Company Announcement no. 11/2010

To: NASDAQ OMX Copenhagen A/S
Hørsholm, Denmark, July 5, 2010

LifeCycle Pharma Announces Positive Results of Phase 2 Clinical Trial For
LCP-Tacro? in De Novo Kidney Transplant Patients

LifeCycle Pharma A/S (OMX:LCP) today announced positive top-line results from a
Phase 2 clinical trial involving 63 patients comparing LCP-Tacro? tablets
administered once daily versus Prograf® (tacrolimus) capsules (Astellas Pharma)
administered twice daily in de novo kidney transplant patients. These data
confirm the previous positive experience with LCP-Tacro? in stable kidney and
liver transplant patients and support comparability of LCP's extended release
tablet formulation of tacrolimus when compared to twice daily Prograf® capsules.
Further, the results indicate that LCP-Tacro? tablets may be safely and
efficaciously administered once daily immediately following a kidney transplant.

"We are very pleased with the results of the maintenance Phase 2 clinical trial
comparing LCP-Tacro? tablets administered once daily versus Prograf® capsules
administered twice daily in de novo kidney transplant patients. These results
are consistent with previous findings related to LCP-Tacro?,? said Dr. William
J. Polvino, President and CEO of LCP. He continued, "There is an enormous unmet
need to help improve transplant therapies, beginning with improving the delivery
of the gold standard anti-rejection therapy tacrolimus. This potential new
therapy continues to build on our commitment to the management of solid organ
rejection.?

Results from the 14 day pharmacokinetic (PK) portion of this Phase 2 study have
previously been reported in April 2009. After the initial 14 day PK period,
patients were maintained on either LCP-Tacro? or Prograf® for an additional 50
weeks to assess longer-term safety and efficacy in a comparative setting. While
not sized and powered to demonstrate safety and efficacy at a statistically
relevant level, once daily LCP-Tacro? appears to be as well tolerated as the
currently approved, immediate release, twice daily product Prograf®.

The Phase 3 development program for LCP-Tacro? consists of an ongoing,
fully-enrolled study in 326 patients with stable kidney transplants along with a
planned Phase 3 study in de novo kidney transplant patients. The latter study is
planned to enroll approximately 540 patients, and enrollment is expected to
begin later this quarter. The study protocol is currently in active review with
the US FDA through the Special Protocol Assessment (SPA) process.

Summary of LCP-Tacro? (de novo Kidney) Phase 2 Clinical Trial Design

The above Phase 2 clinical trial, which commenced enrollment in October 2008,
was an open-label, multi-center, prospective, parallel group study in de novo
kidney transplant patients. The objectives of the study were to determine the
pharmacokinetic profile (AUC0-24, Cmax, Cmin, and Tmax), safety and efficacy of
LCP-Tacro? tablets once daily versus Prograf® capsules twice daily. De novo
kidney transplant candidates who fulfilled all inclusion/exclusion criteria were
randomized to receive either LCP-Tacro? or Prograf® following their kidney
transplantation. A 24-hour pharmacokinetic (PK) profile assessment was performed
on Study Days 1, 7 and 14. Patients continued in the 50 weeks maintenance stage
of the study to evaluate the long-term safety and efficacy of LCP-Tacro? versus
Prograf®.

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: [email protected] Email: [email protected]

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 and reduced peak-to-trough variability when compared to Astellas
Pharma's Prograf®, a twice daily version of tacrolimus, marketed world-wide, and
its once daily version of tacrolimus, Advagraf®, marketed in some European
countries. 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 for months 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 product candidates in clinical trials 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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