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Featured Company News - Janssen Biotech Backs Out of Exclusive Licence Agreement for Development and Commercialization of Capricor's Lead Candidate CAP-1002

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LONDON, UK / ACCESSWIRE / July 10, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Capricor Therapeutics, Inc. (NASDAQ: CAPR), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=CAPR. The Company announced on July 06, 2017, that Janssen Biotech, Inc. has backed out of the exclusive license agreement for the development and commercialization of Capricor's lead cardiology candidate CAP-1002 (allogeneic cardiosphere-derived cells). The termination of the collaboration agreement results in Janssen Biotech not exercising its option and all the rights with regards to CAP-1002 will now completely rest with Capricor. For immediate access to our complimentary reports, including today's coverage, register for free now at:

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CAP-1002 is an allogeneic cardiosphere-derived cell therapy under study in patients who have suffered a large myocardial infarction (commonly known as heart attack and is a blockage of blood flow to the heart muscle).

Impact of the decision

Capricor will now have the option to develop CAP-1002 either independently or by way of collaboration with any third party. All the patents controlled by Janssen Biotech and used in the production of materials for the clinical trials will now be under fully paid-up non-exclusive license with Capricor. Capricorn will have the non-exclusive license to publish, disclose, and utilize the information used by Janssen Biotech in the production of materials for the clinical trials. There are no payments required from either party due to the termination of the license agreement.

Commenting on the development, Linda Marbán, Ph.D. President and CEO of Capricor said:

"Although Janssen's decision removes a potential corporate partner for Capricor, this decision also resolves uncertainty concerning the scope of the license for CAP-1002 and provides Capricor the freedom to enter into new licensing and/or business development opportunities around this promising therapeutic candidate. Following our announcement of positive results from our Phase-I/II HOPE clinical trial in April, we have focused our efforts toward the clinical development of CAP-1002 for DMD. We discussed potential product registration strategies for this indication at our recent meeting with the US Food and Drug Administration, and we look forward to providing an update on our clinical development plans in DMD very shortly."

Capricor now plans to conduct randomized, double-blind, placebo-controlled clinical trials for CAP-1002 and administer the drug intravenously in boys and young men with Duchenne muscular dystrophy (DMD) (a genetic disorder characterized by progressive muscle degeneration and weakness). These clinical trials have been planned for H2 2017 and are subject to regulatory approvals.

Background

Capricor and Janssen Biotech had entered into an exclusive Collaboration Agreement and Exclusive License Option in January 2014 for the development of Capricor'scell therapy program for cardiovascular applications, including its lead product, CAP-1002. As per the agreement, Capricor received an upfront payment of $12.5 million from Janssen Biotech towards the costs of manufacturing. Janssen Biotech got the right to enter into an exclusive license agreement for CAP-1002 with sixty days after Capricor disclosed the results from its Phase-II clinical trials for CAP-1002. If Janssen Biotech had exercised its option rights, Capricor was eligible to receive payments of approximately $325 million. Capricor was also eligible for additional royalty payments on the commercial sales of CAP-1002.

In May 2017, Capricor had indicated that its Phase-II trial of CAP-1002 in adults, who had a large heart attack with residual cardiac dysfunction, had a "low probability of statistically significant difference in effectiveness". Capricor disclosed that its analysis indicated that CAP-1002 had a low probability in achieving its primary endpoint of reduction in scar size when measured with a late gadolinium-enhanced magnetic resonance imaging after 12 months. Janssen Biotech's decision to back out of the collaboration followed this disclosure.

In April 2017, Capricor had indicated that CAP-1002 had potential to be used in the treatment of Duchenne's muscular dystrophy. However, Janssen Biotech did not seem interested in exploring this option.

About Capricor

Capricor Therapeutics is a clinical-stage biotech Company focused on the discovery, development, and commercialization of first-in-class biological therapeutics for the treatment of cardiac and other serious medical conditions. It is also one of the leading Companies working in the field of exosome science and plans to explore the development of the exosome technology as a next generation regenerative medicine platform in a variety of cardiovascular and non-cardiovascular areas.

About Janssen

Janssen Biotech is a Johnson & Johnson Company, and it is developing treatments for patients in six important therapeutic areas of healthcare - Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension. It has a presence in over 150 countries and has a team of over 30,000 employees across the globe.

Last Close Stock Review

On Friday, July 07, 2017, Capricor Therapeutics' stock closed the trading session at $0.67, tumbling 11.84% from its previous closing price of $0.76. A total volume of 194.85 thousand shares was exchanged during the session. The stock currently has a market cap of $16.05 million.

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