Cambrex and BioHeart Complete Cell Therapy Supply Agreement
East Rutherford, NJ and Fort Lauderdale, FL - March 11, 2002 - Cambrex Corporation announced today the completion of a cell therapy supply agreement between Cambrex Corporation and privately held BioHeart, Inc. BioHeart is developing cellular-based therapies to regenerate heart muscle tissue. Under the terms of the agreement, Cambrex will contract manufacture BioHeart’s proprietary autologous MyoCellä therapy. BioHeart has recently received FDA approval to initiate US based clinical trials. Cambrex will support BioHeart’s worldwide clinical trials from its BioWhittaker facilities in Walkersville, MD and Verviers, Belgium.
Cambrex is a leading provider of quality products and innovative services to the pharmaceutical and biologics industries. "This is a unique opportunity for Cambrex to demonstrate its expanded cell therapy manufacturing capabilities, including cell banking and expansion services. We are dedicated to the biotech industry for contract therapeutic applications and have an unwavering commitment to regulatory compliance," commented N. David Eansor, Cambrex Vice President and General Manager, Biotherapeutic Business Unit. "We are extremely excited to be involved with such an innovative technology such as BioHeart’s MyoCell therapy and look forward to a successful partnership to provide a leading-edge therapeutic solution."
"BioHeart and Cambrex share a commitment to product quality and patient safety. With vast experience in cell culture, custom manufacturing and regulatory compliance, Cambrex was our first choice to partner with to carefully and cautiously implement our clinical trials," said Howard J. Leonhardt, Chairman and CEO, BioHeart, Inc. "We are committed to building relationships with respected and qualified partners in order to advance the development of BioHeart’s technology and our ability to meet our clinical and business objectives. With the FDA approval to initiate US based clinical trials, BioHeart will be able to offer physicians and patients another therapy option in the battle against this complex disease condition called heart failure. We look forward to initiating our study in the US over the next few weeks."
Developing New Therapies to Treat Heart Patients
BioHeart's initial product under development is called MyoCell, which is designed to regenerate damaged muscle tissue through the transplantation of skeletal muscle cells. Skeletal muscle cells are obtained during a biopsy and then expanded by Cambrex through a proprietary three-week process. Myoblasts (young muscle cells) are transplanted back into the patient's damaged heart using BioHeart's proprietary delivery devices. The first patient was treated with MyoCell in May 2001 in Europe. Clinical trials of BioHeart’s MyoCell product are currently ongoing in Europe.
The BioHeart-Cambrex agreement is the culmination of an extensive development effort initiated by BioHeart at Cambrex over 18 months ago. "We chose Cambrex to outsource our process development activities in order to rapidly advance towards the clinic and avoid the significant capital investment of our own facility," stated Jack Harvey, BioHeart’s Director of Production and Development. "The FDA approval to initiate US trials is a testament to how well we were able to leverage Cambrex’ substantial cell culture production and the corresponding biological regulatory capabilities. This relationship has advanced our efforts and timeline significantly."
Heart muscle regeneration has been proposed as a treatment option for heart attack patients, since the adult heart cannot regenerate damaged muscle tissue. Survivors of large or severe heart attacks in which part of the heart muscle dies can subsequently suffer from congestive heart failure as the damaged heart muscle causes the heart to pump inefficiently. Cambrex and BioHeart have been working together for over a year on therapeutic cell culturing capacity. Additional terms of the agreement were not disclosed.
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