Drug Development, FDA, New Products

Watch out Endo: Sorrento is after your $1B+ drug with FDA OK of ZTlido

The FDA has given the green light to Sorrento Therapeutics’ painkiller patch for nerve pain, a drug that has the potential to upturn a massive market and bring in peak sales of over $1 billion.

The drug, called ZTlido, is a non-opioid way to treat posterheptic neuralgia, the chronic pain that sometimes develops with shingles. The bandage-like patch will compete with Endo International’s drug Lidoderm, which has been around for a couple decades, along with generic versions of the drug.

The company’s competitive edge isn’t necessarily the drug itself, but the product’s adhesion properties. It sticks better to patients.

Henry Ji

“ZTlido was designed to solve a problem that is commonly reported with transdermal/topical patches: they don’t stay on,” said Henry Ji, chairman and CEO of Sorrento, in a statement. “Based on the adhesion study results with ZTlido, we believe that ZTlido product will be welcomed by healthcare providers, patients and payers who are looking for an effective and efficient, local pain treatment.”

Sorrento put ZTlido under its wing with the acquisition of Pennsylvania-based Scilex Pharmaceuticals in 2016. Scilex originally filed an NDA in July 2015, but it was rejected. Sorrento agreed to pay up to $47.6 million for the company, but 80% of that wasn’t to be paid until ZTlido got FDA approval. Sorrento will likely be writing a check soon.

Raghuram Selvaraju, an analyst at H C Wainwright, told Reuters he expects US sales of the drug to peak at $1.1 billion in 2025.

William Pedranti

The companies are assuming the drug, which will be actively promoted, will be welcomed due to its non-opioid status. There are no opioids approved by the FDA to treat posterheptic neuralgia, but the number one prescribed product first-line is an opioid, according to William Pedranti, COO of Scilex.

More than 100 million prescription lidocaine patches were sold in the US in 2017, according to IMS Health data.

Sorrento expects ZTlido will be available to patients sometime in 2018.


Image: Sorrento Therapeutics headquarters. Sorrento


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