SHIRE GRANTED EU MARKETING AUTHORIZATION FOR VEYVONDI® [VONICOG ALFA, RECOMBINANT VON WILLEBRAND FACTOR] FOR ADULTS WITH VON WILLEBRAND DISEASE
Zug, Switzerland – September 12, 2018 – Canton plc (LSE: SHP, NASDAQ: SHPG) the all-around biotech baton in attenuate diseases, appear today that the European Commission (EC) has accepted Business Authorization for VEYVONDI [vonicog alfa, recombinant von Willebrand factor] (rVWF), for the ysis of bleeding contest and treatment/prevention of surgical bleeding in adults (age 18 and older) with von Willebrand ache (VWD) back desmopressin (DDAVP) ysis abandoned is abortive or not indicated. VEYVONDI should not be acclimated in the ysis of hemophilia A.1 VEYVONDI is the aboriginal and abandoned recombinant von Willebrand Agency (rVWF) ysis in the EU for von Willebrand ache (VWD) that accurately addresses the primary absence or dysfunction of von Willebrand Agency (VWF) while additionally acceptance the anatomy to restore and advance able Agency VIII (FVIII) claret levels.1
“The approval in Europe for VEYVONDI marks a key anniversary in our efforts to accouterment unmet medical needs for those active with von Willebrand disease,” said Andreas Busch, Head of Analysis and Development and Chief Scientific Officer, Shire. “We are aflame to booty the aing accomplish in ensuring that VEYVONDI is broadly accessible beyond Europe to abode the abandoned needs of those afflicted by the activity and in charge of agency replacement.”
The Business Authorization is based on outcomes from three ytic trials of a absolute 80 patients with VWD apparent to VEYVONDI. These accommodate a Phase 1 multicenter, controlled, randomized, single-blind, dose-escalation abstraction of the safety, tolerability and pharmacokinectics (PK) of rVWF:rFVIII in capacity 18 to 60 years of age with astringent VWD; a Phase 3 multicenter, open-label abstraction to appraise the PK, assurance and adeptness of rVWF:rFVIII and rVWF in the ysis of bleeding episodes in developed capacity with astringent VWD; and a Phase 3, prospective, open-label, uncontrolled, non-randomized, all-embracing multicenter abstraction to appraise the hemostatic adeptness and assurance of rVWF with or after rFVIII in 15 developed capacity with astringent VWD adeptness major, minor, or articulate constituent surgical procedures.2
VWD is the best accepted affiliated bleeding disorder, affecting up to 1 percent of the all-around citizenry or about 100,000 bodies in the EU.3,4 VWD is acquired by a absence or dysfunction of VWF, one of several types of proteins in the claret that are bare to facilitate able claret clotting.5 Abandoned a accessory admeasurement of afflicted individuals accept the astringent anatomy of the ache and are in charge of VWF replacement.6 Affection ambit from nosebleeds to bleeding from the gums and accessible bruising. Bleeding from the abdomen and belly can activity but is beneath common.7
With this approval, Canton is now accustomed to bazaar VEYVONDI in the 28 Member States of the European Union (EU), as able-bodied as in Iceland, Lichtenstein and Norway.
About von Willebrand ache (VWD)VWD is the best accepted affiliated bleeding disorder, affecting up to 1 percent of the all-around population.3 VWD is acquired by a absence or dysfunction of VWF, one of several types of proteins in the claret that are bare to facilitate able claret clotting.5 Due to this absence or dysfunction in VWF, claret is not able to array finer in bodies with VWD.6 The majority of cases (70-80%) are due to fractional quantitative VWF absence (Type 1 VWD).8 The best astringent anatomy of VWD (severe Type 3 VWD) is the atomic common, with accident capricious by ethnicity from 0.1 to 5.3 cases per million.9 The alteration may activity spontaneously with no antecedent ancestors history.7 Bleeding acquired by VWD is capricious and its severity varies abundantly amid patients with this disease.10
About VEYVONDI VEYVONDI is adumbrated in adults (age 18 and older) with von Willebrand ache (VWD), back desmopressin (DDAVP) ysis abandoned is abortive or not adumbrated for the ysis of drain and treatment/prevention of surgical bleeding. VEYVONDI should not be acclimated in the ysis of hemophilia A.1
For abounding EU Summary of Artefact Characteristics, including accustomed indication(s) and important assurance advice about marketed products, amuse visit: http://ec.europa.eu/health/documents/community-register/2018/20180831141871/anx_141871_en.pdf1
In the US the artefact has been accustomed for added than two years beneath the barter name VONVENDI® [von Willebrand agency (Recombinant)] and is adumbrated for use in adults (age 18 and older) diagnosed with von Willebrand ache for on-demand ysis and ascendancy of bleeding episodes or perioperative administering of bleeding.
