According to the terms, United Therapeutics will be responsible for the development of MannKind’s dry powder formulation of treprostinil – currently under investigation for the treatment of pulmonary arterial hypertension – as well as regulatory and commercial activities.
MannKind will manufacture clinical and initial commercial supplies of the product at its manufacturing facility in Danbury, Connecticut, before transferring to United Therapeutics for the long-term.
In return, United Therapeutics will pay MannKind $45m (€39m) upfront, as well as potential milestone payments of up to $50m. The firms have also agreed to a research deal, under which MannKind will receive $10m to conduct research, on behalf of United Therapeutics, for products not included in the licensing deal.
MannKind CEO, Michael Castagna, said the agreement is a “great deal overall”, as MannKind looks to recapitalise the company, fund additional pipeline products, and continue to grow inhaled insulin drug Afrezza.
Afrezza expansion with ‘new capital’
MannKind made headlines in 2014 when it partnered with Sanofi for the marketing and commercialisation of Afrezza, a fast-acting mealtime insulin for Type 1 and Type 2 diabetes. However, marketing delays contributed to lower-than-expected revenue, and Sanofi exited the $150m partnership less than a year after the product launch.
MannKind restructured the business to streamline operations following Sanofi’s pull-out, including selling a California manufacturing site and cutting jobs.
However, last week, Castagna said the company had been “revamped” with a largely new management team, and growing Afrezza sales.
“When we look at gross sales, I know Sanofi handed this back to us doing about $7-9m gross. We are on track right now to do $40-45m on a rolling forward basis on gross sales,” he told delegates at the Rodman & Renshaw global investment conference.
“At this point, we know it’s a good drug. We now have some new capital. We will continue to increase our TV spend [on advertising] and Afrezza will continue to grow for years to come as we look forward.”
According to Castagna, “international expansion will be another area [the firm sees] continued growth,” naming Brazil, India, Canada and Mexico as countries on MannKind’s horizons. “We expect to be able to file in those countries later this year, or early next year, and we will be going to Europe next for discussions…,” he added.