U.S. FDA Approves New Indication for Ipsen's Somatuline® Depot (lanreotide) Injection for the Treatment of Carcinoid Syndrome
Ipsen (Euronext: IPN; ADR: IPSEY) (Ipsen), today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental indication for Somatuline® Depot (lanreotide) Injection 120 mg for the treatment of carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analogue rescue therapy.
Somatuline® Depot is also approved for the improvement of progression-free survival (PFS) in patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs).1
Alexandre Lebeaut, MD, Executive Vice-President, R&D, Chief Scientific Officer, Ipsen, said: “The new indication for Somatuline ® Depot offers patients in the U.S. a valuable treatment option for debilitating carcinoid syndrome associated with neuroendocrine tumors. It also reaffirms Ipsen’s global commitment to helping to improve lives of patients with cancer.”
"This new indication for Somatuline ® Depot gives doctors the only somatostatin analog approved by the FDA in adults for both improving progression-free survival in patients with unresectable, well- or moderately- differentiated, locally advanced or metastatic GEP-NETs and for the treatment of carcinoid syndrome," said Cynthia Schwalm, Executive Vice-President, and President, North American Commercial Operations, Ipsen. "The additional approval also confirms Ipsen's commitment to developing research-driven treatments intended to help provide patients battling cancer with new therapy options."
The additional Somatuline® Depot approval for carcinoid syndrome was based on “Evaluation of Lanreotide Depot/Autogel Efficacy and Safety as a Carcinoid Syndrome Treatment (ELECT): A Randomized, Double-Blind, Placebo-Controlled Trial,” published in Endocrine Practice. 1,2
IMPORTANT SAFETY INFORMATION
- Somatuline® Depot is contraindicated in patients with hypersensitivity to lanreotide. Allergic reactions (including angioedema and anaphylaxis) have been reported following administration of lanreotide.
Warnings and Precautions
Cholelithiasis and Gallbladder Sludge
- Somatuline® Depot may reduce gallbladder motility and lead to gallstone formation.
- Periodic monitoring may be needed.
1 Somatuline Depot (lanreotide) Injection Prescribing
Information. Basking Ridge, NJ: Ipsen Biopharmaceuticals, Inc.
2 Endocrine Practice, September 2016, Vol. 22, No. 9, pp. 1068-1080
Hypoglycemia or Hyperglycemia
- Pharmacological studies show that Somatuline® Depot, like somatostatin and other somatostatin analogs, inhibits the secretion of insulin and glucagon. Patients treated with Somatuline® Depot may experience hypoglycemia or hyperglycemia.
- Blood glucose levels should be monitored when Somatuline® Depot treatment is initiated, or when the dose is altered, and antidiabetic treatment should be adjusted accordingly.
- Somatuline® Depot may decrease heart rate.
- In patients in the GEP-NET pivotal trial, 23% of Somatuline® Depot-treated patients had a heart rate of less than 60 bpm compared to 16% of placebo-treated patients. The incidence of bradycardia was similar in the treatment groups. Initiate appropriate medical management in patients with symptomatic bradycardia.
- In patients without underlying cardiac disease, Somatuline® Depot may lead to a decrease in heart rate without necessarily reaching the threshold of bradycardia. In patients suffering from cardiac disorders prior to treatment, sinus bradycardia may occur. Care should be taken when initiating treatment in patients with bradycardia.
Most Common Adverse Reactions
- GEP-NETs: Adverse reactions occurring in greater than 10% of patients who received Somatuline® Depot in the GEP-NET trial were abdominal pain (34%), musculoskeletal pain (19%), vomiting (19%), headache (16%), injection site reaction (15%), hyperglycemia (14%), hypertension (14%), and cholelithiasis (14%).
- Carcinoid Syndrome: Adverse reactions occurring in the carcinoid syndrome trial were generally similar to those in the GEP-NET trial. Adverse reactions occurring in greater than 5% of patients who received Somatuline® Depot in the carcinoid syndrome trial and occurring at least 5% greater than placebo were headache (12%), dizziness (7%) and muscle spasm (5%).
Drug Interactions: Somatuline® Depot may decrease the absorption of cyclosporine (dosage adjustment may be needed); increase the absorption of bromocriptine; and require dosage adjustment for bradycardia-inducing drugs (e.g., beta-blockers).
- Lactation: Advise women not to breastfeed during treatment and for 6 months after the last dose.
To report SUSPECTED ADVERSE REACTIONS, contact Ipsen Biopharmaceuticals, Inc. at +1-855-463-5127 or FDA at +1-800-FDA-1088 or www.fda.gov/medwatch.
