Company Announcement no. 16/2010

To: NASDAQ OMX Copenhagen A/S Hørsholm,
Denmark, October 18, 2010



LifeCycle Pharma Announces First Patient Dosed in LCP-Tacro™ Pivotal Phase 3
Study
in De Novo Kidney Transplant Patients

LifeCycle Pharma A/S (OMX: LCP) today announced dosing of the first patient in
a pivotal Phase 3 clinical study, Study 3002, for LCP-Tacro™ (tacrolimus,
modified release). LCP-Tacro™ is a once-daily formulation of tacrolimus that
uses LCP's proprietary MeltDose® technology. This international trial is a
12-month study designed to evaluate the efficacy and safety of LCP Tacro™
tablets administered once-daily compared to Prograf® (tacrolimus, immediate
release) capsules administered twice-daily as immunosuppressant for the
prevention of acute allograft rejection in de novo adult kidney transplant
recipients. The Company recently announced receipt of an agreement with the
U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA)
regarding Study 3002.

William Polvino, President & Chief Executive Officer of LCP, said, “We are very
pleased that LCP has taken this key step forward in bringing a new important
therapy to transplant patients.”

“We at UCLA are happy to be involved in this Phase 3 study of a medication
which will offer the opportunity to our patients to have a once-daily therapy
that will be more convenient and that may also improve compliance,” added
Suphamai Bunnapradist, M.D., Professor of Medicine and Director of Kidney
Transplant Research at the Ronald Reagan Medical Center and David Geffen School
of Medicine at UCLA, California, USA.
Phase 3 Study Design

The LCP Study 3002 is a randomized, double-blind, multicenter study that will
compare once-daily LCP-Tacro™ against twice-daily Prograf® in de novo adult
kidney transplant patients. The primary endpoint of the study, a composite
endpoint (Biopsy Proven Acute Rejection, graft failure, loss to follow up or
death), will be evaluated after 12-month treatment period to demonstrate the
non-inferiority of LCP-Tacro™ compared to Prograf®. Secondary endpoints will
include safety, tolerability and renal function assessments. The study will be
conducted at approximately 100 transplant centers, primarily in the U.S and
Europe. Patients will participate in a 12-month extension period on treatment
for follow-up safety assessments.

For information about enrolling in the study, please visit
www.clinicaltrials.gov.

For more information, please contact:

LifeCycle Pharma A/S

Johnny Stilou John Weinberg, Senior VP, Commercial
CFO Development and Strategic Planning
Phone: +45 20 55 38 52 Phone: +1 646 200 8508
Email: [email protected] Email: [email protected]

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 Jersey, LCP is a specialty
pharmaceutical company. Clinical development is the core of LCP's efforts to
develop a product portfolio which includes the Company's lead product
candidate, LCP-Tacro™, for immunosuppression, specifically organ
transplantation, and products to combat certain cardiovascular diseases. 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 lipid-lowering product,
Fenoglide®, currently on the U.S. market and a diversified near and medium-term
pipeline with three 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

181010 lifecycle pharma announces first patient first dose in lcp-tacro in phase 3 study 3002.pdf