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Bulgarian approval of AirFluSal Forspiro

RNS


RNS Number : 2893Z

Vectura Group plc

04 February 2014






Vectura Group plc



Bulgarian Regulatory Authority confirm approval of AirFluSal® Forspiro®





Chippenham, UK - 4 February 2014: Vectura Group plc (LSE: VEC; "Vectura" or "the Company") confirms that our partner, Sandoz, has received Bulgarian marketing authorisation for AirFluSal® Forspiro® (formerly known as VR315), an innovative new inhaler for patients with asthma and chronic obstructive pulmonary disease (COPD).

The product was first approved (and now launched) in Denmark on December 18th, 2013 with subsequent market authorisations received in January 2014 in Germany, Sweden, Hungary and Romania. The new product offers the proven combination of salmeterol (a long-acting inhaled β2-agonist) and fluticasone (an inhaled corticosteroid) in an innovative inhalation device.

Bulgaria has approved the 50µg-500µg dosage form for the continuous treatment of patients above 12 years of age with persistent asthma or for symptomatic treatment of COPD. The product's safety, efficacy and equivalence have been proven in multiple clinical trials1,2.

Vectura initially developed the VR315 product and created the design of the innovative inhaler, before licensing the asset to Sandoz in 2006. It was subsequently developed in collaboration with Vectura as AirFluSal® Forspiro® by Aeropharm GmbH in Rudolstadt, Germany, Sandoz' global respiratory Center of Excellence. The innovative and intuitive to use design of the inhaler was awarded the Red Dot Product Design award in 2011, an internationally recognized quality seal awarded by the Design Zentrum Nordrhein Westfalen in Essen, Germany.



[1] Kuna, I. Gath, U. Thyroff-Friesinger, S. Jones. Equivalence of fluticasone propionate/salmeterol delivered via new multi-dose dry powder inhaler and accuhaler™ in adolescent and adult asthma. Ajrccm conference.2013.187.1_MeetingAbstracts.A2611



[2]Sandoz data on file





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Norwegian approval of AirFluSal Forspiro

RNS


RNS Number : 7281Z

Vectura Group plc

10 February 2014






Vectura Group plc



Norwegian Regulatory Authority confirm approval of AirFluSal® Forspiro®





Chippenham, UK - 10 February 2014: Vectura Group plc (LSE: VEC; "Vectura" or "the Company") confirms that our partner, Sandoz, has received Norwegian marketing authorisation for AirFluSal® Forspiro® (formerly known as VR315), an innovative new inhaler for patients with asthma and chronic obstructive pulmonary disease (COPD).

The product was first approved (and now launched) in Denmark on December 18th, 2013 with subsequent market authorisations received in 2014 in Germany, Sweden, Hungary, Romania and Bulgaria. The new product offers the proven combination of salmeterol (a long-acting inhaled β2-agonist) and fluticasone (an inhaled corticosteroid) in an innovative inhalation device.

Norway has approved the 50µg-500µg and 50µg-250µg dosage forms for the continuous treatment of patients above 12 years of age with persistent asthma or for symptomatic treatment of COPD. The product's safety, efficacy and equivalence have been proven in multiple clinical trials1,2.

Vectura initially developed the VR315 product and created the design of the innovative inhaler, before licensing the asset to Sandoz in 2006. It was subsequently developed in collaboration with Vectura as AirFluSal® Forspiro® by Aeropharm GmbH in Rudolstadt, Germany, Sandoz' global respiratory Center of Excellence. The innovative and intuitive to use design of the inhaler was awarded the Red Dot Product Design award in 2011, an internationally recognized quality seal awarded by the Design Zentrum Nordrhein Westfalen in Essen, Germany.



[1] Kuna, I. Gath, U. Thyroff-Friesinger, S. Jones. Equivalence of fluticasone propionate/salmeterol delivered via new multi-dose dry powder inhaler and accuhaler™ in adolescent and adult asthma. Ajrccm conference.2013.187.1_MeetingAbstracts.A2611



[2]Sandoz data on file

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Belgian approval of AirFluSal Forspiro

RNS


RNS Number : 9176Z

Vectura Group plc

12 February 2014






Vectura Group plc



Belgian Regulatory Authority confirm approval of AirFluSal® Forspiro®





Chippenham, UK - 12 February 2014: Vectura Group plc (LSE: VEC; "Vectura" or "the Company") confirms that our partner, Sandoz, has received Belgian marketing authorisation for AirFluSal® Forspiro® (formerly known as VR315), an innovative new inhaler for patients with asthma and chronic obstructive pulmonary disease (COPD). The receipt of the Belgian marketing authorisation by Sandoz triggers a milestone payment to Vectura of €1.5 million.

