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Member Info for bigbob0228


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Member Since: Mon, 7th Apr 2008

Number of Share Chat Posts (all time): 123
Number of Share Chat Posts (last 30 days): 4

Last Posted: Fri 09:07


Post Distribution over the last 30 days




28 May '10

If they were to raise the bid up to 128 they might get a market going ??
30 Apr '10

Many thanks to fundymental from interactive invester for piece below.
30 Apr '10

Yes, we do have an upgrade. Rodman and Renshaw put out a piece on the 26th with a p tgt of 300p. First new piece I've seen for a while.

Boris Peaker, Ph.D., bpeaker@rodm.com
GW PHARMACEUTICALS (GWP.L: PRICE: £1.11; MARKET CAP: £143.48; Market Outperform) - EXTRACTING
SHAREHOLDER VALUE FROM THE CANNABIS PLANT
INITIATING COVERAGE
We are initiating coverage of GW Pharmaceuticals with a Market Outperform rating and a £3/share (300p) 12-month target price. We
believe that the company’s leading drug, Sativex, is safe and efficacious, and we anticipate formal approval in the UK and Spain in 2010.
NEAR-TERM REGULATORY APPROVAL
GW Pharmaceuticals (GW) is a leading pharmaceutical company focused on cannabinoid science, and the development of therapeutics
based on natural cannabinoid compounds. The company’s leading drug is Sativex, which is currently approved for cancer pain and
neuropathic pain in MS in Canada, and is under regulatory review for MS spasticity in the EU and Canada. We believe that the drug has
shown adequate safety and efficacy to justify approval.
ADDICTION CONCERNS ADDRESSED
GW successfully met the requirements of the addiction/drug likeness study requested by the FDA. The 30-subject trial used placebo and
active controls (dronabinol), and showed that Sativex does not appear to be addictive. Additionally, the cancer pain relief study showed
that the lowest dose of Sativex is more efficacious in pain relief than the higher doses, suggesting limited abuse potential in patients with
pain.
MS SPASTICITY AND CANCER PAIN PRESENT LARGE MARKETS
Due to the chronic unmet need in MS spasticity, and the need for new drugs to combat cancer pain, we believe that Sativex may find a
commercial opportunity in combination with existing drugs. Due to the novel mechanism of action and established safety, we don’t see a
direct competitor to Sativex in these markets. We estimate worldwide peak sales potential for Sativex of £350MM + in cancer pain and
£250MM+ in MS spasticity.
EXPERTISE IN CANNABINOID SCIENCE
Sativex is the company’s leading cannabinoid drug, in development for central nervous system indications. GW is a world leader in
cannabinoid science research, and the company’s pipeline includes novel cannabinoids for cancer, diabetes, epilepsy, and other
indications. We believe that the pipeline presents unrecognized upside to long-term oriented investors, while the launch of Sativex is a
potential proof of concept that may bring investor interest into the rest of GW’s pipeline.
VALUATION
GW partnered the commercial rights to Sativex with large companies around the world, and we estimate the company to collect sales
royalties of 30% in the UK, 25% in other European countries, and 20% in the US. GW does not plan to build a commercial organization,
and remains focused on drug discovery, which is largely paid by its partners. Although we anticipate earnings to be
29 Apr '10

May not mean too much but take a look at Yahoo website GWP showing a 215p one year price target,(have we had a broker upgrade)??.
25 Mar '10

Strange 200000 shares bought at 117 pps and the price did not move, somebody trying to keep the price down I think.
21 Mar '10

What next for Sativex cannabis spray?

Following today's RNS and WebCast relating to GW Pharma's cannabis spray Sativex the following steps are anticipated. The drug has now reached day 150 of the decentralised regulatory process (DCP) without any major issues, the only outstanding minor point is the Patient Leaflet:

1. Completion of regulatory documentation for decentralised application (patient information leaflet) with UK as RMS (reference member state) and Spain as CMS (concerned member state) - April 2010?
3. Closure of decentralised phase April-May 2010?
2. Grant of national licences in UK and Spain (following agreement on local labelling and packaging)- 30 days is standard approval - June 2010
4. Launch in UK - June 2010 (Q2 - company state high confidence of Q2 launch)
5. Start of Spanish reimbursement discussions - June 2010
6. Launch in Spain - September 2010 ( 3 months consultation on pricing)
3. Start of mutual recognition process in other European markets with UK as Reference Member state - July 2010?
4. Grant of mutual recognition in other major European markets (6 month approval normal) - Q1 2011 (possibly end 2010)

In parallel reimbursement discussions will be going on. The company will have submitted a price to the UK's Department of Health and unless there have been significant disagreement, Sativex will be reimbursable on the NHS from product launch. NICE (the National Institure of Clinical Excellence) may assess the drug later and boost uptake with the PCT's (Primary Care Trusts) in England and Wales, since budget holders will have guidance on usage. In the meantime prescribers may use the drug as they wish and it will be paid by the NHS. In Scotland, the SMC (Scottish Medicines Consortium) needs to pre-approve drugs before launch, but the company should have this well in hand. In Spain, GW's partner Almirall will in discussions with the Spanish Ministry of Health after licence approval, and this is usually a 3 month process.

UK approval will bring in £10 m from Bayer Schering , and in Spain Almirall will pay £2.5 m on pricing approval and on regulatory approval.

Questions and answers from today's WebCast:
Q. What indication has been approved?
A. Symptomatic improvement in symptoms of MS who have failed on other anti spastcitity medications.
Q. What territories are planned for Mutual Recognition?
A. GW and Almirall are putting together a list. Major commercial markets included. NICE preparation in hands of Bayer Schering, Market access team who have significant expertise..
Q. Any plans to expand label?
A. No, comfortable with indication.
Q. Is cancer pain trial on track for Spring.
A. Yes
Q. What are launch logistics?
A. Sufficient launch stock. Manufacturing licence issued in 2009. Launch batches delivered into distribution chain on approval announcement.
Q. Is there capacity to cater for global demand?
A. Yes, capacity will be ramped up using 3rd parties.
Q. What are
21 Mar '10

GW pharma (GWP) - An exceptional week for GWP as the company announced that all aspects of safety, quality and efficacy had been resolved for the UK/Spanish licence applications for multiple sclerosis drug, Sativex. The stock moved up from around 100p to finish the week at 121p. Though tempting to take profits, there is significant news flow yet to come from the company. A milestone payment from Bayer Schering of £10 million will be triggered on the UK licence approval in May. A further milestone payment of £2.5 million will be due from Almirall (GW's European partner) on Spanish approval, due Q3 (£8 million was paid in 2009). Results from the clinical study in cancer pain have been confirmed for Spring 2010. It is likely that global distribution deals for Asia and Latam will be announced at the interims in May.

The regulatory announcement this week is a ground breaking event for GW pharma. Sativex approval in Europe is now assured. Given the company was founded in 1998 to develop Sativex, the end of a 12 year road is now in sight. Although reimbursement issues are yet to be resolved, the strength of the commercialisation partners (Bayer Schering and Almirall), will no doubt ensure that any issues are resolved
2 Mar '10

if we can break through 107pps resistance level, next stop should be 128pps.
coments please


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