SOURCE: OctoPlus N.V.

September 27, 2007 01:45 ET

OctoPlus in-licenses diabetes product candidate

LEIDEN, NETHERLANDS--(Marketwire - September 27, 2007) -


OctoPlus N.V. ("OctoPlus" or the "Company") (Euronext: OCTO), the drug delivery and development company, announces today that it has acquired exclusive worldwide rights to develop and commercialise a family of compounds, including a GLP-1 agonist product candidate for the treatment of type 2 diabetes from Canadian biopharmaceutical company Theratechnologies (TSX: TH). The product candidate has been selected by OctoPlus for development into a long-acting controlled release formulation that may substantially reduce the required dosing frequency in diabetes therapy, compared to current products on the market or in development, and with a potentially better tolerability profile. OctoPlus has initiated pre-clinical development of this product.

Diabetes is a worldwide health issue: the World Health Organization (WHO) estimates that more than 180 million people worldwide suffer from diabetes and projects that the number of deaths caused by diabetes will increase by more than 50% in the next 10 years if urgent action is not taken. Recent market reports estimate that global sales of anti-diabetics will exceed US$ 22 billion in 2011.

GLP-1 (glucagon-like peptide 1) is a metabolic hormone that plays a central role in glucose handling. Various drug development efforts are directed towards its potential therapeutic benefit in diabetes treatment, and the only currently available GLP-1 based therapy requires twice-daily injections. Last year, GLP-1 based therapy generated US$ 430 million in revenues and this number is expected to grow significantly.

OctoPlus' controlled release technology platform comprises polymer-based drug delivery technologies that can be combined with active pharmaceutical ingredients to gradually release the therapeutic in the body during weeks or months. In July, OctoPlus showed its leading role in controlled release delivery of proteins and peptides with the publication of promising results from an ongoing Phase IIa study with its lead product Locteron™, a controlled release formulation of interferon alfa for the treatment of chronic hepatitis C. OctoPlus' controlled release technology in Locteron shows its potential to induce fewer side effects, improve patient compliance and provide more convenient once-every-two-week dosing in comparison to current therapies, and with similar efficacy.

Under the terms of the license agreement, OctoPlus will pay Theratechnologies milestone payments and royalties during the development and commercialisation of the product. The majority of these milestone payments are related to the successful completion of various clinical phases and the achievement of preset sales levels, and could amount to up to EUR 36 million.

Joost Holthuis, Chief Executive Officer of OctoPlus, comments: "We are delighted to expand our product portfolio with the addition of this promising GLP-1 agonist product candidate in a major therapeutic area. We are fully committed to successfully developing a truly long-acting formulation of this product, which continues to be an unmet need in diabetes therapy. Our recent success with Locteron gives us confidence that we will be able to apply our extensive controlled release experience to GLP-1 based molecules."

For further information, please contact:
Rianne Roukema, Corporate Communications: +31 (71) 524 1071

About diabetes and GLP-1

More than 180 million people worldwide suffer from diabetes, and its incidence is rising. Global sales of anti-diabetics amounted to more than $ 15 billion in 2005 and are expected to exceed $ 22 billion in 2011. An estimated 1 million people die yearly as a result of diabetes. The standard treatment for patients with type 2 diabetes is oral antidiabetics; if that is not sufficient, patients require additional medication such as GLP-1 agonists or insulin. An important asset of diabetes treatment with GLP-1 agonists is that they induce weight loss, which is an added benefit for diabetes patients, who often suffer from excess body weight. In addition, GLP-1 agonists stimulate insulin production under hyperglycaemic conditions; therefore they are less likely to cause hypoglaecemia.

About OctoPlus

OctoPlus N.V. is a product-oriented biopharmaceutical company committed to the creation of improved pharmaceutical products that are based on OctoPlus' proprietary drug delivery technologies and have fewer side effects, improved patient convenience and a better efficacy/safety balance than existing therapies. Rather than seeking to discover novel drug candidates through early stage research activities, OctoPlus focuses on the development of long-acting, controlled release versions of known protein therapeutics, other drugs, and vaccines.

Our pipeline consists of 5 products in preclinical and clinical development. Our lead product is Locteron, a sustained-release formulation of interferon alfa for the treatment of chronic hepatitis C, which we are co-developing with Biolex Therapeutics. Locteron is in Phase IIa clinical development. Furthermore, our pipeline comprises a product candidate for the treatment of chronic middle ear infection, which is also in Phase II development, a pre-clinical GLP-1 product candidate for the treatment of diabetes and two pre-clinical-stage single-shot vaccines.

In addition, OctoPlus is a leading provider of advanced drug formulation and clinical scale manufacturing services to the pharmaceutical and biotechnology industry, with a focus on difficult to formulate active pharmaceutical ingredients in injectable formulations. The earnings and expertise that we derive from rendering formulation and manufacturing services help to support our own drug development programs.

OctoPlus is listed on Euronext Amsterdam under the symbol OCTO. For more information about OctoPlus, please visit our website www.octoplus.nl.

About Theratechnologies

Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company that discovers innovative drug candidates in order to develop them and bring them to market. The company targets unmet medical needs in financially attractive specialty markets. Its most advanced program is tesamorelin, which has recently completed patient recruitment for its confirmatory Phase III clinical trial for a serious metabolic disorder known as HIV-associated lipodystrophy. The company also has other projects at earlier stages of development. For more information, visit www.theratech.com.

This document may contain certain forward-looking statements relating to the business, financial performance and results of OctoPlus N.V. and the industry in which it operates. These statements are based on OctoPlus N.V.'s current plans, estimates and projections, as well as its expectations of external conditions and events. In particular the words "expect", "anticipate", "predict", "estimate", "project", "plan", "may", "should", "would", "will", "intend", "believe" and similar expressions are intended to identify forward-looking statements. We caution investors that a number of important factors, and the inherent risks and uncertainties that such statements involve, could cause actual results or outcomes to differ materially from those expressed in any forward-looking statements. In the event of any inconsistency between an English version and a Dutch version of this document, the English version will prevail over the Dutch version.

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