Matal
14 Jun 2018
Mylan also refused again! Today 08:56(Reuters) - Mylan NV said on Wednesday that U.S. health regulators were unable to approve its generic version of GlaxoSmithKline’s blockbuster inhaled lung drug Advair for the second time, as they found “minor deficiencies†in the treatment . Shares of Mylan fell 4.5 percent to $39.80 after the bell. Mylan did not provide details on the nature of the deficiencies cited by the U.S. Food And Drug Administration and it remains unclear whether the company will be able to resolve them and get approval this year. The FDA has declined to approve several Advair knock-offs in the past from drugmakers including Novartis AG, Hikma Pharmaceuticals and Mylan itself, whose generic was rejected last year. “I don’t think this comes as a big surprise … people realize these are all very difficult-to-make products and they’re going to go through a couple of rounds at the FDA,†Leerink analyst Ami Fadia told Reuters. “They (Mylan) will actually still be at least one year ahead of competition if they got approval this year.†The news bodes well for GSK, which has dominated the lung drug market for decades and was bracing for competition by mid-2018. Even as the British drugmaker puts more marketing muscle on its newer lung drugs, GSK reported revenue of 3,130 million pounds ($4.19 billion) from Advair last year. Mylan said here it expects to receive a formal complete response letter, typically issued to outline concerns and conditions that must be addressed to gain U.S. approval, from the FDA on June 27 and would determine what impact, if any, it would have on its full-year forecast. U.S. – 13 Jun 18 FDA finds deficiencies in Mylan's generic Advair; shares fall Mylan NV said on Wednesday that U.S. health regulators were unable to approve its generic version of GlaxoSmithKline's blockbuster inhaled lung drug Advair for the second time, as they found "minor deficiencies" in the treatment.
Matal
08 Jun 2018
Even the shorters have given up hope! Cannot blame the short funds anymore! Only three funds now listed and total stock shorted is down to a measly 1.83% ... but with zero reflection of that in the sp! Sell in May and go away? lilkley it may drift up a bit but doubtful there will be much change now over the summer months.
Matal
23 May 2018
Re: VEC at good price?? Another poorly researched article! The litigation/court cases over the legacy royalty payments which could be worth around £100 million if VEC win are far more important considerations and so are the plans for a directly substitutable drug/device generic combo for the next generation Ellipta range! "Shares have been weak due to delays in obtaining FDA approval for its generic version of GSK's blockbuster Advair drug. We could therefore see a substantial positive impact on its top line when this finally launches into the market." That will only happen if no-one else beats them to it! BUT... if Mylan get FDA approval for their version of generic Advair with the FDA's latest decision... which is due to be announced next month, they'll have an immense lead and Hikma/VEC will be able to forget all about launching their version of it!I doubt that there'll be a "substantial positive impact on its top line" in 18 months time when Hikma/VEC hope to eventually get approval if Mylan have the generic market sown up by then! But there certainly should be a substantial positive impact on VEC's top line (and bottom line!) if they win the litigation court cases later this year!
raptor66
23 May 2018
VEC at good price?? [link]
Matal
19 May 2018
Re: HIKMA Yep, agree with that, imo the legacy payment/litigation issues which are worth around £100 million in backdated and future payments if we win... and together with the plans for launching a directly substitutable drug/device combo for the next generation Ellipta range of products are worth far more and are far more important than generic Advair. Only things I would add is if GSK's head honcho does let old loyalties to GSK interfere with the FDA decision making, then Mylan's bid is just as much at risk of being thrown out again. The problem with the other side of that particular coin imo is... if they DO win approval... market sentiment will probably see VEC's sp being knocked well back again regardless of the fact that there is nothing in the sp for Advair at the moment... since we would then be proved to be around 18 months minimum behind the generic Advair curve, the race lost and no longer worth pursuing. It's that sentiment thing again!
dave297
19 May 2018
Re: HIKMA Appreciate that Matal but our current SP includes nothing for that product & also includes nothing in respect of our prospective newgeneric products which could also seriously challenge the mighty GSK.The fact that the FDA top honcho is ex GSK could fuel speculation that the powers of evil are conspiring against us -but we have some very profitable products on the market,a strong pipeline & our prospective generic products -so we may thwart attempts to suppress our SP & we could yet recovercstrongky ,or be taken over giving an 'acceptable' exit to We accidental shareholders in Vec.Feeling optimistic this morning !!
Matal
18 May 2018
Re: HIKMA Dave.... be aware that Mylan (MYL.O) are due to hear next month if the U.S. Food and Drug Administration will approve its latest bid for a generic version of Advair! Also the USA litigation hearing has apparently been rescheduled again... back to this years Q4! Dunno what happens if both the USA and UK hearings get scheduled at the same time!
dave297
18 May 2018
HIKMA Trading update today refers to the new Advair generic study being under way & hoping for action early in 2019 , which , if they fill in the gaps this time, bodes well for next year.I havent bought more since my SKP shares were acquired & I have sold a few, at much higher prices.I am probably a fool but I do retain the hope that we will regain our higher ground & will hold for now ,unless a compelling alternative investment tempts me to sell more .
