Proactiveinvestors RSS feed en Sat, 23 Jun 2018 11:13:03 +0100 Genera CMS (Proactiveinvestors) (Proactiveinvestors) <![CDATA[News - GW Pharma set to standout in a blockbuster year for British drug makers ]]> This is the year is expected to be a blockbuster with 12 new drugs set for approval that have the potential to achieve peak sales in excess of US$1bn a year.

According to researchers at Clarivate Analytics, 46 new treatments are slated for US Food & Drug Administration over that period.

The biggest of the bunch is expected to be Hemlibra, an injection for haemophilia that is expected to generate annual revenues of US$4bn by 2022 for its maker, Roche.

That’s still some way short of AbbVie’s Humira (for arthritis) and Gilead’s hepatitis C drug Harvoni, which generated US$14b of sales each last year. But these sorts of products are a rarity as are the common or garden variety blockbuster drug with annual sales of US$1bn or more.

That said, the 2018 pipeline appears to have more promise than previous years. In fact, it is the best result in five years.

READ: GlaxoSmithKline winning over City number crunchers

Four UK companies figure in the Clarivate top-12 with Shingrix, developed for shingles by GlaxoSmithKline, at number-five in the list and Shire’s Lanadelumab, for facial swelling called angiodema, in ninth place.

The award for best of British should go to GW Pharma (LON:GWP), which has developed a treatment for a severe and to date untreatable form of epilepsy.

READ: GW Pharma posts more good data from epilepsy trials

While the Cambridge-based group is now listed solely on NASDAQ in the US, primarily a stock exchange for technology companies, it spent its formative years tapping UK investors for growth capital as a member of the AIM exchange in London.

It should be pointed out GW is delivering a breakthrough in that its product, Epidiolex, will be the first cannabis-based treatment to be approved by the FDA. Its peak sales are put at just under US$1.2bn.

Finally, while it has been a tough year for Indivior with the threat of copycat competition to its best-selling heroin substitute, in Sublocade it may have come up with a money-spinning replacement. It is expected to make around US$1.1bn by 2022.

Thu, 22 Mar 2018 09:11:00 +0000
<![CDATA[News - GW Pharma posts more good data from epilepsy trials ]]> Cannabinoid product developer GW Pharmaceuticals PLC (Nasdaq:GWPH) has revealed more good phase III data for its Epidiolex drug for epilepsy sufferers.

In two types of epilepsy, Dravet Syndrome and Lennox-Gastaut Syndrome, Epidiolex reduced the number of seizures compared to the placebo during both the 14 week treatment period and 12 week maintenance period.

 “We are pleased to present key findings from two pivotal Phase 3 studies of Epidiolex and believe these additional positive data reinforce the robust nature of the results achieved in two of the most difficult-to-treat epilepsy patient populations,” said Justin Gover, GW’s chief executive.

He added it was making good progress both towards a new drug admission for Epidiolex in the US and a commercial launch.

Orrin Devinsky, principal investigator of the Dravet syndrome trial, said he and his colleagues were excited by the prospect of prescribing an appropriately standardized and tested pharmaceutical formulation of cannabidiol.” 

“Dravet syndrome and Lennox-Gastaut syndrome are diagnosed in early childhood and represent some of the most difficult types of epilepsy to treat. 

“Nearly all patients continue to have uncontrolled seizures and other medical needs throughout their lifetime,” he said.

Shares rose 5% to US$117.6.

Mon, 05 Dec 2016 15:18:00 +0000
<![CDATA[News - GW Pharma still has the legs to get over a tenner, but pick your entry point ]]> GW Pharmaceuticals PLC (LON:GWP) has been on a tear of late – but is there any further upside to the stock?

Well, according to our charts guru Zak Mir, it could go as high as £10 a share (current price £8.77); however, Mir says it is worth picking your entry point.

“I would never pay more than the 10-day average, which is £8.23,” he said on the Proactive Investor Bulletin Board Show.   

“Ideally you are looking at dips to the 50-day line, which is way below [the 10-day average] at £6.29.” 

WATCH: Zak gives his verdict on the outlook for GWP

The shares have motored 315% higher since mid-March on the back of some positive results from a late-stage trial of a cannabis-derived drug that treats a severe form of childhood epilepsy.  

Recently, bid speculation has driven the stock on amid reports it has appointed an investment bank to screen interest in the company.  

“It has great fundamental backing and a great chart too,” Mir told host Nick Batsford.  

“We’ve had a rising trend channel and the big vertical move in March. We only retraced a third of that before it went up again   

“We have been gathering momentum ever since.   

“We have a target here even after all the gains as high as £10, given this rising trend channel we have seen.”  

GW, after this year’s performance is AIM’s third largest company with a value of £2.65bn.  

