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Us Patent Granted For Sativex


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US Patent Granted for Sativex in Cancer Pain

 

20 April 2011

Porton Down, UK; 20 April 2011: GW Pharmaceuticals plc (AIM: GWP) today announces that the United States Patent and Trademark Office has issued a Notice of Allowance for a patent which protects the use of Sativex® as a treatment for cancer pain.

 

The patent, entitled “Pharmaceutical Compositions for the Treatment of Pain”, provides an exclusivity period until April 2025. The patent specifically covers a method of treating cancer related pain by administering a combination of the cannabinoids cannabidiol (CBD) and delta-9 tetrahydrocannabinol (THC), the two principal cannabinoids in Sativex®. In addition to this newly granted patent, Sativex® is protected by a number of other patents related to different aspects of the product.

 

Sativex® is currently in Phase III clinical development as a treatment for cancer pain. Cancer pain represents the lead indication for Sativex® in the United States, where the medicine is partnered with Otsuka Pharmaceutical Co. Ltd.

 

Dr Geoffrey Guy, GW’s Chairman, said, “The grant of this US patent covering Sativex® as a treatment for cancer pain is part of a broad platform of intellectual property rights which continue to be developed by GW. GW now has 35 patent families as well as other forms of protection such as plant variety rights and proprietary know-how. We believe that this matrix of intellectual property provides GW with a unique position to benefit from the rich promise within the field of cannabinoid therapeutics.”

 

Sativex® is approved in the UK, Spain, Czech Republic, Canada and New Zealand as a treatment of Multiple Sclerosis spasticity.

 

Enquiries:

 

GW Pharmaceuticals plc (Today) + 44 20 7831 3113

Dr Geoffrey Guy, Chairman (Thereafter) + 44 1980 557000

Justin Gover, Managing Director

 

Financial Dynamics + 44 20 7831 3113

Ben Atwell / John Dineen

 

Peel Hunt LLP +44 207 418 8900

James Steel / Vijay Barathan

 

 

Notes to Editors

 

Patent: “Pharmaceutical Compositions for the Treatment of Pain”

Patent serial number: US 11/115,983. Filed: 27 April 2005. Inventors: Geoffrey Guy and Philip Robson.

 

Patent abstract: The invention relates to treatment of cancer related pain and constipation. Preferably the subject in need is administered a combination of the cannabinoids cannabidiol (CBD) and delta-9-tetrahydrocannabinol (THC). More preferably the cannabinoids are in a predefined ratio by weight of approximately 1:1 of CBD to THC.

 

Sativex® in Cancer Pain

Cancer pain represents the initial target indication for Sativex® in the United States. The Phase III cancer pain programme is being performed in conjunction with GW’s licensing partner for Sativex® in the US, Otsuka Pharmaceutical Co. Ltd. The programme, which is fully funded by Otsuka, includes two Phase III randomised placebo-controlled multi-centre multinational trials as well as a long term extension study. Each Phase III trial will include approximately 370 patients and will evaluate the efficacy and safety of Sativex® versus placebo over a 5 week treatment period.

 

Cancer Pain

Studies suggest that more than one-third of patients with cancer, and more than three-quarters of those with advanced disease, have chronic pain. Large surveys indicate that optimal opioid therapy does not yield sufficient relief in a substantial proportion of these patients.

 

About GW

GW was founded in 1998 and listed on the AIM, a market of the London Stock Exchange, in June 2001. Operating under license from the UK Home Office, the company researches and develops cannabinoid pharmaceutical products for patients who suffer from a range of serious ailments, in particular multiple sclerosis and cancer pain. GW has assembled a large in-house scientific team with expertise in cannabinoid science as well as experience in the development of both plant-based prescription pharmaceutical products and medicines containing controlled substances. GW occupies a world leading position in cannabinoids and has developed an extensive international network of the most prominent scientists in the field.

 

This news release may contain forward-looking statements that reflect GWs current expectations regarding future events, including development and regulatory clearance of the GW’s products. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the success of the GW’s research strategies, the applicability of the discoveries made therein, the successful and timely completion of uncertainties related to the regulatory process, and the acceptance of Sativex® and other products by consumer and medical professionals.

