Sandoz launches generic antibiotic Daptomycin in US, strategically growing injectables portfolio and strengthening hospital offering

• Daptomycin is an antibacterial medicine used to treat adult patients with complicated skin and skin structure infections ¹
• Daptomycin can be used to treat patients with MRSA or “superbug” infections²
• Introduction of Daptomycin further enhances Sandoz industry-leading antibiotic portfolio, which covers 50 percent of antibiotics available worldwide

Princeton, New Jersey, July 13, 2020 — Sandoz Inc. today announced the US market introduction of Daptomycin for injection 500 mg, an AP-rated generic version of Cubicin® (daptomycin)*, for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by Gram-positive bacteria and certain bloodstream infections, including right-sided infective endocarditis.

Daptomycin is an antibiotic that works by killing bacteria or preventing their growth¹, and can be used for difficult to treat infections such as MRSA (methicillin-resistant Staphylococcus aureus) or “superbug” infections². It is administered intravenously to patients under the direct supervision of their doctor.³

“We continually strive to increase the value of our institutional portfolio with the addition of critical, high-quality, affordable medicines like Daptomycin, bringing us one step closer to delivering on our growth strategy and realizing our ambition to become the world’s leading and most valued generics company,” said Carol Lynch, President, Sandoz Inc. “Our sales force now has another important offering, further strengthening its arsenal of injectables for patients being treated in the hospital setting.”

The immediate availability of Daptomycin bolsters Sandoz industry-leading portfolio of generic antibiotics, which covers over 50 percent of the antibiotics available worldwide. And it reinforces the Sandoz strategic focus on growing its injectables portfolio and overall offering in the hospital setting.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Daptomycin is contraindicated in patients with known hypersensitivity to daptomycin.

WARNINGS AND PRECAUTIONS

• Anaphylaxis/hypersensitivity reactions (including life-threatening): Discontinue daptomycin and treat signs/symptoms.
• Myopathy and rhabdomyolysis: Monitor CPK levels and follow muscle pain or weakness; if elevated CPK or myopathy occurs, consider discontinuation of daptomycin.
• Eosinophilic pneumonia: Discontinue daptomycin and consider treatment with systemic steroids.
• Peripheral neuropathy: Monitor for neuropathy and consider discontinuation.
• Potential nervous system and/or muscular system effects in pediatric patients younger than 12 months: Avoid use of daptomycin in this age group.
• Clostridium difficile-associated diarrhea: Evaluate patients if diarrhea occurs.
• Persisting or relapsing Staphylococcus aureus bacteremia/endocarditis: Perform susceptibility testing and rule out sequestered foci of infection.
• Decreased efficacy was observed in adult patients with moderate baseline renal impairment.

ADVERSE REACTIONS

• Adult cSSSI Patients: The most common adverse reactions that occurred in ≥2% of adult cSSSI patients receiving daptomycin 4 mg/kg were diarrhea, headache, dizziness, rash, abnormal liver function tests, elevated creatine phosphokinase (CPK), urinary tract infections, hypotension, and dyspnea.
• Adult S. aureus bacteremia/endocarditis Patients: The most common adverse reactions that occurred in ≥5% of S. aureus bacteremia/endocarditis patients receiving daptomycin 6 mg/kg were sepsis, bacteremia, abdominal pain, chest pain, edema, pharyngolaryngeal pain, pruritus, increased sweating, insomnia, elevated CPK, and hypertension.

Please see full Prescribing Information for additional safety information.

INDICATIONS

Daptomycin for injection is a lipopeptide antibacterial indicated for the treatment of:

• Complicated skin and skin structure infections (cSSSI) in adult patients caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus (including methicillin-resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae subsp. equisimilis, and Enterococcus faecalis (vancomycin-susceptible isolates only) and,
• Staphylococcus aureus bloodstream infections (bacteremia) in adult patients, including those with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates.

Limitations of Use:

Daptomycin for injection is not indicated for the treatment of pneumonia or for the treatment of left-sided infective endocarditis due to S. aureus, and it is not recommended in pediatric patients younger than one year of age due to the risk of potential effects on muscular, neuromuscular, and/or nervous systems (either peripheral and/or central) observed in neonatal dogs.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of daptomycin for injection and other antibacterial drugs, daptomycin for injection should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.

Disclaimer

This media update 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,” “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 media update, 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 media update 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 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 media update as of this date and does not undertake any obligation to update any forward-looking statements contained in this media update 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 needs. 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 2019 sales of USD 9.7 billion. Sandoz is headquartered in Holzkirchen, in Germany’s Greater Munich area.

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REFERENCES

1. Daptomycin. Prescribing Information. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d91ac7e7-2570-4.... Accessed June 29, 2020.

2. University of Michigan Medicine. Health Library. Daptomycin. Available at: https://www.uofmhealth.org/health-library/d04894a1#:~:text=Daptomycin%20is%20an%20antibiotic%20that,or%20%22super%20bug%22%20infections. Accessed June 29, 2020.

3. Mayo Clinic. Drugs and Supplements. Daptomycin (Intravenous Route). Available at: https://www.mayoclinic.org/drugs-supplements/daptomycin-intravenous-route/description/drg-20063292. Accessed June 29, 2020.

*Cubicin® and Emend® are registered trademarks of Merck.

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