Edition 1 / March 2019
Is the available capacity for highly potent drug manufacturing sufficient given the current market demand? What is causing the increased demand and how is CordenPharma’s Highly Potent & Oncology Platform addressing it?
The Financial Markets
2018 was an active year in the IPO market for healthcare companies. There were 130 IPOs, up from 102 the year before, with a total value in excess of $14 billion.1 Among biotechs, Moderna led the way with over $600M, making it the largest IPO in 2018.
How did oncology-focused companies do compared to the rest of the market? When analyzing companies with a focus in oncology and clinical assets, we identified 38 IPOs with a total value of $5.4 billion (Figure 1). That represents 30% of the deals and close to 40% of the value of all IPOs in 2018. If we further set a minimum value of $200 million or more, we identified 7 IPOs, significantly more than previous years (Figure 2). The enthusiasm for healthcare companies with oncology pipelines is also on display among Private Equity and Venture Capital financing firms, reporting record high investments in 2018. As long as the IPO market stays strong offering VC and PE a quick, lucrative exit strategy, oncology market growth is expected to continue.
According to PhRMA, there are over 1,000 oncology projects in the US, up from 836 in 20152 and almost double what it was in 2008. Although biologics are mostly responsible for this growth, small molecule drugs still represent 39% of the clinical pipeline and 70% of the projects reported in Phase III clinical.1 Most of these small molecule assets are highly potent (OEL ≤10µg/m3), and many are being developed in emerging pharmaceutical companies that traditionally rely on CDMOs like CordenPharma for development and manufacturing services. With a healthy financial market for emerging pharma companies and strong pipeline, this market and demand is expected to continue growing in 2019.
CordenPharma – Addressing the Demand Increase
CordenPharma added significant capacity to its Highly Potent API capabilities with the acquisition of the former Pfizer facility CordenPharma Boulder (CO, US) to address this increased demand in the oncology market. With CordenPharma Colorado also in Boulder, the combined expertise of both sites has over 26 years of experience in highly potent manufacturing, engineering controls, containment culture and a robust occupational health program enabling the manufacturing of the most highly potent compounds in research today. The two facilities operate under one leadership team, allowing their combined capacity and know-how to be leveraged for the benefit of the customer. Capabilities range from 1 L to 12,000 L reactors and supporting equipment which are ideal for the production of grams to hundreds of kilos per batch, ranging from clinical to commercial quantities.
Demand for Oral Solid Dose oncology drug products has also been increasing, as it now accounts for 63% of the small molecule clinical candidates. CordenPharma Plankstadt (DE) develops and manufactures formulations for this market. The facility is equipped with development, clinical supply and commercial manufacturing suites. After recent expansion of the development areas, plans to increase manufacturing capacity are currently in progress.
Organized under the Highly Potent & Oncology Platform, our Colorado API facilities work closely with Plankstadt to provide an Integrated Supply approach (from drug substance to drug product) resulting in reduced complexity, de-risked supply chain and shorter lead-times. Services are also provided from the individual sites. The offering is flexible and customizable to meet the current and future needs of CordenPharma’s clients.
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