Israeli company UroGen Pharma (Nasdaq: URGN), which develops delayed release drugs for the bladder, has announced the beginning of a Phase II trial for one of its leading products: delayed release Botox for the treatment of overactive bladder syndrome. The products was developed together with US company Allergan, which developed and markets Botox. Since its UroGen's IPO in May 2017, the company's share price has soared 176%, pushing its market cap up to $479 million.
Allergan will fund and manage the clinical trial itself of the product, which integrates Botox in UroGen's delayed release system - a system with a unique feature - it is a liquid at room temperature, but it solidifies at body temperature. It can therefore be injected into the bladder as a liquid, and then becomes a gel whose material the bladder will not easily get rid of. This contrasts with other drugs that are quickly washed out of the bladder. In UroGen's product, the delayed release compound keeps Allergan's Botox in place. The Botox weakens the bladder's muscular contractions that cause overactive bladder syndrome.
All of these fundamental assumptions will be tested in the current trial on 335 patients. The trial's main goal is to demonstrate effectiveness, reflected in a drop in the number of urine escapes per day.
The licensing agreement between UroGen and Allergan, signed in 2016 before UroGen's IPO, includes a $17.5 million advance and additional unspecified sums, milestone payments, and royalties.
UroGen is already independently conducting a Phase III trial of a product consisting of a delayed release drug for treatment of bladder cancer. Results from this trial, which began several months ago, are expected in late 2019.
Prof. Asher Holzer, one of the founders of IspireMD, founded UroGen in 2005. The company's investors before its IPO included the Pontifax fund, Arkin Holdings, ProQuest Investments, and Chaim Hurvitz's CHealth. UroGen's chairman is urologist Prof. Arie Belldegrun, the founder of Kite Pharma, which he sold for $12 billion. Belldegrun has also personally invested in UroGen. The CEO of UroGen is former Keryx Biopharmaceuticals (Nasdaq: KERX) and XTL Biopharmaceuticals Ltd. (Nasdaq:XTLB); TASE:XTL) CEO Ron Bentsur.
Published by Globes [online], Israel Business News - www.globes-online.com - on November 7, 2017
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