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Worldwide Clinical Trials - Oncology

TFF Pharmaceuticals Inc. And Uniphar Durbin Ireland Ltd. Announce the Launch of Expanded Access Program for Voriconazole Inhalation Powder

Monday, July 31, 2023

Uniphar Durbin Ireland Limited ("Durbin" or the "Company") and TFF Pharmaceuticals, Inc. (Nasdaq: TFFP) have jointly announced the launch of an Expanded Access Program (EAP) for TFF-VORI. This program will grant patients in the United States, Australia, United Kingdom, Canada, and select European countries access to TFF-VORI, which is a next-generation, direct-to-lung, inhaled dry powder formulation of voriconazole. The therapy is being developed for the treatment of pulmonary fungal infections, including pulmonary aspergillosis.

Dr. Harlan Weisman, Chief Executive Officer of TFF Pharmaceuticals, expressed his excitement about collaborating with Durbin to offer the Expanded Access Program for TFF-VORI. He noted that Durbin has a proven track record of executing Expanded Access Programs for leading pharmaceutical companies. Dr. Weisman hopes that this partnership will provide many patients with the opportunity to gain early access to TFF-VORI, especially those who are not eligible for the ongoing clinical trial and have limited or no other treatment options, including those who have not responded well to standard care therapies.

Dan Piggott, Managing Director of Uniphar Group's Product Access Division, expressed his satisfaction with the collaboration and their commitment to providing early access to TFF-VORI for patients suffering from pulmonary aspergillosis and other severe voriconazole-responsive fungal pulmonary infections. The goal is to expand the program to multiple countries in the near future, making this therapy accessible to a broader patient population with limited or no treatment options.

TFF-VORI's direct-to-lung delivery method is predicted to increase localized lung concentrations while reducing systemic exposure, thus improving the therapeutic index of voriconazole. This next-generation formulation is seen as a promising advancement in the treatment of pulmonary fungal infections, as the oral form of voriconazole has been associated with significant drug interactions and toxicities. The therapy is conveniently administered through a dry powder inhaler, enabling ease of use for patients.

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