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

or
Laura Craggs
+44 (0) 207 798 9900
laura.craggs@toniclc,com
References

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
Positive 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 testosterone^1,² 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

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
Degarelix, a novel GnRH blocker from Ferring, moves into phase III

21^st Annual Meeting of the European Association of Urology (EAU), Paris, 5^th – 8^th 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.com
References

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
Degarelix, 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.uk
References

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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PRESS RELEASE 2023
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
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
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 13^th 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.^1–3The 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.com

Samara Barr
Account Manager, Syneos Health Communications PR Europe
+44 (0)7935 076261 (mobile)
Samara.Barr@syneoshealth.com

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Product pipeline

Product pipeline

Through our pipeline, we are researching life-changing medicines that make birth, life and living possible.

Reproductive Medicine & Maternal Health

Title description	Indication	Phase 1	Phase 2	Phase 3	Phase 4
Evalute the effect of carbetocin on the QT/QTc interval in healthy subjects (TQT phase)	Postpartum haemorrhage	✓
ADAM: Assessment of follitropin delta efficacy and safety for treatment of men with idiopathic infertility	Idiopathic male infertility		✓
Rekovelle India: Multicentre trial in India comparing the efficacy and safety of follitropin delta with follitropin alfa in controlled ovarian stimulation in women undergoing ART	Infertility			✓
BEYOND (phase completed): Compare the efficacy and safety of individualised follitropin delta dosing, using a long GnRH agonist protocol and GnRH antagonist protocol in women undergoing controlled ovarian stimulation	Infertility			✓
ADAPT: Assessment of conventional dosing in women undergoing ART with follitropin delta treatment	Infertility				✓

Urology & Uro-oncology

Title description	Indication	Phase 3	Phase 4
Evaluate the safety and efficacy of Adstiladrin administered intravesically to Japanese subjects with high grade BCG-unresponsive non-muscle invasive bladder cancer	High-risk non- muscle invasive bladder cancer (HR NMIBC)	✓
Adstiladrin early utilisation and outcomes in the real-world setting in the U.S. Non-interventional real-world study	High-risk non- muscle invasive bladder cancer (HR NMIBC)		✓
Post-authorisation observational cohort safety study of hyponatraemia and cardiovascular and thromboembolic events in nocturia patients treated with Nocdurna	Nocturia		✓
Non-interventional, observational PAP data-based study to investigate the post-marketing safety by intensive monitoring of Firmagon in Chinese patients (phase completed)	Prostate cancer		✓

Gastroenterology & Microbiome

Title description	Indication	Phase 1	Phase 4
Explore the safety and clinical effectiveness of Rebyota administered by colonoscopy to adults with recurrent Clostridioides difficile infection	Recurrent Clostridioides difficile infection	✓
Pragmatic randomised controlled study of mesalazine and budesonide to assess the effectiveness of two patient management strategies in mild to moderate ulcerative colitis	Ulcerative colitis	✓
Evaluate the safety and tolerability of Rebyota (microbiota suspension) in subjects with recurrent Clostridioides difficile infection	Recurrent Clostridioides difficile infection		✓
Observational study of Rebyota for the prevention of recurrence of Clostridioides difficile infection in adult patients	Recurrent Clostridioides difficile infection		✓
Non-interventional study to describe the safety of Picolax (phase completed)	Bowel preparation		✓

Urology & Uro-oncology

Urology & Uro-oncology

We are developing medicines and researching early stage treatments as part of our sustained commitment to specialty innovation.

Urology & uro-oncology

Urology & 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.

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prostate cancer, bedwetting and nocturia

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Ferring has developed a wide range of innovative treatments to change the lives of people and families around the world.

Reproductive Medicine & Maternal Health

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MENOPUR^® (menotropins for injection) – Status Update

Menopur^® (menotropins for injection) – Status Update

08 May 2023 – Ferring Pharmaceuticals is committed to providing safe and effective treatments for patients.

Where applicable and in accordance with feedback received from health authorities, Ferring has resumed shipments of Menopur® in the United States and other countries.

Ferring suspended shipments after the company was made aware of changes in the manufacturing process of the drug substance for Menopur.

Ferring notified national health authorities and – as a precautionary measure – suspended all shipments of Menopur* (all presentations).

