Dyax Corp. (NASDAQ: DYAX),
a developer of novel biotherapeutics for unmet medical needs, and
Novellus Biopharma AG (Novellus) announced today a strategic partnership
for the development and commercialization of KALBITOR®
(ecallantide) for the treatment of hereditary
angioedema (HAE) and other angioedema indications in select regions
in Latin America, including Argentina, Brazil, Chile, Colombia, Mexico
and Venezuela. KALBITOR
is 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 sales milestones. Dyax
is also eligible to receive royalties on net product sales. Novellus is
solely responsible for all costs associated with necessary development,
regulatory activities, and the commercialization of KALBITOR in the
covered territories. Additionally, Novellus will purchase drug product
from Dyax on a cost-plus basis for commercial supply.
"We are pleased to announce a new partnership for KALBITOR in Latin
America, and look forward to working with Novellus toward its
commercialization in this region,” said Gustav Christensen, President
and Chief Executive Officer of Dyax Corp. “Novellus’ experience in
bringing novel biotherapeutics to market will be important in delivering
KALBITOR to HAE patients in this region. We continue to make strides in
expanding the availability of KALBITOR and delivering an acute HAE
treatment to patients in need around the globe."
“Based on the clinical and commercial success of KALBITOR as an acute
treatment for HAE in the United States, we are excited to bring this
important therapeutic to the Latin American market,” commented David
Muñoz Guzman, Chief Executive Officer of Novellus. “We believe there is
a great opportunity in Latin America to provide solutions for the
management of HAE and we look forward to working with Dyax to bring
KALBITOR to these markets.”
About Dyax
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 other 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 12 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.
About Novellus
Established in 2012, Novellus Biopharma is a Latin American focused
pharmaceuticals company devoted to the development, registration
and commercialization of drugs and other specialty based treatments.
Headquartered in Switzerland, Novellus Biopharma AG strives to be the
first Pan-Latin American provider of innovative and high value-added
treatments for orphan diseases. Backed by specialized healthcare
investors, the Company leverages deep knowledge in the regulatory,
marketing and commercialization field.
Dyax Disclaimer
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 Novellus
include the risks that: Dyax's future benefits from this collaboration
will depend on the efforts and priorities of Novellus, which may be
subject to changes in Novellus' business direction or priorities;
KALBITOR may take longer to gain regulatory approval and market
acceptance in Latin America than Dyax or Novellus 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.
