AEterna Zentaris Partner, Keryx Biopharmaceuticals, Receives Orphan-Drug Designation for Perifosine (KRX-0401) for the Treatment of Multiple Myeloma
QUEBEC CITY, Sept. 16 /PRNewswire-FirstCall/ - AEterna Zentaris Inc. (NASDAQ:
AEZS, TSX: AEZ), ("the Company") a global biopharmaceutical company focused on
endocrine therapy and oncology, today announced that Keryx Biopharmaceuticals,
Inc. (Nasdaq: KERX), its partner and licensee for perifosine in the North
American market, has received orphan-drug designation for this compound from
the U.S. Food and Drug Administration (FDA) for the treatment of multiple
myeloma. In August, Keryx announced that it had reached agreement with the FDA
regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 trial
with perifosine in relapsed/refractory multiple myeloma and that the study is
expected to start by year-end.
Juergen Engel, Ph. D., President and CEO of AEterna Zentaris stated, "We are
very pleased with perifosine gaining Orphan Drug Designation from the FDA as
it would provide extra market exclusivity protection for this compound. We now
look forward to the start of Keryx's Phase 3 trial in multiple myeloma by
year-end."
About Orphan-Drug Designation
Orphan-drug designation is granted by the FDA Office of Orphan Drug Products
to novel drugs or biologics that treat a rare disease or condition affecting
fewer than 200,000 patients in the U.S. The designation provides the drug
developer with a seven-year period of U.S. marketing exclusivity if the drug
is the first of its type approved for the specified indication or if it
demonstrates superior safety, efficacy, or a major contribution to patient
care versus another drug of its type previously granted the designation for
the same indication. It also provides tax credits for clinical research costs,
the ability to apply for annual grant funding, clinical research trial design
assistance and waiver of Prescription Drug User Fee Act (PDUFA) filing fees.
About Multiple Myeloma
Multiple myeloma, a cancer of the plasma cell, is an incurable but treatable
disease. Multiple myeloma is the second most-common hematologic cancer,
representing 1% of all cancer diagnoses and 2% of all cancer deaths. According
to the American Cancer Society, in 2009, there will be an estimated 20,580 new
cases of multiple myeloma and an estimated 10,500 deaths from multiple myeloma
in the United States. To date, several FDA approved therapies exist for the
treatment of multiple myeloma. Despite this progress, patients continue to
relapse, become refractory to prior treatments and eventually die from their
disease. Thus, new therapies are needed to treat these patients and extend
their survival.
About Perifosine
Perifosine is a novel oral anti-cancer agent that modulates several key signal
transduction pathways, including Akt, MAPK, and JNK that have been shown to be
critical for the survival of cancer cells. Perifosine has demonstrated both
safety and clinical efficacy in several tumor types, both as a single agent
and in combination with novel therapies. Perifosine. is currently in Phase 2
clinical development for multiple tumor types, with a Phase 3 in multiple
myeloma, under Special Protocol Assessment (SPA), pending commencement by
year-end.
About AEterna Zentaris Inc.
AEterna Zentaris Inc. is a global biopharmaceutical company focused on
endocrine therapy and oncology, with proven expertise in drug discovery,
development and commercialization. News releases and additional information
are available at www.aezsinc.com.
Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the
safe harbor provisions of the U.S. Securities Litigation Reform Act of 1995.
Forward-looking statements involve known and unknown risks and uncertainties,
which could cause the Company's actual results to differ materially from those
in the forward-looking statements. Such risks and uncertainties include, among
others, the availability of funds and resources to pursue R D projects, the
successful and timely completion of clinical studies, the ability of the
Company to take advantage of business opportunities in the pharmaceutical
industry, uncertainties related to the regulatory process and general changes
in economic conditions. Investors should consult the Company's quarterly and
annual filings with the Canadian and U.S. securities commissions for
additional information on risks and uncertainties relating to the
forward-looking statements. Investors are cautioned not to rely on these
forward-looking statements. The Company does not undertake to update these
forward-looking statements. We disclaim any obligation to update any such
factors or to publicly announce the result of any revisions to any of the
forward-looking statements contained herein to reflect future results, events
or developments except if we are required by a governmental authority or
applicable law.
SOURCE AETERNA ZENTARIS INC.