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MEGASET Study demonstrated effectiveness and tolerability of MENOPUR® after ICSI in GnRH antagonist cycles
Read moreMEGASET 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 MEGASET1 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) treatment2,3. 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 problems4. 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 MEGASET1 (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 profile1,5 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
MENOPUR is a well-tolerated, 1,6 high quality and cost-effective7 treatment associated with higher live birth rate in IVF cycles compared with that seen for women treated with rFSH2,3. 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 more information, please contact
Tonic Life Communications
Jim Baxter
+44 (0) 7900 605 652
jim.baxter@toniclc.comor
Laura Craggs
+44 (0) 207 798 9900
laura.craggs@toniclc,comReferences
- 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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Positive phase III data unveiled for new GnRH blocker degarelix
Read morePositive phase III data unveiled for new GnRH blocker degarelix
Degarelix suppressed testosterone within three days in 96% of patients.
Milan, Italy – 27 March 2008 –
Data from a Phase III study presented at the 23rd Annual European Association of Urology Congress demonstrated that the investigational GnRH blocker, degarelix, produced a significant reduction in levels of testosterone1,2 within three days in more than 96% of study patients.2
The new data show that degarelix provided an extremely fast effect on testosterone levels, close to the immediate effect achieved with surgery (orchidectomy).2,3
The phase III study compared monthly administration of degarelix with monthly LHRH agonist leuprorelin’s 7.5 mg in a 12-month randomised, open-label, parallel-group study in prostate cancer (PCa) patients. In comparison to leuprorelin, degarelix suppressed serum testosterone and Prostate Specific Antigen (PSA) significantly faster. In addition, degarelix was able to sustain these low levels during the entire 12 month study.2
By day 3 of the study, testosterone levels were suppressed to ≤ 0.5ng/mL in 96.1% of patients in the degarelix arms of the study compared to 0% in the leuprorelin arm. By day 14, 100% of patients in the degarelix arms achieved suppression of testosterone levels at ≤0.5ng/mL compared to 18.2% in the leuprorelin arm.2
“Our goal is always to have a fast and sustained reduction in testosterone levels” said Mr John Anderson, Consultant Urological Surgeon, The Royal Hallamshire Hospital, Sheffield, United Kingdom “This new data shows that degarelix produced an extremely rapid impact, approaching the immediacy of surgery.”
After 14 days of treatment, PSA levels had declined in the degarelix treated patients by a median of 64%, while patients who were administered leuprorelin saw an 18% decline. Both treatments were well tolerated and showed similar side effect profiles.
“What patients want is a medical treatment which has the efficacy impact of orchidectomy but without its more distressing physical and psychological effects,” commented Dr Erik Briers, of patient organization Europa Uomo, Belgium. “A pharmaceutical treatment that could offer extremely rapid suppression of testosterone would be a very welcome addition to the options for men with prostate cancer.”
Degarelix went through an extensive clinical programme of more than 20 studies. All studies have found degarelix to be safe, well tolerated and with no evidence of systemic allergic reactions.2,4,5
– Ends –
Notes for editors
About Prostate Cancer
Prostate cancer is the most common form of cancer in men, and the second leading cause of cancer death. In the US 218,890 new cases were estimated for 2007, with a mortality rate of 27,050. In 2005 127,490 new cases were diagnosed in the 5 biggest European countries and 18,310 in Japan.
About degarelix
Degarelix is a GnRH blocker currently being developed for prostate cancer. Ferring submitted a New Drug Application (NDA) to the FDA and EMEA in February 2008.
About Ferring Pharmaceuticals
Ferring is a Swiss-based, research driven, speciality biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of urology, endocrinology, gastroenterology, gynaecology, and fertility. In recent years Ferring has expanded beyond its traditional European base and now has offices in over 40 countries. To learn more about Ferring or our products please visit www.ferring.com.
References
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- Van Poppel H, De La Rosette JJ, Persson B.E, Oleson TK, Degarelix Study Group; Long-term evaluation of degarelix, a gonadotrophin-releasing hormone (GnRH) receptor blocker, investigated in a multicentre randomised study in prostate cancer (CAP) patients. Abstract (23.) Euro Urol Suppl 2007;6(2):28.
- Boccon-Gibod L, Klotz L, Schröder FH, Andreou C, Persson BE, Cantor P, Jensen JK, Olesen TK; Degarelix compared to leuprolide depot 7.5 mg in a 12-month randomized, open-label, parallel-group phase III study in prostate cancer patients. Abstract 537 presented at the 23rd EAU Congress, Milan, Italy, 2008.
- Nielsen S, Connolly M, Persson B, Variation between countries in the perceived use of antiandrogens to prevent flare symptoms: results of a comprehensive survey. Abstract 539 presented at the 23rd EAU Congress, Milan, Italy, 2008.
- Gittelman M, Pommerville P, Persson B, Olesen T, One-year North American multicentre, randomized dose-finding study of degarelix, a gonadotropin-releasing hormone (GnRH) receptor blocker, in prostate cancer patients. Poster presented at 1st EMUC, Barcelona, 2-4 Nov 2007.
- Tammela T, Iversen P, Johansson J, Persson B, Jensen J, Olesen T.Degarelix-a phase II multicentre, randomised dose escalating study testing a novel GnRH receptor blocker in prostate cancer patients (Abstract No. 904) European Urology Supplements 4 (2005) No.3, pp 228.
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Degarelix, a novel GnRH blocker from Ferring, moves into phase III
Read moreDegarelix, a novel GnRH blocker from Ferring, moves into phase III
21st Annual Meeting of the European Association of Urology (EAU), Paris, 5th – 8th April 2006.
Treatment with degarelix results in fast, profound and sustained reductions in testosterone and prostate-specific antigen (PSA) levels without a testosterone surge
Paris, France – April 7, 2006 –
Following the presentation today of the results of the Phase IIb programme with degarelix in prostate cancer, which are in line with previous promising studies, Ferring Pharmaceuticals announced the immediate start of Phase III trials.1
The findings from the international multi-centre trial in 187 men showed that 100% of those treated with an initial dose of 240 mg and a maintenance dose of 160 mg achieved androgen deprivation from day 28 to the full year. Androgen deprivation achieves disease control in prostate cancer patients.
