Dyax Corp. Highlights Recent Progress in Licensing and Funded Research Portfolio
Dyax Corp. (NASDAQ:DYAX) today highlighted recent progress and upcoming milestones in its Licensing and Funded Research Portfolio (LFRP), including, most recently, licensee Eli Lilly and Company’s announcement of the fourth positive Phase 3 study outcome for CYRAMZATM (ramucirumab). Product candidates in Dyax’s LFRP are eligible for royalties on the first ten years of commercial sales from each antibody program, as well as certain milestone payments. The LFRP currently has 10 product candidates in clinical trials and multiple preclinical programs.
“Our proprietary phage display technology, through LFRP licenses and collaborations, has helped give us the financial flexibility to expand our hereditary angioedema (HAE) portfolio and focus on additional opportunities in the plasma kallikrein pathway,” said Gustav Christensen, President and Chief Executive Officer of Dyax. “With Lilly’s most recent announcement, CYRAMZA has now yielded positive outcomes in four Phase 3 clinical trials in three different cancers. Over the next 12 months, we expect a number of milestones to occur in the LFRP with the potential to provide both near and long-term value to Dyax.”
Important progress and upcoming milestones in the LFRP include:
- On September 12, 2014, licensee Eli Lilly and Company reported positive top-line results from the RAISE trial. The RAISE trial is a global, randomized, double-blind Phase 3 study of CYRAMZA plus FOLFIRI (irinotecan, folinic acid and 5-fluorouracil) compared to placebo plus FOLFIRI as a second-line treatment in patients with metastatic colorectal cancer who have progressed on or after first-line treatment with bevacizumab, oxaliplatin and a fluoropyrimidine. Based on the outcome of the RAISE trial, Lilly has announced that it expects to initiate regulatory submissions for CYRAMZA in this indication in the first half of 2015.
- In 2014, Lilly received U.S. Food and Drug Administration (FDA) approval for, and launched, CYRAMZA as a single-agent treatment for patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy, marking the first regulatory approval of an antibody discovered using Dyax’s LFRP platform. Dyax receives a net royalty of 2.5% on the first ten years of commercial sales of CYRAMZA and will recognize its first royalty revenue beginning in the third quarter 2014.
- Lilly has filed a supplemental Biologics License Application (sBLA) with the FDA based on positive results from its RAINBOW study, a Phase 3 trial of CYRAMZA in combination with paclitaxel for the treatment of second-line advanced gastric cancer. Regulatory action for this submission is expected in the first half of 2015. In Europe, Lilly has filed a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) based on positive results from the REGARD study, a Phase 3 trial of CYRAMZA as a single agent in patients with second-line advanced gastric cancer, and the RAINBOW study.
- Lilly is expected to file for approval of CYRAMZA in second-line non-small cell lung cancer (NSCLC) in the second half of 2014 based on positive results from the REVEL study, a global, randomized, double-blind Phase 3 study of CYRAMZA plus docetaxel compared to placebo plus docetaxel in NSCLC patients with progression after prior platinum-based chemotherapy for locally-advanced or metastatic disease.
- The second LFRP candidate being developed by Lilly, necitumumab, is a fully human IgG1 monoclonal antibody that is designed to block the ligand binding site of the human epidermal growth factor receptor (EGFR). Lilly recently presented positive results at the 2014 Annual Meeting of the American Society of Clinical Oncology for the SQUIRE trial, a Phase 3 study of necitumumab in combination with gemcitabine and cisplatin as a first-line treatment for squamous non-small cell lung cancer. Based on the results, Lilly is expected to submit a BLA for necitumumab, which was granted Fast Track status by the FDA, before the end of 2014.
- In the second half of 2014, Amgen Inc., another LFRP licensee, is expected to present results from the final overall survival analysis of TRINOVA-1, a Phase 3 global, multicenter, randomized, double-blind, placebo-controlled study evaluating trebananib, an investigational peptibody, and paclitaxel versus placebo plus paclitaxel in recurrent partially platinum-sensitive or -resistant epithelial ovarian, primary peritoneal or fallopian tube cancer. In 2013, Amgen announced that the TRINOVA-1 trial met its primary endpoint of progression-free survival. Dyax is eligible to receive a milestone payment for this candidate upon product approval.
- Dyax licensee Biogen Idec Inc. (Biogen) has stated that their Phase 2 clinical trial in acute optic neuritis with anti-LINGO, a fully human monoclonal antibody that targets LINGO-1, is fully enrolled. Biogen has also stated that they expect to disclose top-line results from the study, which is referred to as RENEW, in early 2015.
- In 2013, Biogen initiated a randomized, double-blind, parallel-group, dose-ranging Phase 2 clinical trial investigating anti-LINGO used concurrently with Avonex in subjects with relapsing forms of multiple sclerosis. Data from this study, which is referred to as SYNERGY, is expected in 2016.
Dyax is a fully integrated biopharmaceutical company focused on the discovery, development and commercialization of novel biotherapeutics for unmet medical needs. The Company currently markets KALBITOR(R) (ecallantide) for the treatment of acute attacks of HAE in patients 12 years of age and older. Dyax is also developing DX-2930 for the prophylactic treatment of HAE.
Both KALBITOR and DX-2930 were identified using Dyax’s proprietary phage display technology. Dyax has broadly licensed this technology and has a portfolio of product candidates being developed by its licensees, which it refers to as the Licensing and Funded Research Portfolio (LFRP).
For additional information about Dyax, please visit www.dyax.com.
For additional information about KALBITOR, including full prescribing information, please visit www.KALBITOR.com.
This press release contains forward-looking statements, including statements regarding the prospects and timing for the development and commercialization of product candidates in the LFRP and the potential for revenue generated by the LFRP based on successful clinical development, approval and successful commercialization of these product candidates. 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 and its licensees compete. 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 because of uncertainties involved in any future projections, as well as uncertainties associated with various activities and aspects of Dyax’s business, including risks and uncertainties associated with the following: Dyax’s dependence on licensees and collaborators for development, clinical trials, manufacturing, sales and distribution of product candidates in the LFRP; uncertainties as to whether one or more product candidates in the LFRP will achieve development and regulatory milestones and be commercialized and generate royalties; changing requirements and costs associated with Dyax’s planned research and development activities; the uncertainty of patent and intellectual property protection; and other risk factors described or referred to in Item 1A, “Risk Factors” in Dyax’s most recent Annual Report on Form 10-K as updated by 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 of Eli Lilly and Company (registration pending).
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