The product was first approved (and now launched) in Denmark on December 18th, 2013 with subsequent market authorisations received in 2014 in Germany, Sweden, Hungary, Romania, Bulgaria and Norway. The new product offers the proven combination of salmeterol (a long-acting inhaled β2-agonist) and fluticasone (an inhaled corticosteroid) in an innovative inhalation device. The product has now been launched in Denmark and Germany.

Belgium has approved the 50µg-500µg dosage form for the continuous treatment of patients above 12 years of age with persistent asthma or for symptomatic treatment of COPD. The product's safety, efficacy and equivalence have been proven in multiple clinical trials1,2.

Vectura initially developed the VR315 product and created the design of the innovative inhaler, before licensing the asset to Sandoz in 2006. It was subsequently developed in collaboration with Vectura as AirFluSal® Forspiro® by Aeropharm GmbH in Rudolstadt, Germany, Sandoz' global respiratory Center of Excellence. The innovative and intuitive to use design of the inhaler was awarded the Red Dot Product Design award in 2011, an internationally recognized quality seal awarded by the Design Zentrum Nordrhein Westfalen in Essen, Germany.



[1] Kuna, I. Gath, U. Thyroff-Friesinger, S. Jones. Equivalence of fluticasone propionate/salmeterol delivered via new multi-dose dry powder inhaler and accuhaler™ in adolescent and adult asthma. Ajrccm conference.2013.187.1_MeetingAbstracts.A2611



[2]Sandoz data on file

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Interim Management Statement

RNS


RNS Number : 9525Z

Vectura Group plc

13 February 2014






Vectura Group plc



Interim Management Statement



Chippenham, UK - 13 February 2014: Vectura Group plc (LSE: VEC) ("Vectura"), today publishes its Interim Management Statement for the period 1 October 2013 to 13 February 2014.



Financial update



On 18 November 2013, Vectura announced its interim results for the six months to 30 September 2013, reporting a loss before tax of £1.2m and cash of £65.5m.



Vectura's financial performance from 1 October 2013 to date has been in line with the Board's expectations.



Pipeline update

During the period, our partner, Sandoz, announced that it had received marketing authorisation for AirFluSal® Forspiro® (formerly known as VR315), an innovative new inhaler for patients with asthma and/or chronic obstructive pulmonary disease (COPD). To date, marketing authorisations have been received from Denmark, Germany, Sweden, Hungary, Romania, Bulgaria, Norway and Belgium and AirFluSal® Forspiro® has been launched in Denmark and Germany. The approvals in Germany, Romania and Belgium each triggered milestone payments to Vectura of €1.5 million (circa. £1.2m). The Company will continue to provide updates, as and when further market approvals are received.



The roll-out of Seebri® Breezhaler® continues and Novartis reported sales of $58m for the 2013 calendar year on 29 January 2014. Our second partnered programme with Novartis, Ultibro® Breezhaler® (formerly QVA149), received approvals in Japan1 and Europe in September 2013. Novartis reported sales of $6m for the quarter ended 31 December 20132, with new royalty streams to Vectura anticipated from Q1 2014.



Novartis expect the US filing of Seebri® Breezhaler® and Ultibro® Breezhaler® to occur in Q4 2014.



In October 2013, GSK announced that BREO™ ELLIPTA™ for the treatment of COPD was available for sale in the US, followed in December 2013, by the approval by the US Food and Drug Administration (FDA) of ANORO™ ELLIPTA™. Vectura receives royalties from sales of these two products up to a cap of £13m per annum.



Board update

In November 2013, the Company announced the appointment of Bruno Angelici to the Board of Vectura. Bruno became Chairman with effect from 1 February 2014.



