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- 12/01/18--08:56: _India vs Australia:...
- 12/01/18--09:01: _Initial Data from S...
- 12/02/18--04:42: _No, Prime Minister,...
- 12/02/18--05:08: _How a zombie case c...
- 12/02/18--05:23: _McMahon snubs Walla...
- 12/02/18--05:18: _Francesca Hung, Mis...
- 12/02/18--05:08: _Amnesty calls grow ...
- 12/02/18--05:17: _Australia's craft s...
- 12/02/18--05:37: _Once we were the la...
- 12/02/18--05:47: _Pro footballer who ...
- 12/02/18--06:01: _Zogenix Presents Po...
- 12/02/18--07:27: _Lolly Willoughby! H...
- 12/02/18--09:09: _I'm A Celebrity: Ge...
- 12/02/18--20:21: _Bellamy’s Australia...
- 12/02/18--20:44: _Australia: Another ...
- 12/02/18--21:02: _Barty and de Minaur...
- 12/02/18--20:59: _Australia: Governme...
- 12/02/18--21:06: _Further information...
- 12/02/18--21:07: _Australia: Why is g...
- 12/02/18--21:10: _Australia: Foodora ...
- 12/02/18--04:42: No, Prime Minister, an integrity commission is not a 'fringe issue'
- 12/02/18--05:23: McMahon snubs Wallabies in another blow to Cheika's World Cup tilt
- 12/02/18--05:08: Amnesty calls grow amid rampant use of black market farm labour
- 12/02/18--05:37: Once we were the laughing stock of the world, but now its worse
- 12/02/18--20:44: Australia: Another soft month for dwelling approvals - Westpac
- 12/02/18--21:02: Barty and de Minaur facing hot Sydney International fields
- 12/02/18--21:06: Further information on the rights issue
India skipper Virat Kohli says he is now more assured of himself than the last tour here and does not feel the need to get involved in any confrontation with the Australians in the upcoming Test series.
Reported by DNA 10 minutes ago.
*Initial Data from Shire Collaboration Identifies Key Biomarkers That Affect Bleeding Patterns, Response to Treatment for Hemophilia A*
Data from iPATH Collaboration to be presented at the American Society of Hematology's 60^th Annual Meeting
*Cambridge, Mass. - December 1, 2018* - Shire plc (LSE: SHP, NASDAQ: SHPG), RCSI (The Royal College of Surgeons in Ireland), and Science Foundation Ireland (SFI), in collaboration with the Irish Haemophilia Society, today presented new data, from the novel clinical study called The Irish Personalised Approach to the Treatment of Haemophilia (iPATH), illustrating key drivers to implementing truly personalized care for people with hemophilia A during the 60^th American Society of Hematology (ASH) Annual Meeting in San Diego, California.
Standard of care treatment for hemophilia A currently is prophylaxis with recombinant factor VIII (rFVIII) replacement therapy, an approach designed to minimize bleeding episodes using a weight-based dosing strategy.^1 However, the half-life of factor VIII may vary markedly between individual patients, meaning some patients experience FVIII levels too low for sufficient protection from bleeds much earlier than others.^2 As a result, even with prophylactic treatment, some people continue to experience bleeding events.^2 This approach can be improved by integrating FVIII pharmacokinetics (PK) to produce an individualized treatment regimen.^2
In a poster (Poster #1190) presented today at the ASH meeting, captured as part of the ongoing iPATH study, researchers found important biomarkers that influence bleeding risk in people with hemophilia, including a link between type O blood group and shorter half-life, and a link between age and longer half-life.^2 The study also supports the feasibility of using limited, 2-sample PK profiling to capture accurate PK curves that can then be utilized to guide individualized, PK-guided prophylaxis.^2 The 2-sample PK profiling was done through the use of myPKFiT^TM for ADVATE^® [Antihemophilic Factor (Recombinant)], a free web-based, Rx software for use with hemophilia A patients 16 and older weighing at least 45 kilograms and treated with ADVATE.^3
The four-year iPATH program is open to all Irish children and adults with moderate or severe hemophilia.^4 The study is supported by a Science Foundation Ireland (SFI) Strategic Partnership initiative and involves scientific researchers in RCSI, Trinity College Dublin (TCD) and Shire.^4 The iPATH partnership includes the Irish Haemophilia Society, and clinical researchers based in St James's Hospital Dublin, Our Lady's Children's Hospital Crumlin, Cork University Hospital and University Hospital Galway.^4
"This research offers important insights about how we can apply personalized treatment planning for hemophilia as part of routine clinical care. By understanding the link between clinical parameters such as age or blood type, we can appreciate differences in PK and thus response to prophylactic care," said study lead Professor James O'Donnell, Director of the Irish Centre for Vascular Biology, RCSI, and a Consultant Hematologist at the National Coagulation Center in St James' Hospital, Dublin. "Importantly, this also supports the accuracy of simplified, 2-sample PK profiling, giving clinicians confidence that they can generate a reliable PK curve to guide individualized PK-guided dosing and minimize bleeds for their patients."