Last week the drug developer, which is also listed on the US tech exchange, NASDAQ, unveiled more pointers to the efficacy of Epidolex, for childhood seizures.  

Numis analyst Paul Cuddon called it “the most convincing ” data so far. It is expected GW will make a new drug application early next year.  

Last month investors were put on bid alert after a report from Reuters suggested the company had multiple potential suitors.  

The Reuters story also said GW had appointed Wall Street heavyweight Morgan Stanley to oversee the potential beauty parade.  

The interest was very firmly rooted around Epidiolex, which analysts reckon has the potential to deliver annual sales of around US$800mln.

The identities of the potential suitors were unknown; however, the big beasts in this sphere of the drugs market are Novartis (ETX:NOVN), Bayer (ETR:BAYN) and Almirall (BME:ALM). Analysts also reckon Lundbeck (CPH:LUN), Otsuka (TYO:4578) and Biogen (NASDAQ:BIIB) might be in the running.  

Thu, 06 Oct 2016 11:40:00 +0100
<![CDATA[Media files - GW Pharmaceuticals is going to £10 a share says King of Charts ]]> Thu, 06 Oct 2016 10:16:00 +0100 <![CDATA[News - GW Pharmaceuticals data the "most convincing so far", says City heavyweight ]]> “Impressive so far”, is the verdict of one leading City broker, referring to the progress of GW Pharmaceuticals PLC (LON:GWP, NASDAQ:GWPH) and the results from its lead drug for a childhood epilepsy.

Numis, in a note, repeated its 835p valuation of stock in the druggie, which is at the cutting edge of cannabis-derived medicines.

The shares ended the week at 838.5p, up 20%.

The driver? GW unveiled more pointers to the efficacy of Epidolex, for childhood seizures.

Numis analyst Paul Cuddon called it “the most convincing ”data so far.

It is expected GW will make a new drug application early next year.

Earlier this month investors were put on bid alert after a report suggest the company had multiple potential suitors.

The Reuters story also said GW had appointed Wall Street heavyweight Morgan Stanley to oversee the potential beauty parade.

The interest was very firmly rooted around Epidiolex, which analysts reckon has the potential to deliver annual sales of around US$800mln.

The identities of the potential suitors were unknown.

However, the big beasts in this sphere of the drugs market are Novartis (ETX:NOVN), Bayer (ETR:BAYN) and Almirall (BME:ALM).

Numis, in an earlier broker note, reckoned Lundbeck (CPH:LUN), Otsuka (TYO:4578) and Biogen (NASDAQ:BIIB) might also be in the running.

In the year to date the stock has advanced 102%, buoyed by some encouraging headline results from a phase III clinical trial of Epidiolex.

On the back of that the company was able to raise £190mln from US investors to bankroll the further development of its lead product.

Valued at £2.4bn, GW is AIM’s third largest company.

Tue, 27 Sep 2016 11:03:00 +0100
<![CDATA[News - GW Pharmaceuticals seizure drug aces phase three trial ]]> GW Pharmaceuticals plc (NASDAQ:GWPH, LON:GWP) cannabinoid drug Epidiolex has achieved primary endpoint in treating Lennox-Gastaut syndrome - a severe form of childhood epilepsy - speeding through phase three trials.

Back in June, the group’s first pivotal phase three study of Epidiolex for the treatment of seizures in connection with the syndrome revealed favourable results. And then in March, the group released positive results in connection with Dravet syndrome.

Epidiolex was well tolerated during the trial period. The adverse pattern of events was in line with the previously reported two Phase 3 studies.

GW Pharmaceuticals expects to file a new drug application to the FDA in the first half of next year.

 "We feel a tremendous sense of urgency to stop seizures, and believe that the pursuit of new therapies offers hope to individuals who have no currently available therapy to effectively stop their seizures,” said chief executive Philip Gattone.

Shares trading on the London Stock Exchange rose 11% to 775.5p. 

Mon, 26 Sep 2016 14:25:00 +0100
<![CDATA[News - Soaring cannabis stock primed and ready for a take-out ]]> Shares in GW Pharmaceuticals PLC (LON:GWP, NASDAQ:GWPH) were up almost 20% in afternoon trade amid reports the company has multiple potential suitors.

Investors were put on bid alert after it emerged the company had appointed Wall Street heavyweight Morgan Stanley to oversee the potential beauty parade.

The interest comes as the company as it prepares to bring to market Epidiolex, a cannabis-derived medication to treat a severe form of childhood epilepsy.

Analysts say the drug has the potential to deliver annual sales of around US$800mln.

According to Reuters, the financial news agency that broke the story, the identities of the potential GW Pharma suitors are unknown.

