Business Wire

New Analysis of Rekovelle® Data Further Supports Use of AMH to Personalise Fertility Treatment

Del

Ferring Pharmaceuticals announced today a new analysis* of data from the Phase 3 ESTHER-1 trial1 showing that natural variations in anti-Müllerian hormone (AMH) levels during and between a woman’s menstrual cycle have no clinically relevant impact on ovarian response (the number of eggs produced) when using AMH to dose Rekovelle ® (follitropin delta) for ovarian stimulation (OS).2 The data were presented today at the 34th Annual Meeting of the European Society of Human Reproduction and Embryology (ESHRE) in Barcelona, Spain.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180701005093/en/

AMH Infographic (Photo: Business Wire)

AMH Infographic (Photo: Business Wire)

According to the new analysis, for 95% of women treated with Rekovelle, variations in ovarian response were limited to a difference of plus or minus one egg.2 This reinforces that AMH measured on any day of a woman’s menstrual cycle can be used to individualise the dose of Rekovelle. AMH is measured with a companion diagnostic, the Elecsys® AMH Plus immunoassay from F. Hoffmann-La Roche Ltd (Roche).

“We are excited to share the results of this new Rekovelle analysis which add to existing evidence showing AMH is a robust predictor of ovarian response to fertility treatment,” said Professor Klaus Dugi, Chief Medical Officer, Ferring Pharmaceuticals. “I believe these data will further strengthen the growing confidence of doctors in the use of AMH to personalise dosing of fertility treatment for their patients.”

Ovarian response to stimulation varies considerably from woman to woman3 and unexpected extreme responses have implications on efficacy and safety.4,5 Aiming to avoid extremes in ovarian response, the validated Rekovelle dosing algorithm uses AMH and body weight to determine a personalised dose for patients, from the start of treatment.

This analysis of data from the Phase 3 ESTHER-1 trial adds to consistent efficacy results seen with Rekovelle in clinical trials to date. The ESTHER-1 trial showed that women undergoing their first treatment cycle receiving individualised treatment with Rekovelle, compared to conventional dosing regimen with follitropin alfa,Ɨǂ had similar ongoing pregnancy and embryo implantation rates.1

The ESTHER-1 trial also showed that more women receiving individualised treatment with Rekovelle achieved the target response of 8-14 eggs compared to conventional dosing regimen with follitropin alfa.1ǂ§ Evidence shows that beyond 15 eggs there is no additional benefit, in terms of live birth rate, in the number of eggs produced through OS in a fresh cycle.6,7

About Rekovelle (follitropin delta)
Rekovelle is a human recombinant follicle stimulating hormone (rFSH) with an approved dosing algorithm designed for predictable ovarian response.8 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.8,9 Rekovelle is approved for use in ovarian stimulation (OS) for induction of the development of multiple follicles in women undergoing assisted reproductive technologies (ART), such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI).8 The individualised dosing of Rekovelle is determined using an approved algorithm, based on a woman’s anti-Müllerian hormone (AMH) level and body weight.1,8,10 AMH is a biomarker used to assess ovarian reserve and can help predict ovarian response.11 AMH will be measured with a companion diagnostic, the Elecsys® AMH Plus immunoassay from F. Hoffmann-La Roche Ltd (Roche).12,13

As of 15 June 2018, Rekovelle was approved in 37 countries and available in 17 countries worldwide.

About the ESTHER trials
The ESTHER trials (Evidence-based Stimulation Trial with Human recombinant FSH in Europe and Rest of World) were randomised, assessor-blind, controlled, multicentre Phase 3 trials involving patients in 11 countries and over 2,000 cycles of OS.1,14

ESTHER-1 was a trial of 1,326 patients in 11 countries undergoing their first ART cycle. Patients were randomised 1:1 to receive treatment with individualised Rekovelle, a fixed daily dose based on serum AMH levels** and body weight, or conventional follitropin alfa dosing. The co-primary endpoints of ongoing pregnancy rates and ongoing implantation rates were met, demonstrating comparable efficacy of Rekovelle to conventional treatment.1 Rekovelle’s individualised dosing regimen aims to obtain an ovarian response associated with a favourable safety/efficacy profile, i.e. aims to achieve an adequate number of eggs and reduce interventions to prevent ovarian hyperstimulation syndrome.8

ESTHER-2 evaluated the immunogenicity of Rekovelle in a subset of ESTHER-1 patients undergoing repeated cycles of OS for ART. Data demonstrated no increased immunogenicity risk with Rekovelle after exposure in repeated cycles.8,14

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 women’s 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 now employs approximately 6,500 people worldwide, has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries.