Data reviewed by Ferring to date indicates that the safety and efficacy of the product remains unaltered. Ferring is not aware of any evidence indicating that the changes in the manufacturing process pose any risks to patients.

Ferring understands the importance of Menopur to our patients, physicians, and customers and sincerely regrets any inconvenience caused by the supply disruption.

For global medical enquiries contact Ferring at GlobalMedical@ferring.com. For U.S. medical enquiries call 1-888-FERRING (1-888-337-7464), or email MedQueriesUS@ferring.com.

*Menopur, Merapur, Menogon HP, Menotrophin Ferring, HMG injection, Menotropin

ENDOMETRIN^®/ LUTINUS^® (progesterone) – Status Update

ENDOMETRIN^®/ LUTINUS® (progesterone) – Status Update

5 December 2023 – Ferring Ferring Pharmaceuticals has initiated a voluntary and precautionary recall of ENDOMETRIN^® / LUTINUS^® (progesterone) vaginal tablet 100 mg batches in the United States, Canada, Japan, Saudi Arabia, and Turkey.

This action follows detection of Burkholderia bacteria in four unreleased batches of ENDOMETRIN / LUTINUS during final quality control conducted by the contract
manufacturing organization. The recall does not apply to the existing supply in other countries because they have not received batches within the scope of the recall.

Ferring is working with the contract manufacturing organization to determine the root cause and implement corrective measures. While deeper investigations then initially planned are ongoing, production remain suspended. The temporary drug shortage is expected to last until end of Q2 2024. The temporary drug shortage will, in varying degrees, impact approximately 20 countries worldwide.

Multiple alternative progesterone products are available from other manufacturers. Patients with questions should consult with their healthcare provider.

At this time, Ferring has no evidence suggesting that the safety or efficacy of the recalled batches has been impacted. Further, it should be emphasized that Burkholderia was not detected in any of the recalled batches.

Ferring Pharmaceuticals is committed to providing safe and effective treatments for patients. We understand the importance of ENDOMETRIN / LUTINUS to patients, and we sincerely regret any inconvenience caused by this supply disruption.

CARBETOCIN FERRING (carbetocin, room temperature-stable formulation)

CARBETOCIN FERRING (carbetocin, room temperature-stable formulation)

CARBETOCIN FERRING (carbetocin, room-temperature stable formulation) is Ferring’s long-acting, oxytocin analogue that is used to prevent uterine haemorrhage due to postpartum uterine atony.

CARBETOCIN FERRING is intended for use by Health Care Professionals only and is administered via a single intravenous or intramuscular injection as soon as possible after delivery of the infant and preferably before the delivery of the placenta. CARBETOCIN FERRING is contraindicated for use in pregnancy and labour before delivery of the infant, induction or augmentation of labour, serious cardiovascular disorders, epilepsy, renal or hepatic disorders, hypersensitivity to carbetocin, oxytocin or any of the excipients according to the composition.

Please note that product information presented on this website is intended only as a brief summary for the visitor’s convenience in relation to the activities of the Ferring Group. Not all products or indications are licensed in every country and may be subject to further local variations.

For specific product information please consult the summary of product characteristics (SmPC) or the patient information leaflet. For advice on medical issues please consult your local medical practitioner.

To know more about Ferring’s commitment to reduce maternal and infant mortality please visit our Safe Birth page.

CHORAGON® / BREVACTID® (u-hCG)

CHORAGON® / BREVACTID® (u-hCG)

CHORAGON (u-hCG) is a glycopeptide hormone administered by intramuscular injection and used to control the timing of ovulation.

HCG mimics the action of LH and is the drug of choice to trigger ovulation following follicular stimulation and development. It is also used in combination with MENOPUR / MENOGON to stimulate spermatogenesis in male infertility due to hypogonadism.

Please note that product information presented on this website is intended only as a brief summary for the visitor’s convenience in relation to the activities of the Ferring Group. Not all products or indications are licensed in every country and may be subject to further local variations. For specific product information please consult the summary of product characteristics (SPC). For advice on medical issues please consult your local medical practitioner.

GONAPEPTYL® / DECAPEPTYL® daily (triptorelin acetat)

GONAPEPTYL® / DECAPEPTYL® daily (triptorelin acetat)

GONAPEPTYL / DECAPEPTYL* (triptorelin acetat) is a solution for injection containing 0.1 mg/1 ml of triptorelin acetate (per prefilled syringe). It is indicated for the down regulation of the pituitary before and during controlled ovarian hyperstimulation in assisted reproduction techniques.

