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Teva Announces Its Launch of the First Generic PERFOROMIST®, Formoterol Fumarate Inhalation Solution, 20 mcg/2 ML, Used to Treat Chronic Obstructive Pulmonary Disease (COPD), in the United States

June 22, 2021 Off By BusinessWire

TEL AVIV, Israel & PARSIPPANY, N.J.–(BUSINESS WIRE)–Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced its U.S. launch of the first generic version of twice daily PERFOROMIST®, formoterol fumarate inhalation solution, 20 mcg/2 ML, indicated to treat bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

“Teva is pleased to provide patients with first-to-market access to a generic version of PERFOROMIST® (formoterol fumarate inhalation solution),” said Christine Baeder, SVP, Chief Operating Officer US Generics, Teva USA.

With over 500 generic medicines available, Teva has the largest portfolio of FDA-approved generic products on the market and holds the leading position in first-to-file opportunities, with more than 100 pending first-to-files in the U.S. Currently, 1 in 11 generic prescriptions dispensed in the U.S. is filled with a Teva generic product.

PERFOROMIST® (formoterol fumarate inhalation solution) has annual sales of more than $299 million in the U.S., according to IQVIA data as of March 2021.

About Formoterol Fumarate Inhalation Solution, 20 mcg/2 ML

  • Formoterol fumarate inhalation solution is a long-acting beta2 adrenergic agonist (LABA) used to control the symptoms of COPD in adults with COPD. COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both.
  • Formoterol fumarate inhalation solution is only for use with a nebulizer.
  • LABA medicines such as formoterol fumarate inhalation solution help the muscles around the airways in your lungs stay relaxed to prevent symptoms, such as wheezing, cough, chest tightness, and shortness of breath.
  • Formoterol fumarate inhalation solution is for long-term use and should be taken 2 times each day, to improve the symptoms of COPD for better breathing.
  • Formoterol fumarate inhalation solution is not used to treat sudden symptoms of COPD.
  • Formoterol fumarate inhalation solution is not for the treatment of asthma. It is not known if formoterol fumarate inhalation solution is safe and effective in people with asthma.

Formoterol fumarate inhalation solution should not be used in children. It is not known if formoterol fumarate inhalation solution is safe and effective in children.

IMPORTANT SAFETY INFORMATION

Do not use formoterol fumarate inhalation solution if you have asthma.

Before using formoterol fumarate inhalation solution tell your healthcare provider about all of your medical conditions, including if you:

  • have heart problems
  • have high blood pressure
  • have diabetes
  • have seizures
  • have thyroid problems
  • have liver problems
  • are pregnant or plan to become pregnant. It is not known if the medicine formoterol in formoterol fumarate inhalation solution passes into breast milk and if it can harm your baby.
  • are breastfeeding or plan to breastfeed. It is not known if the medicine formoterol in formoterol fumarate inhalation solution passes into breast milk and if it can harm your baby.

Tell your healthcare provider about all the medicines you take including prescription and over-the-counter medicines, vitamins and herbal supplements. Formoterol fumarate inhalation solution and certain other medicines may interact with each other. This may cause serious side effects.

What are the possible side effects of formoterol fumarate inhalation solution?

Formoterol fumarate inhalation solution can cause serious side effects, including:

  • people with asthma who take long-acting LABA medicines, such as formoterol fumarate inhalation solution, without also using a medicine called an inhaled corticosteroid, have an increased risk of serious problems from asthma, including being hospitalized, needing a tube placed in their airway to help them breathe, or death.

    • Call your healthcare provider if breathing problems worsen over time while using formoterol fumarate inhalation solution. You may need a different treatment.
    • Get emergency medical care if:

      • breathing problems worsen quickly
      • you use your rescue inhaler medicine, but it does not relieve your breathing problems
  • COPD symptoms that get worse over time. If your COPD symptoms worsen over time, do not increase your dose of formoterol fumarate inhalation solution, instead call your healthcare provider.
  • using too much of a LABA medicine may cause: chest pain, fast and irregular heartbeat, tremor, increased blood pressure, headache, or nervousness.
  • sudden shortness of breath immediately after use of formoterol fumarate inhalation solution. Sudden shortness of breath may be life-threatening. If you have sudden breathing problems immediately after inhaling your medicine, call your healthcare provider or go to nearest hospital emergency room right away.
  • effects on your heart, including fast or irregular heartbeat, chest pain or increased blood pressure.
  • changes in laboratory levels, including high levels of blood sugar (hyperglycemia) and low levels of potassium (hypokalemia), which may cause symptoms of muscle spasm, muscle weakness or abnormal heart rhythm.
  • serious allergic reactions including rash, hives, swelling of the face, mouth, and tongue, and breathing problems. Call your healthcare provider or get emergency medical care if you get any symptoms of a serious allergic reaction.

