India's Piramal to buy U.S. maker of sterile injectables, antibody drug conjugates

India's Piramal Enterprises made official its intention to purchase Kentucky's Coldstream Laboratories for $30.6 million, a move that will push the company further into the contract manufacturing of drug delivery components like sterile injectable products, lyophilized (freeze-dried) parenterals and antibody drug conjugates.

Piramal CEO Vivek Sharma

Piramal CEO Vivek Sharma said the acquisition allows Piramal "to move further into the injectable market segment and should have strong synergy with our existing Pharma Solutions business," in a statement. "Our strong capabilities in sterile product development and in ADC (antibody drug conjugate) product segment will allow us to offer an integrated solution to our customers."

Coldstream's annual revenues of around $14 million will be added to Piramal's revenues of about $750 million. Coldstream employs 91 people in Lexington, KY, home of the company's FDA-approved sterile injectable facility on the Research Park Campus of the University of Kentucky.

The transaction is expected to close early this year.

Coldstream helps meet its clients' drug delivery manufacturing needs. For example, last fall it announced a partnership to manufacture CytImmune's injectable anticancer candidate, which utilizes gold nanoparticles for targeted drug delivery to the cancerous tumor. CytImmune says the active ingredient is safer when used in the formulation manufactured by Coldstream than when it is systematically administered.

The U.S. company boasts a 22,000 square foot parenteral manufacturing facility, as well as equipment for lyophilizing, or freeze-drying, the products, according to its website. Parenteral delivery is non-oral systematic administration that avoids the gastrointestinal tract, including intramuscular and intravenous injections.

In addition, Coldstream develops and manufactures antibody drug conjugates in collaboration with partner Goodwin Biotechnology. Those drug delivery vectors consist of antibodies linked to anticancer or other drugs. The antibodies are engineered to bind and enter the cell via specific receptors, resulting in targeted delivery of the active ingredient, which separates itself from the associated antibody within the cell.

The bottom line is that manufacturing is an often-overlooked drug delivery challenge. Piramal's acquisition will boost the company's position in advanced manufacturing techniques for pharmaceuticals with unique forms of administration or delivery within the body.

- read the release (PDF)

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