Takeda Comments on Ongoing Phase 1 Review by the European Commission of the Proposed Acquisition of Shire plc
Takeda Pharmaceutical Company Limited (TSE: 4502) (“Takeda”) today issued the following statement with regard to its discussions with the European Commission (“EC”) as part of its Phase 1 review of the proposed acquisition of Shire plc (“Shire”) announced on May 8, 2018 (the “Acquisition”):
Takeda confirms that it is in discussions with the EC in relation to the future potential overlap in the area of inflammatory bowel disease between Takeda’s marketed product Entyvio (vedolizumab) and Shire’s pipeline compound SHP647, which is currently in Phase III clinical trials, and has proposed a remedy of a potential divestment of SHP647 and certain associated rights.
The company remains committed to Entyvio, which has been granted marketing authorization in more than 60 countries and is the cornerstone of Takeda’s diverse specialty gastrointestinal portfolio.
Takeda confirms that there are no discussions with the EC regarding any other marketed products or assets in the pipeline.
Takeda does not anticipate that its discussions with the EC will result in a delay to its previously announced timetable for completion of the transaction. A further announcement will be made as appropriate.
The Acquisition remains subject to certain other conditions, including receipt of the remaining regulatory clearances and approval by the shareholders of both companies.
About Entyvio ® (vedolizumab)
Vedolizumab is a gut-selective biologic and is approved as an intravenous (IV) formulation.1 It is a humanized monoclonal antibody designed to specifically antagonize the alpha4beta7 integrin, inhibiting the binding of alpha4beta7 integrin to intestinal mucosal addressin cell adhesion molecule 1 (MAdCAM-1), but not vascular cell adhesion molecule 1 (VCAM-1).2 MAdCAM-1 is preferentially expressed on blood vessels and lymph nodes of the gastrointestinal tract.3 The alpha4beta7 integrin is expressed on a subset of circulating white blood cells.14 These cells have been shown to play a role in mediating the inflammatory process in ulcerative colitis (UC) and Crohn’s disease (CD).4 5 By inhibiting alpha4beta7 integrin, vedolizumab may limit the ability of certain white blood cells to infiltrate gut tissues.
Vedolizumab IV is approved for the treatment of adult patients with moderately to severely active UC and CD, who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumor necrosis factor-alpha (TNFα) antagonist. Vedolizumab IV has been granted marketing authorization in over 60 countries, including the United States and European Union, with over 200,000 patient years of exposure to date. 6
Vedolizumab is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumor necrosis factor-alpha (TNFα) antagonist.
Vedolizumab is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumor necrosis factor-alpha (TNFα) antagonist.
Important Safety Information
Hypersensitivity to the active substance or to any of the excipients.
Special warnings and special precautions for use
Vedolizumab should be administered by a healthcare professional equipped to manage hypersensitivity reactions, including anaphylaxis, if they occur. Appropriate monitoring and medical support measures should be available for immediate use when administering vedolizumab. Observe all patients during infusion and until the infusion is complete.
In clinical studies, infusion-related reactions (IRR) and hypersensitivity reactions have been reported, with the majority being mild to moderate in severity. If a severe IRR, anaphylactic reaction, or other severe reaction occurs, administration of vedolizumab must be discontinued immediately and appropriate treatment initiated (e.g., epinephrine and antihistamines). If a mild to moderate IRR occurs, the infusion rate can be slowed or interrupted and appropriate treatment initiated (e.g., epinephrine and antihistamines). Once the mild or moderate IRR subsides, continue the infusion. Physicians should consider pre-treatment (e.g., with antihistamine, hydrocortisone and/or paracetamol) prior to the next infusion for patients with a history of mild to moderate IRR to vedolizumab, in order to minimize their risks.
Vedolizumab is a gut-selective integrin antagonist with no identified systemic immunosuppressive activity. Physicians should be aware of the potential increased risk of opportunistic infections or infections for which the gut is a defensive barrier. Vedolizumab treatment is not to be initiated in patients with active, severe infections such as tuberculosis, sepsis, cytomegalovirus, listeriosis, and opportunistic infections until the infections are controlled, and physicians should consider withholding treatment in patients who develop a severe infection while on chronic treatment with vedolizumab. Caution should be exercised when considering the use of vedolizumab in patients with a controlled chronic severe infection or a history of recurring severe infections. Patients should be monitored closely for infections before, during and after treatment. Before starting treatment with vedolizumab, screening for tuberculosis may be considered according to local practice. Some integrin antagonists and some systemic immunosuppressive agents have been associated with progressive multifocal leukoencephalopathy (PML), which is a rare and often fatal opportunistic infection caused by the John Cunningham (JC) virus. By binding to the α4β7 integrin expressed on gut-homing lymphocytes, vedolizumab exerts an immunosuppressive effect on the gut. Although no systemic immunosuppressive effect was noted in healthy subjects, the effects on systemic immune system function in patients with inflammatory bowel disease are not known. Healthcare professionals should monitor patients on vedolizumab for any new onset or worsening of neurological signs and symptoms, and consider neurological referral if they occur. If PML is suspected, treatment with vedolizumab must be withheld; if confirmed, treatment must be permanently discontinued. Typical signs and symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body, clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. The progression of deficits usually leads to death or severe disability over weeks or months.
