Vectura Group

Vectura Group

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Vectura Group Discussion on Interactive Investor

Re: Price has fallon news that got advai... by Andy Reilly

  Tue, 25 Apr 2017 13:38:00 GMT

d297 - well, optimism is looking a tad wobbly today, and IF ONLY FDA approval was guaranteed! Unfortunatly its not, but Bios are exciting and risky, and we are hopefully all 'grown ups' here, and know the score! Hope all goes well for you - AR

By Andy Reilly

Re: Price has fallon news that got advair FD... by dave297

  Tue, 25 Apr 2017 06:37:00 GMT

Hopefully our product will be approved & come under the category of "bigger threat ".
Sunny day in & have to remain optimistic !!


By dave297

Price fall. Teva have gained first FDA on Advair ... by d gaser

  Mon, 24 Apr 2017 17:26:00 GMT

This is why our price fell today, it appears Teva received FDA clearance for their own generic Advair, however, it doesn’t work in the same way as Advair does ,nor can it be used for chronic obstructive disorder ,even though the chemicals used in the same product as GSK ,but it’s the way they have decided deliver them that has cost TEVA , as it’s done via a different delivery system .However it doe’s gives Teva a good two months start on our product provided we get clearance in May, but in the meantime Teva could hoover up 25% of Advairs asthma market .
Be happy
Dave
Today Teva Pharmaceutical Industries Ltd (TEVA.TA) (TEVA.N) on Thursday launched an asthma inhaler that will be the first direct competition to GlaxoSmithKline's (GSK.L) best-selling Advair.
Teva, which won U.S. approval in January to make an inhaler similar to Advair, also launched a generic version of its own inhaler, AirDuo RespiClick.
AirDuo is not a true generic of Advair, but contains the same two active ingredients, fluticasone propionate and salmeterol. However, it delivers a lower dose of salmeterol and uses Teva's RespiClick inhaler rather than copying GSK's device.
"We imagine that there should be sufficient time window for AirDuo to be the sole competing product to Advair," Raymond James analyst Elliot Wilbur said in a client note.
Advair, which brought in 1.83 billion pounds ($2.35 billion) in 2016 sales, is also widely used to treat chronic obstructive pulmonary disease, while AirDuo is only approved for asthma and is not directly substitutable.
"Neither branded AirDuo, nor its authorized generic are therapeutically equivalent or substitutable for Advair," GSK's spokeswoman Sarah Alspach told Reuters.
Still, Teva's product is likely to grab some share of the asthma market. AirDuo could capture 25 percent of the market by 2018, Wilbur said.
However, the bigger threat to GSK will likely come from fully substitutable generic copies of Advair that are still awaiting approval.
LINK


By d gaser

Price has fallon news that got advair FDA clearence TEA by d gaser

  Mon, 24 Apr 2017 17:22:00 GMT

This is why our price fell today, it appears Teva received FDA clearance for their own generic Advair, however, it doesn’t work in the same way as Advair does ,nor can it be used for chronic obstructive disorder ,even though the chemicals used in the same product as GSK ,but it’s the way they have decided deliver them that has cost TEVA , as it’s done via a different delivery system .However it doe’s gives Teva a good two months start on our product provided we get clearance in May, but in the meantime Teva could hoover up 25% of Advairs asthma market .
Be happy
Dave
Today Teva Pharmaceutical Industries Ltd (TEVA.TA) (TEVA.N) on Thursday launched an asthma inhaler that will be the first direct competition to GlaxoSmithKline's (GSK.L) best-selling Advair.
Teva, which won U.S. approval in January to make an inhaler similar to Advair, also launched a generic version of its own inhaler, AirDuo RespiClick.
AirDuo is not a true generic of Advair, but contains the same two active ingredients, fluticasone propionate and salmeterol. However, it delivers a lower dose of salmeterol and uses Teva's RespiClick inhaler rather than copying GSK's device.
"We imagine that there should be sufficient time window for AirDuo to be the sole competing product to Advair," Raymond James analyst Elliot Wilbur said in a client note.
Advair, which brought in 1.83 billion pounds ($2.35 billion) in 2016 sales, is also widely used to treat chronic obstructive pulmonary disease, while AirDuo is only approved for asthma and is not directly substitutable.
"Neither branded AirDuo, nor its authorized generic are therapeutically equivalent or substitutable for Advair," GSK's spokeswoman Sarah Alspach told Reuters.
Still, Teva's product is likely to grab some share of the asthma market. AirDuo could capture 25 percent of the market by 2018, Wilbur said.
However, the bigger threat to GSK will likely come from fully substitutable generic copies of Advair that are still awaiting approval.
LINK


By d gaser

Re: Downgraded by raptor66

  Mon, 24 Apr 2017 12:53:00 GMT

This depicts very negative aspects of Vectura business:

'Unedited extract from Report and Accounts for the nine-month period ended 31 December 2016

RISK MANAGEMENT AND INTERNAL CONTROLS'

LINK

Why is it that VEC have decided to highlight this now, I wonder??


