Press Release: Santhera Grants Exclusive North -2-

Duchenne muscular dystrophy (DMD) is a rare inherited X-chromosome-linked disease, which almost exclusively affects males. DMD is characterized by inflammation which is present at birth or shortly thereafter. Inflammation leads to fibrosis of muscle and is clinically manifested by progressive muscle degeneration and weakness. Major milestones in the disease are the loss of ambulation, the loss of self-feeding, the start of assisted ventilation, and the development of cardiomyopathy. DMD reduces life expectancy to before the fourth decade due to respiratory and/or cardiac failure. Corticosteroids are the current standard of care for the treatment of DMD.

About Catalyst Pharmaceuticals

With exceptional patient focus, Catalyst is committed to developing and commercializing innovative first-in-class medicines that address rare neurological and epileptic diseases. Catalyst's flagship U.S. commercial product is FIRDAPSE(R) (amifampridine) Tablets 10 mg, approved for the treatment of Lambert-Eaton myasthenic syndrome ("LEMS") for adults and for children ages six and up. In January 2023, Catalyst acquired the U.S. commercial rights to FYCOMPA(R) (perampanel) CIII, a prescription medicine approved in people with epilepsy aged four and older alone or with other medicines to treat partial-onset seizures with or without secondarily generalized seizures and with other medicines to treat primary generalized tonic-clonic seizures for people with epilepsy aged 12 and older. Further, Canada's national healthcare regulatory agency, Health Canada, has approved the use of FIRDAPSE(R) for the treatment of adult patients in Canada with LEMS. For additional information about the Company, please visit www.catalystpharma.com.

About Santhera

Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company focused on the development and commercialization of innovative medicines for rare neuromuscular and pulmonary diseases with high unmet medical need. The Company has an exclusive license for all indications worldwide to vamorolone, a dissociative steroid with novel mode of action, which was investigated in a pivotal study in patients with Duchenne muscular dystrophy (DMD) as an alternative to standard corticosteroids. For vamorolone in the treatment of DMD, Santhera has a new drug application (NDA) under review by the U.S. FDA, a marketing authorization application (MAA) under review by the European Medicines Agency (EMA) and an MAA submitted to the UK Medicines and Healthcare products Regulatory Agency (MHRA). The clinical stage pipeline also includes lonodelestat to treat cystic fibrosis (CF) and other neutrophilic pulmonary diseases. Santhera out-licensed rights to its first approved product, Raxone(R) (idebenone), outside North America and France for the treatment of Leber's hereditary optic neuropathy (LHON) to Chiesi Group. For further information, please visit www.santhera.com.

Raxone(R) is a trademark of Santhera Pharmaceuticals.

For further information please contact:

public-relations@santhera.com https://www.globenewswire.com/Tracker?data=ZhqOzwdFnRWMQUj4d_M3skCnYdx8jaJCHGnIHapywSv8qi9uMl9n-sduoeHQYJ4x0x6GOT5ZEg9JQuUEFFOAzOoDJc2VGS_0_lhL9VwrxGFq7suRwgisXeNhEWf-x-V6 or

Eva Kalias, Head Investor Relations & Communications

Phone: +41 79 875 27 80

eva.kalias@santhera.com https://www.globenewswire.com/Tracker?data=Xu5SkMHFqqT8YyDLKArbylPFMAV4dgBWSVwnstHaf_L1q0X3kSFcYCwT4p_Tpm1svwWSVD-tZiguZ22EsZIC5OEG23G9zAtKRnZT_ecP6tM=

Disclaimer / Forward-looking statements

This communication does not constitute an offer or invitation to subscribe for or purchase any securities of Santhera Pharmaceuticals Holding AG. This publication may contain certain forward-looking statements concerning the Company and its business. Such statements involve certain risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of the Company to be materially different from those expressed or implied by such statements. Readers should therefore not place undue reliance on these statements, particularly not in connection with any contract or investment decision. The Company disclaims any obligation to update these forward-looking statements.

# # #

Attachment

-- 2023 06 20_SANN_Catalyst_e_final

https://ml-eu.globenewswire.com/Resource/Download/c5c5483e-7a96-485c-8054-37038a267340

(END) Dow Jones Newswires

June 20, 2023 01:00 ET (05:00 GMT)