Five minutes at CPhI North America with …

 Alex Theodorakis, President of Aptar Pharma North America

PH: You announced this week the approval by the EMA of Takeda Pharmaceutical’s Instanyl® DoseGuard incorporating your e-Lockout system. Please tell us more about it.

Theodorakis: Aptar Pharma’s e-Lockout is an electronic locking system intended to ensure safe patient compliance for the treatment of chronic disease by limiting the number of doses available during a 24 hour period. The EMA recently approved the first commercial use of e-Lockout, integrating Takeda Pharmaceuticals’ multi-dose nasal spray treatment Instanyl®, which is a fast-acting nasal opioid for relieving breakthrough pain in adult cancer patients. This is the first fully- integrated electronic nasal drug delivery device to be approved in the U.S. or in Europe. The e-Lockout is programmable, so if there are, say, four hours between doses, it is locked between dose-taking and the integrated electronic monitor counts down to the availability of the next dose. This is yet another example of Aptar Pharma’s continuous innovation process, which is always working to enable compliant and safe medication delivery.

PH: What else are you doing at the moment?

Theodorakis: One of our innovation focuses is in the connected health area. Recently we began a partnership with Kali Care to develop real-time medication management technology, addressing the challenges of monitoring adherence in ophthalmic clinical trials. The combination of Aptar Pharma’s ophthalmic device expertise, and Kali Care’s ground-breaking digital monitoring system for ophthalmic medications, is likely to have a significant impact in reducing the costs and complexity of ophthalmic clinical trials. This can help improve the whole clinical trial process, in that you need to recruit fewer people because you will know the ones you recruit are actually using the drug, the results are not just from recall, and the data is more reliable. It’s a new and very exciting technology that fits with where Aptar wants to go.

PH: Any other examples in this field?

Theodorakis: We are also developing electronic and connected devices in pulmonary treatment, as we move from traditional drug delivery devices to electronic and now to connected. This represents great opportunities for the future. These devices provide accurate and precise monitoring and are intended to support and improve patient adherence. We have a partnership with Propeller Health on a new inhaler, which combines Aptar MDI components and sensor technology with Propeller electronics directly in the inhaler housing, allowing for accurate and reliable monitoring of when each patient uses their inhaled medication. Information about the use of medications delivered by the cMDI will be put to work as part of the Propeller digital system for patients and providers. Leveraging existing apps, emails, text messages and other feedback, patients are able to learn more about their disease, how to better manage it and how to stay on track with their prescribed dosing instructions. In addition, physicians can identify individuals who need more help controlling symptoms, and care managers can efficiently focus on higher risk patients who need more personalized attention.

PH: You also recently announced an expansion at your US site…

Theodorakis: Yes, we have expanded our North American capacity at our Congers, NY site, specifically focusing on our injectables elastomer production business. Aptar Pharma is a trusted global partner providing premium elastomeric components for injectables. Until now, our injectable manufacturing capacity was mainly in France, and our prescription and consumer healthcare manufacturing mainly in Europe. Aptar Pharma’s newly-expanded, state-of-the-art manufacturing capabilities will be used to complete premium injectable elastomeric component manufacturing, enabling Aptar Pharma to better serve its North American pharmaceutical customers.