Learn more at www.ferring.com, or connect with us on Twitter, Facebook, Instagram, LinkedIn and YouTube.

About the Elecsys ® AMH Plus immunoassay from Roche
The Elecsys® AMH Plus immunoassay from Roche has been shown to provide a precise, reliable and robust measurement of AMH levels.12,13,15,16,17,18 This fully automated Elecsys® AMH Plus immunoassay, run on the cobas ® e and Elecsys® immunoassay analysers, determines AMH levels in 18 minutes, making it appropriate for routine clinical use. The Elecsys® AMH Plus immunoassay is intended to be used for assessment of ovarian reserve, prediction of response to OS and establishment of the individual daily dose of Ferring follitropin delta in combination with body weight in OS for the development of multiple follicles in women undergoing an assisted reproductive technology programme.8,12,15,17,18

References:
_________________________
1 Nyboe Andersen A, Nelson SM, Fauser BC, et al. Individualised versus conventional ovarian stimulation for an in vitro fertilization: a multicenter, randomized, controlled assessor-blinded, phase 3 noninferiority trial. Fertil Steril. 2017 02 [cited 2018 Jun 14];107(2):387-396.
2 Nelson SM, Larsson P, Mannaerts B, et al. AMH variability and its implications for the number of oocytes retrieved following individualized dosing with follitropin delta [abstract]: 34th Annual Meeting of the European Society of Human Reproduction and Embryology (ESHRE); 2018; Barcelona, Spain. Abstract no P-651.
3 Fauser BC, Diedrich K, Devroey P. Evian Annual Reproduction Workshop Group 2007. Hum Reprod Update; 2008 02 [cited 2018 Jun 14];14:1–14.
4 La Marca A, Sunkara SK. Individualization of controlled ovarian stimulation in IVF using ovarian reserve markers: from theory to practice. Hum Reprod Update. 2014 01 [cited 2018 Jun 14;20:124–40.
5 Steward RG, Lan L, Shah AA, et al. Oocyte number as a predictor for ovarian hyperstimulation syndrome and live birth: an analysis of 256,381 in vitro fertilization cycles. Fertil Steril. 2014 04 [cited 2018 Jun 14];101:967–973.
6 Drakopoulos P, Blockeel C, Stoop D, et al. Conventional ovarian stimulation and single embryo transfer for IVF/ICSI. How many oocytes do we need to maximize cumulative live birth rates after utilization of all fresh and frozen embryos? Hum Reprod. 2016 02 [cited 2018 Jun 14];31(2):370-376.
7 Ji J, Liu Y, Hong Tong X, et al. The optimum number of oocytes in IVF treatment: an analysis of 2455 cycles in China. Hum Reprod. 2013 10 [cited 2018 Jun 14];28(10):2728-2734.
8 Rekovelle® Summmary of Product Characteristics. Date of publication 2016 12 [cited 2018 Jun 14]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/003994/WC500220238.pdf.
9 Olsson H, Sandström 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. Journal of Clinical Pharmacology. 2014 11 [cited 2018 Jun 14];54(11):1299–307.
10 Arce JC, Nyboe Andersen A, Fernandez Sanchez M, et al. Ovarian response to recombinant human follicle stimulating hormone: a randomized, anti-Müllerian hormone–stratified, dose–response trial in women undergoing in vitro fertilization/intracytoplasmic sperm injection. Fertility and Sterility. 2014 12 [cited 2018 Jun 14];102(6):1633–1640.
11 La Marca A, Sighinolfi G, Radi D, et al. Anti-Mullerian hormone (AMH) as a predictive marker in assisted reproductive technology (ART). Hum Reprod Update. 2010 03 [cited 2018 Jun 14];16(2):113-130.
12 Deeks ED. Elecsys® AMH assay: a review in anti-Müllerian hormone quantification and assessment of ovarian reserve. Molecular Diagnosis & Therapy. 2015 07 [cited 2018 Jun 14];19: 245-249.
13 Roche Diagnostics. Elecsys® AMH (anti-Müllerian hormone): Method sheet. (2015). Date of publication 2014 [cited 2018 Jun 14]. Available from: http://www.cobas.com/content/dam/cobas_com/pdf/product/Elecsys%20AMH/Elecsys%20AMH%20FactSheet.pdf.
14 Buur Rasmussen A, Mannaerts B, Klein BM, et al. Low immunogenicity potential of follitropin delta, a recombinant FSH preparation produced from a human cell line: Results from phase 3 trials (ESTHER-1 and ESTHER-2). Human Reproduction. 2016 07 [cited 2018 Jun 14];31:385.
15 Gassner D. & Jung R. First fully automated immunoassay for anti-Müllerian hormone. Clinical Chemistry and Laboratory Medicine. 2014 08 [cited 2018 Jun 14];52(8):1143-1152.
16 Anderson RA, Anckaert E, Bosch E, et al. Prospective study into the value of the automated Elecsys® Anti-Müllerian Hormone assay for the assessment of the ovarian growing follicle pool. Fertility and Sterility. 2015 04 [cited 2018 Jun 14];103(4):1074–1080.e4.
17 Nelson SM, Pastuszek E, Kloss G, et al. Two new automated, compared with two enzyme-linked immunosorbent anti-Müllerian hormone assays. Fertility and Sterility. 2015 07 [cited 2018 Jun 14];104(4):1016-1021.e6.
18 Hyldgaard J, Bor P, Ingerslev HJ, et al. Comparison of two different methods for measuring anti-Müllerian hormone in a clinical series. Reproductive Biology and Endocrinology. 2015 09 [cited 2018 Jun 14];13(1):107.

