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Biopharmaceuticals Litigation

 News Release - August 7, 2017

Impax Announces Settlement of Contract Litigation on Opana(R) ER (Oxymorphone Hydrochloride) CII Extended-Release Tablets

HAYWARD, Calif., Aug. 7, 2017 -- (Healthcare Sales & Marketing Network) -- Impax Laboratories, Inc. (NASDAQ: IPXL), today announced a Settlement Agreement (the "Contract Settlement Agreement") to resolve a contract dispute relating to an agreement entered into in June 2010 among Endo International plc ("Endo"), Penwest Pharmaceuticals and Impax regarding the Abbreviated New Drug Application litigation related to the original formulation of Opana® ER (oxymorphone hydrochloride) CII Extended-Release ("ER") tablets (the "2010 ANDA Settlement"). In the 2010 ANDA Settlement, Impax obtained a non-exclusive license to certain then-existing and future Endo patents. Orange Book listed patents for Opana ER extend until November 2029.

The Contract Settlement Agreement includes an amendment to the 2010 ANDA Settlement, whereby Impax agrees to pay Endo a royalty rate that splits Impax's gross profits for its sales of oxymorphone hydrochloride CII ER products, commencing January 1, 2018. The royalty will be eliminated based on certain commercial conditions. Further terms of the settlement were not disclosed.

"We are pleased to have reached an agreement to settle this outstanding contractual litigation," said Paul Bisaro, President and Chief Executive Officer of Impax. "We will continue to make available our generic version of original Opana ER (oxymorphone hydrochloride) CII ER tablets for prescribing physicians that prefer this product to treat patients."

Combined reported net sales of Endo's new formulation of Opana ER and Impax's generic oxymorphone hydrochloride ER tablets (AB-rated to original formulation of Opana ER) were $229 million for the last twelve months ended March 31, 2017.

INDICATIONS AND USAGE

Oxymorphone Hydrochloride Extended-Release Tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Limitations of Usage
  • Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve Oxymorphone Hydrochloride Extended-Release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
  • Oxymorphone Hydrochloride Extended-Release Tablets are not indicated as an as-needed (prn) analgesic.
(OXYMORPHONE HYDROCHLORIDE) CII ER tablets IMPORTANT SAFETY INFORMATION

BOXED WARNING

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTION WITH ALCOHOL; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

Addiction, Abuse, and Misuse

Oxymorphone Hydrochloride Extended-Release Tablets expose patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing Oxymorphone Hydrochloride Extended-Release Tablets, and monitor all patients regularly for the development of these behaviors or conditions.

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of Oxymorphone Hydrochloride Extended-Release Tablets. Monitor for respiratory depression, especially during initiation of Oxymorphone Hydrochloride Extended-Release Tablets or following a dose increase. Instruct patients to swallow Oxymorphone Hydrochloride Extended-Release Tablets whole; crushing, chewing, or dissolving Oxymorphone Hydrochloride Extended-Release Tablets can cause rapid release and absorption of a potentially fatal dose of oxymorphone.

Accidental Ingestion

Accidental ingestion of even one dose of Oxymorphone Hydrochloride Extended-Release Tablets, especially by children, can result in fatal overdose of oxymorphone.

Neonatal Opioid Withdrawal Syndrome Prolonged use of Oxymorphone Hydrochloride Extended-Release Tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

Interaction with Alcohol

Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while taking Oxymorphone Hydrochloride Extended-Release Tablets. The co-ingestion of alcohol with Oxymorphone Hydrochloride may result in increased plasma levels and a potentially fatal overdose of oxymorphone.

Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants

Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.
  • Reserve concomitant prescribing of Oxymorphone Hydrochloride Extended-Release Tablets and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
  • Limit dosages and durations to the minimum required.
  • Follow patients for signs and symptoms of respiratory depression and sedation.
CONTRAINDICATIONS

Oxymorphone Hydrochloride Extended-Release Tablets are contraindicated in patients with:
  • Significant respiratory depression
  • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
  • Hypersensitivity (e.g., anaphylaxis) to oxymorphone, any other ingredients in Oxymorphone Hydrochloride Extended-Release Tablets
  • Moderate and severe hepatic impairment
  • Known or suspected gastrointestinal obstruction, including paralytic ileus
WARNINGS AND PRECAUTIONS

Addiction, Abuse, and Misuse

Oxymorphone Hydrochloride Extended-Release Tablets contain oxymorphone, a Schedule II controlled substance. As an opioid, Oxymorphone Hydrochloride Extended-Release Tablets expose users to the risks of addiction, abuse, and misuse. Because extended-release products such as Oxymorphone Hydrochloride Extended-Release Tablets deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of oxymorphone present.

