Ferring and IMAB sign licensing agreement granting IMAB exclusive rights in Asia to olamkicept for the treatment of autoimmune disease

Saint-Prex, Switzerland– December 19, 2016 –

Ferring Pharmaceuticals and IMAB today announced that they have signed a licensing agreement which grants IMAB exclusive rights to olamkicept (pINN) in Asia.

Olamkicept is a new recombinant protein inhibitor of the interleukin-6 pathway. Interleukin-6 is associated with numerous inflammatory conditions such as inflammatory bowel diseases (IBD) and rheumatoid arthritis.

The agreement provides IMAB with a Phase 2 ready asset with differentiated product profile. Under the terms of the arrangement, IMAB will fund further product development in exchange for an exclusive license in Asia with an option for worldwide use, with the goal of realizing the potential of olamkicept as a biomarker-guided and differentiated interleukin-6 blocker to treat autoimmune disease.

“We are very pleased to acquire the opportunity to further advance olamkicept and build on Ferring’s encouraging Phase 1 results in volunteers and in patients,” said Jingwu Zang, President and CEO of IMAB. “This agreement will accelerate IMAB’s mission to develop impactful therapies for autoimmune disease.”

“IMAB has a strong network of researchers and physicians in the autoimmune area in China and a willingness to develop our drug further in Asia and around the world,” said Alan Harris, Senior Vice President, R&D, Ferring Pharmaceuticals. “We are pleased to partner with IMAB in progressing our drug in this important therapeutic area with many unmet medical needs.”

– ENDS –

About Olamkicept

Olamkicept (pINN) is a recombinant Interleukin-6 (IL-6) soluble receptor antagonist based on an innovation by the Kiel-based German biotech company Conaris. IL-6 is a key cytokine in the pathogenesis of autoimmune diseases such as inflammatory bowel disease and rheumatoid arthritis. Olamkicept is a selective inhibitor of the IL-6 inflammatory pathway expected to be efficacious in disease treatment without affecting the beneficial effects of IL-6 for instance in the acute immune response to infection. The safety of olamkicept has been demonstrated in a phase 1 program.

About Ferring Pharmaceuticals

Headquartered in Saint-Prex, 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.

About IMAB

I-MAB is a Shanghai-based biotech company (天境生物) founded by world-class immunologists in China. It specializes in the discovery and development of innovative biologics in the therapeutic areas of immune-oncology and autoimmune disease for global markets with a focus on China. The company’s current innovative pipeline includes 5 monoclonal antibodies at the preclinical stage and several clinical assets, such as olamkicept, in partnership with global pharma and biotech companies.  I-MAB’s ongoing discovery is focused on developing novel bi-functional and bi-specific antibodies.

For more information, please contact

Ferring Pharmaceuticals
Lindsey Rodger
+41 (0) 58 451 40 23
lindsey.rodger@ferring.com

IMAB
Taylor Guo, PhD
+86 138 183 78490
taylor.b.guo@3rdventure.com

Ferring receives EU approval for REKOVELLE® (follitropin delta)

A novel human recombinant follicle stimulating hormone (human rFSH) administered using an individualised dosing regimen

Saint-Prex, Switzerland – 13 December 2016 –

Ferring Pharmaceuticals announced today that the European Commission (EC) has granted marketing authorisation for REKOVELLE^® (follitropin delta), a human recombinant follicle stimulating hormone (human rFSH), for use in controlled ovarian stimulation 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.¹

REKOVELLE^® is the first rFSH to be derived from a human cell line and is the first rFSH treatment to be administered with an individualised dosing regimen.^1–5 REKOVELLE^®’s individualised dosing regimen is based on a woman’s serum anti-Müllerian hormone (AMH) level and her body weight. With these parameters, a specific daily dose of REKOVELLE^® is determined for each patient from the start of the ART cycle.^1–4,6,7 AMH has surfaced as one of the most reliable biomarkers for assessing ovarian reserve.It can help predict a woman’s ovarian response to gonadotrophin stimulation and can also help guide the dosing of fertility treatments.^8,9 AMH will be measured by a companion diagnostic, the Elecsys^® AMH Plus immunoassay from F. Hoffmann-La Roche Ltd (Roche).^6,7

