dave297
15 Mar 2018
HIKMA Lets hope our results next week result in a recovery in our SP on a comparable level to Hik, or perhaps we too need a new & dynamic CEO with a substantial proven track record in the industry.alternatively if Hik made a lowball offer I suspect most of us would accept to just give us a "reasonable " exit
d gaser
13 Mar 2018
Re: FDA up hold their decission 2012 pos... Hi Matal thought you might like read a report the FDA put out in 2013 giving, new guidance to companies who want to produce an Advair generic product .I have put a link at the bottom of this page to the report and they couldn't have made it much clearer as to what they wanted and it says, they essentially require relatively simple preclinical data backed up by a very short clinical trial", likely only at the lowest approved dose of the reference product. I should also say Teva have all ready received FDA clearance for their product ,be it delivered ,differently to the original product see bottom of page for the links BE HAPPYDAVE Moreover, it looks like the FDA will only require bridging data from an asthma trial for approval, even though both Advair and Symbicort are approved for use both in asthma and the fast-growing COPD market. BE HAPPYDAVE .The US Food and Drug Administration (FDA) has published draft guidance on generic copies of combination drugs for respiratory diseases which could hasten generic competition to GlaxoSmithKline's (GSK) big-selling Advair brand.Advair (fluticasone and salmeterol) has already started to lose patent protection in some markets, including the US in 2010, but it remains a key product for GSK.Sales were around $7.6bn last year across Advair's approved indications in asthma and chronic obstructive pulmonary disease (COPD), accounting for around 18 per cent of the group's turnover and an estimated 25 per cent of profits. Complexities in manufacturing generic versions of Advair that are directly substitutable for the brand have made it remarkably resistant to competition, with Teva and Sandoz both running into difficulties developing their own versions. One complicating factor for would-be rivals is mimicking the delivery profile of GSK's Diskus inhaler.The FDA's new draft guidance provides a simplified framework for companies trying to develop generics of Advair as well as other combination inhaled medicines such as AstraZeneca's Symbicort (budesonide/formoterol), also a blockbuster with sales of $3bn-a-year. Analyst Savvas Neophytou at Panmure Gordon notes that the guidelines "essentially require relatively simple preclinical data backed up by a very short clinical trial", likely only at the lowest approved dose of the reference product. Moreover, it looks like the FDA will only require bridging data from an asthma trial for approval, even though both Advair and Symbicort are approved for use both in asthma and the fast-growing COPD market. How quickly generic drugmakers make use of the new guidance to bring their own combination respiratory therapies to market remains to be seen, but the size of the market opportunity suggests they will not rest on their laurels.www.pmlive.com/pharma_news/fda_guidance_clears_path_for_advair_generics_502704you should also read this as Teva was granted FDA clearance for a copy of Advair, but it's delivered by different inhaler's see link below www.fiercepharma.com/pharma/putting-pressure-advair-teva-launches-airduo-respiclick-and-authorized-generic
Matal
12 Mar 2018
Re: FDA up hold their decission 2012 pos... All the companies who are trying to produce a generic for Advair are just as experienced with FDA submissions procedures as HIK/VEC, they have also been refused and imo are going to find themselves in exactly the same position again. The problem would seem to be one of direct equivalence. These so called generic replacements for Advair/Diskus are in fact NOT an exact or 'true' generic replacement! That I believe is down to the delivery device not being an exact copy! It seems the FDA have NO problem with the GyroHayler replacing Diskus... but they want a further trial undertaken. That is an obstacle that all the rival companies will have to overcome and it will be much harder for them to develop a substitute delivery device of equvilant accuracy and quality as the GyroHayler. Patients will have to be weaned off the Advair/Diskus device and will have to be taught and learn about... and how to use the new devices by their medical practitioners so they get their vitaly important correct dosages. This is going effect all requests for approval and new trials will have to be undertaken by anyone else hoping to introduce a replacement for Advair. HIK and VEC knew this was coming purely as result of the investigations that they have been involved with since the last refusal... and so are in a prime position and prepared to get a new trial undertaken straight away. I do not expect any of the others to get a march on us... in fact I think we will find they will now be firmly at the back of the que and may even call off their projects! The gainer will be GSK for another year, and it's how THEY react to having more time to play with that will have the most impact on future VEC revenues for this product.
