Use of Altea’s PassPort patch technology is intended to provide a viable alternative to injections, which the company believes could potentially improve patient compliance.
Altea has already completed a Phase I trial of the therapeutic and will now continue its development, with Lilly and Amylin funding this as well as the product’s manufacturing and commercialisation costs.
Eric Tomlinson, CEO of Altea, said: “We believe the diabetes care experience of Lilly and Amylin, combined with the transdermal expertise of Altea Therapeutics creates an excellent partnership for the potential development of the world’s first transdermal GLP-1 receptor agonist, transdermal exenatide (Byetta).”
Altea may receive up to $46m (€34.7m) from Lilly and Amylin comprised of an upfront license payment and clinical, regulatory and sales milestones. Altea will also receive royalties on product sales and Lilly and Amylin have made an undisclosed equity investment in the company.
Needle free delivery
PassPort consists of a disposable patch and a reusable handheld applicator that is capable of delivering therapeutics through the surface of the skin that normally have to be injected.
This is achieved by using an electrical pulse to create microchannels through which the therapeutic, such as a water-soluble protein or carbohydrate, can pass.
By applying this technology to the type 2 diabetes market Altea believe they can meet the demand for more convenient forms of drug administration. This demand has also led to Lilly and Amylin developing a once-a-week formulation that would save patients from having to administer daily injections.
Steven Damon, senior vice president, business development at Altea told in-PharmaTechnologist that he was aware of this formulation but believed that his company’s “once a day transdermal exenatide will meet an unmet need in the marketplace”.
In addition although Byetta has been linked to deaths that lead to the US Food and Drug Administration (FDA) moving to strengthen the warning label Damon believes the safety of Altea’s patch “will be established in clinical studies.”
Further PassPort possibilities
Damon outlined the other products being developed with PassPort, which include formulations Altea is taking through preclinical in conjunction with several pharmaceutical companies.
In addition Damon said: “We are developing a once a day Transdermal Basal Insulin Product, also in Phase I clinical development. In addition, we are developing what we hope to be a daily fentanyl citrate patch, in Phase I clinical development, which may greatly increase the safety and efficacy of marketed fentanyl patches.”