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  • GW Pharmaceuticals: High As A Kite And Too Close To The Sun [View article]
    I listened to the presentation. Very persuasive. Bizarrely though that information from Reading University about the 15? children having up to an 80% reduction in fits was available to Otsuka when it decided to hand back Epidiolex to GW for nothing in Sept 2013. Looks like they must have made a huge mistake right?
    Mar 5, 2014. 01:01 PM | 2 Likes Like |Link to Comment
  • 2 Crucial Q4 HALO Earnings Report Morsels You Need To Know- The Rest Was Boiler Plate [View instapost]
    Nasty question from the analyst about potential black box warning for HyQ. And Fezz had always argued that titers were a non issue. They got HyQ a CRL first time around and got SQ Cinryse trial cancelled by the FDA twice. And Torley couldn't even say that that was all sorted now.
    Feb 28, 2014. 02:10 PM | Likes Like |Link to Comment
  • 2 Crucial Q4 HALO Earnings Report Morsels You Need To Know- The Rest Was Boiler Plate [View instapost]
    Trickdog - that's an easy one. Roche make more money selling the non SC versions. They are pricing the SC versions at the same price as the non SC so by not offering the SC in the US they make 5% more profit by saving on the HALO royalty. Also doctors and hospitals have said that they will refuse to deal with Roche if SC is introduced in the US as that will cut their income - can you believe it but it's true. Also of course Roche will be replacing both Mabthera and Herceptin before the expiry of the US patents so the prospects for HALO in the US look bleak. Of course in Europe the situation is different. The patents runs out before the replacements are approved and socialised medicine likes cost cutting. Why US insurance companies aren't beating down Roche's door demanding the introduction of SC or else they won't deal with Roche is beyond me. The free market doesn't always work? But Roche is in a strong position. They can say they can't afford the US trials - or blame the FDA or something like that.
    Feb 28, 2014. 12:24 PM | Likes Like |Link to Comment
  • 2 Crucial Q4 HALO Earnings Report Morsels You Need To Know- The Rest Was Boiler Plate [View instapost]
    When would you expect HALO's pancreatic cancer drug to be approved and on the market? It seems to be at Phase 1 now so presumably it will have to go through large Phase 2 and 3 trials, which could take many years.
    Feb 28, 2014. 08:58 AM | Likes Like |Link to Comment
  • Chelsea Therapeutics: Caution Warranted [View article]
    The ONLY reason for the share price drop since Northera's approval is that investors don't know whether CHTP will try to go it alone - the consequence being a large dilutive fund raising at a substantial discount to the probably fair market price of $6.50 - $7. Uncertainty spells fear. Personally I reckon CHTP is an absolute sitting duck to be taken over. Northera is a VERY attractive drug for a medium sized Pharma like Shire, which is actively looking to spend $4.5b on acquisitions in 2014 (according to its broker Morgan Stanley). To me the radio silence from CHTP confirms that talks are taking place - whether they be takeover or licensing I don't know but IMHO they won't be going it alone. I'm buying.
    Feb 25, 2014. 01:31 PM | 6 Likes Like |Link to Comment
  • GW Pharmaceuticals: High As A Kite And Too Close To The Sun [View article]
    Gasbag - the struggles on efficacy that GW have had with Sativex don't fill me with optimism for the prospects for cancer pain. Not many people are enthused with the efficacy for MS spasticity (hence the poor sales in the three years since launch) and they failed in the phase 3 neuropathic pain trial and the phase 2 cancer pain trial, even though GW/Otsuka elected to continue with three phase 3 cancer pain trials. They failed on MS spasticity originally but after they devised a further trial that virtually guaranteed success they managed to get it approved. I note that the third cancer pain trial has been devised on a similar basis but whether the FDA will be quite as impressed as their European counterparts with a self-devised trial if they fail on the first two is open to question. Lots of questions eh!?


    Feb 23, 2014. 09:30 AM | Likes Like |Link to Comment
  • GW Pharmaceuticals: High As A Kite And Too Close To The Sun [View article]
    http://bit.ly/Mhjhde

    http://bit.ly/MhjeOy

    GWP CEO 9 July 2013
    "The Otsuka research agreement did indeed expire on 30 June. The agreement provides for a period of 3 months for further discussions about next steps. From this point forward, GW holds exclusive worldwide rights to products developed under the collaboration, unless agreed otherwise. If there is any new information in due course, we will of course issue a further announcement."

    Question to CEO 22 October 2013
    "The Epilepsy drug that has caused all the recent excitement seems to have stemmed from the Otsuka research so they returned the rights to you on a drug that a few months later has everyone excited with the one analyst saying it's the most promising drug he's ever seen and values the ADRs at $65. Clearly Otsuka must have taken a somewhat different view. Any thoughts as to why Otsuka let it go?"

    Answer from CEO 23 October 2013
    "Re Otsuka, I can offer little insight into their decision making process but we are obviously pleased to have full ownership of such an exciting programme."
    Feb 21, 2014. 05:14 PM | 1 Like Like |Link to Comment
  • GW Pharmaceuticals: High As A Kite And Too Close To The Sun [View article]
    From GWP website

    London, UK; 13 September 2012 GW pharmaceuticals (LSE:GWP “GW”) is pleased to note the University of Reading’s press release, reproduced below, announcing the publication in the peer-reviewed journal The British Journal of Pharmacology (1) of promising data from studies on cannabidivarin (CBDV), a largely ignored natural compound found in cannabis that could lead to better treatments for epilepsy. This work was funded by, and performed in collaboration with, GW and Otsuka Pharmaceuticals Ltd (Otsuka). Further commentary on this paper can also be found in New Scientist (2).

    In July 2007 GW and Otsuka signed a global cannabinoid research collaboration that currently runs to the end of June 2013. Under this agreement, GW and Otsuka Pharmaceuticals research a range of GW cannabinoids as potential new drug candidates in the field of Central Nervous System (CNS) disorders and oncology.

    Dr Stephen Wright, R&D director at GW Pharmaceuticals said: “These results further underscore the potential of naturally-derived cannabinoids as medicines to treat a broad range of diseases. 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.”
    Feb 21, 2014. 06:43 AM | 1 Like Like |Link to Comment
  • GW Pharmaceuticals: High As A Kite And Too Close To The Sun [View article]
    From Bloomberg 19 July 2013
    "Diabetes, though, is just one of many diseases that GW is taking aim at. It’s developing a pot-based medication to treat inflammation in ulcerative colitis, and is working with Otsuka Pharmaceutical (4578:JP) of Japan on a drug that could treat epilepsy. The company also is carrying out further studies on the MS drug Sativex that could lead to its use for treating pain in cancer patients."

    Under the research agreement in June 2010 Otsuka only had to pay GW $12m over 3 years. So in June 2013 they could have continued the agreement for presumably a similar sum and kept their half share of the rights to Epidiolex. They chose not to even though the promising results from Reading University had been published. Looks like a big mistake on their part - or maybe not.
    Feb 21, 2014. 06:41 AM | 1 Like Like |Link to Comment
  • GW Pharmaceuticals: High As A Kite And Too Close To The Sun [View article]
    Gasbag82 - no not a secret at all - but equally not spelled out to American investors either. GWP (the English company) did a deal with Otsuka in June 2007 whereby Otsuka funded pretty much all of GWP's non Sativex R&D for 3 years, which of course included Epidiolex. In return for paying out all the R&D monies Otsuka got 50% of the ongoing rights on all products resulting from the work. In June 2010 the deal was renewed for another 3 years on the same terms. In June 2013 Otsuka said that they did not wish to renew the deal again and under the terms of the deal had 3 months to agree with GWP who would get what and for how much. In September 2013 Otsuka returned all rights to GWP for nothing. All public information readily available in the British company accounts and statements. When GWP then floated off on Nasdaq this story was kept pretty quiet, which is why people like you don't know that Otsuka thought that Epidiolex wasn't worth anything. Suddenly a doctor in SF says that 2 kids using Epidiolex have had a 90% reduction in fits and the company is worth $1b.

    Well some may say that a company whose Sativex, 3 years after launch, sells less than $2m per quarter because it's efficacy is highly questionable - nothing should be taken for granted.
    Feb 20, 2014. 10:11 PM | 3 Likes Like |Link to Comment
  • GW Pharmaceuticals: High As A Kite And Too Close To The Sun [View article]
    Did you know that Otsuka paid for the development of Epidiolex for the six years ended 30th June 2013 for which it had joint ownership rights with GWPH. At the end of that period Otsuka decided not to continue to fund any further research on GEPH's non sativex drugs and in Sept 2013 gave back their half share of the rights to GWPH for nothing, zero, nada. 5 months on and the value of what they gave back is $1b. Did Otsuka make a huge mistake or have US investors been sold a pup. You decide. But also bear in mind that Otsuka knows way more about GWPH than anybody. They are the US Sativex licensees after all.
    Feb 20, 2014. 01:37 PM | 1 Like Like |Link to Comment
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