September 20, 2012
Dyax Corp. and Kadmon Sign Strategic Licensing Agreement for DX-2400
Novel MMP-14 Inhibitor to be Developed in Multi-Indication Oncology Program
Burlington, MA, and New York, NY, September 20, 2012 – Dyax Corp. (NASDAQ:DYAX) and Kadmon Corporation, LLC (Kadmon) announced today that they have entered into a strategic licensing agreement in which Kadmon has been granted an exclusive worldwide license for the development and commercialization of the fully human monoclonal antibody DX-2400, a potent and selective antibody inhibitor of matrix metalloproteinase 14 (MMP-14). MMP-14 is a key enzyme in a molecular pathway thought to play a role in tumor blood vessel formation (angiogenesis) in addition to affecting tumor growth and cell migration. Under the terms of the agreement, Dyax will receive an upfront payment, and is eligible for significant development and commercial milestone payments, in addition to tiered royalties on commercial sales up to a double-digit rate. As an exclusive licensee, Kadmon will be responsible for further development and commercialization of DX-2400, which is currently in investigational new drug (IND) application-enabling studies.
“Kadmon’s management team has a proven track record of successfully developing and commercializing important, new oncology products,” stated Gustav Christensen, President and Chief Executive Officer of Dyax. “This strategic agreement further validates Dyax’s capabilities to successfully discover novel antibody drug candidates utilizing our proprietary phage display technology and advance the resulting drug candidates into development.”
“This agreement expands on our longstanding relationship with Dyax and their antibody technology platform,” stated Samuel D. Waksal, Ph.D. Chairman and CEO of Kadmon. “We believe MMP-14 is an important piece of the puzzle for overcoming cancer’s growth, proliferation and resistance mechanisms. In particular, its role in tumors and ocular disease neovascularization represents a unique target opportunity that may be complementary to other antiangiogenic therapies on the market and in development. We look forward to developing this candidate, and to fully understanding its synergistic potential with our oncology pipeline products.”
Targeting MMP-14 has therapeutic potential in multiple oncology indications where human tumor tissue sample analysis has confirmed high levels of active MMP-14. In published work, Dyax has previously demonstrated DX-2400 mediated inhibition of primary tumor growth, metastasis and angiogenesis in preclinical models of breast, melanoma and prostate cancer.
DX-2400 was discovered using Dyax’s “gold-standard” phage display technology where Dyax applied its extensive selection and screening expertise to selectively block catalytic activity of a single protease within a larger and closely related family of enzymes. This antibody is another example of the superior functional selectivity available to validate novel biologic targets using Dyax’s phage display libraries.
About Dyax’s Phage Display
Dyax’s proprietary drug discovery technology, phage display, provides an efficient means to identify compounds that interact with a wide array of therapeutic targets. Dyax’s discovery capabilities have been further enhanced through automation, which has enabled the Company to evaluate a large number of molecules binding to each target. In this way, Dyax is able to rapidly identify and select a specific antibody, peptide or small protein with the desired biochemical and biological characteristics. Dyax’s state-of-the-art antibody phage display libraries allow for the rapid isolation of fully human target-specific antibodies from a library of billions of unique antibodies. These libraries are screened using in vitro selection strategies that are tailored to increase the yield of lead candidates with the desired therapeutic properties. 1,2
Dyax is a fully integrated biopharmaceutical company focused on the development and commercialization of novel biotherapeutics for unmet medical needs. The Company’s lead product, ecallantide, has been approved under the brand name KALBITOR in the United States for the treatment of acute attacks of hereditary angioedema (HAE) in patients 16 years of age and older.
Dyax is commercializing KALBITOR in the United States independently, and establishing strategic collaborations to develop and commercialize ecallantide for the treatment of HAE in key regions worldwide. Currently, Dyax has collaboration agreements for regions including Europe, Japan, Russia, the Middle East, Australia and New Zealand. Dyax is also exploring other potential indications for ecallantide, either alone or through collaborations.
Ecallantide and other compounds in Dyax’s pipeline were identified using its patented phage display technology, which rapidly selects compounds that bind with high affinity and specificity to therapeutic targets. Dyax leverages this technology broadly through the Licensing and Funded Research Program (LFRP). Collectively, LFRP agreements generate significant revenue for Dyax in the form of license fees, milestone payments and/or royalties. The success of the Company’s LFRP is illustrated by the program’s advanced licensee pipeline that includes 18 candidates in clinical development. Of those candidates, three are in Phase 3 clinical trials, six are in Phase 2 and nine are in Phase 1.
Dyax is headquartered in Burlington, Massachusetts. For online information about Dyax Corp., please visit www.dyax.com.
About Kadmon Corporation
Kadmon Corporation, LLC is a global company built on a 21st-century paradigm for the translation of innovative science into treatment. The company currently offers products and services for the treatment and management of hepatitis C, and is pioneering novel medicines in areas of serious disease, including oncology, infectious diseases, immunology and neurodegenerative diseases. Emphasizing emerging concepts in molecular biology and genomics, Kadmon is developing treatments and treatment combinations that target the metabolomics and signaling pathways associated with disease, with the goal addressing some of today’s most pressing areas of unmet medical need. For more information, visit www.kadmon.com.
This press release contains forward-looking statements, including statements regarding the expected benefits of Dyax’s license to Kadmon. Statements that are not historical facts are based on Dyax’s current expectations, beliefs, assumptions, estimates, forecasts and projections about the industry and markets in which Dyax competes. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors which may affect the expected benefits of Dyax’s license to Kadmon include the risks that: Dyax’s future benefits from this license will depend on the efforts and priorities of Kadmon, which may be subject to changes in Kadmon’s business direction or priorities; DX-2400 may not show sufficient therapeutic effect or an acceptable safety profile in clinical trials or could take a significantly longer time to gain regulatory approval and market acceptance than Dyax or Kadmon expects or may never gain such approval or acceptance; others may develop technologies or products superior to or on the market before DX-2400; and other risk factors described or referred to in Dyax’s most recent Annual Report on Form 10-K and other periodic reports filed with the Securities and Exchange Commission. Dyax cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Dyax undertakes no obligations to update or revise these statements, except as may be required by law. Dyax specifically disclaims responsibility for information describing Kadmon and its business other than the license with Dyax.
Dyax, the Dyax logo and KALBITOR are the registered trademarks of Dyax Corp.
1. Hoet RM et al. (2005). Generation of high-affinity human antibodies by combining donor-derived and synthetic complementarity-determining-region diversity.Nature Biotechnology, 23(3):344-8.
2. Wassaf D. et al. (2006). High-throughput affinity ranking of antibodies using surface plasmon resonance microarrays.Analytical Biochemistry. 351(2):241-253.