October 18, 2023
U.S. Food and Drug Administration grants temporary discretion to import critical Erythromycin ophthalmic ointment for treatment of newborns.
BOUCHERVILLE, QUÉBEC, October 18, 2023 – LSL Pharma Group Inc. (TSXV: LSL), (the “Company” or “LSL Pharma Group”), a Canadian integrated pharmaceutical company, announced today that it has entered into an exclusive agreement with Fera Pharmaceuticals, LLC (“Fera”), a U.S. specialty pharmaceutical company, to provide Erythromycin ophthalmic ointment USP (5mg/g) for the treatment of newborns in U.S. hospitals.
Given the scarcity of Erythromycin ophthalmic ointment south of the border, the U.S. Food and Drug Administration (“FDA”) granted Fera temporary discretion to import this vital medication. The agreement essentially focuses on fulfilling the need in the one-gram tube market.
Under the terms of the agreement, LSL Pharma Group, via its manufacturing subsidiary Steri-Med Pharma Inc. (“Steri-Med”), could initially supply up to 25% of the four million doses required annually in the U.S. hospital market. More Erythromycin ophthalmic ointment may become available if the drug shortage persists.
“LSL Pharma Group is pleased to respond to this urgent healthcare need by making our eye medication readily available to the U.S. market,” stated François Roberge, President and Chief Executive Officer of LSL Pharma Group. “The priority, after all, is safeguarding the health and well-being of vulnerable newborns. This opportunity is a testament to the solid reputation that Steri-Med is gaining in the global market for sterile ophthalmic medications. We hope that this collaboration will go a long way in meeting patient needs today and opening new doors for the future.”
“We appreciate the collaboration with FDA and Steri-Med in order to ensure adequate supply in the U.S. of this important product,” said Frank DellaFera, President and Chief Executive Officer of Fera.
About LSL Pharma Group
LSL Pharma Group is a Canadian integrated pharmaceutical company specializing in the development, manufacturing and distribution of high-quality natural health products and dietary supplements in solid dosage forms, as well as high quality sterile ophthalmic pharmaceutical products. For more information,
please visit www.groupelslpharma.com, www.laboratoirelsl.com and www.sterimedpharma.com.
About Fera Pharmaceuticals, LLC
Fera Pharmaceuticals, LLC is a privately held U.S. specialty pharmaceutical company committed to expanding valuable treatment choices for the people who need them—to ensure the future is filled with quality therapeutic options to improve care, health and lives. Fera’s focus is in ophthalmology, with the potential to expand into other therapeutic arenas as the needs and opportunities arise. For more information about Fera go to www.ferapharma.com.
Information provided and statements contained in this press release that are not purely historical are forward-looking statements within the meaning of the applicable securities laws. Certain statements in this press release may constitute forward-looking information within the meaning of securities laws. Forward-looking information may relate to LSL Pharma Group’s future outlook and anticipated events, business, operations, financial performance, financial condition or results and, in some cases, can be identified by terminology such as “may”; “will”; “should”; “expect”; “plan”; “anticipate”; “believe”; “intend”; “estimate”; “predict”; “potential”; “continue”; “foresee”, “ensure” or other similar expressions concerning matters that are not historical facts. The reader should not place undue importance on forward-looking information and should not rely upon this information as of any other date. LSL Pharma Group will not update these statements unless applicable securities laws require LSL Pharma Group to do so.
LSL Pharma Group Contact
François Roberge, President and Chief Executive Officer
Fera Pharmaceuticals Contact
Susan McDougal, Executive Vice President