"Every single bleed matters for people with hemophilia. Particularly if a joint or muscle bleed remains untreated, each one can lead to other long term consequences. So a core objective of this research is to better understand the specific characteristics of individuals that affect how and when they are likely to bleed," said Peter Turecek, Senior Director, Global Medical Affairs, Shire. "If we can individualize treatment schedules by estimating PK curves through myPKFiT for ADVATE, we can further personalize treatment with the goal of getting as close as possible to zero bleeds."
"I am very pleased to see such promising research results arising from the iPATH collaboration, a partnership that will positively impact treatment for patients of hemophilia around the world," said Professor Mark Ferguson, Director General of Science Foundation Ireland and Chief Scientific Adviser to the Government of Ireland. "Improving medical approaches to this debilitating disease is crucial, and at Science Foundation Ireland we recognize the importance of funding scientific research that helps us to achieve that. I am confident that this research will provide further insights which will inform best practice for the future of hemophilia treatment, and I look forward to our continued work with Shire and RCSI."
*About the iPATH Collaboration*
The Irish Personalised Approach to the Treatment of Haemophilia (iPATH) study is an ongoing collaboration investigating new personalized treatment approaches by tailoring care based on the needs of individual patients.^4 Patients in Ireland with hemophilia are registered at a single National Coagulation Centre where data on the use of factor concentrates and bleeding rates have already been collected.^4 This provides a unique opportunity to conduct a hemophilia study aimed at better understanding the underlying biology of hemophilia with the goal of developing a personalized approach to hemophilia care that can then potentially be extended to the global hemophilia community.^4 This clinical study approach also has the potential to be adapted for other diseases.^4
*myPKFiT for ADVATE Indications for Use*
The myPKFiT software is intended for use by licensed healthcare professionals (HCPs) who are familiar with hemophilia care. The myPKFiT software can be used to generate ADVATE dosage amount and frequency recommendations for routine prophylaxis for an individual patient 16 years of age and older and body weight of 45 kg or greater, using that patient's age and body weight information and local laboratory FVIII one-stage clotting activity measurements of sparse samples collected from that patient.^3
A minimum of two sparse sampling points are required at the recommended 3-4 hours (± 30 minutes) and at 24-32 hours (±1 hour) post-infusion.
HCPs will also be able to evaluate various prophylaxis dose regimens tailored to an individual patient's needs and treatment plan.
The software output may be used to guide decisions on appropriate ADVATE dose and infusion intervals to maintain FVIII activity levels at or above a user specified minimum FVIII activity level between 1% to 3% above natural baseline for an individual patient in accordance with the FDA-approved dosing recommendations provided in the ADVATE Prescribing Information (PI).
myPKFiT should only be used to evaluate prophylactic dosing regimens for hemophilia A patients treated with ADVATE, as per the ADVATE Prescribing Information (PI).
myPKFiT for ADVATE is not indicated for the treatment of von Willebrand disease. myPKFiT for ADVATE should not be used for patients who have developed neutralizing antibody (inhibitor) to FVIII products.
