Nxera Pharma Expands Manufacturing to Meet Growing Demand for QUVIVIQ®

Nxera Pharma's New Manufacturing Site for QUVIVIQ®

Nxera Pharma Co., Ltd. is making significant strides to enhance the availability of its insomnia treatment, QUVIVIQ® (daridorexant), across the Asia-Pacific region. In a recent approval announcement, Nxera Pharma Japan Co., Ltd., a fully owned subsidiary, has received permission for a manufacturing approval partial amendment that allows the establishment of a new manufacturing site in Asia.

Addressing Growing Demand in Asia

This strategic move is intended to bolster the supply of QUVIVIQ®, particularly to cater to the increasing demand for effective insomnia treatment in Japan and neighboring markets. The new facility is designed to complement Nxera's existing primary manufacturing site located in Europe, enabling the company to leverage enhanced operational efficiency while also reducing manufacturing costs.

Anticipated Profitability through Cost Reduction

Nxera anticipates that the introduction of the new site will lead to improved profitability through significant reductions in manufacturing costs. These cost efficiencies are expected to gradually begin reflecting positively on the company’s financial results starting from the year 2027 and continuing through 2028. The company is determined to optimize production techniques to ensure stable supply for patients who rely on QUVIVIQ®.

Commitment to Long-term Vision

Building on its 2030 Vision, which aims for over JPY 50 billion in sales with a profit margin exceeding 30%, Nxera is committed to maximizing profits through strategic projects, including the establishment of this new facility. The approval for the second API manufacturing site marks the completion of one of several planned cost reduction initiatives, with additional projects slated for completion by the end of 2028.

Strategic Partnerships Enhancing Distribution

In a bid to further enhance its market presence, Nxera has established a commercial partnership with Shionogi & Co., Ltd. for the distribution and sales of QUVIVIQ® in Japan. Under this agreement, Nxera will supply the drug product while Shionogi handles distribution responsibilities. This collaboration is projected to yield a total sales forecast for QUVIVIQ® in Japan to reach JPY 2.5 billion for the fiscal year ending March 2026, complementing Nxera’s own forecasts of JPY 4.0 to JPY 5.0 billion for the fiscal year ending December 2025.

Understanding Nxera Pharma's Vision

Nxera Pharma is at the forefront of biopharmaceutical innovation, actively pursuing new medicines to fulfill unmet medical needs. Its agile operational framework is designed to adapt quickly to market demands, particularly in Japan and the broader Asia-Pacific region. With over 30 active programs in various stages of clinical development, Nxera’s committed to leveraging the NxWave™ discovery platform to explore new opportunities in pharmaceuticals, specifically targeting areas like obesity, neurology, and immunology.

Enhancing the Workforce for Global Goals

With approximately 400 dedicated professionals across multiple key locations, including Tokyo, Osaka, London, Cambridge, Basel, and Seoul, Nxera is well-positioned to adapt and grow in a competitive landscape. The company continues to prioritize innovation and agility in its operations in order to achieve its overarching goals of improving health outcomes.

Future Prospects in the Pharmaceutical Market

The newly established manufacturing site is expected to play a crucial role in Nxera's ambitions as a high-margin biopharmaceutical player. Not only does it reinforce supply chains across North Asia but it also sets the groundwork for future expansion into emerging markets in the region.

Frequently Asked Questions

What is QUVIVIQ® used for?

QUVIVIQ® is a medication designed for the treatment of chronic insomnia in adults.

Where will the new manufacturing site be located?

The manufacturing site will be established in Asia to enhance the availability of QUVIVIQ®.

When are cost reductions from the new site expected to impact profitability?

Cost reductions are anticipated to begin contributing to profitability gradually starting in 2027 and through to 2028.

What is Nxera Pharma's 2030 Vision?

Nxera Pharma aims for sales exceeding JPY 50 billion with a profit margin above 30% by the year 2030.

What other areas of medicine is Nxera focusing on?

Nxera is focusing on addressing unmet needs in obesity, neurology, neuropsychiatry, and immunology and inflammation.

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