|Celldex Announces License of its Cholera and ETEC Vaccine Programs|
NEEDHAM, Mass.--(BUSINESS WIRE)--Jan. 20, 2009--Celldex Therapeutics, Inc. (Nasdaq: CLDX) today announced that it has entered into an exclusive license and development agreement with Vaccine Technologies, Inc. (VTI). Under the license agreement, Celldex has granted a worldwide fee- and royalty-bearing exclusive license to VTI to develop and commercialize Celldex's CholeraGarde(R) and ETEC vaccine programs. Financial details of the agreement with VTI were not disclosed, but include upfront license fees, milestone payments and royalties on net sales of licensed products during the term of the agreement.
VTI plans to continue the clinical development of the CholeraGarde and ETEC programs in conjunction with Celldex's current partners, The International Vaccine Institute (IVI) and the National Institute of Allergy and Infectious Diseases (NIAID), an institute of the National Institutes of Health (NIH), respectively. The IVI is presently conducting a Phase 2 clinical trial of CholeraGarde in Bangladesh, with plans to sponsor additional Phase 2 studies in India and Thailand beginning in the first half of 2009, followed by Phase 3 field studies. IVI has purchased clinical materials produced at Celldex's Fall River, MA manufacturing facility for these trials. The NIAID is presently conducting a Phase 1 study of the ETEC investigational single-dose, oral vaccine designed to offer combined protection against both enterotoxigenic Escherichia coli (ETEC) and cholera at Cincinnati Children's Hospital Medical Center.
"We are pleased to have found a partner with the capabilities to maximize the potential of these important programs to succeed," stated Anthony S. Marucci, President and Chief Executive Officer of Celldex Therapeutics, Inc. "This partnership allows us to monetize the potential of these assets while we focus Celldex's resources on our Precision Targeted Immunotherapy Platform and the clinical and preclinical programs that are emerging from this novel approach to immunotherapy."
VTI is a company with offices and research laboratories in Boston, MA and a vaccine manufacturing facility in Haikou, China. Dr. Yichen Lu, President and CEO of VTI, stated "VTI has several initiatives underway including vaccines targeting hepatitis and influenza. Licensing of the CholeraGarde and ETEC vaccine programs is complementary and consistent with our goal to be a highly competitive vaccine research and development center and manufacturer in China ultimately towards commercialization of vaccines worldwide."
About Celldex Therapeutics, Inc.
Celldex Therapeutics is an integrated biopharmaceutical company that applies its comprehensive Precision Targeted Immunotherapy Platform to generate a pipeline of candidates to treat cancer and other difficult-to-treat diseases. Celldex's immunotherapy platform includes a complementary portfolio of monoclonal antibodies, antibody-targeted vaccines and immunomodulators to create novel disease-specific drug candidates. For more information, please visit http://www.celldextherapeutics.com.
About Vaccine Technologies, Inc.
Emerging threats of infectious diseases create a multibillion-dollar vaccine market worldwide, and the testing of such vaccines (AIDS, Hepatitis) will likely be performed in developing countries. Our innovative vaccine technology platform will launch multiple new therapeutic vaccines and related products that target that global demand. Vaccine Technologies has been formed with the goal of launching an innovative vaccine technology platform and related products into a larger worldwide market. Medical and academic professionals founded the company with extensive experience in the field of HIV/AIDS and hepatitis. The team has experience in establishing multiple R&D facilities, which will be important for the success of the company and deployment of the vaccine technology. For more information, please visit http://www.haikouvti.com.
Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995: This release contains ``forward-looking statements'' made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including those related to the Company's strategic focus and the future development and commercialization of the CholeraGarde and ETEC vaccine programs. Forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, the successful integration of the businesses, multiple technologies and programs of the two companies (Celldex and AVANT) that merged together in 2008 to form our Company; our ability to adapt APC Targeting TechnologyTM to develop new, safe and effective vaccines against oncology and infectious disease indications; our ability to successfully complete product research and further development of our programs; the uncertainties inherent in clinical testing; our ability to manage research and development efforts for multiple products at varying stages of development; Pfizer's and our strategy and business plans concerning the continued development and commercialization of CDX-110; the timing, cost and uncertainty of obtaining regulatory approvals; the failure of the market for the Company's programs to continue to develop; the inability to obtain additional capital; the inability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission, including the Company's Form 10-K for the fiscal year ended December 31, 2007, and its Forms 10-Q and 8-K.
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