TFF Pharmaceuticals Inc. and Uniphar Durbin Ireland Ltd. Announce the Opening of an Expanded Access Program for Voriconazole Inhalation Powder (TFF VORI) for the Treatment of Pulmonary Aspergillosis and Other Voriconazole Responsive Fungal Pulmonary Infections

• Voriconazole Inhalation Powder (TFF VORI) is an investigational, inhaled formulation of voriconazole developed using TFF Pharmaceuticals Thin Film Freezing technology that is currently being evaluated in a Phase 2 trial for the treatment of invasive pulmonary Aspergillosis (IPA). TFF VORI is not currently authorized or approved in any country.
  
  
• The Expanded Access Program covers pulmonary aspergillosis including invasive pulmonary aspergillosis, chronic pulmonary aspergillosis, allergic bronchopulmonary aspergillosis, aspergillus tracheobronchitis, and aspergillus bronchoanastomotic infections as well as other voriconazole responsive fungal pulmonary infections.
  
  
• Uniphar Durbin Ireland Limited has been appointed to implement TFF Pharmaceutical’s Expanded Access Program in the United States, Australia, United Kingdom, Canada, and within select countries in Europe.

DUBLIN, Ireland and FORT WORTH, Texas, July 31, 2023 (GLOBE NEWSWIRE) -- Uniphar Durbin Ireland Limited (“Durbin” or the “Company”), a part of Uniphar Group’s Product Access Division and a leading specialist in the international distribution of specialized pharmaceuticals, and TFF Pharmaceuticals, Inc. (Nasdaq: TFFP), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced the opening of an Expanded Access Program (EAP) enabling patients access to TFF-VORI in the United States, Australia, United Kingdom, Canada and select countries in Europe.

“We are pleased to be working with Durbin to offer the Expanded Access Program for TFF VORI,” said Dr. Harlan Weisman, Chief Executive Officer of TFF Pharmaceuticals. “Durbin has an accomplished track record of successfully executing Expanded Access Programs for some of the most well recognized companies in the pharmaceutical industry, and through this partnership, we expect many patients will have the opportunity to gain early access to TFF VORI. The EAP comes after positive clinical outcomes in two patients with pulmonary fungal infection treated with TFF VORI on a compassionate use basis. The EAP is meant to provide access to TFF VORI in patients who are not eligible for our ongoing clinical trial and who have limited or no other treatment options or who have had unfavorable response to adequate standard of care therapy including to oral or intravenous voriconazole.”

Dan Piggott, Managing Director of Uniphar Group’s Product Access Division stated, “We are very pleased to work with TFF to provide early access to TFF VORI to patients with pulmonary aspergillosis and other devastating voriconazole responsive fungal pulmonary infections. In the months ahead, we look forward to expanding this program across multiple countries so that this therapy can be offered to a patient population with few or no treatment options.”

About TFF VORI: TFF VORI is a next-generation, direct-to-lung, inhaled dry powder formulation of voriconazole in development for the treatment pulmonary fungal infections including pulmonary aspergillosis. TFF VORI is currently under investigation in an ongoing Phase 2 study for the treatment of IPA. Voriconazole is recommended as the first-line treatment for IPA, but in its oral form is associated with significant drug-drug interactions and toxicities. Direct-to-lung delivery is predicted to increase local lung concentrations with diminished systemic exposures to improve the therapeutic index of voriconazole. The therapy can be delivered via a dry powder inhaler to enable ease of administration directly to the lung.

About TFF Pharmaceuticals: TFF Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company using patented thin film freezing technology to develop and transform medicines into dry powder formulations for better efficacy, safety, and stability. The company’s versatile Thin Film Freezing technology platform has broad applicability with the potential to convert many drugs, including vaccines, small and large molecules, and biologics, into an elegant dry powder formulation, highly advantageous for inhalation. TFF has two lead drug candidates in the clinic: TFF VORI (Voriconazole Inhalation Powder) and TFF TAC (Tacrolimus Inhalation Powder). The Company continues collaborations with a broad array of pharmaceutical companies, academic institutions, and government partners to revolutionize healthcare around the globe. The TFF Platform is protected by 120+ patents issued or pending in the U.S. and internationally. To learn more about TFF Pharmaceuticals and its product candidates, visit the Company’s website at .

About Durbin: Uniphar Durbin Ireland Limited, a Uniphar company, is a global, specialist pharmaceutical services and products company who partner with pharmaceutical and biotech companies to provide ethical access to medicines for patients with unmet medical needs. A part of Uniphar Group’s Product Access Division, Durbin works in partnership with global pharmaceutical and biotech companies to provide Expanded Access Programs (EAPs), including Named Patient Supply and Cohort Programs. The company has over 25 years’ experience designing and implementing EAPs and specializes in strategic consultancy, asset specific program design and innovative, customized delivery models.

SAFE HARBOR: This press release contains forward-looking statements regarding TFF Pharmaceuticals, Inc., including, the benefits of the Company’s TFF platform and the Company’s plans to add to its existing pipeline of product candidates. Those forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially. Among those factors are: (i) the risk that the Company may not be able to successfully roll-out its Early Access Program for TFF VORI or, if it can, achieve the expected benefits of the Early Access Program, (ii) the risk that the Company may not be able to successfully conclude clinical testing or obtain pre-market approval of TFF VORI or any of its other dry powder product candidates, (iii) success in the Early Access Program or early phases of pre-clinical and clinical trials does not ensure that later clinical trials will be successful, and interim results of a clinical trial do not necessarily predict final results, (iv) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (v) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, (vi) the risk that the Company will not be able to conclude a long-term commercial agreement with any third-party, and (vi) those other risks disclosed in the section “Risk Factors” included in the Company’s Quarterly Report on Form 10-Q filed with the SEC on May 11, 2023. TFF Pharmaceuticals cautions readers not to place undue reliance on any forward-looking statements. TFF Pharmaceuticals does not undertake, and specifically disclaims, any obligation to update or revise such statements to reflect new circumstances or unanticipated events as they occur, except as required by law.

Durbin Contact:

Mark Haxton 

Uniphar Durbin Ireland Limited

Investor Relations Contact:

Corey Davis, Ph.D.

LifeSci Advisors

(212) 915-2577