Company Announcement no. 12/2010
To: NASDAQ OMX Copenhagen A/S
Hørsholm, Denmark, August 12,2010
LifeCycle Pharma Receives Special
Protocol Assessment (SPA) from FDA for
LCP-Tacro™ Pivotal Phase 3
Study in De Novo Kidney Transplant Patients
LifeCycle Pharma's pivotal
Phase 3 3002 Study for LCP-Tacro™ will be initiated
in 2010.
Hørsholm, Denmark,
August 12, 2010: LifeCycle Pharma A/S (OMX: LCP) today
announced
receipt of agreement with the U.S. Food and Drug Administration (FDA)
on a
Special Protocol Assessment (SPA) of its pivotal Phase 3 study, Study
3002,
for LCP-Tacro™ in patients, who have just received a kidney transplant
(“de
novo” transplant patients).
William Polvino, President & Chief Executive Officer of
LifeCycle Pharma said,
“The SPA Agreement for Study 3002 of LCP-Tacro™ is a
very significant
achievement for LCP. We have now received a formal
green light from the FDA as
to our proposed clinical study design and are
now well-positioned to move
forward with the study start. Further, we
have achieved increased clarity on the
costs and timing to regulatory
approval. LCP re-affirms its expectations of a
target NDA filing in the
first quarter of 2013, and we anticipate study
initiation in the
third quarter of this year.”
“The
optimized and patent-protected formulation used in LCP-Tacro™ provides
desirable once-daily dosing of tacrolimus and is intended to reduce the
peak-to-trough variability in blood levels,” added Dr. John Weinberg,
Senior
Vice President, Commercial Development and Strategic Planning. He
continued,
“We are optimistic that LCP-Tacro™ will provide important
patient benefits
compared to existing treatments, will be a valuable
addition to the therapeutic
regimens available to transplant physicians, and
has significant market
potential.”
The LCP Study 3002 is a randomized,
double-blind, multicenter study that will
compare once-daily LCP-Tacro™
against the current market leading comparator,
twice-daily Prograf® in de
novo kidney transplant patients. A 12-month
treatment period will be
followed by a 12-month blinded extension. The primary
endpoint of the study
will be to demonstrate the non-inferiority of LCP-Tacro™,
compared to
Prograf®, on kidney graft function (biopsy proven acute rejection,
graft
failure, death, or loss to follow up) at 12 months. Secondary endpoints
will include safety, tolerability and renal function assessments. The study
will
be conducted at approximately 75-100 transplant centers, primarily in the
United
States and Europe.
LCP has developed LCP-Tacro™ as an optimized version of the highly
successful
transplant drug, tacrolimus (branded Prograf®). Worldwide sales
of Prograf®
were about 2 billion USD in 2009 (IMS; all rights reserved).
For more information, please contact:
LifeCycle Pharma A/S
William J. Polvino Peter Schøtt Knudsen
President and CEO Head of Investor Relations
Phone: +45 7033 3300 Phone: + 45 2055 3817
Email: WJP@lcpharma.com Email: PSK@lcpharma.com
About Special Protocol Assessments
The Special Protocol Assessment (SPA)
process is a procedure by which the FDA
provides official evaluation and
written guidance on the design and size of
proposed protocols that are
intended to form the basis for a new drug
application (NDA). Final
marketing approval depends on the results of efficacy,
the adverse event
profile and an evaluation of the benefit/risk of treatment
demonstrated in
the Phase 3 clinical program. The SPA agreement may only be
changed
through a written agreement between the sponsor of the clinical program
and
the FDA, or if the FDA becomes aware of a substantial scientific issue
essential to product efficacy or safety.
About LCP-Tacro™ and tacrolimus
Tacrolimus is a leading immunosuppression drug used for the prevention
of
transplant allograft rejection after organ transplantation.
LCP-Tacro™ is being
developed as a once-daily tablet version of tacrolimus,
with improved
bioavailability, consistent pharmacokinetic
performance and reduced
peak-to-trough variability when compared
to currently approved tacrolimus
products. Transplant patients need to
maintain a minimum blood level of
tacrolimus for the prevention of
transplant allograft rejection, but excessive
levels may increase the risk
of serious side effects such as nephrotoxicity and
opportunistic infections.
Therefore, tacrolimus levels need to be managed
carefully, and
transplant patients are typically obliged to make frequent visits
to the
hospital for monitoring and dose adjustments after receiving a new organ.
About LifeCycle Pharma A/S (LCP)
Based in Hørsholm, Denmark, with an office in New York, LCP is an
emerging
specialty pharmaceutical company. Clinical development is the
core of LCP's
efforts to develop a product portfolio which includes
products for
immunosuppression, specifically organ
transplantation, and products to combat
certain cardiovascular diseases. As
a fully integrated company, LCP adapts new
technologies on a fast commercial
timetable. LCP's unique, patented delivery
technology, MeltDose®, can
improve absorption and bioavailability - at low-scale
up costs - not only for
a broad spectrum of drugs already on the market but also
for new chemical
entities. LCP has a cholesterol-lowering product, Fenoglide®,
currently on
the U.S. market and a diversified near and medium-term pipeline
with four
clinical stage product candidates and a number of projects in
preclinical development. LCP is listed on the NASDAQ OMX Copenhagen under the
trading symbol OMX: LCP. For further information, please visit
www.lcpharma.com.
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