The risk of malignancy is increased in patients with ulcerative colitis and Crohn’s disease. Immunomodulatory medicinal products may increase the risk of malignancy.
Prior and concurrent use of biological products
No vedolizumab clinical trial data are available for patients previously treated with natalizumab. Caution should be exercised when considering the use of vedolizumab in these patients. No clinical trial data for concomitant use of vedolizumab with biologic immunosuppressants are available. Therefore, the use of vedolizumab in such patients is not recommended.
Prior to initiating treatment with vedolizumab all patients should be brought up to date with all recommended immunizations. Patients receiving vedolizumab may receive non-live vaccines (e.g., subunit or inactivated vaccines) and may receive live vaccines only if the benefits outweigh the risks.
Adverse reactions include: nasopharyngitis, headache, arthralgia, upper respiratory tract infection, bronchitis, influenza, sinusitis, cough, oropharyngeal pain, nausea, rash, pruritus, back pain, pain in extremities, pyrexia, and fatigue.
Please consult with your local regulatory agency for approved labeling in your country.
For EU audiences, please see the Summary of Product Characteristics (SmPC) for ENTYVIO ® .
Takeda’s Commitment to Gastroenterology
Gastrointestinal (GI) diseases can be complex, debilitating and life-changing. Recognizing this unmet need, Takeda and our collaboration partners have focused on improving the lives of patients through the delivery of innovative medicines and dedicated patient disease support programs for over 25 years. Takeda aspires to advance how patients manage their disease. Additionally, Takeda is leading in areas of gastroenterology associated with high unmet need, such as inflammatory bowel disease, acid-related diseases and motility disorders. Our GI Research & Development team is also exploring solutions in celiac disease and liver diseases, as well as scientific advancements through microbiome therapies.
About Takeda Pharmaceutical Company
Takeda Pharmaceutical Company Limited (TSE: 4502) is a global, research and development-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its R&D efforts on oncology, gastroenterology and neuroscience therapeutic areas plus vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. Innovative products, especially in oncology and gastroenterology, as well as Takeda's presence in emerging markets, are currently fueling the growth of Takeda. Approximately 30,000 Takeda employees are committed to improving quality of life for patients, working with Takeda's partners in health care in more than 70 countries. For more information, visit https://www.takeda.com/newsroom/.
This announcement is not intended to, and does not, constitute, represent or form part of any offer, invitation or solicitation of an offer to purchase, otherwise acquire, subscribe for, sell or otherwise dispose of, any securities whether pursuant to this announcement or otherwise.
The distribution of this announcement in jurisdictions outside the United Kingdom or Japan may be restricted by law or regulation and therefore any person who comes into possession of this announcement should inform themselves about, and comply with, such restrictions. Any failure to comply with such restrictions may constitute a violation of the securities laws or regulations of any such relevant jurisdiction.
Publication on Website
In accordance with Rule 26.1 of the Code, a copy of this announcement will be made available (subject to certain restrictions relating to persons resident in restricted jurisdictions) on Takeda's website at www.takeda.com/investors/offer-for-shire by no later than 12 noon (London time) on October 29, 2018. The content of the website referred to in this announcement is not incorporated into and does not form part of this announcement.
Disclosure requirements of the Code
Under Rule 8.3(a) of the Code, any person who is interested in 1% or more of any class of relevant securities of an offeree company or of any securities exchange offeror (being any offeror other than an offeror in respect of which it has been announced that its offer is, or is likely to be, solely in cash) must make an Opening Position Disclosure following the commencement of the offer period and, if later, following the announcement in which any securities exchange offeror is first identified. An Opening Position Disclosure must contain details of the person's interests and short positions in, and rights to subscribe for, any relevant securities of each of (i) the offeree company and (ii) any securities exchange offeror(s). An Opening Position Disclosure by a person to whom Rule 8.3(a) applies must be made by no later than 3.30 pm (London time) on the 10th business day following the commencement of the offer period and, if appropriate, by no later than 3.30 pm (London time) on the 10th business day following the announcement in which any securities exchange offeror is first identified. Relevant persons who deal in the relevant securities of the offeree company or of a securities exchange offeror prior to the deadline for making an Opening Position Disclosure must instead make a Dealing Disclosure.