VEYVONDI EU IMPORTANT SAFETY INFORMATION1
WARNINGS AND PRECAUTIONSHypersensitivity ReactionsHypersensitivity reactions (including anaphylaxis) may occur. Patients and/or their caregivers should be a of the aboriginal signs of hypersensitivity reactions, which may accommodate but are not bound to tachycardia, bounden of the , asthmatic and/or astute respiratory distress, hypotension, ambiguous urticaria, pruritus, rhinoconjunctivitis, angioedema, lethargy, nausea, ing, paresthesia, restlessness, and may advance to anaphylactic shock. In case of shock, accepted medical ysis for shock should be implemented.
Patients should be anxiously monitored and anxiously empiric for any affection throughout the beverage period. If signs and affection of astringent allergic reactions occur, anon abandon administering of VEYVONDI and accommodate adapted admiring care. Able medical ysis and accoutrement should be accessible for actual use for a abeyant anaphylactic reaction, abnormally for patients with a history of allergic reactions.
VEYVONDI contains trace amounts of abrasion immunoglobulin G (MuIgG) and hamster proteins (less than or according to 2 ng/IU VEYVONDI). Patients advised with this artefact may advance hypersensitivity reactions to these non-human beastly proteins. VEYVONDI contains trace amounts of recombinant agglomeration agency VIII.
Thrombosis and EmismThere is a accident of accident of thrombotic events, decidedly in patients with accepted ytic or class accident factors for occlusion including low ADAMTS13 levels. Therefore, patients at accident accept to be monitored for aboriginal signs of thrombosis, and prophylaxis measures adjoin thromboemism should be instituted according to accepted recommendations and accepted of care.
In patients acute accepted doses of VEYVONDI in aggregate with recombinant agency VIII, claret levels for FVIII:C activity should be monitored to abstain abiding boundless FVIII:C claret levels, which may admission the accident of thrombotic events. Any FVIII that would be administered forth with VEYVONDI should be a authentic FVIII product. A aggregate with a FVIII artefact absolute VWF would affectation an added accident of thrombotic events.
Neutralizing Antibodies (Inhibitors)Patients with VWD, abnormally Type 3, may advance neutralising antibodies (inhibitors) to von Willebrand factor. If the accepted claret levels of (VWF:RCo) are not attained, or if bleeding is not controlled with an adapted dose, an adapted appraisal should be performed to actuate if a von Willebrand agency inhibitor is present. In patients with aerial levels of anti-VWF antibodies, von Willebrand agency ysis may not be able and added ameliorative options should be considered.
Treatment of VWD patients who accept high-titer bounden antibodies may crave a college dosage to afflicted the bounden antibiotic aftereffect and such patients could be managed clinically by administering of college doses of vonicog alfa based on the PK abstracts for anniversary abandoned patient.
The best accepted ancillary furnishings are dizziness, vertigo, dysgeusia, tremor, tachycardia, abysmal venous thrombosis, hypertension, hot flush, ing, nausea, generalised pruritus, discomfort, beverage armpit paraesthesia, electrocardiogram T beachcomber antagonism and added affection rate.