About Ipsen in North America
Ipsen Biopharmaceuticals, Inc. is the US affiliate of Ipsen, a global specialty-driven biopharmaceutical group. The US head office is located in Basking Ridge, New Jersey. Ipsen Biopharmaceuticals Canada, Inc. is an integrated business unit within North America and has its head office located in Mississauga, Ontario. Ipsen Bioscience, Inc., the Ipsen US research and development center focused on the discovery of potentially highly differentiated and competitive products in neurosciences, oncology and rare diseases, is located in Cambridge, Massachusetts. At Ipsen Bioscience, we focus on creating a highly cooperative and passionate R&D organization through partnerships, innovation, and continuous learning to effectively deliver new treatments for patients. At Ipsen, we focus our resources, investments, and energy on discovering, developing, and commercializing new therapeutic options for oncologic, neurologic, and endocrine diseases. For more information on Ipsen in North America, please visit www.ipsenus.com or www.ipsen.ca.
Ipsen is a global specialty-driven biopharmaceutical group focused on innovation and specialty care. The group develops and commercializes innovative medicines in three key therapeutic areas - Oncology, Neurosciences and Rare Diseases. Its commitment to oncology is exemplified through its growing portfolio of key therapies for prostate cancer, neuroendocrine tumors, renal cell carcinoma and pancreatic cancer. Ipsen also has a well-established Consumer Healthcare business. With total sales close to €1.6 billion in 2016, Ipsen sells more than 20 drugs in over 115 countries, with a direct commercial presence in more than 30 countries. Ipsen's R&D is focused on its innovative and differentiated technological platforms located in the heart of the leading biotechnological and life sciences hubs (Paris-Saclay, France; Oxford, UK; Cambridge, US). The Group has about 5,100 employees worldwide. Ipsen is listed in Paris (Euronext: IPN) and in the United States through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information on Ipsen, visit www.ipsen.com.
The forward-looking statements, objectives and targets contained herein are based on the Group’s management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. All of the above risks could affect the Group’s future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today. Use of the words "believes," "anticipates" and "expects" and similar expressions are intended to identify forward-looking statements, including the Group’s expectations regarding future events, including regulatory filings and determinations. Moreover, the targets described in this document were prepared without taking into account external growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by the Group. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably the fact that a promising product in early development phase or clinical trial may end up never being launched on the market or reaching its commercial targets, notably for regulatory or competition reasons. The Group must face or might face competition from generic products that might translate into a loss of market share. Furthermore, the Research and Development process involves several stages each of which involves the substantial risk that the Group may fail to achieve its objectives and be forced to abandon its efforts with regards to a product in which it has invested significant sums. Therefore, the Group cannot be certain that favorable results obtained during pre-clinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the product concerned. There can be no guarantees a product will receive the necessary regulatory approvals or that the product will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Other risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the Group's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Group’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The Group also depends on third parties to develop and market some of its products which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to the Group’s activities and financial results. The Group cannot be certain that its partners will fulfil their obligations. It might be unable to obtain any benefit from those agreements. A default by any of the Group’s partners could generate lower revenues than expected. Such situations could have a negative impact on the Group’s business, financial position or performance. The Group expressly disclaims any obligation or undertaking to update or revise any forward looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. The Group’s business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers. The risks and uncertainties set out are not exhaustive and the reader is advised to refer to the Group’s 2016 Registration Document available on its website (www.ipsen.com).
Somatuline® DEPOT is a registered trademark of IPSEN PHARMA S.A.S.
All other trademarks are the property of their respective owners.
For further information:
Ian Weatherhead, +44 (0) 7584230549
Vice-President, Corporate External communications
Brigitte Le Guennec, +33 (0)1 58 33 51 17
Corporate External Communication Manager
Marisol Peron, +1-908-275-6330
Vice President, NA Communications
Eugenia Litz, +44 (0) 1753 627721
Vice-President Investor Relations
Côme de La Tour du Pin, +33 (0)1 58 33 53 31
Investor Relations Manager
Om Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
Huawei Brings the All-Connected World to Mobile World Congress25.2.2018 13:30 | Pressemelding