Under Rule 8.3(b) of the Code, any person who is, or becomes, interested in 1% or more of any class of relevant securities of the offeree company or of any securities exchange offeror must make a Dealing Disclosure if the person deals in any relevant securities of the offeree company or of any securities exchange offeror. A Dealing Disclosure must contain details of the dealing concerned and of the person's interests and short positions in, and rights to subscribe for, any relevant securities of each of (i) the offeree company and (ii) any securities exchange offeror(s), save to the extent that these details have previously been disclosed under Rule 8. A Dealing Disclosure by a person to whom Rule 8.3(b) applies must be made by no later than 3.30 pm (London time) on the business day following the date of the relevant dealing.
If two or more persons act together pursuant to an agreement or understanding, whether formal or informal, to acquire or control an interest in relevant securities of an offeree company or a securities exchange offeror, they will be deemed to be a single person for the purpose of Rule 8.3.
Opening Position Disclosures must also be made by the offeree company and by any offeror and Dealing Disclosures must also be made by the offeree company, by any offeror and by any persons acting in concert with any of them (see Rules 8.1, 8.2 and 8.4).
Details of the offeree and offeror companies in respect of whose relevant securities Opening Position Disclosures and Dealing Disclosures must be made can be found in the Disclosure Table on the Panel's website at www.thetakeoverpanel.org.uk, including details of the number of relevant securities in issue, when the offer period commenced and when any offeror was first identified. You should contact the Panel's Market Surveillance Unit on +44 (0)20 7638 0129 if you are in any doubt as to whether you are required to make an Opening Position Disclosure or a Dealing Disclosure.
1 Entyvio® Summary of Product Characteristics. March 2018.
2 Soler D, Chapman T, Yang LL, et al. The binding specificity and selective antagonism of vedolizumab, an anti-α4β7 integrin therapeutic antibody in development for inflammatory bowel diseases. J Pharmacol Exp Ther. 2009;330:864-875.
3 Briskin M, Winsor-Hines D, Shyjan A, et al. Human mucosal addressin cell adhesion molecule-1 is preferentially expressed in intestinal tract and associated lymphoid tissue. Am J Pathol. 1997;151:97 110.
4 Eksteen B, Liaskou E, Adams DH. Lymphocyte homing and its roles in the pathogenesis of IBD. Inflamm Bowel Dis. 2008;14:1298 1312.
5 Wyant T, Fedyk E, Abhyankar B. An overview of the mechanism of action of the monoclonal antibody vedolizumab. J Crohns Colitis. 2016;10:1437-1444.
6 Takeda. 2018. Data on file.
7 Entyvio (vedolizumab) Prescribing Information. February 2018.
Takeda (Investor Relations)
+81 3 3278 2306
Takeda (Media – inside Japan)
+1 617 551 2933
+81 3 3278 2095
Takeda (Media – outside Japan)
+1 312 285 3203
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 ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
IFF-LMR Naturals Leads Industry with 90 Certified Vegan Natural Extracts16.11.2018 00:15 | Tiedote
Regulatory News: IFF-LMR, a subsidiary of International Flavors & Fragrances Inc (NYSE:IFF) (Euronext Paris: IFF) (TASE: IFF) announced their industry-leading position of 90 natural extracts in their portfolio certified vegan by the EVE (Expertise Vegan Europe) VEGAN standards. The certified extracts include Rose EssentialTM, Rose UltimateTM, Blackcurrant Buds Absolute, Ylang Oil Complete, Vetiver Oil Haiti, Patchouli Oil Indonesia, and Geranium Heart Oil, among many others. Bertrand de Preville, General Manager, IFF-LMR said, “Our people are passionate about creating the finest ingredients and together, we are committed to delivering premium, 100% pure and natural extracts. We believe in transparency, environmental management and sustainable development.” Mr. de Preville continued, “This certification of 90 extracts is in line with IFF-LMR’s continuous dedication to our planet, people, plants and animals.” The EVE VEGAN label was selected because it is considered one of the most rigor
Rimini Street Expands Investment and Operations in Asia-Pacific15.11.2018 23:00 | Tiedote
Rimini Street, Inc. (Nasdaq: RMNI), a global provider of enterprise software products and services, and the leading third-party support provider for Oracle and SAP software products, today announced that it has expanded its operations in the Asia-Pacific region with the launch of its new subsidiary, Rimini Street New Zealand Limited, and the opening of its new office in Auckland to address the growing demand for Rimini Street’s premium, ultra-responsive support services in New Zealand. Rimini Street’s expansion was announced at a gala event held at The Northern Club in Auckland, where clients, local IT leaders and the special guest of honor, Ambassador Scott P. Brown, the U.S. Ambassador to New Zealand, were hosted by Rimini Street’s general manager for Asia-Pacific, Andrew Powell, and Rimini Street corporate senior executives. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181115005037/en/ Rimini Street launches subsidiary
