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Sweeter terms: Adocia vindicated in $570M diabetes deal with Lilly

By Cormac Sheridan, Staff Writer

DUBLIN – Eighteen months after terminating its interest in Adocia SA’s Biochaperone technology, Eli Lilly and Co. is paying $50 million up front to get it back, and it could hand over another $520 million in development, regulatory and commercial milestones linked to the progress of Adocia’s ultra-fast-acting insulin formulation, Biochaperone Lispro. Adocia will also receive research funding and tiered royalties on eventual product sales.

It’s an expensive error for Indianapolis-based Lilly and complete vindication for Lyon, France-based Adocia. The companies’ previous alliance, which they entered in 2011, involved an up-front payment of $10 million with up to $155 million more to come in milestones. However, Lilly decided to exit that deal in July last year, just before the first milestone payment was due. (See BioWorld Today, July 31, 2013.)

The two companies diverged on how to value the program and on how to develop it further. “They were more cautious and conservative and wanted to stay in healthy volunteers,” Adocia CEO Gérard Soula told BioWorld Today. “We disagreed deeply – and we proved that we were right. But they proved they are not stupid.”

Two game-changing phase II trials, which Adocia completed this year, were persuasive. Each demonstrated that the company’s Biochaperone-based insulin formulation outperformed Lilly’s unmodified equivalent Humalog (insulin lispro) in terms of both insulin absorption and clearance, the two key parameters for post-prandial glucose control. “We started talking again when we had new clinical trial results,” Soula said. “The numbers speak for themselves.”   

Fast-acting insulin therapy is designed to mimic the rapid physiological release of insulin in response to food intake and its rapid clearance once the additional blood glucose has been absorbed. However, none of the products that is currently available is able to match the human pancreas, which can boost insulin levels 1,000-fold within 45 minutes.

Adocia’s Biochaperone technology comprises a set of polysaccharides that shield the molecule of interest from interactions with endogenous molecules, such as albumin or hyaluronic acid or proteolytic enzymes, as it migrates from the site of injection to the bloodstream.

In a phase II trial in 36 type 1 diabetes patients, the Biochaperone-Lispro formulation had a faster onset of action than lispro (23.1 minutes ±7 m vs. 34.4 m ± 15.3 m), an earlier maximum effect (99 m ±42 m vs. 133 m ±45 m) and stronger metabolic effects in the first hour and the first two hours. The company presented those data at the American Diabetes Association meeting in June.

In September, it unveiled data from a second trial involving three doses, in 37 patients with type 1 diabetes, which confirmed the product’s superior pharmacokinetic profile. “We got a dose response – a beautiful linearity between the three doses,” Soula said. At the equivalent dose to the lispro comparator, Biochaperone-Lispro had a faster median time to peak concentration (40 m vs. 60 m) and a faster clearance time, as measured by the time required for insulin concentration to reach half its maximum level (132 m ±41 m vs. 163 m ±49 m).

Lilly is now taking on further development, manufacturing and commercialization of the product, which will follow the FDA’s 505(b)(2) approval pathway. The milestones are split between its progress through the development and regulatory process ($280 million) and its eventual sales performance ($240 million).

Shares in Adocia (PARIS:ADOC) opened Friday at €38.22 (US$46.92), up 40 percent on Thursday’s close of €27.24, capping a major turnaround for the company. The stock hit a low of €5.04 when Lilly walked in July last year.