Dr Chris Blackwell, Chief Executive of Vectura commented:



"Vectura has continued to make strong progress in the period. The ongoing approvals and launch of AirFluSal® Forspiro® de-risks our high value respiratory generic portfolio in Europe and the rest of world and triggers another new valuable royalty stream in addition to the launch of Ultibro® Breezhaler®, together with the continuing and successful roll-out of Seebri® Breezhaler®".





1 Seebri® inhalation capsules in Japan

2 Seebri®, Ultibro®, Breezhaler®, AirFluSal® and Forspiro®are registered trademarks of Novartis









13 Feb N+1 Singer 110.00 Sell
13 Feb Finncap 180.00 Buy

THANKS DREAMCATCHER, WHEN DO WE SELL.

? Going to ask you the same. :-))

Baylis and DC
just found this one know little about them but reading up , see a host of countries approval for marketing and USA hopefully this year, but nothing about the UK, or has it been approved here earlier

26 March 2014 Investor Day, London
21 May 2014 Final Results for the year ending 31 March 2014
19 September 2014 Annual General Meeting
18 November 2014 Interim Results for the six months ending 30 September 2014

Sorry only just seen your post panic, yes you seem to be right about the UK. Have found Approval in Europe .

Thanks DC

Superb this is heading to 200p.

South Korean approval of AirFluSal Forspiro

RNS


RNS Number : 2046B

Vectura Group plc

28 February 2014






Vectura Group plc



South Korean Regulatory Authority confirm approval of AirFluSal® Forspiro®





Chippenham, UK - 28 February 2014: Vectura Group plc (LSE: VEC; "Vectura" or "the Company") confirms that our partner, Sandoz, has received South Korean marketing authorisation for AirFluSal® Forspiro® (formerly known as VR315), an innovative new inhaler for patients with asthma and chronic obstructive pulmonary disease (COPD), making it the first approval in Asia.

The product was first approved in Denmark on December 18th, 2013, with subsequent approvals in Germany, Belgium, Sweden, Norway, Hungary, Romania and Bulgaria and the product has now been launched in Denmark and Germany. The new product offers the proven combination of salmeterol (a long-acting inhaled β2-agonist) and fluticasone (an inhaled corticosteroid) in an innovative inhalation device.

· Visual control features which help reassure the patient about dosing

· Simple lever arm to load the dose

· Clear and accurate dose counter



Vectura initially developed the VR315 product and created the design of the innovative inhaler, before licensing the asset to Sandoz in 2006. It was subsequently developed in collaboration with Vectura as AirFluSal® Forspiro® by Aeropharm GmbH in Rudolstadt, Germany, Sandoz' global respiratory Center of Excellence. The innovative and intuitive to use design of the inhaler was awarded the Red Dot Product Design award in 2011, an internationally recognised quality seal awarded by the Design Zentrum Nordrhein Westfalen in Essen, Germany. It is displayed in design museums in Essen and Singapore.

South Korea has approved the 50µg-250µg and 50µg-500µg dosage forms for the continuous treatment of patients above 12 years of age with persistent asthma or for symptomatic treatment of COPD.

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11 Mar N+1 Singer 159.00 Hold

Acquisition of Activaero

http://www.moneyam.com/action/news/showArticle?id=4771907
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13 Mar Canaccord... 150.00 Buy
13 Mar Finncap 180.00 Buy

SOLDOUT 160p

Vectura: JP Morgan ups target price from 200p to 230p maintaining its overweight rating.

VR315 US development milestone

RNS


RNS Number : 0635D

Vectura Group plc

25 March 2014






Vectura Group plc

VR315 US development milestone





Chippenham, UK - 25 March 2014: Vectura Group plc (LSE: VEC; "Vectura" or the "Company") announces that it has triggered a milestone associated with the development of VR315 in the US.



In August 2011, Vectura signed a licence agreement for the development, manufacturing and commercialisation of VR315 in the US with the US division of a leading international pharmaceutical company. Vectura today announces that it will be recording a further development milestone under this agreement of $3m (£1.8m) in revenues. Vectura is eligible to receive up to a further $29m upon achievement of future pre-determined development milestones. These milestones, together with the initial payment of $10m in August 2011, total $45m. In addition, Vectura will receive a royalty from all VR315 US sales.



Dr. Chris Blackwell, Chief Executive of Vectura:

"This news illustrates the progress being made in the development of VR315 in the US. This milestone further de-risks our high value respiratory generic portfolio in the US, provides an important cash milestone to Vectura and is another step forward in the product's development."