________________________________
* A sub-analysis of the ESTHER-1 study population including 1,326 women (aged 18-40 years). Serum AMH was measured at a random day at screening and at cycle day 2-3 prior to stimulation using the Elecsys® AMH Plus immunoassay (Roche). Limitations: A centralised AMH measuring laboratory was used which may give rise to reduced AMH variability. AMH measurements were compared with samples taken within 3 months prior to ovarian stimulation, longer time intervals may have shown different variability due to the age-related decline in AMH.
Ɨ GONAL-f ® , registered trademark of Merck KGaA, Darmstadt, Germany.
ǂ Conventional dosing of follitropin alfa is 150 IU/d for 5 days, with potential subsequent dose adjustments at a maximum of 450 IU/d.1
§ ESTHER-1 was neither designed nor powered to assess results based on secondary endpoints. Predefined secondary endpoints are used as a measurement to yield supportive evidence to evaluate additional effects relevant to informing the Rekovelle individualised dosing regimen. No confirmatory conclusions can be derived.
** AMH is measured by a companion diagnostic, the Elecsys® AMH Plus immunoassay from F. Hoffmann-La Roche Ltd (Roche).

Contact information

Ferring Pharmaceuticals
Bhavin Vaid
Head of Corporate Communications
+41 58 301 0952 (direct)
+41 79 191 0632 (mobile)
bhavin.vaid@ferring.com
or
Lindsey Rodger
Senior Manager, Corporate Communications
+41 58 451 4023 (direct)
+41 79 191 0486 (mobile)
lindsey.rodger@ferring.com

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

Highlights of China’s No. 1 High-Tech Fair CHTF 201815.11.2018 02:00Pressemelding

The 20th China Hi-Tech Fair (CHTF 2018) is being held from November 14-18 at the Shenzhen Convention and Exhibition Center with the theme “New Development Concept for High Quality Growth.” This year’s CHTF consists of exhibitions, forums, professional meetings, supporting activities, talents exchange meetings and overseas fairs, and features advanced manufacturing, next-generation information technology, AI, life sciences, new materials, new energy, as well as integration of real economy and future industries. Here are some of the highlights of CHTF 2018: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181114005654/en/ International and Belt & Road Pavilion of CHTF (Photo: Business Wire) Themed areas focusing on industry hotspots The IT exhibition will present themed areas like AI, smart manufacturing, smart automotive, sports technology, big data, cloud computing, IoT and blockchain; the environmental exhibition will highlig

MapleStory Prepares for Epic Battle Against the Black Mage in Gathering of Heroes Event14.11.2018 21:00Pressemelding

