Bushu Pharmaceuticals Ltd

Business

CDMO

Global Partners

Outsourcing

Q3 2017

Spera Pharma

Strategic Partnership

<h3>The globalization of healthcare and the demand for drugs worldwide are continuously rising. Currently, the global pharmaceutical market is expanding at a robust compound annual growth rate (CAGR) of 6.3%, according to Evaluate Pharma, with global pharmaceutical R&amp;D spending increasing annually at approximately 2.8%.<sup>1</sup> This spending will drive further growth and is expected to increase added revenues derived from new products currently in the R&amp;D pipeline by 50% in 2022.<sup>1</sup></h3>
<h4>A Strategic Expansion</h4>
<p>A strategy that provides increasing and lasting value to the global pharmaceutical industry involves outsourcing, increasingly with contract partners positioned both operationally and geographically to serve potential markets most effectively. Mordor Intelligence predicts the contract manufacturing sector is likely to expand at a 6.4% annual rate to reach $84 billion in 2021. Grand View Research estimates agree, projecting the global healthcare contract research industry to grow at greater than 6.0% annual and be valued at $45.2 billion by 2022.<sup>2</sup> The Japanese portion of this market will grow faster.</p>
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<p>In the context of global pharmaceutical trends and changing Japanese law, which in the early 2000s allowed companies for the first time to fully outsource the manufacture of pharmaceuticals, Japan has seen the emergence of its own contract research, development and manufacturing services industry, including Bushu Pharmaceuticals Group, which operates Bushu Pharmaceuticals Ltd. Bushu has provided supply chain management hub functions to multinational companies, and is the country’s largest and most comprehensive contract development and manufacturing organization (CDMO), with the capacity to service clients internationally. Bushu is also the first to create a full-service development unit to suit the needs of Japan’s drug developers, as well as those companies looking to enter Japan’s home market or venture into nearby markets with a strong partner.<span style="background-color: transparent">&nbsp;</span></p>
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<h4 class="callout-title"><span style="color: #2c3080">Bringing experience supplying finished goods to more than 40 countries, Bushu helps its customers overcome cultural and other barriers </span><br /><span style="color: #2c3080">to entry.</span></h4>
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<h4>Bushu Pharmaceuticals Ltd.&nbsp;</h4>
<p>Bushu Pharmaceuticals Ltd. has deep roots in Japan, with its operations and quality culture growing from legacy affiliations with Sandoz, Novartis and Japan’s Shionogi &amp; Co. The company operates as a world-class, single-source, end-to-end chemistry, manufacture and control (CMC) contract services provider, accommodating various oral solid dose formulations and full-service packaging operations.</p>
<h4>Spera Pharma, Inc.&nbsp;</h4>
<p>In July 2017, the company’s CMC capabilities were extended further when Takeda spun-out part of its pharmaceutical sciences/CMC business — known now as Spera Pharma, Inc. — to Bushu, and in the process, Bushu will become Takeda’s strategic contract services partner. The acquisition creates a complementary relationship between Takeda and Bushu that aims to improve operating efficiencies and create a more agile organization to serve the needs of both companies. The Spera subsidiary integrates Takeda&#8217;s Pharmaceutical Sciences business, including approximately 200 employees from three main divisions: Chemical Research &amp; Development, Pharmaceutical Technology Research &amp; Development and Analytical Research &amp; Development. The Spera acquisition was particularly strategic for Bushu because it creates a uniquely comprehensive top-tier CDMO in Japan, offering a complete and integrated range of research/development services and networked manufacturing facilities to support client outsourcing strategies in Japan and the region. With Spera, Bushu can offer services from preclinical CMC R&amp;D through regulatory filing and technical transfer stages, and on to clinical trial materials (CTM) and commercial manufacturing. The acquisition also creates excellent economies for Bushu customers by providing a quick and low-risk transition from development to commercialization.&nbsp;</p>
<h4>A Pacific Base for Global Plans</h4>
<p>To meet global markets head-on with its customers, Bushu and Spera have built a capable proactive organization fielding a network of development and manufacturing facilities that are well positioned in Japan to serve the region. Bushu has made it a priority to expand its intellectual capacity through world-class talent acquisition and operational leadership to help set it apart. Bringing experience supplying finished goods to more than 40 countries, Bushu helps its customers overcome cultural and other barriers to entry. Bushu will continue to energize the global strategies of the world’s largest pharmaceutical companies seeking to enter markets in Japan, the Asia-Pacific region and beyond.</p>
<p>Currently, the Bushu Group operates three advanced cGMP manufacturing and development facilities, including Kawagoe, which specializes in drug product manufacturing and packaging, and Misato, which is focused on both oral solid dosage and injectables. The third facility is Spera’s operation in Juso (Yodogawa-ku, Osaka city), which encompasses R&amp;D and clinical trial materials. The combination of these facilities now propels the Bushu Group to its “Number One” CDMO status.</p>
<h4>Quality as a Cultural Imperative</h4>
<p>Culturally, Japanese companies take extreme pride in promoting and maintaining the quality of their products. While this is true for most of the pharmaceutical industry in Japan, Bushu’s attention and focus is especially acute, sustaining quality that extends into every aspect of its operations and provides all partners with a “Japanese-standard” customer experience.</p>
<p>With operations approved by major regulatory bodies including EMA, FDA and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), among others, Bushu’s facilities are cGMP compliant and able to meet the most stringent international regulatory requirements. Certainly, compliant, internationally sanctioned facilities are important and a business imperative, but effective global product strategies require flexibility. This translates to versatile operations geared to manufacture products destined for diverse global markets. The Bushu Group, which now owns the development assets of Takeda, can develop their Quality System further to adapt to other major pharma clients.</p>
<h4><img src="https://thatsnice-testing3.com/legacy/Q3_2017/17Q3_Bushu_sidebar.jpg" alt="17Q3_Bushu_sidebar.jpg"></h4>
<h4>Investing for Success</h4>
<p>Over the past decade, Bushu has invested heavily to upgrade the capabilities of their packaging lines in order to accommodate serialization and other complexities associated with distribution to Japanese and global markets. Bushu’s warehousing and distribution operations, for example, have evolved with state-of-the-art IT-assisted material tracing system and automated material transfer vehicles to manage millions of global product SKUs.</p>
<p>Bushu’s investment into its capabilities and processes is ongoing, and lately a great deal of attention has been paid to implementing advanced automation and controls to better manage manufacturing and process operations more effectively. Much of Bushu Group’s growth and acquisition strategy has been financed by Baring Private Equity Asia.</p>
<p>Ultimately, Bushu Pharmaceuticals&#8217; strategy reflects the interests of its clients. Going forward, Bushu plans to continue its path to growth and extend its pure CDMO play in oral solid dose manufacture and parenteral drug development and manufacture for pharmaceutical companies both internal and external to Japan. But true to its earliest beginnings, the company is dedicated to helping companies realize their outsourcing strategies in this very important region.</p>
<h4>References</h4>
<ol>
<li>Antonio Iervolino, Lisa Urquhart. “EvaluatePharma World Preview 2016, Outlook to 2022.” Evaluate. Sep. 2016. Web.</li>
<li>Healthcare CRO Market To Reach $45.2 Billion By 2022. Grand View Research. Jan. 2016. Web.</li>
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Building the Foundation of Japan’s Premier CDMO