Teva Announces Launch of the First and Only Generic Version of Sandostatin® LAR Depot (octreotide acetate for injectable suspension), in the U.S.

Teva Pharmaceutical Industries

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• This first-to-market launch showcases Teva’s proven strengths in complex generic formulations and enhances Teva’s strategic goal of sustaining a generic powerhouse.
  
• Octreotide acetate for injectable suspension is indicated to treat acromegaly and severe diarrhea for carcinoid syndrome.

PARSIPPANY, N.J., Oct. 01, 2024 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced today the launch of the first and only generic version of Sandostatin^®1 LAR Depot, in the United States.

Octreotide acetate for injectable suspension (the generic version of Sandostatin^® LAR Depot) is indicated to treat acromegaly and severe diarrhea for carcinoid syndrome. Please see the below for more information.

"With today’s launch of octreotide acetate for injectable suspension (the generic version of Sandostatin^® LAR Depot), Teva is providing patients a new option for this important treatment,” said Ernie Richardsen, SVP U.S. Commercial Generics.” He continued, "This first-to-market launch showcases Teva’s expertise in bringing complex generic formulations to market and demonstrates once again our ability to not only sustain a generics powerhouse, but also to bring value to patients and healthcare systems.”

Sandostatin^® LAR Depot had annual sales of $826 million as of July 2024, according to IQVIA data.

What is octreotide acetate for injectable suspension (the generic version of Sandostatin^® LAR Depot)?
Octreotide acetate for injectable suspension (the generic version of Sandostatin^® LAR Depot) is a prescription medication used in patients in whom initial treatment with octreotide acetate injection has been shown to be effective and tolerated for:

• Long-term maintenance therapy in acromegalic patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy, is not an option to reduce GH and IGF-1 levels to normal.
• Long-term treatment of the severe diarrhea and flushing episodes associated with metastatic carcinoid tumors.
• Long-term treatment of the profuse watery diarrhea associated with VIP-secreting tumors.
  

In patients with carcinoid tumors and VIP-secreting tumors, the effect of octreotide acetate injection and octreotide acetate for injectable suspension on tumor size, rate of growth and development of metastases, has not been determined.

IMPORTANT SAFETY INFORMATION
What is the most important information I should know about octreotide acetate for injectable suspension (the generic version of Sandostatin^® LAR Depot)? 
Treatment with octreotide acetate for injectable suspension (the generic version of Sandostatin^® LAR Depot) may affect gallbladder function, with reports of gallstones resulting in complications (inflammation of the gallbladder, bile duct, and pancreas, and requiring surgical removal of the gallbladder); sugar metabolism; thyroid and heart function; and nutritional absorption, which may require monitoring by your doctor. Tell your doctor if you experience signs or symptoms of gallstones or any of their complications.
Patients with carcinoid tumors and VIP-secreting tumors should adhere closely to their scheduled return visits for reinjection in order to minimize exacerbation of symptoms.
Patients with acromegaly should adhere to their return visit schedule to help assure steady control of GH and IGF-1 levels.
What should I tell my doctor before taking octreotide acetate for injectable suspension (the generic version of Sandostatin^® LAR Depot)? 
Tell your doctor if you have a history of heart disease or are taking other medications, including cyclosporine, insulin, oral hypoglycemic agents, beta-blockers, and bromocriptine.
What are the possible side effects of octreotide acetate for injectable suspension (the generic version of Sandostatin^® LAR Depot)? 
In acromegalic patients, the most common side effects of octreotide acetate for injectable suspension include gallstones, diarrhea, abdominal pain, gas, flu-like symptoms, constipation, headache, low red blood cells, injection-site pain, gallstones, high blood pressure, dizziness and fatigue.
In carcinoid tumor and VIP-secreting tumor patients, the most common side effects of octreotide acetate for injectable suspension include back pain, fatigue, headache, abdominal pain, nausea, and dizziness.
These are not all of the possible side effects of octreotide acetate for injectable suspension. Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see the full Prescribing Information.

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global pharmaceutical leader with a category-defying portfolio, harnessing our generics expertise and stepping up innovation to continue the momentum behind the discovery, delivery, and expanded development of modern medicine. For over 120 years, Teva's commitment to bettering health has never wavered. Today, the company’s global network of capabilities enables its ~37,000 employees across 58 markets to push the boundaries of scientific innovation and deliver quality medicines to help improve health outcomes of millions of patients every day. To learn more about how Teva is all in for better health, visit 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, 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. You can identify these forward-looking statements by the use of words such as "should,” "expect,” "anticipate,” "estimate,” "target,” "may,” "project,” "guidance,” "intend,” "plan,” "believe,” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: the launch and commercial success of octreotide acetate for injectable suspension (the generic version of Sandostatin^® LAR Depot); our ability to successfully compete in the marketplace, including: that we are substantially dependent on our generic products; concentration of our customer base and commercial alliances among our customers; delays in launches of new generic products; our ability to develop and commercialize biopharmaceutical products; our ability to achieve expected results from investments in our product pipeline; our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to sustain and focus our portfolio of generics medicines; and other factors discussed in our Quarterly Report on Form 10-Q for the second quarter of 2024 and in our Annual Report on Form 10-K for the year ended December 31, 2023, including in the section 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, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements. 

¹ Sandostatin^® LAR Depot is a registered trademark of Novartis AG.