The development and licensing deal with Tris gives Vernalis exclusive rights to Tris' extended-release technology for use in the US prescription cough cold market. This market comprises approximately 30-35 million prescriptions annually, and is potentially worth over $3 billion at current brand pricing.
The first product resulting from this deal is Tuzistra® XR, which was approved by the US FDA in April 2015 for the relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults 18 years of age and older. Tuzistra® XR, an oral suspension that combines codeine phosphate (an antitussive) and chlorpheniramine maleate (an antihistamine), is a DEA Schedule III (CIII) product. Like other codeine-containing products, Tuzistra® XR has a Boxed Warning relating to the use of codeine in children.
Vernalis has 4 additional products in development in its cough cold pipeline.
Click here for more details on Tuzistra® XR, including the Important Safety Information, full US Prescribing Information including Boxed Warning, and Medication Guide.
The US prescription cough cold market is a seasonal market with approximately 30-35 million prescriptions written each year. Under the development and licensing agreement with Tris, Vernalis will pay Tris to develop up to six unique extended-release equivalents to existing immediate release products.
Vernalis will own all approved products and will commercialise them in the US market. Tris will be responsible for the ongoing product supply.
The US cough cold market comprises two key segments: the narcotic cough market which is controlled by the DEA and totals approximately 14-16 million prescriptions; and the non-narcotic market which totals approximately 16-19 million prescriptions. Both these markets are dominated by short-acting formulations of generic single agent or combination treatments which provide short term relief. Vernalis, through the licensing deal with Tris, is developing long-acting products for this prescription market.
Tris initiated development work on products under our collaboration in March 2012. The FDA approved the first product from the collaboration, Tuzistra® XR (codeine polistirex and chlorpheniramine polistirex) extended-release oral suspension, CIII, on 30 April 2015 and VTI launched Tuzistra® XR into the 2015/2016 cough cold season in September 2015.
Proof-of-concept for Tuzistra® XR was achieved in March 2013 and triggered the payment of a milestone to Tris. Tris then successfully completed pivotal single dose and multi dose bioavailability studies and the NDA for Tuzistra® XR was submitted to the FDA in June 2014, ahead of its approval on 30 April 2015. Both the filing of the NDA and its approval triggered milestone payments to Tris.
Proof-of-concept has been achieved for both CCP-07 and CCP-08, triggering the payment of milestones to Tris. Both programmes are on track for filing with FDA in calendar year 2016.
The remaining two programmes in active development at Tris, CCP-05 and CCP-06, are targeted to achieve proof-of-concept in 2016.
All five Tris programmes are following a 505(b)(2) regulatory pathway which is based on comparative bioavailability.