ירושלים, 2 בינואר 2019 – טבע תעשיות פרמצבטיות בע"מ (NYSE and TASE: TEVA) הודיעה כי סיכמה מחלוקת בינה לבין אמג'ן בנוגע לגרסה הגנרית של טבע למוצר cinacalcet HCL. טבע ואמג'ן היו חלק מתביעת פטנט וטבע קיבלה אישור לאחרונה והשיקה את גרסתה הגנרית בארה"ב.
Cinacalcet is a calcium-sensing receptor agonist indicated for secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease on dialysis. It is also used for the treatment of hypercalcemia in adult patients with parathyroid carcinoma and severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy.
על פי ההסדר, הליטיגציה בין הצדדים תסתיים וטבע הסכימה להפסיק ולמכור את המוצר הגנרי שלה עד למועד הרשיון באמצע 2021, או מוקדם יותר בנסיבות מסוימות. טבע תשלם לאמג'ן סכום לא נקוב כחלק מההסדר. סכום זה ושאר תנאי ההסדר יישארו חסויים.
About Cinacalcet Hydrochloride Tablets
Cinacalcet hydrochloride tablets are indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. Important Limitations of Use: cinacalcet hydrochloride tablets are NOT indicated for use in patients with CKD who are not on dialysis because of an increased risk of hypocalcemia.
Cinacalcet hydrochloride tablets are indicated for the treatment of hypercalcemia in adult patients with Parathyroid Carcinoma.
Cinacalcet hydrochloride tablets are indicated for the treatment of severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy.
IMPORTANT SAFETY INFORMATION
Contraindications: Cinacalcet treatment initiation is contraindicated if serum calcium is less than the lower limit of the normal range.
Hypocalcemia: Cinacalcet lowers serum calcium and can lead to hypocalcemia. Significant lowering of serum calcium can cause paresthesias, myalgias, muscle spasms, tetany, seizures, QT interval prolongation and ventricular arrhythmia. Life threatening events and fatal outcomes associated with hypocalcemia have been reported in patients treated with cinacalcet, including in pediatric patients. The safety and effectiveness of cinacalcet have not been established in pediatric patients.
Decreases in serum calcium can prolong the QT interval, potentially resulting in ventricular arrhythmia. Cases of QT prolongation and ventricular arrhythmia have been reported in patients treated with cinacalcet. Patients with conditions that predispose to QT interval prolongation and ventricular arrhythmia may be at increased risk for QT interval prolongation and ventricular arrhythmias if they develop hypocalcemia due to cinacalcet. Closely monitor corrected serum calcium and QT interval in patients, at risk, receiving cinacalcet.
In clinical studies, seizures were observed in cinacalcet-treated patients. While the basis for the reported seizure rate is not clear, the threshold for seizures is lowered by significant reductions in serum calcium levels. Monitor serum calcium levels in patients with seizure disorders receiving cinacalcet
Concurrent administration of cinacalcet with calcium-lowering drugs including other calcium-sensing receptor agonists could result in severe hypocalcemia. Closely monitor serum calcium in patients receiving cinacalcet and concomitant therapies known to lower serum calcium levels.
Patients with secondary HPT with CKD on dialysis: Serum calcium and serum phosphorus should be measured within 1 week and intact parathyroid hormone (iPTH) should be measured 1 to 4 weeks after initiation or dose adjustment of cinacalcet. Once the maintenance dose has been established, serum calcium should be measured approximately monthly.
Patients with primary HPT or parathyroid carcinoma: Serum calcium should be measured within 1 week after initiation or dose adjustment of cinacalcet. Once maintenance dose levels have been established, serum calcium should be measured every 2 months.
Upper Gastrointestinal Bleeding: Cases of gastrointestinal bleeding, mostly upper gastrointestinal bleeding, have occurred in patients using calcimimetics, including cinacalcet, from postmarketing and clinical trial sources. The exact cause of GI bleeding in these patients is unknown.
Patients with risk factors for upper GI bleeding (such as known gastritis, esophagitis, ulcers or severe vomiting) may be at increased risk for GI bleeding when receiving cinacalcet treatment. Monitor patients for worsening of common GI adverse reactions of nausea and vomiting associated with cinacalcet and for signs and symptoms of GI bleeding and ulcerations during cinacalcet therapy. Promptly evaluate and treat any suspected GI bleeding.
Hypotension, Worsening Heart Failure and/or Arrhythmias: In postmarketing safety surveillance, isolated, idiosyncratic cases of hypotension, worsening heart failure, and/or arrhythmia have been reported in patients with impaired cardiac function, in which a causal relationship to cinacalcet could not be completely excluded and which may be mediated by reductions in serum calcium levels.
Adynamic Bone Disease: Adynamic bone disease may develop if iPTH levels are suppressed below
100 pg/mL.
Drug Interactions with Strong CYP3A4 Inhibitors: Cinacalcet is partially metabolized by CYP3A4. Dose adjustment of cinacalcet may be required if a patient initiates or discontinues therapy with a strong CYP3A4 inhibitor (e.g., ketoconazole, itraconazole). The iPTH and serum calcium concentrations should be closely monitored in these patients.
Drug Interactions with CYP2D6 Substrates: Cinacalcet is a strong inhibitor of CYP2D6. Dose adjustments may be required for concomitant medications that are predominantly metabolized by CYP2D6 (e.g., desipramine, metoprolol, and carvedilol) and particularly those with a narrow therapeutic index (e.g., flecainide and most tricyclic antidepressants).
Common Adverse Reactions: The most common adverse reactions (i.e., incidence ≥25%) associated with cinacalcet were nausea and vomiting.
Please see accompanying Full Prescribing Information.
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 druginfo@tevapharm.com, or Teva’s Public Relations or Investor Relations contacts
אודות טבע
טבע תעשיות פרמצבטיות בע"מ (NYSE & TASE: TEVA) היא מובילה עולמית בגנריקה, עם טיפולים חדשניים בתחומים נבחרים, כולל מערכת העצבים המרכזית, כאב ונשימה. אנו מספקים תרופות גנריות באיכות גבוהה בכמעט כל תחום טיפולי בכדי להתמודד עם צרכי מטופלים אשר אינם זוכים למענה. יש לנו נוכחות מבוססת בגנריקה, תרופות מקור, תרופות ללא מרשם וייצור חומרים כימיים פעילים, ובונים על גבי מורשת בת יותר מ-115 שנה עם מערך מו"פ מאוחד, בסיס תפעולי חזק ותשתית גלובלית נרחבת. אנו חותרים לפעול באופן אחראי ברמה החברתית והסביבתית. המטה שלנו ממוקם בישראל, יש לנו מתקני ייצור ומחקר בכל העולם, ואנו מעסיקים 45,000 עובדים המחויבים לאפשר לשפר את חייהם של מיליוני מטופלים. למידע נוסף על החברה, בקרו באתר www.Teva.co.il