LifeCycle Pharma Submits the Phase 3 Protocol for LCP-Tacro™ (de no kidney) to the FDA

Company Announcement no. 24/2009

To: NASDAQ OMX Copenhagen                 Hørsholm, Denmark, December 23, 2009 

LifeCycle Pharma Submits the Phase 3 Protocol for LCP-Tacro™ (de no kidney) to
the FDA 

LifeCycle Pharma A/S (OMX:LCP)  announced today that LCP has submitted the
phase 3 protocol for LCP-Tacro™ in de novo kidney transplant recipients to the
Food and Drug Administration in United States (“FDA”). LCP will review the
protocol with the Agency and expects that enrollment of patients will begin
near the middle of 2010.  The upcoming Phase 3 study in de novo kidney
transplant patients will run in parallel with LCP's current ongoing Phase 3
study in stable kidney transplant patients. 

About the LCP-Tacro (de novo Kidney) Phase 3 Clinical Trial Design
The Phase 3 clinical trial is planned as a multi-center, prospective, parallel
group study in de novo kidney transplant patients. De novo kidney transplant
candidates are planned to be randomized to receive either LCP-Tacro™ or
Prograf® following their kidney transplantation. As per regulatory
requirements, a traditional composite endpoint consisting of death, graft
failure, biopsy-proven acute rejection or loss to follow up at 12 months after
randomization will be the primary efficacy outcome. 

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. 

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 typically are obliged to make frequent visits
to the hospital for monitoring and dose adjustments for months after receiving
a new organ. 

About Solid Organ Transplant Rejection
The prophylactic treatment of transplant allograft rejection is a major
significant segment of the worldwide immunosuppressive market for which sales
of Prograf® in 2008 were approximately USD 1.9 billion (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 70 33 33 00	Phone: + 45 20 55 38 17
Email: wjp@lcpharma.com	Email: PSK@lcpharma.com

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