d gaser
12 Mar 2018
Re: FDA up hold their decission 2012 pos... Metal I'm not sure what you are trying to say ,regarding our BOD and the way they and HIK have approached this project .You have to remember this is not the first FDA project V.E.C have partnered, but it is the first ,where some thing should have proceeded with out a problem has only been kicked back due to no end of trials criteria being delivered to the F.D.A or undertaken, let me ask you a question ,if you were running a drug trial ,would you not ask those running it what the FDA would require from those trials ?would you then offer some thing different ? .We all ready know the problem didn't arise from the VEC delivery system, so I don't see any problem there, and I know from many years experience of following VEC that they have achieved many successful projects over the years, which included FDA clearances , but to me, what happened here was a mistake due to company rushing to be the first company to deliver an alternative generic Advair product , HIK and VEC both know other companies' are out there, including Tiva who are also close to being the first to gain F.D.A approval , VEC &HIK know that those companies' will now have read this judgement, and like many others will adapt their trials accordingly, before taking their product to the FDA, for approval. That unfortunately gives them an advantage, but who ever is first to get clearance will then take the biggest market share of the Advair market, lets hope it is us as you suggest ,but we have just made it much easier for our competition .BE HAPPYDAVE
Matal
12 Mar 2018
Re: FDA up hold their decission 2012 pos... ... following on from this is also the remarks in the RNS about other prospects in the states. Undoubtedly this disappointing result should at least impart some very important knowledge and experience that the FDA expect to see from any future submission processes... and could well indeed help smooth the path to acceptance for other future ventures and prospects that are currently in the American 'pipeline'."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. 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". (Ends)This report from November 2016 shows up the importance of the above remarks:Vectura has extended its relationship with Hikma after the two UK-listed pharmaceutical companies signed another agreement to work together to develop a generic inhaled drug.Vectura.... specialises in formulating powders and inhalation devices for people with asthma and chronic obstructive pulmonary disease, 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.Hikma and Vectura are already working in partnership to develop other respiratory drugs in the states.... this experience should considerably help them and any other of VEC's partnerships to get it right in the future.
Matal
12 Mar 2018
Re: FDA up hold their decission 2012 possibl... Yes dg, in many ways your right and due to the admittance that they are already prepared to start another trial. (which doesn't get organised in a five minute notice) they obviously have known for a long time what the decision would be! However... really bad news would have been the FDA completely rejecting the submission rather than requesting another trial... and/or HIK/VEC deciding to bin it! On completion of the extra requested trial It's now likely that the new submission next year will be no more than a formality and this is going to be huge arrow in VEC's armoury. It also likely that the other 'competition' will now have severe reservations about THEIR attempts to get a generic off the ground. What we have to the good side which the others possibly haven't... is the substitutability of VEC's GyroHayler for GSK's Diskus delivery device!We still have the GSK litigation to look forward to at the end of the year... but with the uncertainty over the generic now removed and a clear way forward identified and accepted... the case for being short at the current sp levels should also be vastly reduced, particularly in addition to there now being a more realistic chance of an appropriate bid coming in... (we could now even see something on that subject next week). All we need is to receive the expected good 'in-line with expectations' report next week and as long as there are no nasty hidden surprises, we could have a good chance of being back at least above the 100p mark. With the current bidding speculation being more realistic... possibly quite a lot more!
d gaser
12 Mar 2018
FDA up hold their decission 2012 possible end date Personally I hadn't seen this RNS ,so I was at a bit of a loss as to what had happened with regards to previous posts .I must admit it's good to get a formal decision regarding our generic Advair decision from the FDA ,but for them to up hold their original decision, shows it was not ready to be put before the FDA ,and the fact FDA has now requested Hikma to complete an additional Endpoint study is not some thing I would expect ,and I must admit this is a first for me twenty five years I have been investing in medical companies and not once before has this happened . The question now is ,why hadn't Hikma got it right prior to their submitting . This decision is just another kick in the face , and one I don't think helps our position ,what it doe's show though, is pour decision making at the top of these two companies ,which has put back any potential approval date for the generic Advair product until as late as 2020.Thats a further two years before any thing will happen, and by then, its possible others will have beaten us to it .BE HAPPYDAVE RNS ,Vectura Group plc Status update on ANDA for generic Advair Diskus® (VR315)Chippenham, UK - 12 March 2018: Vectura Group plc (LSE: VEC) ("Vectura" or the "Group"
, an industry-leading device and formulation business for inhaled airways products, announces that its partner for a US generic version of Advair Diskus® (VR315), Hikma Pharmaceuticals PLC ("Hikma", has received a response from the US Food and Drug Administration ("FDA" in relation to the dispute resolution process for its abbreviated new drug application ("ANDA" for VR315.Hikma has confirmed that the dispute resolution process has now concluded. The FDA has upheld its original decision and included a request that Hikma completes an additional Clinical Endpoint study. In anticipation of this as one of the potential outcomes, Hikma has already finalised the planning of a new clinical study and expects to start patient enrolment in the coming weeks. Hikma anticipates being able to submit a response to the FDA with new clinical data as early as possible in 2019. Hikma and Vectura have had constructive dialogue with the FDA to resolve the observations made in the Complete Response Letter ("CRL" received on 11th May 2017 and they have been able to address and clarify the majority of the questions raised. As announced on 9th 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® 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. For more information, please contact:Vectura Group plc+44 (0)7471 352 720Andrew Derodra - Chief Financial Officer David Ginivan - VP Corporate CommunicationsElizabeth Knowles - Director Investo
dave297
12 Mar 2018
Re: A good reaction! Our Board will also have a better idea of our value too and now in a much stronger position to negotiate an exit, which, my guess is, James would support
Matal
12 Mar 2018
A good reaction! Now the uncertainty has been removed with the FDA decision being upheld, the sp should now recover to a more appropriate level and reflect the strong business, pipeline cash position and the many other attributes that VEC really has got going for it. There is now a clear way ahead and next years submission for the generic should prove to be a formality. In the meantime, with the uncertainty being removed... imo anyone thinking of making a t/o bid will almost certainly have been waiting for this clarification and now be able more realisticy put a price on the company.