*myPKFiT for ADVATE software is Rx Only. For safe and proper use of the myPKFiT for ADVATE software, please refer to the complete instructions for use in the User Manual.*
*About ADVATE *
ADVATE is a full-length (derived from the complete FVIII gene) recombinant FVIII product that is processed without any blood-based additives.^5
ADVATE is currently approved in 69 countries worldwide, including the United States, Canada, 28 countries in the European Union, Algeria, Argentina, Australia, Brazil, Brunei, Chile, China, Colombia, Ecuador, Hong Kong, Iceland, India, Iraq, Israel, Japan, Kuwait, Macau, Malaysia, Mexico, Morocco, New Zealand, Norway, Panama, Puerto Rico, Qatar, Russia, Saudi Arabia, Serbia, Singapore, South Korea, Suriname, Switzerland, Taiwan, Tunisia, Turkey, Ukraine, Uruguay, and Venezuela.
*ADVATE [Antihemophilic Factor (Recombinant)] Important Information*
ADVATE is a recombinant antihemophilic factor indicated for use in children and adults with hemophilia A (congenital factor VIII deficiency) for:
· Control and prevention of bleeding episodes.
· Perioperative management.
· Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
ADVATE is not indicated for the treatment of von Willebrand disease.
*DETAILED IMPORTANT RISK INFORMATION*
Patients who have life-threatening hypersensitivity reactions, including anaphylaxis, to mouse or hamster protein or other constituents of the product.
*WARNINGS & PRECAUTIONS*
Allergic-type hypersensitivity reactions, including anaphylaxis, have been reported with ADVATE. Symptoms include dizziness, paresthesia, rash, flushing, facial swelling, urticaria, dyspnea, pruritus, and vomiting. Discontinue ADVATE if hypersensitivity symptoms occur and administer appropriate emergency treatment.
Neutralizing antibodies (inhibitors) have been reported following administration of ADVATE predominantly in previously untreated patients (PUPs) and previously minimally treated patients (MTPs). Monitor all patients for the development of factor VIII inhibitors by appropriate clinical observation and laboratory testing. If expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an expected dose, perform an assay that measures factor VIII inhibitor concentration.
· Serious adverse reactions seen with ADVATE are hypersensitivity reactions, including anaphylaxis, and the development of high-titer inhibitors necessitating alternative treatments to factor VIII.
· The most common adverse reactions observed in clinical trials (>5% of subjects) were pyrexia, headache, cough, nasopharyngitis, arthralgia, vomiting, upper respiratory tract infection, limb injury, nasal congestion, and diarrhea*.*
*Please see accompanying ADVATE full Prescribing Information available at *http://www.shirecontent.com/PI/PDFs/ADVATE_USA_ENG.pdf * *
For more information on ADVATE, please visit www.ADVATE.com.
1. Valentino, LA et. Al. A randomized comparison of two prophylaxis regimens and a paired comparison of on-demand and prophylaxis treatments in hemophilia A management. Journal of Thrombosis and Haemostasis. 2012 Mar; 10(3): 359-367.
2. Lavin, M et al. The Irish personalized approach to the treatment of haemophilia (iPATH) - determinants of inter-individual variation in FVIII pharmacokinetics, poster #1190. Presented at American Society of Hematology Annual Meeting 2018 on December 1st.
3. myPKFiT Device User Manual. Baxter Healthcare Corporation; 2015.
4. Shire. Newsroom. Novel clinical study collaboration announced designed to improve clinical care for hemophilia patients through innovative personalized treatment. Accessible at https://www.shire.com/en/newsroom/2017/december/5c9igj. Accessed October 2018.
5. ADVATE Prescribing Information.
*For further information please contact:*
Christoph Brackmann email@example.com +41 41 288 4129
Sun Kim firstname.lastname@example.org +1 617 588 8175
Scott Burrows email@example.com +41 41 288 4195
Katie Joyce firstname.lastname@example.org +1 781 482 2779
Linda Calandra email@example.com +1 917 697 7543
*NOTES TO EDITORS*
Shire is the global biotechnology leader serving patients with rare diseases and specialized conditions. We seek to push boundaries through discovering and delivering new possibilities for patient communities who often have few or no other champions. Relentlessly on the edge of what's next, we are serial innovators with a diverse pipeline offering fresh thinking and new hope. Serving patients and partnering with healthcare communities in over 100 countries, we strive to be part of the entire patient journey to enable earlier diagnosis, raise standards of care, accelerate access to treatment, and support patients. Our diverse portfolio of therapeutic areas includes Immunology, Hematology, Genetic Diseases, Neuroscience, Internal Medicine, and Ophthalmics.
Championing patients is our call to action - it brings the opportunity - and responsibility - to change people's lives.
