Optiscan teams up with US-based Long Grove Pharmaceuticals

• Optiscan enters exclusive five-year collaboration deal with US-based drug company Long Grove Pharmaceuticals
• Companies to work together to develop new intended uses for Long Grove’s intravenous fluorescein sodium contrast agent AK-FLUOR
• AK-FLUOR is used with Optiscan’s fluorescence-based endomicroscopic imaging systems

Special Report: Optiscan has signed an exclusive five-year collaboration with US-based Long Grove Pharmaceuticals to develop new applications for AK-FLUOR, a contrast agent used with Optiscan’s fluorescence-based endomicroscopic imaging devices.  

Optiscan Imaging (ASX:OIL) said the deal combines Optiscan’s cutting-edge digital endomicroscopic hardware and software solutions with private pharmaceutical company Long Grove’s extensive experience in developing high-quality, specialised pharmaceuticals.

Optiscan described Long Grove as a leading provider of high-quality, cost-effective pharmaceuticals with state-of-the-art manufacturing facilities, a strong adherence to rigorous quality assurance processes and reputation for meeting high industry standards.

Long Grove is the legal manufacturer of the proprietary fluorescein sodium contrast agent AK-FLUOR required for use with Optiscan’s fluorescence-based endomicroscopic imaging systems such as its InVue surgical imaging device.

Optiscan said the collaboration deal would simultaneously support:

• Optiscan’s clinical studies and regulatory approvals for its InVue surgical device, and
• Long Grove’s quest to identify new applications for its AK-FLUOR fluorescein sodium drug.

Watch: Optiscan have progressed its cloud-based telepathology streaming software

Initial focus on breast cancer

Optiscan said the agreement could open new clinical and commercial opportunities for both companies and would encompass clinical studies, trials, and regulatory submissions.

Under the deal, Long Grove’s AK-FLUOR (10% fluorescein sodium injections) will be used in combination with Optiscan’s fluorescence-based endomicroscopic imaging devices for surgical applications.

The combination will be evaluated in US clinical studies and trials, starting with breast surgery and expanding to other imaging uses.

The Optiscan-Long Grove device-drug combination will subsequently be used in other imaging modalities including gastrointestinal endoscopy, gastrointestinal surgery, robotic surgery and laparoscopic surgery.

The data from the initial studies will be used to support Optiscan’s US Food and Drug Administration (FDA) regulatory submissions for its InVue device.

Future studies will provide data for regulatory submissions for gastrointestinal, laparoscopic and robotic-assisted surgical procedures.

Long Grove will also provide support to Optiscan for its FDA regulatory submissions by providing access to AK-FLUOR’s existing pharmacokinetic and chemistry, manufacturing and controls (CMC) data.

Optiscan said CMC data could expedite its efforts to obtain the necessary regulatory approvals for its surgical devices to be used in the lucrative US market.

In turn, Optiscan will provide support to Long Grove in relation to US FDA supplementary New Drug Application (NDA) submissions for AK-FLUOR, if new applications for the drug in combination with its devices are identified.

‘Clear-cut win-win’ for both companies

Optiscan CEO and managing director Dr Camile Farah said the collaboration with Long Grove was a “clear-cut win-win” for development strategies of both companies.

“For Optiscan it gives us a supply of Long Grove’s AK-FLUOR which will be used in combination with our fluorescence-based endomicroscopic imaging devices to undertake studies and clinical trials,” he said.

Farah said the data flowing from these studies would be an invaluable resource for Optiscan’s regulatory submissions.

“Having Long Grove’s assistance as we work through US FDA regulatory approval processes for Optiscan’s devices is a significant bonus as we pursue a toehold in the large and lucrative US market,” he said.

“For Long Grove, the collaboration should hopefully identify new uses for its AK-FLUOR drug.

“Optiscan will assist Long Grove complete US FDA supplementary new drug application submissions for any such new applications.”

Seeking out further opportunities

Farah said the collaboration agreement represented another significant step in Optiscan’s ongoing efforts to integrate its technology into clinical practice.

“It provides further evidence that more and more healthcare sector-related groups are wanting to partner with Optiscan’s technology, as they search for ways to enhance and/or expand usage of their own product offerings,” he said.

“We will continue to seek out opportunities to combine Optiscan’s unique IP and in-house expertise with such groups.

“Such partnerships will undoubtedly help accelerate the adoption by clinicians of real-time endomicroscopic imaging, which in turn paves the way for improved outcomes for patients undergoing a range of surgical procedures.”

This article was developed in collaboration with Optiscan, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.