Company Announcement no. 9/2011



To: NASDAQ OMX Copenhagen A/S Hørsholm,
Denmark, June 21, 2011



LifeCycle Pharma Announces Positive Phase III Results: LCP-Tacro(TM) Trial in
Stable Kidney Transplant Patients Meets all Primary Efficacy and Safety
Endpoints


-- LCP-Tacro™ dosed once a day successfully met the primary efficacy end point
compared to Prograf® dosed twice a day
-- LCP-Tacro™ demonstrated a trend towards lower Rejection Rates as determined
by Central Blinded Pathology reading
-- Similar safety and tolerability profiles were demonstrated across both
groups in the study
-- The results were achieved with significantly lower doses of LCP-Tacro™
compared to Prograf®
-- Conference call to discuss the results will be hosted on June 21 at 3pm
CEDT (9am EDT)


LifeCycle Pharma A/S (OMX:LCP) today reported that the company's lead product
candidate, LCP-Tacro™, successfully demonstrated non-inferiority compared to
tacrolimus (Prograf®; Astellas Pharma) in its Phase III trial, Study 3001. The
Phase III Open-label conversion (switch) study in 326 stable kidney transplant
recipients, with Prograf® as the comparator, met its primary efficacy and
primary safety endpoints.


“The results we have seen in this large Phase III study demonstrate that
LCP-Tacro™ allows for patients to be successfully converted from Prograf® to
LCP-Tacro™ at a lower dose and with once-daily convenient dosing,” said Dr.
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., “These data suggest that LCP-Tacro™ may
potentially offer an improvement in outcomes, as well as improved convenience
for our transplant patients due to the once-a-day dosing.”


LCP-Tacro™ demonstrated very good efficacy and a trend toward lower rejection
rates


The primary efficacy endpoint for the study was a comparison between once-daily
sustained-release LCP-Tacro™ and twice-daily immediate-release Prograf®. The
composite primary endpoint comprised Biopsy-Proven Acute Rejection (BPAR,
microscopic evidence of rejection), graft loss (return to dialysis or need for
re-transplant), death and loss to follow-up. BPAR was assessed by both local
and central pathologists blinded with regard to treatment assignment. In the
primary analysis (local pathology for BPAR), the treatment failure rate at
Month 12 for the composite endpoint was 2.5% (4 total treatment failures) for
both LCP-Tacro™ and Prograf®. The 95% confidence interval for the treatment
difference was +/- 4.2%; well within the protocol pre-specified non-inferiority
margin of +9.0%. In the secondary analyses (central blinded pathology for BPAR)
the treatment failure rate during the study, including follow ups, for the
composite endpoint was 2.5% for LCP-Tacro™ and 4.9% for Prograf®. As measured
by the central blinded pathologist, the rates of BPAR were 0.6% for LCP-Tacro™
and 3.1% for Prograf® (p=0.214).

Safety profile positive and lower dose required


The primary safety analyses were the differences between LCP-Tacro™ and
Prograf® treatment groups at Month 12 (Day 360) with respect to the incidence
of adverse events (AEs) and the incidence of predefined potentially clinically
significant laboratory measures including: fasting plasma glucose; platelet
count; white blood cell (WBC) count; aminotransaminases; total cholesterol; low
density lipoprotein (LDL) cholesterol; triglycerides; and estimated glomerular
filtration rate (eGFR). In all instances, there were no statistically
significant differences between the two treatments. More LCP-Tacro™ patients
discontinued the study than Prograf® patients. There was no consistent pattern
to the types of events leading to discontinuation.


In addition, the study results demonstrated that LCP-Tacro™ patients, on
average, required a daily dose that was 20% lower than patients receiving
Prograf®, reflecting the improved absorption provided by LCP's proprietary
MeltDose® formulation.


William Polvino, President & Chief Executive Officer of LifeCycle Pharma said,
“We are very pleased with the results of this Phase III study which means that
yet another important milestone has been reached on the way to obtaining
marketing authorization for LCP-Tacro™. Further confirmatory testing is
underway in LCP's second Phase III study in the de novo kidney transplant
setting, Study 3002. Study results are expected from this second study by the
end of 2012 with regulatory submissions planned in the US and EU in the first
quarter of 2013.”


