BioWorld International Correspondent

BioXell SpA broadened its license agreement with F. Hoffmann-La Roche Ltd. concerning BioXell's lead development candidate, the vitamin D3 analogue BXL 628.

A previous agreement permitted Roche spinout BioXell to develop the compound for four indications: benign prostatic hyperplasia (BPH), secondary hyperparathyroidism, transplant rejection and Type I diabetes. It now has exclusive worldwide rights to develop it in all indications apart from dermatological and topical settings. Basel, Switzerland-based Roche had assigned the latter rights to another spinout, Basilea Pharmaceutica AG, also of Basel. Financial terms were not disclosed.

"It really adds true value to the company," Meenu Chhabra, business development director at Milan, Italy-based BioXell, told BioWorld International. BioXell recently completed a Phase II trial of BXL 628 in BPH and plans to release the data after the summer.

"We're very, very excited about the results. They look very promising," Chhabra said.

The company is planning three additional development programs with the compound, starting with overactive bladder. "We are looking to start our Phase IIa study in the fall," Chhabra said. BioXell can claim significant credentials in that market, which is worth some $1 billion annually. Its chief medical officer, Enrico Colli, led the development of the market-leading product tolterodine, which is marketed as Detrol by New York-based Pfizer Inc. BioXell already has gained data from preclinical models through an academic collaboration with Karl Erik Andersson at Lund University in Sweden.

The company also is planning to move BXL 628 into clinical development in cystitis and another undisclosed urological indication. BXL 628 is one of about 200 vitamin D3 analogues BioXell licensed from Roche when it was spun out at the beginning of 2002. So far, it is the only compound to have entered the clinic.

"We are also focusing on building an in-house library, which by the end of the year should be about 100 compounds," Chhabra said. That would feed into planned clinical development programs in psoriasis and Type I diabetes.

"We're looking at about a 12- to 18-month window. Hopefully we can do something sooner," he said.