Today before the opening bell, Cardium made a series of announcements as well as provided a comprehensive update on its ongoing initiatives. An abridged overview is presented below due to the length of the press releases issued. For detailed information, visit Cardium’s news page at http://dtg.fm/1thP.
Commercialization of FDA-Cleared Excellagen
• Introduced its FDA-cleared Excellagen® professional-use wound care product in March 2012 and entered into a logistics and cold chain services agreement with Smith Medical Partners, a subsidiary of H. D. Smith;
• Awarded ISO 13485:2003 certification for Excellagen, State of California manufacturing license and state clearances to market and sell Excellagen in the U.S., and advanced other international registrations for Excellagen, including CE Mark registration, which is expected in Q2 2013;
• Announced sales and distribution agreements with Academy Medical to market, sell, and distribute Excellagen to its growing base of over 35 U.S. government medical providers, including Veterans Administration and military hospitals;
• Excellagen selected as one of the Top Ten Podiatry Innovations in 2012 by Podiatry Today publication, and awarded the American Podiatric Medical Association’s Seal of Approval for Excellagen’s contributions to improve foot health and mobility;
• Formed the Excellagen Medical Advisory Board comprising leading practitioners, clinicians, and researchers with diversified expertise in the field of advanced wound care, and presented case studies at the Desert Foot 2012 High Risk Diabetic Foot Conference;
• Entered into international agreements with (1) an established pharmaceutical company for the registration, marketing, and distribution of Excellagen in the South Korean market; and (2) Advanced Biosciences Research for the planned commercialization of Excellagen in the Russian Federation and CIS;
• Advanced forward with applications to support the reimbursement process for Excellagen with the Centers for Medicare & Medicaid Services (CMS) and private insurance providers, and broadened marketing and sales efforts into markets with established CPT® codes for surgical debridement procedures and in-hospital surgical markets covered under DRG reimbursement systems.
Advancing Generx Phase 3 Angiogenic Gene Therapy
• Initiated the ASPIRE Phase 3 registration study, a 100-patient randomized and controlled multi-center study being conducted at leading cardiology centers in Russia;
• Published important Generx findings in the peer-reviewed journal Human Gene Therapy Methods demonstrating that Cardium’s innovative technique employing transient cardiac ischemia can be used to dramatically enhance gene delivery and transfection efficiency after a one-time intracoronary administration of adenovector in mammalian hearts;
• Presented at the 2013 Phacilitate Annual Cell & Gene Therapy Forum held in Washington, DC, “Optimizing Phase III Trial Design for Generx (Ad5FGF-4)” on adaptive coronary collateral growth, the biological processes to be targeted by therapeutic angiogenesis, and discussed the lessons learned during the past decade of the company’s Generx clinical development program;
• Favorable patent decision in Europe and successful resolution of a long standing competition between Cardium and its licensor, the University of California, and Boston Scientific Corporation and its licensor, Arch Development, over the rights to key methods for the application of cardiovascular gene therapy in the treatment of coronary heart disease, as is employed in the company’s Generx gene therapy candidate.
Health Sciences Business and Other Strategic Product Initiatives
• Acquired To Go Brands® nutraceutical supplement brand platform with over 25 products being developed and sold through established regional and national food, drug, and mass channel retailers at over 10,000 retail locations;
• Announced expansion of the To Go Brands VitaRocks® Kids vitamin products and retail distribution of the newly-designed VitaRocks product line into select Target stores nationwide;
• Reported plans for the partner-enabled clinical development of Genedexa™ (previously referred to as the Excellarate™ product candidate), a DNA-based Phase 2b/3 product candidate initially for the treatment of chronic, non-healing diabetic foot ulcers and representing the first product extension from the company’s FDA-cleared Excellagen technology platform;
• Developed a new in-house partner-enabled product opportunity, LifeAgain™, a medical analytics and e-commerce platform of algorithms and medical-based programs that were developed by Cardium researchers to support a strategically partnered commercialization of specialized survivable risk life insurance underwritings for cancer patients and patients with chronic medical diseases.
Further Announcements
Cardium invested heavily into its current initiatives, spending $2.6 million for research and development and $6.1 million in selling, general, and administrative expenses. The increased expenditure was associated with the market introduction of Excellagen, initiation of the company’s Generx ASPIRE clinical study, and for Cardium’s nutraceutical initiative, which served as the catalyst for the acquisition of To Go Brands.
In other news, Cardium reported a definitive agreement with its largest shareholder for a financing of up to $4.0 million in gross proceeds. The proceeds will be used to further build Cardium’s medical opportunities portfolio, including its FDA-cleared Excellagen product which is being introduced into targeted would care markets, among other things.
Detailed information on Cardium’s commercialization plans for Excellagen and Generx, as well as an overview of the To Go Brands® Nutraceutical Brand Platform and various in-house initiatives, can be found at http://dtg.fm/W5oO.
To learn more about Cardium Therapeutics and its medical portfolio, visit www.CardiumTHX.com
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