Statements included herein that are not historical facts, including without limitation statements concerning future strategy, plans, objectives, expectations and intentions, projected revenues, the anticipated timing of clinical trials and approvals for, and the commercial potential of, inline or pipeline products, are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire's results could be materially adversely affected. The risks and uncertainties include, but are not limited to, the following:
· Shire's products may not be a commercial success;
· increased pricing pressures and limits on patient access as a result of governmental regulations and market developments may affect Shire's future revenues, financial condition and results of operations;
· Shire depends on third parties to supply certain inputs and services critical to its operations including certain inputs, services and ingredients critical to its manufacturing processes. Any disruption to the supply chain for any of Shire's products may result in Shire being unable to continue marketing or developing a product or may result in Shire being unable to do so on a commercially viable basis for some period of time;
· the manufacture of Shire's products is subject to extensive oversight by various regulatory agencies. Regulatory approvals or interventions associated with changes to manufacturing sites, ingredients or manufacturing processes could lead to, among other things, significant delays, an increase in operating costs, lost product sales, an interruption of research activities or the delay of new product launches;
· the nature of producing plasma-based therapies may prevent Shire from timely responding to market forces and effectively managing its production capacity;
· Shire has a portfolio of products in various stages of research and development. The successful development of these products is highly uncertain and requires significant expenditures and time, and there is no guarantee that these products will receive regulatory approval;
· the actions of certain customers could affect Shire's ability to sell or market products profitably. Fluctuations in buying or distribution patterns by such customers can adversely affect Shire's revenues, financial conditions or results of operations;
· failure to comply with laws and regulations governing the sales and marketing of its products could materially impact Shire's revenues and profitability;
· Shire's products and product candidates face substantial competition in the product markets in which it operates, including competition from generics;
· Shire's patented products are subject to significant competition from generics;
· adverse outcomes in legal matters, tax audits and other disputes, including Shire's ability to enforce and defend patents and other intellectual property rights required for its business, could have a material adverse effect on Shire's revenues, financial condition or results of operations;
· Shire may fail to obtain, maintain, enforce or defend the intellectual property rights required to conduct its business;
· Shire faces intense competition for highly qualified personnel from other companies and organizations;
· failure to successfully execute or attain strategic objectives from Shire's acquisitions and growth strategy may adversely affect Shire's financial condition and results of operations;
· Shire's growth strategy depends in part upon its ability to expand its product portfolio through external collaborations, which, if unsuccessful, may adversely affect the development and sale of its products;
· a slowdown of global economic growth, or economic instability of countries in which Shire does business, could have negative consequences for Shire's business and increase the risk of non-payment by Shire's customers;
· changes in foreign currency exchange rates and interest rates could have a material adverse effect on Shire's operating results and liquidity;
· Shire is subject to evolving and complex tax laws, which may result in additional liabilities that may adversely affect Shire's financial condition or results of operations;
· if a marketed product fails to work effectively or causes adverse side effects, this could result in damage to Shire's reputation, the withdrawal of the product and legal action against Shire;
· Shire is dependent on information technology and its systems and infrastructure face certain risks, including from service disruptions, the loss of sensitive or confidential information, cyber-attacks and other security breaches or data leakages that could have a material adverse effect on Shire's revenues, financial condition or results of operations;
· Shire faces risks relating to the expected exit of the United Kingdom from the European Union;
· Shire incurred substantial additional indebtedness to finance the Baxalta acquisition, which has increased its borrowing costs and may decrease its business flexibility;
· the potential uncertainty among our employees, customers, suppliers, and other business partners resulting from the announcement by Takeda Pharmaceutical Company Limited on May 8, 2018 of a recommended offer for Shire under the UK Takeover Code; and
a further list and description of risks, uncertainties and other matters can be found in Shire's most recent Annual Report on Form 10-K and in Shire's subsequent Quarterly Reports on Form 10-Q, in each case including those risks outlined in "ITEM1A: Risk Factors", and in Shire's subsequent reports on Form 8-K and other Securities and Exchange Commission filings, all of which are available on Shire's website.
All forward-looking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by this cautionary statement. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof. Except to the extent otherwise required by applicable law, we do not undertake any obligation to update or revise forward-looking statements, whether as a result of new information, future events or otherwise.
