Deal with Evoke Pharmaceuticals anticipates FDA approval
In an innovative arrangement between a drug developer and a pharma services firm, Evoke Pharma has agreed to hand off launch, sales and distribution of what it expects to be an FDA-approved drug later this year. The handoff goes to Eversana, which has been making headlines for the past couple years in a steady stream of acquisitions, mostly to provide a full slate of commercialization services.
The drug in question is a nasal spray formulation of metoclopramide, branded as Gimoti, for the relief of symptoms associated with acute and recurrent diabetic gastroparesis. Evoke expects FDA approval in June. Under the multi-year agreement, Eversana will utilize its internal sales organization along with other commercial functions for market access, marketing, distribution and patient support services. It will receive reimbursement of certain costs and a percentage of product profits in the mid to high teens when Gimoti net sales surpass certain administrative, manufacturing and commercialization costs. In addition, Eversana has agreed to provide a $5-million revolving credit facility to Evoke subject to NDA approval.
“Eversana has been built up over time to provide exactly this sort of integrated service to a pharma manufacturer,” says Greg Skalicky, chief revenue officer at Eversana. “Most small pharma companies, if they’re not planning to commercialize themselves, look either to out-licensing, or being acquired. We’re providing an alternative option.”
“We are excited to partner with Eversana, which will allow us to efficiently and rapidly prepare to commercialize Gimoti without the need to invest in a large corporate infrastructure and build out of a sales force,” stated Dave Gonyer, Evoke president and CEO.
An oft-stated belief of the pharma industry is that it should concentrate on its exclusive ability to develop and gain approval for new drugs, and leave the rest of the business to others. And while outsourcing of various functions is commonplace, it remains true that the biggest pharma companies still manage development, manufacturing and commercialization themselves. Over the past several years, privately-held Eversana has acquired (or built up) third-party logistics, patient support services, marketing and sales, regulatory compliance and, most recently a business consulting practice.