The EC approval of REKOVELLE^® is based on a comprehensive clinical data package, including results from the Phase 3 ESTHER trials (Evidence-based Stimulation Trial with Human rFSH in Europe and Rest of World).^2–4 Results of the ESTHER-1 trial were accepted for publication in Fertility & Sterility (article in press and available early online). The data shows that individualised treatment with REKOVELLE^® (follitropin delta), as compared to treatment with conventional rFSH (follitropin alfa), had similar results for the co-primary endpoints of ongoing pregnancy rates and ongoing implantation rates. Patients receiving REKOVELLE^® also reached the optimum oocyte yield (8–14 oocytes) more often than those receiving conventional rFSH treatment, with fewer clinically-relevant instances of poor and excessive ovarian response. In addition, ovarian hyperstimulation syndrome (OHSS) and/or OHSS preventive interventions occurred less frequently (p<0.05) in women receiving REKOVELLE^® than women receiving conventional rFSH treatment.⁴

“REKOVELLE^®’s individualised dosing regimen offers physicians a new method to deliver a consistent, evidence-based approach to personalising treatment for their patients, based on AMH, a highly predictive biomarker,” commented Professor Anders Nyboe Andersen, Principal Investigator of the ESTHER trials. “Using validated protocols for individualisation could help physicians facilitate the best possible outcomes for their patients by ensuring efficacy is maintained while also reducing complications during treatment.”

REKOVELLE^® is an integral part of Ferring’s commitment to translating the practice of personalised medicine into reproductive health and fertility. “Ferring has a long-standing commitment to scientific advancement in reproductive health,” said Michel Pettigrew, President of the Executive Board and COO at Ferring Pharmaceuticals. “As a research-driven company, we believe that by focusing on innovative and personalised approaches, we can continue to lead the way in fertility treatments and help women to plan their futures as mothers.”

About REKOVELLE^® (follitropin delta)

Follitropin delta (also known as FE 999049) is the first recombinant follicle stimulating hormone (rFSH) derived from a human cell line (PER.C6^® cell line).^1–4,5,10 It has been developed for individualised dosing based on a woman’s serum anti-Müllerian hormone (AMH) level, as determined by a companion diagnostic, the Elecsys^® AMH Plus immunoassay from Roche,^4,6,7 and her body weight. Follitropin delta is structurally and biochemically distinct from other existing recombinant FSH treatments.^1–4,5,10 

About the ESTHER trials

The ESTHER trials (Evidence-based Stimulation Trial with Human rFSH 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 controlled ovarian stimulation.^2–4

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.

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.^6,7,11–14 This fully automated Elecsys^® AMH Plus immunoassay, run on the cobas^® e systems and the 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 controlled ovarian stimulation (COS) and establishment of the individual daily dose of Ferring follitropin delta in combination with body weight in COS for the development of multiple follicles in women undergoing an assisted reproductive technology programme.^6,7,11–14

