Business Wire

Ipsen initiates a share buyback program to cover its free share allocation and employee share plans

Jaa

Regulatory News:

Ipsen (Euronext: IPN; ADR: IPSEY), announces today that it has appointed an investment services provider to purchase 250,000 Ipsen SA shares, or about 0.30% of the share capital, over a period of at least 3 months. The shares purchased under this agreement will be mainly allocated to cover its free share allocation plans and its new employee share ownership plan.

This program is made pursuant to the authorization granted by the Combined Shareholder’s meeting held on May 30, 2018.

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, Neuroscience 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 over €1.9 billion in 2017, 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 5,400 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.

Ipsen 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 favourable 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 2017 Registration Document available on its website (www.ipsen.com).

Contact information

For further information:
Ipsen
Media
Ian Weatherhead, +44 (0) 1753 627733
Vice President, Corporate External Communications
ian.weatherhead@ipsen.com
or
Brigitte Le Guennec, +33 (0)1 58 33 51 17
Senior Manager, Global External Communications
brigitte.le.guennec@ipsen.com
or
Financial Community
Eugenia Litz, +44 (0) 1753 627721
Vice President, Investor Relations
eugenia.litz@ipsen.com
or
Myriam Koutchinsky, +33 (0)1 58 33 51 04
Investor Relations Manager
myriam.koutchinsky@ipsen.com

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, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Octapharma announces approval of new Nuwiq® product strengths in Europe, increasing dosing flexibility for patients with haemophilia A18.6.2018 10:06Tiedote

Octapharma announced today that the European Medicines Agency (EMA) has approved an extension of marketing authorisation for its human cell line-derived recombinant factor VIII (rFVIII) product, Nuwiq®. New single dose vial strengths of 2500, 3000 and 4000 International Units (IU) will be available in Europe, in addition to the current strengths of 250, 500, 1000 and 2000 IU. The new Nuwiq® vial strengths have been available in the US since September last year, following approval by the FDA. Nuwiq® is indicated in adults and children of all ages for on-demand treatment and prophylaxis, including during surgery, to prevent and control bleeding episodes in patients with haemophilia A. This expanded array of vial strengths has the potential to increase treatment options for patients with haemophilia A by improving dosing flexibility. Patients who previously required more than one vial per infusion may be able to reduce the number of vials needed. Nuwiq® is the only rFVIII available in an

STATS and SpokeHub Partner to Power Deeper, More Meaningful Conversations Around the 2018 FIFA World Cup18.6.2018 10:00Tiedote

Today, STATS, the worldwide leader in sports data and intelligence, and SpokeHub announced a new partnership to bring STATS Insights to SpokeHub’s social engagement platform, connecting worldwide World Cup football (soccer) fans with content that is more impactful. Download the app today to see the match scores, player insights, and engage with World Cup fans everywhere! STATS Insights leverages more than 37 years of research experience to deliver deep historical and comparative statistical insights, play-by-play descriptions and in-game trends based on events as they happen in the match. Before, during and after each match, SpokeHub will harness STATS Insights to amplify conversations among World Cup football communities. During the game, live Insights will deliver trends on players and teams based on in-game events, statistics and milestones. “No sporting event gets global attention like the World Cup, and every fan is looking for deeper analysis around their favorite teams and playe

Celltrion Completes Resubmission to FDA for Proposed Trastuzumab Biosimilar18.6.2018 05:53Tiedote

Celltrion (KRX:068270) has made a resubmission to the FDA (U.S. Food and Drug Administration) to obtain its marketing approval for CT-P6, a proposed mAb biosimilar to Herceptin® (trastuzumab). Celltrion submitted its abbreviated Biologics License Applications (aBLAs) for CT-P10 and CT-P6 to the FDA in April and May of last year, respectively. However, it received CRLs (complete response letters) from the FDA related to the warning letter issued by the FDA in January 2018, related to the manufacturing facility in Incheon, South Korea. Celltrion had completed the resubmission for the approval of CT-P10, a proposed biosimilar to Rituxan® (rituximab) last month. In accordance with FDA regulations, the approval procedure will be usually finalized within six months from the resubmission, so Celltrion expects the approval for the U.S. market of the two proposed biosimilars within this calendar year. FDA has notified Celltrion of its re-inspection schedule regarding regular audit results, and

CES Asia: Innovation at the Speed of 5G15.6.2018 17:59Tiedote

CES Asia® 2018 wrapped today with the rapid pace of global innovation front and center over the show’s three day duration. The next stage of technology advancements were showcased across vehicle tech, robotics, artificial intelligence (AI), virtual and augmented reality, digital health and more. The event, 24 percent larger than last year in terms of footprint, cemented itself as the place to fully experience how the pace of technology is accelerating globally. CES Asia, the premier event for tech innovation in the Asian marketplace, will return to Shanghai, China, June 11-13, 2019. “5G and AI are igniting growth across the entire tech ecosystem changing the way we interact with technology and the world around us,” said Gary Shapiro, president and CEO, Consumer Technology Association (CTA)™. “It’s incredible to see technology refining and reinventing itself at such a fast pace. Just six months ago we were at CES with life-altering tech all around us. This week, I saw that technology re

bluebird bio Presents New Data from Northstar (HGB-204) and Northstar-2 (HGB-207) Studies of LentiGlobin™ Gene Therapy in Patients with Transfusion-Dependent β-Thalassemia at Annual Congress of the European Hematology Association15.6.2018 13:00Tiedote

bluebird bio, Inc. (Nasdaq: BLUE) announced that new data from the completed Phase 1/2 Northstar (HGB-204) study in adolescents and adults with transfusion-dependent β-thalassemia (TDT) and any genotype, and its ongoing, Phase 3 Northstar-2 (HGB-207) multicenter clinical study of LentiGlobin™ investigational gene therapy in patients with TDT and non-β0/β0 genotypes, will be presented in an oral session on June 16 at the 23rd Annual Congress of the European Hematology Association by Franco Locatelli, M.D., Ph.D., of the IRCCS Ospedale Pediatrico Bambino Gesù of Rome, Italy. “The maturing data from HGB-204 and HGB-207 suggest that one-time treatment with LentiGlobin may address the underlying genetic cause of TDT. With our refined manufacturing process, the majority of patients with TDT and non-β0/β0 genotypes are transfusion-free and producing total hemoglobin at normal or near-normal levels,” said David Davidson, M.D., chief medical officer, bluebird bio. “We are on track to submit a m

bluebird bio Announces New Interim Data from Phase 1 (HGB-206) Study of LentiGlobin™ Gene Therapy in Patients with Severe Sickle Cell Disease at Annual Congress of the European Hematology Association15.6.2018 13:00Tiedote

bluebird bio, Inc. (Nasdaq: BLUE) today announced new interim data from the ongoing HGB-206 Phase 1 multicenter clinical study of LentiGlobin investigational gene therapy in patients with severe sickle cell disease (SCD) will be presented in an oral presentation on Saturday, June 16 at the 23rd Congress of the European Hematology Association (EHA) by Julie Kanter, M.D., Medical University of South Carolina, Charleston, South Carolina. “The consistent production of increased amounts of anti-sickling HbAT87Q in the Group C patients reflects the substantial positive impact of the changes introduced with the amended HGB-206 study protocol and refined manufacturing process. All four Group C patients with greater than or equal to three months follow-up are making over 30 percent anti-sickling HbAT87Q. The first patient treated, now with six months of follow-up, is producing over 60 percent anti-sickling HbAT87Q with a normal total hemoglobin level of 14.2 g/dL,” said David Davidson, M.D., ch

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