“Degarelix is one of the first drugs in the emerging novel GnRH blocker class of treatments for prostate cancer and represents a new option which builds on many years of experience with effective hormonal therapies,” commented Professor Hein Van Poppel of the Department of Urology at the University of Gasthuisberg. Leuven, Belgium. “The results from this trial indicate that degarelix offers a potentially fast, profound and sustained suppression of testosterone and PSA, the well-known marker for prostate cancer.”
“Prostate cancer is the second leading cause of cancer death among men and there is an ongoing need for better treatments,” explained Dr Bo-Eric Persson, Director, Medical Sciences, Urology / Oncology for Ferring Pharmaceuticals. “These results encourage us further that degarelix has the potential to answer some of these unmet needs in prostate cancer treatment.”
How degarelix works
Currently used hormonal treatments for prostate cancer include GnRH (gonadotrphin releasing hormone) agonists. Unlike degarelix, these therapies stimulate the natural hormone’s receptor on the pituitary gland. These agents also have a desired clinical effect, but they stimulate testosterone production before shutting it down. This initial stimulation of the receptors stimulates hormone-dependent tumour growth rather than inhibits it, and may lead to a worsening of cancer symptoms or ‘flare’.
Degarelix is designed to target and block the GnRH receptor. This rapidly prevents the production of testosterone and avoids the surge of testosterone and risk of flare.
Degarelix study findings
Degarelix was investigated in one multicentre, one-year study in Europe/South Africa. The study involved the evaluation of initiation doses of 200 mg and 240 mg administered subcutaneously followed by three maintenance doses 80, 120 and 160 mg given every 28 days. The therapeutic effect was assessed by measuring testosterone and prostate-specific antigen (PSA) levels. 187 patients (age 52-93, median 72 years) with histologically confirmed Prostate Cancer and PSA more than or equal to 2 ng/mL received degarelix subcutaneously every 28 days.
Among those initially treated with 240 mg of degarelix, testosterone levels of less than or equal to 0.5 ng/mL were achieved in 92% of patients at Day 3 and 95% of patients at Day 28 compared with 88% at Day 3 and 86% at Day 28 for those administered with a 200 mg dose.
From Day 28 until Day 364, 100% of patients receiving maintenance doses of 160 mg achieved testosterone levels of less than or equal to 0.5 ng/mL at each monthly visit, compared with 96% of those receiving 120 mg and 92% of those receiving maintenance doses of 80 mg.
No evidence of testosterone surge was detected. PSA levels were reduced by 90% 8 weeks after initiation of therapy, by 94% after 12 weeks and by 96% after 24 weeks of treatment.
About prostate cancer
Prostate cancer is the most common form of cancer in men, and the second leading cause of cancer death. In the US 197,800 new cases, 126,900 in the 5 biggest European countries and 30,400 new cases in Japan were estimated in 2003. In 2002 GLOBOCAN cancer database reported 542,909 new cases of prostate cancer diagnosed worldwide and 204,000 deaths due to this disease.
About Current Treatment Options for Prostate Cancer
Current therapeutic options include surgery, radiation therapy, hormonal manipulation therapy or a combination of these. The approach to treatment is influenced by the patient’s age, stage of cancer and co-existing medical problems, though no agreed treatment pathway exists and treatment patterns vary in different countries.
Several different hormonal approaches are available for prostate cancer including bilateral orchiectomy (surgical removal of the testicles), GnRH analogues and anti-androgens.
About GnRH blockers versus agonists
Naturally occurring GnRH binds to the GnRH receptor on cells in the pituitary gland, triggering the production of luteinising hormone (LH), which subsequently stimulates the production of testosterone. Both GnRH agonists and blockers bind to this same receptor target.
Agonists, however, work initially by stimulating release of LH and hence testosterone production meaning there is surge in testosterone at the start of treatment leading to characteristic flare responses in symptoms and tumour growth. Meanwhile blockers, like degarelix, directly prevent the release of LH, which means testosterone suppression is fast and profound without a surge. In addition, with blockers there is no need to administer a second hormonal agent, called an anti-androgen, normally used to combat the flare responses that accompany the GnRH agonist usage.
About degarelix
Degarelix is a GnRH blocker, a synthetic peptide modelled on the body’s own gonadotrophin-releasing hormone.
About Ferring Pharmaceuticals
Ferring is a Swiss-based research driven, speciality biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of endocrinology, gastroenterology, gynaecology, infertility and urology. In recent years Ferring has expanded beyond its traditional European base and now has offices in over 40 countries. To learn more about Ferring or our products please visit www.ferring.com.
For more information, please contact
Michael George
Corporate Communication Manager, Ferring Pharmaceuticals
+41 58 301 00 53
#CH3-CorporateCommunications@ferring.comReferences
- Van Poppel, de la Rosette, Persson, Jensen, Olesen, A one year, multicentre, randomised study of degarelix, a gonadotrophin-releasing hormone (GnRH) receptor block in prostate cancer patients. 21st Annual Meeting of the European Association of Urology (EAU), Paris, 5th – 8th April 2006.
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Degarelix, a new GnRH blocker from Ferring
Read moreDegarelix, a new GnRH blocker from Ferring
27th Congress of the Société Internationale d’Urologie, Hawaii, USA – October 5, 2004 –
Treatment with degarelix, a novel gonadotrophin-releasing hormone (GnRH) blocker, causes significant reductions in testosterone and prostate-specific antigen (PSA) levels.
The first results from trials of degarelix in patients were presented today. The new findings from a multi-centre, phase II trial in 129 men and conducted in the United Kingdom support positive results seen from earlier research on degarelix, and move it closer to phase III trials, say doctors involved in the study.
