Company Announcement no. 02/2008
To: OMX Nordic Exchange Hørsholm, Denmark, January 18, 2008
LifeCycle Pharma Announces Transplantation Programs on Track
New positive Interim phase II Data Underscores Potential of LCP-Tacro; Kidney
Transplantation Product Candidate to Report Phase II Data in March 2008
Hørsholm, Denmark, January 18, 2008; LifeCycle Pharma A/S (OMX: LCP), an
emerging specialty pharmaceutical company, announced today positive interim
results from an ongoing Phase II clinical trial for LCP-Tacro in stable liver
transplant patients.
The positive interim results for LCP-Tacro in stable liver transplant patients
are based on a pre-planned assessment of 11 stable liver transplant patients and
demonstrated that LCP-Tacro has a superior profile when compared to Prograf®,
namely higher bioavailability, better pharmacokinetics (PK) and once-a-day
tablet administration. Prograf® is currently marketed worldwide by Astellas
Pharma as twice-a-day capsules of tacrolimus. These results are consistent with
the interim results reported from the Phase II clinical trial in stable kidney
patients. In addition, the interim Phase II data further supports the series of
successful Phase I trials of LCP-Tacro, involving more than 150 healthy
volunteers, which demonstrated that LCP-Tacro has a once daily profile and
higher bioavailability of tacrolimus.
LCP has also completed patient enrollment in its Phase II clinical trial for
LCP-Tacro in stable kidney transplant patients.
Top line results for the clinical phase II study LCP-Tacro in stable kidney
transplant patients are expected in March 2008 and top line results for the
clinical phase II study for LCP-Tacro in stable liver patients are expected in
the second quarter of 2008 (2Q08).
LCP's Phase II clinical trial in stable liver transplant patients continues on
track to enroll at least 39 additional patients, bringing the total number of
targeted patients enrolled to 50, in up to 12 sites in the U.S. As with the
kidney Phase II clinical trial, the Company expects that the liver Phase II
clinical trial will confirm the proposed dosing regimen and provide a robust
basis for the initiation of a Phase III clinical trial program in 2008 in
de-novo liver and stable liver transplant recipients.
LCP-Tacro (Liver) Phase II Clinical Trial Design
The Phase II clinical trial, which commenced enrollment in December 2007, is a
three sequence, open-label, multi-center, prospective, conversion study in
stable liver transplant patients to assess and compare the pharmacokinetics
(Cmax, C24, and AUC), and safety of LCP-Tacro (tacrolimus) tablets Once-A-Day
versus Prograf® (tacrolimus) capsules Twice-A-Day. Stable liver transplant
patients who fulfill all I/E (inclusion/exclusion) criteria are enrolled and
kept on Prograf® for 7 days. Following a 24-hour PK assessment on Day 7 to
determine pharmacokinetics for Prograf®, all patients are converted to once
daily LCP-Tacro for 7 days on a specific conversion scheme with no dose changes
allowed until Day 14. On Day 14 and Day 21, a 24-hour LCP-Tacro PK assessment
will be performed. On Day 22, except for patients converted back to their twice
daily dose of Prograf, all patients are enrolling in the 52-week open-label
extension study.
About LCP-Tacro & Tacrolimus
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 in
absorption when compared to Astellas' twice daily version of tacrolimus (Prograf
worldwide) and its prolonged-release version of tacrolimus (Advagraf in Europe).
Clinical trials have demonstrated that LCP-Tacro has a superior bioavailability
and PK profile and is expected to provide significant improvements for patients
currently on Prograf.
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 tacrolimus levels is
complicated by the low bioavailability of Prograf, its variable absorption and
interaction with food and other drugs. The current market size for
immunosuppressants used in transplantation in the seven major markets (US,
Japan, France, Germany, Italy, Spain and UK) is approximately $3.3B and growing
by approximately 5-10% per year. In 2006, worldwide sales of tacrolimus were
approximately $1.4 billion, with some 50% of such sales generated in the United
States, and 30% in Europe.
About LifeCycle Pharma A/S (“LCP”)
LCP is an emerging specialty pharmaceuticals company that, through innovative
technologies, is able to rapidly develop a portfolio of differentiated products
to meet the unique needs of key therapeutic markets and patient populations.
This includes products for immunosuppression, specifically organ
transplantation, and to combat certain cardiovascular diseases. By using its
unique and patented delivery technology, MeltDose®, LCP is able to develop drugs
with enhanced absorption and thereby increased bioavailability. Currently, the
Company has a diversified near- and medium-term pipeline, including a product
ready for US commercialization, five product candidates in clinical trials and
three in preclinical stages of development. LCP is listed on the OMX Nordic
Exchange under the trading symbol (OMX: LCP). For further information, please
visit www.lcpharma.com.
Contact:
LifeCycle Pharma A/S
Flemming Ornskov, MD
President and CEO
+4524200368; fo@lcpharma.com
And
Francesca M. DeMartino
Director, Investor Relations & Corporate Communications
(917) 747-4938; FDM@lcpharma.com
LifeCycle Pharma Announces Transplantation Programs on Track - New positive Interim phase II Data Underscores Potential of LCP-Tacro
| Source: Veloxis Pharmaceuticals A/S
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