Vectura Share Discussion Threads

[s1zematters] 15/3/2018 15:26

All the hallmarks of a short squeeze at Hikma, nee on 30% bounce in last two days meanwhile at vec,, errrr,,,

[boadicea] 15/3/2018 14:18

The share price looks suspiciously anchored to 78.5p today. Is it being supported there or sat on?
Well, at least it's not going down, unlike most of my other shares - in spite of FTSE tending up.
Exceptions are ECK, REC and VEC and I've just realised they rhyme.

[cumnor] 15/3/2018 09:26

Market shrugging off Advair delay foe Hikma and re-rating on basis of underlying business and prospects. Let's see if Ward Lilley can show anything for his tenure at VEC in terms of growing revenue and profits and turning investors' attention back to it's main business or if, as I suspect, its loss of confidence in his abilities is justified, in which case he should be quickly shown the door? imo

[pooroldboy55] 15/3/2018 09:24

I see HIK doing well again today.

[dontay] 15/3/2018 09:18

Starting to turn? Capital Fund Man. S. Africa short reduced, taking VEC total short down to 3%.

[pooroldboy55] 14/3/2018 16:45

I see someone still wants out big time after close o trade of 740000 late not to effect price during day.

[alexchry] 13/3/2018 08:29

cumnor-when it comes to the FDA, I'd rather use the words clarity and optimism than certainty. For the moment that issue is parked for at least a year so we must look at what other good news Vec might have for us. In the shorter term, I am hoping that Flutiform sales have held up despite the competition in Europe and I hope it's not too long before two partners are found to back up Vec's new strategy.

[cumnor] 13/3/2018 00:03

What the shorters don't like is 'certainty'. Today we got a dose of it re VEC's and Hik's plans for the next two years, albeit with the usual reservations but with a degree of optimism re likely hood of approval, as Polaris and others point out, and a hint of the obstacles facing other generic Advair supplicants. VEC has loads more going on and is probably way under valued as it is. So decision time for shorters, esp with take out scenarios also in the mix at this price. I think they need to reassess after today. imo

[dontay] 12/3/2018 22:43

The fact that they are already in agreement, organised and willing to go ahead with a another clinical study, points to them knowing and prepared for quite some time that this was going to be the decision.But also the fact that they are still willing to go ahead and not call it quits, whilst admitting that it's going to be around another two years before they can launch on the market (2020) would seemingly indicate their complete confidence that the market won't have disappeared from under them during that time... and also that they don't foresee any problems with meeting whatever new endpoint the FDA has requested. In the light of this decision its likely the other 'rivals' are going to have even more of a problem getting approval for the substitutability of their delivery devices for Diskus... and HIK/VEC have probably now moved to the front due to the excellence of the GyroHayler as a substitute for GSK's device.

[polaris] 12/3/2018 22:08

I repeat that it is not yet approved by the FDA. In fact, Mylan got a straight rejection in 2017 from the FDA. They can say what they want in a pharma bulletin but until the FDA change their stance then there will be no generic Advair in the US, whether from Hikma, Mylan or Sandoz. When any of them get an approval then it will be a few months tops to get it to market.

[0815exitstrategy] 12/3/2018 20:07

I repeat my post from this morning:
from the generics bulletin March 9th 2018:
"mylan awaits rapid us arrival of rival to advair"....
"we do not see any constrains for manufacturing the requisite quantaties for the launch"....
So it seems mylan is quite confident to launch this year.

[polaris] 12/3/2018 18:04

It is as expected. The FDA want another clinical endpoint study as there is an equivalence issue. This is similar for all the generics and so i do not expect any of the others to be able to get away with anything different. GSK will be happy in their incumbent position for another 12 months or so. In the interim we need to watch the Qlies from them to see the switch rates to other products.

regards,

Paul

[ropey] 12/3/2018 15:09

Thanks ACEUK.

The following is from the Hargreave L news section for VEC:

For Hikma, investors may be waiting for Wednesday's announcement of full-year results to evaluate just how much of a financial impact this will end up having over the coming year, said Henry Croft at Accendo Markets.

"For Vectura, on the other hand, a fresh setback in their bid to bloody the nose of larger rivals has seen previously loyal shareholders jump ship. Having already seen shares fall as much as 42% from their 2018 highs, waiting a further 12 months to receive any further news on the development of the Advair alternative - let alone whether that news is positive or negative - is too much of an endeavour for many to undertake. Whether the Wiltshire-based company can maintain its partnership with Hikma will also be of key concern to both parties."

