UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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FORM
CURRENT REPORT
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Item 8.01 Other Events.
On October 28, 2021, Eton Pharmaceuticals, Inc. issued a press release announcing that it had acquired the U.S. marketing rights to carglumic acid tablets A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.
Eton paid the licensor $3.25 million upon signing and will retain 50% of future product profits with the balance being distributed to the licensor and manufacturer.
Item 9.01 Financial Statements and Exhibits
Exhibit 99.1 Press Release dated October 28, 2021
104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: October 28, 2021 | By: | /s/ W. Wilson Troutman |
| W. Wilson Troutman | ||
| Chief Financial Officer and Secretary | ||
| (Principal Financial Officer) |
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Exhibit 99.1
Eton Pharmaceuticals Announces Acquisition of Approved Orphan Drug Product Carglumic Acid
-Product is the first generic alternative to one of the highest priced pharmaceutical products in the world
DEER PARK, Ill. Oct. 28, 2021 (GLOBE NEWSWIRE) — Eton Pharmaceuticals, Inc (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that it has acquired U.S. marketing rights to carglumic acid tablets.
The product’s Abbreviated New Drug Application, which is owned by Novitium Pharma, was approved by the U.S. Food and Drug Administration on October 13, 2021. The product is an AB-rated, substitutable generic version of Carbaglu®.
“We are pleased to be offering patients a lower cost alternative to one of the most expensive treatments in the world,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals. “With our existing orphan drug commercial footprint and robust patient support services, we believe we are well positioned to commercialize this product. We look forward to working with Novitium to bring the product to patients later this year,” Brynjelsen added.
Carbaglu® is widely regarded as one of the highest priced pharmaceutical products in the world, with the annual cost of treatment estimated to exceed $1 million for many patients. The introduction of Eton’s lower cost alternative is expected to save patients and the U.S. healthcare system millions of dollars annually.
About Eton Pharmaceuticals
Eton Pharmaceuticals, Inc. is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The company currently owns or receives royalties from five FDA-approved products, including ALKINDI® SPRINKLE, Biorphen®, Alaway® Preservative Free, Rezipres®, and carglumic acid, and has five additional products that have been submitted to the FDA.
Company Contacts:
Eton Pharmaceuticals
David Krempa
dkrempa@etonpharma.com
612-387-3740