DECAPEPTYL in men suppresses the action of testosterone and oestrogen making it a standard therapy for diseases that depend on hormones, such as prostate cancer where it slows the development of the cancer.

(*In certain markets, the DECAPEPTYL trademark is owned by Debiopharm International S.A. and is not associated with Ferring.)

Please note that product information presented on this website is intended only as a brief summary for the visitor’s convenience in relation to the activities of the Ferring Group. Not all products or indications are licensed in every country and may be subject to further local variations. For specific product information please consult the summary of product characteristics (SPC). For advice on medical issues please consult your local medical practitioner.

ENDOMETRIN® / LUTINUS® (progesterone)

ENDOMETRIN® / LUTINUS® (progesterone)

LUTINUS / ENDOMETRIN (progesterone) is a vaginal tablet containing 100 mg progesterone per tablet. It is indicated for luteal support as part of an Assisted Reproductive Technology (ART) treatment programme for infertile women.

Please note that product information presented on this website is intended only as a brief summary for the visitor’s convenience in relation to the activities of the Ferring Group. Not all products or indications are licensed in every country and may be subject
to further local variations. For specific product information please consult the summary of product characteristics (SPC). For advice on medical issues please consult your local medical practitioner.

LUTREPULSE® / LUTRELEF® (gonadorelin acetate)

LUTREPULSE® / LUTRELEF® (gonadorelin acetate)

LUTREPULSE® / LUTRELEF® (gonadorelin acetate) is used in replacement therapy of endogenous GnRH-deficiency, for the treatment of infertility in women and men. This can induce sexual development, follicle maturation and ovulation in women whose normal secretion of GnRH (and therefore of FSH and LH) is affected. It can also be used in men to induce sperm production.

LUTREPULSE® / LUTRELEF® is administered automatically using an injection device (Pod). The Pod comes together with the Manager, a remote control used to set up the Pod and monitor its function.

Please note that product information presented on this website is intended only as a brief summary for the visitor’s convenience in relation to the activities of the Ferring Group. Not all products or indications are licensed in every country and may be subject to further local variations. For specific product information please consult the summary of product characteristics (SPC). For advice on medical issues please consult your local medical practitioner.

MENOPUR® / MENOGON® / REPRONEX® (HP-hMG)

MENOPUR® / MENOGON® / REPRONEX® (HP-hMG)

MENOPUR (HP-hMG) is a highly purified human menopausal gonadotrophin containing a 1:1 ratio of FSH (follicle stimulating hormone) and LH (luteinizing hormone) activity.

MENOPUR has indications for treatment of female and male infertility in the following groups of patients*:

• Anovulatory women: MENOPUR can be used to stimulate follicle development in amenorrhoeic patients

• Women undergoing superovulation within a medically assisted fertilisation programme: MENOPUR can be used to induce multiple follicular development in patients undergoing an assisted conception technique such as in-vitro fertilisation (IVF).

• Hypogonadotrophic hypogonadism in men: MENOPUR may be given in combination with human chorionic gonadotrophin (e.g. CHORAGON®) for the stimulation of spermatogenesis.

Please note that product information presented on this website is intended only as a brief summary for the visitor’s convenience in relation to the activities of the Ferring Group.

*Not all products or indications are licensed in every country and may be subject to further local variations. For specific product information please consult the summary of product characteristics (SPC). For advice on medical issues please consult your local medical practitioner.

NORPROLAC® (quinagolide hydrochloride)

NORPROLAC® (quinagolide hydrochloride)

NORPROLAC (quinagolide hydrochloride) is a selective, D2 dopamine agonist that is used for the treatment of elevated levels of prolactin. The secretion of prolactin is reduced by the neurotransmitter dopamine which acts on prolactin-secreting cells in the pituitary gland. NORPROLAC mimics the action of dopamine in the pituitary to reduce prolactin levels. NORPROLAC is provided in tablet form for oral administration.

Please note that product information presented on this website is intended only as a brief summary for the visitor’s convenience in relation to the activities of the Ferring Group. Not all products or indications are licensed in every country and may be subject to further local variations. For specific product information please consult the summary of product characteristics (SPC). For advice on medical issues please consult your local medical practitioner.

