Seroquel Stepping Stone: How Luye Will Use Seroquel to Expand in Emerging Markets

SHANGHAI, June 7, 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.