“Degarelix is one of the first drugs in an emerging, novel class of prostate cancer treatments, in a field where new options to treat tumours that are responsive to hormonal manipulation therapy are desperately needed,” commented Mr Philip Weston MCh FRCS (Urol), Consultant Urological Surgeon of Pinderfields Hospital in Wakefield, UK. “Degarelix potentially offers an alternative for these patients, as it may avoid both the drawbacks associated with traditional agonist therapy, such as the severe flare of disease and symptoms caused by the initial testosterone surge, and the permanence of surgical options.”
“Prostate cancer is the second leading cause of cancer death among men yet there is considerable dispute on when and how best to treat it. Consequently, there is an ongoing need for better treatments,” explained Dr Bo-Eric Persson, Director, Medical Sciences, Urology / Oncology for Ferring Pharmaceuticals, makers of the new compound. “We believe that degarelix has the potential to answer some of these unmet needs in prostate cancer treatment.”
How degarelix works
“The majority of tumours found in newly-diagnosed patients are dependent on testosterone for their continued growth and are linked to raised levels of PSA. Rapidly and directly blocking the body’s normal production of testosterone with degarelix may represent a value for the patients,” Dr Persson continued.
Currently used hormonal treatments for prostate cancer include GnRH agonists. Unlike degarelix, these therapies stimulate the natural hormone’s receptor on the pituitary gland. These agents also have a desired clinical effect, but they stimulate testosterone production before shutting it down. This initial stimulation of the receptors stimulate hormone-dependent tumour growth rather than inhibit it, and may lead to a worsening of cancer symptoms or flare.
Degarelix is designed to target and block the GnRH receptor. This rapidly prevents the production of testosterone and avoids the risk of flare.
New degarelix study findings
The effectiveness of degarelix in suppressing testosterone and reducing PSA levels was studied in the reported randomised, phase II study at 13 centres across the UK. The study compared the effectiveness and safety of three different dosing regimens of degarelix in 129 men with early and late-stage prostate cancer, who had an initial median PSA level of 61 ng/ml and were recommended as candidates for androgen (male hormone) deprivation therapy.
All three dosing schemes of degarelix had fast inhibitory effects on testosterone and PSA levels in a dose-dependent manner.
At the highest dose, 97.5 per cent of patients (n=32) experienced a reduction in testosterone to target levels of less than 0.5 ng/ml within three days of treatment. All the patients in this group reached target suppression levels within the first 28 days and this was sustained in 87.5 per cent of the patients on treatment through to the end of the six-month study period. Five weeks after initiation of treatment the median PSA-reduction in patients on treatment was 90 per cent compared to baseline.
There were no serious adverse events during treatment, however six (4.7 per cent) of the 129 patients withdrew from the study. The most frequently reported adverse reactions to therapy were associated with the drug’s intended action in decreasing secretion of testosterone.
“Degarelix may solve some key problems associated with currently available GnRH agonists and antagonists”, Dr Weston said. “In our study, injection with degarelix rapidly reduced levels of testosterone without the hormonal flare associated with GnRH agonists, and it maintained target levels, resulting in a fast decrease in PSA levels.”
In summary, the researchers conclude, “Results from additional, ongoing, dose ranging studies are required to define the optimal treatment regimen, but these results are extremely encouraging in taking degarelix forward to phase III clinical trials.”
Notes for editors
About Prostate Cancer
Prostate cancer is the second leading cause of cancer death in men in industrialized societies, accounting for around 1 in 6 male cancer-related deaths. It is currently only exceeded by lung cancer but, with the ageing population, is expected to overtake lung cancer within the next ten years. According to the American Cancer Society, in 2004, 230,000 men in the United States will be diagnosed.
Current Treatment Options for Prostate Cancer
Current therapeutic options include surgery, radiation therapy, hormonal manipulation therapy or a combination of these. The approach to treatment is influenced by the patient’s age and co-existing medical problems, though no agreed treatment pathway exists and treatment patterns vary in different countries. Several different hormonal approaches are available for prostate cancer including bilateral orchiectomy (surgical removal of the testicles), GnRH (gonadotrophin-releasing hormone) analogues and anti-androgens.
GnRH agonists versus blockers
Naturally occurring GnRH binds to the GnRH receptor on cells in the pituitary gland, triggering the production of luteinising hormone (LH), which subsequently stimulates the production of testosterone. Both GnRH agonists and blockers bind to this same receptor target.
Agonists work initially by stimulating release of LH and hence testosterone production, but blockers, like degarelix, directly prevent the release of LH, which means there is no surge in testosterone at the start of treatment leading to characteristic flare responses in symptoms and tumour growth. With blockers there is no need to administer a second hormonal agent, called an anti-androgen, normally used to combat the flare responses that accompany the GnRH agonist usage.
Degarelix
Degarelix is a synthetic peptide GnRH blocker, modeled on the body’s own gonadotrophin-releasing hormone.
About Ferring Pharmaceuticals
Ferring is a research driven, specialty biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of endocrinology, gastroenterology, gynaecology, infertility and urology.
In recent years Ferring has expanded beyond its traditional European base and now has operating subsidiaries in over 40 countries.
To learn more about Ferring or our products please visit us at www.Ferring.com.
For more information, please contact
Penny Whitecross / Pat Pearson
Ruder Finn UK Ltd
+44 207 462 8900 (direct)
+44 7796 990 815 (mobile)
pwhitecross@ruderfinn.co.ukReferences
-
- Weston PMT, Hammonds J, Vaughton et al. Degarelix; a novel GnRH antagonist tested in a multicenter, randomised dose-finding study in prostate cancer patients. 27th Congress of the Société Internationale d’Urologie, Hawaii, USA 3-7 October 2004. Podium presentation, 5 October.
