Taxus Cardium Announces Agreement With Dr. Reddy's Laboratories

Taxus Cardium Pharmaceuticals Group Inc. (trading symbol: CRXM) today announced that it has entered into a binding term sheet with Dr. Reddy's Laboratories Ltd.

for an exclusive territorial license covering the co-development, marketing and sales of the Generx® [Ad5FGF-4] angiogenic microvascular gene therapy Phase 3 product candidate for patients with refractory angina, and myocardial ischemia due to cardiac microvascular insufficiency (CMI). The agreement initially covers certain territories and international markets, including Russia, the Commonwealth of Independent States (CIS), Venezuela, Vietnam and Myanmar, and provides the right of first refusal for Dr. Reddy's Laboratories to negotiate additional exclusive license agreements to market and sell the Generx gene therapy product candidate in over 30 other countries in Latin America and the Association of Southeast Asian Nations. Angionetics Inc., a wholly-owned operating unit of Taxus Cardium, is now responsible for the worldwide commercialization of the Generx gene therapy product candidate. Angionetics retains the full Generx commercialization rights for North America, Europe, Japan, China, the Middle East, and Africa. It is planned that Angionetics will advance forward as a company independent from Taxus Cardium and seek to externally finance the Generx U.S.-based FDA-cleared AWARE Phase 3 clinical study, the international ASPIRE Phase 3 clinical development program and additional U.S.-based and international clinical studies for other potential Generx medical indications. As an international co-development partner, Dr. Reddy's Laboratories will assist with local country patient recruitment and relationship building with key opinion leaders to accelerate the Angionetics' international Phase 3 ASPIRE clinical study. Positive safety and efficacy findings from the ASPIRE study were announced at the Annual 2014 Biotechnology Industry Organization Conference following completion of a protocol-specified interim data analysis. In addition, Dr. Reddy's Laboratories will assist with product registrations and regulatory compliance with local country health authorities. The agreement provides economic support that will be used to advance the international Phase 3 clinical study, a cost sharing arrangement for a planned Phase 4 post-marketing clinical study (intended to expand product labeling), and volume-based royalties on net sales. Dr. Reddy's Laboratories' Russian-based business unit markets and sells prescription products through its team of medical representatives and managers who promote the products to physicians across Russia. Additionally, Dr. Reddy's Laboratories also has a separate Hospital division and an OTC division.