Dyax Corp. Highlights Recent Progress in Licensing and Funded Research Portfolio
September 22 2014 - 7:12AM
Business Wire
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
CYRAMZA™ (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:
CYRAMZA™ (ramucirumab)
- 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.
Necitumumab
- 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.
Trebananib
- 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.
Anti-LINGO
- 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.
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 currently
markets KALBITOR® (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.
Disclaimer
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).
Dyax Corp.Jennifer Robinson, 617-250-5741Director, Investor
Relations and Corporate Communicationsjrobinson@dyax.com
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