However it points out the big beasts in this sphere of the drugs market are Novartis (ETX:NOVN), Bayer (ETR:BAYN) and Almirall (BME:ALM).

However London broker Numis reckons Lundbeck (CPH:LUN), Otsuka (TYO:4578) and Biogen (NASDAQ:BIIB) might also be in the running.

Analyst  Paul Cuddon said: “With phase-three data on Epidiolex  (the key attraction)…due in the coming weeks and more data expected in December the timing is intriguing, allowing a potential acquirer an effective first option on the data.”

However he cautioned there are still “significant clinical, regulatory and commercial risks” associated with the treatment.

The shares, which are LSE and Nasdaq-quoted, were up 105p at 631.5p in a busy transatlantic trading session. That values the business at just shy of £2bn.

In the past six months the stock has advanced 178%, buoyed by some encouraging headline results from a phase III clinical trial of Epidiolex.

On the back of that the company was able to raise £190mln from US investors to bankroll the further development of its lead product.

Thu, 08 Sep 2016 14:22:00 +0100
<![CDATA[News - GW Pharmaceuticals's cannabidiol epilepsy drug ready for NDA filing ]]> GW Pharmaceuticals plc (NASDAQ:GWPH, LON:GWP) said it was on track for an NDA (New Drug Application) filing for both its cannabis-derived Dravet Syndrome and Lennox-Gastaut Syndrome indications following positive Phase III trials.

“We believe that these Phase III data show that Epidiolex has the potential to provide a robust and clinically meaningful reduction in seizures in these highly treatment-resistant populations together with an acceptable safety and tolerability profile,” stated chief executive Justin Gover.

Last month, GW raised just over £200mln (US$273mln) from a follow-on offering.

“Our recent successful financing has provided GW with the necessary capital to move forward with confidence in preparing to execute a highly successful launch," added Gover.

The group reported losses for the nine months ended June of £46.7mln (US$62.2mln) compared to £32.3mln reported last year. It said the loss reflected investment in the Phase III pivotal trials program.

It ended the period with £191.2mln (US$254.3mln) cash and cash equivalents, down from the £234.9mln last reported in September.

GW is developing an orphan drug program in the field of childhood epilepsy with a focus on Epidiolex, or cannabidiol, derived from the cannabis plant.

The group also announced today that its chief medical officer Stephen Wright is to retire in May next year after serving 13 years on the board.

Wright was instrumental in the development of the cannabinoid drug and bringing the pushing the group towards a NASDAQ listing, said a statement Tuesday.

GW will look to hire a successor by May 2017.

Tue, 09 Aug 2016 13:02:00 +0100
<![CDATA[News - GW Pharma to raise quarter of a billion dollars from US investors ]]> The UK’s GW Pharmaceuticals PLC (LON:GWP, NASDAQ:GWPH), a world leader in cannabis-based medicines, has outlined plans to raise US$252mln from US investors.

It is doing so via the issue of American Depositary Shares that will be listed on NASDAQ.

The stock is being offer at US$90, a modest discount to last night’s closing price of US$97.

The company said it will file next year for regulatory approval in the US for Epidiolex, used to treat severe epilepsy in children, after what were described as “stellar” late stage clinical trial results.

Wed, 13 Jul 2016 08:24:00 +0100
<![CDATA[News - GW Pharma advances on new epilepsy drug trial success ]]> GW Pharmaceuticals Plc (NASDAQ:GWPH, LON:GWP) rose in Monday’s early deals after the cannabis based medicines company revealed positive results from a Phase 3 trial.

The successful trial was for a potential treatment of Lennox-Gastaut Syndrome, a rare and severe type of childhood onset epilepsy.

In the trial Epidiolex, the drug, was given as an adjunct treatment to patients over a fourteen week period. The drug achieved the trials primary endpoint, which was to show a significant reduction in the monthly frequency of drop seizures compared to a placebo.

The trial results were described as “very exciting” by Linda Laux, who was an investigator for the trial and is director of the Comprehensive Epilepsy Center at the Ann & Robert H. Lurie Children's Hospital of Chicago.

“Lennox-Gastaut syndrome begins in early childhood, is particularly difficult to treat, and the vast majority of patients do not obtain an adequate response from existing therapies,” Laux said.

“These data show that Epidiolex has the potential to provide a robust and clinically meaningful reduction in seizures in this highly treatment-resistant population together with an acceptable safety and tolerability profile, which is consistent with my previous clinical experience with Epidiolex.”

The latest breakthrough follows earlier success, in March, of a separate trial using Epidiolex for another Epilepsy condition called Dravet syndrome.