Large market potential


There are estimated to be 165,000 patients in the US alone living with kidney
transplants. Global sales of immunosuppressants for organ transplantation
exceed $5bn., with Prograf® the market leader with global sales in 2010 of
$2bn. Currently no once-a-day primary immunosuppressant is approved in the US
market. LCP holds the global rights for LCP-Tacro™.


Data presentation and conference call information


The full study results from this LCP-Tacro™ switch study are planned for
presentation at an upcoming scientific meeting. Future announcement will be
made regarding the specific scientific forum. LCP will host a conference call
at 3pm CEDT (9am EDT) today, June 21, 2011, to comment on the results of this
study.


To participate in the call, please dial:

Denmark Toll Free 8088 8464; Denmark Local Call 3272 7625

USA Toll Free 1 866 966 9439; USA Local Call 1 631 510 7498

Conference ID 77191357

The conference call can also be viewed as a live webcast. The link to the
webcast will be posted on the home page of the Company's Website at
www.lcpharma.com.


For more information, please contact:



LifeCycle Pharma A/S John Weinberg, M.D.
William J. Polvino, M.D. SVP, Commercial Operations & Investor
President & CEO Relations
Phone DK: +45 20 21 48 06 Phone: +1 908 304 3389
Phone US: +1 917 647 9107 Email: [email protected]
Email: [email protected]
Anja Leschly
VP, Human Resources and
Communication
Phone: + 45 2055 3818
Email: [email protected]



About LifeCycle Pharma A/S (LCP)

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.


LCP on June 15 announced that it will be holding an Extraordinary General
Meeting on July 7 to approve a resolution to change the company's name to
Veloxis Pharmaceuticals A/S.


For further information, please visit www.lcpharma.com.


Forward-looking statement safe-harbor

All statements other than statements of historical facts included in this
announcement are forward-looking statements that are subject to certain risks,
trends and uncertainties that could cause actual results and achievements to
differ materially from those expressed in such statements. These risks, trends
and uncertainties are in some instances beyond our control. Words such as
“anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “will” and
other similar expressions identify forward-looking statements, although not all
forward-looking statements contain these identifying words. In particular, any
statements regarding clinical trial results and potential regulatory approval
for LCP-Tacro™ are considered forward-looking statements. These forward-looking
statements involve substantial risks and uncertainties and are based on our
assessment and interpretation of the currently available data and information,
current expectations, assumptions, estimates and projections about our business
and the biopharmaceutical and specialty pharmaceutical industries in which we
operate. Important factors that may affect our ability to achieve the matters
addressed in these forward-looking statements include, but are not limited to
whether the results of our Phase 3 clinical trials of LCP-Tacro™ meet the
predetermined endpoints for such trial; our ability to complete the development
of, obtain regulatory approval for, and commercialize, LCP-Tacro™; our ability
to hire and retain personnel in a competitive industry; our reliance on third
parties to manufacture LCP-Tacro™ and to conduct clinical trials for
LCP-Tacro™; competition from existing therapies and therapies that are
currently under development, including Prograf® (tacrolimus), Advagraf®
(tacrolimus), and belatacept; whether we are able to obtain additional
financing, if needed; risks of maintaining protection for our intellectual
property; risks of an adverse determination in intellectual property
litigation; and risks associated with stringent government regulation of the
biopharmaceutical industry. We may not actually achieve the plans, intentions
or expectations disclosed in our forward-looking statements, and you should not
place undue reliance on our forward-looking statements, which speak only as of
the date hereof. Actual results or events could differ materially from the
plans, intentions and expectations disclosed in the forward-looking statements
that we make. We do not have a policy of updating or revising forward-looking
statements and, except as required by law, assume no obligation to update any
forward-looking statements.

210611 LCP Announces Positive Phase III results.pdf