Common side effects of formoterol fumarate inhalation solution include: headache, muscle cramps, dizziness, tremor, nausea, tiredness, nervousness, vomiting, trouble sleeping, dry mouth, or diarrhea.

Tell your healthcare provider if you get any side effect that bothers you or that does not go away. These are not all the possible side effects of formoterol fumarate inhalation solution. For more information, ask your healthcare provider or pharmacist for more information.

Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For more information, please see accompanying full Prescribing Information. A copy may be requested from Teva U.S. Medical Information at 888-TEVA-USA (888-838 2872), [email protected], or Teva’s Public Relations or Investor Relations contacts.

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products. Learn more at www.tevapharm.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding the launch of our generic version of PERFOROMIST® (formoterol fumarate) Inhalation Solution, 20 mcg/2 ML in the United States, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to:

  • the commercial success of our generic version of PERFOROMIST® (formoterol fumarate) Inhalation Solution, 20 mcg/2 ML;
  • our ability to successfully compete in the marketplace, including: that we are substantially dependent on our generic products; consolidation of our customer base and commercial alliances among our customers; delays in launches of new generic products; the increase in the number of competitors targeting generic opportunities and seeking U.S. market exclusivity for generic versions of significant products; our ability to develop and commercialize biopharmaceutical products; competition for our specialty products, including AUSTEDO®, AJOVY® and COPAXONE®; our ability to achieve expected results from investments in our product pipeline; our ability to develop and commercialize additional pharmaceutical products; and the effectiveness of our patents and other measures to protect our intellectual property rights;
  • our substantial indebtedness, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments, may result in a further downgrade of our credit ratings; and our inability to raise debt or borrow funds in amounts or on terms that are favorable to us;
  • our business and operations in general, including: uncertainty regarding the magnitude, duration, and geographic reach of the COVID-19 pandemic and its impact on our business, financial condition, operations, cash flows, and liquidity and on the economy in general; our ability to successfully execute and maintain the activities and efforts related to the measures we have taken or may take in response to the COVID-19 pandemic and associated costs therewith; effectiveness of our optimization efforts; our ability to attract, hire and retain highly skilled personnel; manufacturing or quality control problems; interruptions in our supply chain; disruptions of information technology systems; breaches of our data security; variations in intellectual property laws; challenges associated with conducting business globally, including political or economic instability, major hostilities or terrorism; costs and delays resulting from the extensive pharmaceutical regulation to which we are subject or delays in governmental processing time due to travel and work restrictions caused by the COVID-19 pandemic; the effects of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and coverage; significant sales to a limited number of customers; our ability to successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; and our prospects and opportunities for growth if we sell assets;
  • compliance, regulatory and litigation matters, including: failure to comply with complex legal and regulatory environments; increased legal and regulatory action in connection with public concern over the abuse of opioid medications and our ability to reach a final resolution of the remaining opioid-related litigation; scrutiny from competition and pricing authorities around the world, including our ability to successfully defend against the U.S. Department of Justice criminal charges of Sherman Act violations; potential liability for patent infringement; product liability claims; failure to comply with complex Medicare and Medicaid reporting and payment obligations; compliance with anti-corruption sanctions and trade control laws; and environmental risks;
  • other financial and economic risks, including: our exposure to currency fluctuations and restrictions as well as credit risks; potential impairments of our intangible assets; potential significant increases in tax liabilities; and the effect on our overall effective tax rate of the termination or expiration of governmental programs or tax benefits, or of a change in our business;

and other factors discussed in this press release and in our Annual Report on Form 10-K for the year ended December 31, 2020, including in the sections captioned “Risk Factors” and “Forward Looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

Contacts

IR

United States
Kevin C. Mannix

(215) 591-8912

Israel

Yael Ashman

972 (3) 914-8262

PR

United States
Kelley Dougherty

(973) 658-0237

Israel
Yonatan Beker

972 (54) 888 5898