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Ferring announces results demonstrating the efficacy and safety of follitropin delta for women undergoing in vitro fertilisation using an agonist protocol
Read moreFerring announces results demonstrating the efficacy and safety of follitropin delta for women undergoing in vitro fertilisation using an agonist protocol
- BEYOND is the first randomised controlled trial comparing efficacy and safety of follitropin delta (Rekovelle®) in a gonadotrophin-releasing hormone (GnRH) agonist versus antagonist protocol during first ovarian stimulation cycle for in vitro fertilisation (IVF)/ intracytoplasmic sperm injection (ICSI).1
- An additional estimated 1.3 oocytes were retrieved per woman in the agonist group vs. the antagonist group with similar safety.1
- These data further support physicians when an agonist protocol is indicated or preferred.
- BEYOND reinforces Ferring’s continuous commitment to science and adds to the robust body of clinical evidence on the efficacy and safety of follitropin delta.
Saint-Prex, Switzerland – 17 May, 2024: Ferring, a global biopharmaceutical company, today announced that Human Reproduction published results from the BEYOND trial. This is the first trial to compare individualised follitropin delta dosing using a GnRH agonist versus a GnRH antagonist protocol in women aged 18-40 years, with anti-Müllerian hormone (AMH) levels below 35 pmol/L who are undergoing their first ovarian stimulation cycle for IVF/ICSI.1
Results from this randomised, controlled, open-label, multicentre trial showed that a statistically significant mean difference of 1.3 extra oocytes (95% CI: 0.22; 2.40, p=0.0185) were retrieved for women using the GnRH agonist protocol versus women using antagonist protocol.1 Use of both GnRH agonist and antagonist protocols yielded similar results in safety.1 The results supported a European Medicines Agency (EMA) SmPC label update to include information on the use of follitropin delta using the GnRH agonist protocol.2
Follitropin delta is the only recombinant follicle-stimulating hormone (rFSH) for ovarian stimulation derived from a human cell line that uses individualised dosing calculated through an approved algorithm based on bodyweight and AMH.2 The BEYOND study was set up to address the gap in knowledge when administering a fixed daily dose of follitropin delta in a GnRH agonist protocol.1 Before BEYOND, there were no comparative randomised clinical trial data examining the efficacy and safety of individualised follitropin delta in a GnRH agonist protocol versus an antagonist protocol.1
“It’s important to have data that compares the efficacy and safety of both GnRH protocols, when tailoring a fixed-dose of follitropin delta to individual patients,” said Rita Lobo, M.D. ObGyn, Senior Medical Director, Global R&D and Reproductive Medicine, Ferring Pharmaceuticals. “The BEYOND results provide reassurance to physicians that they can safely prescribe either of the GnRH protocols to effectively tailor treatment strategies to the individual circumstances of each person going through IVF.”
Current European Society of Human Reproduction and Embryology (ESHRE)3 international guidelines recommend the general use of GnRH antagonist protocols over GnRH agonist protocols for ovarian stimulation, given comparable efficacy and better safety profile.4 However for predicted poor responders, GnRH antagonists and GnRH agonists are equally recommended.4 In clinical practice, GnRH agonist protocols can be preferred when there is a need to schedule treatments and during ovulation induction, such as when a patient needs to avoid a weekend oocyte retrieval.5
“The BEYOND trial showcases our continued commitment to science, aimed at pioneering advancements and ongoing evidence generation to support individuals on their personal journeys to build families and live better lives,” said Julia Hoover, Global Franchise Head of Reproductive Medicine, Ferring Pharmaceuticals.
The BEYOND1 study results add to the existing data from the ESTHER6, STORK7 and GRAPE8 randomised clinical trials and the real word evidence PROFILE9 study, addressing the efficacy and safety of follitropin delta across a broad range of patients.
About the BEYOND study
BEYOND was a European-based, multi-centre, randomized, controlled, open-label, parallel-group trial comprised of 437 randomised subjects (435 treated) aged 18-40: 220 subjects randomised to the GnRH agonist protocol (n= 220) and 215 subjects randomised to the GnRH antagonist protocol (n=215). The trial covered the first controlled ovarian stimulation cycle and post-trial activities covered pregnancy follow-up to live birth and 4 weeks after birth. Women 18-40 years old with AMH less than or equal to AMH 35 pmol/L and body mass index (BMI) 17.5-32.0 kg/m2 were enrolled at 16 specialist reproductive health clinics in Austria, Denmark, Israel, Italy, the Netherlands, Norway and Switzerland and were undergoing their first IVF/ISCI cycle. Half of participants had unexplained infertility (fertility with no apparent cause).
The primary endpoint was the number of oocytes retrieved. The main secondary and safety endpoints were the total follitropin delta dose and the number of stimulation days; the proportion of subjects with cycle cancellation due to poor ovarian response or excessive ovarian response; blastocyst number and quality on Day 5 after oocyte retrieval; proportion of subjects with blastocyst transfer cancellation due to risk of ovarian hyperstimulation syndrome (OHSS); pregnancy rates; frequency and intensity of adverse events; proportion of participants with either early or late OHSS of moderate/severe grade10 and the proportion of subjects with late OHSS (including OHSS of moderate/severe grade). The pre-specified post-trial endpoints comprised live birth rate and neonatal health.
Adverse drug reactions
The overall proportions of participants experiencing adverse events and serious adverse events were similar in both the agonist and antagonist treatment groups. A total of 13 participants discontinued from the trial due to an adverse event, comprising 5/202 participants (2.5%) in the GnRH agonist group (COVID-19 infection, n=1; OHSS, n=4) and 8/204 participants (3.9%) in the antagonist group (increased progesterone, n=1; adnexal torsion, n=1; endometrial disorder, n=1; hydrometra, n=1; uterine polyp, n=1). All AEs leading to discontinuation occurred after completion of ovarian stimulation but resulted in fresh blastocyst transfer cancellation.