 

Original Article Here

 

 

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Big Pharma set to take over medical marijuana market

 

By David Edwards

Wednesday, April 20th, 2011 -- 12:05 pm

 

Just as the federal government is clamping down on medical marijuana dispensaries, the Federal Drug Administration (FDA) may be set to give Big Pharma the clearance to take over the market.

 

In 2007, GW Pharmaceuticals announced that it partnered with Otsuka to bring "Sativex" -- or liquefied marijuana -- to the U.S. The companies recently completed Phase II efficacy and safety trials testing and began discussion with the FDA for Phase III testing. Phase III is generally thought to be the final step before the drug can be marketed in the U.S.

 

"GW Pharmaceuticals plc (AIM: GWP) today announces the initiation of the Phase III clinical trials programme of Sativex in the treatment of pain in patients with advanced cancer, who experience inadequate analgesia during optimized chronic opioid therapy," GW said in a statement. "This indication represents the initial target indication for Sativex in the United States."

 

Sativex is the brand name for a drug derived from cannabis sativa. It's an extract from the whole plant cannabis, not a synthetic compound. Even GW defines the drug (.pdf) as marijuana.

 

Yet as the FDA is poised to approve the drug for Big Pharma, state-licensed medical marijuana dispensaries that provide relief for thousands of Americans are under attack by other federal agencies.

 

Lynette Shaw, the owner and founder of Marin Alliance for Medical Marijuana (MAMM) in Fairfax, California, was stunned when the IRS audited her 2008 and 2009 tax returns and disallowed the foundation's business deductions, then demanded millions of dollars in back taxes.

 

The IRS pursued her under § 280E of the federal tax code, which states that no business deductions will be allowed for companies "trafficking in controlled substances".

 

Shaw is now suing the IRS to prevent them from destroying the entire medical marijuana industry.

 

Last week, the Justice Department even threatened to prosecute state employees who license medical marijuana dispensaries.

 

As a result, Washington state Gov. Chris Gregoire (D) said she would veto a bill that would have allowed the state to license growers.

 

In February, marijuana advocacy group NORML warned that the Drug Enforcement Administration (DEA) intended to legalize marijuana for Big Pharma only.

 

"The DEA's intent is to expand the federal government's schedule III listing to include pharmaceutical products containing naturally derived formations of THC while simultaneously maintain existing criminal prohibitions on the plant itself," Paul Armentano, the deputy director of the National Organization for the Reform of Marijuana Laws (NORML), wrote at AlterNet.

 

http://www.rawstory.com/rs/2011/04/20/big-pharma-set-to-take-over-medical-marijuana-market/

 

<hr noshade size="1">

 

I know the W of GW Pharma. Don Wirtshafter founded GW and left the company when he found the direction GW was headed. I'm not the only person who thinks this may be the beginning of the end of medical cannabis as we know it!

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AND... the 'Federal Justice Department' has said that it will NOt follow STATE LAW in Montana, and most of us know what is going on there.

 

AND what happens in OTHER states WILL have repercussions for us in Michigan.

 

It's just a matter of time.

 

AND the only way to get REAL CHANGE is to change the laws at the FEDERAL LEVEL.

 

The 2012 elections are going to be VERY important regarding MMJ and the state's right to pass laws related to MMJ... and to KEEP those laws.

Edited by greenbuddha
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The biggest problem I see with this procedure, #1- what possible credentials could the DEA have in determening the efficacy of a 'Schedule III' drug . Have they been lying to us all along ? They have stiffled ALL research on Cannabis in this country. Then turn around and give a patent to a foreign country ? This is one of the biggest reasons our economy is in the shape it's in, from outsourcing everything. And bleeding us dry, like a friggin vampire, the Drugulaws oooooooooohhhh............... scary

 

Brad wtf is your article talking about ??? Federal Drug Administration, thought FDA was Food and Drug Administration.

 

That OP is from UK the testing started in 2005, hence the 2025 date. That is how long the patent is applicable...

 

....................More Smoke and Mirrors ............. where do you find this crap ???

