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MEGASET Study demonstrated effectiveness and tolerability of MENOPUR® after ICSI in GnRH antagonist cycles

New study completes a missing piece of the fertility treatment jigsaw

Stockholm, Sweden, Wednesday 6 July 2011 - New data1, presented today at the European Society of Human Reproduction and Embryology (ESHRE) meeting, demonstrated the efficacy and tolerability of MENOPUR® (highly purified menotropin) in the Gonadotropin Hormone Releasing Hormone (GnRH) antagonist setting using the infertility treatment technique known as ICSI (Intracytoplasmic Sperm Injection). Results from the MEGASET 1 study reinforce the views of fertility experts and provide additional evidence that MENOPUR is effective in all types of assisted reproduction technology (ART) and fertility treatment protocols, completing a missing piece of the fertility treatment jigsaw.

For some years there has been strong evidence of the efficacy of MENOPUR in IVF using long GnRH agonist protocols, including superior live birth rates compared to recombinant follicle-stimulating hormone (rFSH) treatment 2, 3. However, until now, limited data has been available on the benefits of MENOPUR in GnRH antagonist and ICSI cycles. Current trends in ART are moving toward ICSI as a preferred technique, which is particularly useful in combating male infertility problems 4. As such, the new MEGASET data add an additional piece to the fertility treatment puzzle as the study was carried out using ICSI technique for fertilisation and stimulation with a GnRH antagonist protocol.

"These results reinforce clinical opinion about the efficacy and tolerability of MENOPUR, and enhance our understanding of effective fertility treatment options" explained Pr Anders Nyboe Andersen, Head of the Fertility Clinic at Copenhagen University Hospital. He continued, "Previous studies have demonstrated that MENOPUR is a high quality and efficient product when used in IVF, and the results from MEGASET will strengthen these perceptions".

The MEGASET 1 (MENOPUR in GnRH Antagonist Cycles with Single Embryo Transfer) study was initiated as a randomised, multicentre study, and was designed to demonstrate non-inferiority compared to rFSH with respect to ongoing pregnancy rates. The study demonstrated that controlled ovarian stimulation with MENOPUR in a GnRH antagonist protocol gave ongoing pregnancy rates comparable to those achieved with recombinant follitropin beta.

MEGASET recruited women undergoing fertility treatment and compared the efficacy and safety of two different types of ART: highly purified menotropin (MENOPUR, N=374) and rFSH (Puregon, N=375).

MENOPUR was demonstrated to be non-inferior to rFSH with respect to ongoing pregnancy rate for both the intention to treat (ITT) - participants who were randomised and exposed to the investigational medicinal product - and the per protocol (PP) - all participants except those who were excluded because of a major protocol deviation - populations in a GnRH antagonist protocol. The ongoing pregnancy rate was 30% with MENOPUR and 27% with recombinant FSH for the PP population (95% CI of difference: -3.8; 9.8) and 29% and 27% respectively for the ITT population (95% CI of difference: -4.2; 8.6).

In addition, MEGASET revealed that subcutaneous injections of MENOPUR in a new multi-dose formulation have a good safety profile 1, 5 and are associated with good local tolerability in patients undergoing controlled ovarian stimulation.

"Around one in seven couples have fertility problems, and infertility can have a profoundly distressing and devastating impact. However, excellent results can be achieved in treating infertility if patients are rapidly investigated and referred for appropriate treatment" explained Sandra Dill, iCSi international patient coalition. "These data will hopefully provide additional information, clarity and confidence to couples navigating the often confusing assisted conception landscape".

MENOPUR is a well-tolerated, 1, 6 high quality and cost-effective 7 treatment associated with higher live birth rate in IVF cycles compared with that seen for women treated with rFSH 2, 3. It belongs to a class of drugs known as gonadotrophins and contains both FSH (follicle stimulating hormone) and hCG-driven (human chorionic gonadotrophin) LH-activity (luteinizing hormone). MENOPUR is used to stimulate the development of multiple follicles in women participating in an ART programme. MENOPUR is also used to treat infertility in women caused by anovulation (no development of follicles and no ovulation). MENOPUR is used by approximately half a million patients each year and is currently licensed in 97 countries across the world.

About Ferring Pharmaceuticals
Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of reproductive health, urology, gastroenterology and endocrinology. Ferring's fertility portfolio of treatments gives infertile couples the chance to have babies and includes its flagship brand MENOPUR (HP-hMG), a recognised high quality treatment for infertility. Ferring has operating subsidiaries in over 45 countries. To learn more about Ferring or our products please visit www.ferring.com.

- ENDS -

For further information, please contact:
Tonic Life Communications
Jim Baxter
Tel: +44 (0) 7900 605 652
email: jim.baxter@toniclc.com
Laura Craggs
Tel: +44 (0) 207 798 9900
email: laura.craggs@toniclc,com



 Nyboe Andersen A., A. Pellicer A., Devroey P., Arce J.C. Randomised trial (MEGASET) comparing highly purified menotropin and recombinant FSH in a GnRH antagonist cycle with single blastocyst transfer. O-296 ESHRE 2011
  Platteau P, Nyboe Andersen A, Loft A, Smitz J, Danglas P, Devroey P. Highly purified HMG versus recombinant FSH for ovarian stimulation in IVF cycles. Reprod Biomed Online 2008;17(2): 190-198Al-Inany HG, Abou-Setta
  AM, Aboulghar MA, Mansour RT, Serour GI. Highly purified hMG achieves better pregnancy rates in IVF cycles but not ICSI cycles compared with recombinant FSH: a meta-analysis. Gynecol Endocrinol 2009;25(6):372-8.
  Palermo G, Joris H, Devroey P, Van Steirteghem AC. Pregnancies after intracytoplasmic injection of single spermatozoon into an oocyte. Lancet 1992;340(8810):17-8
  Helmgaard L., Klein B.M., Arce J.C. Twice-daily assessments of the local tolerability associated with a new MENOPUR multi-dose formulation during controlled ovarian stimulation. Oral communication Andersen and local tolerability poster P-299  ESHRE 2011
  European and Israeli Study Group on Highly Purified Menotropin versus Recombinant Follicle-Stimulating Hormone. Efficacy and safety of highly purified menotropin versus recombinant follicle-stimulating hormone in in vitro fertilization/intracytoplasmic sperm injection cycles: a randomized, comparative trial. Fertil Steril 2002;78(3): 520-528.
  Lloyd A, Kennedy R, Hutchinson J, Sawyer W. Economic evaluation of highly purified menotropin compared with recombinant follicle stimulating hormone in assisted reproduction. Fertil Steril 2003: 80(5): 1108-1113.

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