PABAL® / DURATOCIN® / LONACTENE® / DURATOBAL® (carbetocin)

PABAL® / DURATOCIN® / LONACTENE® / DURATOBAL® (carbetocin)

PABAL / DURATOCIN / LONACTENE / DURATOBAL (carbetocin) is Ferring’s long-acting, oxytocin analogue that is used to prevent haemorrhage following caesarean section.

Haemorrhaging from the uterus can occur following an incomplete abortion, a caesarean section or following the final stage of labour, once the placenta has been expelled, due to insufficient tone in the uterus (atony).

PABAL is administered via a single intravenous injection before or after the delivery of the placenta.

Please note that product information presented on this website is intended only as a brief summary for the visitor’s convenience in relation to the activities of the Ferring Group. Not all products or indications are licensed in every country and may be subject to further local variations. For specific product information please consult the summary of product characteristics (SPC). For advice on medical issues please consult your local medical practitioner.

PROPESS® / CERVIDIL® (dinoprostone)

PROPESS® / CERVIDIL® (dinoprostone)

PROPESS® / CERVIDIL®* (dinoprostone) is indicated for initiation of cervical ripening in patients at term.

PROPESS is administered through a vaginal insert contained in a polyester pouch with a withdrawal tape.
PROPESS releases dinoprostone at a constant and controlled rate. If, for any reason, treatment must be interrupted, the vaginal insert can quickly and easily be pulled out.

Please note that product information presented on this website is intended only as a brief summary for the visitor’s convenience in relation to the activities of the Ferring Group. Not all products or indications are licensed in every country and may be subject to further local variations. For specific product information please consult the summary of product characteristics (SPC). For advice on medical issues please consult your local medical practitioner.

REKOVELLE®

REKOVELLE®

REKOVELLE® (follitropin delta) is the first recombinant follicle stimulating hormone (FSH) derived from a human cell line.

REKOVELLE® is indicated for controlled ovarian stimulation (COS) for the development of multiple follicles in women undergoing assisted reproductive technologies (ART) such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle.

REKOVELLE® is administered using an individualised dosing regimen according to a woman’s serum anti-Müllerian hormone (AMH) level and her body weight.

AMH is a biomarker used to assess ovarian reserve and predict ovarian response to COS. AMH levels are measured using a companion diagnostic, the Elecsys® AMH Plus immunoassay from Roche.

Please note that product information presented on this website is intended only as a brief summary for the visitor’s convenience in relation to the activities of the Ferring Group. Not all products or indications are licensed in every country and may be subject to further local variations. For specific product information please consult the summary of product characteristics (SPC). For advice on medical issues please consult your local medical practitioner.

TRACTOCILE® (atosiban)

TRACTOCILE® (atosiban)

TRACTOCILE (atosiban) is a treatment indicated to delay imminent pre-term birth, which is the main cause of death and disability in new-born infants. The active ingredient, atosiban, is an oxytocin/vasopressin antagonist that blocks the action of oxytocin and is able to prevent uterine contractions and relax the uterus.

TRACTOCILE is administered by an intravenous infusion in three successive stages to delay imminent preterm birth.

Please note that product information presented on this website is intended only as a brief summary for the visitor’s convenience in relation to the activities of the Ferring Group. Not all products or indications are licensed in every country and may be subject to further local variations. For specific product information please consult the summary of product characteristics (SPC). For advice on medical issues please consult your local medical practitioner.

Gastroenterology & Microbiome

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CORTIMENT®MMX® (budesonide)

CORTIMENT®MMX® (budesonide)

CORTIMENT®MMX® (budesonide)* is indicated in adults for induction of remission in patients with active mild-to-moderate active ulcerative colitis where 5-ASA (aminosalicylate) treatment is not sufficient.

CORTIMENT®MMX® contains budesonide, a locally acting glucocorticosteroid, in a novel, patented, oral tablet formulation utilizing MMX® multimatrix colonic delivery technology that is designed to result in the controlled release and distribution of budesonide throughout the length of the colon.

