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LifeCycle Pharma To Initiate Phase II Clinical Trial Of LCP-Tacro For Organ Transplantation

July 27, 2017

Summary: LifeCycle Pharma will initiate a Phase II clinical trial of LCP-Tacro for the prevention of organ rejection in kidney transplant patients following the update of its initial Investigational New Drug Application (IND) in the United States (U.S.)

LifeCycle Pharma has also reached protocol agreement with the U.S. Food and Drug Administration (FDA) for its first Phase II trial in kidney transplant recipients.

LifeCycle Pharma A/S (OMX:LCP) today announced it will initiate a Phase II clinical trial program using LCP-Tacro to prevent organ rejection in kidney transplant patients. The clinical trial protocol has been reviewed by the FDA, and LifeCycle Pharma has revised it to be in line with FDA recommendations. As a result, LifeCycle Pharma expects to initiate a Phase II clinical trial soon.

The trial is designed as a conversion study in stable kidney transplant recipients, with patients being switched to LCP-Tacro once-a-day from Prograf(R) twice-a-day. Up to 60 patients will be investigated at 10-12 sites in the U.S. and Canada, and the initial clinical trial results are expected by year end 2007, or early 2008. This study is considered to form the basis for initiation of a subsequent Phase III program in de-novo kidney transplant recipients.

A Phase II clinical study in liver transplant recipients is expected to follow this year.

"The initiation of the Phase II study using LCP-Tacro is a step forward in the development of our organ transplantation franchise," said Dr. Flemming Ornskov, President and CEO of LifeCycle Pharma. "We are encouraged by the progress LifeCycle Pharma has made, and eager to advance LCP-Tacro to Phase II clinical trials," added Dr. Ornskov.

"This is the start of an exciting clinical development program. LCP-Tacro will bring the convenience of once-daily administration of tacrolimus and may optimize outcomes after kidney transplantation," said Dr. Shamkant Mulgaonkar, Chief of the Transplant Division at St. Barnabas Healthcare System, Livingston, New Jersey, USA and a clinical investigator in the first Phase II study.

About transplantation and kidney transplantation:

In order to prevent the patient's immune system from rejecting the transplanted organ, immunosuppression therapy is required for the lifetime of the graft in conjunction with a base maintenance drug and adjunctive therapies. In 2005, over 50,000 solid organ transplants were conducted in seven major markets (U.S., Japan, France, Germany, Italy, Spain, and the United Kingdom). The number of transplant patients waiting for organs is expected to continue to outpace the number of organs available. The current market size for immunosuppressants used in transplantation in the seven major markets is approximately $3.3bn, and is estimated to grow by approximately 5-10% per year.

Kidney transplantation is normally recommended for patients with end-stage kidney disease or kidney failure caused by severe, uncontrolled hypertension, diabetes, infections, intoxication, or inflammation.

Kidney transplants account for approximately 60% of all transplants performed annually in the seven major markets, and kidney transplants generally offer the best outlook for patients with end-stage kidney disease. Most centers have patient and organ survivals of over 90% at one year, and more than 80% at three years. Approximately 50% of transplanted kidneys are still functional after 10 to 15 years.

About LCP-Tacro:

Tacrolimus is a leading immunosuppressive medication to prevent rejection after organ transplantation. LCP-Tacro is being developed as a once-daily tablet version of tacrolimus, with improved bioavailability and reduced variability; compared to both Astellas' twice daily version of tacrolimus (Prograf(R)), and its modified-release version of tacrolimus for organ transplants. This is expected to represent significant improvements for patients.

Transplant patients need to maintain a minimum level of tacrolimus in the blood to prevent organ rejection, but too high levels increase the risk of serious side effects such as, kidney damage or hypertension. Therefore, tacrolimus levels need to be managed carefully. Transplant patients are typically obliged to make frequent visits to the hospital for monitoring and dose adjustments for months after receiving a new organ. Management of the tacrolimus levels is complicated by the low bioavailability of Prograf, its variable absorption, and its interaction with food and other drugs.

About LifeCycle Pharma A/S:

LifeCycle Pharma, headquartered in Horsholm, Denmark, is an emerging pharmaceutical company with a broad and late stage product pipeline in therapeutic areas of cholesterol management, hypertension, organ transplant and autoimmune diseases. LifeCycle Pharma's proprietary technology platform, MeltDose(R) technology, offers lower dosing, reduced side effects and improved safety and patient compliance, as well as reduced product development time and development costs. LifeCycle Pharma is listed on the OMX Nordic Exchange under the trading symbol (LCP). Please visit lcpharma for further information about LifeCycle Pharma A/S.

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