Dyax Corp. and CVie Therapeutics Announce Partnership to Develop and Commercialize KALBITOR® (ecallantide) for Hereditary Angioedema (HAE) and Other Angioedema Indications in China, Hong Kong and Macau
BURLINGTON, Mass. & HONG KONG--(BUSINESS WIRE)--
Dyax Corp. (NASDAQ: DYAX),
a developer of novel biotherapeutics for unmet medical needs, and CVie
Therapeutics (CVie), a subsidiary of Lee's Pharmaceutical Holdings Ltd.,
announced today a strategic partnership for the development and
commercialization of KALBITOR® (ecallantide) in the treatment
angioedema (HAE) and other angioedema indications in China, Hong
Kong and Macau. KALBITOR
is currently marketed in United States for the treatment of acute
attacks of HAE in patients 16 years of age and older.
Under the terms of the exclusive license agreement, Dyax will receive an
upfront payment and is eligible to receive future development,
regulatory and sales milestones. Dyax is also eligible to receive
royalty on net product sales. CVie is solely responsible for all costs
associated with development, regulatory activities, and the
commercialization of KALBITOR in China, Hong Kong and Macau.
Additionally, CVie will purchase drug product from Dyax on a cost-plus
basis for commercial supply.
"Our partnership with CVie is another milestone in our effort to expand
the global development and commercialization of KALBITOR, and to reach
HAE patients in need around the world," said Gustav Christensen,
President and Chief Executive Officer of Dyax Corp. "If approved,
KALBITOR would become the first novel therapy available for HAE in
China, where presently only steroids are used. We are pleased to have
secured a new partnership for KALBITOR in this region, and look forward
to working with CVie toward its commercialization."
"KALBITOR is an important addition to our portfolio of products focused
on the treatment of patients with rare diseases," commented Dr. Benjamin
Li, Chief Executive Officer of CVie. "As a novel therapeutic for acute
HAE attacks, we anticipate that KALBITOR will allow us to provide a far
more comprehensive disease management solution than is currently offered
to HAE patients in China."
Dyax is a fully integrated biopharmaceutical company focused on the
discovery, development and commercialization of novel biotherapeutics
for unmet medical needs. The Company's key value drivers are the KALBITOR®
(ecallantide) business and the angioedema portfolio, as well as the
Licensing and Funded Research Program (LFRP).
Dyax developed KALBITOR on its own and, since February 2010, the Company
has been selling it in the United States for the treatment of acute
attacks of hereditary angioedema (HAE) in patients 16 years of age and
older. Outside the United States, the Company has established
partnerships to obtain regulatory approval for and commercialization of
KALBITOR in certain markets and is evaluating opportunities in others.
The Company is currently developing products to expand its angioedema
portfolio, including diagnostic strategies to identify plasma kallikrein
(bradykinin) mediated (PKM) angioedema and a therapeutic candidate,
DX-2930, for the prophylactic treatment of HAE and PKM angioedemas.
KALBITOR and DX-2930 were identified using Dyax's 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 LFRP. This program has provided the Company a
portfolio of product candidates being developed by its licensees, which
currently includes 13 royalty and/or milestone bearing product
candidates in various stages of clinical development, including three in
Phase 3 trials.
Dyax is headquartered in Burlington, Massachusetts. For additional
information about Dyax, please visit www.dyax.com.
CVie is a joint venture between Lee's Pharmaceutical Holdings Ltd. and a
U.S. venture capital firm and is a standalone drug development company
specialized in cardiovascular diseases. CVie owns two phase II assets
that target cardiovascular disease with significant unmet medical need.
In its first day of operation, CVie has successfully filed to the SFDA
the application for a global Phase IIb clinical study (Protocol No.
CVT-CT-1207-001) in China for one of its portfolio products
Rostafuroxin. The study aims to using pharmacogenomic approach to
evaluate the antihypertensive effect of different doses of Rostafuroxin
in comparison with LosartanR, assessed by office and ambulatory blood
pressure monitoring in a hypertensive population. It is expected to
initiate the clinical trial respectively in Italy at Q4 2012 and in
China at Q3 2013.
About Lee's Pharmaceutical Holdings Limited
Lee's Pharmaceutical Holdings Limited is a research-based
biopharmaceutical company listed in Hong Kong with over 19 years
operation in China's pharmaceutical industry. It is fully integrated
with strong infrastructures in drug development, manufacturing, sales
and marketing. It has established extensive partnership with over 20
international companies and currently has 14 products in the market
place. Lee's focuses on several key disease areas such as
cardiovascular, oncology, gynecology, dermatology and ophthalmology.
Lee's development program is lauded with 30 products stemming from both
internal R&D efforts and collaborations with US, European and Japanese
companies and aspiring to combat diseases such as liver cancer and
pulmonary hypertension. The mission of Lee's is to become a successful
biopharmaceutical group in Asia providing innovative products to fight
diseases and improve health and quality of life. Additional information
about Lee's Pharmaceutical is available at www.leespharm.com.
This press release contains forward-looking statements, including
statements regarding the prospects for therapeutic benefits and
treatment advantages 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 expected benefits of Dyax's collaboration with CVie
include the risks that: Dyax's future benefits from this collaboration
will depend on the efforts and priorities of CVie, which may be subject
to changes in CVie's business direction or priorities; KALBITOR may take
longer to gain regulatory approval and market acceptance in China, Hong
Kong and Macau than Dyax or CVie expects or may never gain such approval
or acceptance; products other than KALBITOR may be approved or gain
market acceptance before KALBITOR; and other risk factors described or
referred to in 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 marks of Dyax Corp.
Jennifer Robinson, 617-250-5741
Relations and Corporate Communications
Source: Dyax Corp.
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