About GnRH protocols
Gonadotrophin-releasing hormone (GnRH) agonists and antagonists are used as concomitant treatment during ovarian stimulation to prevent premature luteinisation and ovulation for IVF/ICSI.11,12
About follitropin delta (Rekovelle)
Follitropin delta is a human cell line-derived rFSH with an approved dosing algorithm designed for a predictable ovarian response.2 It is the first rFSH derived from a human cell line (PER.C6® cell line). Follitropin delta is structurally and biochemically distinct from other existing rFSH gonadotrophins.2,13 Follitropin delta is approved in certain markets for use in controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART), such as IVF or ICSI cycle. The individualised dosing of follitropin delta is determined using an approved algorithm, based on a woman’s AMH level and body weight.2,6 AMH is a biomarker used to assess ovarian reserve and can help predict ovarian response.6,14 The follitropin delta dose should be based on AMH level, measured using the ELECSYS AMH Plus immunoassay from Roche, the ACCESS AMH Advanced from Beckman Coulter, or LUMIPULSE G AMH from Fujirebio.2 Follitropin delta is approved in certain markets for use.
About Ferring Pharmaceuticals
Ferring Pharmaceuticals is a privately owned, research-driven, specialty biopharmaceutical group committed to building families and helping people live better lives. We are leaders in reproductive medicine and maternal health, and in areas of gastroenterology and urology. We are at the forefront of innovation in microbiome-based therapeutics and uro-oncology intravesical gene therapy. Ferring was founded in 1950 and employs more than 7,000 people worldwide. The company is headquartered in Saint-Prex, Switzerland, and has operating subsidiaries in more than 50 countries which markets its medicines in over 100 countries.
Learn more at www.ferring.com, or connect with us on LinkedIn, Instagram, YouTube, Facebook and X (Twitter).
References
- Lobo R, Soerdal T, Ekerhovd E et al. “BEYOND: A Randomized Controlled Trial Comparing Efficacy and Safety of Individualized Follitropin Delta Dosing in a GnRH Agonist Versus Antagonist Protocol During the First Ovarian Stimulation Cycle.” Human Reproduction, 2024, deae092. https://doi.org/10.1093/humrep/deae092
- Follitropin Delta (Rekovelle) Summary of Product Characteristics. Date of publication 2017. Approved on 12 December 2016 and last updated on the EMA website in October 2023. Available from https://www.ema.europa.eu/en/medicines/human/EPAR/rekovelle [Accessed May 2024].
- European Society of Human Reproduction and Embryology (ESHRE) Reproductive Endocrinology Guideline Group. (October 2019). Ovarian Stimulation for IVF/ICSI. ESHRE Reproductive Endocrinology Guidelines.
- Ovarian Stimulation, The ESHRE Guideline Group On et al. “ESHRE guideline: ovarian stimulation for IVF/ICSI†.” Human reproduction open vol. 2020,2 hoaa009. 1 May. 2020, doi:10.1093/hropen/hoaa009
- Feichtinger M, Karlström PO, Olofsson JI, et al. Weekend-free scheduled IVF/ICSI procedures and single embryo transfer do not reduce live-birth rates in a general infertile population. Acta Obstetricia et Gynecologica Scandinavica 2017;96: 1423-1429.
- Andersen, A. N., Nelson, S. M., Fauser, B. et al. (2017). Individualized versus conventional ovarian stimulation for in vitro fertilization: A multicenter, randomized, controlled, assessor-blinded, phase 3 noninferiority trial. Fertility and Sterility, 107(2), 387-396.
- Ishihara O, Arce JC, Japanese Follitropin Delta Phase 3 Trial G. Individualized follitropin delta dosing reduces OHSS risk in Japanese IVF/ICSI patients: a randomized controlled trial. Reprod Biomed Online. 2021 May;42(5):909-18. PubMed PMID: 33722477. Epub 2021/03/17.
- Qiao J, Zhang Y, Liang X, et al. A randomised controlled trial to clinically validate follitropin delta in its individualised dosing regimen for ovarian stimulation in Asian IVF/ICSI patients. Hum Reprod. 2021 Jun 28;36(9):2452-62. PubMed PMID: 34179971. Epub 2021/06/29.
- Blockeel C, Griesinger G, Rago R, et al. Prospective multicenter non-interventional real-world study to assess the patterns of use, effectiveness and safety of follitropin delta in routine clinical practice (the PROFILE study). Frontiers in Endocrinology. 2022 Dec 22;13:992677. PMID: 36619578.
- Golan A, Ron-el R, Herman A, et al. Ovarian hyperstimulation syndrome: an update review. Obstet Gynecol Surv 1989;44: 430-440.
- Lambalk CB, Banga FR, Huirne JA, et al. GnRH antagonist versus long agonist protocols in IVF: a systematic review and meta-analysis accounting for patient type. Hum Reprod Update 2017;23: 560-579.
- Toftager M, Bogstad J, Lossl K, et al. Cumulative live birth rates after one ART cycle including all subsequent frozen-thaw cycles in 1050 women: secondary outcome of an RCT comparing GnRH-antagonist and GnRH-agonist protocols. Hum Reprod 2017;32: 556-716 567.
- Olsson H, Sandstrom R, Grundemar L. Different pharmacokinetic and pharmacodynamic properties of recombinant follicle-stimulating hormone (rFSH) derived from a human cell line compared with rFSH from a non-human cell line. J Clin Pharmacol. 2014 Nov;54(11):1299-307. PubMed PMID: 24800998. Epub 20140521.
- Meczekalski, B et al. “Fertility in women of late reproductive age: the role of serum anti-Müllerian hormone (AMH) levels in its assessment.” Journal of endocrinological investigation vol. 39,11 (2016): 1259-1265. doi:10.1007/s40618-016-0497-6
For more information, please contact
Amy Cheshire
Director, Corporate Communications
Amy.Cheshire@ferring.comSamara Barr
Senior Account Manager, Syneos Health Communications
Samara.Barr@syneoshealth.com -
Ferring announces abstract of the first prospective, multi-national, real-world study of Rekovelle® (follitropin delta) at the congress of the Pacific Society for Reproductive Medicine
Read moreFerring announces abstract of the first prospective, multi-national, real-world study of Rekovelle® (follitropin delta) at the congress of the Pacific Society for Reproductive Medicine
- PROFILE is the first prospective, multi-national, observational, real-world study of Rekovelle in clinical practice, conducted in more than 940 women from 10 countries across Europe, North America and Australia.
