SHANGHAI, June 6, 2018 /PRNewswire/ -- The $538 million acquisition by Luye Pharma Group
Ltd. (HKSE:2186) of Seroquel quetiapine fumarate from AstraZeneca
plc (LSE:AZN; NYSE:AZN) will lay the commercial groundwork in new
emerging markets for the Chinese pharma's internal CNS
pipeline.
On May 7, Luye licensed exclusive
rights to market the dibenzothiazepine atypical antipsychotic and
its extended-release formulation, Seroquel XL, in 51 countries
spanning developed and emerging markets. While Luye already markets
products in developed and some emerging markets such as
Russia and Indonesia, the deal will give Luye access to
additional emerging markets including Mexico, Brazil, Saudi
Arabia and South
Africa.
Seroquel and Seroquel XL are marketed to treat bipolar disorder,
schizophrenia, depression and mania.
In markets covered by the deal, 2017 sales of Seroquel and
Seroquel XL totaled $85 million and
$63 million, respectively. Seroquel's
compound patents have expired globally, and Seroquel XL's
formulation patents have expired in most markets.
Luye plans to use the same local distributors for Seroquel as
AZ, which VP of International Business and Strategy Sammy Jiang
said will enable the pharma to establish name recognition and
develop local sales relationships ahead of its planned 2H19 launch
of its internal schizophrenia and bipolar disorder candidate
LY03004, which comprises risperidone extended-release
microspheres.
Jiang said Luye plans to launch LY03004 first in established
markets, such as the U.S., EU and China, followed by launches in emerging
markets one to three years later. The company anticipates following
a similar launch strategy for its other CNS therapies.
Luye has three other candidates in its CNS pipeline. The most
advanced are LY03003, an extended release microsphere formulation
of rotigotine for Parkinson's disease, and LY03005, an oral
serotonin-norepinephrine-dopamine triple reuptake inhibitor (SNDRI)
to treat major depressive disorder (MDD). Luye expects to begin
Phase III studies for both therapies this year, with initial launch
of LY03003 expected in 2020, followed by LY03005 in 2021.
Jiang said Luye also plans to use its Seroquel distribution
channels to bring three CNS products that it markets in the U.S.
and EU into emerging markets: a rivastigmine transdermal patch to
treat Alzheimer's disease and fentanyl and buprenorphine
transdermal patches for pain relief.
Luye's entry into new markets builds upon a global expansion
that began to accelerate in 2014, driven by successful IND filings
in the U.S., Jiang said. The company established a German
manufacturing center through its 2016 acquisition of transdermal
drug delivery business Acino Holding AG and opened its second U.S.
R&D center in 2017 in Boston,
Mass. Its first is in Princeton,
N.J.
Luye's other core areas are oncology, cardiovascular and
metabolic diseases.
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SOURCE Luye Pharma Group Ltd.