LifeCycle Pharma to Initiate Phase II Clinical Trial of LCP-Tacro for Organ Transplantation

    Protocol Agreement With the FDA for First Phase II Trial in Kidney
    Transplant Recipients

    HORSHOLM, Denmark, June 21 /CNW/ - Summary: LifeCycle Pharma will
initiate a Phase II clinical trial of LCP-Tacro for the prevention of organ
rejection in kidney transplant patients following the update of its initial
Investigational New Drug Application (IND) in the United States (U.S.)
    LifeCycle Pharma has also reached protocol agreement with the U.S. Food
and Drug Administration (FDA) for its first Phase II trial in kidney
transplant recipients.
    LifeCycle Pharma A/S (OMX:LCP) today announced it will initiate a Phase
II clinical trial program using LCP-Tacro to prevent organ rejection in kidney
transplant patients. The clinical trial protocol has been reviewed by the FDA,
and LifeCycle Pharma has revised it to be in line with FDA recommendations. As
a result, LifeCycle Pharma expects to initiate a Phase II clinical trial soon.
    The trial is designed as a conversion study in stable kidney transplant
recipients, with patients being switched to LCP-Tacro once-a-day from
Prograf(R) twice-a-day. Up to 60 patients will be investigated at 10-12 sites
in the U.S. and Canada, and the initial clinical trial results are expected by
year end 2007, or early 2008. This study is considered to form the basis for
initiation of a subsequent Phase III program in de-novo kidney transplant
    A Phase II clinical study in liver transplant recipients is expected to
follow this year.
    "The initiation of the Phase II study using LCP-Tacro is a step forward
in the development of our organ transplantation franchise," said Dr. Flemming
Ornskov, President and CEO of LifeCycle Pharma. "We are encouraged by the
progress LifeCycle Pharma has made, and eager to advance LCP-Tacro to Phase II
clinical trials," added Dr. Ornskov.
    "This is the start of an exciting clinical development program. LCP-Tacro
will bring the convenience of once-daily administration of tacrolimus and may
optimize outcomes after kidney transplantation," said Dr. Shamkant Mulgaonkar,
Chief of the Transplant Division at St. Barnabas Healthcare System,
Livingston, New Jersey, USA and a clinical investigator in the first Phase II

    About transplantation and kidney 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 in conjunction with a base maintenance drug and adjunctive
therapies. In 2005, over 50,000 solid organ transplants were conducted in
seven major markets (U.S., Japan, France, Germany, Italy, Spain, and the
United Kingdom). The number of transplant patients waiting for organs is
expected to continue to outpace the number of organs available. The current
market size for immunosuppressants used in transplantation in the seven major
markets is approximately $3.3bn, and is estimated to grow by approximately 5 -
10% per year.
    Kidney transplantation is normally recommended for patients with
end-stage kidney disease or kidney failure caused by severe, uncontrolled
hypertension, diabetes, infections, intoxication, or inflammation.
    Kidney transplants account for approximately 60% of all transplants
performed annually in the seven major markets, and kidney transplants
generally offer the best outlook for patients with end-stage kidney disease.
    Most centers have patient and organ survivals of over 90% at one year,
and more than 80% at three years. Approximately 50% of transplanted kidneys
are still functional after 10 to 15 years.

    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(R)), and its modified-release version of tacrolimus for organ
transplants. This is expected to represent significant improvements for
    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. Transplant patients are
typically 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 its interaction with food and other drugs.

    About LifeCycle Pharma A/S:

    LifeCycle Pharma, headquartered in Horsholm, 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 proprietary technology platform,
MeltDose(R) 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 for further
information about LifeCycle Pharma A/S.

For further information:

For further information: LifeCycle Pharma A/S, Michael Wolff Jensen,
Executive Vice President and CFO, Tel: +45-40-74-62-44

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