Since Sanofi broke off its commercialisation deal for Afrezza last week, there has been some speculation about the future of the inhaled insulin product and of MannKind Corporation itself whose share price dropped to a historic low following the news.
But speaking to investors at the JP Morgan Healthcare Conference in San Francisco yesterday, newly appointed CEO Matthew Pfeffer said with Sanofi’s exit, the company is now “in control of [its] own destiny… [MannKind’s] hands are somewhat unshackled and things are moving forward very, very rapidly.”
Licensing and in-house pipeline
The company’s recovery will be led by its Technosphere delivery platform, he said, which can be used to increase bioavailability and offer a more convenient administration of active pharmaceutical ingredients (APIs) on top of insulin.
Pfeffer added the firm had hoped to announce its first licensing deal for the tech at the conference, but while this didn’t happen, an agreement is close and “could actually yield some short term cash… and could make a big difference for us to show that the technology is sustainable.”
Such “opportunistic” licensing opportunities will supplement the firm’s own technology-based product pipeline, he continued. “It's getting a lot of attention internally and externally. We think that there is a big future for that technology and we're continuing to exploit it.”
The platform uses the excipient fumaryl diketopiperazine (FDKP) which is highly soluble at pH 6.0 - the prevailing physiological pH in the lungs - in order to avoid both hepatic first pass metabolism and degradation in peripheral circulation in the delivery of an API.
In the case of Afrezza this is mealtime insulin, but MannKind’s Chief Medical Officer Raymond Urbanski said the company is investigating Technosphere with a number of candidates, including treprostinil for pulmonary arterial hypertension, palonosetron for chemo-induced nausea, and epinephrine for anaphylaxis.
“The physiometric profile of drugs that we give via this route shouldn’t be surprising,” he said. “It’s identical to what we see with Afrezza as we laid it to insulin.”
Dearth of a salesman?
Sanofi’s exit has left a space for a potential pharma partner, something MannKind is now free to pursue, but Pfeffer said there is also an opportunity to “move some of the barriers and take advantage of some of the learnings that we have from our experience with Sanofi,” to take on the marketing and commercialisation jobs itself.
While Pfeffer and Urbanski refused to throw Sanofi “under the bus,” he admitted the former partner “made a number of errors along the way,” both in the price of the drug (which was at a significant premium to other insulins on the market) and with its approach to sales.
“Sanofi took on the tact of your classic 1990s drug launch – sales rep, rep to doc, doc writes script etc,” Urbanski said. “The environment is changing, especially with Afrezza- it’s an innovative new way of treating diabetics - so maybe that rep-doc paradigm is not the way to go.”
Furthermore, the job of the sales rep has been hindered over the past decade through regulations such as the Sunshine Act, and so he said MannKind is looking instead the firm is looking at alternative and less cost-intensive methods of marketing and sales.
“We’re thinking we can go more through social media, patient advocacy groups, more through diabetes education where this would really help drive sales and utilisation without having the huge cost of a sales force.”
Welcome to Twitter
While exact strategies are still being discussed, one immediate action discussed was the news that MannKind yesterday created a Twitter account to help spread the word.
Already the company has “a huge number of followers,” according to Pfeffer, though at last count the number stood at 440, just shy of half the number this reporter has (#egoboost ... follow me @DanJamesStanton).