MISSISSAUGA, ON, Dec. 15 /CNW/ - EMD Serono, a Division of EMD Inc., Canada, an Affiliate of Merck KGaA, Darmstadt, Germany, and Tercica Inc., a subsidiary of the Ipsen Group (Euronext: IPN, ADR: IPSEY), a global biopharmaceutical group, today announced a five year agreement for the exclusive distribution and promotion by EMD Serono of Ipsen's Somatuline® Autogel® for the treatment of acromegaly in Canada.
Under the terms of the agreement, EMD Serono will be responsible for promotion, distribution, and patient support services and Ipsen will retain ownership of the product. The agreement is for Somatuline® Autogel®, which was approved by Health Canada in July 2006 and to date has been promoted and distributed by Tercica, Inc., a subsidiary of the Ipsen Group.
Somatuline® Autogel® (lanreotide) is indicated for:
- The long-term treatment of patients with acromegaly due to pituitary tumors, who have had inadequate response to, or cannot be treated with, surgery and/or radiotherapy;
- The relief of symptoms associated with acromegaly.
"We're very excited to work with Ipsen to expand patient access to Somatuline® Autogel® in Canada, not only through distribution and healthcare provider support and education but, more importantly, through the provision of comprehensive patient support services, which can further enhance the patient experience with this important therapy," said Deborah M. Brown, President of EMD Serono, Canada. "This partnership supports our mission to bring innovative products and services to patients with unique healthcare needs."
Jean-Christophe Tellier, President and General Manager of Tercica, the North American-based subsidiary of the Ipsen Group said, "We are pleased to partner with EMD Serono to promote and distribute Somatuline® Autogel® in the Canadian market and expand access to this important therapy for patients with acromegaly. EMD Serono's established experience in endocrinology and best-in-class patient services make them an attractive partner and one which we believe will provide excellent service to our Canadian customers."
Acromegaly is a relatively rare, slowly progressive, chronic hormonal disorder, characterized by the hypersecretion of growth hormone, which is usually the result of a benign tumor affecting the pituitary gland. Although most commonly diagnosed in middle-aged adults, the symptoms of acromegaly can appear at any age and if not treated can result in serious illness and premature death. Complications may include severe disfigurement, heart disease, diabetes, arthritis and sleep apnea. The goal of treatment in acromegaly is to reduce growth hormone (GH) and age adjusted insulin-like growth factor 1 (IGF-1) levels and where possible to achieve normalization of the values in an age-adjusted manner. Stopping or reducing the overproduction of growth hormone is not easy; a combination of surgery, drug therapy and radiation therapy is often used to combat the disease and its symptoms. It is estimated that approximately 2,000 Canadians suffer from acromegaly.1
Treatment with Somatuline® Autogel® has been shown in clinical trials to decrease the levels of GH in the majority of patients by >50%. Treatment also decreased the GH level to the desired level of ≤2.5 ng/mL in 50-57% of patients and decreased IGF-1 to age-adjusted normal levels in 55-59% of the patients. The availability of three dose strengths of the drug product in convenient pre-filled syringes with small volumes of drug allows for adjustment of the dose based on the response seen in the patient. The side effects that occurred most often are similar to those experienced with the administration of natural somatostatin. These tend to be gastrointestinal (GI) side effects, hyperglycemia, cholelithiasis and formation of gallbladder sludge, and bradycardia. In the majority of patients these side effects are tolerable.2 3
About Somatuline® Autogel®
The active substance in Somatuline® and Somatuline® Autogel® is lanreotide, a somatostatin analogue that inhibits the secretion of several endocrine, exocrine and paracrine functions. It is particularly effective in inhibiting the secretion of growth hormones and certain hormones secreted by the digestive system. Somatuline® and Somatuline® Autogel® are sustained-release formulations for injection containing lanreotide. Somatuline® was initially launched in France in 1995. At 31 December 2009, sales of Somatuline® and Somatuline® Autogel® amounted to almost € 140 million and the drugs were marketed in over 45 countries (including 26 in Europe) for the treatment of acromegaly. Somatuline® Autogel® is approved by Health Canada for the long-term treatment of patients with acromegaly due to pituitary tumors who have had inadequate response to or cannot be treated with surgery and/or radiotherapy and for the relief of symptoms associated with acromegaly.
