Mithra Signs LSA with Alvogen for Commercialization of Estelle? in Hong Kong and Taiwan
[caption id="attachment_9277" align="aligncenter" width="1079"] Press Release[/caption]
Mithra grants exclusive license to Alvogen for commercialization of its combined oral
contraceptive Estelle? in Hong Kong and Taiwan
? Agreement follows licensing deals for Estelle? with market leaders in U.S., Europe, Russia,
Canada, Brazil, Japan, South Korea, Middle East and South Africa
Liege, Belgium, 6 January 2020 ? 7 :30 CET ? Mithra (Euronext Brussels: MITRA), a company dedicated
to Women?s Health, today announces that it has signed an exclusive license and supply agreement
with Alvogen for the commercialization of Estelle? in Hong Kong and Taiwan. Estelle? is Mithra?s novel
combined oral contraceptive (COC) product candidate, containing 15 mg Estetrol (E4) and 3 mg
drospirenone (DRSP).
Alvogen is a global, privately owned pharmaceutical company focused on developing, manufacturing
and selling generic, brand, over-the-counter brands (OTC) and biosimilar products for patients around
the world. Alvogen has commercial operations in 35 countries with 2,800 employees and operates four
manufacturing and development hubs in the U.S., Romania, Korea and Taiwan.
Under the term of this 20-year agreement, Alvogen will distribute Estelle? in Hong Kong and Taiwan
where the hormonal contraception market is worth approximately EUR 20 million per year. More than
half of the market is dominated by DRSP/EE, Estelle?s? benchmark 1
. Mithra will receive down
payments, sales-related milestones, royalties and recurring revenues bases on Minimal Annual
Quantities (MAQ). Moreover, Mithra will manufacture Estelle? at its Contract Development and
Manufacturing Organization facility in Belgium.
This agreement follows a number of licensing deals for Estelle? with key commercial partners in
leading markets, including the United States, Europe, Russia, Japan/ASEAN, Brazil, Canada, South
Africa, South Korea, Israel and Middle East.
Fran?ois Fornieri, CEO Mithra Women?s Health, commented: ?We are pleased to have finalized the
agreement with Alvogen for the commercialization of our contraceptive Estelle? in Hong Kong and
Taiwan. After the landmark deal signed in October with Mayne Pharma for the United States, we
continue to extend Estelle's licenses with best-in-class partners to maximize the potential of our
innovative product in core territories?.
Commenting on the transaction, Petar Vazharov, Executive Vice President of Alvogen APAC, said:
?Strengthening our Asian presence with branded assets is an integral part of our persistent efforts to
generate growth and establish economies of scale in the Asia Pacific region. We are positive that the
innovation of Estelle? is a strong addition to our women healthcare focus here in Asia. ?
1
IQVIA 2018 Data
investors.mithra.com 2
06-01-2020 PRESS RELEASE
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For more information, please contact:
Alexandra Deschner (IRO) : +32 490 58 35 23 - investorrelations@mithra.com
Maud Vanderthommen (Press) : +32 473 58 61 04 ? press@mithra.com
About Mithra
Mithra (Euronext: MITRA) is a Belgian biotech company dedicated to transforming Women?s Health by offering
new choices through innovation, with a particular focus on contraception and menopause. Mithra?s goal is to
develop products offering better efficacy, safety and convenience, meeting women?s needs throughout their life
span. Its three lead development candidates are built on Mithra?s unique native estrogen platform, Estetrol (E4):
Estelle?, a new era in oral contraception, PeriNesta?, the first complete oral treatment for perimenopause and
Donesta?, the next-generation hormone therapy. Mithra also develops and manufactures complex therapeutics
in the areas of contraception, menopause and hormone-dependent cancers. It offers partners a complete
spectrum of research, development and specialist manufacturing at its technological platform Mithra CDMO.
Active in more than 85 countries around the world, Mithra has an approximate headcount of 250 staff members
and is headquartered in Li?ge, Belgium. www.mithra.com
About Estelle?
Estelle? is Mithra?s novel combined oral contraceptive (COC) product candidate based on Estetrol (E4)15 mg and
drospirenone (DRSP) 3 mg. E4 is a native estrogen that is produced by the human fetus, passing the maternal
blood at relatively high levels during pregnancy. In two phase III clinical studies conducted in 3,725 women,
E4/DRSP showed positive top-line results against primary efficacy and safety endpoints and achieved positive
secondary endpoints including good bleeding profile, cycle control, and tolerability. Mithra has signed 9 licensing
deals for Estelle? with a number of leading women?s health companies covering Europe, Japan, South Korea,
ASEAN, Russia, Brazil, Canada, Middle East, North Africa, Southern Africa and United States.
About Alvogen
Alvogen is a global, privately owned pharmaceutical company focused on developing, manufacturing and selling
generic, brand, over-the-counter brands (OTC) and biosimilar products for patients around the world. Alvogen
has commercial operations in 35 countries with 2,800 employees and operates four manufacturing and
development hubs in the US, Romania, Korea and Taiwan. North America is Alvogen?s single largest market, other
key markets include: South Korea, West Balkan, Poland, Romania, Bulgaria, Hungary, Taiwan, Ukraine, Russia,
Japan and China.
Important information
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