(*CORTIMENT®MMX® has been developed by Cosmo Pharmaceuticals S.A. Ferring is the licensee in the EU and Asia (excluding Japan), Australia, Canada, Latin America and Africa. In the United States, where the product is available as UCERIS®, the licensee is Salix Pharmaceuticals, Inc.

CORTIMENT is a trademark of Ferring B.V. MMX is a trademark of Cosmo Pharmaceuticals S.A. UCERIS is a registered trademark of Santarus, Inc, a wholly owned subsidiary of Salix Pharmaceuticals, Inc.)

Please note that product information presented on this website is intended only as a brief summary for the visitor’s convenience in relation to the activities of the Ferring Group. Not all products or indications are licensed in every country and may be subject to further local variations. For advice on medical issues please consult your local medical practitioner.

GLYPRESSIN® (terlipressin)

GLYPRESSIN® (terlipressin)

GLYPRESSIN (terlipressin) is indicated for the treatment of bleeding oesophageal varices and in some countries for the treatment of hepato-renal syndrome type 1.

GLYPRESSIN is administered to patients by the healthcare professional giving an injection directly into a vein.

Please note that product information presented on this website is intended only as a brief summary for the visitor’s convenience in relation to the activities of the Ferring Group. Not all products or indications are licensed in every country and may be subject to further local variations. For advice on medical issues please consult your local medical practitioner.

PENTASA® (mesalazine)

PENTASA® (mesalazine)

PENTASA® (mesalazine) is Ferring’s product used for the treatment and long-term management of inflammatory bowel diseases (IBD) (Ulcerative colitis and Crohn’s disease).

PENTASA is prescribed to treat the mild to moderate symptoms of active IBD as well as being used widely as maintenance therapy to reduce the risk of recurrent attacks.

PENTASA is available orally as tablets and granules (sachets) within Europe and the rest of the world, excluding the USA. In the USA, Shire US, Inc. sells PENTASA under a trademark license from Ferring.
Topical formulations (suppositories and enemas) are also available for administration via the rectum, allowing a high concentration of the drug to be in contact with areas of inflammation at the lower end of the digestive tract.

Oral PENTASA has a prolonged-release formulation, helping to ensure release of active mesalazine throughout the entire length of the intestine from the duodenum to the rectum. Topical PENTASA formulations (enemas and suppositories) enable active mesalazine to remain in contact with the inflamed mucosa for several hours.

Please note that product information presented on this website is intended only as a brief summary for the visitor’s convenience in relation to the activities of the Ferring Group. Not all products or indications are licensed in every country and may be subject to further local variations. For advice on medical issues please consult your local medical practitioner.

PICOPREP® (sodium picosulphate, magnesium oxide, citric acid)

PICOPREP® (sodium picosulphate, magnesium oxide, citric acid)

PICOPREP® (sodium picosulphate, magnesium oxide, citric acid) is indicated to clean the bowel prior to Xray examination or endoscopy, to clean the bowel prior to surgery when judged clinically necessary.
PICOPREP® has approved dosing for children as of 1 year old and adults.

Please note that product information presented on this website is intended only as a brief summary for the visitor’s convenience in relation to the activities of the Ferring Group. Not all products or indications are licensed in every country and may be subject to further local variations. For advice on medical issues please consult your local medical practitioner.

REBYOTA™ (fecal microbiota, live — jslm)

REBYOTA™ (fecal microbiota, live — jslm)

REBYOTA™ (fecal microbiota, live —jslm) is a novel first-in-class microbiome-based treatment approved by the U.S. FDA for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older, following antibiotic treatment for recurrent CDI. CDI can cause debilitating symptoms such as severe diarrhoea, fever, stomach tendeness or pain, loss of appetite and nausea. Up to 35% of CDI cases responding to initial antibiotic treatment may recur and up to 60% of these cases will experience further multiple recurrence.

This product is currently approved for use in the United States only.

Please note that product information presented on this website is intended only as a brief summary for the visitor’s convenience in relation to the activities of the Ferring Group. Not all products or indications are licensed in every country and may be subject to further local variations. For specific product information please consult the summary of product characteristics (SPC). For advice on medical issues please consult your local medical practitioner.

Urology & Uro-Oncology

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ADSTILADRIN® (nadofaragene firadenovec-vncg)

ADSTILADRIN® (nadofaragene firadenovec-vncg)

ADSTILADRIN® (nadofaragene firadenovec-vncg) is a non-replicating adenovirus vector-based gene therapy approved by the U.S. FDA for the treatment of adult patients with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours.