Matal
12 Mar 2018
A good reaction! Now the uncertainty has been removed with the FDA decision being upheld, the sp should now recover to a more appropriate level and reflect the strong business, pipeline cash position and the many other attributes that VEC really has got going for it. There is now a clear way ahead and next years submission for the generic should prove to be a formality. In the meantime, with the uncertainty being removed... imo anyone thinking making a t/o bid will almost certainly have been waiting for this clarification and now be able more realistic price on the company.
Matal
11 Mar 2018
Possibly more substance.... ... than the previous rumours from the Telegraph! 10 MARCH 2018 • 8:45PMBritish copycat drug makers are on bid alert after Stada, the German pharma firm, revealed it is on the hunt for acquisitions in order to gain access to the UK generic drugs market.Claudio Albrecht, Stada’s chief executive, admitted it is currently weighing up a swoop in the UK market, adding that work on pinpointing an acquisition is already happening.Mr Albrecht was tight-lipped on a UK target but City analysts suggested that beleaguered London-listed firms Vectura and Hikma could fit the bill – two companies developing generic drugs, products with expired patents.The German drugs giant has cut its dividend to boost its war chest and has targeted cost savings of $100m (£72m) by 2020.[link]
d gaser
07 Mar 2018
Re: shorts being closed Hi AR Hopefully things will get better after the 21 march .I have just looked again at the shorts, and believe it or not ,another two other companies have opened shorts while companies like Algert securities and capital fund south Africa have all increased their shorts on the 2nd March,that explains why the Volume since Friday is high . I topped up last week at 71p, so I'm hopping things will get back to normal next week . I'm just keeping every thing crossed that the accounts on the 21 are good ,and that the company hasn't reduced their margins in order to keep the cash flowing in, if they have, then this could crash again . We need good news such as a contract or up front payment before then , in order to boost the S/P ,but if nothing appears then I fear any gains could shorted again. We also need support from our BOD, The directors need to show the market they believe in VEC them self's , by buying shares on the open market in quantity ,and not just a few hundred as they have been doing recently. The share buy back was a complete failure, if it was done in the hope they could push the price up before the end of year accounts are issued ,as their free share allowance for next year is based on the share price on that day ,if they haven't met the target price,then they can say good by to free shares this year . look after your self BE Happy Dav
Matal
07 Mar 2018
Re: shorts being closed ShortTracker shows they have merely reduced... not closed all! Total shorts figures now down from 3.55% to just below 3%. The sp was up over 5% yesterday and down over 7% today on no news... but VERY interesting that the number of thousands of small bot trades seem to have sharply declined since the buy back completed.... although still in evidence today. The sp was/is being worked/manipulated by someone, somewhere. HIK report on the 14th which hopefully might steady the ship if nothing else!
Andy Reilly
06 Mar 2018
Re: shorts being closed dg - hope you are right - there seems to be resistance around 85p, but glad those shorts are closing for now... They will possibly be back on any sign of VEC faltering - lets just hope results support a better SP! ATB
d gaser
05 Mar 2018
shorts being closed I checked short trader today, and found that two companies have now closed their shorts ,global assets, and JPMorgan. Hopefully we will now see the S.P move north ,before the end of year figures are realised BE HAPPYDAVE
