Ipsen and Invida Enter into a Partnership for the Commercialization of Ipsen's Specialty Care Drugs in South-East Asia
PARIS & SINGAPORE, Apr 27, 2010 (BUSINESS WIRE) -- Regulatory News:
-- New Geographical Footprint for Ipsen's Specialty Care Portfolio in Oncology and Endocrinology
-- Diphereline(R)1, Somatuline(R) Autogel(R) and Increlex(R) to be Commercialized by Invida in Certain Asian Countries
Ipsen, a global biopharmaceutical group, and Invida Group, the leading healthcare commercialization solutions partner in the Asia Pacific region, announced today an agreement for the exclusive distribution and promotion by Invida of Ipsen's drugs Diphereline(R) 3.75mg & 11.25mg, Somatuline(R) Autogel(R) and Increlex(R) in selected countries in South-East Asia. Invida will be in charge of filing and commercialising the drugs in the different countries. The agreement is for an initial period of five years renewable for an additional period of five years, and covers Singapore, Malaysia, Philippines, Indonesia, Thailand and India, with the exception of Diphereline(R) for Thailand. In the context of the agreement, Ipsen will receive payments upon achievement by Invida of certain commercial milestones.
Christophe Jean, Executive Vice President, Chief Operating Officer, Ipsen said, "We are very pleased to partner with Invida, a well-established healthcare group in Asia, that will optimize time-to-market in the region while allowing us to work with a single, trusted partner. This agreement contributes to expand the geographical reach of Ipsen's specialty care portfolio in the Asia Pacific region and give physicians and patients access to innovative treatments in severe conditions in oncology and endocrinology."
John Graham, Invida Group CEO, said, "This partnership is an excellent opportunity for Invida to expand its specialty care offerings in the region, a segment which we feel possesses immense potential for Invida as the demand grows throughout Asia. We are thrilled to partner with Ipsen, as both our companies are strongly focused on bringing innovative products to market. We feel that by introducing Ipsen's drugs into these countries, we will be able to improve the lives of patients while advancing the standard of care for these important indications. This partnership will allow Ipsen to leverage Invida's local expertise, proven methodology, and market insights to commercialize these products to a wide audience throughout Asia."
The active substance in Diphereline(R)/Decapeptyl(R) is triptorelin, a decapeptide analogue of GnRH (Gonadotrophin Releasing Hormone), a hormone secreted by the hypothalamus, which initially stimulates the release of pituitary gonadotrophins (hormones produced by the pituitary gland), which in turn control hormonal secretions by the testes and ovaries. Debiopharm, which holds the patent to the pamoate formulations of Decapeptyl(R), granted Ipsen an exclusive licence to market Decapeptyl(R) within the European Union and in certain other countries. Decapeptyl(R) contains a formulation that was initially developed and continues to be used mainly in the treatment of advanced metastatic prostate cancer. Additional indications have been subsequently developed (uterine fibroids, endometriosis, in vitro fertilisation, precocious puberty) in some countries. Decapeptyl(R) is available in monthly or quarterly sustained-release formulations, as well as a daily formulation. Decapeptyl(R)'s sales in 2009 amounted to more than EUR 250 million.
About Somatuline(R) Autogel(R)
The active substance in Somatuline(R) and Somatuline(R) Autogel(R) is lanreotide, a somastatin 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(R) and Somatuline(R) Autogel(R) are sustained-release formulations for injection containing lanreotide. As far as Ipsen is aware, this is the first semi-solid formulation for injection without any excipient, since the active substance itself controls the sustained release. Somatuline(R) was initially developed and continues to be used for the treatment of acromegaly and was subsequently developed for the treatment of symptoms associated with neuroendocrine tumours (particularly of a carcinoid type). Somatuline(R) was initially launched in France in 1995. At 31 December 2009, sales of Somatuline(R) and Somatuline(R) Autogel(R) amounted to almost EUR 140 million and the drugs were marketed in over 45 countries (including 26 in Europe) for the treatment of acromegaly and neuroendocrine tumours.
The active substance in Increlex(R) is a recombinant insulin-like growth factor of human origin (IGF-1). IGF-1 is the direct hormonal mediator of stature and bone growth and must be present for normal growth of bones and cartilage in children. In severe primary IGF-1 deficiency, children's serum IGF-1 levels are low despite the presence of normal or elevated GH levels. If the IGF-1 is not present in sufficient quantities, the child will not reach a normal stature. In October 2006, Tercica Inc. granted Ipsen the rights to develop and market Increlex(R) worldwide, with the exception of the United States, Japan, Canada, the Middle East and Taiwan. Ipsen's acquisition of Tercica in 2008 gave it full access to this molecule (IGF-1). The only indication filed for Increlex(R) is the treatment of severe primary IGF-1 deficiency in children and adolescents. Increlex(R) has been marketed in the United States since the beginning of 2006. It was granted orphan drug status by the EMEA on 5 April 2006 and marketing authorisation in the European Union on 9 August 2007. Increlex(R) is currently marketed by Ipsen in most European countries. Increlex(R)'s sales in 2009 were close to EUR 21 million.
Ipsen is a global biopharmaceutical group with total sales in excess of 1 billion euros in 2009, and total worldwide staff of more than 4,400. Its strategy is based on fast growing specialty care drugs in oncology, endocrinology, neurology and hematology, and primary care drugs, which significantly contribute to research financing. This strategy is also supported by an active policy of partnerships. Ipsen's specific Research & Development (R&D) centers and peptide & protein engineering platform give the Group a competitive edge. Almost 900 people are dedicated to the discovery and development of innovative drugs for patient care. In 2009, R&D spend reached close to EUR200 million, representing more than 19% of total Group sales. Ipsen's shares are traded on Segment A of Euronext Paris (stock code: IPN, ISIN code: FR0010259150). Ipsen's shares are eligible to the "Service de Reglement Differe" ("SRD") and the Group is part of the SBF 120 index. For more information on Ipsen, visit our website at www.ipsen.com.
The forward-looking statements, objectives, perspectives and targets contained herein are based on the Group's management strategy, current views, and assumptions regarded as reasonable by the Group. These forward-looking statements depend on conditions or facts likely to happen in the future, and not exclusively on historical data. 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 perspectives, objectives or targets described in this document were prepared without taking into account external growth assumptions which may alter these parameters. 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 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 Autorite des Marches Financiers.
Invida improves the lives of patients in Asia by commercializing differentiated pharmaceutical products of superior quality - the result of which will allow all our stakeholders to prosper. We do this through our proven brand marketing and sales know-how, strong expertise across a number of key therapeutic categories and deep experience in all critical Asian markets. Comprehensive functional capabilities provide rapid market access delivered by our passionate team of professionals.
With more than 4,000 employees in 13 markets in Asia Pacific, Invida operates across the commercial value chain from regulatory approval and product launch to lifecycle management. We manage a portfolio of proprietary healthcare brands as well as licensed products from small biotech firms and large multinational companies. Partnering is a critical component of Invida's business model. We collaborate closely with our partners in developing effective strategies and put our extensive experience behind maximizing the potential of the assets entrusted to us.
(1) Depending on the countries, Decapeptyl(R) is marketed under different brand names (Diphereline(R), Pamorelin(R), Arvekap(R)) - triptorelin embonate (INN) = triptorelin pamoate (USAN)
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