For more information, please contact

Lindsey Rodger
+41 (0) 58 451 40 23
lindsey.rodger@ferring.com

Marion Lindsay
+41 58 301 04 15
marion.lindsay@ferring.com

References

1. REKOVELLE® Summary of Product Characteristics (SmPC) – Available upon request.
2. Nyboe Andersen A et al. Efficacy and safety of follitropin delta in an individualised dosing regimen: A randomised, assessor-blind, controlled phase 3 trial in IVF/ICSI patients (ESTHER-1). Human Reproduction 2016; 31: 324
3. Buur Rasmussen A 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; 31: 385
4. Nyboe Andersen A et al. Individualized versus conventional ovarian stimulation for in vitro fertilization: a multicenter, randomized, controlled, assessor-blinded, phase 3 noninferiority trial. Fertil Steril. In press, available early online. doi.org/10.1016/j.fertnstert.2016.10.033
5. Arce J-C, Nyboe Andersen A, Fernandez Sanchez M, 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.
6. Deeks ED. Elecsys® AMH assay: a review in anti-Müllerian hormone quantification and assessment of ovarian reserve. Mol Diagn Ther 2015; 19: 245-249.
7. Roche Diagnostics. Elecsys® AMH (anti-Mullerian hormone): Method sheet. 2015. https://pim-eservices.roche.com. Last accessed Novemober 2016.
8. Nelson SM et al.  Anti-Müllerian hormone-based approach to controlled ovarian stimulation for assisted conception. Hum Reprod. 2009 Apr;24(4):867–75.
9. Fleming R, Broekmans F, Calhaz-Jorge C, et al. Can anti-Mullerian hormone concentrations be used to determine gonadotropin dose and treatment protocol for ovarian stimulation? Reproductive BioMedicine Online 2013;26:431–439.
10. 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. J Clin Pharmacol 2014; 54(11):1299–307.
11. Gassner D, Jung R. First fully automated immunoassay for anti-Müllerian hormone. Clin Chem Lab Med. 2014;52(8):1143-52.
12. Anderson RA, Anckaert E, Bosch E, et al. Prospective study into the value of the automated Elecsys antimüllerian hormone assay for the assessment of the ovarian growing follicle pool. Fertil Steril. 2015;103(4):1074–80.e4.
13. Nelson SM, Pastuszek E, Kloss G, et al. Two new automated, compared with two enzyme-linked immunosorbent antimüllerian hormone assays. Fertil Steril. 2015 Oct;104(4):1016-1021.e6.
14. Hyldgaard J, Bor P, Ingerslev HJ, et al. Comparison of two different methods for measuring anti-mullerian hormone in a clinical series. Reprod Biol Endocrinol. 2015 Sep 22;13(1):107.

Ferring Pharmaceuticals collaborates with MetaboGen AB on development of microbiome-based treatment for intrahepatic cholestasis of pregnancy (ICP)

Saint-Prex, Switzerland – 5 December 2016 –

Ferring Pharmaceuticals and MetaboGen AB today announced a multi-year research collaboration aimed at developing a microbiome-based product to prevent and treat intrahepatic cholestasis of pregnancy (ICP), a potentially serious liver disorder which affects around 400,000 pregnant women annually.

The genes and gene products produced by the trillions of microorganisms that live in the human body are collectively known as the microbiome. Current research into the microbiome is changing perspectives on health and disease, but there are still many factors that are not yet properly understood.

MetaboGen AB has developed and patented a concept for how patterns of bacteria in the gut could affect ICP. Ferring will fund an exploratory study to demonstrate this concept and define differences in the microbiome of healthy women and women with a history of IPC. Recruitment of patients for the 18-month study will begin on  December 6, 2016 and will be conducted in cooperation with the Women’s Clinic in Lund, Sweden.

“Ferring is one of the few pharmaceutical companies actively investing in research and development of new products in the obstetrics field,” said Alan Harris, Senior Vice President, R&D, Ferring Pharmaceuticals. “This collaboration demonstrates Ferring’s commitment to advancing research in the microbiome field in order to identify and develop innovative treatments that work on the body’s own terms, in this case for mothers and babies.”

“ICP is an indication in need of new and effective products that can improve both quality of life and quality of treatment for patients,” said Sara Malcus, CEO, MetaboGen AB. “We are very pleased to partner with a scientific leader in women’s health, and look forward to working with Ferring in this exciting area.”

