QUÉBEC CITY, July 27, 2015
/PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ)
today announced that it has started promoting Saizen®
[somatropin (rDNA origin) for injection] in 25 territories in
the United States, pursuant to its
co‑promotion agreement signed this past May with EMD Serono, the
U.S. biopharmaceutical businesses of Merck KGaA, Darmstadt,
Germany. 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 details Saizen®
to designated medical professionals in addition to EMD Serono's
current promotional activities. Payment to Aeterna Zentaris is
based on new eligible patient starts on Saizen®, above
an agreed-upon baseline.
Jude Dinges, Senior Vice
President and Chief Commercial Officer of Aeterna Zentaris,
commented, "Our sales force has initiated the promotion of
Saizen®, a product with a broad portfolio of devices and
comprehensive patient support services. 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 in support of
Saizen®."
David A. Dodd, Chairman and Chief
Executive Officer of Aeterna Zentaris also stated, "This exciting
start of the field promotion of Saizen® represents
another important step in 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 a leader in the field of growth
hormone and offers us with Saizen®, a perfect fit with
the endocrinology portfolio that we are developing. We will
continue to look for products that we can co-promote, in-license or
acquire 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 produce adequate amounts of growth hormone and
it may have childhood and adulthood onset. In children, growth
hormone deficiency causes poor growth, while in adults, symptoms
may include reduced energy levels and muscle strength, altered body
composition, reduced bone mineral density (osteoporosis), lipid
abnormalities, and insulin resistance.
It is estimated that the incidence of growth hormone deficiency
in children is between one in 4,000 and one in 10,000. Adult onset
growth hormone deficiency can also be a significant problem, which
affects 3 in 10,000 each year.
About Saizen® [somatropin (rDNA origin) for
injection]
Saizen® for Injection is a formulation of a
recombinant human growth hormone. 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 an acute critical illness caused by certain types of heart or
abdominal 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, the most common side
effects included pain in joints, muscle pain, tingling and
numbness, carpal tunnel syndrome, increased blood sugar
(hyperglycemia).
Other possible side effects may include return of tumor or
cancerous growths, headaches, changes in vision, nausea, vomiting,
or pancreatitis. In children, worsening of scoliosis or hip and
knee pain can be observed.
For full prescribing information, please see
www.saizenus.com.
About EMD Serono, Inc.
EMD Serono, a subsidiary of Merck KGaA, Darmstadt, Germany, is a leading U.S. biopharmaceutical
company focused exclusively on specialty care. For more than 40
years, EMD Serono has integrated cuttingedge science, innovative
products and devices, and industryleading 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
immunooncology. 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, 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 U.S. 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.