Justin Gover, GW Pharmaceuticals chief executive, said: “We are delighted to announce positive results in this Phase 3 trial of Epidiolex in patients with Lennox-Gastaut syndrome, and particularly pleased that this result is consistent with our recent Phase 3 pivotal data for Epidiolex in Dravet syndrome.

“We believe that this result further demonstrates that Epidiolex offers the potential to be a new effective therapy within the field of treatment-resistant childhood-onset epilepsies.”

Gover said the company was now looking forward to the submission of a new drug application to the US Food and Drugs Administration in the first half of 2017.

In New York, GW Pharmaceutical American Depository Receipts (ADRs) advanced around US$9 or 11% to change hands at US$92.30. Meanwhile, in London, GW shares were up 74p or 14.6% at 580p.

Mon, 27 Jun 2016 10:27:00 +0100
<![CDATA[News - Orphan Drug Designation for GW's cannabis seizure treatment ]]> Biotech group GW Pharmaceuticals PLC (NASDAQ:GWPH LON:GWP) has been granted exclusive approval for its cannabis-based seizure treatment.

The US Food and Drug Administration (FDA) has granted Orphan Drug Designation for the group’s cannabidiol (CBD) for the treatment of the rare genetic disorder, Tuberous Sclerosis Complex (TSC).

The drug is the third orphan indication that the group is targeting within it Epidiolec clinical development program. Earlier this month the group commenced phase III clinical trials for the CBD treatment as a therapy to treat seizures in combination with other TSC treatments.

A common symptom of TSC is epilepsy, which occurs in around 80-90% of sufferers and is the leading cause of morbidity and mortality.

The Epidiolec  program includes a further four phase III pivotal trials in Dravet syndrome and Lennox-Gastaut syndrome, both rare and fatal forms of childhood-onset epilepsy.

The FDA Orphan Drug Designation entitles GW Pharmaceuticals to a seven-year exclusive market period.

Shares were up almost 2% on AIM this morning to 515p per share. On NASDAQ, GW shares last traded at $86.23 up by around 4%.

Thu, 21 Apr 2016 12:27:00 +0100
<![CDATA[News - GW Pharmaceuticals moves boss to US ]]> GW Pharmaceuticals (LON:GWP) is shifting its chief executive to the US to spearhead the company’s overseas development of its cannabis-based drugs.

Justin Gover is moving to GW’s new base in Southern California, where he will oversee the creation of a US business.

It has also appointed the former president of US drug group Allergan’s North American pharmaceutical  division, Julian Gangolli, as the president of its own operation in the region.

GW  commercialised the world's first plant-derived cannabinoid prescription drug, Sativex, which is approved for treating spasticity due to multiple sclerosis in 27 countries outside the US.

It is also developing a childhood epilepsy drug called Epidiolex as well as treatments for pain associated with advanced cancer, glioma, type 2 diabetes and schizophrenia.

It will be hoping to benefit from the increasing liberalisation of cannabis laws in the US, where some states have authorised its use as a medication.

As president of the North American pharmaceutical division of Allergan from 2004 to April this year, Gangolli ran a 1,400-strong commercial operation with sales topping $3.8bn last year.

GW’s chairman Geoffrey Guy said: "As Epidiolex nears its final stages of clinical development and as GW prepares for future US launch, the time is right to start building our in-house US commercial infrastructure.

“Julian's experience at building and running a major US pharmaceutical business built on specialty products will be complemented by the re-location of Justin to the US with his intimate knowledge of GW, its products and pipeline. Together, they will spearhead GW's US growth."


GW is also expanding manufacturing and research & development operations in the UK, where it employs 325 staff, up from 190 two years ago. Shares in GW rose 7.5p or 1.3% to 603.5p at 14:47 in London.

Tue, 19 May 2015 15:03:00 +0100
<![CDATA[News - GW Pharmaceuticals raises US$179mln in US ]]> GW Pharmaceuticals (LON:GWP), the maker of cannabis based drug treatments, has closed a US$179mln funding in North America.

The Salisbury based pharmaceutical firm is issuing 1.6mln American Depositary Shares priced at US$112 each. The underwriters of the offer now have the option to purchase an additional 240,000 ADS.

ADS issued through the offer will be listed on the NASDAQ Global Market.

The offer was facilitated by Morgan Stanley, BofA Merrill Lynch and Cowen and Company which acted as the joint book-running managers, while Piper Jaffray & Co was the lead manager.

Wed, 06 May 2015 09:43:00 +0100
<![CDATA[News - Higher costs extend GW Pharmaceuticals losses ]]> Shares in GW Pharmaceuticals (LON:GWP) took a knock as the British drug maker blamed higher research and development for steeper full-year losses.

The company, which develops medicines using cannabis extracts, spent £43.5mln on testing and other product development activities in the year to September, a £10.8mln increase on last year.

