Lutate, (177Lutetium_DOTA0-Tyr3-Octreotate), is a radiolabeled somatostatine analog which selectively targets somatostatine receptors which are over-expressed in tumor cells and destroys them through the delivered radiation.
The objective of the study, which will recruit about 300 patients and 40 clinical centres in Europe and US, is to evaluate the efficacy and safety of Lutate versus the standard treatment.
Lutate has been shown to be an effective and safe treatment for GEP-NETs in an investigator sponsored clinical study at the Erasmus Medical Center, Rotterdam, Netherlands, where over 600 patients have been treated with this innovative radiopharmaceutical. The study showed Lutate extended patients’ lives by between 3.5 and six years in comparison to current treatments, including chemotherapy. It was also shown to significantly improve quality of life, as measured by a number of function and symptom scales, especially in patients with proven tumor regression.
Lutate has been granted Orphan Drug status by both the FDA and EMEA, which gives it protection from competition for seven years in the US and 10 years in Europe following approval.
“We are very excited to have been selected as partner of choice for AAA in support of this important clinical trial and we look forward to a successful collaboration” said Luigi Visani, Chief Executive Officer of Pierrel Research. “This important project underlines the strong competitive advantages that Pierrel Research, through its unique combination of medical, regulatory, operational and technological expertise, offers to pharmaceutical & biotechnology companies, delivering real partnerships and a risk sharing approach.”
Stefano Buono, Chief Executive Officer of AAA, said: “This is a significant milestone for AAA. Lutate is a highly promising new radiopharmaceutical and is the lead product in AAA’s development portfolio of promising radiotherapy products. We look forward to working with Pierrel Research as we move the compound towards registration. We anticipate that the Colleretto Giacosa site and a second potential facility for the production of Lutate and other Radio Metabolic Therapies at the IRST (Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori) in Meldola, Italy, would be able to produce sufficient quantities of Lutate to meet European demand, as well as developing new drugs”.
Pierrel SpA is an Italian publicly traded (PRL.MI) pharmaceutical services company with global operations throughout Europe and in the US. Pierrel S.p.A., a global provider to the pharmaceutical and life science industries, specialized in Clinical Research (Contract Research), pharmaceutical production Contract Manufacturing) and development, registration and licensing of new drugs or formulations (Pierrel Pharma), is listed in the Italian Stock Exchange market. The Pierrel Group enjoys over 60 years experience in the pharmaceutical sector and is one of the main European manufacturers of local and dental anaesthetic drug products. The CRO division, Pierrel Research, with over 20 subsidiaries, operates both in Europe and USA, providing consultancies and full services for research and development of new molecules and drug products. The manufacturing plant in Capua, near Naples (Italy), has been authorized by FDA for the production of sterile small volumes parental drugs. Pierrel Pharma has recently obtained the NDA approval of its dental anaesthetic Orabloc® in Canada, USA and Russia. Pierrel S.p.A Corporate office is located in Milan, Italy.
Pierrel Research International AG, is a global contract research organization with over 20 subsidiaries and operates both in Europe and the USA, providing consultancy and full services for the research and development of new molecules and drug products. It is a wholly owned subsidiary of Pierrel S.p.A.
Advanced Accelerator Applications (www.adacap.com) is a European Pharmaceutical Group founded in 2002 to develop innovative diagnostic and therapeutic applications and products. AAA’s main research focus is in the field of Molecular Imaging and Therapy of the individual patient with a serious disease (the so-called Personalized Medicine). AAA is a European leader in the production and commercialization of PET (Positron Emission Tomography) radiopharmaceuticals. AAA currently has 10 production and R&D facilities in five countries (France, Italy, Switzerland, Spain and USA) and 147 employees. For the year ending December 31, 2010, AAA reported sales of € 27.4 million, EBITDA of € 6.5 million*, total assets of € 80 million and shareholders’ equity of € 38.7 million.
*not included in EBITDA are IFRS 2 charges of €1M, i.e. share-based payments to AAA employees
Per ulteriori informazioni:
Pierrel S.p.A.
Investor Relator
Dott. Aurelio Matrone
Email: investor.relations@pierrelgroup.com
tel. +39 02 2413491
fax +39 02 24134201
Image Building
Media Relations
Simona Raffaelli, Emanuela Borromeo, Camilla Castaldo
E-mail: pierrel@imagebuilding.it
Tel. 02/8901.1300
AAA
Veronique Mermet
E-mail: info@adacap.com
Tel. +33 4 50 99 30 70
Twister communications group
Anna Lisa Bassi, abassi@twistergroup.it
Elisa Piacentino, epiacentino@twistergroup.it
Tel. 02/4348114.602
