European Union's First Gene Therapy Approval Represents Major Advancement For Industry
SAN DIEGO, Nov. 6, 2012 /PRNewswire/ -- Cardium Therapeutics (NYSE MKT: CXM) today reported that uniQure's Glybera® (alipogene tiparvovec) approval by the European Commission, the first gene therapy approval by a major health regulatory authority, represents a significant milestone and validation for the gene therapy industry. Glybera® is a treatment for patients diagnosed with an inherited metabolic disease called familial lipoprotein lipase deficiency (LPLD or familial hyperchylomicronemia), who suffer from severe or multiple pancreatitis attacks despite dietary fat restrictions. The European Commission's marketing authorization of Glybera covers all 27 European member states and uniQure plans to apply for regulatory approval in the U.S., Canada and other countries.
"The EU approval of Glybera represents a major milestone for the global gene therapy industry," stated Christopher J. Reinhard, Chairman and CEO of Cardium. "This is an important step forward for our field and the millions of patients expected to benefit from new and innovative gene-based therapeutics. Gene therapy offers the opportunity to simplify treatments for serious medical problems and to develop new products for which there are no current medical treatments."
Cardium's late-stage gene therapy Generx product candidate (Ad5FGF-4) is a disease-modifying interventional cardiology biologic being developed as a one-time non-surgical treatment for patients with coronary artery disease. Generx can be delivered using a standard cardiac catheter and is capable of promoting and enhancing cardiac perfusion in the heart through the enlargement of pre-existing collateral arterioles (arteriogenesis) and the formation of new capillary vessels (angiogenesis).
Cardium is an asset-based health sciences and regenerative medicine company focused on the acquisition and strategic development of innovative products and businesses with the potential to address significant unmet medical needs and having definable pathways to commercialization, partnering or other economic monetizations. Cardium's current portfolio includes the Tissue Repair Company, Cardium Biologics, and the Company's newly-acquired To Go Brands® nutraceutical business. The Company's lead commercial product, Excellagen® topical gel for wound care management, has received FDA clearance for marketing and sale in the United States. Cardium's lead clinical development product candidate Generx® is a DNA-based angiogenic biologic intended for the treatment of patients with myocardial ischemia due to coronary artery disease. To Go Brands® develops, markets and sells dietary supplements through established regional and national retailers. In addition, consistent with its capital-efficient business model, Cardium continues to actively evaluate new technologies and business opportunities. News from Cardium is located at www.cardiumthx.com.
Except for statements of historical fact, the matters discussed in this press release are forward looking and reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond our control and may cause actual results to differ materially from expectations. For example, there can be no assurance that the approval of a gene therapy in Europe will improve the prospects for other gene therapy products; that results or trends observed in one clinical study or procedure will be reproduced in subsequent studies or in actual use; that new clinical studies will be successful or will lead to approvals or clearances from health regulatory authorities, or that approvals in one jurisdiction will help to support studies or approvals elsewhere; that the company can attract suitable commercialization partners for our products or that we or partners can successfully commercialize them; that our product or product candidates will not be unfavorably compared to competitive products that may be regarded as safer, more effective, easier to use or less expensive or blocked by third party proprietary rights or other means; that the products and product candidates referred to in this report or in our other reports will be successfully commercialized and their use reimbursed, or will enhance our market value; that our To Go Brands business can be successfully integrated and expanded; that new product opportunities or commercialization efforts will be successfully established; that third parties on whom we depend will perform as anticipated; that we can raise sufficient capital from partnering, monetization or other fundraising transactions to maintain our stock exchange listing or adequately fund ongoing operations; or that we will not be adversely affected by these or other risks and uncertainties that could impact our operations, business or other matters, as described in more detail in our filings with the Securities and Exchange Commission. We undertake no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof.
Copyright 2012 Cardium Therapeutics, Inc. All rights reserved.
Cardium Therapeutics®, Generx®, Cardionovo™, Tissue Repair™, Gene Activated Matrix™, GAM™, Excellagen®, Excellarate™, Osteorate™, MedPodium®, Appexium®, Linée®, Alena®, Cerex®, D-Sorb™, Neo-Energy®, Neo-Carb Bloc®, Neo-Chill™, and Nutra-Apps® are trademarks of Cardium Therapeutics, Inc. or Tissue Repair Company. To Go Brands® is a trademark of To Go Brands, Inc.
(Glybera® and other trademarks belong to their respective owners)
SOURCE Cardium Therapeutics