HAZELWOOD, Mo.--Jun. 7, 2012-- Mallinckrodt LLC, the Pharmaceuticals business of Covidien (NYSE: COV), today announced that it has entered into a co-promotion agreement with Zogenix Inc. (NASDAQ: ZGNX) for SUMAVEL® DosePro® (sumatriptan injection), a prescription medicine given with a needle-free delivery system to treat adults who have been diagnosed with acute migraine or cluster headaches.
Under terms of the agreement, Mallinckrodt's U.S. sales force will sell SUMAVEL DosePro to its customer base of prescribers. Zogenix will continue to record all product revenues and Mallinckrodt will be compensated based on a percentage of net sales from prescriptions generated by Mallinckrodt. The agreement runs through June 30, 2014, and can be extended.
"This agreement represents a key component of our growing pharmaceuticals business as we prepare to spin off from Covidien next year," said Mark Trudeau, President, Pharmaceuticals. "We believe that the combined resources of these two companies will enable us to leverage our talented and successful sales force where it can make the most difference for prescribers and patients.
"We are leaders in pain management," Mr. Trudeau said. "This opportunity allows us to help patients who suffer from migraine manage its often-debilitating impact, as well as to build out our existing pain management franchise. We look forward to working with Zogenix and to providing SUMAVEL DosePro to our customers."
Covidien's Pharmaceuticals business is the largest U.S. supplier of opioid pain medications and among the top 10 generic pharmaceuticals manufacturers in the U.S., based on prescriptions. Its branded portfolio includes EXALGO® (hydromorphone HCl) Extended-Release Tablets (CII) and PENNSAID® (diclofenac sodium topical solution) 1.5% w/w. Mallinckrodt is also one of the world's leading producers of bulk acetaminophen.
"Adding Mallinckrodt's large sales force to the efforts of our 95 sales representatives will double our reach into prescribers of migraine products and significantly expand the sales coverage for SUMAVEL DosePro within the primary care market," said Roger Hawley, Chief Executive Officer, Zogenix. "The Mallinckrodt team has a track record of commercial success in the pain market, and is committed to educating its customers on the potential benefits of SUMAVEL DosePro as an exciting treatment option. Our team will remain engaged with neurologists, headache specialists and other key migraine prescribers, while working closely with Mallinckrodt at the field level to effectively drive sales."
SUMAVEL DosePro is the first and only needle-free delivery system for subcutaneous sumatriptan for the treatment of acute migraine and cluster headache. In clinical studies1, sumatriptan injection provided migraine relief within 10 minutes for 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 through March 2012.
Covidien announced last December that the Company planned to spin off its pharmaceuticals business into a stand-alone company, a process that is expected to be completed in mid-2013.
1 Cady RK, Wendt JK, Kirchner JR, Sargent JD, Rothrock JF, Skaggs Jr., H. Treatment of Acute Migraine with Subcutaneous Sumatriptan. JAMA 1991; 265:2831-2835.
About SUMAVEL DosePro
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.
SUMAVEL DosePro should only be used where a clear diagnosis of migraine or cluster headache has been established. SUMAVEL DosePro is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine and should not be administered intravenously. For a given attack, if a patient does not respond to the first dose of SUMAVEL DosePro, the diagnosis of migraine or cluster headache should be reconsidered before administration of a second dose.
IMPORTANT SAFETY INFORMATION
SUMAVEL DosePro is contraindicated in patients with uncontrolled hypertension, in patients with history, symptoms or signs of ischemic heart disease, coronary artery vasospasm, cerebrovascular or peripheral vascular disease including ischemic bowel disease and in patients with other significant underlying cardiovascular diseases or known hypersensitivity to sumatriptan. SUMAVEL DosePro should not be given to patients in whom unrecognized coronary artery disease is predicted by the presence of risk factors without a prior cardiovascular evaluation.
