Vectura Share Discussion Threads

[a1ord53] 15/5/2017 20:17

dp1umb - still Btg holder

[dp1umb] 15/5/2017 18:22

A1ORD was or are you a holder of BTG or Axisshield?

[dunderheed] 15/5/2017 17:14

alex sorry for your disappointment mate - however the merger was really par for the course (regarding value destruction) with the skp mgt!!

[ifthecapfits] 15/5/2017 16:50

Ouch. Nearly bought some on the initial fall too. Watching with interest for a possible purchase.

[alexchry] 15/5/2017 16:31

a1ord53-disappointing to see the share price slide so much but there has been no good news since the merger. As a holder of SKP for many, many years I hoped that the merger would lead to even better things but so far there's been nothing to cheer about. The only glimmer of hope seems to be if the rejection of the Advair generic proves to only be a delay in approval. I hope the AGM has some positive news, we certainly need it.

[a1ord53] 15/5/2017 16:00

vectura kaput ?
all products worth nothing ?
all what counts adna ?
Short sellers smells blood - bustards

[dontay] 14/5/2017 23:58

dp1umb... I have no idea if it's unusual or not, I do think it's irrelevant to the recent FDA refusal though. VEC took the decision to go down a different route way back in 2010 and Novartis have as much right as anyone else to develop their own generic. It's well known that only around one in eight applications get FDA approval at the first time of asking and I think most savvy investors and certainly the big boys will have expected exactly what we got. The good news for me is that the device itself appears to have passed muster. It is VEC's Gyrohaler, the replacement for GSK's complex Discus device which is hard to replicate. Refusal for that reason could well have turned out to be insurmountable. VEC's generic substitute has been widely priced in as being worth around 15p a share on approval although the good sentiment might have given it a bit more of a premium than that if we had got it. So far the share price reverse has also been reasonably in line with that 15p a share territory which I believe points to the fact that at least some of the rejection was already priced in. I also believe that VEC has been underpriced recently due to the uncertainty of what was going to happen with the application... I wouldn't be in the least surprised to find that the share price level might well eventually strengthen and rise now that the uncertainty has been removed for a while. We shall have to wait and see. However, IMO the expectations of seeing £2 a share even with approval, let alone near the analysts inflated targets... were always at least another year away... so I don't see this as any great detriment. All only my opinion!

[dp1umb] 14/5/2017 18:43

Dontay yes I have read this, but don't you find it unusual to have a partner in Europe the don't follow it through in the USA? Then to top it off Novatis are only a few months behind Vecturas application!

[carpadium] 14/5/2017 18:14

And seven years later...a great example of the tentative risk involved when investing in pharma industry.

[dontay] 14/5/2017 17:22

dp1umb... it wasn't a case of Novartis 'dropping' VEC. Although there was an agreement dating back to 2006 for Novartis (Sandoz generic unit) to have an option to partner VEC for the States operation in addition to the rest of the world the agreement was mutually cancelled in 2010. VEC subsequently appointed Hikma as their partner for the USA development. This was the announcement VEC made about the change with Novartis at the time:Chippenham, UK – 18 March 2010: Vectura Group plc (LSE:VEC) ("Vectura"), the specialty pharmaceutical company,announces today that it has agreed with Sandoz AG to take full control of the US development and commercialisation of VR315, its combination product for asthma/COPD. Good progress continues to be made with the development of VR315. In Europe, there is no change to the agreement signed in April 2006, and Sandoz will continue to be fully responsible for the development, manufacture and commercialisation of the product.Under the revised agreement, Vectura regains full rights and responsibilities for the development and commercialisation of VR315in the US and is released from its profit share obligations. There acquisition of full control of this important product in the us is part of Vectura's strategy to become a cash-generativespecialty pharmaceutical company, and VR315 will form the cornerstone stone of Vectura's nascent US operations.

[carpadium] 13/5/2017 22:12

Copied from ii thread with thanks to burnchat...

What To Know About New FDA Chief Scott Gottlieb
May 11, 2017

Scott Gottlieb, MD, was confirmed yesterday to head the FDA by a Senate vote of 57 to 42. Readers of Managed Care got some insight into Gottlieb’s priorities when we interviewed him last year.

