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

HORSHOLM, Denmark, June 21, 2011 /PRNewswire/ -- 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, U.S.A., "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 3 p.m. CEDT (9 a.m. EDT) today, June 21, 2011, to comment on the results of this study.

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.

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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.

SOURCE LifeCycle Pharma A/S