Announcement no. 13/2007
To OMX Nordic Exchange Hørsholm, Denmark, 31 May 2007
LifeCycle Pharma Announces Positive Phase I Clinical Results
for its Transplantation Product Candidate, LCP-Tacro
-
Heads into US Phase II Clinical Trials for Organ Transplantation
Summary: LifeCycle Pharma announces positive Phase I clinical results for its
transplantation product candidate, LCP-Tacro - Heads into US Phase II clinical
trials for organ transplantation
Hørsholm, Denmark, 31 May 2007; Today LifeCycle Pharma A/S (OMX:LCP) announces
positive results from its Phase I clinical trial program of LCP-Tacro, a
proprietary, once-daily tacrolimus tablet.
A series of Phase I trials, involving more than 150 healthy volunteers
demonstrate that LCP-Tacro:
Has a once-daily profile.
Delivers consistently higher bioavailability of about 50% compared to Prograf®.
Reduces peak levels (Cmax) and reduces peak (Cmax) / trough (Cmin) fluctuation
compared to Prograf®.
“The once-daily profile and significant increase in bioavailability, compared to
Prograf®, that has been demonstrated for our LCP-Tacro product candidate in an
extensive Phase I program is encouraging, and provides the foundation to quickly
advance it into Phase II trials for organ transplantation, said Dr. Flemming
Ornskov, President and CEO of LifeCycle Pharma“. LifeCycle Pharma's long-term
strategy is to concentrate on and commit significant resources to the
development of a number of product candidates for organ transplantation as it
moves towards becoming a fully integrated specialty pharmaceutical company”
added Dr. Ornskov.
About the studies:
LifeCycle Pharma has conducted a series of Phase I studies in more than 150
healthy volunteers to demonstrate the profile of LCP-Tacro under single-dose and
multi-dose (steady-state) conditions. In addition to this, dose-linearity,
food-effect and diurnal pharmacokinetic studies have been completed.
About transplantation:
In order to prevent the patient's immune system from rejecting the transplanted
organ, immunosuppression therapy is required for the lifetime of the graft with
a base maintenance drug and adjunctive therapies. In 2005, over 50,000 solid
organ transplants were conducted in the 7 major markets (US, Japan, France,
Germany, Italy, Spain and UK). The number of transplant procedures is expected
to grow steadily every year; however, the number of patients waiting for
transplants is predicted to grow even faster, as there is a lack of organs. The
current market size for immunosuppresssants used in transplantation in the 7
major markets is approximately $3.3bn and is estimated to grow by approximately
5-10% per year.
About LCP-Tacro:
Tacrolimus is a leading immunosuppressive medication to prevent rejection after
organ transplantation. LCP-Tacro is being developed as a once-daily tablet
version of tacrolimus, with improved bioavailability and reduced variability
compared to both Astellas' twice daily version of tacrolimus (Prograf®) and its
modified-release version of tacrolimus for organ transplants. This is expected
to represent significant improvements for the patients.
Transplant patients need to maintain a minimum level of tacrolimus in the blood
to prevent organ rejection, but too high levels increase the risk of serious
side effects such as kidney damage or hypertension. Therefore, tacrolimus levels
need to be managed carefully and transplant patients typically are obliged to
make frequent visits to the hospital for monitoring and dose adjustments for
months after receiving a new organ. Management of the tacrolimus levels is
complicated by the low bioavailability of Prograf®, its variable absorption and
interaction with food and other drugs.
For further information please contact:
LifeCycle Pharma A/S
Michael Wolff Jensen
Executive Vice President and CFO
Tel. +45 40 74 62 44
---oo0oo---
About LifeCycle Pharma A/S:
LifeCycle Pharma, headquartered in Hørsholm, Denmark, is an emerging
pharmaceutical company with a broad and late stage product pipeline in
therapeutic areas of cholesterol management, hypertension, organ transplant and
autoimmune diseases. LifeCycle Pharma's product candidates are proprietary and
designed to improve the quality of existing drugs by enhancing the release and
absorption of drugs in the human body. LifeCycle Pharma's proprietary technology
platform, MeltDose® technology, offers lower dosing, reduced side effects and
improved safety and patient compliance, as well as reduced product development
time and development costs. LifeCycle Pharma is listed on the OMX Nordic
Exchange under the trading symbol (LCP). Please visit www.lcpharma.com for
further information about LifeCycle Pharma A/S.
LifeCycle Pharma Announces Positive Phase I Clinical Results - Heads into US Phase II Clinical Trials for Organ Transplantation
| Source: Veloxis Pharmaceuticals A/S
Attachments
