Dyax Announces New Developments Related to Phage Display-Discovered Drug Candidates
Sanofi-aventis to Acquire Dyax's Ophthalmic Partner, Fovea Pharmaceuticals
Sanofi-aventis also Licenses Phase 1 Drug Candidate from Merrimack Pharmaceuticals, a Dyax Licensee
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Oct. 13, 2009-- Dyax Corp. (NASDAQ: DYAX) announced today new developments involving drug candidates identified using the Company's proprietary phage display technology as a result of two deals recently announced by sanofi-aventis.
Sanofi-aventis announced plans to acquire Fovea Pharmaceuticals, Dyax's partner for DX-88 in ophthalmic indications in the European Union (EU). DX-88 (FOV 2302), one of Fovea's three pipeline products, is in Phase 1 development for the treatment of retinal vein occlusion (RVO) induced macular edema. Under the terms of the Dyax-Fovea partnership agreement, Fovea has exclusive rights to the intravitreal formulation of DX-88 in ophthalmic indications in the EU. Fovea will fully fund development for the RVO induced macular edema program for approval in worldwide markets. Dyax retained rights for ophthalmic indications for all territories outside the EU.
Separately, sanofi-aventis announced an exclusive collaboration and licensing agreement with Merrimack Pharmaceuticals, a licensee under Dyax's Licensing and Funded Research Program (LFRP), for rights to MM-121. The fully human monoclonal antibody, MM-121, was identified using Dyax's proprietary antibody phage display library and is currently in Phase 1 development in oncology. Dyax is eligible to receive milestones associated with the development of MM-121, as well as royalties upon commercialization. To date, one marketed product and fifteen product candidates in various stages of development have been identified using Dyax's proprietary phage display libraries under the LFRP.
Dyax already has a relationship with sanofi-aventis which began in February 2008 when sanofi-aventis licensed rights to Dyax's fully human monoclonal antibody DX-2240 and to the company's proprietary phage display technology in a deal valued up to $500 million for Dyax. Dyax received $25 million in upfront payments in 2008.
"We are pleased that DX-88 in retinal disease has been recognized as a key asset in the proposed acquisition of Fovea," said Gustav A. Christensen, President and Chief Executive Officer of Dyax. "Furthermore, these deals, which involve two drug candidates generated from our proprietary phage display libraries, further validate our technology as an important drug discovery platform."
About Dyax's Phage Display
Dyax's proprietary drug discovery platform, 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 allows for the rapid isolation of fully human target-specific antibodies from a library of billions of unique antibodies. These extensive 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 focused on advancing novel biotherapeutics for unmet medical needs, with an emphasis on inflammatory and oncology indications. Dyax utilizes its proprietary drug discovery technology to identify antibody, small protein and peptide compounds for clinical development. Dyax's lead product candidate is DX-88 (ecallantide), a recombinant small protein that is currently being evaluated for its therapeutic potential in two separate indications. On June 1, 2009, Dyax submitted a response to the FDA's Complete Response letter regarding the review of Dyax's Biologics License Application (BLA) of DX-88 for the treatment of hereditary angioedema (HAE). The FDA accepted the submission and assigned Dyax's BLA a new Prescription Drug User Fee Act (PDUFA) action date of December 1, 2009. DX-88 has orphan drug designation in the U.S. and E.U., as well as Fast Track designation in the U.S., for this indication. Additionally, DX-88 is being evaluated in two Phase 2 trials for the reduction of blood loss during on-pump cardiothoracic surgery (CTS), which are being conducted by Dyax's partner, Cubist Pharmaceuticals. Dyax licensed to Cubist the intravenous formulation of DX-88 for surgical indications in North America and Europe. DX-88 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 with over 70 revenue generating licenses and collaborations for therapeutic discovery, as well as in non-core areas such as affinity separations, diagnostic imaging, and research reagents. Under a debt financing agreement between Cowen Health Care Royalty Partners (CHRP) and Dyax, CHRP is entitled to receive a specified percentage of the net royalties, including all milestones fees and other payments, receivable by Dyax under its Licensing & Funded Research Program (LFRP) through 2016. Dyax is headquartered in Cambridge, Massachusetts. For online information about Dyax Corp., please visit www.dyax.com.
This press release contains forward-looking statements, including statements regarding the expected benefits of Dyax's licenses with Fovea Pharmaceuticals and Merrimack Pharmaceuticals. 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 licenses with Fovea Pharmaceuticals and Merrimack Pharmaceuticals and include the risks that: Dyax's future benefits from its non-exclusive licensing program depend on the efforts and priorities of its licensees, which may be subject to changes in each licensee's business direction or priorities; others may develop technologies or products superior to Dyax's phage display technologies; Dyax may not be able to obtain and maintain intellectual property protection for its technologies; 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 Fovea Pharmaceuticals and Merrimack Pharmaceuticals and its business other than the license with Dyax.
Dyax and the Dyax logo 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
Source: Dyax Corp.
Ivana MagovÄeviÄ‡-Liebisch, 617-250-5759
Executive Vice President Corporate Development
and General Counsel
Nicole Jones, 617-250-5744
Director, Investor Relations
and Corporate Communications