Abuse, or misuse of Oxymorphone Hydrochloride Extended-Release Tablets by crushing, chewing, snorting, or injecting the dissolved product will result in the uncontrolled delivery of the oxymorphone and can result in overdose and death.

Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing Oxymorphone Hydrochloride Extended-Release Tablets. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug. Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product.

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended. Respiratory depression from opioid use, if not immediately recognized and treated, may lead to respiratory arrest and death.

Neonatal Opioid Withdrawal Syndrome

Prolonged use of Oxymorphone Hydrochloride Extended-Release Tablets during pregnancy can result in withdrawal signs in the neonate. Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts.

Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants

Patients must not consume alcoholic beverages or prescription or non-prescription products containing alcohol while on Oxymorphone Hydrochloride Extended-Release Tablet therapy. The co-ingestion of alcohol with Oxymorphone Hydrochloride Extended-Release Tablets may result in increased plasma levels and a potentially fatal overdose of oxymorphone.

Profound sedation, respiratory depression, coma, and death may result from the concomitant use of Oxymorphone Hydrochloride Extended-Release Tablets with benzodiazepines or other CNS depressants (e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol). Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.

Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioid analgesics alone. Because of similar pharmacological properties, it is reasonable to expect similar risk with the concomitant use of other CNS depressant drugs with opioid analgesics.

Risk of Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients The use of Oxymorphone Hydrochloride Extended-Release Tablets in patients with acute or severe bronchial asthma in unmonitored setting or in the absence of resuscitative equipment is contraindicated.

Patients with Chronic Pulmonary Disease: Oxymorphone Hydrochloride Extended-Release Tablets treated patients with significant chronic obstructive pulmonary disease or cor pulmonale, and those with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression are at increased risk of decreased respiratory drive including apnea, even at recommended dosages of Oxymorphone Hydrochloride Extended-Release Tablets.

Elderly, Cachectic, or Debilitated Patients: Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients because they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients.

Monitor such patients closely, particularly when initiating and titrating Oxymorphone Hydrochloride Extended-Release Tablets and when Oxymorphone Hydrochloride Extended-Release Tablets are given concomitantly with other drugs that depress respiration. Alternatively, consider the use of non-opioid analgesics in these patients.

Anaphylaxis, Angioedema, and Other Hypersensitivity Reactions

Potentially life-threatening hypersensitivity reactions, including anaphylaxis and angioedema, have occurred in patients treated with Oxymorphone Hydrochloride Extended-Release Tablets in the postmarket setting. The most commonly described clinical features in these reports were swelling of the face, eyes, mouth, lips, tongue, hands, and/or throat; dyspnea; hives, pruritus, and/or rash; and nausea/vomiting. If anaphylaxis or other hypersensitivity occurs, stop administration of Oxymorphone Hydrochloride Extended-Release Tablets immediately, discontinue Oxymorphone Hydrochloride Extended-Release Tablets permanently, and do not rechallenge with any formulation of oxymorphone. Advise patients to seek immediate medical attention if they experience any symptoms of a hypersensitivity reaction.

Adrenal Insufficiency

If adrenal insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids. Wean the patient off of the opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers.

Use in Patients with Hepatic Impairment

Oxymorphone Hydrochloride Extended-Release Tablets are contraindicated in patients with moderate or severe hepatic impairment. In patients with mild hepatic impairment reduce the starting dose to the lowest dose and monitor for signs of respiratory and central nervous system depression.

Severe Hypotension

Monitor these patients for signs of hypotension after initiating or titrating the dosage of Oxymorphone Hydrochloride Extended-Release Tablets. In patients with circulatory shock, Oxymorphone Hydrochloride Extended-Release Tablets may cause vasodilation that can further reduce cardiac output and blood pressure. Avoid the use of Oxymorphone Hydrochloride Extended-Release Tablets in patients with circulatory shock.

Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness

Monitor such patients for signs of sedation and respiratory depression, particularly when initiating therapy with Oxymorphone Hydrochloride Extended-Release Tablets.

