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LifeCycle Pharma Heads into Pivotal Trials with its Immunosuppression Product Print E-mail
01 Feb 2006
Hørsholm, Denmark |Jan 31, 2006 | LifeCycle Pharma A/S announced today that it has achieved promising clinical results in a  Phase I study for its LCP-Tacro, a proprietary, once-daily tacrolimus tablet formulation.

"Our Phase I study clearly demonstrates that LCP-Tacro has a sustained release profile, allowing it to be dosed once daily in contrast with the original version of tacrolimus (Prograf®) which must be administered twice daily," said Michael Beckert, MD., Chief Operating Officer at LifeCycle Pharma. "Based on these results, we will now move LCP-Tacro rapidly into pivotal clinical trials for organ transplantation. Our once-daily LCP-Tacro product offers a clear advantage to patients," Michael Beckert added.

"With these promising data, we also have the opportunity to expand the commercial realm of our tacrolimus product to autoimmune disorders outside transplantation," said Jan Møller Mikkelsen, Chief Executive Officer at LifeCycle Pharma. "In less than three years, we have been able to complete clinical trials for five products, all of which establish the benefit of our MeltDose® technology in improving the properties of existing marketed products," Jan Møller Mikkelsen added.
About Tacrolimus

Sales of Prograf® (tacrolimus), currently marketed by Astellas Pharma, have been in excess of $1 billion over the past 12 months and continue to demonstrate strong growth. In the United States, sales of Prograf® have increased almost 15 percent over the past 12 months. The active ingredient of Prograf®, tacrolimus, is an immunosuppressant approved for certain indications within the organ transplantation segment, as well as rheumatoid arthritis.

For further information, please contact:
Jan Møller Mikkelsen, President & CEO, tel. +45 70 33 33 00
Michael Wolff Jensen, CFO, Executive Vice President, tel. +45 70 33 33 00
About LifeCycle Pharma A/S:

LifeCycle Pharma A/S was founded in June, 2002 as a spin-off from H. Lundbeck A/S. Its investors include H. Lundbeck A/S, Novo A/S, Nordic Biotech, Alta Partners (USA), and Adamant Biomedical Investments (Switzerland), as well as the LifeCycle executives. The company is based in Hørsholm, Denmark, and currently employs a staff of 40.

The company utilizes its proprietary MeltDose® technology to improve the bioavailability of known and established compounds so that patients can absorb them more effectively. LifeCycle Pharma's pipeline contains five products in clinical trials, of which the first - the cholesterol-lowering LCP-FenoChol® - is expected to reach the market in 2007.

LifeCycle Pharma's strength is in selecting high-value drugs with absorbtion issues, improving their formulations, and taking them to the market in short time frames, thus substantially reducing risk as compared with other pharma and biotech companies.

SOURCE: LifeCycle Pharma A/S




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