Building on its success in delivering beautifully-designed and powerful high-end mobile devices, Huawei Consumer Business Group (CBG) today unveiled the HUAWEI MateBook X Pro, the HUAWEI MediaPad M5 Series and the HUAWEI 5G customer-premises equipment (CPE), the world’s first commercial terminal device supporting the globally recognized 3GPP telecommunications standard for 5G. With stunning new design updates and outstanding performance advances, Huawei’s new devices showcase the power of technology to deliver innovative computing experiences ready for the mobile world. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180225005135/en/ MateBook X Pro (Photo: Business Wire) “At Huawei, we’re guided by a vision of an all-connected world, and to achieve that goal, we invest significantly in research and development to understand the ways in which people interact and connect with technology,” said Richard Yu, CEO of Huawei CBG. “We’
The 6th Annual World Patient Safety, Science & Technology Summit Kicked off with an Important Announcement about the Progress Being Made to Save Lives in Hospital Settings24.2.2018 10:00 | Pressemelding
The 6th Annual World Patient Safety, Science & Technology Summit kicked off with an important announcement about the progress being made to save lives in hospital settings. Nearly 4,600 hospitals in 44 countries have committed to adopting patient safety processes that are proven to eliminate preventable deaths in hospitals. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180224005027/en/ England’s Health and Social Care Secretary, Rt. Hon. Jeremy Hunt, launches groundbreaking new measures on Day One of the 6th Annual World Patient Safety, Science & Technology held in London (Photo: Business Wire) The Patient Safety Movement Foundation has taken on an inspiring and ambitious goal of reducing preventable patient deaths in hospitals to ZERO by 2020. The annual Summit in central London plays a major role in taking on that challenge with the participation of 300 global leaders, medical experts, medical technology CEOs, and patient
WuQi Technologies is Latest Licensee of CCww’s NB-IoT UE Protocol-Stack Software24.2.2018 09:06 | Pressemelding
Communications Consultants Worldwide Ltd. (CCww), global innovator of 3GPP® technologies, has licensed its NB-IoT protocol-stack software to WuQi Technologies Inc., a leading global developer of highly integrated mixed-signal SoC solutions, and the latest licensee of CCww’s NB-IoT Release 13 UE protocol-stack software. Communications Consultants Worldwide (CCww) is working with WuQi Technologies for the integration of its NB-IoT protocol-stack software onto WuQi Technologies’ highly innovative SoC. This relationship, catalyzed by T2M, is enabling the production of a highly integrated, very low power, NB-IoT SoC chipset targeting IoT Smart City, Smart Home, and wearable applications. CCww’s CEO, Richard Carter, said, “NB-IoT is CCww’s latest cellular Protocol-stack SW. We are excited to be working with WuQi to enable a sector-leading NB-IoT SoC, pushing back boundaries of performance and battery life for the next generation of IoT. See our demonstration at the Mobile World Congress (Hal
IDEMIA and Octo Telematics Reinvent Car Sharing Experience by Adding Facial Recognition to EasyOpen Solution23.2.2018 15:57 | Pressemelding
IDEMIA, the global leader in Augmented Identity for an increasingly digital world, announces today that it has implemented facial recognition technology on EasyOpen, a solution previously developed with its partner Omoove, a wholly-owned Octo Telematics company, Europe’s leading Shared Mobility technology provider. The digital enrolment process combined with facial recognition technology will securely enroll and authenticate the driver before EasyOpen automatically opens the car. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180223005506/en/ (Photo: Idemia) You will never rent a car the same way thanks to EasyOpen solution that combines IDEMIA’s expertise in secure service enablement and Omoove’s experience in Shared Mobility platforms and on-board technology. The first version of the solution was launched last year and allows drivers, who have already registered on the application, to use their smartphones as a key to open
SM-Optics Unveils First FLEXSET Chip, Paving the Way to Optical Micro Nodes23.2.2018 14:00 | Pressemelding
SM-Optics launches FLEXSET, a single chip embedding multiple processing functionalities raising the bar for performances, density and architectural flexibility. The FLEXSET is the heart of the Lightmode product family. FLEXSET OTN switching matrix scales from 300Gbps to 1Tbps and can be addressed by ports spanning from traditional low-speed services like 2Mbps over micro-OTN, to layer2 and layer3 over ODUFlex, 100G over ODU4 and 200G over FlexO. Thanks to its embedded capabilities including multi-technology OAM, packet processing, synchronization and fast protection functions, FLEXSET operates by design at the lowest latency performances and features an Intel Stratix 10 FPGA. Following the launch of micro-OTN, a revolutionary approach to efficiently extend OTN protocol to low speed services, the launch of FLEXSET advances the vision of a highly interconnected metro network and of micro nodes. Revolving around functional block elements, micro nodes collapse in few rack units OTN and pho
Bitcoin Miner HashGains’ Crowdsale to Build Green Cloud Mining Data Centers Receives Excellent Response23.2.2018 13:56 | Pressemelding
HashGains.com, a leading cryptocurrency mining platform, has launched its crowdsale program to build mega cryptocurrency cloud mining data centers in India and Canada which uses renewable energy like wind and solar as source of energy. “With the growing worries around bitcoin mining causing environmental damage, difficulty levels of mining increasing and returns heading southwards, there was no better opportunity but to build green energy data centers which run on free sources of energy like wind and solar, ensuring handsome mining rewards while taking care of environment,” said Mr Anuj Bairathi, CEO & Founder, HashGains, who is crypto enthusiast himself. HashGains is a growing cloud mining platform with more than 10,000 active customers enjoying mining returns and is expected to reach the mark of 1 million customers by 2020. To handle such a massive growth and ever growing demand of customers, it becomes even more important that mega mining centers are planned which can serve needs of