TORONTO, March 2 /PRNewswire-FirstCall/ - Bradmer Pharmaceuticals Inc., a biotechnology company dedicated to the development and commercialization of cancer therapies, today announced that it has entered into a development and manufacturing agreement with Laureate Pharma for the process development and manufacture of cGMP batches of the basic antibody precursor of Neuradiab, Bradmer’s anticipated multi-center clinical candidate.
“Neuradiab has been evaluated in multiple Phase I and Phase II trials conducted by Duke University for the treatment of glioblastoma multiforme. Over 160 patients have safely received Neuradiab treatment and the results have clearly demonstrated the important clinical benefit of this product,” said Mark C. Rogers, M.D., Chief Executive Officer of Bradmer. “This manufacturing contract, incorporating Laureate Pharma’s unique expertise and experience, is an important step in our plans towards initiating a multi- center clinical trial over the next year.”
The cGMP manufacturing process is a regulatory requirement for drugs undergoing clinical testing, and provides for rigorous production control, monitoring, and record-keeping. Laureate Pharma has already initiated the project and expects to complete the manufacturing prior to the end of 2006. Terms of the agreement were not disclosed.
“We are excited to apply our experience and expertise in monoclonal antibody development and production to Bradmer’s important new clinical candidate for patients that suffer from brain cancer,” said Robert J. Broeze, Ph.D., President and Chief Executive Officer of Laureate Pharma. “Our relationship with the management of Bradmer and its potential new cancer therapy Neuradiab fulfills our pursuit of working with innovative partners and products.”
Neuradiab was recently granted Orphan Drug Status by the U.S. Food and Drug Administration. The Orphan Drug Designation provides eligibility for a special seven-year period of market exclusivity upon marketing approval, potential tax credits for research, potential grant funding for research and development, the possibility of reduced filing fees for marketing applications and, particularly, assistance with the review of clinical trial protocols.
Neuradiab Treatment
Neuradiab is a monoclonal antibody, conjugated to radioactive iodine, used to treat glioblastoma multiforme (GBM), the most common and deadly form of brain cancer. Neuradiab delivers tumor-killing radiation specifically to residual brain tumor cells after surgery, with minimal impact on normal brain tissue. To date, 6 clinical trials have been completed involving over 160 GBM cancer patients. In a recent Phase II trial of newly diagnosed GBM patients, Neuradiab, used in combination with the current standard therapy, extended median survival by 42% to 91 weeks compared with 64 weeks for a historical control group. Bradmer intends to initiate a multi-center clinical trial at the leading U.S. GBM treatment sites across the country in late 2006 or early in the first quarter of 2007.
Each year over 30,000 new cases of GBM are diagnosed in world’s seven largest healthcare markets. The current standard of care for GBM patients is surgical resection followed by radiation and temozolomide. GBM tumors typically have infiltrating edges that are very difficult to completely remove with surgery. The Neuradiab therapy is delivered directly into the surgical resection cavity in a separate procedure after the initial surgery. Neuradiab delivers a concentrated level of radiation specifically to the remaining cancer cells by targeting tenascin. Tenascin is a protein over-expressed in 99% of GBM cells but absent from normal brain cells.
About Bradmer Pharmaceuticals Inc. (www.bradmerpharma.com)
Bradmer Pharmaceuticals is a biotechnology company focused on the development and commercialization of new and innovative cancer therapies. Bradmer’s lead clinical candidate, Neuradiab, was developed at Duke University Medical Center as a proprietary therapy for a particularly aggressive form of brain cancer. To date, the treatment has been used in over 160 patients with excellent results and has completed a Phase II clinical trial conducted by researchers at Duke University. Bradmer is currently in the process of organizing a multi-center clinical trial of the licensed treatment.
About Laureate Pharma
Laureate Pharma is a full service biopharmaceutical development and protein production company located in Princeton, NJ. The company is dedicated to supporting the development and commercialization of pharmaceutical products for pharmaceutical and biopharmaceutical companies. Laureate Pharma provides a wide range of specialized product development services from process design and development to full-scale cGMP production, purification and aseptic filling, as well as corresponding testing, validation, analytical services and regulatory support. Laureate is focused on two active segments of the biopharmaceutical industry: monoclonal antibodies and recombinant protein products. Mammalian cells are grown in stirred-tank or hollow-fiber bioreactors for production of biopharmaceutical proteins, which are purified by state-of-the-art semi-automated chromatography systems. Laureate Pharma, Inc. is a wholly owned partner company of Safeguard Scientifics . For more information on Laureate Pharma, please contact Michael Cavanaugh, Vice President Sales, Marketing, and Business Development at (609) 919-3400, by email at info@laureatepharma.com or visit www.laureatepharma.com.
The TSX Venture Exchange Inc. has in no way passed upon the merits of the Qualifying Transaction and has neither approved nor disapproved the contents of this release.
Bradmer Pharmaceuticals Inc.'s common shares have not been registered under the Securities Act of 1933, as amended (the “Securities Act”) or any state regulatory agency in the United States. The resale or transfer by a U.S. investor of such common shares of Bradmer Pharmaceuticals Inc. is subject to the requirements of Rule 904 of Regulation S of the Securities Act or such other applicable exemption thereunder, and other applicable state securities laws.
Except for historical information, this press release may contain forward-looking statements, which reflect the Company’s current expectation regarding future events. These forward-looking statements involve risk and uncertainties, which may cause but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Company’s ongoing quarterly and annual reporting.
Bradmer Pharmaceuticals Inc.
CONTACT: Bradmer Pharmaceuticals Inc., Mr. Brian Brohman, Chief FinancialOfficer, Phone: (502) 657-6038, Fax: (502) 657-6039, E-mail:bbrohman@bradmerpharma.com, Internet: www.bradmerpharma.com; InvestorRelations, Ross Marshall, The Equicom Group Inc., Phone: (416) 815-0700(Ext. 238), Fax: (416) 815-0080, E-mail: rmarshall@equicomgroup.com
