Atlanta-based Altea Therapeutics has inked a $46 million deal with Eli Lilly and Amylin Pharmaceuticals to develop and commercialize a daily transdermal patch delivering sustained levels of Byetta (exenatide).
The Byetta patch will use Altea's PassPort Transdermal Delivery System, which is designed to administer biological drugs through the skin rather than by injection or infusion. "Transdermal patches are extremely limited by the fact that the skin only accepts drugs that are lipid-soluable," explained Altea's CEO Eric Tomlinson, PhD, in an interview with FierceBiotech. "Our technology conditions the skin's surface to accept more types of drugs."
The PassPort Deliver System applies a painless pulse of energy–self-administered daily by the patient–to the surface of the skin. This creates tiny channels in the skin that allow water-soluble and macro-molecular drugs to pass through the surface. Users can then apply a regular transdermal patch to the treated area. The companies say the patch form of Byetta would have the benefit of eliminating injections, which may increase therapy compliance.
"We'd been working with Lilly in other ways prior to this," said Tomlinson. "We are constantly looking at different compounds and were very interested in Byetta. We did preclinical feasibility testing in animal, then Phase I in both healthy subjects and those with type II diabetes. Based on the results of that study, we agreed that this was plausible product." Altea is now in the midst of planning the longer development path for transdermal Byetta. Next up? Another Phase I trial of the transdermal patch.
Lilly and Amylin will fund all product development, manufacturing and commercialization activities for the product. Altea gets an upfront licensing payment of $46 million and royalties on future product sales. Lilly and Amylin also made an equity investment in Altea Therapeutics, which "gives them a small ownership" of the company.
The Lilly/Amylin deal isn't Altea's only project. "We're in the midst of numerous feasibility studies for other pharma companies," some of which will proceed to clinical development. As Altea works with larger partners, the company plans to learn from and take advantage of Big Pharma's immense resources. "We have benefited enormously from working with Lilly and Amylin in terms of our corporate growth and understanding how we can develop our products."