BURNABY, BC, April 6 /PRNewswire-FirstCall/ - Chromos Molecular Systems Inc. , a public biopharmaceutical company, has signed a contract with AppTec Laboratory Services, Inc. (“AppTec”) for scale-up and manufacture of its monoclonal antibody drug product candidate CHR-1103. Chromos has used its proprietary ACE System to engineer cell lines for CHR-1103; AppTec will scale up and manufacture CHR-1103 for use in preclinical toxicology studies and Phase I clinical trials.
“This contract is an important step forward in the development of CHR-1103,” said Alistair Duncan, President and CEO of Chromos. “We are pleased to use our team’s proven expertise in cell line engineering with the ACE System to develop our product candidates cost effectively and to work in partnership with AppTec to manufacture this innovative treatment for multiple sclerosis (MS).”
CHR-1103 is one of two drug product candidates gained through Chromos’ acquisition of Targeted Molecules Corporation in February 2006. A humanized monoclonal antibody for the treatment of the inflammatory disease, CHR-1103 is being developed initially to treat acute flares associated with relapsing forms of MS. The drug’s unique mechanism of action has the potential to reduce the severity of a relapse and stem the residual neurological damage that often accompanies progression of the disease, positioning CHR-1103 to fill an unmet medical need for an effective acute treatment of MS.
Chromos plans to file an Investigational New Drug (IND) application for CHR-1103 in 2007. The Company’s second product candidate, CHR-1201, is being developed to treat acute thrombosis and offers the possibility of effective treatment of thrombosis involving the brain without the risk of bleeding.
The ACE System is Chromos’ proprietary platform for rapidly generating production-quality cell lines. The ACE System’s performance, speed and versatility are key advantages for generating cell lines for research, development and manufacture of biopharmaceuticals.
Chromos and AppTec are strategic partners who offer the biopharmaceutical industry a broad range of cell line engineering and contract manufacturing services. The companies formed a non-exclusive co-marketing agreement in February 2005. They are jointly marketing Chromos’ expertise with cell line engineering with its ACE System and AppTec’s expertise in scale-up, manufacturing and testing of biopharmaceuticals, offering customers a high-yield, fast-track solution.
About Chromos
Chromos is a biopharmaceutical company with two drug development programs focused on inflammatory diseases and thrombotic disorders. The Company’s lead program, CHR-1103, is a humanized monoclonal antibody being developed as a treatment for acute relapses associated with relapsing forms of MS. Chromos generates revenue from its proprietary platforms - the ACE System and REM technology - to support its drug development programs. For more information about Chromos, visit our website at www.chromos.com.
About AppTec
AppTec offers comprehensive testing, contract research and development, and cGMP manufacturing services for biopharmaceuticals, medical devices, cellular therapeutics and tissue-based products from a unique single-source platform. The company has three facilities - St. Paul, MN (also the corporate headquarters); Philadelphia, PA; and Atlanta, GA - all of which are GLP and cGMP compliant and FDA registered. The St. Paul and Atlanta facilities are also ISO certified.
With its 75,000-square-foot, state-of-the-art facility in Philadelphia, AppTec provides integrated, one-stop services for mammalian-cell-culture-based biopharmaceuticals and cellular therapeutics - from complete testing services, to process development and custom manufacturing, including final formulation and fill. Testing services for the biotechnology/biopharmaceutical industries include cell line characterization, viral and process validation, gene therapy vector testing, molecular biology, mycoplasma testing and analytical services.
For medical products, AppTec provides comprehensive biosafety testing including biocompatibility (in vivo and in vitro), chronic toxicity, genotoxicity, microbiology, chemistry, sterilization validation, viral clearance studies, environmental monitoring, and package testing. Contract services include cGMP processing/manufacturing for cells, tissues, and tissue-based products.
The company has 300 employees, seven sales territory offices located across the United States, and a business development office in Europe.
Risks and Uncertainties
Certain of the statements contained in this press release are forward-looking statements which involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Chromos (the “Company”), or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements.
To the extent possible, management implements strategies to reduce or mitigate the risks and uncertainties associated with the Company’s operations. Operating risks include (i) the continued availability of capital to finance the Company’s activities; (ii) the Company’s limited cash position, (iii) the ability to successfully obtain proof of the effectiveness of the Company’s technology (iv) the ability to complete and maintain corporate alliances relating to the development and commercialization of the Company’s technology; (v) the ability to obtain and enforce patent and other intellectual property protection for the Company’s technology; (vi) market acceptance of the Company’s technology; (vii) the competitive environment and impact of technological change; (viii) the Company’s ability to attract and retain employees to carry out its business plans and (ix) the timely development and commercialization of any technology or products that are contingent on the completion and maintenance of corporate alliances with third parties. Further details on Chromos’ operating risks can be found in the Company’s Quarterly and Annual Reports to Shareholders.
FOR FURTHER INFORMATION: Chromos: AppTec: Kathryn Hayashi, CA Lawrence Thomas Vice President, Finance EVP Business Development Tel: 604-415-7132 larry.thomas@apptec-usa.com Email: khayashi@chromos.comwww.apptec-usa.comwww.apptec-europe.com
Chromos Molecular Systems Inc.
CONTACT: Chromos: Kathryn Hayashi, CA, Vice President, Finance, Tel: (604)415-7132, Email: khayashi@chromos.com; AppTec: Lawrence Thomas, EVPBusiness Development, larry.thomas@apptec-usa.com; www.apptec-usa.com;www.apptec-europe.com