[dontay] 12/3/2018 14:26

Referencing in the this RNS to other USA approval intentions for three major drugs, this latest experience with the FDA should indeed stand them in good stead and provide some better understandings of the stringent requirements the FDA expect to see from approval submissions for other VEC/HIK products that are in the 'states pipeline'. This report from 2016 also highlights the close partnership with Hikma.Vectura.... will partner with generic drug specialist Hikma to develop and commercialise salmeterol, a generic version of GlaxoSmithKline's respiratory drug Serevent.Under the terms of the agreement, Jordan-based Hikma is responsible for clinical development, commercialising the drug in the US, and manufacturing it. The deal allows it to leverage the manufacturing and commercial capabilities of its recently acquired US generics business, West-Ward Pharmaceuticals.In turn Vectura will finish formulating the drug so that it can be inhaled as a powder.The company will get an initial payment of $375,000 and further potential milestone payments of up to $1.125m.James Ward-Lilley, chief executive of Vectura, said the treatment, dubbed VR730, had good market potential and that Vectura was pursuing other opportunities to develop generic inhalers with third parties."We are starting to develop three to five new generic inhalation assets that we expect to progress further with partners," he said. "This adds to our exciting pipeline."Hikma and Vectura are already working in partnership to develop two other respiratory drugs, including a generic version of Glaxo's Advair. The copycat treatment is set to be second-to-market in the US, with a potential approval date of May 10 next year.Vectura is due to unveil half-year results on Wednesday, the first set of numbers since it merged with Skyepharma in a £441m deal in June.

[dontay] 12/3/2018 12:21

What? Not that I can see!?

[aceuk] 12/3/2018 12:17

Hikma and Vectura have had constructive dialogue with the FDA to resolve the observations made in the Complete Response Letter ("CRL") received on 11(th) May 2017 and they have been able to address and clarify the majority of the questions raised. As announced on 9(th) November 2017, Hikma, supported by Vectura, decided to progress a dispute resolution process regarding the remaining outstanding issue, namely the different interpretation of the results from the Clinical Endpoint Study. This process has now concluded. Both Vectura and Hikma remain confident in the approvability of the product and are committed to bringing this cost-effective alternative to Advair Diskus(R) to the market as quickly as possible.

James Ward-Lilley, Chief Executive Officer, commented:

"Whilst the outcome of the dispute resolution process is disappointing, we now have a clear pathway forwards, and we and our partner Hikma remain confident in, and committed to the approval of VR315. Assuming the successful execution of the new study and a standard regulatory review, we now expect a potential approval and launch during 2020.

"Importantly, we are one of the few first movers into this complex area and in this process we have cleared up a significant number of issues which we believe has strengthened our insight and likelihood of success. These learnings support our confidence that we have the capabilities to achieve US regulatory approval for our extensive inhaled generic pipeline, which includes versions of the three current largest US inhaled brands."

The FDA's decision will have no impact on Vectura's revenue or R&D expectations for the year.



You are clearly on a different string ropey

[ropey] 12/3/2018 11:27

In the RNS, the last para suggests that the relationship between VEC & Hikma may not be sustainable in time for the approval !!!.....

Is there an issue in the relationship and if so can it be overcome ?

I suspect without Advair on VEC's books, it would seriously impact their revenues/profits going forward.

[rathean] 12/3/2018 10:25

Re-read the RNS and I'm happy to continue holding. I agree with previous comments this news slows the growth of VEC but growth will occur nonetheless with existing income streams.This remains an attractive business and with the Chinese becoming increasingly aggressive in the pharma market and US consolidation VEC remains an attractive portfolio proposition imo.

[cumnor] 12/3/2018 09:26

Agree Alord, but its management's and the CEO's job to highlight its products and potential in the market, besides allowing shorters dictate the focus on temporary negatives like advair-which they have successfully done, (and I thank them for that as I have bought loads at this level). But a competent CEO would have handled this very differently-VEC is one of the leading inhalation device designers in the world-think what Nasdaq would make of it, and has several solid income streams and great products and cash which will guarantee income for years. The CEO should have dictated the story rather than act rabbit like blinded by the hedgies and shorters. He shouldn't be there-seriously. BTW advair will be a big product for VEC-wait and see. imo

[cantrememberthis2] 12/3/2018 09:09

Could be a take out of stops this morning... wouldn't be surprised. Seems very vulnerable at this price from predators.

[a1ord53] 12/3/2018 09:08

I think Vec and Hikma being treating unfair . The both company have cash generating products and new products in pipelines. But being treating like they have nothing but Advair generic.
There should be reasons and interest of either shortsellers or take over group/s. Major shareholders should support companies and in particularly Vectura, cause oversold and undervalued imo..

[cantrememberthis2] 12/3/2018 08:53

cumnor, what are timeframes here, got 33,000 of these this morning... looking for another 17000