BioWorld International Correspondent

PARIS - ProSkelia SAS and BioXell SpA entered a collaboration to discover and develop drug candidates based on vitamin 3D analogues for osteoporosis and secondary hyperparathyroidism (HPT).

Vitamin 3D analogues are secosteroid hormones that play a role in regulating calcium and bone metabolism, cell proliferation and differentiation, and the immune system as a whole.

The companies are collaborating in both the research and development phases, including clinical trials, with each bearing its own costs. BioXell will provide vitamin 3D compounds, together with medicinal chemistry support and relevant intellectual property, while ProSkelia will contribute its expertise in the area of bone disease and be responsible for the pharmacology side, according to its corporate development manager, Enrico Bastianelli. They will share any revenues generated by the collaboration.

Bastianelli told BioWorld International that "if all goes to plan, we hope to have identified a number of preclinical candidates within 12 to 18 months and to have selected one candidate and a backup for clinical development after another 12 to 18 months."

Vitamin 3D analogues are one of two therapeutic approaches, along with TREM receptor biology, that Milan, Italy-based BioXell is exploiting to generate new therapies in two therapeutic areas - urology and inflammatory diseases. Its lead product, in Phase II trials, is for benign prostatic hyperplasia.

The French company ProSkelia, which was spun off from Strasbourg-based Aventis SA in July 2002 and is based in the biotechnology science park created by Aventis on the site of its former research and development center in Romainville, is specialized in bone diseases and hormone disorders.

It has developed two discovery platforms based on steroid biology and bone biology and has three drug candidates in clinical development in four indications, all of which were spawned by its research into new selective steroid modulators. Its lead compound is Trim Patch (PSK 3987), a combined trimegestone-estradiol patch that is entering Phase III trials as a hormone-replacement therapy. The other two are a topical anti-androgen (PSK 3841), which is in Phase II in alopecia and acne, and a designer estrogen (PSK 3471), which is in Phase I for osteoporosis.

ProSkelia has another five candidate compounds in preclinical development in three different therapeutic areas, and plans to broaden the therapeutic approaches later by applying steroid biology to hormone disorders and hormone-related cancers, anti-resorptive biology to skeletal oncology and bone metastasis, and anabolics to bone and joint reconstruction. Its business strategy is to establish proof of concept for drug candidates in clinical trials and then to license them out for the final development and commercialization of the product. It plans to retain rights to products in certain countries, especially in Europe.

ProSkelia was established with funding of €59.4 million provided by two investors - Aventis (42 percent) and Warburg Pincus, of London (58 percent). The company employs about 100 people.

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