Sartorius Stedim Biotech and Lonza Modify Relationship for Supply of Cell Culture Media15.11.2018 21:15 | Tiedote
Sartorius Stedim Biotech (SSB) (Paris:DIM), a leading international supplier of the biopharmaceutical industry, and Lonza announced today that they have modified their current agreement for supply of cell culture media by mutual accord. The agreement, signed in 2012, gave SSB exclusive sales and marketing rights for certain cell culture media and buffers developed and manufactured by Lonza for use in biopharmaceutical manufacturing processes. Lonza retained sales for research-based products, among others. Under agreements signed today, SSB will continue to offer current and future Lonza media and buffers on a non-exclusive basis as part of its extensive portfolio of products for cell-based development and manufacturing. Lonza Pharma & Biotech resumes sales and marketing of all its media products for both manufacturing and research. Customers of both companies will continue to be able to source media products for their specific needs. “We have a long-standing and productive partnership
Intertops Poker Launches its 20 Event Strong SOFT Series for its Recreational Player Base15.11.2018 20:46 | Tiedote
Intertops Poker has launched a new tournament series aimed and created for its recreational and casual player base, with impressive prizes up for grabs. The Intertops Poker SOFT Series is spread across 20 events and offers a combined prize pool of $24,850, including a $4,100 World Series of Poker Caribbean prize package. The series starts on 19th November and will conclude on 25th November. It is available to players from all countries and markets wanting to test their skills and have fun at the tables. There are a wide range of buy-ins to suit all budgets, and the tournament kicks-off with two $500 freerolls before the series gets underway proper on 20th November. Each SOFT Series event winner will receive an Intertops Poker Soft Series Champion hoodie and a seat at the table for the Champions Tournament. The highlight of the series, the Champions Tournament takes place on 25th November at 6:30pm ET and has a guaranteed World Series of Poker Caribbean prize worth $4,100. The World Ser
Telstra: Capital Planning & Delivery Named PMO of the Year15.11.2018 20:21 | Tiedote
Today, Project Management Institute (PMI), the world’s leading association for the project, program and portfolio management profession, announced that Telstra: Capital Planning & Delivery (Melbourne, Australia) has been awarded the 2018 PMO of the Year Award. In 2012, Telstra created the Capital Planning and Delivery (CP&D) function as a dedicated capability within the Finance and Strategy organization. Their purpose was clear – support the annual capital investment allocation, prioritization, and planning processes to better support investment programs and projects. Since that time, it has created a single enterprise wide investment gating model, created a sponsorship engagement model going from 0% of sponsors engaged at the start to 77% today, and enabled a culture of never stopping projects to one that stops non-viable efforts. With many other accomplishments, the core was a cultural transformation. Engagement of sponsors, enabling project management development opportunities and c
Acuris Risk Intelligence and FinScan® Announce Global Strategic Partnership15.11.2018 19:12 | Tiedote
Acuris Risk Intelligence, an independent provider of data intelligence for Anti-Money Laundering (AML), Anti-Corruption and Cyber Security; and FinScan, a global leader in AML compliance solutions, have joined forces to deliver an integrated platform for seamless and efficient watch list screening and customer due diligence. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181115005681/en/ FinScan provides advanced sanctions, Politically Exposed Persons (PEP) and adverse media screening solutions for organisations worldwide. Its intelligent matching technology drastically reduces false positives and the risk of missing true hits. By combining FinScan’s accuracy and scalability with Acuris Risk Intelligence’s specialised knowledge, the partnership enables clients to screen customers and vendors against any high-risk or sanction lists using the deployment method of their choice. Joel Lange, managing director at Acuris Risk Intel
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