This product is currently approved for use in the United States only.

Please note that product information presented on this website is intended only as a brief summary for the visitor’s convenience in relation to the activities of the Ferring Group. Not all products or indications are licensed in every country and may be subject to further local variations. For specific product information please consult the summary of product characteristics (SPC). For advice on medical issues please consult your local medical practitioner.

FIRMAGON® (degarelix)

FIRMAGON® (degarelix)

FIRMAGON® (degarelix) is a treatment for men with advanced hormone-dependent prostate cancer. It has a novel mechanism of action that is different from traditional LHRH agonist therapy commonly used.

Decreasing testosterone levels can cause the cancer cells to die, thus reducing the size of the tumour and delaying its growth.

To date, FIRMAGON has been approved in 74 countries.

Please note that product information presented on this website is intended only as a brief summary for the visitor’s convenience in relation to the activities of the Ferring Group. Not all products or indications are licensed in every country and may be subject to further local variations. For specific product information please consult the summary of product characteristics (SPC). For advice on medical issues please consult your local medical practitioner.

MINIRIN® (desmopressin)

MINIRIN® (desmopressin)

MINIRIN® (desmopressin) is indicated for the treatment of bedwetting in children and nocturia in adults.
Both conditions are usually caused by an overproduction of urine at night, and MINIRIN acts on the kidneys to reduce this. Bedwetting can be traumatic for children, affecting their well-being and self-esteem. For adults with nocturia, waking up several times a night to urinate can lead to sleep deprivation affecting a patient’s quality of life.

Please note that product information presented on this website is intended only as a brief summary for the visitor’s convenience in relation to the activities of the Ferring Group. Not all products or indications are licensed in every country and may be subject to further local variations. For specific product information please consult the summary of product characteristics (SPC). For advice on medical issues please consult your local medical practitioner.

NOCDURNA® (desmopressin)

NOCDURNA® (desmopressin)

NOCDURNA® (desmopressin) is indicated for the symptomatic treatment of nocturia due to idiopathic nocturnal polyuria in adults. Nocturia, the need to awaken at night to pass urine, is a complex medical condition with various contributing factors. The night-time overproduction of urine, nocturnal polyuria, is responsible for nocturia in up to 88% of cases. NOCDURNA® once-daily lyophilisate tablets are administered sublingually (without the need for water) in gender specific low doses, tailored specifically for men (50 mcg) and women (25 mcg).

Please note that product information presented on this website is intended only as a brief summary for the visitor’s convenience in relation to the activities of the Ferring Group. Not all products or indications are licensed in every country and may be subject to further local variations. For specific product information please consult the summary of product characteristics (SPC). For advice on medical issues please consult your local medical practitioner.

Endocrinology

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ZOMACTON® (somatropin)

ZOMACTON® (somatropin)

ZOMACTON® (somatropin) is a synthetic human growth hormone (hGH) produced by recombinant DNA technology.

The main use for the product is to treat Growth Hormone Deficiency (GHD) in children.

How to use ZOMACTON

Somatropin is broken down by the digestive system and therefore cannot be taken by mouth. It needs to be administered through the skin as an injection.

Cases of Growth Hormone Deficiency (GHD) should ideally be treated on a nightly basis (at bedtime) with somatropin. The dose and exact schedule of administration is based on an individual assessment of each patient, but the treatment is over several years.

Please note that product information presented on this website is intended only as a brief summary for the visitor’s convenience in relation to the activities of the Ferring Group. Not all products or indications are licensed in every country and may be subject to further local variations. For advice on medical issues please consult your local medical practitioner.

Orthopaedics

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EUFLEXXA (1% sodium hyaluronate)

EUFLEXXA (1% sodium hyaluronate)

Ferring’s product EUFLEXXA® (1% sodium hyaluronate) is an ultra-high purity hyaluronan, called hyaluronic acid (HA). HA is the natural substance found in the fluid that surrounds a healthy knee joint and helps cushion, lubricate, and protect the knee as it moves throughout the day.

EUFLEXXA® is injected into the knees of osteoarthritis sufferers to improve movement and reduce pain.

