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Announced today & fortunately BTG has been a better investment for me ,so far ,than VEC Today’s acquisition demonstrates the US appetite to use their strong $s to make acquisitions in the U.K. Perhaps we will survive long enough as an independent company to enable shares to achieve an acceptable exit some time in the Not too distant future ?
Yep, it also has the potential to be even more positive. Now this has had the ok for paediatric use in Europe there is every chance it'll also be taken up in Japan. That could also have the potential for opening up a tad more general interest in Fluti from over the pond!
The litigation hearing in front of a High Court Patent judge (which is being instigated by GSK) is scheduled to start in the Patent Court next week. As per usual in these cases... a 5 day window has been booked into the court diary. If VEC lose the action it's possible that the downside should probably be limited to bearing the cost of the action... plus of course GSK will hang on to the capped £15m. per yr royalty money that has been withheld since July 2016.
Also losing this hearing could cause VEC to have a re-think and cancel the scheduled USA trial by jury action which has been instigated by VEC.
I don't expect a loss reulting in the company not getting what they haven't got anyway... to have a major downward impact on the sp. On other hand positive sentiment plus getting their hands on all that lovely dosh would indeed have an impact on the sp! I very much doubt that they'll win but live in hope and fingers crossed.
More good news today -not transformational but positive .
"Following interactions with US FDA, the Open-Inhale-Close dry powder inhaler device has the potential to be developed as an AB-rated substitutable drug-device combination for generic versions of the GSK Ellipta® portfolio".
"Pharmaceutical and device development work has progressed in parallel with partnering discussions. The new device is an evolution of Vectura's lever-operated multi-dose [LOMI] device and builds on Vectura and Hikma's shared experience with the VR315[US] programme, enabling accelerated development under this new agreement".
They now have priceless experience gained of what's needed to meet the FDA stringent requirements through the prolonged effort to bring generic Advair Diskus development programme to completion.
IMO, going on this all the rhetoric.... there is a strong likelihood they've been preparing for the first trials of a substitutable generic version of Breo® Ellipta to be starting as early as next spring. I also believe they are the only game in town in the generic substitutable Ellipta 'space'. They have around 4-5 years start on any other possible generic Ellipta player... due to already owning the device IP. Others would have to start device trialling from scratch.
This partnership plan has the potential to at least halve GSK's eventual projected $3Bn p.a. market for their Ellipta range. There's a gonna be a war starting very soon imo.
Nice agreement with Hikma today but I think the shadow of the looming court case with GSK will still bear down on us atm until resolution, seems to be hard work generally with all my shares atm - I'm assuming it's the Brexit factor
Charts pointing to a return to 100-110p
Vec is far from being a 1 trick pony & my view is that the sum of the parts valuation substantially exceeds our current SP.Very early days but todays RNS but must have added to our value & my hope now is for positive newsflow over the coming weeks/months in order to facilitate a rerate.
Interesting times! Emma Walmsley knew this was in the offing, but she can't be happy about this deal. The fact that she didnt make any early moves... (especially given VEC's recent low capilisation figure) to forestall this agreement, could indicate there might yet be more surprises to come on the subject of generic Ellipta during of the litigation hearing.
It would also be interesting to know what the clauses in this partnership agreement with Hikma stipulate in the event of Emma deciding she wants to go ahead and remove VEC from the game board. I also wonder if Hikma would be interested acquiring a new generic device wing! A 'big boys battle' for VEC... could quite conceivably commence very shortly!
The sp could well start ticking up again from here once the market gets fully tuned in to what the overall impact of this is going to be.
Makes even more sense now.
Agreed that not the best deal possible -but a deal with a very successful & growing conpany which ,if successful,should still result in very decent cash flows to Vec ,thereby increasing our value .Most agree that Vec is undervalued,partly due to disappointment in our performance to date & partly as we have been vulnerable to manipulators .Perhaps this will be the first of other deals/announcements which will demonstrate our worth & allow our SP to achieve fair value -whatever that may be
"he generics business continued to perform ahead of expectations, despite a challenging US retail market, with continued price erosion.
“We have made good progress with our cost reduction initiatives, including the consolidation of our manufacturing and distribution facilities, and this is supporting the strong improvement in the profitability of our generics business this year,†Hikma said.
The company added that it had signed an agreement with Vectura to develop and commercialise their Open, Inhale, Close (OIC) dry product inhaler (DPI) platform, including generic versions of GSK's five Ellipta DPI products.
"The generic respiratory market is a key area of focus for Hikma. This agreement leverages the investment we have made and the experience we are gaining through our generic Advair Diskus development programme," it said.
Hikma will make an upfront payment of $15m to Vectura with $5m payable on transfer of the first product to Hikma's manufacturing facility to enable clinical manufacturing".
not a brilliant agreement, which is why the sp has dropped back at bit already. Hickma have screwed out a good deal from their own prospective, it could have been better from VEC's prospective. With VEC being firmly under the cosh and having to deliver at least something... probably a case of 'beggars can't be choosers. Still, it's what we've been waiting for and at least things are now moving on... although it'll be a couple of years before we see anything tangible form this, hopefully and together with a successful outcome form the litigation issues... the sp will now be allowed to have some normal breathing space.
...rather good timing by Prudential wasn't it!!!!?
