r-FSH biosimilar meets primary endpoint in phase III pivotal study
Burgdorf, Switzerland, June 6 th , 2012 – FINOX Biotech (Finox AG) announced today that the pivotal phase III study (FIN3001) with AFOLIA, a biosimilar recombinant Follicle Stimulating Hormone (r-FSH), in patients undergoing assisted reproduction technology (ART), has met its primary endpoint.
AFOLIA demonstrated clinical and statistical equivalence to the reference product, Gonal-f ® . Equivalence was defined by retrieving similar numbers of oocytes during a standard treatment duration of 10 to 16 days with a fixed dose of r-FSH. The equivalence margins required that the difference in the number of oocytes retrieved not exceed ±2.9 oocytes. Results prove that AFOLIA is “biosimilar” to Gonal-f ® : the number of oocytes retrieved were 11.3 in the AFOLIA group, compared to 10.8 in the Gonal-f ® group. The treatment difference was 0.52 with a 95%CI of -0.81 to 1.79. The pre-defined equivalence margin was met.
Anjan Selz, Chief Executive Officer of FINOX Biotech commented: "I am extremely pleased with the outstanding FIN3001 results. We will be working with the Health Authorities to make this valuable biosimilar medicine available to ART patients as soon as possible. Submission of the registration dossier to the European Health Authorities is expected by the fourth quarter of 2012."
About the FIN3001 study FIN3001 is an assessor-blinded, multicenter, phase III study including a total of 410 patients in a 2:1 randomization scheme in favor of AFOLIA. The treatment effect and the safety profile of AFOLIA in controlled ovarian stimulation is compared to the widely used reference medicine, Gonal-f ® .
Secondary endpoints included the number of days treated with FSH, the total dose of FSH received, the quality of oocytes retrieved, the quality of embryos transferred and other important clinical parameters for ART. The results from the secondary endpoints were also similar in both treatment groups.
About the safety and tolerability of AFOLIA Both treatment groups showed a similar safety profile. The safety data set comprised 410 patients (randomized 2:1), who received at least one dose of study treatment. Mean exposure to study treatment was identical in both treatment groups. AFOLIA in this patient population was well tolerated. The number of adverse events reported and patients discontinuing treatment due to adverse events was very similar between the two groups.
About AFOLIA AFOLIA is a new “biosimilar” medicine: an almost exact copy of the originator product that was produced using recombinant DNA technology. Both AFOLIA and the reference product Gonal-f ® are formulations of the naturally occurring hormone FSH, which plays a key role in human reproduction. AFOLIA is the result of a targeted drug development process aimed to replicate as closely as possible the reference product. AFOLIA has a number of key beneficial characteristics. i.e. equivalent clinical efficacy and safety vs. Gonal-f ® , but using a substantially more attractive injector device. The AFOLIA injector pen is a single-use, one-a-day disposable device, which avoids the complications of a multi-use pen. The self-injection process is reduced to only three steps, which enhances ease-of-use and patient acceptance.
About AFOLIA in other clinical development programs FINOX Biotech has agreed with the US-FDA via a Special Protocol Assessment to conduct a pivotal phase III study (FIN3002) for registration of AFOLIA in the USA. A US IND application has been filed.
About FINOX Biotech FINOX Biotech (FINOX AG) is a biopharmaceutical company with its corporate headquarters in Burgdorf, Switzerland. Finox’ first product will be AFOLIA, a biosimilar r-FSH of Gonal-f ® . Currently, FINOX Biotech identifies partners to market AFOLIA in Europe, USA and other regions of the world. The company was founded in 2007 with the vision to develop biosimilars positively differentiated through dedicated devices. Product development and industrialization is realized within a network of specialized western European partners.
For further information please visit www.finox.ch or contact our CEO, Anjan Selz (firstname.lastname@example.org / 0041 79 434 91 00) FINOX Biotech / Technikumstrasse 2 / 3401 Burgdorf / Switzerland
Posted: June 2012