Please note that product information presented on this website is intended only as a brief summary for the visitor’s convenience in relation to the activities of the Ferring Group. Not all products or indications are licensed in every country and may be subject to further local variations. For specific product information please consult the summary of product characteristics (SPC). For advice on medical issues please consult your local medical practitioner.

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Ferring Announces Recipients of Innovation Grants Program 2017-2018
Ferring 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.com

Bhavin Vaid
Head of Corporate Communications
+41 58 301 09 52 (direct)
+41 79 191 06 32 (mobile)
bhavin.vaid@ferring.com

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Ferring announces the start of the PRONOUNCE Trial for patients with advanced prostate cancer and cardiovascular disease receiving degarelix or leuprolide
Ferring announces the start of the PRONOUNCE Trial for patients with advanced prostate cancer and cardiovascular disease receiving degarelix or leuprolide

Saint-Prex, Switzerland – 8 February 2016 –

Ferring Pharmaceuticals announced today the commencement of the Phase 3b PRONOUNCE Trial. The trial will compare the occurrence of major adverse cardiovascular events (MACEs) in patients with prostate cancer and cardiovascular disease (CVD), receiving the GnRH receptor antagonist, degarelix, to patients receiving a GnRH receptor agonist, leuprolide.

Prostate cancer is the second most common form of cancer in men worldwide with 1.1 million cases diagnosed and over 300,000 deaths in 2012.¹ Androgen deprivation therapy (ADT) is considered the gold-standard treatment for patients with advanced prostate cancer.² However, ADT has shown to be associated with increased risk for CVD. This increase in risk is particularly apparent within the first year of treatment initiation.³^,4,5

A retrospective analysis of pooled data from six Phase 3 clinical trials suggests that there may be a difference in the risk of a major CV event when patients with prostate cancer and a history of CVD were treated with the GnRH antagonist, as compared to GnRH agonists.⁶ The PRONOUNCE Trial has been initiated to compare the cardiovascular safety profile of two types of ADT treatment, the GnRH antagonist (degarelix) and a GnRH agonist (leuprolide) over a one year treatment period. The primary endpoint of the PRONOUNCE Trial is time from patient randomization to the first confirmed occurrence of the composite MACE endpoint.

“Since increased risk of CVD is found among men at advanced age and with prostate cancer, it is critical that cardiovascular status is considered in the management of patients in which ADT is initiated” said Dr. Howard Scher, Chief of the Genitourinary Oncology Service at the Memorial Sloan-Kettering Cancer Center and co-principal investigator of the PRONOUNCE Trial. “The PRONOUNCE Trial could provide valuable insight into the cardiovascular safety profile of GnRH antagonists and GnRH agonists and contribute to informed clinical decision making.”

Ferring Pharmaceuticals is partnering with Duke Clinical Research Institute (DCRI), an institute of the Duke University School of Medicine, USA, to conduct the PRONOUNCE Trial. The DCRI will provide academic leadership with its world-renowned CVD clinical trial expertise.

“This eagerly anticipated trial represents the first cardiovascular outcomes trial conducted in patients with cancer and represents a unique collaboration among cardiologists, oncologists, and urologists who are involved in the care of patients with CVD and prostate cancer,” said Dr. Matthew Roe, Associate Professor of Medicine at Duke University Medical Center and the Duke Clinical Research Institute.

The PRONOUNCE Trial will enroll approximately 900 patients over 50 trial sites in the USA and Canada with the First Patient First Visit (FPFV) due to take place in February 2016.

Dr. Pascal Danglas, Chief Medical Officer, Ferring Pharmaceuticals, commented: “The start of the PRONOUNCE Trial marks another important milestone in Ferring’s long-standing commitment to improving the lives of men living with prostate cancer and addressing the unmet needs of patients with prostate cancer and pre-existing CVD.”

– ENDS –

About the CHAMPION trial

The PRONOUNCE Trial is a large, 1-year, randomised, controlled, prospective cardiovascular safety trial comparing the occurrence of independently adjudicated major adverse cardiovascular events (MACEs) in patients with prostate cancer and CVD receiving degarelix (GnRH antagonist) to patients receiving leuprolide (GnRH agonist). Further information on the PRONOUNCE trial is available at: https://clinicaltrials.gov/ct2/show/NCT02663908?term=pronounce&rank=1.