MapleStory, the iconic global MMORPG from Nexon America, is bringing the first phase of its long-awaited battle with the sinister villain, the Black Mage. Between November 14 through November 28, players can take part in the “Gathering of Heroes” event to join the Maple Alliance and prepare their armies to soon combat the Black Mage. The Black Mage has long been the main antagonist behind MapleStory. His story originated with the role of bringing balance to Maple World, but turned dark as he realized the only way to save Maple World was to destroy it. Now that his seal has been broken, players will need to work together to defeat the legendary boss. The Gathering of Heroes event adds the Maple Alliance outpost, where players can hone their skills and prepare to level up in preparation of for their battle against the Black Mage, as well as adds various leveling updates. The main goal of the Alliance is to gather “Determination” and power up the holy light in the outpost to be able to fi

SpinalCyte Announces Sustained 12-Month MRI Outcomes After CybroCell™ Injection14.11.2018 20:07Pressemelding

SpinalCyte, LLC, a Texas-based regenerative medicine company focused on regrowth of the spinal disc nucleus using its universal donor product, CybroCell™, today announced that a single injection of modified human dermal fibroblasts (HDFs), resulted in significant improvements of disc height and pain reduction 12 months after injection of the cell therapy for patients with degenerative disc disease (DDD). The trial assessed patients using the Oswestry Disability Index (ODI), Visual Analogue Scale (VAS) and disc height via MRI scans. Using composite scoring, 54% of the treatment arm patients met all three endpoints as compared to only 17% with the placebo (p=0.0003). Over 84% of patients in the treatment group of CybroCell™ or CybroCell™ with platelet rich plasma (PRP) injections had an increase or no change in disc height compared to 25% for the placebo saline injection. Analyzed individually, 83% of spinal discs that were injected with CybroCell™ had an increase or no change in disc he

Raising Awareness about Early Onset Dementia: “Don’t Leave me now”, Written by Brian Daniels14.11.2018 16:55Pressemelding

The Fondation IPSEN is delighted to invite you to a theatre performance about familial upheavals when a family member is affected by Alzheimer’s disease or cerebral dementia (November 21 st at 4pm). This play has been written by playwright Brian Daniels and directed by Jeni Draper, has had more than 200 performances and explores with insight and humour the impact of early onset dementia on family life. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181114005695/en/ (Graphic: Business Wire) Free entrance, but registration is mandatory (limited seats): Please click here NOVEMBER 21 st , 4 pm “Le Petit Théâtre de la Fondation IPSEN” 65 quai George Gorse 92150 Boulogne-Billancourt (Metro Line 9, Pont-de-Sèvres) About the Project Our “Science for People” program is composed of accessible meetings and webinars to improve access to science. Brian Daniels’ play “Don’t leave me now” is about caregivers of people with Alzheimer’s Dise

HCL Technologies Celebrates 10 Years of Success in the Nordics14.11.2018 16:44Pressemelding

HCL Technologies (HCL), a leading global technology company, is celebrating its 10-year anniversary in the Nordic region. During this time, the company has achieved significant successes, which have seen the Nordics grow to become HCL’s largest market in Europe. Today, HCL employs more than 1,600 people in the Nordics representing 31 nationalities, with 55 large-scale transformational clients including four out of the six Fortune Global 500 companies in the region. While several significant milestones have been successfully achieved, HCL looks forward to the future and is dedicated to helping its clients in the Nordics to drive innovation and growth. The celebration coincides with a series of initiatives to mark this occasion starting with the opening of a new office at HCL’s Nordics headquarters in Central Stockholm. “We are humbled by the success that we have achieved together with our clients, colleagues and partners in the Nordics,” said Pankaj Tagra, EVP Nordic and DACH Head, HCL

The Next Industrial Transformation is Here: Rockwell Automation is Helping Businesses Prepare to Succeed at Automation Fair 201814.11.2018 16:35Pressemelding

Today, at its annual Automation Fair, Rockwell Automation unveiled its new brand promise: Expanding Human Possibility by combining the imaginations of people with the intelligence of machines. The brand promise supports the company’s emphasis on bringing The Connected Enterprise to life and how, by linking people, machines and data across an entire business, manufacturers become more effective and productive. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181114005671/en/ Blake Moret, chairman and CEO, Rockwell Automation, shares his vision for bringing the Connected Enterprise to life and how manufacturers can expand human possibility by linking people, machines and data across their businesses, helping them to become more effective and productive. (Photo: Business Wire) “The new Rockwell Automation brand emphasizes the central role that people play in advanced manufacturing and underscores our focus on ways we maximize per