The spending spree widened pre-tax losses to £19.6mln over the twelve months, which is nearly double last year’s loss of £10.4mln. 

GW and its investors have been pumping money into advancing Epidiolex, a drug program in the field of childhood epilepsy.

Justin Gover, GW's chief executive said he expects to complete much of the Epidiolex development program by 2015 as well as start to build a US commercial presence in anticipation of future launch.

Clinical trials are set to be completed by the middle of 2016 and launch the drug in early 2017.

The firm’s flagship product is its cannabinoid prescription drug Sativex, which is approved in 27 countries outside the US to treat spasticity due to multiple sclerosis.

Sativex is in phase three clinical development as a potential treatment of pain linked to advanced cancer.


Total revenue climbed to £30mln, up from £27.3mln. Sativex product sales revenues totalled £4.4mln.


Cover added that the company is looking to progress multiple clinical trials for its cannabinoid product pipeline. 


Shares were 20p lower at 372p, a drop of 5%.

Tue, 02 Dec 2014 16:36:00 +0000
<![CDATA[News - GW Pharmaceutical to raise US$104mln in US ]]> Cannabis based medicine firm GW Pharmaceutical (LON:GWP) confirmed it will raise US$104mln through the listing of American depository shares (ADS) onto the NASDAQ.

The company, which has developed a cannabinoid treatment for spasticity caused by multiple sclerosis, has already launched one product and is developing a pipeline of other medicines.

Just yesterday, the company revealed results, which it called promising, from a study in which its new product Epidiolex was given to children and young adults with a form of hard to treat epilepsy.

Epidiolex takes the form of a flavoured syrup. It does not contain THC, the psychoactive compound in marijuana.

GW chief executive Justin Glover said: "We have been delighted with the continued support from US investors.

“Today's successful financing follows the recent release of promising data on our pipeline product Epidiolex in treating children and young adults with treatment-resistant epilepsy, and allows us not only to advance rapidly the development of this product candidate but also to commence preparations for future commercialisation.”

"We are very excited about GW's future prospects, not only for Epidiolex but also for the rest of our product portfolio, and look forward to reporting continued progress during the remainder of this year and beyond."

Through the underwritten funding, 1.7mln ADS are being sold at a price of US$86.83 each. GW itself is issuing 1.2mln of the ADS, whilst separately a further 500,000 ADS will be sold on behalf of certain existing shareholders which include the company’s directors.

The funding is expected to close on June 25.

Thu, 19 Jun 2014 08:21:00 +0100
<![CDATA[News - GW Pharmaceuticals ready to accelerate childhood epilepsy drug development ]]> GW Pharmaceuticals (LON:GWP) told investors its lead epilepsy product candidate has the potential to meet significant unmet needs in childhood epilepsy, and the US$101mln it raised recently it can accelerate the programme.

It raised the cash through the issue of ADS shares on the NASDAQ exchange this month, and it is to be ploughed into the Epidiolex development programme.

Epidiolex has a US Food & Drug Administration (FDA) orphan drug designation for the treatment of Dravet syndrome (a type of childhood epilepsy), and approval has been granted for a programme to treat 125 children.

Treatment is now beginning in this programme, and initial data is expected by mid-2014.

Other programmes are ongoing and will provide findings this year also.

In the meantime work continues on the Sativex drug, with separate Phase 3 trials ongoing for cancer pain and MS. Also following recent approvals, the Sativex drug has now been approved in 25 countries.

“With the new funds raised, we have the financial strength to accelerate this development program whilst retaining global commercial rights," said chief executive Justin Gover.

"In addition to our orphan epilepsy programme, as we move through 2014, we expect a significant amount of milestones, including Phase 3 cancer pain data for Sativex as well as important clinical progress across our robust pipeline of cannabinoid product candidates."

Revenues in three months to December 31 were £7.5mln, up from £5.2mln in the same period of the prior year, and the group made a £2.8mln loss, versus a £2.1mln profit in the three months to December 31 2012.

Wed, 05 Feb 2014 09:45:00 +0000
<![CDATA[News - GW Pharmaceuticals puts another potential treatment in the pot ]]> Cannabis-based drug maker GW Pharmaceuticals (LON:GWP) has potentially added a new treatment to its development pipeline following a positive outcome in a university research programme.

The research carried out at Reading University, and part funded by GW, has demonstrated for the first time that a previously unstudied chemical present in cannabis, called cannabidivarin (or CBDV)  could lead to more effective treatment for people with epilepsy.

In the study the chemical strongly suppressed seizures, GW said.

GW already has already developed and commercialised a cannabis based treatment – in the form of a spray – for people suffering from multiple sclerosis. And it continues to explore other potential treatments.

