HAYWARD, Calif., March 30, 2017 /PRNewswire/ -- Impax Laboratories, Inc. (IPXL) announced today that Judge Richard G. Andrews of the U.S. District Court, District of Delaware, has found that the U.S. patents 6,750,237 and 7,220,767 protecting Zomig® (zolmitriptan) Nasal Spray are not invalid and are infringed by the Lannett Holdings, Inc. and Lannett Company, Inc. (the "Defendants") ANDA .
As previously announced, Impax Laboratories, AstraZeneca UK, and AstraZeneca AB (the "Plaintiffs"), brought suit against Defendants for alleged patent infringement based on the filing of the Defendants Abbreviated New Drug Application relating to Zolmitriptan Nasal Spray, 5mg, generic to Zomig® Nasal Spray. At the trial, the Defendants had made certain arguments related to AstraZeneca standing and the Court provisionally ruled in the Plaintiffs favor on that point. The Court order allows Defendants one week to request an opportunity to cross-examine an AstraZeneca witness on the standing issue, in which case the Court will schedule a hearing. Otherwise, the parties are to submit an agreed form of final judgment within two weeks. This ruling is also subject to a potential appeal by the Defendants.
"We are pleased with the court's decision upholding the validity of the patents for Zomig Nasal Spray," said Paul Bisaro, President and CEO of Impax. "We look forward to continuing to supply this product to patients and will continue to actively protect our intellectual property."
About ZOMIG Nasal Spray
ZOMIG Nasal Spray was first approved by the U.S. Food and Drug Administration (FDA) in September 2003 for the acute treatment of migraine attacks, with or without aura, in adults. In clinical trials, ZOMIG Nasal Spray provided relief in as soon as 15 minutes for some patients and the maximum effect was reached within 2–4 hours for most adult patients. At 2 hours, 69% of patients taking the 5mg dose had headache response (taking the patient from moderate to severe pain to mild or no pain) and 36% were pain free. 1
ZOMIG Nasal Spray is a serotonin (5-HT)1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years and older.
Limitations of Use:
Use ZOMIG only after clear diagnosis of migraine has been established. If a patient has no response to ZOMIG treatment for the first migraine attack, reconsider the diagnosis of migraine before ZOMIG is administered to treat any subsequent attacks. ZOMIG is not indicated for the prevention of migraine attacks. Safety and effectiveness of ZOMIG have not been established for cluster headache. ZOMIG Nasal Spray is not recommended in patients with moderate to severe hepatic impairment.
Important Safety Information
- ZOMIG is contraindicated in patients with
- History of coronary artery disease (CAD) or coronary artery vasospasm
- Symptomatic Wolff-Parkinson-White syndrome or other cardiac accessory conduction pathway disorders
- History of stroke, transient ischemic attack, or hemiplegic or basilar migraine
- Peripheral vascular disease
- Ischemic bowel disease
- Uncontrolled hypertension
- Recent (within 24 hours) use of another 5-HT1 agonist (eg, another triptan), or an ergotamine-containing medication
- Monoamine oxidase (MAO)-A inhibitor used in past 2 weeks
- Known hypersensitivity to ZOMIG, ZOMIG-ZMT, or ZOMIG Nasal Spray. Anaphylaxis, anaphylactoid, and hypersensitivity reactions including angioedema have occurred in patients receiving zolmitriptan.
- Myocardial ischemia, myocardial infarction and Prinzmetal Angina: Perform cardiac evaluation in patients with multiple risk factors and, if satisfactory, administer first dose of ZOMIG in a medically supervised setting
- Arrhythmias: Discontinue ZOMIG if these occur
- Sensations of tightness, pain and pressure in the chest, throat, neck, and jaw commonly occur after treatment with 5-HT1 agonists like ZOMIG and are usually non-cardiac in origin: Perform a cardiac evaluation if these patients are at cardiac risk
- Cerebrovascular events, some fatal; non-coronary Gastrointestinal Ischemic Reactions and Peripheral Vasospastic Reactions; and increases in blood pressure (which have been very rarely associated with serious clinical events) have been reported with ZOMIG. Discontinue use of ZOMIG if any of these events occur
- Overuse of acute migraine drugs may lead to exacerbation headache (medication overuse headache). Detoxification of patients, including withdrawal of the overused drugs, and treatment of withdrawal symptoms may be necessary
- Serotonin syndrome may occur with triptans, including ZOMIG, particularly during co-administration with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and MAO inhibitors. Discontinue ZOMIG if serotonin syndrome is suspected
- The most common adverse reactions in adults (=5% and > placebo; in any dosage strength) in clinical trials for ZOMIG Nasal Spray were: unusual taste, paresthesia, hyperesthesia, and dizziness
- The most common adverse reaction in pediatrics (ages 12 and 17 years; =5% and > placebo; in either the 2.5 or 5 mg ZOMIG dose groups) in clinical trials for ZOMIG Nasal Spray was unusual taste.
For full Prescribing Information see www.Zomig.com.
About Impax Laboratories, Inc.
Impax Laboratories, Inc. (Impax) is a specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of central nervous system disorder branded products. Impax markets its generic products through its Impax Generics division and markets its branded products through the Impax Specialty Pharma division. Additionally, where strategically appropriate, Impax develops marketing partnerships to fully leverage its technology platform and pursues partnership opportunities that offer alternative dosage form technologies, such as injectables, nasal sprays, inhalers, patches, creams, and ointments.
For more information, visit Impax's website at: www.impaxlabs.com.
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Investor Relations and Corporate Communications
- ZOMIG Nasal Spray Prescribing Information. Updated November 2016.
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