Teva Launches Ovaleap®▼ (follitropin alfa, r-hFSH) In UK

Recombinant Human Follicle-Stimulating Hormone (r-hFSH) Biosimilar Now Available for the Treatment of Infertility

Teva UK Limited recently announces the launch of Ovaleap (follitropin alfa, r-hFSH) recombinant human follicle-stimulating hormone in the UK. Ovaleap is a fertility treatment for anovulation, stimulation of follicular development and spermatogenesis, which has been approved by the European Medicines Agency (EMA).

Ovaleap is a biosimilar to Gonal-f (follitropin alfa, r-hFSH) from Merck Serono. It has the same indication and, comparable efficacy and safety profile.¹ Ovaleap is administered via a re-useable self-injection pen – the Ovaleap Pen – which can hold three different cartridge sizes (300 IU, 450 IU and 900 IU).¹

Europe has the lowest fertility rate in the world.² In the UK, approximately one in seven couples will experience infertility issues.³

In the UK, Ovaleap is licensed for the treatment of anovulation and the stimulation of follicular development in women in conjunction with assisted reproductive technologies (ART) or with a luteinising hormone.¹ It is also indicated for the stimulation of spermatogenesis in men.¹

Christophe Pelletier, Vice President Women’s Health Europe, Teva Pharmaceuticals, said: “As a leading global pharmaceutical company that delivers patient-centric healthcare solutions to millions of people every day, we hope that by providing a r-hFSH alternative, more people facing infertility will be able to access and benefit from treatment.”

Ovaleap received Marketing Authorisation from the European Commission in September 2013, following a detailed review by the European Medicines Agency of the quality and biological properties of the product, and of safety, efficacy and tolerability data.

Ovaleap has demonstrated therapeutic equivalence with Gonal-f in clinical trials, including a Phase III study in infertile women undergoing IVF, showing no difference between the two treatments in the number or quality of eggs (oocytes) retrieved from the ovaries,⁴ or in the number of babies born.⁴ Ovaleap is also proven to have a comparable safety profile to its reference product.⁴

About Ovaleap and the Ovaleap Pen

Ovaleap (follitropin alfa, r-hFSH) is a biologic rFSH treatment that is licensed in the following indications:¹

In adult women

• Anovulation (including polycystic ovarian syndrome) in women who have been unresponsive to treatment with clomifene citrate
• Stimulation of multifollicular development in women undergoing superovulation for ART, such as IVF, gamete intra-fallopian transfer and zygote intra-fallopian transfer
• Ovaleap, in association with a luteinising hormone (LH) preparation, is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials these patients were defined by an endogenous serum LH level <1.2 IU/L

In adult men

• The stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human chorionic gonadotropin therapy

Patients can self-administer Ovaleap using the CE-approved Ovaleap Pen,¹ a convenient, re-useable injection pen, designed for ease-of-use, accuracy and flexible dosing for all indications. The pen can hold three cartridge sizes (300 IU, 450 IU and 900 IU) and patients can use the pen to adjust their dose by 12.5 IU increments, as instructed by their doctors. The Ovaleap Pen has a number of features designed to give healthcare professionals peace of mind that their patients are self-administering Ovaleap correctly. These include:

• A large dosing window with legible numbers confirms the dose size, while a clear cartridge holder lets the patient see how much medication is inside
• A dial-back feature allows quick and easy correction if the dose is set incorrectly
• The injection is administered at the simple press of a side-button

About Biosimilars

A biosimilar is a biological medicine that is similar to another, approved biological medicine.⁵  To be approved in Europe, a biosimilar must be shown to have equivalent quality, safety and efficacy to its reference product.⁵

REFERENCES

1. Ovaleap Summary of product Characteristics.

2. ESHRE Capri Workshop Group. Europe the continent with the lowest fertility. Hum Reprod Update. 2010. 16 (6):590–602

3. Fertility: assessment and treatment for people with fertility problems, National Collaborating Centre for Women’s and Children’s Health Commissioned by the National Institute for Health and Clinical Excellence, February 2013. Available at:www.nice.org.uk/guidance/cg156/evidence/full-guideline-188539453 [Accessed Jan 2016]

4. Gertz B, Strowitzki T. Phase 3 study of efficacy, safety, and tolerability of XM17 (Ovaleap) compared to Gonal-f in women undergoing assisted reproductive technologies [abstract]. Presented at the 10th Congress of the European Society of Gynecology, September 18-21, 2013: Brussels, Belgium

5. Biosimilar Medicines. European Medicines Agency. Available at: www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/document_listing/document_listing_000318.jsp [Accessed Oct 2015]

About Teva UK Limited
Teva UK Limited is one of the UK’s top ten pharmaceutical manufacturers, with a presence in the generics, branded respiratory, CNS and hospitals markets. It has the widest range of any UK generic pharmaceutical company and markets solid and liquid dose, injectable and respiratory medicines to healthcare professionals. The company is part of Teva Pharmaceutical Industries Ltd. For more information, visit www.tevauk.com.

About Teva
Teva Pharmaceutical Industries Ltd. is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions to millions of patients every day. Headquartered in Israel, Teva is the world’s largest generic medicines producer, leveraging its portfolio of more than 1,000 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, Teva has a world-leading position in innovative treatments for disorders of the central nervous system, including pain, as well as a strong portfolio of respiratory products. Teva integrates its generics and specialty capabilities in its global research and development division to create new ways of addressing unmet patient needs by combining drug development capabilities with devices, services and technologies. Teva's net revenues in 2014 amounted to $20.3B. For more information, visit www.tevapharm.com.