Company Announcement no. 26/2007
To: OMX Nordic Exchange Hørsholm, Denmark, November 7, 2007
LifeCycle Pharma Announces Positive Results From Head-to-Head Clinical Trial of
LCP-Tacro Versus Advagraf® For the Prevention of Organ Rejection After
Transplantation
Data Shows LCP-Tacro Has Superior Profile When Compared to Advagraf, Currently
Marketed in a few European Countries by Astellas Pharma as a Once-A-Day
Formulation of Tacrolimus
Hørsholm, Denmark, November 7, 2007; LifeCycle Pharma A/S (OMX: LCP) (the
“Company” or “LCP”), an emerging specialty pharmaceutical company, today
announced results from a Phase I head-to-head clinical trial comparing
LCP-Tacro, the Company's lead product candidate being developed as a once-daily
tablet version of tacrolimus, to Advagraf, currently marketed in a few European
countries as a once-daily capsule version of tacrolimus. The results confirm
that with LCP-Tacro, the Company is developing an improved version of tacrolimus
when compared to both Advagraf and Prograf®, the latter being the world's
leading drug for immunosuppression following organ transplantation.
The Phase I head-to-head clinical trial, designed as a multi-dose trial,
enrolled 19 healthy volunteers. Clinical data confirmed that LCP-Tacro, when
compared to Advagraf, demonstrated:
* Approximately 50% higher bioavailability
* Flatter product profile, (i.e. a lower Cmax/Cmin, or peak-to-trough, ratio)
*In other words, the difference in blood plasma concentration when measured
at the highest and the lowest points is less when compared to Advagraf
* Potential for administration at lower daily doses
“The results of this head-to-head clinical trial represent yet another
breakthrough for LCP as we continue to demonstrate LCP-Tacro's superiority to
both Prograf and Advagraf,” said Dr. Flemming Ornskov, President and CEO of
LifeCycle Pharma. “The data from this Phase I clinical trial is consistent with
the Phase I clinical trial data we witnessed for LCP-Tacro when compared to
Prograf, now in Phase II for the prevention of organ rejection after kidney
transplantation. We have every reason to believe that the clinical data that
supports LCP-Tacro's superior profile when compared to Prograf is reproducible
and we will also demonstrate a superior profile to Advagraf,” added Dr. Ornskov.
"The results from LCP's head-to-head trial are excellent and promising for
transplant patients and physicians world-wide," commented Dr. Sundaram Hariharan
of the Medical College of Wisconsin, Milwaukee WI, USA. "The clinical data
reported by LCP to date support the Company's objective of developing an
improved version of tacrolimus. LCP-Tacro's once-a-day profile will provide ease
of administration leading to greater patient compliance and its better
bioavailability could ultimately lead to lower daily dosing. All these
challenges exist with current approved medications for solid organ
transplantation."
The results of this study come less than two weeks after LCP announced positive
interim Phase II clinical trials results for LCP-Tacro in stable kidney
transplant patients, which confirmed a superior profile of a once-a-day tablet
formulation and higher bioavailability when compared to Prograf, also currently
marketed worldwide by Astellas Pharma as a twice-a-day capsule formulation.
While the Company's current regulatory filings do not contain additional
protocols to compare LCP-Tacro to Advagraf, the Company may conduct subsequent
studies once LCP-Tacro enters Phase III clinical trials and pending Advagraf's
broader geographic availability.
About LCP-Tacro & Tacrolimus
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
when compared to both Astellas' twice daily version of tacrolimus (Prograf
worldwide) and its prolonged-release version of tacrolimus (Advagraf in Europe).
Clinical trials have demonstrated that LCP-Tacro has a superior profile and is
expected to provide significant improvements for the 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 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. Management of the tacrolimus levels is
complicated by the low bioavailability of Prograf, its variable absorption and
interaction with food and other drugs. The current market size for
immunosuppressants used in transplantation in the 7 major markets (US, Japan,
France, Germany, Italy, Spain and UK) is approximately $3.3B and is estimated to
grow by approximately 5-10% per year.
About LifeCycle Pharma A/S (“LCP”)
LCP is an emerging specialty pharmaceuticals company that, through innovative
technologies, is able to rapidly develop a portfolio of differentiated products
to meet the unique needs of key therapeutic markets and patient populations.
This includes products for immunosuppression, specifically organ
transplantation, and to combat certain cardiovascular diseases. By using its
unique and patented delivery technology, MeltDose®, LCP is able to develop drugs
with enhanced absorption and thereby increased bioavailability. Currently, the
Company has a diversified near- and medium-term pipeline, including a product
ready for US commercialization, four product candidates in clinical trials and
four in preclinical stages of development. LCP is listed on the OMX Nordic
Exchange under the trading symbol (OMX: LCP). For further information, please
visit www.lcpharma.com.
Contact:
Flemming Ornskov
President and CEO
+45 (24) 20 03 68; (917) 288-6446
Michael Wolff Jensen
EVP and CFO
+45 4074-6244; MWJ@lcpharma.com
Francesca M. DeMartino
Director, Investor Relations & Corporate Communications
(917) 747-4938; FDM@lcpharma.com
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LifeCycle Pharma Announces Positive Results From Head-to-Head Clinical Trial of LCP-Tacro Versus Advagraf®
| Source: Veloxis Pharmaceuticals A/S
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