– ENDS –

About Intrahepatic Cholestasis of Pregnancy (ICP)

Intrahepatic cholestasis of pregnancy (ICP) is a potentially serious liver disorder that can develop in pregnancy. IPC affects about 400,000 pregnant women annually and is a recurrent disease: 70% of women who have been diagnosed with ICP during their first pregnancy will be affected again in following pregnancies. In addition to itching, which may be intense and very uncomfortable for the mother, there are links between ICP and preterm birth and gestational diabetes.

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.

About MetaboGen AB

MetaboGen is a research-driven company with a focus on the microbiome and its impact on health, based in Gothenburg, Sweden. The company was founded based on break through science from the labs of Professor Fredrik Bäckhed (University of Gothenburg) and Professor Jens B Nielsen (Chalmers University of Technology). Since 2011, MetaboGen develops products based on advanced mapping of the intestinal microflora composition. In 2014 BioGaia AB invested in the company. MetaboGens technology along with more than 25 years of experience in the development of probiotics from BioGaia, provides the company with a unique opportunity to develop the next generation of microbial products.

For more information see www.metabogen.com

For more information, please contact

Ferring Pharmaceuticals
Lindsey Rodger
+41 (0) 58 451 40 23
lindsey.rodger@ferring.com

Ferring Pharmaceuticals and Aché Laboratórios Farmacêuticos collaborate on nanotechnology R&D platform

Saint-Prex, Switzerland – 30 November 2016 –

Ferring Pharmaceuticals and Aché Laboratórios Farmacêuticos today announced a long-term collaboration aimed at improving the bioavailability, efficacy and safety profile of oral therapeutic medicines through nanotechnology. Potential benefits of research in this area include a reduction of adverse effects, increased patient adherence to treatment and more convenient dosing.

From 2017, a joint R&D centre and programme, named Nanotechnology Innovation Laboratory Enterprise (NILE), will be housed at Aché’s R&D centre in São Paulo, Brazil, funded by Ferring and Aché and governed by a joint steering committee.

The centre will explore nanotechnology as a delivery system for future medicines through programmes designed to match each company’s therapeutic needs. For Ferring, this means a focus on peptides and proteins in reproductive health, gastroenterology and urology. For Aché, it represents a strategic platform to accelerate new therapeutic entity developments addressing different technical needs in order to deliver better product solutions.

“Peptides and proteins delivered orally are challenged by their inherent poor bioavailability and stability in the gastrointestinal tract, leading to less predictive therapeutic effect,” said Alan Harris, Senior Vice President, R&D, Ferring Pharmaceuticals. “Our collaboration is focused on developing new nanotechnology-based pharmaceutical treatments to solve these challenges and better serve the needs of our patients.”

“Developing new therapeutic entities by improving drug delivery characteristics of existing molecules could help improve quality of life for patients all over the world,” said  Paulo Nigro, CEO of Aché. “By collaborating along the R&D path in this exciting field, we will create a unique scientific environment able to tackle the main challenges in existing formulations and address unmet medical needs.”

The collaboration will be inaugurated with the first NILE International Nanotechnology Workshop, taking place in São Paulo from 1 – 2 December 2016 and featuring Brazilian and international nanotechnology experts from leading academic sites around the world.

– ENDS –

About Nanotechnology

Nanotechnology is a branch of technology focused on understanding and controlling matter at the very smallest scales. At nanoscale, properties can be very different when compared to those with which we are familiar. Such radical new properties mean that nanotechnology has the potential to revolutionise current drug delivery technologies, and offers many opportunities to create revolutionary new drug delivery systems, formulations for poorly soluble drugs and novel devices. In addition to the potential advantages of enhancing systemic administration, nanoparticulate drug delivery systems can also be used for site-specific delivery, thus alleviating unwanted toxicity due to nonspecific distribution, helping to improve patient compliance and provide favourable clinical outcomes. Nanotechnology platforms will help in the development of advanced drug-delivery systems to decrease the failure rate of new active pharmaceutical ingredients (APIs), bio-therapeutic agents and vaccines caused by poor absorption, or distribution, significant drug toxicity, and rapid metabolism or excretion.

