- Deal Worth Up to $8.4 Million Plus Royalties Includes $2 Million Equity Investment In A&G -
COLUMBIA, Md. and INCHEON, South Korea, June 7 /PRNewswire/ -- A&G Pharmaceutical, Inc. and Celltrion, Inc. have entered into an agreement for clinical production of a novel A&G theranostic monoclonal antibody. Celltrion will perform bioprocess development, scale-up, and cGMP manufacturing and provide all clinical materials to support toxicology studies as well as Phase I and Phase II U.S. clinical studies on A&G's anti-GP88 monoclonal antibody. The anti-GP88 antibody is currently in preclinical development by A&G as a cancer therapeutic. The agreement provides Celltrion exclusive commercialization rights in Asia, including Japan, to anti-GP88 oncology therapies. In return, A&G will receive clinical materials and milestones worth up to $6.4 million as well as royalties on any future anti-GP88 cancer therapeutic product sales by Celltrion in Asia. A&G retains all commercialization rights to its anti-GP88 monoclonal antibody in North America, Europe, and the rest of the world.
Under the terms of a separate investment agreement, A&G will also receive a $2 million equity investment from Celltrion.
GP88 is a biomarker produced by cancer cells that is found in 80% of breast cancers and is not present in normal tissue. A&G is developing a monoclonal antibody that neutralizes the function of GP88. Used as monotherapy or in combination with other anti-cancer agents, this new antibody drug has the potential to be therapeutically effective in the majority of breast cancers, with additional potential application in prostate cancer, ovarian cancer, and other cancers.
"GP88 represents an exciting new theranostic approach for cancer treatment and an outstanding potential market opportunity," said Jung-Jin Seo, CEO of Celltrion. "We look forward to the partnership between A&G's groundbreaking oncology research and drug development and Celltrion's biomanufacturing and Asian commercialization capabilities."
"We are delighted to partner with Celltrion, a company with a world-class reputation and outstanding expertise in large-scale manufacturing of antibodies and other biopharmaceutical products," said Ginette Serrero, PhD, CEO of A&G. "We look forward to working with them to advance this promising novel cancer therapy."
About A&G Pharmaceutical (http://www.agrx.net)
A&G Pharmaceutical is a theranostics company creating and developing monoclonal antibodies to cancer-specific targets as a basis for novel therapeutic and diagnostic products. A&G's therapeutics division is pursuing development of anti-GP88 and other monoclonal antibody drugs for cancer. On the diagnostics side, A&G is developing test kits that will improve early detection, diagnosis, and treatment of breast cancer based on GP88. One of these -- a biopsy test kit currently in clinical trials -- will also serve as a companion diagnostic to anti-GP88 immunotherapy. A&G's Precision Antibody(TM) service unit generates revenue to fund the drug development effort by accelerating the creation of novel, customized antibodies for leading pharmaceutical and biotechnology companies as well as federal laboratories. A&G has raised $5.5 million of equity capital and is located in Columbia, Md.
About Celltrion (http://www.celtrion.com)
Established in 2002, Celltrion is one of the largest biopharmaceutical contract manufacturers of therapeutic monoclonal antibodies and recombinant proteins in the world. Celltrion recently completed construction of a 50,000- liter mammalian cell culture facility and initiated an expansion to build an additional 120,000 liters by 2010. Celltrion is headquartered in South Korea in a government-designated Free Economic Zone. This designation has enabled Celltrion to obtain ongoing support from South Korean governmental agencies. The company currently employs 220 people worldwide with a mission to be a leading custom manufacturer of biologics.
For more information:
Vice President of Business Development
Seungsuh Hong, Ph.D.
President, Celltrion USA
Source: A&G Pharmaceutical, Inc.