Genovate Announces Plans to Submit a New Drug Application for PMR to the U.S. Food & Drug Administration in the Second Half of 2025

TAIPEI, May 28, 2024 /PRNewswire/ -- Genovate Biotechnology Co., Ltd. (TPEx: 4130), a Taiwan-based specialty pharmaceutical company, today announced its plans to submit a New Drug Application (NDA) with the United States Food and Drug Administration (US FDA) for PMR, an investigational once daily extended-release form of cilostazol for the treatment of Intermittent Claudication, in the second half of 2025.

In the written responses to the pre-NDA meeting package, the FDA confirmed that the clinical studies conducted are sufficient to support the submission of a marketing application under the 505(b)(2) regulatory pathway. The key study in the submission package, GBL23-001 (NCT06167265), is a randomized, fully replicate crossover study designed to evaluate the bioequivalence and within-subject variability between PMR 145 mg once daily and the immediate-release tablet of cilostazol 100 mg twice daily. This study is expected to be completed in mid-2024, and the top-line results have shown that the primary endpoints of the study were achieved, and the decision to submit the application was made following the successful outcome of study GBL23-001. Furthermore, Genovate has been improving the PMR formulation and its manufacturing processes in order to address additional FDA comments. All clinical study and manufacturing data are expected to be included in the final submission package. 

"We are pleased to share what we believe is an efficient regulatory pathway for PMR with the goal of bringing a new treatment option to the people who suffer from intermittent claudication and recurrence of cerebral infarction, from the US to the globe." said Chia-Chen Chu, General Manager of Genovate. 

About PMR (Cilostazol Extended-Release Tablets) 
PMR, a novel extended-release (ER) formulation of cilostazol, was designed to reduce the concentration-dependent side effects associated with immediate-release (IR) tablet form of cilostazol. Cilostazol is currently available in IR tablet form at 50 and 100 mg strengths administered twice daily. The IR formulation of cilostazol, marketed as Pletal® in the US (Pletaal® in Taiwan and other Asian countries), was first available in Japan in 1988 for the treatment of peripheral arterial diseases and the prevention of recurrence of cerebral infarction and later approved by the US FDA in 1999 for the treatment of intermittent claudication (IC). Cilostazol is a specific PDE III inhibitor that can cause reduced platelet aggregation and increased vasodilatation. Cilostazol showed good efficacy in preventing secondary strokes, notably reducing the rates of ischaemic stroke recurrence. Nevertheless, the results from eight placebo-controlled clinical trials indicated that 15.4% of patients withdrawn from cilostazol treatment were as a result of adverse reactions. Headache, palpitations, and diarrhea were the most frequently reported adverse reactions among these patients. These adverse reactions were attributable to the peak concentration of cilostazol. Genovate is developing an ER tablet form of cilostazol, PMR, to be administered once daily aiming to improve adherence and to reduce the side effects associated with the high peak-to-trough variation of the concentration of cilostazol IR.

About Intermittent Claudication
Peripheral arterial disease (PAD) affects over 200 million people globally and around 8.5 million Americans over the age of 40. PAD occurs as a result of the narrowing or blockade of blood vessels that carry blood from the heart to the legs. The main symptom of PAD observed in approximately 70% of patients is intermittent claudication (IC), a condition that presents as pain and cramping in the lower extremities (thigh, calf, hip and buttock muscles), as a result of limited blood flow. IC is commonly viewed as a signal of substantial atherosclerosis, suggesting a higher likelihood of heart attack or stroke. The symptoms of IC are intermittent, exacerbated when walking or during exercise, and are alleviated with rest, but reoccur when activity resume; as a result, IC can be very debilitating, drastically affecting the quality of life of those affected. In severe cases, IC may require surgical intervention, but in general, it can be treated and managed with a combinational approach including medication, life style changes that modify or eliminate risk factors, and exercise program. Drugs improving blood flow such as anti-clotting agents (aspirin), anti-hypertensives, statins, and phosphodiesterase (PDE) III inhibitors such as cilostazol are currently used to treat IC.

About Genovate Biotechnology Co., Ltd. 
Genovate Biotechnology Co., Ltd. is a Taiwan-based, fully integrated specialty pharmaceutical company focusing on the new drug development in new formulation, new active ingredient, new treatment modality in cardiovascular, autoimmune, neurodegenerative, and liver diseases. Genovate is equipped with PIC/S GMP manufacturing, marketing, and distribution capabilities.

Forward-Looking Statements
All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements regarding the timing of any regulatory process or ultimate approvals for PMR for the treatment of IC. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including the risks and uncertainties associated with the projected timeline of our NDA submission, whether FDA will agree with our interpretation of the data or the adequacy of data to support an NDA, the FDA's review of our NDA, market conditions, as well as risks and uncertainties inherent in Genovate's business. The events and circumstances reflected in the company's forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, the company does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

SOURCE Genovate Biotech