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Failed drugs reincarnated
RAMAT GAN, Israel—Biopharmaceutical company Optimata Ltd. and generic giant Teva Pharmaceutical Industries Ltd. have teamed up to fast-track the development of cancer drugs by using bio-stimulation technology aimed at salvaging drugs that failed clinical tests.
The linchpin of the process—and the collaboration—is the Optimata Virtual Patient (OVP), which allows companies to rescue and redirect the clinical development of discontinued drug candidates, shelved by originator pharmaceutical firms.
Under the terms of the partnership, announced June 30, Optimata will receive upfront payments, development milestones and royalty payments. In addition, partner Teva, headquartered in Tikya, Israel, has made an undisclosed equity investment in Optimata.
Both companies are keeping the specific financials confidential and close to the vest.
Dr. Pini Orbach, chief operating officer of Optimata, says the company "seeks arrested oncology compounds. Then, by applying our OVP technology, we ascertain that under certain regimens, in given populations, there is a safer way to use the drugs in question.
"We shall utilize available preclinical or clinical data, as well as the PK/PD profile of the drug in question, and the safety profile of the drug in order to run virtual clinical trials using our OVP technology," Orbach adds. "Based on results from the virtual trials, recommended optimal regimens and the patient population for the specific solid tumor indication should be identified. This is our first step in the drug rescue proof-of-concept in the clinic."
Optimata's Virtual Patient monitors the interaction of drugs in patients and permits drug developers to carry out clinical trials and predict optimal treatments, according to the company. This technology should allow Teva to "fix" drugs that failed advanced clinical development tests by monitoring changes in dosing and timing.
Optimata further states that its Virtual Patient applies the technology to recommend improved treatment, including improved schedules, combination therapies, safety profiles and optimal pairing of clinical indications and patient-populations for given drug candidates. Virtual Patient has been successfully validated in a series of clinical trials in breast cancer patients undergoing chemotherapy, the company says.
Shir Altay, a Teva spokesman, says the largest benefit to Teva that the collaboration with Optimata brings is "the ability to potentially license in, and then develop, clinical-stage products that have failed development by the innovator but, following analysis using Optimata'' Virtual Patient technology, have potential for further development and commercialization." Salvaging failed cancer drugs provides Teva with an easy entry to the cancer drug market, where it hopes to expand.
Orbach told Drug Discovery News that the choice of a partner for the project was clear. Having Teva as a partner "is clearly a transforming event in the history of our company," he says.
"The initiative was ours, and Teva was receptive from the start. We had known Teva for quite some time and previously discussed potential future projects based on our OVP technology. Recently, these talks materialized to an actual business deal," he says.
The largest benefit to Optimata in this endeavor is the "partnering and working experience with a world class pharma partner, as well as the opportunity to prove the concept of our technology in perspective clinical trials," Orbach says. "With this new collaboration, we continue to fulfill Optimata's goal of accelerating the oncology drug development process."
Optimata has been in the cancer field since it was created in 2000, he says, adding, "the various models the company has developed for solid tumor cancer indications are innovative and are central to our proprietary IP."
From the start, Optimata validated its technology both in clinical trials and in preclinical projects with leading pharmas such as Eli Lilly & Co., Orbach says. Additionally, the company obtained validations in retrospective clinical trials in two medical centers, one in Israel and the other in the United Kingdom.
"Each of our projects undertaken to date was an additional validation step on our route," he says. "Our goals are to strengthen our cooperation and experience with leading pharmaceutical companies, to bring back oncology shelved drugs into clinical trials and to prove that our technology and business model could attain market significance."
Optimata's collaboration with Teva "is focusing currently on the oncology drugs market," Orbach says.
"We already have a technological potential in other therapeutic areas which we hope to further develop in the near future," he adds.
Founded in 2000 by Prof. Zvia Agur, a biomathematician and pioneer in the field of disease control modeling, Optimata has developed a family of proprietary mathematical algorithms, which simulate the dynamics of key biological and pathological processes in patients undergoing drug treatment, according to the company Web site. These simulations facilitate quantitative assessment of drug effects on the disease, in conjunction with different aspects of its side effects.