases on the basis of small trials if the results are impressive and the existing solutions are unsatisfactory.

Urogen hopes to launch the product this year

Urogen appointed Novartis Oncology CEO Elizabeth Barrett as its CEO. Barrett, a very senior manager in the cancer sector, has close connections with Urogen chairperson Prof. Arie Belldegrun, who founded and managed cancer company Kite Pharma, before selling it to US company Gilead for $12 billion. Belldegrun also had a number of earlier impressive exits in the pharmaceutical field.

Urogen's market cap before the announcement of the trial results was $878 million. The company's product is a polymer that assumes liquid form at room temperature and become a gel at body temperature, thereby facilitating delayed release of drugs in places in the body where drugs are usually easily washed away, making them ineffective. The urinary tract is the first place in the body for which the drug was developed, with the first product being designed for treatment of low-malignancy cancer in the upper urinary tract. Urogen has products for treatment of worse forms of cancer in the upper urinary tract and bladder cancer in the pipeline.

Urogen previously said that good trial results would probably enable it to obtain FDA approval by mid-2019, in which case it planned to launched the project by the end of the year. Urogen intends to prepare production facilities before approval is granted, so that it can launch the product during this year. The company's commercial activity is currently in the US, but it is incorporated in Israel, where its development center is located.

Published by Globes, Israel business news - en.globes.co.il - on January 8, 2019

© Copyright of Globes Publisher Itonut (1983) Ltd. 2019

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Pharmaceutical laboratory Photo: Shutterstock
Pharmaceutical laboratory Photo: Shutterstock
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