Dyax Corp. Provides Update On DX-2930 Clinical And Commercial Supply Initiatives

BURLINGTON, Mass.--(BUSINESS WIRE)--Dyax Corp. (NASDAQ:DYAX) today provided an update regarding its ongoing manufacturing initiatives for DX-2930. Discovered by Dyax, DX-2930 is an investigational fully human monoclonal antibody inhibitor of plasma kallikrein being developed for the prevention of hereditary angioedema (HAE) attacks.

“We are utilizing our expertise to deliver a first-class quality product and consequently contribute to the availability of this important medicine and the improvement of the health status of patients.”

Dyax’s manufacturing partner, Rentschler Biotechnologie GmbH (Rentschler), is responsible for providing cGMP (Current Good Manufacturing Practice) drug substance for certain future clinical trials and commercial supply. In preparation for commercial-scale production, Rentschler has commenced characterization and validation of the DX-2930 manufacturing processes. In addition, Rentschler will also support Dyax in the preparation of its submissions to regulatory authorities for marketing approval of the product. If DX-2930 is approved, Rentschler will be responsible for producing commercial supply. Dyax and Rentschler entered into a definitive manufacturing services agreement in 2014.

“Rentschler is a leading manufacturer of FDA and EMA licensed products, has extensive expertise in high quality production of monoclonal antibodies, and an excellent track record in manufacturing products for both clinical trials and commercial markets,” said Gustav Christensen, President and Chief Executive Officer of Dyax. “Their knowledge will be important as we work to prepare the CMC (Chemistry, Manufacturing and Controls) dossiers and other requisite regulatory filings. We look forward to initiating the Phase 3 trial for DX-2930 in HAE patients during the latter part of this year, and we expect that supportive results from this study will be the basis for our BLA submission to the FDA for marketing authorization.”

“We are extremely pleased to be working with Dyax to produce DX-2930,” said Dr. Klaus Schoepe, Vice President of Project Management at Rentschler. “We are utilizing our expertise to deliver a first-class quality product and consequently contribute to the availability of this important medicine and the improvement of the health status of patients.”

About DX-2930

DX-2930 is a novel, fully human monoclonal antibody inhibitor of plasma kallikrein (pKal) which is currently being developed as a subcutaneous injection for the prevention of HAE attacks. Uncontrolled pKal activity leads to excessive generation of bradykinin, a vasodilator thought to be responsible for the localized swelling, inflammation and pain characteristically associated with HAE.

About Rentschler Biotechnologie

Rentschler is a CDMO with over 40 years proven track record in biopharmaceuticals. Focused on the utilization of mammalian cell lines, Rentschler’s long experience covers the development and production of recombinant proteins in compliance with international GMP standards. Rentschler’s customized solutions range from supporting drug candidate selection, cell line and process development capabilities as well as GMP manufacturing to comprehensive analytics and fill & finish. Rentschler’s state-of-the-art manufacturing facility includes bioreactors up to 3,000 L stainless steel and up to 2,000 L single-use. The long-term experience with international regulatory affairs complements the offerings. Rentschler’s full-service concept allows flexibility on the individual project requirements. For more information, please visit www.rentschler.de.

About Dyax

Dyax is a biopharmaceutical company focused on the development and commercialization of novel biotherapeutics for unmet medical needs. The Company is developing DX-2930 for the prevention of HAE attacks. In March 2015, the Company reported positive safety, pharmacokinetic, biomarker and proof-of-concept efficacy results from its Phase 1b clinical trial of DX-2930 in HAE patients. DX-2930 has received Fast Track and Breakthrough Therapy designation from the FDA. Additionally, Dyax markets KALBITOR^® (ecallantide) for the treatment of acute attacks of HAE in patients 12 years of age and older.

Both DX-2930 and KALBITOR were identified using Dyax’s proprietary phage display technology. Dyax has broadly licensed this technology under its Licensing and Funded Research Portfolio (LFRP). The current portfolio includes one FDA approved product, Eli Lilly and Company’s CYRAMZA^® (ramucirumab), for which Dyax receives royalties, and multiple product candidates in various stages of clinical development for which the Company is eligible to receive future milestones and/or royalties.

For additional information about Dyax, please visit www.dyax.com.

For additional information about KALBITOR, including full prescribing information, please visit www.KALBITOR.com.

Disclaimer

The press release contains forward-looking statements, including statements regarding the prospects for the clinical and commercial manufacture of DX-2930, the potential therapeutic advantages of DX-2930 as a treatment for HAE; and prospects for future milestone payments and/or royalties for product candidates licensed under our LFRP. 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 press release are not guarantees of future performance and involve certain risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. There are many factors that could cause actual results to differ materially from those in these forward-looking statements. These factors include the following: the success of commercial scale production of DX-2930; supply disruptions that may result from a number of factors including shortages in product raw materials, labor or technical difficulties, regulatory inspections or restrictions, shipping or customs delays or any other performance failure by any third-party manufacturer or supplier on which we rely; the adequacy of our CMC dossiers and other requisite regulatory filings that will be required to permit application for regulatory approval of DX-2930; even if DX-2930 progresses through clinical trials and gains regulatory approval, it may not gain market acceptance; others may develop technologies or products superior to DX-2930 or that reach the market before DX-2930; Dyax is dependent on the expertise, effort, priorities and contractual obligations of third parties in the manufacture, quality control, storage and clinical development of DX-2930; competition from new and existing treatments for HAE; product candidates in our LFRP may not progress in clinical development or receive commercial approval; milestone payments and /or royalties due under our LFRP may be delayed, withheld, or challenged by our licensees; 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 trademarks of Dyax Corp.

CYRAMZA is a trademark owned by or licensed to Eli Lilly and Company, its subsidiaries, or affiliates.