Elbion AG Acquires Late-Stage Product Candidate From DrugAbuse Sciences, Inc. For Treatment Of Alcohol Dependence
- Category: Small Molecules
- Published on Monday, 22 January 2007 02:00
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LEUVEN, Belgium | Jan 19, 2007 | elbion NV, a leading European drug discovery and development company, today announced it has acquired a number of product candidates from the French biotechnology company DrugAbuse Sciences. The most advanced candidate, Naltrexone Depot, a sustained release formulation of naltrexone, will become elbion’s lead product and the company expects it to enter pivotal Phase III clinical trials in 2007. A second asset acquired is Buprenorphine Depot, a sustained release buprenorphine indicated for the treatment of opiate addiction.
The acquisition of the DrugAbuse Sciences candidates was made in return for a financial consideration comprising elbion shares. Full financial terms were not disclosed.
Naltrexone Depot is a novel, sustained release formulation of naltrexone, an antagonist that blocks receptors in the brain and is used in the treatment of opiate and alcohol abuse. Unlike conventional naltrexone dosage forms (i.e. daily tablets), Naltrexone Depot is designed as a simple once-a-month intramuscular injection which elbion believes will offer significant advantages in the treatment of alcoholism where patient treatment compliance is a major limiting factor.
Previous clinical trials with Naltrexone Depot have shown encouraging results with a trend towards greater levels of abstinence from alcohol for patients receiving treatment compared to those on placebo.
elbion intends to begin a pivotal Phase III trial in 2007 with an improved formulation of Naltrexone Depot. elbion is collaborating on formulation development work with Brookwood Pharmaceuticals, a US drug delivery company and acquired a licence to certain Brookwood technologies as part of the asset acquisition. Brookwood will supply the product for trials.
Bernd Kastler, CEO of elbion, said: “This agreement brings us another advanced clinical product to add to our pipeline and one which we believe can be a significant value driver for elbion. Alcohol dependence has a profound effect on the lives of millions of people around the world and we believe that Naltrexone Depot has the potential to play a major role in their treatment. We intend to initiate a well-designed Phase III programme with an improved formulation of the product, and then to commercialise Naltrexone Depot through our own sales and marketing operations in certain territories and through licensees in others.”
Patrick Langlois, Chairman of DrugAbuse Sciences said: “Today's announcement of elbion's acquisition of the Naltrexone Depot programme and other assets from DrugAbuse Sciences is good news for the future of what we believe is a very high value product. We are confident elbion's clinical expertise and the plans they have put in place for the development and commercialisation of Naltrexone Depot will allow the full potential of the product to be realized and bring value to DrugAbuse Sciences investors through their holdings in elbion.”
Arthur J. Tipton, Ph.D., President and CEO, Brookwood Pharmaceuticals said: “Brookwood Pharmaceuticals strongly believes in the technical and market potential of the long-acting naltrexone under development at elbion. We have developed a positive relationship with the senior team at elbion and are enthused to be working with such a dynamic organization. We look forward to accelerating to market important products for the treatment of alcohol and opiate abuse.”
Buprenorphine depot is in pre-clinical development. elbion intends to develop the product for the treatment of opiate addiction.
Ann De Beuckelaer PhD Phone: +32 (0) 16 31 62 84
Media Contacts: Citigate Dewe Rogerson
Chris Gardner/ Valerie Auffray/ Yvonne Alexander Phone: +44 (0) 207 638 95 71
elbion NV is a Belgian company focused on the discovery and development of new drugs for CNS and immunological diseases. The Company has its headquarters in Leuven and also has significant R&D facilities in Radebeul, Germany.
Including Naltrexone Depot, elbion has a maturing pipeline with three products in the clinic for areas of significant commercial potential and a further portfolio of high quality late pre-clinical development compounds. ELB245 is an established CNS compound that elbion is developing for overactive bladder. It is in Phase II. ELB353, a highly potent PDE4 inhibitor is in Phase I trials for chronic inflammation.
elbion’s strategy is to grow its pipeline through its own integrated drug discovery activities leveraging its expertise in CNS and immunology and also by targeted in-licensing and M&A. elbion will maximise the value of its product portfolio by further partnering of its compounds and through selectively marketing products building its own sales and marketing operation.
In addition to its own clinical pipeline, elbion has a research agreement with Gilead Sciences for the discovery and development of new drugs for the treatment of hepatitis C virus (HCV).
elbion was formed in 2006 through the merger of elbion AG and 4AZA Bioscience NV. elbion AG began operations through a management buyout from Degussa Group in 2002. 4AZA was founded in 2002 as a spin-off from the Catholic University of Leuven.
About Naltrexone Depot
Naltrexone Depot is a novel, sustained release formulation of naltrexone in development for the treatment of alcohol and opiate abuse. The product is formulated for once-a-month intramuscular injection. From the injection site, naltrexone is slowly released into the blood and then into the central nervous system (CNS) where it blocks endorphin receptors. The sustained release mechanism promotes an effective concentration of naltrexone in the CNS over a whole month, thereby potentially improving treatment outcomes by reducing non-compliance often reported with daily naltrexone tablet administration, a significant hurdle in addiction treatment. Alcohol abuse affects more than 20 million people in the US and Europe.
About Brookwood Pharmaceuticals
Brookwood Pharmaceuticals, Inc. is a product-focused drug delivery company that applies its patented and proprietary technologies to design, formulate, and manufacture improved pharmaceutical products. The clinical applications of Brookwood technologies are diverse with current partnered programs covering metabolic diseases, cancer, orthopedic applications, drug/alcohol addiction, psychosis, ocular diseases and sun-induced conditions, and programs ranging from preclinical to Phase III.
The company holds more than 20 drug-delivery patents, and has expertise and facilities for feasibility studies, formulation and product analysis, scale up, clinical lot preparation, and production of final dosage forms. Brookwood Pharmaceuticals has a wide-range of delivery technologies particularly for long-acting parenterals such as injectable microparticles and injectable solid implants to deliver small molecules, peptides, proteins, nucleic acids, and other biological macromolecules. In addition to microspheres and implants, Brookwood provides drug delivery technology with solid-lipid nanoparticles, liposomes, and hydrophobic drug salts, novel biodegradable matrices, and supplies biodegradable polymers through its Lakeshore Biomaterials subsidiary.
SOURCE: elbion NV