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BioXell 2006 Interim Results: Strong Financial Position to Support Development Programs and Expanded Pipeline


Milan, Italy, 18th September 2006 – BioXell S.p.A. (SWX: BXLN) today reported its 2006 interim financial results. The first six months of 2006 were significant for BioXell on multiple fronts as the Company reported positive clinical results with its lead product candidate Elocalcitol, now in three Phase II programs, and continued to expand its pipeline with the addition of several new product candidates. Following a private financing in March and its initial public offering on the SWX Swiss Exchange in June 2006, BioXell’s cash and marketable securities were € 77.6m (CHF 122 million) on June 30, 2006. The Company’s burn rate for the first six months was € 0.7m per month, and is expected to increase by more than 50% for the second half of the year.

Highlights of the six month period included:
• Positive clinical results for Elocalcitol in Overactive Bladder
• Completed recruitment ahead of schedule for clinical trial in Chronic Prostatitis
• Expanded pre-clinical pipeline with selection of BXL082 for osteoporosis and BXL083 for secondary hyperparathyroidism
• Acquired option right from Roche to develop BXL746
• In-licensed MNAC13 for chronic and acute pain
• Completed Series C2 financing
• Launched successful IPO on SWX Swiss Exchange
• Strong financial position: € 78m (CHF 122m) in cash and marketable securities

“We are extremely pleased with our half-year results, both operationally and financially,” remarked Dr. Francesco Sinigaglia, CEO of BioXell. “Elocalcitol continues to show promise in multiple urological indications, and our pipeline is now considerably stronger than it was just six months ago. The proceeds raised from our IPO will allow us to continue to invest in medicines for unmet medical needs.”

In May, BioXell successfully completed its Phase IIa trial in patients with Overactive Bladder. The magnitude of the effect seen on the primary endpoint (mean volume voided per micturition) was in line with what is observed with anti-muscarinics, today’s “gold standard” treatment, and the compound continues to exhibit a placebo-like tolerability profile. In early 2007 BioXell will begin a large, pan-European Phase IIb trial which could potentially be used as one of the pivotal trials for registration.
BioXell is on track to complete the enrolment of its 500+ patient Phase IIb trial in Benign Prostatic Hyperplasia by the end of the year. The Company has also completed enrolment of its Phase II trial in Non-bacterial Chronic Prostatitis ahead of schedule; results will be available in the second half of this year.

Additional VD3 compounds
In April BioXell signed an agreement with Roche that gives BioXell option rights to BXL746, a unique analogue which has already completed a Phase I study. The Company is evaluating the compound in several different models of inflammatory diseases, and expects to reach a decision on whether to exercise its option by the beginning of next year. In addition, the collaboration with ProStrakan has yielded two promising compounds which could enter pre-clinical development: BXL082 for osteoporosis and BXL083 for secondary hyperparathyroidism.

The Company has begun development on MNAC13, which represents an innovative approach to treating chronic pain and a promising potential alternative to current treatments available today.

Strong Financial Position
Combined cash, cash equivalents, and investment securities totalled € 77.6m on June 30, 2006, which includes € 10.4m received from the Series C2 financing in March, and € 32.1m in proceeds from the IPO after deducting issuance costs.

During the first half of this year, BioXell invested € 5.9m in research and development activities vs. € 5.1m for the same period in 2005. The Phase II clinical programs as well as the investment in BXL746 and MNAC13 were the primary drivers of the R&D spending. Total operating expenses in the first half of 2006 amounted to € 8.7m (vs. € 7.2m in 2005).

Key figures

In € million, except per share data | H1 2006 | H1 2005
Revenues | 1.3 | 1.0
Research & Development | (5.9) | (5.1)
General & Administrative | (2.8) | (2.1)
Operating Loss | (7.4) | (6.2)
Net Loss | (7.0) | (5.7)
Basic and Diluted Loss per Share, in € | (1.82) | (1.61)

Notes: Unaudited consolidated figures in accordance with US GAAP

Half-year report
BioXell’s 2006 Interim Report is available on the internet ( and can be ordered from:
BioXell S.p.A. (Investor Relations), Centro Direzionale Milano 2 Palazzo Vasari, 20090 Segrate (MI), Italy.

About BioXell
BioXell (SWX: BXLN) is a biopharmaceutical company focused on the discovery and development of drugs that exploit novel mechanisms of action to treat urological, inflammatory, and related disorders with significant unmet medical needs and representing large markets. The Company was founded in 2002 as a spin-out from Roche. BioXell’s strategic goal is to become a fully integrated pharmaceutical company by maximizing the commercial potential of its product portfolio and leveraging existing platforms into profitable partnerships. BioXell’s lead compound, Elocalcitol, derived from its proprietary VD3 (Vitamin D3) technology platform, is in Phase II clinical trials for the treatment of three distinct urological indications, Benign Prostatic Hyperplasia (BPH), Overactive Bladder (OAB) and Non-bacterial Chronic Prostatitis (CP), and is expected to enter a fourth Phase II clinical trial in Interstitial Cystitis (IC) in the first half of 2007.
Since 2005 BioXell has a TREM-1 fusion protein in development for the treatment of septic shock in an exclusive partnership with Merck & Co., Inc. Furthermore, in 2006 BioXell in-licensed from Lay Line Genomics S.p.A. a novel anti-TrkA monoclonal antibody, MNAC13, which represents a potential new approach to the treatment of pain.
In June 2006, BioXell listed its shares on the main segment of the SWX Swiss Exchange. BioXell currently employs 58 people and has sites in Milan, Italy and Nutley, NJ, USA.
More information on BioXell can be found at:

This press release does not constitute or form part, or all, of any offer or invitation to sell or issue, or any solicitation of any offer to purchase or subscribe for, any securities, nor shall part, or all, of these materials or their distribution form the basis of, or be relied on in connection with, any contract or investment decision in relation to any securities. This press release contains forward-looking statements based on the currently held beliefs and assumptions of the management of BioXell, which are expressed in good faith and, in their opinion, reasonable. Forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause the actual results, financial condition, performance, or achievements of BioXell, or industry results, to differ materially from the results, financial condition, performance or achievements expressed or implied by such forward-looking statements. Given these risks, uncertainties and other factors, recipients of this document are cautioned not to place undue reliance on these forward-looking statements. BioXell disclaims any obligation to update these forward-looking statements to reflect future events or developments.


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