"These results further underscore the potential of naturally-derived cannabinoids as medicines to treat a broad range of diseases,” said Dr Stephen Wright, GW Pharmaceuticals’ director of research and development. 

“GW has established a track record of discovering and commercialising such compounds with Sativex®now on the market for treating spasticity associated with multiple sclerosis and in late stage development for the treatment of cancer pain. 

“Our research into CBDV has consistently produced highly promising results demonstrating its potential as a novel anticonvulsant and GW hopes during 2013 to advance CBDV into human clinical trials."


Thu, 13 Sep 2012 08:49:00 +0100
<![CDATA[News - GW Pharmaceuticals’ Sativex given positive evaluation by German health watchdog ]]> GW Pharmaceuticals (LON:GWP) was notified by its partner Almirall that the German federal health watchdog G-BA has given a positive evaluation for the cannabis-derived Sativex treatment.

Sativex is indicated as a supplemental treatment for patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not adequately responded to other anti-spasticity medications.

The G-BA has determined that there was an indication of minor added benefit of Sativex as an add-on therapy in MS-induced spasticity, according to Almirall, its exclusive licence partner for the EU except UK.

GW managing director Justin Gover said:"This determination by the G-BA is a positive step for GW. We now look forward to our partners, Almirall, commencing price negotiations in Germany."

Nomura Code, a European investment bank focused on healthcare and clean technology, said in a note it views the latest announcement as positive for GW Pharma and its partner, as in its view there was always the possibility that the G-BA, despite the last line nature of Sativex, issued a determination of no additional benefit.

“While the benefit has been determined as minor, this is unsurprising in our view, and we believe Almirall and GW Pharmaceuticals have a reasonable basis from the perspective of subsequent pricing negotiations,” The bank said.

“For now we maintain our Neutral rating and fair value of 100-105 pence as we await final pricing determination in Germany and indications of an acceleration of uptake of Sativex in launched markets,” Nomura Code added.

The stock was last trading at 82 pence.

Sativex is also in Phase III clinical development as a treatment for cancer pain.

Fri, 22 Jun 2012 11:27:00 +0100
<![CDATA[News - GW Pharmaceuticals says Sativex sales top expectations, but full year profit drops ]]> GW Pharmaceuticals (LON:GWP) told investors that while its full year profits declined, they still topped expectations thanks to stronger than anticipated sales of its cannabis based multiple sclerosis drug Sativex.

In the twelve months to end September, GW posted a pre-tax profit of £2.5 million, below last year’s £4.6 million profit, but ahead of expectations for 2011.

Revenues reached £29.6 million, in line with revenues of £30.7 million in 2010, as Sativex sales jumped 59 percent to £4.4 million, while milestone income amounted to £5.3 million compared to £11.2 million a year earlier. The group’s cash position has increased from £25.2 million at the end of 2010 to £28.3 million.

Sativex sales were lifted by its launch in the UK, Germany, Spain and Denmark during the past year with GW expecting further approvals and launches in Europe in the current financial year.

The drug is expected to be launched in the Czech Republic, Italy, Sweden, and Austria in the coming months.

The group has also signed license agreements to commercialise Sativex in Australasia, Asia (excluding Japan and China), the Middle East and Africa.

“The recent launch of Sativex in the key German market has been particularly encouraging and with the international commercial roll-out of Sativex gathering pace, we look forward to continued sales growth and further approvals and launches in Europe in the year ahead,” said chairman of GW Geoffrey Guy.

“Beyond Europe, we look forward to working with Novartis to commercialise Sativex in a number of key emerging markets.”

The group also updated investors on its ongoing research and development (R&D) activities.

Recruiting for two Sativex Phase III cancer pain trials is currently on track; the trial is currently in an advanced stage of planning and is due to begin in the first half of 2012.

Meanwhile, three Phase IIa clinical trials of GW’s medicines, GWP42003 and GWP42004, in diabetes and metabolic disease are currently underway. In addition, phase IIa clinical trial of GWP42003 in ulcerative colitis is expected to kick off in the first quarter of 2012.

“We remain confident that our ongoing research programme provides a wealth of opportunity for further growth and value creation,” said Guy.

Shares in GW Pharmaceuticals traded at 98 pence this morning, down two percent from Monday’s close. The group currently has a market cap of £130.3 million.

Tue, 22 Nov 2011 10:04:00 +0000
<![CDATA[News - GW Pharma launches Sativex in Denmark after law change ]]>

GW Pharmaceuticals (LON: GWP) is to launch its Sativex therapy for multiple sclerosis sufferers in Denmark later this month after the country recently approved the medicine.

GW Pharma, and its Spanish partner Almirall, reported that Denmark’s Interior and Health Minister had approved Sativex – which will be the first cannabis-based medicine in Denmark after a change to Danish laws.

