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US submission for NVA237 and QVA149
RNS
RNS Number : 5943B
Vectura Group plc
08 January 2015



Vectura Group plc



Submission of regulatory applications to US FDA and robust Phase III results for QVA149 and NVA237



· Submissions to US FDA completed for QVA149 and NVA237 in Q4 2014



· Pivotal Phase III results for QVA149 and NVA237 met their primary endpoints and significantly improved lung function in COPD patients1-5



· US trials for QVA149 demonstrated significant improvements in overall health status compared to placebo1,2





Chippenham, UK - 8 January 2015: Vectura Group plc (LSE: VEC; "Vectura" or "the Company"), confirms the information released today by our partner Novartis announcing that the New Drug Applications (NDAs) for QVA149 and NVA237 for the long-term maintenance treatment of chronic obstructive pulmonary disease (COPD) were submitted to the US Food and Drug Administration (FDA) by Novartis in Q4 2014. Vectura is eligible to receive milestone payments upon the acceptance of applications by the US FDA.



In addition, positive top-line results were announced today by Novartis from the pivotal Phase III clinical trial programmes for QVA149 (indacaterol/glycopyrronium bromide) and NVA237 (glycopyrronium bromide) to support the application. The results from the EXPEDITION (including FLIGHT 1, 2 and 3 studies) and GEM (including GEM 1, 2 and 3 studies) clinical trial programmes met their primary and secondary endpoints.



The FLIGHT 1 and 2 studies met their primary objectives with twice-daily QVA149 demonstrating statistically significant and clinically meaningful improvements in lung function (FEV1 AUC0-12) at Week 12, compared to indacaterol and glycopyrronium bromide in moderate-to-severe COPD patients1,2,9. Improvements in overall health status, a secondary endpoint based on the St George's Respiratory Questionnaire (SGRQ) total score, and rescue medication usage were also seen with QVA149 compared to placebo at Week 121,2. The common adverse events reported for QVA149 were comparable to the individual components and placebo across the EXPEDITION studies1,2.



In the GEM 1 and 2 studies, twice-daily NVA237 demonstrated significant and clinically meaningful improvements in lung function (FEV1 AUC0-12h) at Week 12 in moderate-to-severe COPD patients compared to placebo; meeting its primary objective4,5,9. An improvement in health status was also observed in patients at Week 12. The adverse events reported for NVA237 were comparable to placebo across the GEM studies4,5.



Data from the EXPEDITION and GEM programmes are expected to be presented at major medical congresses later this year.



COPD symptoms can have a major negative impact on a patient's ability to breathe and perform essential daily activities, thereby reducing their quality of life6,7. There is an urgent need for new treatment options in COPD because many patients remain symptomatic despite medical therapy8.





About EXPEDITION

The EXPEDITION Programme consisted of studies, including FLIGHT 1 and 2, which were identical 12-week, multi-centre, randomised, double blind, parallel-group, placebo and active controlled studies to assess the efficacy, safety, and tolerability of QVA149 (indacaterol/glycopyrronium bromide) in moderate-to-severe COPD patients. The primary objective was to compare twice-daily QVA149 27.5/12.5 mcg to its monotherapy components in terms of lung function (FEV1 AUC0-12h) at Week 121,2.



FLIGHT 3 was a 52-week randomised double blind, parallel-group study to assess the safety and tolerability of twice-daily QVA149 27.5/12.5 mcg compared to once-daily indacaterol 75 mcg in moderate-to-severe COPD patients. The primary endpoint was the overall rate of adverse events reported during the study3.



About GEM

GEM 1 and 2 were 12-week multi-centre, randomised, double-blind, placebo controlled studies to assess the efficacy and safety of twice-daily NVA237 (glycopyrronium bromide) 12.5 mcg in moderate- to-severe COPD patients. The primary objective was to compare twice-daily NVA237 to placebo in terms of lung function (FEV1 AUC0-12h) after 12 weeks of treatment4,5. The objective of GEM 3 was to determine safety and tolerability of twice-daily NVA237 12.5 mcg compared to once-daily indacaterol 75 mcg in moderate-to-severe COPD patients.



About QVA149

Twice-daily QVA149 (indacaterol/glycopyrronium bromide) 27.5/12.5 mcg, as used in the EXPEDITION programme, is being submitted for US registration only. Outside of the US, QVA149 has been developed/marketed as Ultibro® Breezhaler® 110/50 mcg, which is a once-daily maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD10. Once-daily Ultibro® Breezhaler® is currently approved for use in over 50 countries, including countries within the EU and Latin America, Japan, Canada, Switzerland and Australia.



About NVA237

Twice-daily NVA237 (glycopyrronium bromide) 12.5 mcg, as used in the GEM trials, is being submitted for US registration only. Outside of the US, NVA237 has been developed/marketed as Seebri® Breezhaler® 50 mcg, which is a once daily medication indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD and is approved for use in over 70 countries, including countries within the EU and Latin America, Japan, Canada, Switzerland and Australia11. Glycopyrronium bromide was exclusively licensed to Novartis in April 2005 by Vectura and its co-development partner Sosei.



Ultibro®, Seebri® and Breezhaler® are registered trademarks of Novartis AG.



About COPD

COPD is associated with chronic morbidity and mortality and The World Health Organisation (WHO) estimates that 210 million people worldwide have COPD12. Deaths from COPD are projected to increase over the next 10 years by more than 30% unless underlying risk factors are addressed13. COPD is the third leading cause of death in America, claiming the lives of 134,676 Americans in 201014 and COPD is now the third leading cause of death worldwide15.



COPD is progressive (usually gets worse over time), and can be a life-threatening disease7,12. It makes it difficult to breathe, with symptoms that have a destructive impact on patients' function (i.e. activity limitation, decreased mobility) and quality of life7,14. It is often considered to be a disease of later years, but estimates suggest that 50% of those with COPD are now less than 65 years old, resulting in increases in absenteeism, premature retirement and reductions in workforce participation16,17.

VEC Vectura- Pharma/Bio co. Long,secured deals over last few days with some big US companys Risky but broker backing is very strong.



Date Broker Rec. Price Old target price New target price Notes
08 Jan 15 Oriel Securities Buy 150.50 207.00 207.00 Reiterates
08 Jan 15 Investec Buy 150.50 148.00 163.00 Upgrades
08 Jan 15 N+1 Singer Hold 150.50 147.00 156.00 Retains
07 Jan 15 Canaccord Genuity Buy 150.50 192.00 192.00 Reiterates
06 Jan 15 finnCap Buy 150.50 202.00 202.00 Reiterates
05 Jan 15 JP Morgan Cazenove Overweight 150.50 230.00 230.00 Reiterates

Lifted from across the road......

Good news today - and it seems $35m will be coming VEC's way soon if I follow this morning's comment from Finncap correctly....

"Vectura: NVA237/QVA149 regulatory submission (BUY)

The regulatory submissions of NVA237 and QVA149 to the US regulator were completed by Novartis (Vectura’s licensee), as expected, in Q4 2014. On acceptance of the dossiers (which can take up to 60 days), Vectura will receive milestone payments (we estimate US$35m), with further milestone payments due on regulatory approval, and royalties of an estimated 5% payable on sales in the US.

Novartis has also released positive top-line clinical results from the Phase III trials performed to support US registration, with both drugs demonstrating statistically significant and clinically meaningful improvements in lung function. We make no changes to our forecasts, reiterating our 202p target price and our Buy recommendation."

From Peel Hunt wed - nice 248p target price.

Janssen's prior acquisition of Respivert is certainly an intriguing portent....

"Vectura (Buy TP 248p)
Janssen deal.

Vectura announced a deal with Janssen Biotech (part of J&J and developer of approved drugs such as Zytiga) for the exclusive development of Janssen's novel anti-inflammatory therapies in development for the treatment of asthma/COPD. The collaboration will initially focus on the development of a Phase 2 candidate, with the potential to include additional clinical-stage candidates. Janssen will lead the clinical development of the assets, with Vectura providing its expertise and technologies (devices, formulation) in dry powder inhalers (DPI).

This deal is in line with the strategy outlined at the Business Review Day last March, which unveiled Vectura's Gyrohaler-related devices platform, which includes several different device options, as an approved multi-dose DPI platform available for licensing. Detailed deal terms are not disclosed, but we would imagine a typical structure of modest 7 figure upfronts and milestones together with full FTE funding of Vectura resources (people) and mid single digit royalties on eventual sales. Such a structure implies no rise in Vectura's own R&D investment, though will utilise some of the bandwidth of its employee base, in return for near-term milestones and development services payments and a share in the upside should the products get to market.

The precise products are not disclosed, but note that Janssen acquired the UK companyRespivert a few years ago, which has a promising portfolio of anti-inflammatory compounds in development. This deal is a positive step forward, adding a further large pharma partner and is exactly in line with Vectura's stated strategy and is a validation of its status as a partner of choice in targeting airways diseases. We make no changes to our valuation at the moment pending more information on this programme in the future."

More here about this being a "multi-million dollar" deal:

Http://www.businessweekly.co.uk/biomedtech-/18009-vectura-clinches-multi-million-dollar-janssen-deal

Extract:

"Tuesday, 06 January 2015 09:08
Tony Quested

Vectura clinches multi-million dollar Janssen deal
.
Vectura in Cambridge UK has secured a landmark deal with US heavyweight Janssen Biotech Inc to develop inhaler technology to treat asthma and COPD (chronic obstructive pulmonary disease).

While no financial deals were disclosed to the markets, Business Weekly understands the payback stacks up to several million dollars.

The deal comprises handsome upfront and development milestones and a tiered royalty on net sales.

etc"

Vectura to present at JP Morgan Conference

RNS

RNS Number : 5910B
Vectura Group plc
09 January 2015




Vectura Group plc


Vectura to present at the 33rd Annual J.P. Morgan Healthcare Conference, San Francisco

Chippenham, UK - 9 January 2015: Vectura Group plc ("Vectura"; LSE: VEC) announces today that it is scheduled to present at the 33rd Annual J.P. Morgan Healthcare Conference on Wednesday, 14 January 2014, at 4:30pm PST (12.30am 15 January GMT). The conference runs from 11-15 January 2015, at the Westin St. Francis Hotel in San Francisco, CA.

The presentation will be webcast live and can be reached from Vectura's website at http://www.vectura.com/investors/reports-presentations/2015.aspx. Listeners are encouraged to visit the site at least 15 minutes prior to the scheduled presentation to register, download and install any necessary audio software. A PDF of the presentation will also be available on Vectura's website at the same time.

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Enquiries

Vectura Group plc
+44 (0)1249 667700
Karl Keegan, Chief Corporate Development Officer
Fleur Wood, Corporate Investor Relations



FTI Consulting
+44 (0)20 3727 1000
Ben Atwell / John Dineen / Ulla Lundhus

6 Jan 2015 Vectura Group PLC VEC JP Morgan Cazenove Overweight 142.38 144.75 - - Reiterates

NDA acceptance for QVA149 and NVA237
RNS
RNS Number : 6561G
Vectura Group plc
05 March 2015



Vectura Group plc



US FDA filing acceptance of NDAs for QVA149 and NVA237



Chippenham, UK - 5th March 2015: Vectura Group plc (LSE: VEC; "Vectura" or "the Company"), confirms that Novartis' New Drug Applications (NDAs) for QVA149 and NVA237 for the long-term maintenance treatment of chronic obstructive pulmonary disease (COPD) have been accepted for review by the US Food and Drug Administration (FDA). The filings were submitted by Novartis in Q4 2014. The acceptances trigger milestone payments to Vectura of $12.5m and $7.5m respectively.

-Ends-

A moderately good start to the year and climbing Sp has been lost after they ann a problem with major drugs co SKB ( DYOR )...it seems previous deals have been rather poor, with VEC getting rather little for "better" powders. Now they appear to have the inhaler/delivery improved further. . . you'd expect that would mean they'd share the profits - but it seems there is an issue and SKB have the upper hand ( Unless VEC can find ANOther to distribute the product . . . makes me wonder if BTG Sales force couldn't do this as they should by now have the warehousing ).
One wonders if the income won't dip in the short-term meaning there will be a cash-call - Oh dear.
Their products appear to be good-enough against existing puffers . . . . but to get the Market excited, I think they need to make it far clearer how these differ and why one model is better-suited, compared with another they make . . .otherwise it looks like clutter, to my mind.
8 Sept 2016...sp ~150p
EDIT (24April2017)-sp ~150p nothing worthwhile to report, I guess.
EDIT(20Oct2018)-oh dear sp 70p ish.... mighty fallen... anyone?
EDIT (25NoV2018)- Seems VEC's sp was hardly knocked with the failure of asthma-trial . . . you'd think just giving a puff to someone with asthma would show if it worked - if not, then move-on. Why put money into Trials if it didn't hold great promise?