Business Wire

Ipsen: Somatuline® Autogel® 120 mg Receives Japanese Approval for a New Indication for the Treatment of Gastro-Entero-Pancreatic Neuroendocrine Tumors

Jaa

Regulatory News:

Ipsen (Euronext: IPN; ADR: IPSEY) and Teijin Pharma Limited, the core company of the Teijin Group’s healthcare business, today announced that Teijin Pharma has received approval from the Japanese Ministry of Health, Labour and Welfare for Ipsen's subcutaneous drug Somatuline® (lanreotide) for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP NET). The drug is approved in Japan for the treatment of acromegaly and pituitary gigantism since 2012.

The request for the additional approval was filed in July 2016, based on Ipsen’s investigational, pivotal phase III randomised placebo-controlled trial (CLARINET) in 204 patients with GEP NET conducted in 14 countries, and an open-label single group multicenter Phase II trial (J-001) in 32 patients with NET that Teijin Pharma conducted in Japan. This approval establishes Somatuline® as the first drug available in Japan for the treatment of pancreatic NET.

Harout Semerjian, Executive Vice-President & President, Specialty Care International & Global Franchises said: "We are pleased that Somatuline ® is now also available for Japanese patients suffering from gastrointestinal and pancreatic neuroendocrine tumors. In line with our commitment to serve NET patients worldwide, this is a significant step after our partner Teijin launched Somatuline ® for the treatment of acromegaly and pituitary gigantism in Japan in January 2013."

Akihisa Nabeshima, President of Teijin Pharma said: "It is our great pleasure to now have the capacity to provide a new therapeutic option to NET patients in Japan. We will continue to focus on drug discovery and improve the quality of life of patients by offering them new treatment options to fulfill unmet medical needs.”

About Neuroendocrine Tumors
NETs are malignant tumors arising from neuroendocrine cells. Most of the NET tumors present with metastasis and are discovered fortuitously. In some patients, excess hormones secreted from a NET can lead to severe diarrhea, peptic ulcers or hypoglycemia. While incidence rates are relatively rare, at about 3.5 gastrointestinal NET patients and 1.3 pancreatic NET patients per 100,000 people in Japan, the number of patients has been increasing year by year due to disease awareness and better diagnosis1.

The primary treatment for NETs is removal by surgery, but if this is not possible as the disease is usually disseminated, or if a tumor relapses following surgery, another option is a medical treatment.

About Somatuline ®

The active substance in Somatuline® is lanreotide acetate, a somatostatin analogue that inhibits the secretion of several endocrine, exocrine and paracrine functions. It has been shown to be effective in inhibiting the secretion of GH and certain hormones secreted by the digestive system. Somatuline® is marketed as Somatuline® Depot® within the United States and as Somatuline® Autogel® in other countries where it has marketing authorization. Somatuline® is indicated for the treatment of acromegaly and neuroendocrine tumors in 70 countries.

< Product Summary >

BRAND NAME   SOMATULINE ® 60 mg for s.c. Injection;

SOMATULINE ® 90 mg for s.c. Injection;

SOMATULINE ® 120 mg for s.c. Injection

GENERIC NAME   lanreotide acetate
DOSAGE FORM   Sustained -release Injection (pre-filled syringe with needle)
INDICATIONS   To ameliorate oversecretion of growth hormone and/or IGF-I (Somatomedin-C) as well as improvement of symptoms associate with the following diseases:

Acromegaly, Pituitary gigantism (when response to surgical therapies has not been satisfactory or surgery is difficult to be performed)

 

Gastroentero-pancreatic neuroendocrine tumors

DOSAGE AND ADMINISTRATION   In adults, 90 mg of lanreotide is usually administered by deep subcutaneous injection at 4-week intervals for 3 months, followed by 60, 90 or 120 mg every 4 weeks. The dosage may be adjusted according to the patients’ clinical condition.  

In adults, 120 mg of lanreotide is usually administered by deep subcutaneous injection at 4-week intervals

The additional indication is described in the underlined part.

The indication for Gastroentero-pancreatic NETs is approved for SOMATULINE ® 120 mg for s.c. Injection alone.

About the Teijin Group
Teijin (TSE: 3401) is a technology-driven global group offering advanced solutions in the areas of environmental value; safety, security and disaster mitigation; and demographic change and increased health consciousness. Its main fields of operation are high-performance fibers such as aramid, carbon fibers & composites, healthcare, films, resin & plastic processing, polyester fibers, products converting and IT. The group has some 170 companies and around 19,000 employees spread out over 20 countries worldwide. It posted consolidated sales of JPY741.3 billion (USD 6.5 billion) and total assets of JPY 964.1 billion (USD 8.5 billion) in the fiscal year ending March 31, 2017. Please visit www.teijin.com

About Ipsen
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.

Forward Looking Statement
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).

1 Tetsuhide Ito et al J Gastroenterol (2015) 50:58-64

Contact information

Ipsen
Media
Didier Véron
Senior Vice-President, Public Affairs and Communication
Tel.: +33 (0)1 58 33 51 16
E-mail: didier.veron@ipsen.com
or
Brigitte Le Guennec
Corporate External Communication Manager
Tel.: +33 (0)1 58 33 51 17
E-mail : brigitte.le.guennec@ipsen.com
or
Financial Community
Eugenia Litz
Vice-President, Investor Relations
Tel.: +44 (0) 1753 627721
E-mail: eugenia.litz@ipsen.com
or
Côme de La Tour du Pin
Investor Relations Manager
Tel.: +33 (0)1 58 33 53 31
E-mail: come.de.la.tour.du.pin@ipsen.com
or
Teijin
Corporate communications
Teijin Limited
+81 3 3506 4055
pr@teijin.co.jp

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme tältä julkaisijalta, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

