Sandoz in-licenses brand and authorized generic of respiratory medicine Proventil® HFA (albuterol sulfate) Inhalation Aerosol from Kindeva Drug Delivery, with immediate generic availability in US

PRINCETON, N.J., March 16, 2021 /PRNewswire/ -- Sandoz Inc. today announced the in-licensing of commercial distribution rights to the brand and authorized generic of respiratory inhalation medicine Proventil^® HFA (albuterol sulfate) Inhalation Aerosol from Kindeva Drug Delivery, a global contract development and manufacturing organization supplying the product. Our albuterol sulfate authorized generic is immediately available to patients in the US.

There has been a surge in demand for albuterol medicines over the past year. Hospitals increasingly switched to using metered-dose albuterol inhalers rather than nebulizers to treat the growing number of COVID-19 patients. Pharmacies also saw increased demand for albuterol inhalers after the CDC recommended that Americans stock up on necessary medications.²

“With the commercial distribution rights to the brand and authorized generic of Proventil^® HFA, we are excited to work to increase supply and help ensure patients who need albuterol have access to this important medicine,” said Keren Haruvi, President, Sandoz Inc. “This deal delivers on our strategy to grow our respiratory portfolio and brings us closer to our ambition to be the world’s leading and most valued generic company.”

Albuterol sulfate is used to treat patients four years and older suffering from bronchospasm, a condition where the muscular coat of the bronchial tubes contracts, resulting in a narrowing of the breathing airways.³ Exercise or other physical activities can also bring on symptoms in most people who have asthma and may occur either during or right after being active.⁴

“We are pleased to partner with Sandoz on the distribution of the authorized generic of Proventil from our manufacturing site in Northridge, California,” said Aaron Mann, CEO of Kindeva Drug Delivery. “Combining Kindeva’s long track record of formulating, developing and manufacturing complex combination drug products with the Sandoz legacy of successfully commercializing critical drug therapies will help more patients access this important medicine.”

Millions of patients worldwide rely on Sandoz to consistently produce and deliver the medicines they need. The comprehensive, resilient and geographically diverse nature of our supply chain network helps Sandoz to ensure reliability in manufacturing and access to high-quality medicines for clinicians and patients. The brand and authorized generic of Proventil^® HFA are both manufactured in California.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
Albuterol sulfate inhalation aerosol is contraindicated in patients with a history of hypersensitivity to albuterol or any other albuterol sulfate inhalation aerosol components.

WARNINGS
Paradoxical Bronchospasm: Inhaled albuterol sulfate can produce paradoxical bronchospasm that may be life threatening. If this occurs, albuterol sulfate inhalation aerosol should be discontinued immediately and alternative therapy instituted.

Deterioration of Asthma: Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient needs more doses of albuterol sulfate inhalation aerosol than usual, this may be a marker of destabilization of asthma and requires re-evaluation of the patient and treatment regimen.

Use of Anti-Inflammatory Agents: The use of beta-adrenergic-agonist bronchodilators alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents (e.g., corticosteroids).

Cardiovascular Effects: Albuterol sulfate inhalation aerosol, like other beta-adrenergic agonists, can produce clinically significant cardiovascular effects in some patients as measured by pulse rate, blood pressure, and/or symptoms. If these occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce ECG changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. Albuterol sulfate inhalation aerosol, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

Do Not Exceed Recommended Dose: Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma. The exact cause of death is unknown, but cardiac arrest following an unexpected development of a severe acute asthmatic crisis and subsequent hypoxia is suspected.

Immediate Hypersensitivity Reactions: Immediate hypersensitivity reactions may occur after administration of albuterol sulfate, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema.

PRECAUTIONS

General
Albuterol sulfate, as with all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension; in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus; and in patients who are unusually responsive to sympathomimetic amines.

As with other beta-agonists, albuterol may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects. The decrease is usually transient, not requiring supplementation.

The action of albuterol sulfate inhalation aerosol should last up to 4 to 6 hours. Albuterol sulfate inhalation aerosol should not be used more frequently than recommended. Do not increase the dose or frequency of albuterol sulfate inhalation aerosol without consulting the physician.

ADVERSE REACTIONS
During a clinical trial with albuterol sulfate inhalation aerosol, the following adverse events (whether considered drug related or unrelated to drug) occurred at a rate of 3% or greater and more frequently in the albuterol sulfate inhalation aerosol treatment group than in the placebo group: upper respiratory tract infection, rhinitis, nausea, vomiting, tremor, tachycardia, nervousness, respiratory disorder, allergic reaction/symptoms, fever, inhalation site sensation, inhalation taste sensation, back pain, and urinary tract infection.

DRUG INTERACTIONS
Beta-Blockers: Beta-adrenergic-receptor blocking agents not only block the pulmonary effect of beta-agonists, such as albuterol sulfate inhalation aerosol, but may produce severe bronchospasm in asthmatic patients. Patients with asthma should not normally be treated with beta-blockers.

Diuretics: The ECG changes and/or hypokalemia which may result from the administration of nonpotassium-sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Caution is advised in the coadministration of beta-agonists with nonpotassium-sparing diuretics.

Albuterol-Digoxin: Carefully evaluate the serum digoxin levels in patients who are currently receiving digoxin and albuterol.

Monoamine Oxidase Inhibitors or Tricyclic Antidepressants: Albuterol sulfate inhalation aerosol should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, because the action of albuterol on the cardiovascular system may be potentiated.

Please see full Prescribing Information for additional safety information.

INDICATION
Albuterol sulfate inhalation aerosol is indicated in adults and children 4 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Neither can there be any guarantee that, if approved, such generic or biosimilar products will be approved for all indications included in the reference product’s label. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; the particular prescribing preferences of physicians and patients; competition in general, including potential approval of additional generic or biosimilar versions of such products; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit Sandoz from selling its products; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Sandoz
Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. Our purpose is to pioneer access for patients by developing and commercializing novel, affordable approaches that address unmet medical need. Our ambition is to be the world’s leading and most valued generics company. Our broad portfolio of high-quality medicines, covering all major therapeutic areas, accounted for 2020 sales of USD 9.6 billion.

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References:

¹ Albuterol Sulfate aerosol. Prescribing Information.

² Allergic Living. COVID-19 and Albuterol Shortage: 6 Strategies for Asthma Patients. Available at: https://www.allergicliving.com/2020/03/30/covid-19-and-albuterol-shortage-6-strategies-for-asthma-patients/. Accessed February 15, 2021.

³ American Academy of Allergy Asthma and Immunology. Bronchospasm Defined. Available at: https://www.aaaai.org/conditions-and-treatments/conditions-dictionary/bronchospasm. Accessed February 15, 2021.

⁴ FDA. FDA Approves First Generic of a Commonly Used Albuterol Inhaler to Treat and Prevent Bronchospasm. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-commonly-used-albuterol-inhaler-treat-and-prevent-bronchospasm. Accessed February 15, 2021.

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