$50m gift entices Adocia to take Lilly back
Biotech gets big pharma, biotech loses big pharma, biotech gets big pharma back again. This is the story of Lilly’s new partnership with Adocia for the ultrafast insulin BioChaperone Lispro, a project the US group spurned just 17 months ago.
Adocia’s development through proof of concept earned it a second, even bigger paycheck: this time a clean $50m up-front that comes with a commitment from Lilly to develop and commercialise the type 1 diabetes project. “They were thinking that the timeline to develop the project would be very long, perhaps too long,” Adocia's chief executive, Gérard Soula, tells EP Vantage of Lilly’s first decision to terminate. “We showed that we can quickly jump into a phase I/II clinical trial and prove the value of the project.”
In addition to the up-front fee, Lilly signed the ultrafast version of Humalog for a promise of up to $520m in milestones, and tiered sales royalties. Thus the decision to walk away the first time comes at some cost to Lilly, which signed on in 2011 for a $10m up-front payment and just $156m in milestones.
The deal encompasses two projects: BioChaperone Lispro U100 and U300. The BioChaperone technology adds a molecular complex to therapeutic proteins to improve their bioavailability. Adocia shares were up 42% to a record high of €38.62 in mid-day trading today.
Shots and pumps
Lilly’s decision to take up with Adocia again followed positive phase IIa data from the U100 project that showed a significant increase in early insulin exposure and a significantly shorter time to peak insulin Lispro concentration compared with Humalog in type 1 diabetics (Interview – Adocia hopes ultrafast insulin will be a sweet target for partners, October 8, 2014).
U300 is a higher-concentration version that has not yet entered the clinic. As a strategic product, however, it could figure more prominently as the medtech sector works towards an artificial pancreas that can predict blood sugar peaks and deliver insulin to counterbalance them (Therapeutic focus – Artificial pancreas projects will deliver over time, October 4, 2013). An insulin analogue would need to be able to duplicate the behaviour of endogenous insulin in that setting.
“To have more product in a smaller container is very important,” Mr Soula said of insulin produced for pumps.
While the big payday in diabetes has for years been the long-acting insulins like Sanofi’s Lantus, the pendulum has swung back towards mealtime delivery. MannKind’s success at getting the inhalable Afrezza approved and partnered signifies that the market might not be exhausted completely. Afrezza is administered at the beginning of a meal rather than 15 minutes before as with Lilly’s Humalog, on which Adocia’s project is based.
This timing issue is pressing when the ingestion of food is unpredictable, as with diabetic children, Adocia believes – data indicate that BioChaperone Lispro can be administered after a meal and keep blood sugar under control.
Getting back in the game
Competition from Novo Nordisk also likely forced Lilly’s hand. Of the insulin giants – Novo, Lilly and Sanofi – Lilly alone has missed the long-acting end of the spectrum and has only lately been able to make up for it. Basaglar, the biosimilar Lantus that Lilly sponsored with Boehringer Ingelheim, and its pegylated Humalog have both stalled in late-stage development.
But at the other end of the market Lilly was in danger of being caught out. Next year Novo should report data on its ultrafast version of NovoRapid called FIAsp or NN1218. With nothing in the pipeline, Adocia’s candidate, with which Lilly was already familiar, became a ripe target.
Mr Soula cites one other potential advantage to the BioChaperone Lispro project: “To my knowledge Novo has not announced a high-concentrate ultrafast insulin,” he said.
Most of the time, big pharma’s decision to terminate a partnership is a disaster for a small biotech. Adocia shows that on occasion perseverance pays off.