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.”
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.
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.
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.