JERUSALEM--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today announced the exclusive first-to-file launch of a generic version of Cialis®1 (tadalafil) tablets (2.5 mg, 5 mg, 10 mg, 20 mg) in the U.S.
Tadalafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED), the signs and symptoms of benign prostatic hyperplasia (BPH), and both ED and the signs and symptoms of BPH (ED/BPH).
Teva’s EVP and Head of Global R&D, Hafrun Fridriksdottir said, “We’re proud to offer an affordable treatment option for the estimated 30 million men affected by ED, many of whom will also have symptomatic BPH which is estimated to affect 15 million men in the United States.”
Brendan O’Grady, EVP and Head of North America Commercial at Teva added, “This launch represents an important addition to our generics portfolio, building on our exclusive launch of a generic version of Viagra® (sildenafil) tablets last year. We’re committed to ensuring that patients are able to access this medicine.”
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.
Cialis® had annual sales of nearly $1.93 billion in the U.S., according to IQVIA data as of July 2018.
About Tadalafil Tablets
Tadalafil tablets are indicated for the treatment of erectile dysfunction (ED), the signs and symptoms of benign prostatic hyperplasia (BPH), and ED and the signs and symptoms of BPH (ED/BPH). If tadalafil tablets are used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks.
IMPORTANT SAFETY INFORMATION
Nitrates: Tadalafil tablets are contraindicated in patients using any form of organic nitrate, either regularly and/or intermittently. In clinical pharmacology studies, tadalafil was shown to potentiate the hypotensive effect of nitrates.
Hypersensitivity Reactions: Tadalafil tablets are contraindicated in patients with a known serious hypersensitivity to tadalafil (or ADCIRCA®). Hypersensitivity reactions have been reported, including Stevens-Johnson syndrome and exfoliative dermatitis.
Concomitant Guanylate Cyclase (GC) Stimulators: Do not use tadalafil in patients who are using a GC stimulator, such as riociguat. Phosphodiesterase 5 (PDE5) inhibitors, including tadalafil, may potentiate the hypotensive effects of GC stimulators.
Cardiovascular: Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Therefore, treatments for erectile dysfunction, including tadalafil, should not be used in men for whom sexual activity is inadvisable as a result of their underlying cardiovascular status. Patients who experience symptoms upon initiation of sexual activity should be advised to refrain from further sexual activity and seek immediate medical attention.
PDE5 inhibitors, including tadalafil tablets, are mild systemic vasodilators. While this effect should not be of consequence in most patients, physicians should consider this potential when prescribing tadalafil tablets.
Patients with left ventricular outflow obstruction, (e.g., aortic stenosis and idiopathic hypertrophic subaortic stenosis) can be sensitive to the action of vasodilators, including PDE5 inhibitors.
Patients with certain types of cardiovascular disease were not included in clinical safety and efficacy trials for tadalafil, and therefore tadalafil is not recommended for the following groups of patients:
- Myocardial infarction within the last 90 days
- Unstable angina or angina occurring during sexual intercourse
- New York Heart Association Class 2 or greater heart failure in the last 6 months
- Uncontrolled arrhythmias, hypotension (<90/50 mm Hg), or uncontrolled hypertension
- Stroke within the last 6 months
Potential for Drug Interactions When Taking Tadalafil Tablets for Once Daily Use: Tadalafil tablets for once daily use provides continuous plasma tadalafil levels which physician’s should consider when evaluating the potential for interactions with medications (e.g., nitrates, alpha-blockers, anti-hypertensives and potent inhibitors of CYP3A4) and with substantial consumption of alcohol.
Prolonged Erection: There have been rare reports of prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) for this class of compounds. Priapism, if not treated promptly, can result in irreversible damage to the erectile tissue. Patients who have an erection lasting greater than 4 hours, whether painful or not, should seek emergency medical attention. Tadalafil should be used with caution in patients who have conditions that might predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia), or in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie’s disease).
Effects on the Eye: Physicians should advise patients to stop use of all PDE5 inhibitors, including tadalafil, and seek medical attention in the event of a sudden loss of vision in one or both eyes. Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a rare condition and a cause of decreased vision, including permanent loss of vision. Physicians should consider whether their patients with underlying NAION risk factors could be adversely affected by use of PDE5 inhibitors. Individuals who have already experienced NAION are at increased risk of NAION recurrence. PDE5 inhibitors, including tadalafil, should be used with caution in these patients and only when the anticipated benefits outweigh the risks. Individuals with “crowded” optic disc are also considered at greater risk for NAION compared to the general population. Patients with known hereditary degenerative retinal disorders, including retinitis pigmentosa, were not included in the clinical trials, and use in these patients is not recommended.
