Entrepreneur Jeffrey Yordon somehow cut through the clutter of the biotech start-ups so in vogue 5 years ago to attract millions in venture capital for the liftoff of Sagent Pharmaceuticals ($SGNT). The company--part manufacturer, part developer, part injectables and packaging specialist and part dealmeister--last week proclaimed the launch of vecuronium bromide for injection, a neuromuscular blocking agent, in 10- and 20-milligram single-use vials.
The drug, hardly Sagent's first, is noteworthy because it's a generic and an injectable, so unsurprisingly it appears on the FDA's list of medicines in short supply. As of yesterday, the FDA listed shortages of the drug by four manufacturers. Bedford Labs and Sun Pharmaceuticals both cite an increase in demand, while Hospira ($HSP) cites a manufacturing delay and Teva ($TEVA) says the drug is "on manufacturing hold."
Yet Sagent has plied a multinational-relationship network to make the drug available. "We are pleased to offer our customers a source," Yordon said in a phone interview. It's one of more than two dozen injectables the company now offers, some with familiar names like ampicillin, bacitracin and heparin. And there's a mother lode in the pipeline behind them.
Yordon credits partnerships with raw material suppliers, product developers, formulators, manufacturers and most importantly customers--the pharmacists in hospitals, surgical centers and specialty distributors, especially for oncology--with his company's success to date.
The Sagent machine is by no means based on a Big Pharma model, nor a biotech's, nor a CMO's. Sagent fits into that vague category of "specialty pharma," which cries out for adjectives. The company's diverse specialty business includes injectables, generics and oncology products.
"We have some products waiting for approval for drugs desperately needed," Yordon said. "We have 7 or so fairly far along. We found some good companies in Western Europe that can make these products."
He is clear about seeing Sagent as part of the solution to the growing problem of drug shortages. "We have told the FDA that we will try to step up, and they've appeared interested."
Sagent has 37 partnerships approved in 23 countries. "The bulk of what we need [for our business] has been approved," he explains. Yet the only manufacturing plant that Sagent has an ownership stake in is a 300,000-square-foot facility now being built in China.
Yordon's affinity for oncology drugs is evident in the 81 ANDAs Sagent has pending and hopes some might see commercial light by end of year.
"Oncology drugs are increasingly important to this country," Yordon said. "Many aren't being manufactured because of margin." But if one oncology product is not available in a cancer patient's treatment cocktail, he added, "there's no expectation the cocktail will meet its objective."
- see the Sagent announcement
- here's the FDA shortages list (alpha, by drug), near the bottom is vecuronium bromide for injection