The news comes just days after the company announced it would be launching Sativex in Germany this July after that county’s health authorities also approved the treatment. 

Sativex is a first-in-class ‘endocannabinoid’ (cannabis-based) system modulator for the treatment of spasticity in MS. It is delivered by a spray that can be delivered into the mouth either onto the inside of the cheek or under the tongue.

Spasticity (also known as muscle stiffness) has a negative impact on patients’ daily lives as it reduces their capacity to carry out everyday activities such as walking and keeping upright, as well as having an impact on their general mobility, bladder function and quality of sleep.

According to GW Pharma, around half of people with MS do not manage to find relief from these symptoms with currently-available treatments.

The firm says that evidence generated from clinical trials shows that Sativex has a positive impact on spasticity in MS, while alleviating associated symptoms.

In addition to the launch of Sativex in Germany and Denmark, GW Pharma expects to launch the treatment in Sweden by the end of this year and in Italy, the Czech Republic and Austria in 2012.

At 11:11am this morning, GW Pharma’s shares were down a penny at 120 pence each. 



Wed, 08 Jun 2011 11:34:00 +0100
<![CDATA[News - GW Pharma to launch MS treatment in Germany after regulatory approval ]]>

GW Pharmaceuticals (LON:GWP) is prepared to launch its Sativex treatment for multiple sclerosis in Germany this July after the country’s health authorities granted regulatory approval for the treatment. Sativex is already available for MS patients in the UK and in Spain.

The medicine is a first-in-class ‘endocannabinoid’ (cannabis-based) system modulator for the treatment of spasticity in MS. It is delivered by a spray that can be delivered into the mouth either onto the inside of the cheek or under the tongue.

Spasticity (also known as muscle stiffness) has a negative impact on patients’ daily lives as it reduces their capacity to carry out everyday activities such as walking and keeping upright, as well as having an impact on their general mobility, bladder function and quality of sleep.

According to GW Pharma, around half of people with MS do not manage to find relief from these symptoms with currently-available treatments.

The firm says that evidence generated from clinical trials shows that Sativex has a positive impact on spasticity in MS, while alleviating associated symptoms.

“Having recently successfully launched Sativex in Spain, we are very pleased to have now received regulatory approval in Germany,” said Justin Gover, GW Pharma’s managing director. “Germany has the largest MS population in Europe and we look forward to offering people with MS in Germany the opportunity to benefit from Sativex as a new first in class treatment to treat their spasticity.”

The approval of the medicine in Germany follows the successful completion in March this March of the European Mutual Recognition Procedure (MRP) with all six countries involved – Germany, Denmark, Sweden, Italy, the Czech Republic and Austria – recommending approval. GW Pharma plans to make a further MRP submission later this year in order to expand the approval of Sativex.

GW Pharma’s share price was up 0.2 per cent at midday today at 120.25 pence.


Thu, 26 May 2011 11:58:00 +0100
<![CDATA[News - GW Pharma receives Czech approval for Sativex spray for MS ]]>

GW Pharmaceuticals (LON:GWP) this morning said its cannabis-derived spray has been approved in the Czech Republic for patients with multiple sclerosis.

After a protracted regulatory sign off her in the UK, Sativex was given the green light in six other European countries including Germany, Italy and Sweden last month under an EU mutual recognition pact.

Launch timing in each country will be dependent on national regulations concerning pricing and reimbursement. 

GW's marketing partner, Almirall, anticipates Sativex will launch in Germany, Denmark and Sweden before the year-end.

The endorsement of its efforts came earlier this week when it unveiled a landmark agreement with Novartis to sell the product in a number of overseas markets.

City broker Peel Hunt said GW could not have chosen a better partner than the Franco-Swiss drugs giant. 

Novartis recently gained US and European regulatory approval for the first oral MS treatment, Gilenya, which analysts believe could make $3 billion in peak annual sales.

Setting a 178 pence a share price target, Peel Hunt analyst Paul Cuddon told investors: “(We) see an excellent buying opportunity given the recent share price weakness.”

In the year to date the shares have fallen 6 per cent and closed last night at 108.5 pence, valuing the GW at £143 million. 

Sativex is currently undergoing phase III clinical development for the treatment of cancer pain.

Fri, 15 Apr 2011 08:07:00 +0100
<![CDATA[News - GW Pharmaceuticals finds a new supporter: Great Point Partners Healthcare Fund ]]> GW Pharmaceuticals (AIM: GWP), which develops and manufactures a range of cannabinoid medicines announced that it had successfully placed 7.55 million shares at 78 pence per share – a 1 pence premium to the closing price yesterday.

The bulk of the placing was taken up by US Healthcare Fund, Great Point Partners, while M&G Investment Management took up enough stock to maintain its equity interest in the company.