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.

About Aché Laboratórios Farmacêuticos

Aché is a Brazilian company with 50 years of experience in the Latin American pharmaceutical market. Aché has four industrial production sites in Brazil and employees nearly 4,500 people. Half of them are focused on demand generation in the field offering a portfolio of more than 300 brands in nearly 800 submissions to meet the needs of healthcare professionals and consumers. Even though the core business is in the prescription medicines, Aché is also present in OTC, Generics, Skin Cosmetics and Nutraceuticals. In all, 130 therapeutic classes and more than 20 medical specialties are served. Recently, with the creation of Bionovis, it has began operating in Biotechnology field. Aché exports to 20 countries in Americas, Africa, Middle East and Japan.

To know more about Aché, please visit www.ache.com.br.

For more information, please contact

Ferring Pharmaceuticals
Lindsey Rodger
+41 (0) 58 451 40 23
lindsey.rodger@ferring.com

Aché Laboratórios Farmacêuticos
Deyvis Drusian Gomes
CDI Public Relations
+ 55 (11) 3817-7994
deyvis@cdicom.com.br

Ferring receives positive CHMP opinion for REKOVELLE® (follitropin delta)

If approved, Ferring’s novel human recombinant follicle stimulating hormone (FSH) would be administered using an individualised dosing regimen

Saint-Prex, Switzerland – 17 October 2016 –

Ferring Pharmaceuticals announced today that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for REKOVELLE^® (follitropin delta), recommending that the European Commission grants marketing authorisation for use in controlled ovarian stimulation 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.^1–3 The European Commission has authority to grant marketing authorisation for medicines in the 28 countries of the European Union (EU). Following a European Commission decision, authorisation can also be granted by national authorities in Norway and Iceland.

If approved, REKOVELLE^® would be 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.^4,5 This can help to predict ovarian response to controlled ovarian stimulation and thus identify patients who may be at higher risk of experiencing reduced efficacy or increased safety concerns.^4,6,7 The individualised dosing regimen determines a specific daily dose of REKOVELLE^® for each patient, with the aim of maintaining efficacy and improving safety during controlled ovarian stimulation. AMH would be measured by a companion diagnostic, the Elecsys^® AMH Plus immunoassay from F. Hoffmann-La Roche Ltd (Roche).^8,9

“The individualised dosing regimen for REKOVELLE^® aims to further enrich the personalised care that fertility specialists offer their patients,” said Dr Per Falk, M.D. Ph.D., Chief Scientific Officer and Executive Vice President at Ferring Pharmaceuticals. “If approved, this would be the first pairing of a drug with a companion diagnostic for individualised dosing in reproductive medicine.”

The CHMP positive opinion is based on a comprehensive clinical development programme, including the Phase 3 ESTHER trials (Evidence-based Stimulation Trial with Human recombinant FSH in Europe and Rest of World), involving 1,326 patients in 11 countries, and over 2,000 cycles of controlled ovarian stimulation.^1–3,10,11

Non-inferiority was demonstrated in a Phase 3 trial for the co-primary endpoints of ongoing pregnancy rate and ongoing implantation rate for REKOVELLE^® compared to follitropin alfa (conventional treatment and dosing regimen). Secondary endpoints, including the number of oocytes retrieved and number of blastocysts obtained, were comparable between both groups. The Phase 3 clinical trials also demonstrated no increased immunogenicity risk and a good safety profile for REKOVELLE^® with repeated cycles of controlled ovarian stimulation.^3,11

About REKOVELLE^® (follitropin delta)

Follitropin delta (also known as FE 999049) is the first recombinant follicle stimulating hormone (FSH) derived from a human cell line.^1,12 It has been developed for individualised dosing based on a woman’s serum anti-Müllerian hormone (AMH) level, as determined by a companion diagnostic, the Elecsys^® AMH Plus immunoassay from Roche,^1,5,6,8,9 and her body weight. Follitropin delta is structurally and clinically distinct from other existing recombinant FSH treatments.^1,12

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 fertility clinics in Europe, Canada, Brazil and Russia.^2,3

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.

