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Tudorza reduces exacerbations and demonstrates cardiovascular safety in COPD patients

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må, dec 04, 2017 08:04 CET

Phase IV ASCENT trial meets primary endpoints in COPD patients 
with cardiovascular risk factors

Findings support supplemental New Drug Application (sNDA)

AstraZeneca today announced positive top-line results of the Phase IV ASCENT trial for
Tudorza

Pressair
(aclidinium bromide 400 μg, twice-daily), a long-acting muscarinic antagonist (LAMA), in patients with moderate to very severe chronic obstructive pulmonary disease (COPD), with a history of cardiovascular disease and/or significant cardiovascular risk factors.

When added to background therapy,
Tudorza
met the primary efficacy endpoint, demonstrating a statistically significant reduction in the annual rate of moderate or severe COPD exacerbations compared to placebo.
Tudorza
also met the primary safety endpoint, demonstrating time to first major adverse cardiovascular event (MACE) comparable to placebo. In the trial patients were randomised to receive
Tudorza
or placebo.

Tudorza
, also marketed as
Eklira
and
Bretaris
, is available in more than 50 countries. Aclidinium bromide is also the LAMA in
Duaklir
(aclidinium bromide/formoterol fumarate), which is marketed in more than 30 countries and under development for the US and China.

Steve Lewington, Global Medicine Leader, Respiratory, AstraZeneca, said: “The ASCENT data demonstrate that
Tudorza,
when added to background therapy, reduces exacerbation rates in patients with cardiovascular disease or risk factors and adds to the established efficacy and safety profile of aclidinium bromide. Based on these results, AstraZeneca plans to submit an sNDA for an expanded label for
Tudorza
in the US.”

Dr. Kenneth Chapman, Professor of Medicine in the Faculty of Medicine University of Toronto, said: “Cardiovascular disease is the most common comorbidity for patients living with COPD. It is therefore very encouraging to see that aclidinium is effective in reducing exacerbation rates with no increase in cardiovascular events in this at-risk patient population.”

ASCENT is a post-marketing requirement (PMR) trial requested by the US Food and Drug Administration (FDA) to evaluate MACE for up to three years with aclidinium bromide. The trial included more than 3,600 patients from Canada and the US. The safety and tolerability profile of
Tudorza
was consistent with its label.

A full analysis of the data is ongoing. Full results will be provided to the US FDA and presented at a forthcoming medical meeting. AstraZeneca plans to submit an sNDA for an expanded
Tudorza
label.

In April 2017, AstraZeneca entered a strategic collaboration with Circassia Pharmaceuticals for the development and commercialisation of
Tudorza
and
Duaklir
(aclidinium bromide/formoterol) in the US.

– ENDS –

NOTES TO EDITORS

About COPD

COPD is a progressive disease associated mainly with tobacco smoking, air pollution or occupational exposure, which can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness. It affects an estimated 329 million people worldwide and is predicted to be the third leading cause of death by 2020. Improving lung function, reducing exacerbations and managing daily symptoms such as breathlessness are important to the management of COPD. Cardiovascular comorbidities are one of the most frequent systemic manifestations that have the biggest effect on patients with COPD, contributing substantially to disease progression, clinical outcomes, mortality and resource use.

About ASCENT

ASCENT is a double-blind, randomised, placebo-controlled, parallel-group, Phase IV trial to evaluate the effect of
Tudorza
on time to first MACE and reduction of moderate or severe exacerbations in patients with moderate to very severe COPD. Both
Tudorza
and placebo were administered twice-daily (morning and evening) via the
Pressair
dry-powder inhaler (DPI). Patients in the trial also continued background therapy including maintenance and reliever medications and excluding anticholinergics. The rate of moderate or severe COPD exacerbations was measured per patient per year during the first year of treatment. MACE is a composite measure of the total of cardiovascular death, non-fatal heart attack and non-fatal stroke. ASCENT was conducted in 3,630 patients and concluded after at least 122 patients had experienced an adjudicated MACE.

About
Tudorza

Tudorza
(aclidinium bromide) is a LAMA delivered through the
Pressair
DPI.
Tudorza
was approved in the US in 2012 for the long-term maintenance treatment of bronchospasm associated with COPD, including chronic bronchitis and emphysema. Aclidinium bromide was approved in Europe in 2012 for the maintenance treatment of COPD. Globally, it is now available to patients in more than 50 countries under the
Tudorza, Eklira
and
Bretaris
brand names. Aclidinium bromide is the LAMA in
Duaklir
(aclidinium bromide/formoterol fumarate)
,
which is approved in more than 30 countries and under development for the US and China. 