Opioids may also obscure the clinical course in a patient with a head injury. Avoid the use of Oxymorphone Hydrochloride Extended-Release Tablets in patients with impaired consciousness or coma.

Risks of Use in Patients with Gastrointestinal Conditions Oxymorphone Hydrochloride Extended-Release Tablets are contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus.

The oxymorphone in Oxymorphone Hydrochloride Extended-Release Tablets may cause spasm of the sphincter of Oddi. Opioids may cause increases in serum amylase. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms.

Increased Risk of Seizures in Patients with Seizure Disorders Monitor patients with a history of seizure disorders for worsened seizure control during Oxymorphone Hydrochloride Extended-Release Tablets therapy.

ADVERSE REACTIONS

Adverse reactions in =2% of patients in placebo-controlled trials: nausea, constipation, dizziness, somnolence, vomiting, pruritus, headache, sweating increased, dry mouth, sedation, diarrhea, insomnia, fatigue, appetite decreased, and abdominal pain.

DRUG INTERACTIONS

Serotonergic Drugs: Concomitant use may result in serotonin syndrome. Discontinue Oxymorphone Hydrochloride Extended-Release Tablets if serotonin syndrome is suspected.

Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics: Avoid use with Oxymorphone Hydrochloride Extended-Release Tablets because they may reduce analgesic effect of Oxymorphone Hydrochloride Extended-Release Tablets or precipitate withdrawal symptoms.

Monoamine Oxidase Inhibitors (MAOIs): Can potentiate the effects of oxymorphone. Avoid concomitant use in patients receiving MAOIs or within 14 days of stopping treatment with an MAOI.

USE IN SPECIFIC POPULATIONS

Pregnancy

Risk Summary

Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome. Available data with Oxymorphone Hydrochloride Extended-Release Tablets in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage.

Clinical Considerations

Fetal/Neonatal adverse reactions

Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes may cause fetal-neonatal physical dependence and neonatal withdrawal syndrome shortly after birth. Observe newborns for symptoms of neonatal opioid withdrawal syndrome, and manage accordingly.

Labor or delivery

Opioids cross the placenta and may produce respiratory depression and pyscho-physiologic effects in neonates. An opioid antagonist, such as naloxone must be available for reversal of opioid-induced respiratory depression in the neonate. Oxymorphone Hydrochloride Extended-Release Tablets are not recommended for use in women during and immediately prior to labor, when use of shorter acting analgesics or other analgesic techniques are more appropriate. Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression.

Lactation

Risk Summary

There is no information regarding the presence of oxymorphone in human milk, the effects on the breastfed infant, or the effects on milk production. Because of the potential for serious adverse reactions, including excess sedation and respiratory depression in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with Oxymorphone Hydrochloride Extended-Release Tablets.

Clinical Considerations

Monitor infants exposed to Oxymorphone Hydrochloride Extended-Release Tablets through breast milk for excess sedation and respiratory depression. Withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breast-feeding is stopped.

Females and Males Reproductive Potential

Infertility

Chronic use of opioids may cause reduced fertility in females and males of reproductive potential. It is not known whether these effects on fertility are reversible.

Pediatric Use

The safety and effectiveness of Oxymorphone Hydrochloride Extended-Release Tablets in patients below the age of 18 years have not been established.

Geriatric Use

Of the total number of subjects in clinical studies of Oxymorphone Hydrochloride Extended-Release Tablets, 27% were 65 and over, while 9% were 75 and over. No overall differences in effectiveness were observed between these subjects and younger subjects. There were several adverse events that were more frequently observed in subjects 65 and over compared to younger subjects. These adverse events included dizziness, somnolence, confusion, and nausea. On average, age greater than 65 years was associated with a 1.4-fold increase in oxymorphone AUC and a 1.5-fold increase in Cmax.

Oxymorphone is known to be substantially excreted by the kidney and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because the elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Hepatic Impairment

Patients with mild hepatic impairment have an increase in oxymorphone bioavailability of 1.6-fold.

Renal Impairment

Patients with moderate to severe renal impairment were shown to have an increase in oxymorphone bioavailability compared to the subjects with normal renal function. See Full Prescribing Information , for complete drug information including additional important risk information about oxymorphone hydrochloride extended-release tablets.

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, please visit the Company's Web site at: www.impaxlabs.com.

"Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995: 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.


Source: Impax Laboratories

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