Andy Reilly
17 May 2018
Re: AGM Trading Update d297 - I hope you are right - the chart doesnt suggest more buying pressure too soon, BUT lets just hope a bit more good news comes along to support and lift the SP! It may well take some time to get over this period of drift - sentiment is a funny old thing! ATB
dave297
17 May 2018
AGM Trading Update Reiterated that we remain on target for the year & that lots of newsflow to follow - so , & despite our pathetic SP, I remain optimistic & for the first time since my SKP shares were acquired , I may be tempted to buy more as our SP has to improve over the next few months on an expected flow of positive news & as we get closer to our relaunch ( together with HIK) of our Advair Generic
Matal
10 May 2018
Advair still in the news! The US Food and Drug Administration (FDA) announced Thursday that it has denied Mylan’s petition that sought to block certain generic applications for Advair (fluticasone propionate and salmeterol).After receiving a complete response letter (CRL) for its generic Advair in March 2017, Mylan had argued in a December 2017 petition that FDA refrain from approving generic versions of Advair, which are inhalers for asthma and COPD made by GlaxoSmithKline, if they rely on multiple-batch pharmacokinetic bioequivalence study designs unless FDA concludes that such study designs are valid. Some have suggested the petition targeted Sandoz's Advair generic.In its response rejecting the petition, FDA said it has not made any final determinations on approving generic versions of the inhaler. FDA also rejected previous citizen petitions from GSK and Sandoz.But bringing generic versions of Advair to market has proven to be a tricky situation, and not just for Mylan.Novartis’ Sandoz also received a CRL for its generic and so did Hikma and Vectura for their version this March.Sandoz has said it plans to launch generics either later this year or in 2019, while Hikma said FDA called for another clinical trial to get its generic approved and it anticipates another submission in 2019.GSK predicted that after a mid-2018 introduction of a substitutable generic competitor to Advair in the US, full year 2018 US sales would be around £750 million ($1 billion). GSK said 2017 sales of the drug, first approved in 2000, were £3.13 billion ($4.23 billion).According to GoodRx, Advair prices have increased by about 35% between January 2013 and 2017.
Andy Reilly
25 Apr 2018
Re: Reasons for recent rise and fall per... r66 - Thanks for the feed back - I will have to google what went on at SKP as I cant remember, but I remember it was extraordinary, and amazing that Directors think they can get away with such behaviour! ATB
raptor66
25 Apr 2018
Re: Reasons for recent rise and fall per... Founder and Co-founder of SKP were kicked out by the major shareholders for their misdeeds. New board flogged the injectables (Exparel) and concentrated on bringing Flutiform to the market.SKP was on the road to profitability before we were merged with loss-making VEC.
d gaser
24 Apr 2018
Re: Reasons for recent rise and fall per... Have taken this from todays Barclays smart investor note .BE HAPPYDAVE WebFG News) - Japenese biopharmaceutical company Sosei confirmed that, contrary to recent press speculation about a possible offer for inhaler specialist Vectura, it did not intend to make a bid.However, to ensure it wasn't completely out of the conversation for a potential acquisition of the pharmaceuticals company, Sosei left some breathing room for itself by pointing to Rule 2.8 of the UK Panel on Takeovers and Mergers' code of conduct.Note 2 of Rule 2.8 states that Sosei, and any person acting in concert with it, reserves the right to set aside the restrictions in Rule 2.8 with the agreement of the board of Vectura, if any third party announces a firm intention to make an offer for Vectura, if Vectura announces a "whitewash" proposal, or if there has been a material change of circumstances.In other news, Vectura's chief financial officer Andrew Derodra announced on Friday that he would be leaving respiratory medicines maker to take a new role within the industry, agreeing to take up the vacant post of finance head at diagnostic services company Unilabs.As of 1530 BST, Vectura shares, which began to slip shortly after the announcement, were down 6.38% to 81.45p and more than 50% lower than last year's highs.Vectura has been hit by delays to the US regulatory approval for a generic version of GlaxoSmithKline's Advair Diskus asthma drug developed in partnership with Hikma. The pair said last month they will carry out further clinical trials after the US Food & Drug Administration called for 'major' amendments to their new drug application.
Andy Reilly
24 Apr 2018
Re: Reasons for recent rise and fall perhaps... M - Well VEC is taking a hammering! It realy does make you wonder whether, at current depressed levels, any other pharma will come in and make an offer - VEC really is struggling at the moment..... But that is sentiment for you... I hope VEC recovers, but as I say, it may well take some time! ATB to all holders - ARThe chart isnt a pretty sight!
