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CAMBRIDGE, Mass.(BUSINESS WIRE)
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
About Dyax
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.
Dyax Disclaimer
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
Dyax Corp.
Ivana Magovevi?-Liebisch, 617-250-5759
Executive
Vice President Corporate Development
and General Counsel
imagovcevic@dyax.com
or
Nicole
Jones, 617-250-5744
Director, Investor Relations
and Corporate
Communications
njones@dyax.com
Source: Dyax Corp.
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