Business Wire

Ferring Announces Positive Outcome of European Decentralised Procedure (DCP) for Testavan®, a Treatment for Men with Hypogonadism

Jaa

Ferring Pharmaceuticals today announced the positive outcome of the European Decentralised Procedure (DCP) for Testavan® (transdermal testosterone gel 2%), a testosterone replacement therapy for adult male hypogonadism, when testosterone deficiency has been confirmed by clinical features and biochemical tests. The Netherlands acted as Reference Member State (RMS) on behalf of all 31 European Economic Areas (EEA) countries.1

Men suffering from hypogonadism symptoms, including erectile dysfunction and fatigue, often remain untreated due to barriers that delay diagnosis and lack of treatment options,” said Per Falk, Executive Vice President and Chief Science Officer, Ferring Pharmaceuticals. “Ferring is committed to delivering innovative healthcare solutions to treat a number of male urologic conditions. With the positive outcome of the DCP, hypogonadal patients in many European countries will soon have access to a convenient treatment to normalise testosterone and relieve symptoms.

Testavan’s fast-drying gel formulation is based on Ferring’s Advanced Skin Technology (F.A.S.T.), a proprietary transdermal gel technology, which enhances bioavailability of testosterone through the skin. Testavan’s low dose and volume, in addition to its unique hands-free applicator, were designed to ensure patient convenience. The hands-free applicator may lower the risk of transference of testosterone skin residue from the patient to others.8-10

In phase III trials, men treated with Testavan achieved normalised testosterone levels by month three, with improvements in quality of life and fatigue scores over three months, and early and sustained increase in erectile function score at one and three months. Assessment measures included testosterone responder rate, defined as the percentage of subjects achieving normalised levels of testosterone (300-1050 ng/dL); the Multidimensional Assessment of Fatigue (MAF); general well-being assessment (Short Form 12 Health Survey, SF-12); International Index of Erectile Function (IIEF).

About male hypogonadism

Male hypogonadism is a condition characterised by low levels or absence of testosterone due to certain medical conditions, and signs and symptoms of testosterone deficiency. Male hypogonadism is reported to have an incidence of 2-6% in men aged 40-79 years and becomes more common with age.3 There is a substantial quality of life and clinical burden associated with hypogonadism in men, and can be associated with comorbidities such as diabetes, metabolic syndrome, cardiovascular diseases, and adverse bonehealth.3,11-14

About Testavan

Testavan, the new 2% testosterone gel, uses a proprietary hydroalcoholic and highly viscous topical formulation. The product is homogeneous, transparent and nonstaining, and comes in a metered dose dispenser that includes a hands-free cap applicator for precise dispensing and application. The starting dose is 23 mg testosterone, delivered by one pump actuation, contained in 1.15 g of gel, and the highest dose is 3.45 g of gel containing 69 mg testosterone (delivered by 3 pump actuations).1

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. 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 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 and @Ferring, or connect with us on Facebook, Instagram and LinkedIn.

# # #

References

1 Ferring Pharmaceuticals. Data on file 2018.
2 Nieschlag E, Behre HM (eds). Andrology: male reproductive health and dysfunction. 3rd edn. Heidelberg: Springer, 2010.
3 Dohle G. et al. Guidelines on Male Hypogonadism. EAU guidelines 2017. Available at: http://uroweb.org/guideline/male-hypogonadism/#note_4 Last accessed: March 2018
4 Belkoff L. et al. Efficacy and safety of testosterone replacement gel for treating hypogonadism in men: Phase III open label studies. Andrologia 2018 Feb;50(1). doi: 10.1111/and.12801. Epub 2017 Mar 10.
5 Arver S. et al. A new 2% testosterone gel formulation: A comparison with currently available topical preparations. In Press. Andrology 2018.
6 Cunningham G et al. Efficacy and safety of a new topical testosterone replacement gel therapy for the treatment of male hypogonadism. Endocr Pract 2017;23(5):557-565.
7 Testavan Summary of Product Characteristics. Ferring Pharmaceuticals.
8 Alberti I. et al. Pharmaceutical development and clinical effectiveness of a novel gel technology for transdermal drug delivery. Expert Opin Drug Deliv 2005;2:935-950.
9 Olsson H. et al. Pharmacokinetics and Bioavailability of a New Testosterone Gel Formulation in Comparison to Testogel in Healthy Men. Clin Pharmacol Drug Dev 2014;3(5):358-64.
10 Efros M., Carrara D., Neijber A. The efficacy, bioavailability and safety of a novel hydroalcoholic testosterone gel 2% in hypogonadal men: results from phase II open-label studies. Andrologia 2016;48(6):637-645.
11 Kalyani RR, Dobs AS. Androgen deficiency, diabetes, and the metabolic syndrome in men. Curr Opin Endocrinol Diabetes Obes 2007;14(3):226-234.
12 García-Cruz E. et al. Metabolic syndrome in men with low testosterone levels: relationship with cardiovascular risk factors and comorbidities and with erectile dysfunction. J Sex Med 2013;10(10);2529-2538.
13 Rodriguez-Tolrà J. et al. Effects of testosterone treatment on bone mineral density in men with testosterone deficiency syndrome. Andrology 2013;1(4):570-575.
14 Zarotsky V. et al. Systematic literature review of the risk factors, comorbidities, and consequences of hypogonadism in men. Andrology 2014;2(6):819-834.

