Indena and Nerviano Medical Sciences Agree To Scale Up New High Potency Molecules

Two leading Italian research centers join forces to develop new chemicals

Milan, July 18th 2006 - Indena S.p.A., world leader in the identification, development and production of active principles derived from plants, and Nerviano Medical Sciences, the largest pharmaceutical R&D facility in Italy and one of the largest oncology-focused, integrated discovery and development companies in Europe, announce a co-development agreement.

Indena has commissioned Nerviano to handle the scale up and manufacturing of two new drug candidates for preclinical and clinical development: IDN 5404 and IDN 5243.

With this agreement the two companies are sharing synergistically their main competencies, from one side Indena has discovered two new molecules from botanical origin and has set the original semi-synthetic path, Nerviano, thanks to their specialization in highly potent compound present at its API – Pharmaceutical Sciences Business Unit, will scale up the process.

IDN 5404 is a highly potent API selected for its action against tumor resistance to cisplatin and topotecan. IDN 5243 is a novel muscle relaxant agent for the treatment of muscular skeletal pain.
Both molecules are approaching Phase I after having successfully completed preclinical.
Indena has high hopes from this collaboration with Nerviano M.S. with its very advanced and flexible technological platform for the manipulation of highly potent active principles whether as APIs or their finished dosage form.

According to Dario Bonacorsi, Indena President and CEO, “this agreement shows how Italian companies can come together to compete worldwide on new research projects”.

"We are proud and eager to work on concrete projects such as the two Indena molecules; we look forward to being able to expand the collaboration to include other highly potent molecules, which could even be jointly developed by our two research centers, said Giampiero Duglio, CEO of Nerviano Medical Sciences.

IDN 5404
A novel thiocolchicine dimer selected for its cytotoxic activity in nanomole range concentrations on several human tumor cell lines and in particular on a tumor cell line resistant to cisplatin and topotecan (Bernacki, AACR Annual Meeting, 2005). This particular behavior was related to a dual mechanism of action. As well as other colchicine structure based compounds, IDN 5404 was able to interact with microtubule dynamic and to inhibit the activity of topoisomerase-I nuclear enzymes in a different manner to the classical topo-I inhibitors camptothecins (Raspaglio 2005, Biochemical Pharmacology 69:113). In pre-clinical in vivo testing, IDN 5404 formulated as a nanoparticle of albumin, is active after systemic administration in human ovarian and colon carcinomas xenograft showing a superior efficacy than the reference standard irinotecan (Desai, AACR annual meeting, 2005). IDN 5404 also possesses anti-angiogenic properties as demonstrated in the study recently reported at the last Annual AACR Meeting by Trieu V. (97th AACR, April 2006). The compound shows a potent action in disrupting established microvessels and high efficacy on a human colon tumor model superior to Combretostatin, a well known vascular target agent.
Based on these overall findings IDN 5404, could represent an innovative tool in the fight against drug resistance to conventional antitumor agents.
IDN 5243
IDN 5243 is an original NCE fruit of collaboration between Indena and major Italian Universities, with excellent muscle-relaxant action. The molecule showed significant anti-inflammatory activity by intraperitoneal route at 10 mg/kg in both carrageenin induced edema and granuloma tests. It is endowed with analgesic activity and provides good muscle-relaxant action Toxicological studies have been completed and the drug proved to be well tolerated. Phase I clinical trials in healthy volunteers are envisaged for late 2006.

Indena is the world's leading company dedicated to the identification, development and production of active principles derived from plants, for use in the pharmaceutical, health food and cosmetics industries. Indena, a privately owned Italian company, reported 170 million Euro in consolidated turnover in 2005, mostly generated abroad. The key to Indena's success is its research, covering: the screening of medicinal plants for their pharmacological benefits; the identification of new active principles; and the development of extraction and purification systems at the cutting-edge of industrial application. Backed up by over 80 years of botanical experience, the phyto-chemical research is carried out in Indena's own Settala Research Center, near Milan. Indena also co-operates with the world's most prestigious universities and private research institutions in the biological assessment of safety and effectiveness up to clinical phase I. The company, with around 800 employees, including 10% dedicated to full-time research, manages cultivation, manufacturing, and distribution operations in more than 40 countries throughout the world. The Company's experts communicate and interact constantly with the major international regulatory authorities such as WHO, EMEA, and ESCOP, and work with all the main pharmacopoeias.

Nerviano Medical Sciences is a private Italian company owned by the Congregazione dei Figli dell'Immacolata Concezione who incorporated the company into their group in May 2004 following acquisition of the same from Pfizer. Nerviano Medical Sciences is the largest pharmaceutical R&D facility in Italy and one of the largest oncology-focused, integrated discovery and development companies in Europe. A total of almost 700 highly skilled and experienced scientists, technicians and managers are involved in oncology R&D projects from target validation through to clinical phase II. Nerviano Medical Sciences operates in joint association with keynote international academic institutions, other R&D facilities and through partnerships with leading drug companies and biotechs.

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