BioWorld International Correspondent

BioXell SpA grossed CHF57.8 million (US$46.3 million) in an initial public offering on the Swiss Stock Exchange in Zurich to fund ongoing clinical and preclinical development of its portfolio of six drug candidates.

Net of expenses, the company has added about €33 million (US$41.3 million) to its cash reserves, which had stood at €42 million on March 31, said Chief Financial Officer Alex Martin. An overallotment option of up to 196,965 shares would, if exercised in full, yield an additional CHF8.7 million.

The IPO came in at the bottom of the price range the Milan, Italy-based company originally set at the outset of the book-building period, and the number of shares issued also represented its minimum target. BioXell issued about 1.3 million new shares, priced at CHF44 per share, having published an indicative range of CHF44 to CHF48 and a total maximum offering of nearly 1.8 million new shares. The newly issued shares represent 25 percent of the company's stock.

The stock held its own immediately after shares began trading on June 22. The shares opened at CHF44.50 and climbed slightly to close at CHF45.

BioXell launched its IPO shortly after steep declines on global stock markets in early June. Was the company tempted to postpone the transaction? "Many people advised us not to go against the market, but at the same time we felt that the company was ready and had a strong story to tell," CEO Francesco Sinigaglia told BioWorld International. The company's choice of exchange was heavily influenced by its history, as a spinout from Basel, Switzerland-based F. Hoffmann-La Roche Ltd., in January 2002.

"A large part of the management team has been working in Switzerland. We understand the culture," Sinigaglia said.

The company, which had raised some €76 million in funding prior to the IPO, plans to use proceeds to continue its existing development programs. Its lead molecule, elcalcitol (formerly BXL628), is undergoing Phase II trials in three urology indications - benign prostatic hyperplasia (BPH), non-bacterial chronic prostatitis and overactive bladder - and is about to enter a Phase II study in a fourth, interstitial cystitis.

The BPH program is the most advanced. A large-scale Phase IIb trial has recruited some 400 of the planned 500 participants. Enrollment should be completed by the year's end, Sinigaglia said, and "data will be available in the second half of 2007."

The chronic prostatitis program is progressing faster than expected.

"Recruitment has been going extremely well, so we will have the data in the second half of 2006," Sinigaglia said. "That will be our next milestone."

The condition is poorly understood, BioXell said, and a diagnosis is generally made on an exclusionary basis. Yet the company estimates that 28 million men have chronic prostatitis, which is associated with pelvic pain and problems with sexual function, and there is no approved treatment. "Because of the unmet medical need, there would certainly be an opportunity to go directly into Phase III," Martin said.

"The good news here is we have identified a biomarker," Sinigaglia said. The company has observed elevated levels of interleukin-8 in the semen of men with both BPH and chronic prostatitis, and it is seeking validation of that finding in the two ongoing studies.

Elcalcitol is one of a series of vitamin D3 analogues BioXell obtained when it was spun out from Roche, and it is as yet unpartnered. Although the company has received approaches from several sources, Martin said, it plans to continue development in-house at present, although it will seek a partner before commercialization.

"The additional cash we've raised will give us the added flexibility to take a partner at the time of our choosing," he said.

The company has in-licensed two molecules in the past six months. It licensed MNAC13, a humanized monoclonal antibody in preclinical development as a pain therapeutic, from LayLine Genomics SpA, of Rome. BXL746, which the company licensed from Roche, belongs to a new class of vitamin D3 analogues and is in preclinical development for inflammatory bowel disease.

It has two further vitamin D3 analogues in preclinical development, BXL082 and BXL083, for osteoporosis and secondary hyperparathyroidism, respectively. Both are the result of a collaboration agreement with ProStrakan Group plc, of Galashiels, UK. It also out-licensed a TREM receptor program to Merck & Co. Inc., of Whitehouse Station, N.J. (See BioWorld International, May 25, 2005.)

Following the IPO, Roche remains BioXell's third largest shareholder, with an 8.5 percent stake. Its two largest shareholders are MPM Capital, of Boston, and Index Ventures, of Geneva, which hold 17.4 percent and 12 percent stakes, respectively. n