Aachen, Germany & Toronto, Canada - Grünenthal, a global leader in pain management and related diseases, and
Apotex Inc. ("Apotex"), the largest Canadian-based pharmaceutical
company, today announced they have entered into a licensing agreement
whereby Apotex will have the exclusive Canadian rights to Nebido®
(testosterone undecanoate), a long-acting injectable therapy indicated
for the treatment of male hypogonadism (testosterone deficiency).[1]
Under the agreement, Searchlight Pharma, Apotex's branded medicine
division, will pursue marketing authorisation and will market and
distribute the productin Canada upon regulatory approval. Grünenthal
will receive an upfront payment, regulatory milestone payments, anda
margin on the sales.
This agreement deepens the existing partnership between Grünenthal and
Apotex and strengthens their shared commitment to expanding Canadian
patients' access to important therapies.
"We are delighted to expand our partnership with Apotex and further
strengthen the global presence of the brand," says Jan Adams, Chief
Commercial Officer (CCO) at Grünenthal. "Through this agreement, we are
providing a valuable and well-established brand that can benefit
countless people living with testosterone deficiency in Canada."
"This marks an important step in Apotex's mission to broaden access to
innovative medicines and advance our purpose as a Force for Health,"
says Mark Nawacki, President, Searchlight Pharma. "Nebido® addresses a
recognised need in men's health and represents our first entry into
testosterone therapy – opening a meaningful new therapeutic area for
Apotex while strengthening our branded portfolio and expanding our
presence in specialty care."
Grünenthal acquired the global rights for the brand in 2022 as part of
its growth strategy. Since 2017, the company has invested over €2
billion in successful mergers and acquisitions (M&A) transactions,
diversifying its portfolio, enhancing its profitability, and driving
business growth. Grünenthal continues to expand the footprint of these
brands and to create synergies throughout Grünenthal's infrastructure,
including manufacturing, supply, logistics, and commercial activities.
About hypogonadism (testosterone deficiency)
Male hypogonadism due to a reduced or absent secretion of testosterone
from the testes is characterised by clinical symptoms such as low
libido, erectile dysfunction, asthenia, small testes and decreased
muscle mass. These symptoms are sometimes misinterpreted as signs of
stress and ageing. In addition to physical symptoms, there can also be
psychological symptoms, including depression. One in six men over 50
live with symptomatic androgen deficiency[2]. Only one in ten men
between the age of 30 to 79 with symptomatic androgen deficiency
receives treatment[3].
About Nebido®
Nebido® is an injectable long-acting depot preparation of testosterone
undecanoate. Nebido® is indicated for testosterone replacement therapy
in adult men with confirmed hypogonadism, a condition caused by
insufficient testosterone levels. The product is directly administered
by a physician every 10 – 14 weeks.
About Apotex
Apotex is a Canadian-based global health company. We improve everyday
access to affordable, innovative medicines and health products for
millions of people around the world, with a broad portfolio of generic,
biosimilar, and innovative branded pharmaceuticals, and consumer health
products. Headquartered in Toronto, with regional offices globally,
including in the United States, Mexico, and India, we are the largest
Canadian-based pharmaceutical company and a health partner of choice for
the Americas for pharmaceutical licensing and product acquisitions.Learn
more about us at www.apotex.com.
About Grünenthal
Grünenthal is a global leader in pain
management and related diseases. As a science-based, fully integrated
pharmaceutical company, we have a long track record of bringing
innovative treatments and state-of-the-art technologies to patients
worldwide. Our purpose is to change lives for the better – and
innovation is our passion. We focus all our activities and efforts on
working towards our vision of a World Free of Pain.
Grünenthal is headquartered in Aachen, Germany, and has affiliates in 28
countries across Europe, Latin America, and the U.S. Our products are
available in approx. 100 countries. In 2024, Grünenthal employed around
4,300 people and achieved revenues of €1.8 billion.
Learn more about us at: www.grunenthal.com|
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[1] https://www.medicines.org.uk/emc/product/14631/smpc
[2] Araujo, A. B., Esche, G. R., Kupelian, V., O’Donnell, A. B.,
Travison, T. G., Williams, R. E., ... & McKinlay, J. B. (2007).
Prevalence of symptomatic androgen deficiency in men. The Journal of
Clinical Endocrinology & Metabolism, 92(11), 4241-4247.
[3] Hall, S. A., Araujo, A. B., Esche, G. R., Williams, R. E., Clark, R.
V., Travison, T. G., & McKinlay, J. B. (2008). Treatment of symptomatic
androgen deficiency: results from the Boston Area Community Health
Survey. Archives of internal medicine, 168(10), 1070-1076.
Media Contacts:
Apotex
Media, media@apotex.com
Grünenthal
Maren Thurow
Head of Global Communications
+44 7917 196855
Maren.Thurow@grunental.com
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