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.
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.