Company Announcement no. 20/2007
To: OMX Nordic Exchange Hørsholm, Denmark, September 5, 2007
LifeCycle Pharma Initiates Head-to-Head Clinical Trial of LCP-Tacro versus
Advagraf®, Both Tacrolimus Immunosuppressants, For Use in Organ Transplantation
Company Also Provides Progress Update on Additional LCP-Tacro Phase II Clinical
Trials in Kidney and Liver Transplant Recipients
Summary: LifeCycle Pharma initiates head-to-head clinical trial of LCP-Tacro
versus Advagraf® and provides update on ongoing Phase II trials for LCP-Tacro in
kidney and liver transplant recipients.
Hørsholm, Denmark, September 5, 2007; LifeCycle Pharma A/S (OMX:LCP), an
emerging specialty pharmaceutical company focused on developing and
commercializing differentiated versions of existing drugs in large therapeutic
areas such as cardiovascular disease, organ transplantation and
immunosuppression, including recently Food and Drug Administration approved
LCP-FenoChol, a fenofibrate for the treatment of hyperlipidemia and
hypertriglyceridemia, today announced that it has initiated a Phase I clinical
trial for its product candidate LCP-Tacro, a once-daily tacrolimus tablet used
as an immunosuppressant in organ transplant recipients.
The Phase I clinical trial will be conducted as a head-to-head study of
LCP-Tacro versus Advagraf®, which is currently available in Germany and the UK
as a once-daily formulation of Prograf®. The clinical trial will enroll 24
healthy volunteers and clinical trial results are expected before year-end 2007.
“Our Phase I clinical trials of LCP-Tacro versus Prograf showed positive
results, including a clear, once-daily profile and 50% higher bioavailability
than Prograf,” said Dr. Flemming Ornskov, President and CEO of LCP. “We
anticipate that the results of the clinical trial comparing LCP-Tacro to
Advagraf will show similar results and demonstrate that our product candidate,
LCP-Tacro, also has more advantages when compared to Advagraf.”
In addition to the Phase I clinical trial of LCP-Tacro versus Advagraf, the
Company is conducting two Phase II clinical trials in organ transplantation,
specifically kidney and liver. The Phase II clinical trial for LCP-Tacro in
kidney transplant recipients, and the most advanced, is progressing as
previously communicated with enrollment underway and clinical trial results
expected by year-end 2007 or early 2008. The Phase II clinical trial for
LCP-Tacro in liver transplant recipients is also on track, with patient
enrollment scheduled to commence in the coming months and clinical trial results
expected in the first half of 2008.
About Organ 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 $3.3B 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 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.
About LifeCycle Pharma A/S ("LCP A/S"):
LCP A/S, headquartered in Hørsholm, Denmark, is an emerging specialty
pharmaceutical company focused on developing and commercializing a portfolio of
innovative products in therapeutic areas such as cholesterol management,
hypertension, organ transplantation and autoimmune diseases. LCP's proprietary
MeltDose® technology, offers lower dosing, reduced side effects, improved safety
and patient compliance, and reduced product development costs and times.
LCP-FenoChol, a fenofibrate for the treatment of hyperlipidemia and
hypertriglyceridemia, is LCP's first FDA approved product (approved in August
2007). LCP is listed on the OMX Nordic Exchange under the trading symbol
(OMX:LCP). For further information, please visit www.lcpharma.com.
Contact:
Francesca M. DeMartino
Director, Investor Relations & Corporate Communications
(201) 633-4729
FDM@lcpharma.com
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LifeCycle Pharma Initiates Head-to-Head Clinical Trial of LCP-Tacro versus Advagraf®
| Source: Veloxis Pharmaceuticals A/S
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