RCSI is ranked among the top 250 (top 2%) of universities worldwide in the Times Higher Education World University Rankings (2019) and its research is ranked first in Ireland for citations. It is an international not-for-profit health sciences institution, with its headquarters in Dublin, focused on education and research to drive improvements in human health worldwide. RCSI has been awarded Athena SWAN Bronze accreditation for positive gender practice in higher education.
*About Science Foundation Ireland *
Science Foundation Ireland funds oriented basic and applied research in the areas of science, technology, engineering, and mathematics (STEM) which promotes and assists the development and competitiveness of industry, enterprise and employment in Ireland. The Foundation also promotes and supports the study of and engagement with STEM and promotes an awareness and understanding of the value of STEM to society and, in particular, to the growth of the economy. See www.sfi.ie.
Science Foundation Ireland runs the #BelieveInScience campaign to promote the potential that science and discovery offer Ireland, today and in tomorrow's world. The #BelieveInScience campaign sees Science Foundation Ireland work in partnership with the Irish research community to share a mutual passion for science with the public; to promote an understanding of the ability of science, technology, engineering and maths (STEM) to create positive change in the world and to drive a sustainable economy in Ireland. Reported by GlobeNewswire 5 minutes ago.
If governments of whatever complexion are to overcome a trust deficit in Australia, individuals and institutions at a national level need to be subject to subpoena power scrutiny and a requirement they testify under oath.
Reported by Brisbane Times 5 hours ago.
The Chelmsford deep sleep scandal happened in the 1960s and '70s. Now a publisher is being asked to prove the truth of issues when most players are long dead.
Reported by Brisbane Times 4 hours ago.
The abrasive back-rower and former favourite of Michael Cheika has opted not to return to Australia in the lead-up to the 2019 World Cup.
Reported by Brisbane Times 4 hours ago.
Feeling like an outsider in a community then lacking in diversity, and burdened by perfectionism, a girl with 'everything' became seriously depressed.
Reported by Brisbane Times 4 hours ago.
Unlike most farmers, Emma Germano is prepared to say openly what others won’t: that the use of undocumented workers on Australia’s farms is rampant.
Reported by Brisbane Times 4 hours ago.
Sales of Australian craft spirits are soaring as gin, whisky, vodka and liqueur drinkers turn away from the big name brands to local, independent producers.
Reported by Brisbane Times 4 hours ago.
At first the world laughed at Australia's political instability, but more serious consequences are emerging as international summit season comes to an end.
Reported by Brisbane Times 4 hours ago.
Hakeem Ali Mohamed Ali AlAraibi has been living and playing in Australia since fleeing his homeland after being tortured
Reported by Independent 3 hours ago.
Data Presented During Late-Breaker Session at 72^nd American Epilepsy Society Annual Meeting
Additional New Analyses Underscore Psychosocial Burden on Family
EMERYVILLE, Calif., Dec. 02, 2018 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a pharmaceutical company developing therapies for the treatment of rare diseases, today announced results from a post-hoc analysis of its investigational drug, FINTEPLA^® (ZX008), on caregiver-reported everyday executive function in children and young adults with Dravet syndrome, who participated in the Company’s first pivotal Phase 3 clinical trial, Study 1. These data, as well as results from two analyses assessing the impact of Dravet syndrome on patients’ siblings and caregivers, will be presented during the 72^nd American Epilepsy Society (AES) Annual Meeting taking place in New Orleans. Full posters can be found on www.zogenix.com here.
In Study 1 (poster 2.406), of the 119 total patients in the trial, 77 patients, aged 5-18 years, were assessed using the Behavior Rating Inventory of Executive Function (BRIEF^®) scale. The BRIEF scale was developed to assess everyday executive function in the home and school environments for children and young adults from 5-18 years of age. The data from Study 1 were mapped to the BRIEF^®2 scale, which is a more current, validated version with more stable and sensitive scales for assessing changes related to everyday executive function. Patients were randomized to one of three treatment groups: FINTEPLA 0.8 mg/kg/day (30 mg maximum daily dose; n=28), FINTEPLA 0.2 mg/kg/day (n=24) or placebo (n=25). Using the BRIEF2 scale, Reliable Change Index scores (RCIs) were calculated to evaluate whether changes from baseline to end of study in individual scores were clinically meaningful or were changes greater than expected due to measurement error, practice effects, and other factors, such as age.