About Circassia

In April 2017, AstraZeneca entered a strategic collaboration with Circassia Pharmaceuticals for the development and commercialisation of
Tudorza
and
Duaklir
in the US. Under the terms of the collaboration Circassia was granted the rights to
Duaklir
in the US. Circassia is also leading the promotion of
Tudorza
in the US and was granted an option to gain the full commercial rights in the future. AstraZeneca has received a minority equity stake in Circassia. AstraZeneca will complete ongoing development activities and continue to manufacture and supply both medicines. AstraZeneca will receive $100 million at the approval of
Duaklir
in the US, or 30 June 2019, whichever is earliest, and Circassia will pay AstraZeneca tiered percentage royalties on potential future US sales of
Duaklir
.

About AstraZeneca in Respiratory Disease

Respiratory disease is one of AstraZeneca’s main therapy areas, and the Company has a growing portfolio of medicines that reached more than 18 million patients in 2016. AstraZeneca’s aim is to transform asthma and COPD treatment through inhaled combinations at the core of care, biologics for the unmet needs of specific patient populations, and scientific advancements in disease modification.

The Company is building on a 40-year heritage in respiratory disease and AstraZeneca’s capability in inhalation technology spans both pMDIs and dry powder inhalers, as well as the innovative Aerosphere Delivery Technology. The company’s biologics include
Fasenra
(anti-eosinophil, anti-IL-5Rɑ), which is now approved in the US, received a positive CHMP opinion in the EU and is under regulatory review in Japan, tralokinumab (anti-IL-13), which has completed Phase III trials, and tezepelumab (anti-TSLP), which successfully achieved its Phase IIb primary and secondary endpoints. AstraZeneca’s research is focused on addressing underlying disease drivers focusing on the lung epithelium, lung immunity and lung regeneration.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas – Oncology, Cardiovascular Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

For more information, please visit
www.astrazeneca.com
and follow us on Twitter @AstraZeneca.

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Syncro Group announces strategic partnership with Ninetone Group AB

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Syncro Group, which offers the AI platform Collabs for effective and transparent influencer marketing, today announces that the company has signed a strategic partnership with Ninetone Group AB, a premier influencer marketing agency. This partnership will utilize Collabs’ innovative platform to enhance Ninetone’s operational efficiency and open new revenue streams by expanding brand collaborations for their talents.

“We are thrilled to partner with Ninetone, as they embody the type of serious market actor Collabs was designed to support,” said Ebbe Damm, CEO of Syncro Group.

 

“With Collabs, we can not only streamline our existing operations but also expand into new areas by effectively matching our creators with ideal brand opportunities,” said Patrik Frisk, CEO of Ninetone Group.

 

The collaboration will begin in May 2024, with both companies actively working to integrate and optimize their joint operations.

 

Key Partnership Objectives:

  1. CRM Integration: Ninetone will leverage Collabs as a Customer Relationship Management (CRM) tool to manage communications and collaborations more efficiently for the talents they represent.

  2. Commercial Engagements Expansion: Utilizing Collabs’ infrastructure, Ninetone will streamline its engagements with brands, enhancing its ability to connect creators not only signed by the agency but also those outside its exclusive roster. This approach will allow Ninetone to explore new revenue opportunities by finding more relevant brand partnerships for their creators.

 

For further information, please contact:

Ebbe Damm, CEO, Syncro Group
Phone:  +46 70 546 46 00

Email:   ebbe.damm@syncro.group

 

About Syncro Group

Syncro enables collaboration between people and brands through innovative tech. Syncro has offices in Sweden and Denmark, with headquarter in Stockholm.

 

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Syncro tecknar strategiskt partnerskap med Ninetone Group AB

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Syncro Group, som erbjuder AI-plattformen Collabs för effektiv och transparent influencer marketing, meddelar idag att bolaget tecknat ett strategiskt partnerskap med Ninetone Group AB, en ledande influencer marketing-byrå. Detta partnerskap kommer att använda Collabs innovativa plattform för att förbättra Ninetones operativa effektivitet och öppna nya intäktsströmmar genom att utöka varumärkessamarbeten för deras talanger.

”Vi är glada över att samarbeta med Ninetone, eftersom de förkroppsligar den typ av seriösa marknadsaktörer som Collabs är designade att stödja”, säger Ebbe Damm, vd för Syncro Group.

 

”Med Collabs kan vi inte bara effektivisera vår befintliga verksamhet utan också expandera till nya områden genom att effektivt matcha våra kreatörer med idealiska varumärkesmöjligheter”, säger Patrik Frisk, vd för Ninetone Group.

 

Samarbetet påbörjas i maj, 2024, och bägge företag aktivt arbetar för att integrera och optimera sin gemensamma verksamhet.

