Zogenix Inc., a pharmaceutical company commercializing and developing products for the treatment of CNS disorders and pain, and Mallinckrodt LLC, the pharmaceuticals business of Covidien, enter into an exclusive co-promotion agreement for Sumavel DosePro (sumatriptan injection) needle-free delivery system in the United States.
Sumavel DosePro (sumatriptan injection) is indicated for the acute treatment of migraine attacks, with or without aura, and the acute treatment of cluster headache episodes.
Under terms of the agreement, Mallinckrodt's sales team will begin selling Sumavel DosePro to its customer base of prescribers. The initial term of the agreement will be through June 30, 2014, and can be extended by mutual agreement of the parties in additional six month increments. Zogenix will continue to record all product revenues and Mallinckrodt will be compensated in the form of a quarterly service fee that is calculated as a percentage of net sales over a baseline amount to their prescriber audience.
Sumavel DosePro is the first and only needle-free delivery system for subcutaneous sumatriptan for the treatment of acute migraine and cluster headache. Clinical data has shown that Sumavel DosePro can provide migraine pain relief within 10 minutes for some patients (16% of patients versus 4% for placebo). The product was launched in January 2010 and sales have grown sequentially every quarter since launch, reaching over 129,000 total prescriptions at the end of the first quarter 2012.
"We are pleased to have Mallinckrodt join our efforts to bring Sumavel DosePro to a broader audience of prescribers who are committed to helping patients manage the debilitating impact of migraine," said Roger Hawley, chief executive officer of Zogenix. "Adding Mallinckrodt's large sales force to the efforts of our 95 sales representatives will double our reach to prescribers of migraine products and significantly expand our sales coverage for Sumavel DosePro within the primary care market. The Mallinckrodt team has extensive experience in the pain market, and is committed to educating their customers on the unique benefits of adding Sumavel DosePro as an exciting migraine treatment option. Our team will remain engaged with neurologists, headache specialists, and other key migraine prescribers while working closely with our new partner at the field level to effectively drive sales and implement our new sales campaign which we've recently introduced."
Mark Trudeau, president of Mallinckrodt, added, "We are leaders in pain management, and the inclusion of Sumavel DosePro to our sales efforts allows us to grow in that space, as we prepare to spin off from Covidien next year. We look forward to working with Zogenix and to launching Sumavel DosePro to our customers."
According to the National Headache Foundation, acute migraines affect nearly 30 million Americans, primarily women between the ages of 25 and 40, who are treated by primary care physicians, neurologists and headache specialists. Tablets are a treatment option for some of these migraine sufferers, but not all patients are satisfied with tablet therapy. Fast-acting, non-oral options are needed, particularly for those who experience migraine attacks associated with sudden onset, waking, nausea or vomiting. The US Headache Consortium has recently endorsed updated migraine treatment guidelines which support a "toolbox" approach to providing treatment options.