Sudden Hearing Loss: Sudden decrease or loss in hearing, sometimes with tinnitus and dizziness has also been reported in men taking PDE5 inhibitors, including tadalafil. It is not possible to determine whether these hearing events are related directly to the use of PDE5 inhibitors or to other factors.
Alpha-blockers and Antihypertensives: Physicians should discuss with patients the potential for tadalafil to augment the blood-pressure-lowering effect of alpha-blockers and antihypertensive medications. Caution is advised when PDE5 inhibitors are coadministered with alpha-blockers. PDE5 inhibitors, including tadalafil, and alpha-adrenergic blocking agents are both vasodilators with blood-pressure-lowering effects. When vasodilators are used in combination, an additive effect on blood pressure may be anticipated. In some patients, concomitant use of these two drug classes can lower blood pressure significantly, which may lead to symptomatic hypotension (e.g., fainting).
Renal Impairment: Creatinine clearance less than 30 mL/min or on hemodialysis: Tadalafil tablets for daily use is not recommended; tadalafil tablets for use as needed—5 mg not more than once every 72 hours. Creatinine clearance 30 to 50 mL/min: For tadalafil tablets for daily use treatment of BPH or ED/BPH, start dosing at 2.5 mg and increase to 5 mg based upon individual response. Tadalafil tablets for use as needed, start dosing at 5 mg not more than once per day with a maximum dose of 10 mg not more than once every 48 hours.
Hepatic Impairment: In patients with mild or moderate hepatic impairment, the dose of tadalafil should not exceed 10 mg. Because of insufficient information in patients with severe hepatic impairment, use of tadalafil in this group is not recommended. Tadalafil for once daily use has not been extensively evaluated in patients with mild or moderate hepatic impairment. Therefore, caution is advised if tadalafil for once daily use is prescribed to these patients. Because of insufficient information in patients with severe hepatic impairment, use of tadalafil in this group is not recommended.
Alcohol: Physicians should inform patients that substantial consumption of alcohol (e.g., 5 units or greater) in combination with tadalafil can increase the potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness, and headache.
Concomitant Use of Potent Inhibitors of Cytochrome P450 3A4 (CYP3A4): For patients taking potent inhibitors of CYP3A4 such as ritonavir, ketoconazole, and itraconazole, the dose of tadalafil tablets should be limited to 10 mg no more than once every 72 hours. If once daily use is prescribed the maximum recommended dose is 2.5 mg.
Combination With Other PDE5 Inhibitors or Erectile Dysfunction Therapies: The safety and efficacy of combinations of tadalafil and other PDE5 inhibitors or treatments for erectile dysfunction have not been studied. Inform patients not to take tadalafil with other PDE5 inhibitors, including ADCIRCA®.
Effects on Bleeding: Tadalafil has not been administered to patients with bleeding disorders or significant active peptic ulceration. Although tadalafil has not been shown to increase bleeding times in healthy subjects, use in patients with bleeding disorders or significant active peptic ulceration should be based upon a careful risk-benefit assessment and caution.
Counseling Patients About Sexually Transmitted Diseases: The use of tadalafil offers no protection against sexually transmitted diseases. Counseling patients about the protective measures necessary to guard against sexually transmitted diseases, including Human Immunodeficiency Virus (HIV) should be considered.
Consideration of Other Urological Conditions Prior to Initiating Treatment for BPH: Prior to initiating treatment with tadalafil for BPH, consideration should be given to other urological conditions that may cause similar symptoms. In addition, prostate cancer and BPH may coexist.
Common Adverse Reactions: The most common adverse reactions reported in clinical trials (≥ 2%) were headache, flushing, dyspepsia, nasal congestion, back pain, myalgia, pain in limb, naspharyngitis, upper respiratory tract infection, cough, diarrhea, urinary tract infection, gastroesophageal reflux disease, abdominal pain, gastroenteritis, and hypertension.
For more information, please see accompanying Full Prescribing Information. 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 tadalafil tablets, 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 tadalafil, including due to a potential launch of an Authorized Generic version;
- 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; 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 substantially increased indebtedness and significantly decreased cash on hand, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments, and 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 the 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 sales 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, 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 Cialis® is a registered trademark of Eli Lilly and Company.