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The smart nebuliser FOX wins Red Dot Design Award

RNS


RNS Number : 6607D

Vectura Group plc

01 April 2014








Vectura Group plc



The smart nebuliser FOX wins Red Dot Design Award





Chippenham, UK - 1 April 2014: Vectura Group plc (LSE: VEC; "Vectura" or the "Company") announces that the smart nebuliser device FOX has won the 2014 Red Dot Award for product design.

The award winning FOX inhaler is a smart and efficient handheld nebuliser for treatment of respiratory diseases. Its breathing control enables highly accurate drug delivery to the small airways.

The FOX inhalation system is a hand-held, self-contained, battery-powered, mesh nebuliser device with high performance using Activaero's* own vibrating mesh aerosol generator. The mesh-based aerosolisation engine used in FOX is proprietary to Activaero*, the rights having been in-licensed to Activaero* on an exclusive basis from a third party. The FOX inhalation system also makes use of a flow sensing/controlling valve system and is both re-chargeable and Bluetooth®-enabled. The latter feature allows for remote firmware updates without cable connection or for the system to upload patient use data for review by a healthcare professional.

The clear and user centric design of FOX make inhalation treatments potentially shorter in duration and more convenient.

Bernhard Müllinger, Chief Technical Officer at Vectura GmbH states "During the design process of FOX we undertook extensive market research to understand a device that patients use intuitively in the right way. Since most dose delivery errors associated with respiratory therapies are caused by inappropriate breathing patterns, we developed a LED lighting to prompt users to breathe correctly during dose administration. The device also features key-lock indicators for intuitive assembly of the components." FOX is fully battery powered and can be recharged with standard phone chargers with micro-USB connectors. Patients who use the FOX device can use the device at home, during work or while traveling.

Red Dot CEO and founder Dr. Peter Zec, notes, "Our experts assessed the quality of the entries with the utmost care and attention…But only the best products receive an award from the jury. This is especially reflected in the percentage of successful entries in the Red Dot Award, which is much smaller in contrast to other international design competitions. Therefore, the winners can be proud of their achievements - with their entries, they stood out from the rest and were able to pass the test in front of the critical eyes of the experts."

Design winners are celebrated during a presentation at the acclaimed Red Dot Gala on 7 July 2014. The award-winning products will be displayed in a special exhibition at the Red Dot Design Museum in Essen, Germany from 8 July to 3 August 2014.



* Vectura GmbH (formerly Activaero GmbH) is a wholly owned subsidiary of Vectura Group plc

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FAVOLIR Regulatory Update

RNS


RNS Number : 5869E

Vectura Group plc

11 April 2014








Vectura Group plc

FAVOLIR Regulatory Update





Chippenham, UK - 11 April 2014: Vectura Group plc (LSE: VEC; "Vectura" or the "Company") announces that it will initiate a pivotal study in Europe later this calendar year for FAVOLIR, its investigational product for severe, uncontrolled asthma.



This decision underlines the Company's planned strategy for a broad European development programme for FAVOLIR, rather than a country-specific approach, and this decision follows a recent meeting with the German regulator (BfArM) regarding the local development options for the product.



Dr. Chris Blackwell, Chief Executive of Vectura:



"The feedback that we received from BfArM is in-line with our own expectations. The constructive dialogue that we have had with the BfArM has helped us in our planning for the upcoming European pivotal trial and we look forward to taking the development of FAVOLIR to the next stage. FAVOLIR is an important product and is of potentially high value to all stakeholders."



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GSK milestone

RNS


RNS Number : 7748F

Vectura Group plc

29 April 2014






Vectura Group plc



GSK milestone





Chippenham, UK - 29 April 2014: Vectura Group plc (LSE: VEC; "Vectura" or "the Company") announces that it has triggered a £2m milestone associated with its licence and option to license agreement with GSK following the launch of ANORO™ ELLIPTA™ in the US.

In August 2010, GSK entered into a licence and an option to license agreement for certain of Vectura's dry powder formulation patents. Under the terms of the licence and option to license agreement, Vectura received an up-front payment of £10m in September 2010 and was due to receive a further £10m in milestones. All £10m of these milestones have now been triggered.



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