AMRI Burlington Contracted As Aseptic Fill Manufacturer for Market Introduction of Excellagen® Wound Care Product
Published on Tuesday, 05 June 2012 08:38 Written by TradersHuddle Staff
ALBANY, N.Y., June 5, 2012 /PRNewswire/ -- AMRI (NASDAQ: AMRI) announced today that its Burlington site was contracted by Cardium Therapeutics (NYSE MKT: CXM) and its subsidiary, Tissue Repair Company ("Cardium") to manufacture sterile pre-filled syringes in support of the U.S. introduction of Excellagen®, a professional-use, formulated collagen-based product for the management of diabetic foot ulcers, pressure ulcers and other dermal wounds. AMRI's highly collaborative approach to technical transfer enabled Cardium to meet its commercial introduction timeline and overall business needs.
Excellagen is a new, FDA-cleared, highly-refined fibrillar collagen-based topical gel (2.6%) designed to support favorable wound-care management. Its unique high molecular weight bovine Type I collagen formulation is topically applied through easy-to-control, pre-filled, single use syringes. Excellagen is intended for physician use following debridement procedures, and is engineered to support a favorable wound healing environment for non-healing lower extremity ulcers in diabetic patients. Excellagen was introduced to the U.S. market by Cardium Therapeutics on March 30, 2012.
"We are pleased to be supporting Cardium's U.S. marketing introduction of Excellagen," said Thomas E. D'Ambra, Ph.D., Chairman, President and CEO of AMRI. "As a growing number of healthcare companies like Cardium face technically rigorous product manufacturing needs, we believe they will look to AMRI given our enhanced quality, proven experience, and scientific excellence to successfully address these challenges and ensure the highest manufacturing standards. We congratulate Cardium on the commercialization of Excellagen, a product that will address an unmet market need and provide a benefit to a growing patient population."
Dr. D'Ambra continued, "Supporting the Excellagen commercial market entry is a good illustration of further opportunities ahead and a validation of the market potential for AMRI's participation in the aseptic dosage form business."
"We are pleased to have AMRI as the aseptic fill manufacturer of our Excellagen sterile easy-to-use, pre-filled syringes," stated Christopher J. Reinhard, Chairman and CEO of Cardium. "We look forward to an ongoing and collaborative relationship with AMRI as we continue to introduce Excellagen to the U.S. market."
AMRI's commitment to quality has been enhanced by the recent addition of key personnel at the AMRI Burlington site, including the recent hire of Thomas McGrath, Director of Quality for Aseptic Services. In addition, AMRI SMARTSOURCING™, an approach to providing services to the pharmaceutical and biotechnology industries focused on better customer outcomes, reaffirms AMRI's commitment to customer value and ensures customers will have access to high quality scientific performance and experienced project management with the accountability of delivering results in a cost-competitive manner at all stages of the product pipeline.
Albany Molecular Research, Inc. (AMRI) is a global contract research and manufacturing organization offering customers fully integrated drug discovery, development, and manufacturing services. For over 21 years AMRI has demonstrated its adaptability as the pharmaceutical and biotechnology industries have undergone tremendous change in response to multiple challenges. This experience, a track record of success and locations in the United States, Europe and Asia now provides our customers with SMARTSOURCING™, a full range of value-added opportunities providing customers informed decision-making, enhanced efficiency and more successful outcomes at all stages of the pipeline. AMRI has also successfully partnered R&D programs and is actively seeking to out-license its remaining programs for further development.
AMRI Burlington offers clients innovative aseptic formulation and filling services for pre-clinical through small-volume, commercial-scale production of liquid-filled parenterals, biologics and medical devices in vials, syringes and other custom containers.
Cardium Therapeutics (NYSE MKT: CXM) is a health sciences and regenerative medicine company focused on the acquisition and strategic development of new and innovative bio-medical product opportunities and businesses with the potential to address significant unmet medical needs that have definable pathways to commercialization, partnering and other economic monetizations. Cardium's current medical opportunities portfolio, which is focused on health sciences and regenerative medicine, includes the Tissue Repair Company, Cardium Biologics, and the Company's in-house MedPodium® Health Sciences healthy lifestyle product platform. The Company's lead commercial product Excellagen® topical gel for wound care management, has recently 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. In addition, consistent with its capital-efficient business model, Cardium continues to actively evaluate new technologies and business opportunities. In July 2009, Cardium completed the sale of its InnerCool Therapies medical device business to Royal Philips Electronics, the first asset monetization from the Company's biomedical investment portfolio. News from Cardium is located at www.cardiumthx.com.
Forward-Looking Statements for Cardium Therapeutics
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 stated expectations. For example, there can be no assurance that Excellagen can be effectively supplied to enable us to meet our overall business needs; that we can successfully introduce Excellagen into wound care markets for the treatment of diabetic foot ulcers or other dermal wounds; that our product or product candidates will not be unfavorably compared to other competitive products that may be regarded as safer, more effective, easier to use or less expensive; that results or trends observed in one clinical study or procedure will be reproduced in subsequent studies or procedures or in actual use; that clinical studies and regulatory clearances even if successful will lead to product advancement or partnering; that that FDA or other regulatory clearances or other certifications, or other commercialization efforts will effectively enhance our businesses or their market value; that our products or product candidates will prove to be sufficiently safe and effective after introduction into a broader patient population; that new collaborative partners will be found; that additional product opportunities will be established; 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.
Cardium Therapeutics™, Generx®, Tissue Repair™, Excellagen®, and MedPodium®
are trademarks of Cardium Therapeutics, Inc. or Tissue Repair Company.
SOURCE AMRI; Cardium Therapeutics
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