Skyepharma Share Discussion Threads

[cityfarmer] 29/12/2015 20:51

Cap160 sounds like you have been through the SKP sausage machine same as me - Black and Edgington brings back memories think it was a tent or marque rental company before SKP -what a journey we have been on .... almost put me in a nut house more than once!

Dunders - you are also a blast from the past hope all is well? I am the official daddy but you can be my little SKP helper :-)

[gersemi] 29/12/2015 18:30

What a stock and so much growth to come

[evil_doctor_facilier] 29/12/2015 18:24

Now 4 bagged for me in circa 2 years, i honesty dont see anything else at this time that i would buy with the money ,if i sold out.
This and redd have been the best low risk double long term holds of the last two years, incredibly fortunate to have been on both.

[cap160] 29/12/2015 18:22

Pacira still on the rise--touched 80 dollars earlier

[dunderheed] 29/12/2015 17:46

Yeah but I'm still the daddy of this stock citifarmer! !

[cap160] 29/12/2015 16:08

WhooHoooo. 4 QUID

[cityfarmer] 29/12/2015 13:42

“Turkeys”; may have been more appropriate in years gone by due to the right good stuffing we took year on year on year... although prefer “babies” today and hope they will grow up to be something we can all be proud of – personally do think they will (are) :-)

[scotches] 29/12/2015 13:19

Well that's the 15th anniversary just passed of my first dabble here in these turkeys, sorry I mean babies, bought on a "friend's" tip. It just needs to double from here and I finally get my money back! However there is now some genuine hope it might do exactly that - rather than just sitting in the portfolio waiting to be used to offset CGT.

[cityfarmer] 29/12/2015 09:39

Hi SKPers
Well another year passes and been another very encouraging one for us long suffering SKP holders. We do seem to be making great progress on a number of fronts and particularly pleased with the last two announcements. I have been with these babies for 18yrs plus and never felt more confident regarding future success and what’s different this time - we have a far better financial base (and at one point never thought I would be ‘ever’ able to say that…).
Very best wishes to you all for 2016 and hopeful, this will be a good one for us SKPers
The Official SKP Daddy

[soundbuy] 29/12/2015 09:07

Cheers all.........

[leonasdad] 28/12/2015 02:06

cap160, fhmktg and stentorian make the market for skyefarma read interestingly invigorating.

[cap160] 27/12/2015 15:46

Stentorian I too am eagerly awaiting the pre close update with an share price around 430p if news is good. Fingers crossed

[stentorian] 27/12/2015 15:16

fhmktg,

Flutiform 250/10 micrograms version delivers fluticasone propionate 230 micrograms (Inhaled corticosteroid ("ICS")(the anti-inflammatory)and formoterol fumarate dihydrate 9 micrograms (Long acting beta2 antagonist ("LABA")(the bronchodilator). Flutiform is a combination inhaler containing ICS/LABA.

As SKP-2076 is disclosed as a novel triple ICS/LABA/LAMA for asthma with with potential for relatively quick development for Europe. It is implied that formoterol will be the LABA as the only other existing alternative being used in a pMDI is salmeterol - used in GSK's Seretide/Advair. SKP having no experience with saleterol would not be able to quickly develop it for Europe hence the reason it must be formoterol.

GINA (Global Initiative for Asthma) guidelines are well established that ICS/LABA combinations will remain the mainstay of the therapy for Asthma. The addition to ICS/LABA of a Long Acting Muscarinic Antagonist ("LAMA")such as Tiotropium or Glycopyrroniummay offer more efficiencies.

Finally, I'm looking forward to the pre-close update for the full year. Last year it was on Monday, 12 January 2015. By parity of reasoning, it should be on Monday, 11 January 2016.

Here's wishing all a happy, healthy and wealthy New Year in 2016

[fhmktg] 27/12/2015 13:31

Bill and Quackers,
Thanks for your postings, unless I'm missing something obvious, I can't find whether SP2076 uses formiterol as the proposed LABA and fluticasone as the ICS, with a known or novel LAMA or whether it is a completely 'new' triple combination.

Leaving aside my witterings, I'm enormously encouraged for the future of SKP and hope I'm around to reap the benefits of my faith- a tripling of the share price will see me back into long term profit.
Dum spiro spero!

Happy New Year!

[qackers] 27/12/2015 12:54

Reminder from trading statement as to future developments.