Contact information

Ferring Pharmaceuticals
Bhavin Vaid
Head of Corporate Communications
+41 583010952 (direct)
+41 791910632 (mobile)
bhavin.vaid@ferring.com
Lindsey Rodger
Senior Manager, Corporate Communications
+41 584514023 (direct)
+41 791910486 (mobile)
lindsey.rodger@ferring.com

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

World Leader in High-End Mobile Security, Kaymera Technologies, to Expand Adaptive Mobile Threat Defense Footprint18.10.2018 16:56Tiedote

Kaymera Technologies, the leader in high-end Mobile Threat Defense solutions, today announced that BGŻ BNP Paribas have chosen the Kaymera’s Adaptive Mobile Threat Defense Platform to help protect personal and business-related mobile data across its employee base and business partners. According to a recent reports survey of IT Security professionals on Bring Your Own Device (BYOD), one in five organizations has suffered a mobile security breach, primarily driven by malware and malicious WiFi. 24% of organizations confirmed their mobile devices have connected to malicious WiFi networks while 48% were unsure if there have been any mobile security incidents. With at least one device in every large organization likely infected with malware, and one-third of executives experiencing network attacks, most enterprises are looking for a strong defense system against mobile threats. “We were looking for solutions to further increase mobility across our organization by boosting our mobile securi

Piraeus Bank Signs Financing Agreement of €40 million with Thomas Cook Hotel Investments18.10.2018 16:18Tiedote

Piraeus Bank signed a financing agreement of €40 million with Thomas Cook Hotel Investments (TCHI), a joint venture between Thomas Cook plc and LMEY Investments AG. Piraeus Bank is the sole financial partner of TCHI in Greece and the financing will be used to invest in local hotel properties. Thomas Cook Hotel Investments was established in March 2018 to support the growth of Thomas Cook’s own-brand hotels in Spain and Greece. The portfolio of TCHI includes owned hotel properties in Rhodes and Crete under the brand of Sunwing. Thomas Cook Group is one of the world’s leading leisure travel groups, with sales of £9 billion in the year ended 30 September 2017, serving over 20 million customers annually. Thomas Cook was the biggest international tour operator in Greece this year, while it served 3 million customers. Funding of tourism, a vital sector for the Greek economy, is a key priority for Piraeus Bank. With a tourism portfolio in excess of €2 billion, the Bank supports tourism busine

StarLeaf Reinforces Its Global Expansion With New Office in Norway18.10.2018 16:00Tiedote

StarLeaf, a leading provider of premium meeting room solutions and video conferencing services, has expanded its global reach with a new office in Oslo, Norway, enabling it to meet increased demand and serve local customers and partners. This announcement is further testament to the company’s fast-paced growth in key markets, which sees StarLeaf systematically increase its global footprint into key regions and countries. “Norway has a prominent history of originating and using video conferencing and collaboration technologies. However, today businesses are looking for next-generation solutions that deliver greater flexibility and scalability, to match their plans for growth and investment,” said Peter Sanevall, StarLeaf Country Manager for the Nordics Countries. “With the opening of our Oslo office, we are well-positioned to address this demand.” StarLeaf provides an end-to-end business collaboration and meeting room solution delivered by the StarLeaf Cloud and its premium hardware sys

Starbucks Evolves Structure in EMEA to Accelerate Long-Term Strategic Growth18.10.2018 15:30Tiedote

Starbucks Coffee Company (NASDAQ: SBUX) today announced our intention to fully license Starbucks operations in France, the Netherlands, Belgium and Luxemburg to its longstanding strategic partner Alsea, S.A.B. de C.V. (BMV: ALSEA), the largest independent chain restaurant operator in Latin America. Under this proposal, which is subject to relevant local laws, and discussions with relevant employee representatives, Alsea will have the rights to operate and develop Starbucks stores in these markets, building on Starbucks regional growth agenda that drives value through strategic licensed relationships. At the same time the company would introduce a new support structure in its head office in London to better serve an increasingly licensed strategy. “We’re very pleased to build on our 16-year history with Alsea, a long-term strategic partner to Starbucks, with the intention to license our business operations in France, the Netherlands, Belgium and Luxemburg,” said John Culver, group presi

Visa Expands Tokenization Partnership With Netflix to Improve Digital Payments Experience Globally18.10.2018 15:00Tiedote

Building on a pilot program that began in 2017, Visa (NYSE: V) today announced an expansion of Netflix’s use of the Visa Token Service, with a key focus of improving card-not-present authorization rates and enabling a more seamless and secure merchant and customer experience globally. Visa and Netflix are working together to realize the benefit of higher authorization rates resulting from global issuer lifecycle management of Visa tokens. With the Visa Token Service, card details can be replaced with a unique digital identifier used to process payments without exposing the cardholder’s sensitive account information. For those Visa tokens, issuers around the world can push dynamic updates on lost, stolen or expired credentials to enable a frictionless merchant and customer experience. As part of the effort to expand these benefits more broadly to issuers and card-not-present merchants generally, Visa is now working with Netflix and other token participants to measure these improvements

FLIR Systems Announces Industry-First Deep Learning-Enabled Camera Family18.10.2018 15:00Tiedote

FLIR® Systems, Inc. (NASDAQ: FLIR) today announced the FLIR Firefly® camera family, the industry’s first deep learning inference-enabled machine vision camera. The FLIR Firefly, which integrates the Intel® Movidius™ Myriad™ 2 Vision Processing Unit (VPU), is designed for image analysis professionals using deep learning for more accurate decisions, and faster, easier system development. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181018005168/en/ FLIR Firefly Integrates Intel® Movidius™ Myriad™ 2 VPU to Enable Deep Neural Networks for On-Camera Inference (Photo: Business Wire) Traditional rules-based software is ideal for straightforward tasks such as barcode reading or checking a manufactured part against specifications. The FLIR Firefly combines a new, affordable machine vision platform with the power of deep learning to address complex and subjective problems such as recognizing faces or classifying the quality of a sol

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme