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Exciting times for this company.

200p I imagine in 2014.

Huge market in Germany.

Swedish approval of AirFluSal Forspiro

RNS


RNS Number : 6121X

Vectura Group plc

14 January 2014








Vectura Group plc



Swedish Regulatory Authority confirm approval of AirFluSal® Forspiro®





Chippenham, UK - 14 January 2014: Vectura Group plc (LSE: VEC; "Vectura" or "the Company") confirms that our partner, Sandoz, has today received Swedish 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 in Denmark on December 18th, 2013 and Germany on January 13th, 2014. 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.



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



The receipt of the marketing authorisations in Sweden, Germany and Denmark follows the successful completion of EU decentralised procedures also including Norway for the 50-500 µg and 50-250 µg dosage forms and for the 50-500 µg dosage form Germany, Belgium, Bulgaria, Hungary, Luxembourg and Romania. We will communicate as and when further market approvals are received.



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] P Kuna, I Gath, U Thyroff-Friesinger, S Jones. Equivalence of an innovative multidose salmeterol/fluticasone dry powder inhaler vs

comparator in paediatric asthma. Submitted ERS - Reference September 2013

[2]Sandoz data on file

German approval of AirFluSal Forspiro

RNS


RNS Number : 5123X

Vectura Group plc

13 January 2014








Vectura Group plc



German Regulatory Authority confirm approval of AirFluSal® Forspiro®





Chippenham, UK - 13 January 2014: Vectura Group plc (LSE: VEC; "Vectura" or "the Company") confirms that our partner, Sandoz, has today received German 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 German marketing authorisation by Sandoz triggers a milestone payment to Vectura of €1.5 million.

The product was first approved in Denmark on December 18th, 2013. 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.

Germany 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 in the same patient group. The product's safety, efficacy and equivalence have been proven in multiple clinical trials1,2.

"This approval further de-risks our high value respiratory generic portfolio in Europe and the Rest of the World and, provides a significant cash milestone to Vectura." said Chris Blackwell, CEO of Vectura. "Once launched, the royalty stream from AirFluSal® Forspiro® will contribute to Vectura's differentiated top line growth".

The receipt of the marketing authorisations in Germany and Denmark follows the successful completion of EU decentralised procedures which also include Belgium, Bulgaria, Hungary, Luxembourg, Romania, Sweden and Norway. We will communicate as and when further market approvals are received.



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] P Kuna, I Gath, U Thyroff-Friesinger, S Jones. Equivalence of an innovative multidose salmeterol/fluticasone dry powder inhaler vs

comparator in paediatric asthma. Submitted ERS - Reference September 2013

[2]Sandoz data on file

-Ends-

14 Jan N+1 Singer 110.00 Sell
14 Jan Finncap 180.00 Buy

Hungary approval of AirFluSal Forspiro

RNS


RNS Number : 8443X

Vectura Group plc

16 January 2014



Hungarian Regulatory Authority confirm approval of AirFluSal® Forspiro®





Chippenham, UK - 16 January 2014: Vectura Group plc (LSE: VEC; "Vectura" or "the Company") confirms that our partner, Sandoz, has received marketing authorisation in Hungary 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 in Denmark on December 18th, 2013, with subsequent marketing authorisations received earlier this week in Germany and Sweden. 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.

Hungary has approved the 50-500µg dosage form for the continuous treatment of patients above 12 years of age with persistent asthma or for symptomatic treatment of COPD in adults. 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 Vecturaas 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]P Kuna, I Gath, U Thyroff-Friesinger, S Jones. Equivalence of an innovative multidose salmeterol/fluticasone dry powder inhaler vs

comparator in paediatric asthma. Submitted ERS - Reference September 2013

[2]Sandoz data on file

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:-))

Romanian approval of AirFluSal Forspiro

RNS


RNS Number : 8026Y

Vectura Group plc

29 January 2014






Vectura Group plc



Romanian Regulatory Authority confirm approval of AirFluSal® Forspiro®





Chippenham, UK - 29 January 2014: Vectura Group plc (LSE: VEC; "Vectura" or "the Company") confirms that our partner, Sandoz, has received marketing authorisation in Romania 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 Romanian 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 earlier in January 2014 in Germany, Sweden and Hungary. 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.

Romania 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

-Ends-

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





-Ends-

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

-Ends-

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

-Ends-

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.

-Ends-