Adams pushes Rx

The US-based specialty pharmaceutical company saw net sales for 2007 increase by 39 per cent to $331.6m despite reporting an 11 per cent decline in sales to $46.9m for the fourth quarter compared to the prior year period. Adams chief executive and president Michael Valentino said the company expected to continue on its strong line of growth well into 2009, when the company would really push its prescription portfolio into the respiratory market. "Based on our current planning assumptions, we expect to continue to execute effectively in the marketplace and produce top-line growth in excess of 20 per cent in fiscal 2008, while experiencing meaningful financial leverage that should produce diluted earnings per share growth in excess of 40 per cent,"​ Valentino said in a statement. "In fiscal 2009, our regulatory and marketing strategies should continue to bear fruit. An FDA approval of our Mucinex with Codeine product would allow us to begin bridging to our long-term diversification strategy which includes building a portfolio of prescription respiratory products. We have confidence in our ability to continue to deliver strong growth over the long-term, which will be driven by meaningful financial leverage from our existing businesses. As a result, diluted earnings per share growth should continue to exceed top-line growth for the next several years." ​ Net sales of the adult Mucinex (guaifenesin) franchise grew seven per cent in 2007 to $254.7m, led by growth in Mucinex DM (guaifenesin and dextromethorphan HBr extended-release bi-layer tablets) which generated sales of $94.6m, an increase of 60 per cent over the prior year period. Meanwhile, the new line of Mucinex for Children products, which were launched in August last year, generated sales of $29.2m in fiscal 2007. In March, Adams entered into a licensing and collaboration agreement with MonoSol Rx, a privately held drug delivery company, to use an oral thin-film drug delivery technology to develop and market two or more respiratory products in North America. The move could mean Adams could be the first company to develop prescription respiratory products using a thin-film delivery system. Meanwhile, the company has received a Paragraph IV Certification Notice letter, advising that Perrigo R&D Co., has submitted an Abbreviated New Drug Application (ANDA) for guaifenesin 600 mg single-ingredient extended-release tablets. Adams currently markets Mucinex SE, single-ingredient 600 mg extended-release guaifenesin, the only available FDA-approved extended-release, single-ingredient guaifenesin product. In a statement today, the company said it planed to vigorously defend its market position for single-entity Mucinex as well as its patent portfolio protecting the Company's oral solid, extended-release guaifenesin products. Adams is evaluating Perrigo's notice letter and has 45 days to commence a patent infringement lawsuit against Perrigo that would automatically stay the FDA from approving Perrigo's ANDA for 30 months or until a district court decision that is adverse to Adams, whichever may occur earlier.