By raptor66

Re: Downgraded by dave297

  Mon, 24 Apr 2017 12:36:00 GMT

Apparently concern over the outcome of the FDA decision expected on 10th May,while being generally optimistic about our portfolio & prospects.Lets hope we get great news on 10th may .

By dave297

Downgraded by raptor66

  Mon, 24 Apr 2017 10:59:00 GMT

Vectura downgraded today by N+1 Singer to sell, price target 132p.

Does anyone know the reason for this?


By raptor66

Re: ..HBM Healthcare Investments (Cayman... by dave297

  Tue, 11 Apr 2017 21:56:00 GMT

HBM owned approaching 30% of SKP & I thought that following the acquisition their holding in Vec reduced to about 10%

By dave297

Re: ..HBM Healthcare Investments (Cayman) L.... by d gaser

  Tue, 11 Apr 2017 16:02:00 GMT

you have to open the 6 months account page which is on the right of the link at the bottom of the page
pagewww.hbmhealthcare.com/en/unternehmen/profil.php
Be Happy
Dave


By d gaser

..HBM Healthcare Investments (Cayman) L... by d gaser

  Tue, 11 Apr 2017 12:18:00 GMT

Sorry the web site I posted on my last post didn't open and was the Swiss web site any way which is OK if you can read it ,the company is apparently listed on the Swiss market .,this one I believe, is their USA site
www.hbmhealthcare.com/en/unternehmen/profil.php

BE HAPPY
DAVE


By d gaser

...HBM Healthcare Investments (Cayman) Ltd. by d gaser

  Tue, 11 Apr 2017 12:05:00 GMT

interesting R.N.S this morning it appears H.B.M Healthcare Investments (Cayman) Ltd. have taken a 10% holding in Vec , their is also a sub holder that's a ltd company called Morestan Nominees Ltd A/C SEG and intotal they now hold 67,818,316 personaly I don't have any knowledge of either company ,so I Googled them and they are a strange mix .see links
.www.hbmhealthcare.com/wAssets/docs/pressemitteilungen-en/2017/20170403-Media-Release.pdf

LINK


BE HAPPY
DAVE
--
RNS

Full name of person(s) subject to the notification obligation: iii

HBM Healthcare Investments (Cayman) Ltd.

4. Full name of shareholder(s) (if different from 3.):i Morestan Nominees Ltd A/C SEG

5. Date of the transaction and date on which the threshold is crossed or
reached: v 6 April 2017

6. Date on which issuer notified: 10 April 2017

7. Threshold(s) that is/are crossed or
reached: vi, vii 10%
8 Total number of shares held 67,818,316

be happy
dave


By d gaser

Barclays suggest Hickma will get approval . by d gaser

  Mon, 10 Apr 2017 17:03:00 GMT

This I found very interesting those of you who have the Barclays up dates will have seen this article about Advair and the chances of Hikma Pharmaceuticals being the first to get out a Generic equivalent,and approved by the FDA ,and according to Barclays Hikmas has benefited from the expertise of Vectura ,how all ready have an Advair Discus approved in Europe.
----
Hikma Pharmaceuticals

Hikma Pharmaceuticals got a boost on Monday as Numis upgraded the stock to 'buy' from 'add'.
It said that following Mylan's Complete Response Letter, the market is now overly discounting Hikma's prospects for gaining approval of its generic version of GlaxoSmithKline's bestselling asthma drug Advair this year.
In addition, the share price is now also heavily discounting the core business, Numis said.
"If Hikma gains FDA approval this year, most likely with minor deficiencies in a complete response letter, we see potential for a slight upgrade to our low-end FY17 forecasts, and a material upgrade to our low-end FY18 forecasts (potentially more than 10%), and envisage a higher multiple being warranted post upgrades (14x FY18 EV/EBITDA well underpinned versus peers)."
Numis reckons Hikma has a stronger chance of approval than Mylan because it included 12-18 year olds in its study and has benefited from the expertise of Vectura, a business that, unlike Mylan, has a generic version of Advair Diskus approved in Europe in partnership with Sandoz.
"In our opinion the current share price is well underpinned by the core business (more than 25% upside), with a free option on generic Advair. This is an asymmetric risk worth taking, with the catalyst now a month away and potential for more than 50% returns if Hikma's generic Advair is approved first time, or with minor deficiencies."
In its final results on 15 March, Hikma said it expected revenue for the Generics business to be around $800m this year, with an improvement in the mix of sales and new product launches more than offsetting the impact of increased competition on the marketed portfolio and a reduction in contract manufacturing revenue.
The group said certain new launches were expected to contribute around 15% of Generics revenue in 2017, primarily generic Advair, which was assumed to be launched in the second half of the year.
Numis has a 2,350p price target on Hikma.


