Seqens

CDMO

Commercialization

HPAPI

Q1 2019

<h3><span style="color: #1f1f42">Shifting needs in the pharmaceutical market are driving a demand for the manufacture of highly potent active pharmaceutical ingredients at a variety of scales. By building a new potent unit that expands our potent compound production capabilities from small to commercial scale, Seqens is expanding the scope of our contract manufacturing services.<span class="Apple-converted-space">&nbsp;</span></span></h3>
<h4><span style="color: #2fb998">Potent Market Growth</span></h4>
<p><span>The growing oncology market and an increasing interest in targeted therapies is driving global attention to highly potent APIs (HPAPIs). According to market research firm MarketsandMarkets, the global HPAPI market will expand at a compound annual growth rate of 8.7%, from $17.72 billion in 2018 to $26.84 billion by 2023.<sup>1<span class="Apple-converted-space">&nbsp;</span></sup></span></p>
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<h4><span style="color: #2fb998">Looking to Go Commercial<span class="Apple-converted-space">&nbsp;</span></span></h4>
<p><span>Seqens, previously the pharmaceutical synthesis and specialty ingredients company Novacap, has been involved in the small-scale production of potent compounds for many years. As an element of our growth strategy, the company was seeking an opportunity to construct a potent unit at one of our network sites in Europe and the United States — in 2018, this plan officially came to fruition.<span class="Apple-converted-space">&nbsp;</span></span></p>
<p><span>Seqens was chiefly responsible for manufacturing the clinical quantities of our client’s potent HPAPI drug, which was moving into phase III. This client wanted to keep their business with us, and building a potent facility was a clear path to expanding our capacity in potent manufacturing and better serving our customer. Construction of our Safebridge level 3 facility, which is located outside Paris, France, was initiated in Q4 2018 and will be completed by fall 2019. Our overall expansion investment is anticipated to be ~$30 million.</span></p>
<h4><span style="color: #2fb998">Safebridge Level 3 Facility</span></h4>
<p><span>Within the facility, our potent unit was designed with the guidance of Safebridge Consultants, who are industry experts in potent manufacturing. The potent unit is designed to maintain a maximum level of particles in the working environment of 100 ng/m<sup>3</sup>. This level will allow for the production of Safebridge category 3 potent compounds — molecules with occupational exposure limits ranging from approximately 30 ng/m<sup>3</sup> to 10 µg/m<sup>3</sup>.</span></p>
<p><span>The modular unit is specifically designed to be flexible and allow for future investments as customer needs evolve. Once completed, the initial capacity will be 10–15 tons per year, depending on the chemistry involved. A second, smaller train with a capacity of 1–2 tons/year will fill the gap between our existing R&amp;D capabilities and the larger train. As a result, Seqens will be able to support projects across the full development cycle from R&amp;D through commercialization; we plan to expand the facility as needed, depending on demand.<span class="Apple-converted-space">&nbsp;</span></span></p>
<h4><span style="color: #2fb998">New Capabilities for our Custom Development and Manufacturing Services</span></h4>
<p><span>Seqens has a long history of providing excellent services in custom development and contract manufacturing for the biotech and pharma industries. This additional facility will provide our clients with even more possibilities to reach the market on time. It is a perfect fit with our existing R&amp;D and production platforms. <span style="color: #2fb998">Companies</span> facing needs for high-volume potent active pharmaceuticals can now benefit from our full range of services, including bench R&amp;D, solid-state chemistry, biocatalysis, project management and regulatory support. <span class="Apple-converted-space">&nbsp;</span></span></p>
<p>At Seqens, we understand how to conduct chemistry in a contained environment. We leverage our years of experience manipulating many different types of molecules to optimize routes, simplify processes and make them more scalable.<span class="Apple-converted-space">&nbsp;</span></p>
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<h4 class="callout-title"><span style="color: #2fb998">Corporate values and business ethics should be closely linked and, when selected wisely and implemented effectively within a comprehensive risk management framework, often create market value and differentiation.&nbsp;</span></h4>
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<h4><span style="color: #2fb998">Meet Seqens</span></h4>
<p><span>Seqens, which was formed in December 2018, combines the contract development and manufacturing operations from our subsidiaries PCI Synthesis, PCAS, Uetikon and Proteus (biocatalysis). The name reflects the company’s core synthesis activities, combined with the sequencing of competencies, molecules and technologies to take science to the next level.</span></p>
<p><span>Our assets include 24 manufacturing plants and three R&amp;D centers in Europe, North America and Asia. Our core expertise is in developing and producing highly complex molecules using a unique set of skills and a very broad spectrum of technologies. Particular expertise has been developed in high-pressure reactions, hydrogenation, Grignard chemistry and low-temperature technology. With all of these capabilities, we are an integrated global leader in synthesis of active pharmaceutical and specialty ingredients.<span class="Apple-converted-space">&nbsp;</span></span></p>
<h4>References</h4>
<ol>
<li><em>High Potency APIs /HPAPI Market worth 26.84 Billion USD by 2023</em>. MarketsandMarkets. Apr. 2018. Web.</li>
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