Roche: Israel too tough over clinical trials

Sophie Kornowski-Bonnet
Sophie Kornowski-Bonnet

Roche head of partnering Sophie Kornowski-Bonnet warns over-regulation could push Israel away from the forefront of science.

Roche head of partnering Sophie Kornowski-Bonnet wants to deliver a message to the Israeli regulator: "There are countries that need to improve their system of clinical trials in order to take part in the clinical trials game, which is an important element in pharmaceutical development. We sometimes lead 100 clinical trials in Israel at any given moment, and we therefore know that it's hard to get trials approved in Israel, especially those based on a genetic database. A year is sometimes necessary in Israel to negotiate the beginning of such a trial, and it worries us a little that if this doesn't improve, Israel won't be in the forefront of science. Obviously, we understand that it is necessary to protect the patient and the reliability of information, but at the same time, the pace of approving trials must be quickened, and simple, anonymous genetic databases created, because the patients need these solutions."

In Israel, Roche invests in companies in the very early stages in partnership with the Pontifax venture capital fund. According to Kornowski-Bonnet, the company has founded several companies in the framework of the Chief Scientist's incubators "at an investment of several hundred thousand dollars from us in each company, and a lot of our support and guidance, in exchange for first refusal rights. The companies are in the field of cancer and rare diseases, and of the companies we founded, we continued to support three of them after the initial investment, although we have not yet integrated any real project into Roche. The companies are cCAM Biotherapeutics in the immuno-oncology field; Plexicure, which develops antibodies for cancer; and ProMining Therapeutics, which has created a new platform for developing drugs in a various fields. In the Rnai sector (inhibition of gene expression, G.W.), Quiet Therepeutics is very interesting.

"If we don't eventually sign contracts with these companies, someone else may do it because of their progress under our guidance," Kornowski-Bonnet says.

"Globes": Will it not disturb you if a company fostered by you enriches the portfolio of a competing company?

Kornowski-Bonnet: "We'll get the companies we really want from this project. If someone else wants them more than we do, they probably deserve them. That's part of our vision as a pharmaceutical company."

Does your company plan to invest in more companies in Israel?

"If we find more projects in similar stages, we'll be glad to invest in them on the current format. It suits us very much."

Your products are leading targets for attack by the biosimilars. What is your position on this question?

"We're an innovative company; we don’t deal in imitations right now. As we see it, these two things don't go together. Generics is suitable for chemical molecules that are relatively easy to produce. Biosimilars aren't exactly the same as the original drug, and it’s therefore very important to make sure that they're safe, and it's important for us to make sure we have a dialogue with the decision makers in order to make sure that the comparison with our drug is correct.

"Even though these are our competitors, we share all of our information with the US Food and Drug Administration (FDA), so that they can verify that the other drugs meet the standard.

"We think it will be a great challenge for companies to both produce these products and prove in clinical trials that they are similar enough, and we want to make sure that everyone knows what the challenges are before these drugs go to the market, so that the consumer's aren't sacrificed on the altar of saving money. Obviously, if there's strong clinical information, they'll use these drugs, and that's fine."

Published by Globes [online], Israel business news - www.globes-online.com - on May 13, 2015

© Copyright of Globes Publisher Itonut (1983) Ltd. 2015

Sophie Kornowski-Bonnet
Sophie Kornowski-Bonnet
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