Following 14 weeks of treatment, patients treated with FINTEPLA experienced clinically meaningful improvement on the Behavior Regulation and Emotion Regulation Indexes compared with those in the placebo group (p=0.02). A significantly greater proportion of patients in the pooled FINTEPLA treatment group also showed benefit on the Plan/Organize scale of the Cognitive Regulation Index compared with the placebo group (p
“The clinically meaningful impact of FINTEPLA on behavioral and emotional regulation is encouraging, as these are considered the ‘building blocks’ necessary for higher-level cognitive function,” said Gerard A. Gioia, Ph.D., Division Chief, Neuropsychology, Children’s National Health System, Rockville, MD, co-author of the BRIEF and BRIEF2 scales. “Ongoing studies will be important for fully evaluating the longer-term impacts of FINTEPLA treatment on executive function.”
Two other presentations at AES (posters 2.423 and 2.424) include new analyses of data from the Sibling Voices Survey, which was developed by Zogenix to assess the emotional impact of growing up with a sibling with severe childhood epileptic encephalopathies (EE), such as Dravet syndrome and Lennox-Gastaut syndrome. Both analyses involved anonymous sibling and parent respondents representing 107 families of patients with EE, and these new findings again underscore the need to address disease burden on the family in addition to the patient.
· The first analysis evaluated the psychosocial concerns of siblings growing up with a brother or sister with a severe EE. Young siblings (aged 13-17) reported feelings of guilt, resentment, and jealousy toward their sibling. Most adult siblings expressed concern over the psychological/emotional toll of caring for their affected sibling should care transition from their parents to themselves.
· A second analysis compared parental perception to that of siblings on quality of life and mood symptoms. There was a more than two-fold difference between parental perception and siblings’ responses on items regarding “sadness about the sibling’s diagnosis,” “not getting enough attention from mom and dad,” and “how stressed are you over your sibling’s diagnosis.”
*About Study 1**
*The randomized, double blind, placebo controlled, Phase 3 study enrolled 119 patients across sites in the U.S., Canada, Europe and Australia. The median age of patients was 8 years (range, aged 2-18 years). Following a six-week baseline observation period, patients were randomized to one of three treatment groups: FINTEPLA 0.8 mg/kg/day (30 mg maximum daily dose; n=40), FINTEPLA 0.2 mg/kg/day (n=39), and placebo (n=40) in which FINTEPLA or placebo was added to current regimens of antiepileptic drugs. Patients were titrated to their target dose over two weeks and then remained at that fixed dose for 12 weeks. The mean baseline convulsive seizure frequency across the study groups was approximately 40 seizures per month.
As previously reported, Study 1 met its primary objective demonstrating that FINTEPLA, at a dose of 0.8 mg/kg/day, was superior to placebo as adjunctive therapy in the treatment of Dravet syndrome in children and young adults based on change in the frequency of convulsive seizures between the 6-week baseline observation period and the 14-week treatment period (p10% in any treatment group) in Study 1 included diarrhea, vomiting, fatigue, pyrexia, nasopharyngitis, upper respiratory tract infection, fall, weight decreased, decreased appetite, lethargy, seizure and somnolence. Prospective cardiac safety monitoring throughout the study did not identify clinical or echocardiographic evidence of valvular heart disease or pulmonary hypertension in any patient.
Zogenix is committed to developing and commercializing transformative therapies to improve the lives of patients and their families living with rare diseases. For more information, visit www.zogenix.com.
*Forward Looking Statements*
Zogenix cautions you that statements included in this press release or in the poster presentations that are not a description of historical facts are forward-looking statements. Words such as "believes,""anticipates,""plans,""expects,""indicates,""will,""intends,""potential,""suggests,""assuming,""designed" and similar expressions are intended to identify forward-looking statements. These statements include Zogenix’s plans to present data and other posters at AES and the potential efficacy of FINTEPLA (ZX008) and the potential for FINTEPLA to relieve the psychosocial burden of patients with Dravet syndrome or their families. These statements are based on Zogenix’s current beliefs and expectations. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release or in any poster presentation due to the risks and uncertainties inherent in Zogenix's business, including, without limitation: the uncertainties associated with the clinical development and regulatory approval of product candidates such as FINTEPLA; unexpected adverse side effects or inadequate therapeutic efficacy of FINTEPLA that could limit approval and/or commercialization, or that could result in recalls or product liability claims; and other risks described in Zogenix's prior press releases as well as in public periodic filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
Investors: Andrew McDonald
Founding Partner, LifeSci Advisors LLC
646-597-6987 | Andrew@lifesciadvisors.com
Media: Rachel Lipsitz
Public Relations, Syneos Health
858-449-9575 | firstname.lastname@example.org Reported by GlobeNewswire 3 hours ago.
