JERUSALEM – Teva Biologic Industries Ltd., (NYSE and TASE: TEVA) today appear the barrage of a all-encompassing adaptation of Uceris1 (budesonide) extended-release tablets, 9 mg, in the U.S.
Budesonide extended-release tablets are a glucocorticosteroid adumbrated for the consecration of absolution in patients with active, balmy to abstinent ulcerative colitis.
‘The barrage of all-encompassing budesonide extended-release tablets signals an important accession to Teva’s portfolio,’ said Brendan O’Grady, EVP and arch of North America Commercial. ‘We abide to be focused on bringing affordable all-encompassing analysis options to our customers, including those alive with chronic, life-long altitude like ulcerative colitis.’
With about 550 all-encompassing medicines available, Teva has the better portfolio of FDA-approved all-encompassing articles on the bazaar and holds the arch position in first-to-file opportunities, with over 100 awaiting first-to-files in the U.S. Currently, one in seven all-encompassing prescriptions dispensed in the U.S. is abounding with a Teva all-encompassing product.
Uceris had anniversary sales of about $196 actor in the U.S., according to IMS abstracts as of May 2018.
About Budesonide Extended-Release Tablets
Budesonide extended-release tablets are adumbrated for the consecration of absolution in patients with active, balmy to abstinent ulcerative colitis.
Important Safety Information
Budesonide extended-release tablets are contraindicated in patients with hypersensitivity to budesonide or any of the capacity of budesonide extended-release tablets. Anaphylactic reactions accept occurred with added budesonide formulations.
When glucocorticosteroids are acclimated chronically, systemic furnishings such as hypercorticism and adrenal aishment may occur. Glucocorticosteroids can abate the acknowledgment of the hypothalamus-pituitary-adrenal (HPA) arbor to stress. Back budesonide extended-release tablets are a glucocorticosteroid, accepted warnings apropos glucocorticoids should be followed.
Care is bare in patients who are transferred from glucocorticosteroid analysis with college systemic furnishings to glucocorticosteroids with lower systemic effects, such as budesonide extended-release tablets, back affection attributed to abandonment of steroid therapy, including those of astute adrenal aishment or amiable intracranial hypertension, may develop.
Patients who are on drugs that aish the allowed arrangement are added affected to infection than advantageous individuals. Chicken pox and measles, for example, can accept a added austere or alike baleful advance in affected patients or patients on immunosuppressant doses of glucocorticosteroids. In patients who accept not had these diseases, accurate affliction should be taken to abstain exposure. Glucocorticosteroids should be acclimated with caution, if at all, in patients with alive or quiescent tuberculosis infection, basic fungal, bacterial, systemic viral or abject infections.
Reduced alarmist action affects the aishment of glucocorticosteroids, and added systemic availability of articulate budesonide has been approved in patients with alarmist cirrhosis.Caution should be taken in patients with hypertension, diabetes mellitus, osteoporosis, comestible ulcer, glaucoma or cataracts, or with a ancestors history of diabetes or glaucoma, or with any added action breadth glucocorticosteroids may accept exceptionable effects.
The best accepted adverse reactions (2%) in analytic trials were headache, nausea, decreased claret cortisol, high belly pain, fatigue, flatulence, belly distension, acne, urinary amplitude infection, arthralgia, and constipation.
Teva Biologic Industries Ltd. (NYSE and TASE: TEVA) is a arch all-around biologic aggregation that delivers high-quality, patient-centric healthcare solutions acclimated by millions of patients every day. Headquartered in Israel, Teva is the world’s better all-encompassing medicines producer, leveraging its portfolio of added than 1,800 molecules to aftermath a advanced ambit of all-encompassing articles in about every ameliorative area. In specialty medicines, Teva has a world-leading position in avant-garde treatments for disorders of the axial afraid system, including pain, as able-bodied as a able portfolio of respiratory products. Teva integrates its generics and specialty capabilities in its all-around analysis and development analysis to actualize new means of acclamation unmet accommodating needs by accumulation biologic development capabilities with devices, casework and technologies. Teva’s net revenues in 2017 were $22.4 billion.
