Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today announced the launch of a generic version of EXJADE®1 (deferasirox) Tablets for Oral Suspension, 125 mg, 250 mg and 500 mg, in the U.S.
Deferasirox Tablets for Oral Suspension are an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients two years of age and older.
“We’re proud to offer an affordable generic treatment option with the launch of Deferasirox Tablets for Oral Suspension in the U.S.,” said Brendan O’Grady, EVP and Head of North America Commercial. “We continue striving to enable access to medicines for people living with chronic, complex conditions.”
With nearly 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 over 100 pending first-to-files in the U.S. Currently, one in eight generic prescriptions dispensed in the U.S. is filled with a Teva generic product.
EXJADE® had annual sales of $134 million in the U.S., according to IQVIA data as of December 2018.
About Deferasirox Tablets for Oral Suspension
Deferasirox Tablets for Oral Suspension are indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older.
Limitations of Use: Controlled clinical trials of deferasirox with myelodysplastic syndromes (MDS) and chronic iron overload due to blood transfusions have not been performed. The safety and efficacy of deferasirox when administered with other iron chelation therapy have not been established.
IMPORTANT SAFETY INFORMATION
WARNING: Renal Failure, Hepatic Failure, and Gastrointestinal Hemorrhage. Deferasirox can cause acute renal failure and death, particularly in patients with comorbidities and those who are in the advanced stages of their hematologic disorders. Deferasirox can cause hepatic injury including hepatic failure and death. Deferasirox can cause gastrointestinal (GI) hemorrhages, which may be fatal, especially in elderly patients who have advanced hematologic malignancies and/or low platelet counts.
Deferasirox is contraindicated in patients with: estimated GFR less than 40 mL/min/1.73m2; poor performance status; high-risk myelodysplastic syndromes; advanced malignancies; platelet counts less than 50 x 109/L; or known hypersensitivity to deferasirox or any component of deferasirox tablets for oral suspension.
Nonfatal upper GI irritation, ulceration and hemorrhage have also been reported in patients, including children and adolescents, receiving deferasirox. The risk of gastrointestinal hemorrhage may be increased when administering deferasirox in combination with drugs that have ulcerogenic or hemorrhagic potential, such as nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, oral bisphosphonates, or anticoagulants. There have been reports of ulcers complicated with gastrointestinal perforation (including fatal outcome). Neutropenia, agranulocytosis, worsening anemia, and thrombocytopenia, including fatal events, have been reported in patients treated with deferasirox. Preexisting hematologic disorders may increase this risk.
Deferasirox has been associated with serious and fatal adverse reactions in the postmarketing setting among adults, predominantly in elderly patients. Deferasirox has been associated with serious and fatal adverse reactions in pediatric patients in the postmarketing setting. Deferasirox may cause serious hypersensitivity reactions (such as anaphylaxis and angioedema), with the onset of the reaction usually occurring within the first month of treatment. Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) which could be life-threatening or fatal have been reported during deferasirox therapy. Cases of erythema multiforme have been observed. Rashes may occur during deferasirox treatment.
Auditory disturbances (high frequency hearing loss, decreased hearing), and ocular disturbances (lens opacities, cataracts, elevations in intraocular pressure, and retinal disorders) were reported at a frequency of less than 1% with deferasirox therapy in the clinical studies. The frequency of auditory adverse events irrespective of causality was increased among pediatric patients who received deferasirox doses greater than 25 mg/kg/day when serum ferritin was less than 1,000 mcg/L.
In clinical trials of patients with transfusional iron overload, the most frequently occurring (greater than 5%) adverse reactions for deferasirox were diarrhea, vomiting, nausea, abdominal pain, skin rashes, and increases in serum creatinine.
For more information, please see accompanying Full Prescribing Information, including the Boxed Warning. A copy may be requested from Teva US Medical Information at 888-TEVA-USA (888-838-2872), firstname.lastname@example.org, or Teva’s Public Relations or Investor Relations contacts.
1 EXJADE® is a registered trademark of Novartis Pharmaceuticals Corporation
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 43,000 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 the launch and potential benefits of the generic version of EXJADE®, 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 uncertainty of the commercial success of our generic version of EXJADE;
- our ability to successfully compete in the marketplace, including: that we are substantially dependent on our generic products; competition for our specialty products, especially COPAXONE®, our leading medicine, which faces competition from existing and potential additional generic versions and orally-administered alternatives; the uncertainty of commercial success of AJOVY® or AUSTEDO®; competition from companies with greater resources and capabilities; efforts of pharmaceutical companies to limit the use of generics, including through legislation and regulations; consolidation of our customer base and commercial alliances among our customers; the increase in the number of competitors targeting generic opportunities and seeking U.S. market exclusivity for generic versions of significant products; price erosion relating to our products, both from competing products and increased regulation; delays in launches of new products and our ability to achieve expected results from investments in our product pipeline; our ability to take advantage of high-value opportunities; the difficulty and expense of obtaining licenses to proprietary technologies; 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: failure to effectively execute our restructuring plan announced in December 2017; uncertainties related to, and failure to achieve, the potential benefits and success of our new senior management team and organizational structure; harm to our pipeline of future products due to the ongoing review of our R&D programs; our ability to develop and commercialize additional pharmaceutical products; potential additional adverse consequences following our resolution with the U.S. government of our FCPA investigation; compliance with sanctions and other trade control laws; manufacturing or quality control problems, which may damage our reputation for quality production and require costly remediation; interruptions in our supply chain; disruptions of our or third party information technology systems or breaches of our data security; the failure to recruit or retain key personnel; variations in intellectual property laws that may adversely affect our ability to manufacture our products; challenges associated with conducting business globally, including adverse effects of political or economic instability, major hostilities or terrorism; significant sales to a limited number of customers in our U.S. market; 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: costs and delays resulting from the extensive governmental regulation to which we are subject; the effects of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and coverage; governmental investigations into selling and marketing practices; potential liability for patent infringement; product liability claims; increased government scrutiny of our patent settlement agreements; failure to comply with complex Medicare and Medicaid reporting and payment obligations; 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 our Annual Report on Form 10-K for the year ended December 31, 2018, including the sections thereof captioned "Risk Factors." 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.