The placing will raise gross proceeds of US$11.2 million (£6.6 million) for GW Pharmaceuticals, who said the funds would be used for additional clinical trials and research & development.

In addition, GW Pharmaceuticals issued to Great Point warrants to subscribe for approximately 3.776 million shares, 1.888 million of which have an exercise price of 105 pence per share, and the remaining 1.888 million have an exercise price of 175 pence per share.

The warrants can be exercised at any time prior to the fifth anniversary of their issue.

The new shares represent approximately 7.0 per cent of the Company's issued share capital prior to the subscription.

Following the placing, Great Point will hold 5.8% of GW Pharmaceuticals, while M&G will hold 10.8%.
Justin Gover, Managing Director of GW, said: 'We are pleased that such a prominent US healthcare fund has sought to take this significant equity stake in GW. Great Point's investment widens and internationalises GW's institutional shareholder base and reflects GW's emerging presence in the US market. The investment also serves to further enhance GW's strong cash position.'

Thu, 06 Aug 2009 08:01:00 +0100
<![CDATA[News - Sativex study boosts GW Pharma ]]>
The results of the study are a boost for GW Pharma, which despite gaining approval for the use of Sativex(R) in Canada, is still attempting to gain access to the U.S. Market. The company said that a "pivotal" Phase III trail into MS neuropathic pain had recruited 339 patients. and would the be largest clinical trial to date. Results from the Phase III trial are expected in the first half of 2008.

Salvitex(R) is produced from two key ingredients derived from the cannabis plant.

Dr Stephen Wright, GW Pharma's R&D Director added "The results add to what we know from short-term clinical trials, and we look forward to seeing the results of our ongoing pivotal study in the same condition in the first half of next year."
Wed, 17 Oct 2007 10:30:00 +0100
<![CDATA[News - 2007 a pivotal year for GW Pharmaceuticals ]]> Preliminary results from GW Pharmaceuticals (AIM: GWP) helped the share price recover some of the losses from a disappointing 2006 share performance. GW develops and manufactures cannabinoid medicines, including Sativex which is currently available in Canada on prescription and in restricted use in Spain. If you hadn?t already guessed, GW makes pain-relief drugs based on cannabis. And it is this use of cannabis as a medicinal form of pain relief that has slowed the commercialisation of the product. One can only imagine the additional scrutiny a new drug must undergo when the primary source of the medicine is a plant that falls foul of most western laws.

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Despite the hurdles, GW has made considerable progress in developing the drug pipeline. Sativex was approved in Canada in 2005 as a treatment for symptomatic relief of neuropathic pain in adults. The market may be relatively small in Canada, but the approval gained the company much needed revenues and breathing space to continue working on approval processes for Sativex in other territories. Since the initial approval in Canada, the company has applied for additional approval to use the product in the treatment of pain in patients with advanced cancer that cannot be relieved by opioid medications.

The company?s strategy for Sativex is to seek approval for its use in four particular areas; MS spasticity, MS neuropathic pain, peripheral neuropathic pain and cancer pain. GW is targeting multiple applications across various territories including Europe, United States, Canada and the United Kingdom. Success in seeking approval for the product is patchy, but the company does have regulatory applications and Phase III trials ongoing in a number of target markets, so this is certainly not an early stage drug development company. It should be noted that GW is caring out Phase III trials for each of its four core areas of pain relief. Therefore regulatory approval for one type of pain relief does not guarantee approval for use in other types of pain relief. This also means that GW has to carry out multiple Phase III trials in different territories until it has built up enough data to submit directly to regulatory bodies without having to duplicate the work. The key to GW?s success in 2007 will be gaining regulatory approval beyond Canada and limited use in Spain. Clearly the big market the crack is the United States, but Europe and the United Kingdom are important markets too.

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Perhaps unusually, Canada approved the drug before the United States. The two countries health agencies tend to work in parallel to one another and drug approvals tend to occur in the United States first with Canada shortly following. It may just be that GW?s acceptance in Canada and relative success to date may help boost its chances of approval in the United States. Preliminary results for the period ending 30th September, 2006 were in line with market expectations. The company had revenues of £1.98 million of which £1.25 million came directly from Sativex sales. The company also booked a one off £12 million European licence signature fee from Almirall which will be recognised over 15 years. Cash in the bank surged to £19.9 million and the net loss was £11.9 million.

GW isn?t valued on revenues however; instead it is valued on the potential revenue strength of Sativex and other drugs the company is researching. The most important milestone in 2007 will likely be the signing of a licensing partner for the United States and regulatory approval in four European countries to market Sativex for MS Spasticity.

Mon, 30 Jan 2006 00:00:00 +0000