On approval, Hikma will pay a share of distributable net profit of up to a mid-teen percentage for each portfolio product. Hikma will also pay sales milestones on the achievement of certain cumulative net sales targets. Vectura will contribute up to $70 million towards Hikma's development activities for the portfolio. Vectura's contribution to the development costs will be deferred and made through a reduced profit share mechanism following commercial launch of the first product. 1Global Data, October 2018
Hikma (auto correct)
Thursday 08 November, 2018 Hikma Pharmaceutical Hikma announces agreement with Vectura RNS Number : 7055G Hikma Pharmaceuticals Plc 08 November 2018 London, 8 November 2018 - Hikma Pharmaceuticals PLC (Hikma, Group) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated Ba1 Moody's / BB+ S&P, both stable) today announces that it has signed an agreement with Vectura Group plc (Vectura) for the global development and commercialisation of generic versions of GSK's Ellipta® portfolio, utilising Vectura's proprietary Open-Inhale-Close dry powder inhaler device. Siggi Olafsson, Chief Executive Officer of Hikma, said: "The generic respiratory market is a key area of pipeline focus for Hikma. This agreement leverages the investment we have made and the experience we have gained through our generic Advair Diskus® programme. By strengthening and expanding our partnership with Vectura, we will develop a pipeline of complex respiratory products that will enable us to deliver sustainable long-term growth." A significant opportunity to bring complex respiratory products to market Following interactions with the US FDA, Vectura and Hikma believe the Open-Inhale-Close dry powder inhaler device has the potential to be developed as an AB-rated substitutable drug-device combination for generic versions of the GSK Ellipta® portfolio. This presents a significant opportunity, with net sales for Ellipta® products in the US projected to be $4 billion by 2024 and approximately $5.5 billion globally1. The Open-Inhale-Close dry powder inhaler programme includes the development of AB-rated substitutable generics of up to five GSK respiratory medicines. Hikma and Vectura have agreed to develop and commercialise at least three of the portfolio products. A substitutable generic version of Breo® Ellipta® (fluticasone furoate and vilanterol trifenatate) will be prioritised for the first wave of development. Pharmaceutical and device development work has progressed in parallel with partnering discussions. The new device is an evolution of Vectura's lever-operated multi-dose (LOMI) device and builds on Vectura and Hikma's shared experience with the generic Advair Diskus® programme, enabling accelerated development under this new agreement. Financial considerations Upon signing, Hikma will make an upfront payment of $15 million to Vectura. Vectura will be responsible for, and fund, initial device and formulation development. Hikma will be responsible for clinical development, regulatory submission and commercialisation. Upon transfer of the first product to Hikma's manufacturing facility to enable clinical manufacturing, Hikma will make a $5 million milestone payment to Vectura. Thereafter, Hikma will make milestone payments of up to $75 million at various stages of development, including the delivery of pharmacokinetic clinical trials, pivotal clinical trials, ANDA submissions and FDA approvals. On appr
Well they had better hurry up because there is a queue forming... and they are about to start stamping their feet.
What will The Shorters & Manipulators make of todays exciting news-although i expect we will be marked down to 60p.
with view to our partnership with HIK re Advair it was always likely that any generic launch of the Ellipa range would also be partnered with them.By market cap they are around 10 X bigger than ourselves & it is probably not unreasonable to assume that if anyone showed an interest in acquiring us that they may want first choice.
Yep, it could go either way from here. I doubt we will get the outcome of the litigation for quite some time after the hearing has been completed. It's quite normal to take even a couple of months. I'm expecting/hoping the phase 111 trial results will be announced sometime soon... those results will be far and away more significant than the earlier trial. Fingers crossed it's good news and we'll be looking down, if it's bad we could well end up looking up from the current sp level!
The Hik trial for generic Advair is still having its re-run so dunno if we'll get much on that till it's completed. The timescales for market launch, working backwards from their stated/hoped for launch date of early 2020 and allowing for several months from FDA submission to approval... and from that to scaling up production... seems to point to the trial probably being completed mid next spring.
I think it's those phase 111 results we'll be getting next... it also could be that any prospective partnership for the Generic Ellipta plans will be delayed until the litigation issues are resolved. Hope not but the outcomes could cause a delay due to a 'play safe and wait and see' situation for any prospective partner.
Many balls stil in the air. This stock certainly needs patience, also disappointing that the sp has been kept firmly under lock and key whilst the Pru have been busy acquiring 31 million shares, under 'normal' conditions that would have seen a positive uptick in the sp. It once again shows up that the sp is certainly being 'managed'.
If it is being 'managed' (and I'm confident it Is) then upside of that particular 'idea' is that imo the sp is at a falsely low level. But, and although obviously disappointing... the short term intraday sp isn't important for a Pharma investment if looking outwards a couple of years. I remain confident that this will substantially re-bound over the next couple of years unless it's bought out first.
We were promised much newsflow in the second half ,which should make for a busy few weeks on the RNS front before 31st December.Hopefully Hikma s trading up date this week will start the ball rolling with positive progress reported on our Advair study, followed by a much hoped for successful outcome of our litigation with GSK -apart from expected progress on our prospective new products & Partnerships.
this has been a woeful investment so far but perhaps the worm is about to turn ?
Only one fund, Conner, Clark and Lunn Investment Managmeng are short VEC (0.6%)
Perhaps quite strongly indicative that not many are willing to bet against VEC. Also seems that Prudential with a 31 million share buy are positively betting on them being successful on all fronts.
Prudential must have some real confidence in VEC's future by entering the fray at this time... an inaugural buy of 31million shares and giving themselves a just over 5% holding.
another wild day with big price swings,when will we break out of this 68 to 73 trading range?GLA.
Yes... and imo the reason is Kyorin have today reported results on sales for Q2... which also included Y6.1Bn for H1 FY19 for Flutiform. Y0.7Bn ahead of last year and Y0.4Bn ahead of market estimates.