Date: 2015-10-02
Type of information: Product acquisition
Compound: Moxatag® (amoxicillin extended release tablets)
Company: Vernalis (UK) Pragma Pharmaceuticals (USA - NY)
Therapeutic area: Infectious diseases
Type agreement: product acquisition
Action mechanism: antibiotic. Amoxicillin is a semi-synthetic antimicrobial belonging to the penicillin class of antimicrobials with activity against gram-positive bacteria. It acts through the inhibition of biosynthesis of cell wall mucopeptide. Moxatag® is an extended-release formulation of amoxicillin intended to provide once-daily dosing. Through its delivery system, Moxatag® releases medicine in 3 separate pulses over time in different parts of the intestinal tract. This timed release of medicine throughout the day ensures that there is enough amoxicillin in your system to treat your infection with 1 dose each day for 10 days.
Disease: tonsillitis and/or pharyngitis secondary to streptococcus pyogenes in adults and paediatric patients 12 years of age or older.
Details: * On October 2, 2015, Vernalis announced that it has acquired the US rights to Moxatag® (amoxicillin extended release tablets) from Pragma Pharmaceuticals. Moxatag® is the first and only approved once-daily formulation of the antibiotic, amoxicillin. Under the terms of the transaction, Vernalis will take over supply chain responsibility and will pay Pragma royalties on net sales and further potential sales related milestones. 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 in adults and paediatric 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.
Financial terms: 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. The consideration payable does not materially impact the Group’s cash resources.
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