Catalyst Pharmaceuticals Announces Exclusive Licensing and Supply Agreement with DyDo Pharma for the Development and Commercialization of Firdapse® in Japan

CORAL GABLES, Fla., June 28, 2021 (GLOBE NEWSWIRE) – Catalyst Pharmaceuticals, Inc. (“Catalyst”) (Nasdaq: CPRX), a commercial-stage, patient-centric, licensing-focused biopharmaceutical company, developing and commercializing new high-quality drugs for patients with rare diseases, today announced that it has entered into an exclusive licensing and supply agreement with DyDo Pharma, Inc. (“DyDo Pharma”) for the development and marketing of Firdapse® (amifampridine) 10 mg tablets in Japan for the treatment of Lambert-Eaton myasthenic syndrome (“LEMS”). LEMS is a rare autoimmune neuromuscular disease characterized by debilitating and progressive muscle weakness and fatigue.

Under the terms of the agreement, DyDo Pharma will have the common rights to develop Firdase® (amifampridine phosphate) and the exclusive rights to market the product in Japan. DyDo Pharma will be responsible for funding all clinical, regulatory, marketing and commercialization activities in Japan. Catalyst will be responsible for clinical and commercial supply, as well as supporting DyDo Pharma in its efforts to obtain regulatory approval for the product from Japanese regulatory authorities. Subject to satisfaction of the terms and conditions set forth in the License and Supply Agreement, Catalyst will receive an upfront payment and be eligible to receive further development and sales milestones for Firdapse.®, as well as a transfer price on the product supplied to DyDo Pharma.

“DyDo Pharma’s experienced team and commitment to rare diseases make the company an attractive choice for Catalyst for the development and distribution of our amifampridine product for the treatment of LEMS in Japan,” said Patrick J. McEnany, President and CEO of Catalyst. “Given the limited availability of treatment options for LEMS in Japan, we look forward to working with DyDo Pharma to address this unmet medical need by hopefully providing a new treatment option for patients and their families. . “

“We are very happy to have acquired a license for the Japanese rights of Firdapse®, which Catalyst sells in the United States, ”said Yasunori Inaoka, President and Managing Director of DyDo Pharma. “In the future, we will continue to develop with the aim of obtaining marketing authorization for Firdapse® as a treatment for LEMS in Japan, so that we can provide a new treatment option for Japanese LEMS patients who are currently suffering with their families in the absence of an approved treatment.

MTS Health Partners, LP acted as financial advisor to Catalyst in connection with the transaction.

About Firdapse® (amifampridine) Tablets 10 mg

Firdapse® is an oral, nonspecific, voltage-dependent inhibitor of potassium (K +) channels which depolarizes the presynaptic membrane and slows or inhibits repolarization. This action causes slow voltage-gated calcium channels (Ca2 +) to open, allowing further influx of Ca2 +. In turn, it induces exocytosis of synaptic vesicles containing acetylcholine (ACh) to release more ACh into the synaptic cleft, improving neuromuscular transmission and improving muscle function. Firdapse® has received orphan drug designation by the Japanese Ministry of Health, Labor and Welfare and has already been approved for use in the United States, Europe and Canada for the treatment of adults with SML.

About Catalyst Pharmaceuticals

Catalyst Pharmaceuticals is a patient-centric, commercial-stage biopharmaceutical company focused on the licensing, development and commercialization of new, high-quality drugs for patients living with rare diseases. With a focus on the patient, Catalyst is committed to developing a strong pipeline of cutting-edge, first-rate or first-rate drugs for other rare diseases. Catalyst’s New Drug Request for Firdapse® (amifampridine) 10 mg tablets for the treatment of adults with SML was approved in 2018 by the US Food & Drug Administration (“FDA”), and Firdapse® is commercially available in the United States as a treatment for adults with SML. Additionally, Canada’s national healthcare regulatory agency, Health Canada, recently approved the use of Firdase® (amifampridine) for the treatment of patients in Canada with SMLS.

Firdapse® is currently being evaluated in clinical trials for the treatment of MuSK-MG and has received orphan drug designation from the FDA for myasthenia gravis.

About DyDo Pharma

DyDo Pharma is the wholly owned Rare Disease Pharmaceuticals subsidiary of DyDo Group Holdings. DyDo Group Holdings, Inc. operates in the following segments: Domestic Beverage Business, International Beverage Business, Pharmaceutical Business, Food Business and Other Businesses. The domestic beverage industry accounts for over 70% of total sales, and the beverages are sold from widely available vending machines in Japan. The company was founded on January 27, 1975 and is headquartered in Osaka, Japan.

Catalyst forward-looking statements

This press release contains forward-looking statements. Forward-looking statements involve information that is known and unknown risks and uncertainties, which could cause Catalyst’s actual results for future periods to differ materially from expected results. A number of factors, including (i) whether DyDo Pharma can obtain regulatory approval for the marketing of Firdapse® in Japan, (ii) whether the clinical trial that will have to be performed in Japan to obtain the right to market Firdase® in Japan will be successful, (iii) whether, if approved, DyDo can successfully market Firdapse® in Japan, (iv) if such marketing of Firdapse® in Japan will be profitable, and (v) the factors described in Catalyst’s annual report on Form 10-K for fiscal 2020 and other documents filed by Catalyst with the United States Securities and Exchange Commission (SEC) could adversely affect Catalyst. Copies of documents filed by Catalyst with the SEC are available from the SEC, may be viewed on the Catalyst website, or may be obtained on request from Catalyst. Catalyst does not undertake any obligation to update the information contained in this document, which is only valid as of this date.

CONTACT: Media Contact David Schull Russo Partners (212) 845-4271 [email protected] Company Contact Patrick J. McEnany Catalyst Pharmaceuticals Chief Executive Officer (305) 420-3200 [email protected]

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