Date: 2015-04-07
Type of information: Licensing agreement
Compound: Generx® (alferminogene tadenovec [Ad5FGF-4])
Company: Taxus Cardium (USA - CA) Dr. Reddy's Laboratories (India)
Therapeutic area: Cardiovascular diseases
Type agreement: licensing development commercialisation
Action mechanism: gene therapy. Generx [Ad5FGF-4] is an angiogenic gene therapy product candidate. It includes a myocardial delivery vector; a therapeutic transgene and proprietary methods of gene therapy. The construct utilizes an adenovirus serotype 5 delivery vector that is replication-deficient, non-integrating and drives short-term transient expression of the Fibroblast Growth Factor-4 (FGF-4) transgene. The product is designed to stimulate the body's natural healing response to ischemic coronary artery disease by promoting microvascular angiogenesis and arteriogenesis, and enhancing cardiac perfusion. When administered by an interventional cardiologist into the coronary arteries under transient ischemic conditions through the use of a standard balloon catheter, Generx distributes into the heart's microvascular pathways and transfects heart cells by binding to cell surface coxsackievirus-adenovirus receptors. These receptors are found throughout the heart, and the binding of Generx to these receptors is enhanced by the induction of transient ischemia and the use of agents like nitroglycerin to boost cell permeability during administration.
The transfected heart cells then express and release FGF-4 protein, which promotes the growth of new blood vessels that increase blood flow to ischemic heart tissue. In addition, the Generx FGF-4 transgene has been modified to include a signal peptide, which allows its effective secretion from cells that express the protein (such as cardiac myocytes). Preclinical studies showed that therapeutic efficacy is significantly increased by the presence of such a signal sequence in the growth factor DNA construct.
Disease: refractory angina, myocardial ischemia due to cardiac microvascular insufficiency
Details: * On April 7, 2015, Taxus Cardium Pharmaceuticals Group announced that it has entered into a binding term sheet with Dr. Reddy's Laboratories 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, 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. 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.
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