Kamada (KMDA)

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Kamada Announces Receipt of Marketing Authorization for Glassia® for Treatment of Alpha-1 Antitrypsin Deficiency in Switzerland

https://finance.yahoo.com/news/kamada-announces-receipt-marketing-authorization-110000324.html

Switzerland is the first European country to approve Glassia®, which received U.S. FDA approval in 2010

Glassia will be commercialized by IDEOGEN AG in Switzerland and the therapy is expected to be available to patients and providers during the second half of 2023

The current Alpha-1 Antitrypsin Deficiency (AATD) market in Switzerland is estimated to be over $15 million annually

REHOVOT, Israel and HOBOKEN, N.J., May 16, 2023 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a commercial stage global biopharmaceutical company with a portfolio of marketed products indicated for rare and serious conditions and a leader in the specialty plasma-derived field, today announced that Swissmedic has granted marketing authorization for Glassia®[Alpha-1 Proteinase Inhibitor (Human)] in Switzerland for chronic augmentation and maintenance therapy in adults with clinically evident emphysema due to severe hereditary Alpha-1 antitrypsin deficiency (AATD).

“Switzerland is the first European country to approve Glassia for AATD, representing a significant milestone for Kamada, in a market which is currently estimated to be over $15 million annually,” said Amir London, Kamada’s Chief Executive Officer. “The commercial launch of the product in Switzerland is expected to occur during the second half of this year, upon obtaining the required reimbursement coverage. To ensure wide access to eligible patients, we are excited to partner with the IDEOGEN Group, a company focused on the commercialization of specialty medicines for rare diseases across Europe.”

"We are delighted to announce our partnership with Kamada for the commercialization of Glassia in Switzerland. IDEOGEN is focused on rapidly introducing essential U.S. Food and Drug Administration (FDA)-approved therapies that enhance patients' quality of life into the European markets and serving as a reliable partner for leading international biopharmaceutical companies," stated H. Tuygan Göker, Founder, Chairman, and CEO of IDEOGEN Group. "With Glassia's expanded label and the advantage of a ready-to-infuse liquid form, the product represents a compelling treatment alternative for AATD patients in Switzerland. Currently, according to the official Swiss Alpha-1 Patient Registry, approximately 200 patients are undergoing treatment for this devastating medical condition. Furthermore, it is estimated that approximately 1,400 patients remain undiagnosed and unaware of their developing AATD. Our specialized medical and clinical expertise, as well as our operational agility and expertise, in combination with Glassia’s product profile, have the potential to positively impact the current AATD treatment landscape in Switzerland."

Glassia previously received FDA approval in 2010, and the product is approved for use in multiple other international markets, including Argentina, Russia, Israel, and Brazil. In the U.S., Kamada currently receives royalties, anticipated to be in the range of $10 million to $20 million per year through 2040, for Glassia from Takeda. Ex-U.S. sales of Glassia were approximately $6 million in 2022.

In addition to its focus on expanding the commercialization of Glassia in the international markets, Kamada is also committed to advancing the development of an Inhaled AAT treatment, conductingthe InnovAATe study, an ongoing pivotal Phase 3 clinical trial ofInhaled AAT for patients with AATD. The Company intends to meet with the FDA and the European Medicines Agency to discuss study progress and potential opportunities to shorten regulatory pathways in the first half of 2023.

About Glassia®
GLASSIA is an Alpha1 -Proteinase Inhibitor (Human), indicated for chronic augmentation and maintenance therapy in individuals with clinically evident emphysema due to severe hereditary deficiency of Alpha1, also known as alpha1-antitrypsin (AAT) deficiency. GLASSIA increases antigenic and functional (anti-neutrophil elastase capacity, ANEC) serum levels and antigenic lung epithelial lining fluid levels of Alpha1.