​Vernalis Therapeutics Inc. announced that its parent company, Vernalis plc, has acquired U.S. rights to MOXATAG® (amoxicillin extended-release tablets) from Pragma Pharmaceuticals, LLC.

MOXATAG® is the first and only approved once-daily formulation of the widely-used antibiotic amoxicillin.

Approved by the FDA in 2008, MOXATAG® is a penicillin-class antibacterial indicated for the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes (S. pyogenes) in adults and pediatric patients 12 years of age or older. It was approved based on a Phase III efficacy study and is protected by six Orange Book listed patents, the last of which expires in 2027. It has not been actively promoted since 2010.

Vernalis Therapeutics will be responsible for the sales, marketing, and distribution of MOXATAG® in the United States.

In consideration for the acquisition, Vernalis has paid to Pragma an undisclosed up-front cash payment and will make a further payment upon successful manufacture of re-launch finished dose product, expected to be by the end of 2015. Vernalis will take over supply chain responsibility for MOXATAG® in the United States and will pay Pragma royalties on net sales and further potential sales-related milestones.

“The addition of MOXATAG®, a once-daily formulation of the widely-used antibiotic amoxicillin, further underscores Vernalis Therapeutics’ commitment to building a commercial presence in the U.S. market,” said Tom Parker, Senior Vice President of Commercial Operations, Vernalis Therapeutics, Inc. “We look forward to re-launching the product in early 2016, and believe it will be a natural complement to our recently launched 12-hour codeine-based prescription medication, TuzistraT XR, as both products offer patients and physicians an extended-release alternative to existing treatments.”

The U.S. Antibiotic Market According to IMS Health, (MAT February 2015 data) 14 million patients diagnosed with tonsillitis and/or pharyngitis secondary to S. pyrogenes were treated with antibiotics, and of these patients, three million people 12 years of age and older were treated with amoxicillin. The target market is estimated to be between two and three million prescriptions annually for patients 12 years of age or older that are treated by primary care physicians.