- This study provides evidence of the effectiveness of Rekovelle across a broad range of patients in a real-world clinical setting and supports its efficacy and safety profile, as previously demonstrated in randomised controlled trials (RCTs).1-4
- In the study, 74.0% of patients had between 4 and 19 oocytes retrieved and the ongoing pregnancy rates were similar to Phase 3 RCTs.1-3
- Rekovelle is the only recombinant follicle-stimulating hormone (rFSH) for ovarian stimulation (OS) that uses individualised dosing calculated through an approved algorithm based on bodyweight and anti-Müllerian hormone (AMH) levels.
Saint-Prex, Switzerland – Tuesday, 14th March – Today, an oral poster of the first post-authorisation Phase 4 real-world study, PROFILE, is being presented at the 13th Congress of the Pacific Society for Reproductive Medicine (PSRM) 2023 in Australia. The large, prospective, multi-national study confirms the effectiveness and safety of Rekovelle in routine clinical practice, with ongoing pregnancy rates similar to Phase 3 RCTs.1-3,5 The study was first published in Frontiers of Endocrinology in December 2022.5
The PROFILE study enrolled 944 women who had not previously undergone in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI). Results highlighted that with Rekovelle, almost three-quarters (74.0%) of women had between 4-19 oocytes retrieved and 255 women (27.0%) achieved an ongoing pregnancy at 10-11 weeks after transfer. The ongoing pregnancy rate was similar to the rates observed in the Phase 3 RCTs.1–3 The first cycle cumulative ongoing pregnancy rate after fresh and/or frozen transfer was 36.4%. The research also showed a 3.9% incidence of ovarian hyperstimulation syndrome (OHSS), with most cases of OHSS being of mild to moderate intensity, (n=30 [3.2%]) and all participants with OHSS made a full recovery.5
“Up to now, we have more than 2,000 patients in the RCTs for Rekovelle – ESTHER-1 and -2, GRAPE and STORK trials – but these had strict inclusion and exclusion criteria. Real-world data extends efficacy and safety data to all patients. In fact, in PROFILE there were nearly no restrictions other than that the participants were seeking to become pregnant, had no contraindications to rFSH, and had not previously undergone ovarian stimulation,” said Professor Christophe Blockeel, from Brussels IVF, the Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel and Vrije Universiteit Brussel, who was the principal investigator of the PROFILE study.
In countries where it is licensed, Rekovelle is the only rFSH for OS that has an individualised fixed daily dose calculated using an approved algorithm based on bodyweight and levels of AMH. AMH is a biomarker used to predict ovarian response.6 In PROFILE, physicians used the Rekovelle dosing algorithm for nearly all participants (95%), although some made minor adjustments to the prescribed starting dose or adjusted the dose during OS based on clinical factors. Adverse drug reactions (ADRs) were monitored for all initiated OS cycles, and the number of ADRs leading to treatment and study discontinuation was low (n=4).
“Ferring is committed to building healthy families of every shape and size by developing innovative fertility treatments. We are committed to seeking insights throughout the research and development of our treatments, so it is therefore encouraging to see that in an observational study of real-world clinical practice, Rekovelle confirmed its effectiveness through ongoing pregnancy rates, similar, or higher than RCTs,” said Christina Lloyd, Senior Vice President and Head of Reproductive Medicine and Maternal Health, Ferring Pharmaceuticals.
About the PROFILE study
In the PROFILE study (Prospective multicentre non-interventional study to assess the patterns of use of Rekovelle in women undergoing in vitrO Fertilisation or Intracytoplasmic sperm injection procedures in routine clinicaL practicE), 1,258 women were screened between March 2018 and October 2020, and 1,013 met the inclusion and exclusion criteria. A total of 944 participants initiated their first OS cycle at 34 specialist fertility clinics across Australia, Austria, Belgium, Canada, Germany, Italy, Netherlands, Poland, Spain and UK in which Rekovelle is licensed. The primary endpoint was the real-world treatment patterns of follitropin delta, including starting daily dose, number of days of treatment, deviations from the approved dosing schedule as per the summary of product characteristics (per-label), use of dosing algorithm, and use of other treatments during OS, such as GnRH protocol, triggering methods of follicle maturation and luteal phase support. Secondary endpoints included cycle cancellations, pregnancy outcomes for Cycle 1, and OHSS and other ADRs for all initiated cycles. Participants could initiate up to three OS cycles with Rekovelle; however, utility and effectiveness data were only analysed for Cycle 1 as the study was terminated early due to the COVID-19 pandemic, during which many fertility clinics closed or provided reduced services.
Real-World Utilisation Patterns of Rekovelle
The study aimed to observe the real-world utilisation patterns, effectiveness, and safety profile of follitropin delta in women ≥18 years naïve to OS undergoing IVF or ICSI. According to the data collected during the study, most participants received Rekovelle as specified in the approved label without dose deviations. In PROFILE, nearly all patients (95%) had their starting dose calculated using the algorithm, although some physicians then made minor adjustments to the prescribed starting dose during the OS cycle based on clinical factors. “We wanted to know if physicians are really using the dosing algorithm, and the answer is yes, the vast majority did. I think this really reflects how Rekovelle is being used in the real world and physicians are using the algorithm in those countries where it is approved,” said Professor Blockeel. In PROFILE, the mean total dose of follitropin delta was slightly higher than observed in randomised clinical trials, reflecting differences in bodyweight and AMH levels of the participants.1-5 The PROFILE study had no enrolment restrictions for bodyweight or AMH levels, and the overall study population had a higher mean bodyweight and had lower or comparable median AMH levels than the RCT cohorts.1-3,5
Adverse Drug Reactions
ADRs were monitored for all initiated OS cycles (1,130 cycles for 944 participants). Forty-nine participants (5.2%) reported 58 ADRs. The number of ADRs leading to treatment and study discontinuation was low (four participants experiencing six ADRs: OHSS, n=2 events; vomiting, n=1 event; headache, n=1 event; rash, n=1 event and premature ovulation, n=1 event). The most frequent ADR was any grade of ovarian hyperstimulation syndrome (OHSS; n=37 [3.9%]), which was similar to the incidence of OHSS in the Rekovelle arm during the first cycle of the RCT ESTHER-1 (3.5%).1 In the PROFILE study, most cases of OHSS were of mild or moderate intensity (n=30 [3.2%]) and all participants with OHSS made a full recovery.
