Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today announced the launch of a generic version of Elidel®1 (pimecrolimus) Cream, 1% in the U.S.
Pimecrolimus Cream, 1% is a topical prescription medicine to be used as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate eczema (atopic dermatitis) in non-immunocompromised adults and children 2 years of age and older who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable.
Brendan O’Grady, EVP and Head of North America Commercial at Teva said, “We’re proud to offer another affordable treatment option. This launch represents an important addition to our generics portfolio and underscores our commitment to ensuring that patients have more treatment options.”
With over 550 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 over 100 pending first-to-files in the U.S. Currently, one in seven generic prescriptions dispensed in the U.S. is filled with a Teva generic product.
Elidel® Cream, 1% had annual sales of approximately $218.4 million in the US, according to IQVIA data as of October 2018.
About Pimecrolimus Cream, 1%
Pimecrolimus Cream, 1% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable.
IMPORTANT SAFETY INFORMATION
WARNING: Long-term Safety of Topical Calcineurin Inhibitors Has Not Been Established. Although a causal relationship has not been established, rare cases of malignancy (e.g., skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including Pimecrolimus Cream, 1%. Continuous long-term use of topical calcineurin inhibitors, including Pimecrolimus Cream, 1%, in any age group should be avoided, and application limited to areas of involvement with atopic dermatitis. Pimecrolimus Cream, 1% is not indicated for use in children less than 2 years of age.
Pimecrolimus Cream, 1% is contraindicated in individuals with a history of hypersensitivity to pimecrolimus or any of the components of the cream. Pimecrolimus Cream, 1% should not be used in immunocompromised adults and children, including patients on systemic immunosuppressive medications. The use of pimecrolimus cream, 1% should be avoided on malignant or pre-malignant skin conditions. Malignant or pre-malignant skin conditions, such as cutaneous T-cell lymphoma (CTCL), can present as dermatitis. Pimecrolimus Cream, 1% should not be used in patients with Netherton’s Syndrome or other skin diseases where there is the potential for increased systemic absorption of pimecrolimus. The safety of Pimecrolimus Cream, 1% has not been established in patients with generalized erythroderma.
Before commencing treatment with Pimecrolimus Cream, 1%, bacterial or viral infections at treatment sites should be resolved. The use of Pimecrolimus Cream, 1% may cause local symptoms such as skin burning (burning sensation, stinging, soreness) or pruritus. During the course of treatment, it is prudent for patients to minimize or avoid natural or artificial sunlight exposure, even while Pimecrolimus Cream, 1% is not on the skin. The potential effects of Pimecrolimus Cream, 1% on skin response to ultraviolet damage are not known.
In clinical trials, cases of lymphadenopathy were reported while using Pimecrolimus Cream, 1%. The safety and efficacy of Pimecrolimus Cream, 1% in immunocompromised patients have not been studied. In clinical trials, the most commonly reported adverse reactions (greater than or equal to 1%) were application site burning, headache, nasopharyngitis, cough, influenza, pyrexia and viral infection.
For more information, please see accompanying Full Prescribing Information, including Boxed Warning. A copy may be requested from Teva US Medical Information at 888-4-TEVA-USA (888-838-2872) or firstname.lastname@example.org, or Teva’s Public Relations or Investor Relations contacts.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global leader in generic medicines, with innovative treatments in select areas, including CNS, pain and respiratory. We deliver high-quality generic products and medicines in nearly every therapeutic area to address unmet patient needs. We have an established presence in generics, specialty, OTC and API, building on more than a century-old legacy, with a fully integrated R&D function, strong operational base and global infrastructure and scale. We strive to act in a socially and environmentally responsible way. Headquartered in Israel, with production and research facilities around the globe, we employ 45,000 professionals, committed to improving the lives of millions of patients. 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 Teva's generic version of Elidel®2, 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:
and other factors discussed in our Annual Report on Form 10-K for the year ended December 31, 2017, including in the section captioned “Risk Factors,” and in our other filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov and www.tevapharm.com. 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.
1 ELIDEL® is a registered trademark of Meda Pharma
S.A.R.L. used under license © 2017 Valeant Pharmaceuticals North America
2 ELIDEL® is a registered trademark of Meda Pharma S.A.R.L. used under license © 2017 Valeant Pharmaceuticals North America LLC.
Kevin C. Mannix
972 (54) 888 5898