In ytic trials, one case of clinically asymptomatic abysmal attitude occlusion (DVT) was appear for a accountable in the anaplasty abstraction who had absolute hip replacement. In addition, one post-marketing case of DVT has been appear spontaneously for an aged patient.
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NOTES TO EDITORS
Shire is the all-around biotechnology baton confined patients with attenuate diseases and specialized conditions. We seek to advance boundaries through advertent and carrying new possibilities for accommodating communities who generally accept few or no added champions. Relentlessly on the bend of what’s next, we are consecutive innovators with a assorted activity alms beginning cerebration and new hope. Confined patients and partnering with healthcare communities in over 100 countries, we strive to be allotment of the absolute accommodating adventure to accredit beforehand diagnosis, accession standards of care, advance admission to treatment, and abutment patients. Our assorted portfolio of ameliorative areas includes Immunology, Hematology, Genetic Diseases, Neuroscience, Internal Medicine, and Ophthalmics. Championing patients is our alarm to activity – it brings the befalling – and albatross – to change people’s lives.
Statements included herein that are not actual facts, including after limitation statements apropos approaching strategy, plans, objectives, expectations and intentions, projected revenues, the advancing timing of ytic trials and approvals for, and the bartering abeyant of, inline or activity products, are advanced statements. Such advanced statements absorb a cardinal of risks and uncertainties and are accountable to change at any time. In the accident such risks or uncertainties materialize, Shire’s after-effects could be materially abnormally affected. The risks and uncertainties include, but are not bound to, the following:
a added account and description of risks, uncertainties and added affairs can be begin in Shire’s best contempo Annual Report on Anatomy 10-K and in Shire’s consecutive Quarterly Letters on Anatomy 10-Q, in anniversary case including those risks categorical in “ITEM1A: Accident Factors”, and in Shire’s consecutive letters on Anatomy 8-K and added Securities and Barter Commission filings, all of which are accessible on Shire’s website.
All advanced statements attributable to us or any being acting on our account are especially able in their absoluteness by this cautionary statement. Readers are cautioned not to abode disproportionate assurance on these advanced statements that allege abandoned as of the date hereof. Except to the admeasurement contrarily appropriate by applicative law, we do not undertake any obligation to amend or alter advanced statements, whether as a aftereffect of new information, approaching contest or otherwise.
1 European Commission. Veyvondi Summary of Artefact Characteristics. Accessible at: http://ec.europa.eu/health/documents/community-register/2018/20180831141871/anx_141871_en.pdf
2 Recombinant von Willebrand Factor; rVWF; vonicog alfa; BAX 111. Analytic Overview. May 2017.
3 World Federation of Hemophilia. What is von Willebrand ache (VWD)? Accessible at: www.wfh.org/en/page.aspx?pid=673.
4 European Medicines Agency. EU/3/10/814. Accessible at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/orphans/2010/12/human_orphan_000865.jsp&mid=WC0b01ac058001d12b.
5 National Hemophilia Foundation. Von Willebrand Disease. Accessible at: https://www.hemophilia.org/Bleeding-Disorders/Types-of-Bleeding-Disorders/Von-Willebrand-Disease.
6 National Organization for Attenuate Disorders. Von Willebrand Disease. Accessible at: https://rarediseases.org/rare-diseases/von-willebrand-disease/.
7 Attenuate Diseases. Von Willebrand Disease. Accessible at: https://rarediseases.org/rare-diseases/von-willebrand-disease/.
8 Kujovic, J.L. Von Willebrand’s Ache and Menorrhagia: Prevalence, Diagnosis, and Management. Accessible at: https://onlinelibrary.wiley.com/doi/pdf/10.1002/ajh.20372.
9 Verma, A., Yaish, H. et al. Type 3 Von Willebrand Ache with Alloantibodies and Its Challenging Administering During Episode of Bleeding. Accessible at: http://www.bloodjournal.org/content/116/21/1405.
10 National Hemophilia Foundation. “VWD Summit Highlights.” HEMAWARE website. https://hemaware.org/story/vwd-summit-highights.
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