GSMA: Multiple Mobile Operators Launch Live Commercial Low Power Wide Area Networks in Licensed Spectrum Worldwide21.2.2018 12:00Tiedote

The GSMA today announced that momentum behind Mobile IoT, or licensed Low Power Wide Area (LPWA), networks continues to grow on a global basis. To date, 23 mobile operators have commercially launched 41 Mobile IoT networks worldwide across both NB-IoT1 and LTE-M2. This growth is supported by 34 IoT Labs and an expanding community of over 800 organisations in the GSMA’s Mobile IoT Innovators Community. According to GSMA Intelligence forecasts, by 2025 there will be 3.1 billion cellular IoT connections, including 1.8 billion licensed LPWA connections. “2018 is the year that Mobile IoT networks will scale. We have seen huge growth in the availability of commercial networks in licensed spectrum and anticipate seeing many more launches this year. This is underpinned by an expanding community of organisations developing innovative new solutions and a number of IoT Labs helping companies to test out new products and services,” said Alex Sinclair, Chief Technology Officer, GSMA. “Mobile IoT ne

Clientron to Present Its POS Innovation at EuroCIS 201821.2.2018 12:00Tiedote

Clientron Corp., a global leading provider of POS, thin client, and embedded systems, will display its latest POS solutions for the retail market at the world’s leading retail show, EuroCIS 2018, from February 27 to March 1, 2018 in Dusseldorf, Germany. At its Booth (Hall 10, Booth E73), Clientron will introduce its innovative POS terminals and various built-in POS peripherals available on the market today in order to meet the demands of omnicommerce experience. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180221005007/en/ Clientron to present its POS innovation at EuroCIS 2018 At the event, Clientron's displays will include: the innovative PST650 all-in-one POS terminal with a built-in high speed thermal printer and a small, lightweight form factor for counter space savings; the most affordable POS terminal, PT2000, in a fanless design with long life span support to both entry and mainstream POS market segments; and the ne

Fake Medicines Continue to Threaten Consumers – EU Member States have an Obligation to Act21.2.2018 11:12Tiedote

According to The Alliance for Safe Online Pharmacy in the EU (ASOP EU), the illegal manufacturing and distribution of fake medicines is an enormous and growing public health risk with an untold cost to lives. "Vast profits are made by organized criminal gangs who often use the proceeds to support other criminal activities. The Internet provides the ideal channel to buy illegally distributed fake medicines. Price, convenience and secrecy have driven consumer demand, creating the perfect environment for over 35,000 illegally operating websites." Under article 85d of the Falsified Medicines Directive, each EU Member State is obliged to raise awareness about the risks of buying medicines online. To better understand how countries are meeting these obligations to educate and protect consumers, the European Union’s Alliance for Safe Online Pharmacy (ASOP EU) and the European Alliance for Access to Safe Medicines (EAASM), has convened a series of discussions with many Member States. Based on

Triton Digital Integrates Platform 161 with a2x® to Provide Marketers and Buyers with Access to Premium Digital Audio Advertising Inventory21.2.2018 11:00Tiedote

Triton Digital®, the global technology and services leader to the digital audio and podcast industry, announced today the integration of its audio advertising marketplace, a2x®, with Platform 161, a leading DSP for advertisers, agencies and publishers. The integration provides Platform 161’s advertisers with the ability to add online audio from top-tier broadcasters and streaming music services to their programmatic, omnichannel buys through both open auction and private marketplace (PMP) deals. “We are proud to partner with Triton Digital to provide our marketers with access to a wide range of digital audio inventory from music services, live streaming radio, podcasts, and more through the a2x programmatic audio marketplace,” said Marco Kloots, CEO at Platform 161. “The personal, highly-engaging nature of digital audio will undeniably enhance our marketers omnichannel buys, enabling them to both scale their buys and connect with their target audience in a native, immersive manner acro

Posiflex Showcases Stylish New Line of Touch Screen Terminals and Self-Service & Interactive Kiosks at EuroCIS 201821.2.2018 11:00Tiedote

Posiflex Technology, Inc. unveils an entirely new line of dynamic touch screen terminals that embodies a new era for Posiflex and point-of-sale hardware – the RT Series. With an elegant housing and a strikingly thin profile, the RT Series brings a modern aesthetic to the counter and makes a retail business look even more attractive. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180221005002/en/ Make Your Business Look More Attractive with Posiflex RT Series (Photo: Business Wire) Available in 15” (4:3) screen or 15.6” (16:9) widescreen, the RT Series provides multiple CPU selection from Intel Celeron all the way to Core i5 CPU to fit each unique need. The patented fanless technology allows the unit to run silently and perform in harsh environments that involves dust and liquid spills. “POS terminal is no longer just a cold and hard business tool; it has evolved to be an extension of the brand offering a more dynamic in-store

Arix Bioscience and Ipsen Sign a Strategic Agreement to Develop and Commercialise Innovative Therapies21.2.2018 10:00Tiedote

Regulatory News: Arix Bioscience plc (LSE:ARIX) (“Arix”), a global healthcare and life science company supporting medical innovation, and Ipsen (Euronext: IPN; ADR:IPSEY), a global specialty-driven biopharmaceutical company focused on innovation and specialty care, today announced a strategic agreement to develop and commercialise innovative therapies. Arix will provide Ipsen with access to its unique network of professional and scientific advisors, and the chance to invest in opportunities in Arix’s new and existing businesses. In return, Ipsen will contribute research, development and commercial expertise to the partnership. Arix and Ipsen will collaborate to identify opportunities and jointly create new companies focused primarily on the development and commercialisation of innovative therapies for patients. Joe Anderson, Chief Executive Officer of Arix Bioscience plc, commented: “This agreement brings together Ipsen’s deep expertise in drug development and commercialization with Ar

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme