LSL Pharma Group Inc. and Fera Pharmaceuticals, LLC are collaborating on an exclusive distribution agreement to supply erythromycin ophthalmic ointment USP (5mg/g) for the treatment of newborns in U.S. hospitals.
Let’s start with the players.
Headquartered in Locust Valley, New York, Fera Pharmaceuticals is a privately-held specialty biotechnology company focused on expanding therapeutic treatment options within the ophthalmic space.
A Canadian integrated pharmaceutical company, LSL Pharma Group specializes in developing, manufacturing, and distributing high-quality natural health products (via subsidiary Steri-Med Pharma Inc.) and dietary supplements as well as high-quality sterile ophthalmic pharmaceutical products (via subsidiary Laboratoire LSL Inc.).
Now Erythromycin.
Erythromycin ophthalmic ointment is a macrolide antibiotic intended to treat certain bacterial infections like streptococci (viridans or pyogenes), Neisseria gonorrhoeae, Chlamydia trachomatis, and Haemophilus influenzae type B (HiB) to name a few.
The formulation’s mechanism of action inhibits both bacterial protein synthesis and the assembly of the 50S ribosomal unit, which in turn reduces the bacteria’s ability to proliferate within tissue.
How about from an ophthalmic standpoint?
From an ophthalmic standpoint, it’s formulated as a topical ointment and can be applied with a thin ribbon to the inner portion of the lower lid (palpebral conjunctiva) to provide localized treatment to protect the eyes from bacterial insult.
Of note, the ointment is packaged in a 5 mg/g, 1-gram tube.
And its indication?
Erythromycin eye ointment is indicated for the treatment of superficial ocular infections including ophthalmia neonatorum, a condition where a newborn is infected by a pathogen which then causes conjunctivitis (pink eye) within the first month of birth.
Symptoms can start as early as 24 hours or 2 to 5 days after infection, and include:
- Eye redness
- Significant mucopurulent discharge
- Eyelid swelling
- Corneal scarring
- Ocular perforation
- Blindness
Now what’s the situation?
Per the companies, a “scarcity of Erythromycin ophthalmic ointment south of the border” has led the FDA to grant Fera “temporary discretion to import this vital medication” into the United States to fulfill the U.S. market need in the prevention of ophthalmia neonatorum.
And this agreement?
The exclusive agreement details that LSL Pharma Group—via Steri-Med—will initially supply up to 25% of the 4 million doses of erythromycin required in the U.S. hospital market.
Pending a continued shortage and resulting market need, the company would supply additional doses.
Why use Steri-Med to manufacture Erythromycin?
The LSL Pharma Group subsidiary actually already manufactures erythromycin ophthalmic ointment 5mg/g (0.5%) in 3.5g tubes and 50 x 1g single-use doses, along with other various sterile ophthalmic products (all entirely designed in Canada), including:
- Ointments
- Creams
- Gels
- Drops