CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dyax Corp. (NASDAQ: DYAX) and CMIC Co., Ltd, (CMIC) announced today an agreement to develop and commercialize subcutaneous DX-88 (ecallantide) for the treatment of hereditary angioedema (HAE) and other angioedema indications in Japan. DX-88 has been approved by the U.S. Food and Drug Administration (FDA) and is marketed as KALBITOR® (ecallantide) for the treatment of acute attacks of HAE in patients 16 years of age and older.
Under the terms of the agreement, Dyax will receive $4 million upfront and $102 million in future development and sales milestones for DX-88 in HAE and other angioedema indications. CMIC is solely responsible for all costs associated with development, regulatory activities, and commercialization of DX-88 for all angioedema indications in Japan. CMIC will purchase drug product from Dyax on a cost-plus basis for clinical and commercial supply. Additionally, Dyax is eligible to receive royalties of 20%-24% on net product sales.
“Our agreement with CMIC represents another significant advancement for our DX-88 global partnering strategy,” said Gustav Christensen, President and Chief Executive Officer of Dyax Corp. “As Japan is an important market for us, it was critical to align with a company that has experience developing orphan drugs.” He adds, “We view CMIC’s licensing collaborations with Ucyclyd Pharma, Inc. and Orphan Europe SARL as examples of their dedication to developing treatments for rare diseases. We look forward to working with CMIC toward the common goal of having DX-88 approved and commercialized for the benefit of Japanese HAE patients.”
“Based on the clinical advantages of KALBITOR in the United States, we are excited to develop and commercialize DX-88 in Japan and believe there is an opportunity for significant adoption,” states Dr. Kazuo Nakamura, Chief Executive Officer of CMIC. “Patients desire a non-plasma derived treatment for HAE which currently is not available in Japan. As such, DX-88 presents an advantageous option for patients and represents a significant market opportunity.”
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 1:10,000 to 1:50,000 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. Dyax utilizes its proprietary drug discovery technology to identify antibody, small protein and peptide compounds for clinical development. Our lead product, DX-88, has been approved under the brand name KALBITOR® (ecallantide) in the United States for the treatment of acute attacks of hereditary angioedema in patients 16 years of age and older.
In June 2010, Dyax announced a strategic partnership with Sigma-Tau to develop and commercialize subcutaneous DX-88 for the treatment of hereditary angioedema (HAE) and other therapeutic indications throughout Europe, North Africa, Middle East and Russia. Dyax and Sigma-Tau will work together with the European Medicines Agency as they review our Marketing Authorization Application for potential approval to market DX-88 in the European Union for HAE.
DX-88 is being investigated for its therapeutic potential in other angioedema indications and, through a collaboration with Fovea Pharmaceuticals (a subsidiary of sanofi aventis), is in a Phase 1 trial for retinal vein occlusion-induced macular edema.
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. Dyax is headquartered in Cambridge, Massachusetts. For online information about Dyax Corp., please visit www.dyax.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 prospects for therapeutic benefits and treatment advantages 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.
As Japan’s first contract research organization (CRO), CMIC provides services that contribute to the efficient, expeditious implementation of clinical trials. Utilizing its abundant experience, CMIC comprehensively supports pharmaceutical companies in carrying out their core processes of drug development, manufacturing and marketing. Contributing to the maximization of pharmaceutical company value, CMIC offers a broad lineup of services.
In addition to the fee-for-service type business, CMIC has a pharmaceutical business of orphan drugs. CMIC in-license Japan right of orphan drugs with unmet medical needs, develop it for Japan marketing approval, and then market it. 1st example of such product is Normosang®, a drug for acute porphyria marketed by Orphan Europe SARL in EU. Sodium Phenylbutyrate is the 2nd product for CMIC’s Orphan drug business. For further details, please visit the CMIC website at http://www.cmic.co.jp/e/.