*So what's Holly's secret to success?*
Editorial Use Only
Mandatory Credit: Photo by James Gourley/ITV/REX/Shutterstock (9983660a)
Holly Willoughby and Declan Donnelly
'I'm a Celebrity...Get Me Out of Here!' TV Show, Series 18, Australia - 18 Nov 2018
She’s now one of the highest paid female TV presenters – earning a reported £500k for 21 days co-hosting with …Continue reading »
The post Lolly Willoughby! How This Morning presenter Holly has gone from girl next door to savvy businesswoman appeared first on CelebsNow. Reported by Now 2 hours ago.
Georgia Toffolo has been pictured arriving back in Australia this weekend, but it's not to hand her crown over as per the long-standing tradition of the ITV series.
Reported by MailOnline 4 minutes ago.
The Bellamy's Australia Ltd (ASX:BAL) share price has surged a massive 11% higher on Monday. Is it too late to invest?
Reported by Motley Fool 2 hours ago.
Matthew Hassan, research analyst at Westpac, points out that the Australian dwelling approvals declined 1.5% in October, in line with the consensus forecast but with both the headline and detail a touch better than the Westpac’s expectations.
“Approvals remain locked in a clear downtrend but this month's update eases some of the downside risks that had been emerging around non high rise approvals in particular.”
“Going into the October update we were expecting headline approvals to reconnect with this clear downtrend. Instead the decline is somewhat milder and detail mixed rather than weak.”
“All states recorded declines in October, Vic showing less of a pull back than might have been expected (–2.6%mth, –13.7%yr) given last month's high rise spike; and SA notably weaker (–17%mth, –24.8%yr). Across the other majors: NSW approvals were down –0.5%mth, –16.5%yr; Qld –1.1%mth, –13.3%yr; and WA –0.1%mth, –23.1%yr.”
“Overall, the October approvals report is weak but not quite as weak as we had feared. While the detail eases some of the downside risks to the outlook our view remains that residential building will see a significant 5% decline in 2019.”
Reported by FXstreet.com 2 hours ago.
Australia's top-ranked male and female players will have their work cut out at Homebush in January.
Reported by Brisbane Times 1 hour ago.
Proposed changes increase the thresholds for determining a large proprietary company under the Corporations Act 2001.
Reported by Mondaq 2 hours ago.
Capital increase of the Zur Rose Group
*Further information on the rights issue*
On 29 November 2018, the Zur Rose Group announced the successful completion of its capital increase with gross proceeds of CHF 200 million. Prior to this, on 19 November 2018, the Group had announced in a press release on the terms of the planned capital increase by way of a rights offering that KWE Beteiligungen AG, the largest shareholder holding 14.5 percent of the voting rights, had declared towards the Company that it would exercise all of its subscription rights.
However, the order to exercise its subscription rights, which was duly submitted by KWE Beteiligungen AG to its principal bank which confirmed receipt of the order in writing, was mistakenly not transmitted by KWE Beteiligungen AG’s principal bank to the capital increase banks. Therefore, KWE Beteiligungen AG’s subscription rights were not validly exercised in the rights issue, and no shares were allocated to KWE Beteiligungen AG.
As a result, the 385,714 shares that would have been subscribed by KWE Beteiligungen AG were not included in the total of 889,239 shares subscribed by existing shareholders in the rights issue that was communicated in the press release of 28 November 2018. Accordingly, such shares could not be considered to have been taken-up during the rights exercise period when determining the number of shares available in the International Offering.
KWE Beteiligungen AG has informed the Zur Rose Group that it is promptly seeking a solution with its principal bank. The incident will not have an effect on the settlement and delivery of the shares issued in the offering, scheduled for 4 December 2018, nor will it affect the capital structure of the Zur Rose Group.