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.^8,9,13–16 This fully automated Elecsys^® AMH Plus immunoassay uses 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 controlled ovarian stimulation (COS) and establishment of the individual daily dose of Ferring follitropin delta in combination with body weight in COS for the development of multiple follicles in women undergoing an assisted reproductive technology program.^8,9,13–16

For more information, please contact

Lindsey Rodger
Head of Corporate Communications
+41 (0) 58 451 40 23
lindsey.rodger@ferring.com

Marion Lindsay
+41 58 301 04 15
marion.lindsay@ferring.com

References

1. Arce J-C, Nyboe Andersen A, Fernandez Sanchez M, 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.
2. ESTHER-1 trial. www.clintrials.gov Available at: https://clinicaltrials.gov/ct2/show/NCT01956110. Last accessed: September 2016.
3. ESTHER-2 trial. www.clintrials.gov. Available at: https://clinicaltrials.gov/ct2/show/NCT01956123. Last accessed: September 2016
4. Fleming R, Broekmans F, Calhaz-Jorge C, et al. Can anti-Mullerian hormone concentrations be used to determine gonadotropin dose and treatment protocol for ovarian stimulation? Reproductive BioMedicine Online 2013;26:431–439.
5. La Marca A and Sunkara SK. Individualization of controlled ovarian stimulation in IVF using ovarian reserve markers: from theory to practice. Hum Reprod Update 2014;20: 124–140.
6. American Society for Reproductive Medicine. Medications for Inducing Ovulation – A guide for patients. Available here. Last accessed: September 2016.
7. Nelson SMet al.  Anti-Müllerian hormone-based approach to controlled ovarian stimulation for assisted conception. Hum Reprod. 2009 Apr;24(4):867–75.
8. Deeks ED. Elecsys® AMH assay: a review in anti-Müllerian hormone quantification and assessment of ovarian reserve. Mol Diagn Ther 2015; 19: 245-249.
9. Roche Diagnostics. Elecsys® AMH Plus: Method sheet. 2016.
10. Nyboe Andersen A and Arce JC on behalf of the ESTHER-1 trial group. Efficacy and safety of follitropin delta in an individualised dosing regimen: A randomised, assessor-blind, controlled phase 3 trial in IVF/ICSI patients (ESTHER-1). Poster presented at 32nd Annual Meeting of the European Society of Human Reproduction and Embryology (ESHRE) in Helsinki, 3–6 July 2016. Hum Reprod. 2016;31(Supp 1):i315.
11. Buur Rasmussen A et al, on behalf of the ESTHER-1 and ESTHER-2 trial group.  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). Poster presented at 32nd Annual Meeting of the European Society of Human Reproduction and Embryology (ESHRE) in Helsinki, 3–6 July 2016. Hum Reprod. 2016;31(Supp 1):i376.
12. 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. J Clin Pharmacol 2014; 54(11):1299–307.
13. Gassner D, Jung R. First fully automated immunoassay for anti-Müllerian hormone. Clin Chem Lab Med. 2014;52(8):1143-52.
14. Anderson RA, Anckaert E, Bosch E, et al. Prospective study into the value of the automated Elecsys antimüllerian hormone assay for the assessment of the ovarian growing follicle pool. Fertil Steril. 2015;103(4):1074–80.e4.
15. Nelson SM, Pastuszek E, Kloss G, et al. Two new automated, compared with two enzyme-linked immunosorbent antimüllerian hormone assays. Fertil Steril. 2015 Oct;104(4):1016-1021.e6.
16. Hyldgaard J, Bor P, Ingerslev HJ, et al. Comparison of two different methods for measuring anti-mullerian hormone in a clinical series. Reprod Biol Endocrinol. 2015 Sep 22;13(1):107.