Dyax and Sigma-Tau Group Expand Agreement for KALBITOR® (ecallantide) in Hereditary Angioedema
Additional Territories Include Countries in Latin America and
Expanded Agreement Includes $7M in Upfront Payment, Up to $10M in
CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Dyax Corp. (NASDAQ: DYAX)
and Defiante Farmaceutica S.A., an affiliate of the pharmaceutical group
Sigma-Tau (Sigma-Tau), announced today an expansion of their strategic
partnership for KALBITOR® (ecallantide) in the treatment of
hereditary angioedema (HAE) and other therapeutic indications to include
development and commercialization rights in Latin America, excluding
Mexico and the Caribbean, Taiwan, Singapore and South Korea. Under their
existing agreement, Defiante holds these rights in Europe, North Africa,
the Middle East, Russia, Australia and New Zealand, with Dyax retaining
rights to KALBITOR in other territories, including the U.S., where it is
approved for the treatment of acute attacks of HAE in patients 16 years
of age and older.
Dyax will receive an upfront payment of $7 million and is eligible to
receive up to $10 million in regulatory, approval and reimbursement
milestones. Consistent with their existing agreement, Dyax is also
eligible to receive sales milestones and royalties equal to 41% of net
sales of KALBITOR, less cost of goods sold. Sigma-Tau is also
responsible for costs associated with regulatory approval and
commercialization in their additional territories.
"The addition of these new territories to our strategic agreement with
Sigma-Tau is another important step in our ongoing KALBITOR strategy,"
stated Gustav Christensen, President and Chief Executive Officer of Dyax
Corp. "We will work with our partner to maximize the global reach and
commercial potential of KALBITOR and position it to be the HAE treatment
of choice internationally."
"The expansion of our agreement with Dyax speaks to the success of this
partnership, our continued dedication to KALBITOR and our ongoing
mission to provide treatment options to patients with rare diseases,"
said Mr. Ugo Di Francesco, Sigma-Tau Group Executive Vice President and
Chief Executive Officer. "The addition of these territories to our
agreement enhances our global offerings in the specialty pharmaceutical
business and gives us the opportunity to provide an important new
treatment option to HAE patients in Latin America and Southeast Asia."
Hereditary angioedema (HAE) is a rare acute inflammatory condition
characterized by episodes of severe, often painful swelling affecting
the extremities, gastrointestinal tract, genitalia, and larynx. HAE is
caused by low or dysfunctional levels of C1 esterase inhibitor (C1-INH),
a naturally occurring molecule that inhibits plasma kallikrein, a key
mediator of inflammation, and other serine proteases in the blood. HAE
is estimated to affect 1 in 10,000 to 1 in 50,000 individuals. Learn
more at www.HAEHope.com.
Dyax is a fully integrated biopharmaceutical company focused on
discovering, developing and commercializing 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 partnerships to develop and commercialize
ecallantide for the treatment of HAE in key regions worldwide.
Currently, Dyax has partnership agreements for regions including Europe,
Japan, Russia, the Middle East, Israel, North Africa, Australia and New
Zealand. The company is also exploring other potential indications for
ecallantide, either alone or through partnerships, including
drug-induced angioedema and retinal vein occlusion-induced macular edema.
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), which has approximately 75 revenue generating
licenses and collaborations for therapeutic discovery, as well as for
affinity separations, diagnostic imaging, and research reagents. The
success of the Company's LFRP royalty portfolio is illustrated by the
program's advanced licensee pipeline that includes 17 candidates in
clinical development. Of those candidates, four are in Phase 3 clinical
trials, four are in Phase 2 and nine are in Phase 1.
Sigma-Tau is a leading, all Italian capital, international
pharmaceutical group that invests in the research, development and
marketing of innovative and effective treatments to improve patient
well-being and quality of life. Sigma-Tau Group has headquarters in
Pomezia (Rome, Italy), and subsidiaries in France, Switzerland, the
Netherlands, Belgium, Portugal, Germany, UK, India, US and Spain, these
two latter with a production plant. It has over 2400 employees and an
extensive network of licensees worldwide. Sigma-Tau was founded in Italy
in 1957 and achieved a global turnover of €673 million in 2010.
Sigma-Tau invests on average 16% of its turnover in R&D, and employs
approximately 400 researchers currently working on a significant
discovery pipeline, studying, through clinical and pre-clinical trials,
26 different molecules, mostly (11) new and original, and 18 owned by
the Sigma-Tau Group. Therapeutic areas in which the company's research
and development are focused include rare and neglected diseases,
oncology, immunology and Biotech. Sigma-Tau website: www.sigma-tau.it.
This press release contains forward-looking statements, including
statements regarding the prospects for therapeutic benefits of KALBITOR
for HAE. 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 prospects for
therapeutic benefits of KALBITOR for HAE include the risks that: others
may develop technologies or products superior to KALBITOR or that are on
the market before KALBITOR; KALBITOR may not gain market acceptance;
Dyax is dependent on the expertise, effort, priorities and contractual
obligations of third parties in the manufacture, marketing, sales and
distribution of KALBITOR; and other risk factors described or referred
to Item 1A, "Risk Factors" 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, the Dyax logo and KALBITOR are registered trademarks of Dyax Corp.
Ivana Magovčević-Liebisch, 617-250-5759
Corporate Development and General Counsel
Director, Investor Relations and
Bruno Chiavazzo, (39) 06-91394181
Communications — Press Office
Source: Dyax Corp.
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