Cautionary Note Apropos Forward-Looking Statements
This columnist absolution contains advanced statements aural the acceptation of the Private Securities Action Reform Act of 1995 apropos Teva’s all-encompassing adaptation of Uceris, which are based on management’s accepted behavior and expectations and are accountable to abundant risks and uncertainties, both accepted and unknown, that could account our approaching results, achievement or achievements to alter decidedly from that bidding or adumbrated by such advanced statements. Important factors that could account or accord to such differences accommodate risks apropos to: The ambiguity of the bartering success of our all-encompassing adaptation of budesonide, including due to a abeyant barrage of an Authorized All-encompassing version; our adeptness to auspiciously attempt in the marketplace, including: that we are essentially abased on our all-encompassing products; antagonism for our specialty products, abnormally COPAXONE, our arch medicine, which faces antagonism from absolute and abeyant added all-encompassing versions and orally-administered alternatives; antagonism from companies with greater assets and capabilities; efforts of biologic companies to absolute the use of generics including through legislation and regulations; alliance of our chump abject and bartering alliances amid our customers; the access in the cardinal of competitors targeting all-encompassing opportunities and gluttonous U.S. bazaar exclusivity for all-encompassing versions of cogent products; amount abrasion apropos to our products, both from aggressive articles and added regulation; delays in launches of new articles and our adeptness to accomplish accepted after-effects from investments in our artefact pipeline; our adeptness to booty advantage of high-value opportunities; the adversity and amount of accepting licenses to proprietary technologies and the capability of our patents and added measures to assure our bookish acreage rights; our essentially added acknowledgment and decidedly decreased banknote on hand, which may absolute our adeptness to acquire added indebtedness, appoint in added affairs or accomplish new investments, and may aftereffect in a added decline of our acclaim ratings and our disability to accession debt or borrow funds in amounts or on agreement that are favorable to us; our business and operations in general, including: abortion to finer assassinate the restructuring plan appear in December 2017; uncertainties accompanying to, and abortion to achieve, the abeyant allowances and success of our new chief administration aggregation and authoritative structure; abuse to our activity of approaching articles due to the advancing analysis of our R&D programs; our adeptness to advance and commercialize added biologic products; abeyant added adverse after-effects afterward our resolution with the U.S. government of our FCPA investigation; acquiescence with sanctions and added barter ascendancy laws; accomplishment or affection ascendancy problems, which may accident our acceptability for affection assembly and crave cher remediation; interruptions in our accumulation chain; disruptions of our or third affair advice technology systems or breaches of our abstracts security; the abortion to recruit or absorb key personnel; variations in bookish acreage laws that may abnormally affect our adeptness to accomplish our products; challenges associated with administering business globally, including adverse furnishings of political or bread-and-er instability, above hostilities or terrorism; cogent sales to a bound cardinal of barter in our U.S. market; our adeptness to auspiciously bid for acceptable accretion targets or licensing opportunities, or to able and accommodate acquisitions and our affairs and opportunities for advance if we advertise assets; compliance, authoritative and action matters, including: costs and delays consistent from the all-encompassing authoritative adjustment to which we are subject; the furnishings of reforms in healthcare adjustment and reductions in biologic pricing, agreement and coverage; authoritative investigations into sales and business practices; abeyant accountability for apparent infringement; artefact accountability claims; added government analysis of our apparent adjustment agreements; abortion to accede with circuitous Medicare and Medicaid advertisement and acquittal obligations and ecology risks; added banking and bread-and-er risks, including: our acknowledgment to bill fluctuations and restrictions as able-bodied as acclaim risks; abeyant impairments of our abstract assets; abeyant cogent increases in tax liabilities and the aftereffect on our all-embracing able tax amount of the abortion or cessation of authoritative programs or tax benefits, or of a change in our business and added factors discussed in our Anniversary Report on Form 10-K for the year concluded December 31, 2017, including in the area captioned ‘Risk Factors,’ and in our added filings with the U.S. Securities and Exchange Commission, which are accessible at www.sec.gov and www.tevapharm.com. Advanced statements allege alone as of the date on which they are made, and we accept no obligation to amend or alter any advanced statements or added advice independent herein, whether as a aftereffect of new information, approaching contest or otherwise. You are cautioned not to put disproportionate assurance on these advanced statements.
Kevin C. Mannix
Tel: 215- 591-8912
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