The New York Times is reporting this morning that Gottlieb promises to “divest himself from several health care companies and recuse himself for one year from decisions involving those businesses….”
Some Democratic senators weren’t swayed. During the confirmation hearing, Sen. Patty Murray of Washington said, “He has not convinced me he can withstand political pressure from this administration, or that he will be truly committed to putting our families’ health first. I’ve grown increasingly concerned about whether he can lead the FDA in an unbiased way, given his unprecedented industry ties.”
Gottlieb, 44, is a resident fellow at the American Enterprise Institute and a leading conservative expert on health care policy. Gottlieb served on the advisory boards for GlaxoSmithKline and Daiichi Sankyo, as well as doing other consulting work for large drug companies.

[dp1umb] 13/5/2017 11:46

Dontay point taken , but I don't understand why Novatis worked with us on the generic version then dropp vectura in the usa(by far the biggest market) and are now bullish on there application !

[dontay] 13/5/2017 09:39

dp1umb... Novartis (Sandoz unit) is a VEC's partner and have successfully marketed and launched the generic in Europe and some Latin American countries... but Novartis wanted to concentrate on the rest of the world and made it clear they were not interested in taking on the marketing and launching of the generic in the states. The states is always a much larger, difficult and complex undertaking, only one in eight applications get approved without any hassle... and it was always planned as a 'stand alone' much later exercise. It's simply that Hikma who were appointed as the partner for the states.

[dp1umb] 13/5/2017 01:26

Why did are biggest partner novatis stop using are device in the USA in there Copy of Advair?

[dontay] 12/5/2017 23:21

do 1umb... No material issues were raised regarding the substitutability of the proposed device.

[dp1umb] 12/5/2017 21:56

Question one have we got any link with novatis generic version of Advair?

Maybe we have in Europe only!

Maybe novatis know there's a problem with vecturas inhaler ? Because they predicted that Mylan and vecturas applications would be turned down and that there's would be successful!

[best1467] 12/5/2017 18:07

As is usually the case with any FDA related ,expect a complete lack of any detail.This will go on for sometime as for vec we are still in the dark as to any resolution to the glaxo dispute.
I dofeel this was expected news and partly priced in so would not be expecting much downside from current value.

[dontay] 12/5/2017 17:06

Thanks for that Carpadium... regardless of what folk think about Trump, one thing he says he wants to sort out is exactly the sentiments expressed in cummor's post! Maybe he's a good guy after all! :) Popper Joe, this is the link to the article: http://www.livecharts.co.uk/share_prices/Hikma-and-Vectura-disappointed-by-FDA-s-gener-news25920815.htmlHow true that bit about the Mylan generic is I'm not sure, that that is also the first reference I've seen to what the supposed problem with their application was. However I believe it's possible that there was at least one substantial difference in the clinical trials... with the cravat that I'm not entirely sure of my facts here... my understanding is that Mylan did not include under 18 year olds in their trials, but VEC did! It's interesting also that Mylan have publicly disagreed with the FDA findings. How good that will do them and what difference it will make remains to be seen!I doubt any of us are going to be any wiser about this problem until Hikma/VEC have had their meeting with the FDA. Mylan's refusal was back in March... it is only now that the reasons are becoming public.

[alexchry] 12/5/2017 16:51

I, too, hope that there are some positive plans for VEC. The merger is around 12 months old and there has been virtually nothing but bad news, not necessarily the fault of VEC management. I'd been pinning my hopes on generic Advair approval but now I can't see anything on the horizon that will give a significant boost to the share price I just hope Flutiform sales are going from strength to strength. I agree with Carpadium, should have smelled a rat when VEC talked about risk.

[carpadium] 12/5/2017 16:45

Another choice post from yesterday's Hikma thread, certainly don't disagree with sentiment. Thanks cumnor.

cumnor11 May '17 - 08:43 - 490 of 495 0 0
Entirely predictable. Make no mistake, this rejection of Mylan's and Hikma's products will cost the US taxpayer hundreds of millions and many lives. It is well known the FDA guys are entirely in the pockets of 'big pharma' so will reject generics like advair from small companies which have been shown to be perfectly safe, on any whim or technicality. The loser of course is the US patient forced to pay extortionate prices for their healthcare, to keep the FDA in clover and 'busy' pretending to be an independent arbiter of pharma regulation.
Given how the US healthcare system works many partially and uninsured (there are tens of millions) poorly controlled asthmatic or copd patients will die because they cannot afford expensive branded inhalers while they await the FDA prevaricators who continue to deny them affordable drugs lest it hurt the profits and bonuses of their buddies on Wall Street. If Trump wants healthcare for all and cheap drugs then a purge of the FDA gravy train sham needs to be first in his line of sight. imo

[carpadium] 12/5/2017 16:39

Saw the same post yesterday on the Hikma thread posted by broadwood, the $11m milestone payment re. ANDA approval lost for now particularly stood out, never mind all those healthy 15% royalty payments. Vectura must have had a good indication of what the FDA were deciding, their warning of risks and subsequent effect on earnings, which at the time I thought obvious and a little unnecessary, preceded a little too timely.

Where to now for Vectura and shareholders? Do we just mark time for the rest of the year, hope Ultibron in the US is motoring better than expected, hope flutiform stock levels can cope with demand, hope JW-L comes up with some development well-received?

Whilst still invested hoping to hear his thoughts, maybe fresh plans pretty soon.

[popper joe] 12/5/2017 16:22

Dontay, thanks for this. Is it from a single report? or have you gathered together a number of articles/reports? It is the first time I have seen reference to Mylan's major classification being "due to substitutability issues directly related to human factor studies." Where was that reported?

[dontay] 12/5/2017 15:01

After receiving an unfavourable verdict from US drug regulators, Hikma Pharamceuticals and Vectura felt there was a "low likelihood" that their generic version of asthma treatment Advair would be approved this year.Hikma, the proposed manufacturer of the drug that will be delivered using a Vectura inhaler and a drug formulation, received a Complete Response Letter from the US Food and Drug Administration categorised as 'major', which means the drug application will require significant amendments.'Major' categorisations can have two outcomes - either requiring major amendments from a large number of minor observations, or a major amendment due to a major observation such as bioequivalence or a device issue requiring further study.Hikma said it would need to fully review the CRL and discuss it with the FDA, but both believed there was "a low likelihood of approval this year" and for Vectura this meant it does not anticipate receiving an approval milestone or sales royalties for the VR315 programme in 2017."Based on the initial assessment no material issues were raised regarding the substitutability of the proposed device," Hikma said."Hikma and Vectura are committed to bringing this important product to the US market and have confidence in the future approval of the programme as an AB rated substitutable product."Vectura is due to receive a $11m milestone payment on approval of the abbreviated new drug application (ANDA) plus a mid-teen percentage royalty on net sales of VR315 in the US.Investors in the drug device maker have had high hopes for this programme, with analysts at RBC recently calling VR315's approval in the US "arguably the most important launch from Vectura's pipeline for the next circa-4 years".Earlier in the week Mylan received a CRL for its generic Advair also classified as "major" by the FDA, but it had substitutability issues directly related to human factor studies.Broker Numis presumed the programme will incur "a minimum 12-month delay, with a full review of the letter and discussions with the FDA crucial to resolving the path ahead".As no material issues were raised regarding the substitutability of the proposed device, analyst Paul Cuddon said he only saw potential for "very modest downside" for Hikma with the company's valuation well underpinned by the injectables, generics and branded divisions."Advair is a complex product, with multiple device, formulation, dosing, useability and manufacturing complexities. There remains a significant need for lower cost generic options in the class, given the high patient co-pays and overall costs to the US healthcare system. Hikma was confident in its application, but has now been given detail of where its application falls short."Earlier in the week Cuddon pointed out that a 'major' CRL could have two outcomes.The first would require "amendment from a larger number of what are still minor observations (possible given complexity of combination inhalers) that FDA then responds to in 10 months - this would significantly de-risk eventual approval (equivalent to previous FDA "approvable" letter) but imply a longer time to market".The second 'major' CRL outcome could require "a major amendment due to a major observation (e.g. bioequivalence, device issue requiring further study, equivalent to previous "not approvable" letter) - this is the scenario that implies a valuation downgrade, though at current levels we see it potentially creating an attractive buying opportunity below the value of approved products".Hikma's fluticasone propionate and salmeterol inhalation powder is designed as a treatment for asthma and the maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease, as part of the ANDA is delivered using Vectura's proprietary dry powder inhaler and formulation technology.

[cap160] 12/5/2017 12:18

AGM 25th May may give us a little clarity on FDA requirements---perhaps?