About EMD Serono, Canada
EMD Serono is a Division of EMD Inc., Canada. EMD Inc., Canada, is an affiliate of Merck KGaA, Darmstadt, Germany. In Canada, EMD Serono provides innovative drug therapies that address unmet medical needs in the areas of neurodegenerative diseases, fertility and endocrinology. EMD Serono employs approximately 150 people across Canada and is headquartered in Mississauga, Ontario. For more information, please visit www.emdserono.ca
About Merck KGaA, Darmstadt, Germany
Merck KGaA is a global pharmaceutical and chemical company with total revenues of € 7.7 billion in 2009, a history that began in 1668, and a future shaped by approximately 40,000 (including EMD Millipore) employees in 64 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since. For more information, please visit www.merckserono.com or www.merck.de
Ipsen is a global biopharmaceutical group, with sales exceeding 1 billion euros in 2009. The Group has total worldwide staff of more than 4,400 employees, of which nearly 900 contribute to the discovery and development of innovative drugs for patient care. Ipsen's development strategy is based on fast growing specialty care drugs in oncology, endocrinology, neurology and hematology, and on primary care drugs. This strategy is also supported by an active policy of partnerships. Ipsen's research & development (R&D) centers and its peptide & protein engineering platform give the Group a strong competitive edge. In 2009, R&D expenditure totaled close to €200 million, representing nearly 20% of total Group sales. Ipsen's shares are traded on segment A of Euronext Paris (stock code: IPN, ISIN code: FR0010259150) and eligible to the "Service de Règlement Différé" ("SRD"). The Group is part of the SBF 120 index. Ipsen has implemented a Sponsored Level I American Depositary Receipt (ADR) program, which trade on the over-the-counter market in the United States under the symbol IPSEY. For more information on Ipsen, visit our website at www.ipsen.com.
The forward-looking statements, objectives and targets contained herein are based on the Group's management strategy, current views, and assumptions regarded as reasonable by the Group. Such statements involve known and unknown risks and uncertainties that the Group may not be able to control or mitigate and that may cause actual results, performance or events to differ materially from those anticipated herein. Moreover, the targets described in this document were prepared without taking into account external growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by the Group. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Notably, future currency fluctuations may negatively impact the profitability of the Group and its ability to reach its objectives. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties. The Group does not commit nor gives any guarantee that it will meet the targets mentioned above. Furthermore, the Research and Development process involves several stages each of which involve the substantial risk that the Group may fail to achieve its objectives and be forced to abandon its efforts with regards to a product in which it has invested significant sums. Therefore, the Group cannot be certain that favorable results obtained during pre-clinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the product concerned. The Group also depends on third parties to develop and market some of its products which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to the Group's activities and financial results. The Group expressly disclaims any obligation or undertaking to update or revise any forward looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. The Group's business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers.
1 Murphy G, Perras C, Desjardins B, Chen S, Moulton K, Jonker D, Perlman K, Pasieka J,,Ezzat S, Cripps C, Mensinkai S, Skidmore B. Octreotide for endocrine, oncologic, and gastrointestinal disorders: systematic review and budget impact analysis [Technology report number 111]. Ottawa: Canadian Agency for Drugs and Technologies in Health; 2008.
2 Somatuline® Autogel® Product Monograph, September 3, 2006.
3 Health Canada SUMMARY BASIS OF DECISION (SBD) Pr SOMATULINE® AUTOGEL® 60 mg, 90 mg, 120 mg lanreotide / unit (syringe) Extended-release supersaturated solution Ipsen Limited Submission Control No. 098949.
For further information: For further information:
Contact: Norm Berberich
Tel. 1 905 919-0163