AcuCort AB (publ) (Spotlight Stock Market: ACUC) today announces that the company has signed an exclusive commercial agreement with the global biopharmaceutical company Kamada Ltd., (NASDAQ: KMDA; TASE: KMDA.TA). The agreement gives Kamada the exclusive right to the marketing and sales as well as the distribution of AcuCort’s drug Zeqmelit™ for, among other things, the treatment of acute allergy on the Israeli market.
Kamada Ltd., a leading global biopharmaceutical company, has a well-established infrastructure for marketing, sales, and distribution of commercial pharmaceutical products in more than 30 countries. The company is reputable and has a strong position in its home market in Israel where Kamada today distributes more than 20 pharmaceutical products.
Under the terms of the agreement, Kamada is responsible for the commercialization of Zeqmelit™ in Israel and has the exclusive right to marketing, sales, and distribution of the drug in this market. Thus, it is incumbent on Kamada to register Zeqmelit™ in Israel. Kamada’s assessment is that the company will be able to apply for registration and market approval to the Israeli authority MOH, Ministry of Health, in the first quarter of 2023. The processing of the submitted application is expected to take between 8 – 24 months.
”We are very pleased to sign this commercial agreement with Kamada regarding the Israeli market. Kamada is a very reputable company and Zeqmelit™ will complement their product portfolio in allergy. The agreement is a historic and commercial milestone for AcuCort. It is also a confirmation that AcuCort’s innovative drug Zeqmelit™ is commercially interesting and attracts partners,” says Jonas Jönmark, CEO of AcuCort AB.
In the development of Zeqmelit™, AcuCort has managed to combine the benefits of the well-proven substance dexamethasone and the patented user-friendly oral film for quick availability and relief in emergency situations such as severe and acute allergic reactions.
This information is information that AcuCort AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person below, on November 23 2022.
For more information, please contact:
Jonas Jönmark, CEO, AcuCort AB
Telephone: + 46 (0)70 365 5400
About AcuCort AB (publ)
AcuCort has developed and commercializes Zeqmelit™, a new fast-dissolving oral film to put on the tongue, based on the well-known cortisone substance dexamethasone. The drug is a smart product in a new, innovative, patented, and user-friendly dosage form primarily for the treatment of severe and acute allergic reactions, croup in children and chemotherapy-induced nausea and vomiting (CINV) and for the treatment of patients with COVID-19 who need supplemental oxygen therapy. Zeqmelit™ is approved in Sweden, Denmark and Norway. Altogether, this strengthens the company’s assessment that the time to commercialization may be relatively short. AcuCort (ticker: ACUC) is listed on the Spotlight Stock Market in Sweden. Please visit www.acucort.se.
About Kamada Ltd.
Kamada Ltd. (the “Company”) is a vertically integrated global biopharmaceutical company, focused on specialty plasma-derived therapeutics, with a diverse portfolio of marketed products, a robust development pipeline and industry-leading manufacturing capabilities. The Company’s strategy is focused on driving profitable growth from our current commercial activities as well as our manufacturing and development expertise in the plasma-derived biopharmaceutical market. The Company’s commercial products portfolio includes its developed and FDA approved products GLASSIA® and KEDRAB® as well as its recently acquired FDA approved plasma-derived hyperimmune products CYTOGAM®, HEPAGAM B®, VARIZIG® and WINRHO®SDF. The Company has additional four plasma-derived products which are registered in markets outside the U.S. The Company distributes its commercial products portfolio directly, and through strategic partners or third-party distributors in more than 30 countries, including the U.S., Canada, Israel, Russia, Brazil, Argentina, India and other countries in Latin America and Asia. The Company has a diverse portfolio of development pipeline products including an inhaled AAT for the treatment of AAT deficiency for which the Company is currently conducting the InnovAATe clinical trial, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial. The Company leverages its expertise and presence in the Israeli pharmaceutical market to distribute in Israel more than 20 products that are manufactured by third parties and have recently added eleven biosimilar products to its Israeli distribution portfolio, which, subject to EMA and the Israeli MOH approvals, are expected to be launched in Israel through 2028. FIMI Opportunity Fund, the leading private equity investor in Israel, is the Company’s lead shareholder, beneficially owning approximately 21% of the outstanding ordinary shares.