About degarelix

Degarelix is an antagonist form of androgen deprivation therapy that reversibly binds to the GnRH receptors, inhibiting the production of testosterone immediately. By suppressing the production of testosterone, tumour growth is inhibited.⁷ Degarelix was approved for the treatment of advanced hormone-dependent prostate cancer in the US in 2008, and in the EU in 2009. Today it is available in approximately 53 countries around the world, including Asia, Latin America and the Middle East.

About prostate cancer

Prostate cancer is the second most common form of cancer in men worldwide accounting for 15% of the cancers diagnosed in men. It is the fifth leading cause of death from cancer in men accounting for 6.6% of the total male deaths in 2012.¹ Prostate cancer develops from cells in the prostate gland that begin to grow out of control. In most cases, prostate cancer grows slowly and can remain undetected throughout a man’s life, although it can grow and spread quickly.⁸ The seven types of standard treatment are: watchful waiting or active surveillance, surgery, radiation therapy or radiopharmaceutical therapy, hormone therapy, chemotherapy, biologic therapy or bisphosphonate therapy.⁷

About Ferring Pharmaceuticals

Headquartered in Switzerland, 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, endocrinology and orthopaedics. Ferring has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries.

To learn more about Ferring or its products please visit www.ferring.com.

For more information, please contact

Helen Gallagher
+41 58 301 00 51
helen.gallagher@ferring.com

Nicole Barraud-Estoppey
+41 58 301 00 53
nicole.barraud-estoppey@ferring.com
References

WHO GLOBOCAN 2012: http://globocan.iarc.fr/old/FactSheets/cancers/prostate-new.asp#MORTALITY [Last Accessed: January 2016]

Chowdhury S et al. Trends in Urology and Men’s Health. 2014:5: 26-27

Keating NL et al. J Clin Oncol. 2006 Sep 20;24(27):4448-56.

D’Amico AV et al. J Clin Oncol. 2007 Jun;25(17):2420-2425

Kintzel PE. Pharmacotherapy. 2008;28(12):1511-22.

Albertsen PC et al. Eur Urol. 2014 ;65:565-73

National Cancer Institute. Prostate Cancer (PDQ(R)): Treatment: Treatment Option Overview. http://www.cancer.gov/types/prostate/patient/prostate-treatment-pdq [Last Accessed: January 2016]

American Cancer Society. Cancer Reference Information, Overview: Prostate Cancer. http://www.cancer.org [Last Accessed: January 2016]
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33 results for gnrh

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

Stockholm, Sweden – Wednesday 6 July 2011 –

MENOPUR

About Ferring Pharmaceuticals

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References

Positive phase III data unveiled for new GnRH blocker degarelix

Milan, Italy – 27 March 2008 –

Notes for editors

About Prostate Cancer

About degarelix

About Ferring Pharmaceuticals

References

Degarelix, a novel GnRH blocker from Ferring, moves into phase III

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 –

How degarelix works

Degarelix study findings

About prostate cancer

About Current Treatment Options for Prostate Cancer

About GnRH blockers versus agonists

About degarelix

About Ferring Pharmaceuticals

For more information, please contact

References

Degarelix, 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.

How degarelix works

New degarelix study findings

Notes for editors

About Prostate Cancer

Current Treatment Options for Prostate Cancer

GnRH agonists versus blockers

Degarelix

About Ferring Pharmaceuticals

For more information, please contact

References

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

About the PROFILE study

Real-World Utilisation Patterns of Rekovelle

Adverse Drug Reactions

About Rekovelle (follitropin delta)

About Ferring Pharmaceuticals

References

For more information, please contact

Product pipeline

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Urology & uro-oncology

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Reproductive Medicine & Maternal Health

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Orthopaedics

Ferring Announces Recipients of Innovation Grants Program 2017-2018

Saint-Prex, Switzerland – 26 January, 2018 –

About Ferring Pharmaceuticals

About Ferring Research Institute Inc

For more information, please contact

Ferring announces the start of the PRONOUNCE Trial for patients with advanced prostate cancer and cardiovascular disease receiving degarelix or leuprolide

Saint-Prex, Switzerland – 8 February 2016 –

About the CHAMPION trial

About degarelix

About prostate cancer

About Ferring Pharmaceuticals

For more information, please contact

References

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