*Investors and analyst contact*
Marcel Ziwica, Chief Financial Officer
Email: email@example.com, phone: +41 58 810 11 49
Lisa Lüthi, Head of Corporate Communications
Email: firstname.lastname@example.org, phone: +41 52 724 08 14
*Zur Rose Group*
The Swiss Zur Rose Group is Europe's largest online pharmacy and one of the leading medical wholesalers in Switzerland. With its business model, it offers high-quality, safe and cost-effective pharmaceutical care and thus contributes to reducing healthcare costs. It is also characterized by the continuous further development of digital services in the field of drug management in order to increase therapy safety. The creation of added value and a pronounced patient orientation make the Group an important strategic partner for service providers, cost units and industry.
The Zur Rose Group is internationally present with strong brands, including Germany's best-known pharmacy brand DocMorris. The company employs over 1,000 people at various locations and generated a turnover of CHF 983 million in the 2017 financial year. The shares of Zur Rose Group AG are listed on the SIX Swiss Exchange (securities number 4261528, ISIN CH0042615283, ticker ROSE). The CHF 115 million corporate bond issued in July 2018 is also listed on the SIX Swiss Exchange (securities number 42146044, ISIN CH0421460442, ticker ZRO18). Further information at zurrosegroup.com
This document and the information contained herein are not for distribution in or into (directly or indirectly) the United States, Canada, Australia or Japan or any other jurisdiction in which the distribution or release would be unlawful. This document does not constitute an offer of securities for sale in or into the United States, Canada, Australia or Japan.
This document does not constitute an offer to sell, or a solicitation of an offer to purchase, any securities in the United States. The securities of Zur Rose Group AG to which these materials relate have not been and will not be registered under the United States Securities Act of 1933, as amended (the "Securities Act"), and may not be offered or sold in the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act. There will not be a public offering of securities in the United States. Any sale in the United States of the securities mentioned in this communication will be made solely to “qualified institutional buyers” as defined in, and in reliance on, Rule 144A under the Securities Act.
This document is not an issuance or listing prospectus or a similar document in the sense of article 652a, article 752 and/or article1156 of the Swiss Code of Obligations or articles 27 et seq. of the Listing Rules of the SIX Swiss Exchange and was not reviewed by any competent authority. Any offer of securities of Zur Rose Group AG will be made solely by means of, and on the basis of, an offering memorandum that will contain detailed information about the group and its management as well as risk factors and financial statements. Any person considering the purchase of any securities of Zur Rose Group AG must inform itself independently based solely on such offering memorandum (including any supplement thereto).
This document does not constitute an "offer of securities to the public" within the meaning of Directive 2003/71/EC of the European Union, as amended (the "Prospectus Directive") of the securities referred to herein in any member state of the European Economic Area (the "EEA"). Any offers of the securities referred to in this document to persons in the EEA will be made pursuant to an exemption under the Prospectus Directive, as implemented in member states of the EEA, from the requirement to produce a prospectus for offers of the Securities. In any EEA Member State that has implemented the Prospectus Directive, this document is only addressed to and is only directed at qualified investors in that Member State within the meaning of the Prospectus Directive, i.e., only to investors who can receive the offer without an approved prospectus in such EEA Member State.
In the United Kingdom, this document is only being distributed to and is only directed at persons who (i) are investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (as amended) (the "Order") or (ii) are persons falling within Article 49(2)(a) to (d) of the Order (high net worth companies, unincorporated associations, etc.) (all such persons together being referred to as "Relevant Persons"). This document is directed only at Relevant Persons and must not be acted on or relied on by persons who are not Relevant Persons. Any investment or investment activity to which this document relates is available only to Relevant Persons and will be engaged in only with Relevant Persons.
This communication may contain statements about the future that use words such as, for example, "believe", "assume", "expect" and other similar expressions. Such statements about the future are subject to risks, uncertainties, and other factors, which can cause the true results of the company to differ significantly from that which is expressly or implicitly assumed in these statements. In view of these uncertainties, the reader should not depend on this type of statement about the future. The company gives no undertaking whatever to update such statements regarding the future, or to adapt them to future events or developments. Reported by EQS Group 1 hour ago.
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