Impax Announces Favorable Ruling Regarding Patent Validity for Zomig® (zolmitriptan) Nasal Spray

HAYWARD, Calif., March 30, 2017 /PRNewswire/ -- Impax Laboratories, Inc.(NASDAQ: 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

Indication

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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To the extent any statements made in this news release contain information that is not historical; these statements are forward-looking in nature and express the beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause the Company's future results, performance, or achievements to differ significantly from the results, performance, or achievements expressed or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to: fluctuations in the Company's operating results and financial condition; the volatility of the market price of the Company's common stock; the Company's ability to successfully develop and commercialize pharmaceutical products in a timely manner; the impact of competition; the effect of any manufacturing or quality control problems;  the Company's ability to manage its growth; risks related to acquisitions of or investments in technologies, products or businesses; risks relating to goodwill and intangibles; the reduction or loss of business with any significant customer; the substantial portion of the Company's total revenues derived from sales of a limited number of products; the impact of consolidation of the Company's customer base; the Company's ability to sustain profitability and positive cash flows; the impact of any valuation allowance on the Company's deferred tax assets; the restrictions imposed by the Company's credit facility and indenture; the Company's level of indebtedness and liabilities and the potential impact on cash flow available for operations; the availability of additional funds in the future; any delays or unanticipated expenses in connection with the operation of the Company's manufacturing facilities; the effect of foreign economic, political, legal and other risks on the Company's operations abroad; the uncertainty of patent litigation and other legal proceedings; the increased government scrutiny on the Company's agreements to settle patent litigations, product development risks and the difficulty of predicting FDA filings and approvals; consumer acceptance and demand for new pharmaceutical products; the impact of market perceptions of the Company and the safety and quality of the Company's products; the Company's determinations to discontinue the manufacture and distribution of certain products; the Company's ability to achieve returns on its investments in research and development activities; changes to FDA approval requirements; the Company's ability to successfully conduct clinical trials; the Company's reliance on third parties to conduct clinical trials and testing; the Company's lack of a license partner for commercialization of Numient® (IPX066) outside of the United States; impact of illegal distribution and sale by third parties of counterfeits or stolen products; the availability of raw materials and impact of interruptions in the Company's supply chain; the Company's policies regarding returns, rebates, allowances and chargebacks; the use of controlled substances in the Company's products; the effect of current economic conditions on the Company's industry, business, results of operations and financial condition; disruptions or failures in the Company's information technology systems and network infrastructure caused by third party breaches or other events; the Company's reliance on alliance and collaboration agreements; the Company's reliance on licenses to proprietary technologies; the Company's dependence on certain employees; the Company's ability to comply with legal and regulatory requirements governing the healthcare industry; the regulatory environment; the effect of certain provisions in the Company's government contracts; the Company's ability to protect its intellectual property; exposure to product liability claims; changes in tax regulations; uncertainties involved in the preparation of the Company's financial statements; the Company's ability to maintain an effective system of internal control over financial reporting; the effect of terrorist attacks on the Company's business; the location of the Company's manufacturing and research and development facilities near earthquake fault lines; expansion of social media platforms and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission.  Forward-looking statements speak only as to the date on which they are made, and the Company undertakes no obligation to update publicly or revise any forward-looking statement, regardless of whether new information becomes available, future developments occur or otherwise.

CONTACT:                                                            
Mark Donohue
Investor Relations and Corporate Communications 
(215) 558-4526                                                       

References

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SOURCE Impax Laboratories, Inc.