Tercica Receives Marketing Approval for Increlex in the European Union
- Category: Proteins and Peptides
- Published on Friday, 10 August 2007 04:00
- Hits: 2224
BRISBANE, CA, USA | August 8, 2007 | Tercica, Inc. (Nasdaq:TRCA) today announced that the European Commission has granted marketing authorization for Increlex(R) (mecasermin) 10 mg/ml solution for injection. The authorized indication is for the long-term treatment of growth failure in children and adolescents with severe primary insulin-like growth factor-1 deficiency (Primary IGFD).
The Orphan Drug designation that Increlex(R) received for the authorized indication will provide ten years of marketing exclusivity in the European Union. Ipsen (Euronext:IPN) is Tercica's marketing partner for Increlex(R) in the European Union.
As a result of this marketing authorization, Tercica will receive a milestone payment of EUR 15 million (approximately U.S. $20 million) from Ipsen under the companies' licensing agreement, and following any necessary local pricing reviews, Ipsen will launch Increlex(R) in the European Union.
"We are excited to bring the first treatment innovation in the short stature field since growth hormone, initially to the United States and today to the European Union," said Dr. John A. Scarlett, Tercica's President and Chief Executive Officer. "Our collaboration with Ipsen provides us with a very strong partner to commercialize Increlex in the European Union and together we look forward to providing this important medical advance to the children in the European Union suffering from severe Primary IGFD," added Dr. Scarlett.
The active ingredient of Increlex(R) is recombinant human insulin-like growth factor-1 (IGF-1). IGF-1 is the direct mediator of growth hormone's (GH) effect on statural growth, and must be present for normal growth of bones and cartilage in children. In Primary IGFD, children's serum IGF-1 levels are low, despite the presence of normal or elevated GH level. Without adequate IGF-1, children cannot achieve normal height. Severe Primary IGFD is defined by: height standard deviation score less than or equal to -3.0, basal IGF-1 levels below the 2.5th percentile for age and gender, GH sufficiency, and exclusion of secondary forms of IGF-1 deficiency, such as malnutrition, hypothyroidism or chronic treatment with pharmacologic doses of anti-inflammatory steroids. In children with this disorder, low IGF-1 levels are due to growth hormone resistance associated with mutations in GH receptors, post-GH receptor signaling pathways, or to defects in IGF-1 gene expression. As such, these children cannot be expected to respond adequately to exogenous GH treatment. Some individuals may also have a range of metabolic disorders, including lipid abnormalities, decreased bone density, obesity and insulin resistance.
Increlex(R) has been marketed in the United States by Tercica, Inc. since early 2006. Exclusive rights to develop and commercialize Increlex(R) were licensed to Ipsen in October 2006 for all regions of the world except the United States, Japan, Canada, Taiwan and certain countries of the Middle East and North Africa.
Tercica is a biopharmaceutical company committed to improving endocrine health by partnering with the endocrine community to develop and commercialize new therapeutics for pediatric and adult growth disorders, and for adult metabolic disorders. For further information on Tercica, please visit www.tercica.com.
Ipsen is an innovation driven international specialty pharmaceutical group with over 20 products on the market and a total worldwide staff of nearly 4,000. The company's development strategy is based on a combination of products in targeted therapeutic areas (oncology, endocrinology and neuromuscular disorders) which are growth drivers, and primary care products which contribute significantly to its research financing. This strategy is also supported by an active policy of partnerships. The location of its four Research and Development centres (Paris, Boston, Barcelona, London) gives the Group a competitive edge in gaining access to leading university research teams and highly qualified personnel. In 2006, R&D expenditure was EUR 178.3 million, i.e. 20.7% of consolidated sales, which amounted to EUR 861.7 million while total revenues amounted to EUR 945.3 million (in IFRS). Seven hundred people in R&D are dedicated to the discovery and development of innovative drugs for patient care. Ipsen's shares are traded on Segment A of Eurolist by Euronext(TM) (stock code: IPN, ISIN code: FR0010259150). Ipsen's shares are eligible to the "Systeme a Reglement Differe" ("SRD") and the Group is part of the SBF 250 index. For more information on Ipsen, visit our website at www.ipsen.com.
Forward Looking Statements (Tercica)
Except for the historical statements contained herein, this press release contains forward-looking statements concerning Tercica's prospects and expectations, including without limitation, that: (A) Increlex(R) will receive ten years of EU orphan drug marketing exclusivity for the treatment of severe Primary IGFD; (B) Ipsen will launch Increlex(R) in the European Union, and (C) Tercica will receive a EUR 15 million milestone payment from Ipsen. Because Tercica's forward-looking statements are subject to risks and uncertainties, there are important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include, without limitation, risks and uncertainties related to the following: the risks and uncertainties disclosed from time-to-time in reports filed by Tercica, including most recently Tercica's Form 10-Q for the quarter ending June 30, 2007 filed with the SEC on Aug 2, 2007. Tercica disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.
Forward Looking Statements (Ipsen)
The forward-looking statements and targets contained herein are based on Ipsen's management's current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. Moreover, the Research and Development process involves several stages at each of which there is a substantial risk that the Group will fail to achieve its objectives and be forced to abandon its efforts in respect of a product in which it has invested significant sums. Therefore, the Group cannot be certain that favourable 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. Ipsen 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. Ipsen's business is subject to the risk factors outlined in its information documents filed with the French Autorite des Marches Financiers.
SOURCE: Tercica, Inc.