Aeterna Zentaris and Ascend Therapeutics®
to join forces in selling EMD Serono's growth hormone deficiency
therapy product
QUÉBEC CITY, May 7, 2015 /CNW
Telbec/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) and
EMD Serono, Inc., the U.S. and Canadian biopharmaceutical
businesses of Merck KGaA, Darmstadt, Germany, today announced the finalization of a
promotional services agreement that will allow Aeterna Zentaris to
promote Saizen® [somatropin (rDNA origin) for injection] to
designated medical professionals in specified territories in
the United States. Saizen® is
a recombinant human Growth Hormone (r-hGH) registered in the U.S.
for the treatment of growth hormone deficiency (GHD) in children
and adults.
Under the agreement, Aeterna Zentaris will detail
Saizen® to designated medical professionals, representing an
important incremental field promotion activity in support of the
product. Payment to Aeterna Zentaris will be based on new, eligible
patient starts on Saizen® above an agreed-upon baseline.
Aeterna Zentaris has subcontracted with Ascend
Therapeutics® US, LLC, with whom it previously
established a co-promotion agreement that is currently underway, to
detail Saizen® in territories not covered by Aeterna Zentaris.
Financial terms of the agreement were not disclosed.
Jude Dinges, Senior Vice
President and Chief Commercial Officer of Aeterna Zentaris,
commented on the agreement: "In collaboration with Ascend
Therapeutics, our combined 53 sales representatives are eager and
poised to begin detailing Saizen®. We recognize the value of direct
promotion in this category and we look forward to achieving
increased market share and growth for Saizen® by significantly
increasing the share-of-voice and impact in support of the
product."
David A. Dodd, Chairman and Chief
Executive Officer of Aeterna Zentaris stated regarding the
promotional services agreement, "This agreement with EMD Serono, a
leading US biopharmaceutical company, is another important step
toward the transformation of Aeterna Zentaris into a commercially
operating company. With its ongoing efforts in the development of
electronic recombinant human growth hormone injection devices, EMD
Serono is leading innovation in the field of growth hormones, and
offers us with Saizen®, a perfect fit for our endocrinology
portfolio we are developing and pursuing. We will continue to look
for products that we can co-promote or in-license in our core areas
of endocrinology and oncology as we build our portfolio and our
commercial capabilities."
About Growth Hormone Deficiency (GHD)
Growth hormone deficiency occurs when the pituitary gland in the
brain is unable to release or produce adequate amounts of growth
hormone. In children, growth hormone deficiency causes slow growth,
and without treatment, few will reach their full height potential
as an adult.
It is estimated that the incidence of growth hormone deficiency
in children is between one in 4,000 and one in 10,000. Non
childhood related adult growth hormone deficiency can also be a
significant problem which affects three in 10,000 each year. It is
recognized as a specific clinical syndrome.
About Saizen® [somatropin (rDNA origin) for
injection]
Saizen for Injection is a formulation of a recombinant human
growth hormone (GH). In the U.S. Saizen lyophilized product in 5 mg
and 8.8 mg strengths is registered for the treatment of appropriate
patients with pediatric and adult growth hormone deficiency.
Important Risk Information
Saizen® should not be used in children and adults with a
critical illness caused by certain types of heart or stomach
surgery, serious injury or a sudden and severe breathing problem,
cancer or other tumors, certain types of eye problems caused by
diabetes or in children with Prader-Willi syndrome who are severely
overweight or have a history of breathing problems including sleep
apnea.
The most common side effects reported in clinical trials in
children were local reactions at the injection site (such as pain,
numbness, redness and swelling), hypothyroidism, low blood sugar,
seizures or convulsions, worsening of skin psoriasis, or swelling
associated with fluid retention. In adults, pain in joints, muscle
pain, tingling and numbness, carpal tunnel syndrome, increased
blood sugar or hyperglycemia.
Other possible side effects are return of tumor or cancerous
growths, headaches, changes in vision, nausea, vomiting, or
pancreatitis. In children, worsening of scoliosis or hip and knee
pain.
For full prescribing information, please see
www.saizenus.com.
About EMD Serono
EMD Serono, a subsidiary of Merck KGaA, Darmstadt, Germany, is a leading US biopharmaceutical
company focused exclusively on specialty care. For more than 40
years, EMD Serono has integrated cutting-edge science, innovative
products and devices, and industry-leading patient support and
access programs. EMD Serono has deep expertise in neurology,
fertility and endocrinology, as well as a robust pipeline of
potential therapies in neurology, oncology, immunology and
immuno-oncology. Today, EMD Serono has more than 1,100 employees
around the country with commercial, clinical and research
operations based in the company's home state of Massachusetts.
For more information, please visit www.emdserono.com.
About Merck KGaA, Darmstadt, Germany
Merck KGaA of Darmstadt, Germany, is a leading company for innovative
and top-quality high-tech products in healthcare, life science and
performance materials. The company has six businesses –
Biopharmaceuticals, Consumer Health, Allergopharma, Biosimilars,
Life Science and Performance Materials – and generated sales of €
11.3 billion in 2014. Around 39,000 employees work in 66 countries
to improve the quality of life for patients, to foster the success
of customers and to help meet global challenges. Merck KGaA,
Darmstadt, Germany, is the world's
oldest pharmaceutical and chemical company – since 1668, the
company has stood for innovation, business success and responsible
entrepreneurship. Merck KGaA, Darmstadt, Germany holds the global rights to the Merck
name and brand. The only exceptions are Canada and the
United States, where the company operates as EMD Serono, EMD
Millipore and EMD Performance Materials.
About Aeterna Zentaris
Aeterna Zentaris is a specialty biopharmaceutical company
engaged in developing and commercializing novel treatments in
oncology, endocrinology and women's health. For more information,
visit www.aezsinc.com.
Forward-Looking Statements
This press release contains forward-looking statements made
pursuant to the safe harbor provisions of the US Securities
Litigation Reform Act of 1995. Forward-looking statements involve
known and unknown risks and uncertainties that could cause Aeterna
Zentaris'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 and clinical trials, the successful and timely
completion of clinical studies, the risk that safety and efficacy
data from any of our Phase 3 trials may not coincide with the data
analyses from previously reported Phase 1 and/or Phase 2 clinical
trials, the ability of Aeterna Zentaris to efficiently
commercialize one or more of its products or product candidates,
the ability of Aeterna Zentaris to take advantage of business
opportunities in the pharmaceutical industry, uncertainties related
to the regulatory process, the ability to protect our intellectual
property, the potential of liability arising from shareholder
lawsuits and general changes in economic conditions. Investors
should consult Aeterna Zentaris' quarterly and annual filings with
the Canadian and US securities commissions for additional
information on risks and uncertainties relating to forward-looking
statements. Investors are cautioned not to place undue reliance on
these forward-looking statements. Aeterna Zentaris 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, unless required to do so by a governmental authority
or by applicable law.
SOURCE Aeterna Zentaris Inc.