By d gaser

Re: launch of product using FOX� smart nebul... by dave297

  Wed, 05 Apr 2017 14:23:00 GMT

dg-useful additional milestone & modest royalty income but proof of concept will be enhanced & roll out in other territories will hopefully follow.
This is a relatively minor victory in our in our ambitions for great success & further success on 10th May should represent an opportunity for a further re rating.we will hopefully discover another reason why GSK are trying to shaft us in respect of royalties due as their revenue from Advair will reduce substantially if our generic version is accepted .


By dave297

launch of product using FOX® smart nebuliser. by d gaser

  Wed, 05 Apr 2017 13:50:00 GMT

The news keeps coming yet still no movement of the S/P ,
Be Happy
Dave


Vectura Group plc


First launch of a product incorporating Vectura's FOX® smart nebuliser technology
Chippenham, UK - 5 April 2017: Vectura Group plc (LSE: VEC) ("Vectura", "the Group"), an industry-leading device and formulation business for inhaled airways products, confirms that its partner Bayer AG ("Bayer") has launched Breelib™, the new nebuliser for Ventavis® (iloprost), in Poland. BreelibTM has been developed by Bayer in collaboration with Vectura, adapting Vectura's FOX® handheld smart nebuliser device and utilising its unique flow rate and volume control technology. The launch triggers a €5 million milestone for the Group. Whilst the future financial value of this programme for the Group will be limited given the small patient population, this launch is an important validation of the FOX® technology and its future potential. Vectura is eligible to receive annual milestones on the anniversary of this first launch on a decreasing scale, over six years, to the total value of €5.75 million.
The application of Ventavis® with the Breelib™ nebuliser was approved by the European Medicines Agency in October 2016. Following the EC Declaration of Conformity, marketability of the medical device was granted by the EU Notified Body in December 2016.

The new BreelibTM device developed through this collaboration (VR876) with Bayer in the EU and Rest of World territories, excluding the US, has been designed to deliver Ventavis® at an optimal particle size and to allow for a breath-actuated nebulisation at a fixed volume and flow rate, utilising the FOX®'s unique flow rate and volume control technology and thereby improving delivery to the lungs. In a clinical trial that compared BreelibTM with a currently recommended nebuliser, the new device demonstrated a reduction in mean inhalation time of each inhalation from approximately 11 minutes to approximately 3 minutes, providing for a significant reduction in the overall daily treatment duration for patients. These clinical trial results will be published in due course.

James Ward-Lilley, Chief Executive Officer of Vectura:
"We are pleased to have supported Bayer in this collaboration enhancing drug delivery and ease of device usage for patients with pulmonary arterial hypertension. The launch of the Breelib device marks an important validation of Vectura's mesh based handheld device technology using the FOX smart nebuliser. Breelib's proprietary flow-rate and volume control system is also utilised in Vectura's jet based AKITA nebuliser platforms. Vectura expects to increase the utilisation of the mesh based nebuliser platforms with a number of further partnering collaborations."

- Ends -

Enquiries

Vectura Group plc +44 (0)1249 667700
Andrew Derodra - Chief Financial Officer
Fleur Wood - Director Communications
Elizabeth Knowles - Director Investor Relations and Analysis

Consilium Strategic Communications +44 (0)20 3709 5700
Mary-Jane Elliott / Sue Stuart / Jessica Hodgson vectura@consilium-comms.com


About Vectura
Vectura, a FTSE250 company listed on the London Stock Exchange (LSE: VEC), is an industry-leading device and formulation business for inhaled airways products offering a uniquely integrated inhaled drug delivery platform. With our extensive range of device and formulation technologies, integrated capabilities and collaborations, we are a leader in the development of inhalation products, increasing our ability to help patients suffering from respiratory diseases.
Vectura has seven inhaled, four non-inhaled and ten oral products marketed by partners with growing global royalty streams, and a portfolio of drugs in clinical development, a number of which have licence agreements with several global pharmaceutical and biotechnology companies including Hikma, Novartis, Sandoz, Mundipharma, Kyorin, Baxter, GSK, UCB, Ablynx, Grifols, Bayer, Chiesi, Alm


By d gaser

Re: Launch of UtibronTM Neohaler® in the... by Andy Reilly

  Tue, 04 Apr 2017 20:40:00 GMT

sos - gloomy even! AR

By Andy Reilly