Serious cardiovascular events, including death, have been reported when taking sumatriptan, including patients with no findings of cardiovascular disease. Considering the extent of use of sumatriptan in patients with migraine, the incidence of these events is extremely low. Cerebrovascular events, some fatal, have been reported in patients treated with sumatriptan. In a number of cases, it appears possible that the cerebrovascular events were primary, sumatriptan having been administered in the incorrect belief the symptoms experienced were a consequence of migraine when they were not. It is important to advise patients not to administer SUMAVEL DosePro if a headache being experienced is atypical.
Do not use SUMAVEL DosePro and any ergotamine-containing or ergot-type medication within 24 hours of each other; do not use SUMAVEL DosePro and another 5-HT1 agonist (e.g. triptan) within 24 hours of each other (with the exception of a single dose of another sumatriptan product, provided the doses are separated by at least 1 hour). SUMAVEL DosePro is not generally recommended for use with MAO-A inhibitors. The development of a potentially life-threatening serotonin syndrome may occur with triptans, including treatment with SUMAVEL DosePro, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). SUMAVEL DosePro should be used during pregnancy only if the potential benefit justifies the potential risk.
In controlled clinical trials with sumatriptan injection, the most common adverse reactions were injection site reactions, tingling, warm/hot sensation, burning sensation, feeling of heaviness, pressure sensation, feeling of tightness, numbness, feeling strange, tight feeling in head, flushing, tightness in chest, discomfort in nasal cavity/sinuses, jaw discomfort, dizziness/vertigo, drowsiness/sedation and headache.
For full prescribing information, please click here: http://www.zogenix.com/downloads/SV0468.0611_SDP_PI.pdf
For more information about SUMAVEL DosePro, please visit www.SUMAVELDosePro.com.
• Non-steroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
• PENNSAID is contraindicated in the perioperative setting of coronary artery bypass graft (CABG) surgery.
• NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.
WARNING: POTENTIAL FOR ABUSE, IMPORTANCE OF PROPER PATIENT
SELECTION AND LIMITATIONS OF USE
Potential for Abuse
EXALGO contains hydromorphone, an opioid agonist and a Schedule II controlled substance with an abuse liability similar to other opioid analgesics. EXALGO can be abused in a manner similar to other opioid agonists, legal or illicit. These risks should be considered when administering, prescribing, or dispensing EXALGO in situations where the healthcare professional is concerned about increased risk of misuse, abuse, or diversion. Schedule II opioid substances which include hydromorphone, morphine, oxycodone, fentanyl, oxymorphone and methadone have the highest potential for abuse and risk of fatal overdose due to respiratory depression.
Proper Patient Selection
EXALGO is an extended-release formulation of hydromorphone hydrochloride indicated for the management of moderate to severe pain in opioid tolerant patients when a continuous around-the-clock opioid analgesic is needed for an extended period of time. Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day or an equianalgesic dose of another opioid, for a week or longer.
EXALGO is for use in opioid tolerant patients only.
Fatal respiratory depression could occur in patients who are not opioid tolerant.
Accidental consumption of EXALGO, especially in children, can result in a fatal overdose of hydromorphone.
Limitations of Use
EXALGO is not indicated for the management of acute or postoperative pain.
EXALGO is not intended for use as an as-needed analgesic.
EXALGO tablets are to be swallowed whole and are not to be broken, chewed, dissolved, crushed or injected. Taking broken, chewed, dissolved or crushed EXALGO or its contents leads to rapid release and absorption of a potentially fatal dose of hydromorphone.
Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading product lines in three segments: Medical Devices, Pharmaceuticals and Medical Supplies. With 2011 revenue of $11.6 billion, Covidien has 41,000 employees worldwide in more than 65 countries, and its products are sold in over 140 countries. Mallinckrodt, the Pharmaceuticals business of Covidien, manufactures active pharmaceutical ingredients, including bulk acetaminophen, opioid pain medications, nuclear and contrast media diagnostic agents. Sales in 2011 were $2.0 billion. Please visit www.covidien.com to learn more about our business.