Skyepharma PLC - SKP
Trading Update and Capital Markets Meeting
Released 07:00 26-Nov-2015


RNS Number : 9953G
Skyepharma PLC
26 November 2015




SKYEPHARMA PLC - TRADING UPDATE AND CAPITAL MARKETS MEETING

LONDON, UK, 26 November, 2015 - Skyepharma PLC (LSE: SKP), the expert oral and inhalation drug development company, today publishes an update ahead of its Capital Markets meeting being held today. This comprises a trading update, the latest status of SKP-2075, the disclosure of SKP-2076 as a triple ICS (inhaled corticosteroid) / LABA (long-acting beta agonist) / LAMA (long-acting muscarinic antagonist) combination and further development of the oral business.

Trading update
Overall trading to date has continued to perform in line with the Board's expectations for the full year. In addition, the Group has benefited from higher cash receipts and as a result, year-end cash is expected to be ahead of the Board's previous expectations.

flutiform®
flutiform®, the combination of the fast-acting LABA formoterol, and the most widely prescribed ICS fluticasone, has now been approved in 38 countries and launched in 30. In addition, applications for marketing authorisations are currently under review in a further 15 countries.

In Europe, good progress continues to be made on the development of a breath-actuated version of flutiform®. If approved and launched, Skyepharma would be eligible for revenues on this product from royalties, milestones and filled-canister supply in the same manner as for sales of flutiform®. In addition, progress is being made with the COPD (chronic obstructive pulmonary disease) clinical study, following completion in May of the recruitment of over 1,700 patients. Mundipharma has now met with the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to agree on what is required for the resubmission of its application for a European paediatric indication of flutiform® for asthma and is considering the timing of this.

In Asia-Pacific, including China, Mundipharma has completed recruitment for a clinical trial of flutiform® for COPD involving more than 900 patients treated over a 12-week period. Preparations are also being made for a clinical trial in China for asthma which will commence once the Chinese Food and Drug Administration (CFDA) has approved the investigational new drug application.

In Japan, Kyorin reported gross sales of flutiform® of Yen 3.0 billion (£16.0 million1) in the six months ended 30 September 2015, compared with Yen 0.9 billion (£5.2 million1) in the comparable prior year period and Yen 3.6 billion (£20.3 million1) for the full year ended 31 March 2015.

In Latin America, the Group's partner, Sanofi, has obtained approval in Colombia for flutiform®, which is already approved in Argentina. Further filings are in preparation. Skyepharma and Sanofi are in discussions with a third party to commercialise flutiform® in Latin America.

Development pipeline

The Group continues to make encouraging progress in implementing its strategy to develop inhalation products with developments for the new products, SKP-2075 and SKP-2076. These products are aimed at the global market for the treatment of asthma and/or COPD currently worth approximately U.S.$29 billion per annum2.

SKP-2075
Skyepharma commenced work on the first product candidate (SKP-2075) for COPD using the novel inhaled therapy platform acquired from Pulmagen in 2014. SKP-2075 is being developed as a single capsule dry powder inhaler, comprising fluticasone propionate and a low dose of theophylline. Good progress has been made in formulating the product and with commencement of non-clinical studies for the treatment of COPD/smoking asthma. The Board believes that the treatment of COPD/smoking asthma is a clinically important medical need and SKP-2075 has the potential to be one of the first products developed for this patient group. A Phase II efficacy and safety clinical trial is planned to commence in 2016 and expected to be concluded during 2017. It is being designed to produce statistically significant results with a view to partnering SKP-2075 for further development and commercialisation. The Board has decided to extend the scope of the clinical programme by generating dose-ranging data at the same time to offer the potential for a relatively quick development for Europe which the Board believes adds considerable value to the project. The cost of the additional investment in developing SKP-2075 is expected to be circa £2 million per annum for each of 2016 and 2017 and is expected to be offset by further revenues from flutiform® supply with the additional capacity planned to come on stream during 2016.

SKP-2076
Skyepharma commenced feasibility work on a new inhaled product candidate, SKP-2076, early in 2015. SKP-2076 is a triple ICS/LABA/LAMA combination product incorporating known chemical entities aimed at the potential market for asthma patients who are not adequately controlled on current combination ICS/LABA therapies. Encouraging progress is being made with the initial formulation for SKP-2076, which is expected to move into GMP pilot scale manufacturing in 2016. In light of the positive experience with flutiform®, the Board believes that SKP-2076 could add significant value to Skyepharma's respiratory franchise and has the potential for relatively quick development for Europe. Skyepharma is already engaged in partnering discussions to licence and fund the further development of this product after the initial formulation stage.

Oral developments
As previously announced, the Group is developing Soctec™, a concept for a novel, proprietary gastro-retentive drug delivery platform technology comprising a buoyant self-orienting capsule. It is targeted at gastro-retention and aims to retain the drug delivery device in the upper gastro-intestinal ("GI") tract for as long as possible with the active ingredient being released for delivery for local action or absorption in the stomach or the upper GI tract. After an encouraging proof of concept study, progress is being made with further development to optimise the Soctec™ technology and plan for potential scale up. This technology is being marketed to potential partners.