About Rekovelle (follitropin delta)
Rekovelle is a human rFSH with an approved dosing algorithm designed for a predictable ovarian response.7 It is the first rFSH derived from a human cell line (PER.C6® cell line). Rekovelle is structurally and biochemically distinct from other existing rFSH gonadotrophins.7, 8 Rekovelle is approved in certain markets for use in OS for induction of the development of multiple follicles in women undergoing assisted reproductive technologies (ART), such as IVF or ICSI. The individualised dosing of Rekovelle is determined using an approved algorithm, based on a woman’s AMH level and body weight.7-9 AMH is a biomarker used to assess ovarian reserve and can help predict ovarian response.6 The Rekovelle dose should be based on AMH level, measured using the ELECSYS AMH Plus immunoassay from Roche, the ACCESS AMH Advanced from Beckman Coulter, or LUMIPULSE G AMH from Fujirebio.7 Rekovelle is not approved in all markets.
About Ferring Pharmaceuticals
Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group committed to helping people around the world build families and live better lives. Headquartered in Saint-Prex, Switzerland, Ferring is a leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology. Ferring has been developing treatments for mothers and babies for over 50 years and has a portfolio covering treatments from conception to birth. Founded in 1950, privately-owned Ferring employs over 7,000 people worldwide. The company has operating subsidiaries in more than 50 countries and markets its products in over 100 countries.
Learn more at www.ferring.com, or connect with us on Twitter, Facebook, Instagram, LinkedIn and YouTube.
References
- Nyboe Andersen A, Nelson SM, Fauser BC, Garcia-Velasco JA, Klein BM, Arce JC, et al. Individualized versus conventional ovarian stimulation for in vitro fertilization: a multicenter, randomized, controlled, assessor-blinded, phase 3 noninferiority trial. Fertil Steril. 2017 Feb;107(2):387-96 e4. PubMed PMID: 27912901. Epub 2016/12/04.
- Qiao J, Zhang Y, Liang X, Ho T, Huang HY, Kim SH, et al. A randomised controlled trial to clinically validate follitropin delta in its individualised dosing regimen for ovarian stimulation in Asian IVF/ICSI patients. Hum Reprod. 2021 Jun 28;36(9):2452-62. PubMed PMID: 34179971. Epub 2021/06/29.
- Ishihara O, Arce JC, Japanese Follitropin Delta Phase 3 Trial G. Individualized follitropin delta dosing reduces OHSS risk in Japanese IVF/ICSI patients: a randomized controlled trial. Reprod Biomed Online. 2021 May;42(5):909-18. PubMed PMID: 33722477. Epub 2021/03/17.
- Bosch E, Havelock J, Martin FS, Rasmussen BB, Klein BM, Mannaerts B, et al. Follitropin delta in repeated ovarian stimulation for IVF: a controlled, assessor-blind phase 3 safety trial. Reprod Biomed Online. 2019 Feb;38(2):195-205. PMID: 30594482. Epub 2018/12/14.
- Blockeel C, Griesinger G, Rago R, Larsson P, Sonderegger YLY, Rivière S, et al. Prospective multicenter non-interventional real-world study to assess the patterns of use, effectiveness and safety of follitropin delta in routine clinical practice (the PROFILE study). Frontiers in Endocrinology. 2022 Dec 22;13:992677. PMID:
- Arce JC, La Marca A, Mirner Klein B, Nyboe Andersen A, Fleming R. Antimullerian hormone in gonadotropin releasing-hormone antagonist cycles: prediction of ovarian response and cumulative treatment outcome in good-prognosis patients. Fertil Steril. 2013 May;99(6):1644-53. PubMed PMID: 23394782. Epub 2013/02/12.
- Follitropin Delta (Rekovelle) Summary of Product Characteristics. Date of publication 2016. Approved on 12 December 2016 and last updated on the EMA website in March 2022. Available from https://www.ema.europa.eu/en/medicines/human/EPAR/rekovelle [Accessed March 2023].
- Olsson H, Sandstrom R, Grundemar L. Different pharmacokinetic and pharmacodynamic properties of recombinant follicle-stimulating hormone (rFSH) derived from a human cell line compared with rFSH from a non-human cell line. J Clin Pharmacol. 2014 Nov;54(11):1299-307. PubMed PMID: 24800998. Epub 20140521.
- Arce JC, Andersen AN, Fernandez-Sanchez M, Visnova H, Bosch E, Garcia-Velasco JA, et al. Ovarian response to recombinant human follicle-stimulating hormone: a randomized, antimullerian hormone-stratified, dose-response trial in women undergoing in vitro fertilization/intracytoplasmic sperm injection. Fertil Steril. 2014 Dec;102(6):1633-40 e5. PubMed PMID: 25256937. Epub 2014/09/27.
For more information, please contact
Amy Cheshire
Director, Corporate Communications
+44 (0) 7442 272229
Amy.Cheshire@ferring.comSamara Barr
Account Manager, Syneos Health Communications PR Europe
+44 (0)7935 076261 (mobile)
Samara.Barr@syneoshealth.com -
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Urology & Uro-oncology
Read moreUrology & uro-oncology
Ferring is committed to the development of medicines to treat urological disorders such as diabetes insipidus, enuresis and nocturia. Ferring’s lead product in this area is MINIRIN® (desmopressin) which effectively treats enuresis in children and nocturia in adults. A vasopressin receptor agonist designed to bring additional treatment benefits in this therapy area is in early stage development.