Edited by solabeirtan
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What I read is that the feds are going to give us (the USA) medical marijuana, in the form of a spray, patch or pill. But they are certainly stepping up pressure on states with medical cannabis laws with, I think, the goal of stopping anyone but approved entities from cultivating cannabis. They can't regulate and tax independent growers like they can commercial producers.

 

THEY (the G-men) still hate cannabis, medicinal or otherwise. THEY do not understand that smoked cannabis is very effective for many conditions. THEY still believe the government lies. THEY still have alot to learn!

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What I read is that the feds are going to give us (the USA) medical marijuana, in the form of a spray, patch or pill. But they are certainly stepping up pressure on states with medical cannabis laws with, I think, the goal of stopping anyone but approved entities from cultivating cannabis. They can't regulate and tax independent growers like they can commercial producers.

 

THEY (the G-men) still hate cannabis, medicinal or otherwise. THEY do not understand that smoked cannabis is very effective for many conditions. THEY still believe the government lies. THEY still have alot to learn!

My exception was with your source, apparently provided by them [GW or Otsuka] as they are not very familiar with our divisions of government [ ie: Federal Drug Administration ] . It is a worthy subject to be extremley alarmed at. My appologies if I came off a little rude there. I just dont know how to act sometimes.....

 

Looking into it further , it turns out that GWs' "US" partner is also in another market: The second largest pharmii co in Japan. behind Takeda. They have been here since 1989 . this is where the ' wtf ' goes. Something is starting to stink here now, I think .

 

Im sure it has something to do with keeping health care costs down ? Providing jobs and opportunities for our economy ??? Covered by our insurance companies ??? .....................................................................................peace

 

Wiki - Otsuka_Pharmaceutical........................Otsuka-us couple pics of hydro tomatoes, no sativex info ...

 

So you got the Feds licensing a UK pharmii to hire a Japanese Pharmii to grow and sell cannabis products in the USA legally ? ? ?

Edited by solabeirtan
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Additional supporting documentation...

 

 

by Paul Armentano

Paul Armentano is the deputy director of NORML (the National Organization for the Reform of Marijuana Laws), and is the co-author of the book Marijuana Is Safer: So Why Are We Driving People to Drink (2009, Chelsea Green).

 

If the Feds Get Their Way, Big Pharma Could Sell Pot --

But Your Dime Bag Would Still Send You to Jail

 

We should be very wary about the DEA allowing regulation and marketing of pharmaceutical products containing plant-derived THC.

 

Read the whole story here:

http://www.alternet.org/drugs/150009/if_the_feds_get_their_way,_big_pharma_could_sell_pot_--_but_your_dime_bag_would_still_send_you_to_jail?page=1

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More than anything, I think these articles represent the Feds continued mixed message: we can't grow it or use it, but it's fine for Big Pharm to manipulate it into a pill or patch. And no doubt insurance companies will pick up the tab (eventually) if it's pumped out of a factory. Big Pharm and insurance are 2 of the biggest lobby groups in DC.... $ talks.

 

We all know there is no justification for a Schedule 1 status; the proof of medical benefit has been there for decades and there are certainly other drugs (like morphine) that have a much higher potential for abuse, that are classified as Schedule II and used every single day.

Folks on the boards here are aware the US has held a patent on Cannabinoids (as antioxidants and neuroprotectants), since 2003, right? The medical evidence and statements made in their filing are nothing short of astounding!

 

This is another press release I came across this week (dated 4/18/11), apparently a California company announcing "a patent filed for extracting cannabinoids (CBD) from cannabis." They state: "The THC-free cannabinoid material will be formulated into capsules, tablets, and topicals. CannaBank expects to release the first CBD-infused products into the marketplace over the next several months."

 

In the middle of the press release is this statement: "Cannabidiol... had originally been listed in the Federal Register (7372) as a Schedule 1 drug or substance but was notably absent from the list in a Code of Federal Regulations change since April 1, 2010" Can anyone shed a light on that?? Did I miss something??

 

My gut reaction to all this Big Pharm news is to wanna puke. The eternal optimist in me is reminded poppy flowers grow everywhere--maybe, just maybe, once the real drug pushers are able to profit with Uncle Sam's blessing, they might just leave us alone. But I won't hold my breath; I'll keep educating and advocating.

 

 

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