A second technology is also under development for gastro-retention, aimed at higher payload requirements, and is currently in the final prototyping stage. Materials are being manufactured in preparation for a clinical proof of concept trial to be conducted in H1 2016.

The Group's licence partner for its SKP-1041 sleep maintenance product, Somnus Therapeutics, Inc. ("Somnus"), has been unable to secure further development funding despite a successful Phase II dose-ranging study. Somnus is, therefore, in the process of transferring all rights, materials and data back to Skyepharma. The Group has no current plans to develop SKP-1041. The only impact on the Group will be the earlier release of the remaining U.S.$0.3 million (£0.2 million) of deferred income, from the U.S.$5 million milestones paid by Somnus to date, as revenues in 2015.

Hikma Pharmaceuticals PLC ("Hikma") and Skyepharma have established a collaboration to develop complex oral generic products and a first development project is being carried out.

Peter Grant, Chief Executive Officer of Skyepharma, commented:
"We remain on track to deliver substantial growth in revenues in 2015, with continued contributions from flutiform, Pacira's EXPAREL and the GSK Ellipta-range products. This strong performance underpins our ability to invest in building the pipeline for additional future growth as well as meeting anticipated future demand for flutiform.

"Today we have announced our plans to build on the success of flutiform by developing SKP-2076, a new ICS/LABA/LAMA triple combination product for the treatment of asthma. We believe SKP-2076 has the potential for relatively quick progress through clinical trials in Europe, putting Skyepharma in a position to benefit from the anticipated new market for fixed-combination triple therapies for asthma. SKP-2075 also has the potential for relatively quick development in Europe with our plan to generate dose-ranging data as part of our Phase II programme. With SKP-2075 in COPD/smoking asthma and SKP-2076 in asthma, additional potential indications and markets for flutiform and novel oral delivery technologies in development, we have a promising pipeline which we believe can deliver significant additional long-term growth."

Capital Markets meeting
A Capital Markets meeting is being held this morning at the offices of FTI Consulting in London. Skyepharma management team members and two external speakers will make a series of presentations to provide a detailed review of Skyepharma's development pipeline as well as an update on the progress of the Group's key growth drivers and strategy. Further details of today's event are listed at the end of this press release and the Skyepharma presentations will be available on Skyepharma's website before the end of today.


1 Using exchange rates for the relevant period
2 Company analysis based on: i) Chronic obstructive pulmonary disease. Forecast. Datamonitor, DMKC0047510, Publication Date: 03/10/2014 ii) Asthma. Forecast, DMKC0082148, Publication Date: 18/06/2014 iii) Extrapolation of main market sales to global sales numbers with a factor of 25%



-Ends-

[bill hunt] 23/12/2015 15:10

fhmktg

Peter Grant, Chief Executive Officer of Skyepharma, commented:

"This new partnership further expands our excellent relationship with Mundipharma based on our successful collaboration on flutiform, which is growing well in multiple markets. The ICS/LABA/LAMA triple combination is a natural extension of the flutiform franchise and we believe it has the potential to provide an important additional treatment option for doctors and patients. SKP-2076 is a great example of innovation at Skyepharma, leveraging our expertise and strong relationships with partners to generate benefits for patients and value for shareholders."

[diesel] 23/12/2015 15:07

MM....
News in 2016
Paediatric approval for Fluti in Europe, results from clinical trial in China, COPD trials in Europe and China,
Progress on breath actuated formulation, and possible release in Sth America.
Plus news following today's announcement and on their oral technology Soctec.
I am also expecting Pacira to resume previous growth trajectories.

[mastermatto] 23/12/2015 13:38

Hi Diesel,

What news are we looking out for in the New Year? Are company earnings being released in the new year? I am debating whether to increase my holding.

[diesel] 23/12/2015 13:08

There's a lot of news due in 2016, I don't see any reason why the growth tragectory of the the last couple of years cannot be continued.
Happy Xmas all....

[polaris] 23/12/2015 11:12

Nice Christmas present for my trading position to close this am. Looks like SKP is going to end the year on a high.

Back to watching for another trading position for me.

regards all,

Paul

[cap160] 23/12/2015 10:55

And Merry Xmas to you too Peter Grant et al.

[fhmktg] 23/12/2015 09:42

Anybody know if Fluti is part of the SP-2076 formulation?
If this is based on known components could this be fast tracked through approvals in Europe?