 

Huvudmål för partnerskapet:

  1. CRM-integration: Ninetone kommer att utnyttja Collabs som ett CRM-verktyg (Customer Relationship Management) för att hantera kommunikation och samarbeten mer effektivt för de kreatörer som de representerar.

  2. Expansion av kommersiella engagemang: Genom att använda Collabs infrastruktur kommer Ninetone att effektivisera sina engagemang med varumärken, vilket förbättrar Nintones förmåga att koppla samman kreatörer som inte bara har kontrakt med byrån utan även externa kreatörer. Detta tillvägagångssätt gör det möjligt för Ninetone att utforska nya intäktsmöjligheter genom att hitta mer relevanta varumärkespartnerskap för sina kreatörer.

 

För ytterligare information, vänligen kontakta:

Ebbe Damm, VD, Syncro Group
Telefon:  070 546 46 00

E-post:  ebbe.damm@syncro.group

 

Om Syncro Group

Syncro Group AB (publ) är ett noterat bolag på Spotlight Stock Market under SYNC B med en egenutvecklad unik AI-plattform inom influencer marketing som är en del av att forma den nya digitala ekonomin och möjliggör samarbete mellan människor och varumärken – via tech. Syncro har kontor i Sverige och Danmark, med huvudkontor i Stockholm. För mer information, gå in på www.syncro.group.

 

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Återköp av aktier i Hoist Finance under vecka 16, 2024

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Hoist Finance AB (publ) (LEI-kod: 549300NPK3FB2BEL4D08) (”Hoist Finance”) har under perioden 15 april 2024 – 19 april 2024 återköpt sammanlagt 185 000 egna aktier (ISIN: SE0006887063) inom ramen för det återköpsprogram som styrelsen infört.

Återköpen är en del av det återköpsprogram om högst 10 procent av samtliga aktier i bolaget till ett sammanlagt belopp om högst 100 000 000 SEK som Hoist Finance offentliggjorde den 6 februari 2024. Återköpsprogrammet, som löper under perioden från och med den 8 februari 2024 intill årsstämman den 7 maj 2024, genomförs i enlighet med EU:s marknadsmissbruksförordning (EU) nr 596/2014 (”MAR”) och Kommissionens delegerade förordning (EU) nr 2016/1052 (”Safe Harbour-förordningen”). Syftet med återköpsprogrammet är att justera bolagets kapitalstruktur och därigenom bidra till att skapa ett ökat värde för Hoist Finance aktieägare. Avsikten är att de aktier som återköps ska dras in genom beslut vid kommande bolagsstämmor.

Aktier i Hoist Finance har återköpts enligt följande:

Datum

Aggregerad daglig volym (antal aktier)

Viktat genomsnittspris per dag (SEK)

Totalt dagligt transaktionsvärde (SEK)

15 april 2024

40 000

49,6061

1 984 244

16 april 2024

40 000

48,9543

1 958 172

17 april 2024

40 000

50,5608

2 022 432

18 april 2024

35 000

50,1106

1 753 871

19 april 2024

30 000

50,3204

1 509 612

Totalt ackumulerat under vecka 16 2024

185 000

 

9 228 331

Totalt ackumulerat under återköpsprogrammet

1 880 022

 

88 589 397

 

Samtliga förvärv har genomförts på Nasdaq Stockholm av Carnegie Investment Bank AB (publ) för Hoist Finance räkning.

Efter ovanstående förvärv uppgår Hoist Finance innehav av egna aktier per den 19 april 2024 till 1 880 022. Det totala antalet aktier i Hoist Finance, inklusive de egna aktierna, uppgår till 89 303 000 och antalet utestående aktier, exklusive de egna aktierna, uppgår till 87 422 978.

Fullständig information om de genomförda transaktionerna enligt artikel 5.3 i MAR och artikel 2.3 i Safe Harbour-förordningen biläggs detta pressmeddelande.

För vidare information vänligen kontakta:

Christian Wallentin, CFO och Vice VD

ir@hoistfinance.com
+46 8 55 51 77 90

Om Hoist Finance

Hoist Finance är en förvaltare specialiserad på förfallna lån. I över 25 år har vi fokuserat på att investera i och förvalta skuldportföljer. Vi är en partner till internationella banker och finansiella institut i hela Europa och förvärvar portföljer av förfallna lån. Vi är också en partner till privatpersoner och små och medelstora företag som befinner sig i en skuldsituation och vi skapar långsiktigt hållbara återbetalningsplaner som gör det möjligt för dem att omvandla förfallna skulder till skulder som betalas av. Vi finns på 13 marknader i Europa och aktierna är noterade på Nasdaq Stockholm. För mer information, besök hoistfinance.com.

 

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