Quark Pharmaceuticals Inc., which develops RNA-based drugs has announced success in a Phase II trial of its product for preventing kidney damage during open-heart surgery. Quark is one of Israel's most veteran biotech companies. Over a decade ago, the company reported that it had received an investment from Oracle founder Larry Ellison. The company has since spent hundreds of millions of dollars on its activity.
During open-heart surgery, the kidney lacks oxygen at certain moments and has excessive oxygen at other moments. Quark's drug prevents the damage liable to affect the kidney in these situations. The company is already in Phase III clinical trials for a different indication of the same drug - preventing damage to a transplanted kidney during kidney transplants - a process in which the kidney is also liable to suffer from lack of oxygen when it is outside the body and excessive oxygen (immediately after the transplant). This damage can sometime cause rejection of the kidney following the transplant and failure in the transplant, even when there is a match with the immune system.
Quark founder, CEO, and chairman Dr. Daniel Zurr previously told "Globes" that if the Phase III trials results for the product are good, it may be possible to market the product with no further trials. Zurr today said, "The market for preventing kidney damage during open-heart surgery is enormous. 300,000 such operations are carried out yearly in the US alone, and the product is relevant to an absolute majority of them. The market is worth billions. Many companies have tried to develop drugs of this type, but have never managed to pass Phase II." Zurr notes that the full trial results will be published soon at a conference, but meanwhile reveals that it is meeting all the targets with great statistical significance. The trial includes 341 patients who underwent surgery and were at risk of developing kidney problems following the operation.
The product was developed in cooperation with pharmaceutical giant Novartis, which has an option for an additional investment in the company and in development of the product, contingent on success in the trial, and an exclusive option to buy marketing rights for the product, if an when it is approved. Quark has already received payments in the millions of dollars from this cooperation
Despite Quark's many years in the market and the substantial amounts invested in it, the company has yet to bring a product to market, because the road from the breakthrough research it conducted to a commercial product has proved significantly longer than estimated by the company. This has taken a long time for all the companies in the iRNA (using RNA in intervention in transcription of proteins from genes) and SiRNA (preventing transcription of proteins from genes), and no product of this type has yet reached the market.
Zurr notes that the company has spent $400 million since it was founded, with a substantial proportion of this sum coming from cooperation agreements with Novartis and Pfizer, and with Japanese companies that bought rights at an earlier stage. Quark conducts its research in Israel, while its development is in the US. The actual owners of the company are Japanese. The major shareholder in Quark is Softbank Investments (SBI), which injects tens of millions of dollars into the company annually. Zurr says, "They thought about holding an IPO for the company in Japan, and they may still be thinking about it, but that has nothing to do with us." Ellison, incidentally, no longer owns a stake in Quark.
Quark previously had a cooperation agreement with Pzifer for a drug for preventing age-related macular degeneration (AMD) and diabetic macular edema (DME). Zurr says, "We got good results from both of them, but Pfizer waived the product, because it thought that it would be unable to compete with Lucentis, another drug that reached this market a few years ago. We think that we can fit in with Lucentis, and are now entering Phase II trials, still in the framework of the agreement with Pfizer, after redesigning the royalties agreement." In the new agreement, Quark is leading and managing the trials.
Other pre-clinical trials products in Quark's pipeline include a product for preventing baldness (mainly as a result of treatments for cancer), a drug for restoring hearing after damage to hair cells, for preventing damage from heart attacks, improving reception of lung transplants, and treatment of pain following spinal cord injuries.
Zurr has been managing the company for 20 years, almost since it was founded. "In the first 10 years, we only discovered the genes whose activity we want to disrupt. In the ensuing 13 years, we have been developing the drugs. Today, I tell myself, 'You're crazy.' It's like climbing Mount Everest without equipment, but we're close to the top, so we have no regrets."
Published by Globes [online], Israel Business News - www.globes-online.com - on July 31, 2017
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