Codexis and Arch prepare for generic Lipitor market

By Gareth Macdonald

- Last updated on GMT

Codexis and Arch Pharmalabs’ expanded supply and development deal will see the latter produce APIs used in the manufacture of atorvastatin, principal component of Pfizer’s cholesterol buster Lipitor.

With Pfizer’s drug set to lose patent protection around 2010, depending on the market, Codexis and Arch are clearly gearing up to service the large number of generic drugmakers that are expected to launch competitor products.

Codexis and Arch also plan to produce a range of generic intermediates and active pharmaceutical ingredients (APIs) for the production of montelukast, esomeprazole and various types of carbapenem antibiotics, which the firms have been producing since 2005.

Codexis, which is preparing to conduct an initial public offering, said it was unable to respond to in-PharmaTechnologist’s questions.

In a statement the firm’s CEO, Alan Shaw, commented that: “Market drivers for both the innovator and generics sectors of the global pharmaceutical market are converging, as both sectors accelerate their search for high quality manufacturing at the lowest possible cost.

“This new agreement is targeted at addressing this convergence, coupling proven biocatalysis technology with large-scale manufacturing capability,” he added.

These thoughts were echoed by Arch’s managing director, Ajit Kamath, who said that: "Codexis and Arch have built a successful partnership over three years based on anticipating customer needs and consistently meeting them in the rapidly-growing global market for high quality, low-cost pharmaceutical intermediates and APIs​."

Kamath added that: "We are now well-positioned to build on this success, serving the growing global demand for cost-effective, high-quality pharmaceuticals."

Codexis’ $100m IPO

In April, Codexis announced plans to raise $100m by floating the company publicly. The firm said that the proceeds will be used as working capital and to invest in furthering development of its biocatalysts.

Biocatalysts have a lot of potential for applications within pharmaceutical manufacturing. Unlike their chemical counterparts they operate at lower temperatures and pressures and consequently require less expensive, specialist machinery.

In addition biocatalysts do not produce the same levels of wasteful by-products as traditional chemical processes. The creation of by-products is reduced by altering the genetic makeup of the enzymes, creating bespoke tools for specific tasks.

Lower energy costs and less waste should ensure that biocatalysts enable cleaner and more economical production method, which Codexis hopes will be attractive to clients in the pharmaceutical industry.

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