For the treatment of patients with advanced prostate cancer, Ferring has launched a 1-month dosing regimen of FIRMAGON® (degarelix), a gonadotropin-releasing hormone (GnRH) receptor antagonist, in the US, Europe and through a partner in Japan. We are conducting clinical studies to further demonstrate the benefits of therapy using a (GnRH) receptor antagonist in the treatment of advanced prostate cancer.
Discover more about bladder cancer,
prostate cancer, bedwetting and nocturia
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Our products
Read moreCARBETOCIN FERRING (carbetocin, room temperature-stable formulation) CHORAGON® / BREVACTID® (u-hCG) GONAPEPTYL® / DECAPEPTYL® daily (triptorelin acetat) ENDOMETRIN® / LUTINUS® (progesterone) ENDOMETRIN®/ LUTINUS® (progesterone) – Status Update LUTREPULSE® / LUTRELEF® (gonadorelin acetate) MENOPUR® / MENOGON® / REPRONEX® (HP-hMG) MENOPUR® (menotropins for injection) – Status Update NORPROLAC® (quinagolide hydrochloride) PABAL® / DURATOCIN® / LONACTENE® / DURATOBAL® (carbetocin) PROPESS® / CERVIDIL® (dinoprostone) REKOVELLE® TRACTOCILE® (atosiban) -
Ferring Announces Recipients of Innovation Grants Program 2017-2018
Read moreFerring Announces Recipients of Innovation Grants Program 2017-2018
Saint-Prex, Switzerland – 26 January, 2018 –
Ferring Pharmaceuticals today announced the recipients of the 2017-2018 Innovation Grants Program, an annual initiative of the Ferring Research Institute (FRI) based in San Diego. This global program supports research in the fields of reproductive medicine and women’s health, urology, gastroenterology, hepatology, and endocrinology.
“The quality of applications received in response to the 2017-2018 Ferring Innovation Grants call for proposals was outstanding. We have funded programs that we believe represent the leading edge of research in their therapeutic fields, and very much look forward to seeing the outcome of the innovative projects proposed by this year’s grant awardees,” said Keith James, President Ferring Research Institute, Senior Vice President Research and Development.
Now in its fifth year, the Innovation Grants Program received 300 submissions. Each submission was reviewed for its scientific merit, and a short list of finalists were invited to submit more detailed applications for consideration. A total of 13 projects were chosen to receive grant funding from Ferring this year. In addition to the United States, projects have been funded in Canada, the United Kingdom, Australia, and Portugal. This year’s recipients, together with the grant titles, are:
- Stéphane Bolduc – CHU de Québec – Université Laval Research Center
Identify protein(s) secreted by urothelial cell carcinoma (UCC) involved in modification of tumor-associated stroma by activation of Cancer-Associated Fibroblasts (CAF).
- Marcello Costa – Flinders University
Enteric neuropeptides modulation of colonic motility in health and disease
- Warren Foster – McMaster University
Evaluation of a novel therapeutic intervention for the management of endometriosis in a mouse model
- Andrew Horne – University of Edinburgh
Targeting TGFβ-1 with an extracellular peptide inhibitor to treat women with peritoneal endometriosis
- Joseph Hurt – University of Colorado School of Medicine
Adiponectin receptor regulation of myometrial contractility suggests novel therapeutic targets to augment uterine quiescence and prevent preterm birth
- Ursula Kaiser – Brigham and Women’s Hospital, Harvard Medical School
Differential modulation of LH and FSH by GnRH analogs for improved treatment of reproductive disorders
- Sarah Marshall – Monash University
Exploring novel therapies for preeclampsia: the role of soluble prorenin receptor on vasculature function
- Kathryn Meier – Washington State University
FSH receptor as a therapeutic target in prostate cancer
- Victor Navarro – Brigham and Women’s Hospital, Harvard Medical School
Targeting the Kappa Opioid Receptor to Regulate LH Pulses in PCOS Patients
- Willis Samson – Saint Louis University School of Medicine
A Novel Ligand (Adropin) – Receptor (GPR19) Handshake: Implications for the Control of Growth Hormone Secretion
- John Taylor – Kansas University Medical Center
The Role of d-Dopachrome Tautomerase in Bladder Cancer Tumorigenesis
- Suraj Unniappan – University of Saskatchewan
- Nesfatin-1 and Nesfatin-1 Like Peptide Regulation of Growth and Stress Hormones: Novel Targets for Endocrine Diseases
- Henrique Veiga-Fernandes – Champalimaud Foundation
Activation of type 3 Innate Lymphoid Cells and innate IL-22 secretion via RET signaling for Inflammatory Bowel Disease treatment
About Ferring Pharmaceuticals
Ferring Pharmaceuticals is a research-driven, speciality biopharmaceutical group committed to helping people around the world build families and live better lives. Headquartered in Saint-Prex, Switzerland, Ferring is a leader in reproductive medicine and women’s health, and in specialty areas within gastroenterology and urology. Ferring has been developing treatments for mothers and babies for over 50 years. Today, over one third of the company’s research and development investment goes towards finding innovative and personalised healthcare solutions to help mothers and babies, from conception to birth. Founded in 1950, Ferring now employs approximately 7,000 people worldwide, has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries.
Learn more at www.ferring.com and @Ferring, or connect with us on Facebook and LinkedIn.
About Ferring Research Institute Inc
Located in San Diego, California Ferring Research Institute Inc. (FRI) is a global therapeutics research center for Ferring Pharmaceuticals. FRI is committed to delivering a pipeline of innovative therapies which improve the lives of patients in the areas of reproductive medicine and women’s health, urology, gastroenterology and hepatology.
For more detailed information please visit www.ferring-research.com.
For more information, please contact
Lindsey Rodger
Senior Manager, Corporate Communications
+41 58 451 40 23 (direct)
+41 79 191 0486 (mobile)
lindsey.rodger@ferring.comBhavin Vaid
Head of Corporate Communications
+41 58 301 09 52 (direct)
+41 79 191 06 32 (mobile)
bhavin.vaid@ferring.com - Stéphane Bolduc – CHU de Québec – Université Laval Research Center
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