Harrow has officially completed the transfer of its new drug applications (NDAs) for three FDA-approved ophthalmic medicines: Ilevro (nepafenac ophthalmic suspension) 0.3%, Nevanac (nepafenac ophthalmic suspension) 0.1%, and Maxidex (dexamethasone ophthalmic suspension) 0.1%.
Give me some background on these medications.
Here’s a brief rundown on each of the FDA-approved drugs:
Ilevro and Nevanac are both nonsteroidal, anti-inflammatory eye drops indicated for the treatment of pain and inflammation associated with cataract surgery.
Maxidex, on the other hand, is an adrenocortical steroid formulated as a sterile topical ophthalmic solution for steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe.
See here for complete details on the indications, usage, and contraindications for each product.
Didn’t Harrow just acquire these?
Yes! In January 2023, the company acquired the exclusive U.S right to five FDA-approved branded ophthalmic products from Novartis.
In addition to Ilevro, Nevanac, Maxidex, the deal also included Vigamox (moxifloxacin hydrochloride ophthalmic suspension) 0.5% and Triesence (triamcinolone acetonide injectable suspension) 40 mg/mL.
How much was the deal worth?
Harrow paid a total of $130 million at the closing of the transaction; an additional $45 million will be due to Novartis following the commercial availability of Triesence (expected later in 2023).
How long was the transfer period supposed to last?
Originally, the two companies agreed for Novartis to sell the five products in the U.S. market for 6 months during a non-disclosure agreement (NDA) transfer period, during which it was then supposed to transfer all net profits to Harrow.
However, the transfer period completed earlier than expected, enabling Harrow to initiate market access, marketing, inventory management, and national sales detailing strategies for the products.
Any update on the remaining two drugs?
The company expects to complete the NDA transfer for Vigamox and Triesence by the end of 2023.
Where can I order these newly-available products?
Product orders can be made directly through Cardinal’s Cordlogistics, Harrow’s customer service ordering partner that includes a wholesaler distribution system encompassing McKesson and AmerisourceBergen.