SANDOZ con Tilray (pioneros) y la marijuana "no cumbustible"

"THIS INDUSTRY HAS ITS SHARE

OF GREAT ANNOUNCEMENTS,

BIG EGOS AND EMPTY PROMISES,

WHEREAS TILRAY HAS HIT ITS MILESTONES QUIETLY,

ONE AT A TIME."

Brendan Kennedy

Tilray’s founder and CEO 

• -Sandoz Canada and Tilray finalize alliance to provide Canadians with greater access to high-quality, non-combustible medical cannabis options; 
• -Eight co-branded oil and capsule medical cannabis products are available to the 270,000 Canadian patients using medical cannabis in consultation with their doctors; 
• -Alliance will conduct research into product innovation and dosing, and enhance healthcare professionals and patient education specifically in the medical cannabis field.

Ver.

Sandoz / Novartis y la marijuana (no "combustible")...

Sandoz Canada today announced that it has finalized its collaboration agreement with Tilray, a Health Canada licensed producer of medical cannabis, allowing Sandoz Canada to become the first Canadian pharmaceutical company to enter the medical cannabis field. 
The alliance will support the rising interest in medical cannabis1 by providing patients with medical treatment options of stringent manufacturing standards that are adapted to their medical conditions, advocating for broader access to products, and increasing product innovation, research and education.

Eight Sandoz and Tilray co-branded non-combustible medical cannabis products are currently available from Tilray through Health Canada’s Access to Cannabis for Medical Purposes Regulations (ACMPR), including cannabis capsules and ingestible oils. Sandoz will not work in the soon-to-be legalized recreational combustible cannabis area.

“As a leading patient-focused company, Sandoz Canada is committed to discovering new ways to improve and extend the lives of Canadians by increasing access to life enhancing medications, said Michel Robidoux, President and General Manager, Sandoz Canada. 
“As such, we have taken this innovative approach and significant step forward to be the first Canadian pharmaceutical company to support access to medical cannabis for patients and their physicians who have determined that medical cannabis is an effective option for their health conditions.” (Más)

Medical Cannabis in Canada

"In the future, we will be able to leverage Sandoz’s substantial sales force, which is something we could not build up on our own. Furthermore, our collaboration will involve the development of new product formulations.  

Sandoz already has the expertise to develop sprays, patches and many other form factors, and we have started thinking about what will be possible to develop for the Canadian and global market."

Brendan Kennedy

Tilray’s founder and CEO

  Ver también:

USA: FDA aprueba EPIDIOLEX primer cannabinoide

Sandoz / Novartis y la marijuana (no "combustible")...

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TORONTO — Licensed medical marijuana producer Tilray Inc. has formed an exclusive alliance with Sandoz Canada, in what it says is the first collaboration between a cannabis producer and a local affiliate of so-called Big Pharma.

Tilray, headquartered in Toronto with production facilities in British Columbia, has signed a binding letter of intent with the Quebec-based affiliate of Sandoz International GmbH, part of global healthcare company Novartis.

As part of the agreement announced Monday, Tilray will become the exclusive collaborator with Sandoz Canada on cannabis-based medical products which are non-smokable or non-combustible such as gel caps and sprays for the domestic market.

Subject to future regulatory changes, the aim is to distribute on a wholesale level these co-branded products to Canadian hospitals and pharmacies, said Tilray’s chief executive officer Brendan Kennedy.

There is still much skepticism towards the medical marijuana industry, and this collaboration with a recognized pharmaceutical company will help alleviate that, he said. 

 

Ver:
How Canada's Tilray is boosting the medical marijuana industry in Australia

As well, patients and physicians may feel more comfortable with cannabis-based products in forms such as pills and creams that are familiar.

“That was part of the opportunity we saw… To distribute Tilray products that have the Sandoz logo that pharmacists, physicians and patients are used to seeing in their pharmaceutical packages. I think that will give physicians confidence and trust in our brand and our product,” he said in an interview.

Ver:

A Novartis también le gusta el cannabis / Sativex

This agreement is the latest example of widening acceptance of cannabis as medicine, as Canada moves to legalize marijuana for recreational use later this year.
(Más)

Ver

Ver también:

Mobile pot bus is rolling into Burnaby

SANDOZ "solo" frente con el cannabis:

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Sandoz Canada announced on June 19th the finalization of its collaboration with Tilray and is now able to enter the medical cannabis field. The company has worked with Tilray to distribute their eight Sandoz and Tilray co-branded products. 


Ver:
SANDOZ con Tilray (pioneros) y la marijuana "no cumbustible"


Sandoz utilizes Tilray’s Access to Cannabis for Medical Purposes Regulations (ACMPR) license to create cannabis capsules and edible oils.

The company will not venture into the recreational markets of Canada and does not have intentions to expand into the combustible cannabis market.

The Sandoz medical cannabis products will be available to over 270,000 Canadian patients.(Ver)

Novartis concluye primer gran negocio global de cannabinoides.

In a watershed moment for medical cannabis advocates in the United States, Swiss giant Novartis' Sandoz AG unit has tied up with Tilray, a Canadian medical cannabis producer, marking perhaps the first big endorsement of the controversial plant by a large, multinational pharmaceutical company.

Ver también: 
Sandoz / Novartis y la marijuana (no "combustible")...
 
The deal exemplifies changing attitudes in the US, where more Americans live in states that have legalized the sale of medical and/or recreational cannabis than in anti-cannabis jurisdictions. Tilray, which supplies cannabis flower and extract products to patients, physicians, healthcare facilities and researchers in 12 countries, has an existing alliance with Sandoz Canada.
   
Under the so-called framework agreement, Sandoz AG may support Tilray in commercializing and branding the Nanaimo, British Columbia-based company's non-smokable/non-combustible products; the Canadian pot producer may supply and/or license such products to and from Sandoz AG; and significantly, the two may collaborate in developing such products.

"The (expanded) partnership also helps legitimize cannabis in international markets, which could impact prevalence within existing markets as well as help influence countries considering medical cannabis legalization," Cowen's Vivien Azer wrote in a note.

The landmark FDA approval of GW Pharma's cannabis-derived medicine Epidiolex earlier this year paved the way for a plethora of small and mid-sized drug developers — including Insys Therapeutics, Zynerba, InMed Pharma, Kannalife and Axim Biotech — that are hoping to hitch their wagon to the cannabis star, either by developing synthetic or natural cannabis-derived therapeutics or devising novel delivery mechanisms for its absorption. 

Ver:

GW Pharmaceuticals dobla su valor gracias al cannabis (Epidiolex)

Two big deals over the course of this year have also underscored the lucrative potential of the plant, with alcohol giant Constellation Brands spending a mammoth $4 billion to secure a 38% stake in Canadian cannabis company Canopy Growth, and cigarette maker Altria forking out $1.8 billion to take a 45% stake in another Canadian pot company Cronos.

Meanwhile, the US federal government continues to consider cannabis as a schedule 1 substance — on par with LSD and heroin — with no medical value, infuriating researchers who contend the classification has dramatically slowed the scientific and medical investigation of the plant. Nevertheless with House Democrats taking back seats this November, pro-marijuana legislation is expected to heat up.

"There is ample evidence that the cannabis plant has numerous useful applications in medicine and the law is obsolete," said Marc Feldmann, an Oxford professor and immunologist whose work led to the discovery and subsequent commercialization of the world’s largest selling drug class, anti-TNF. "This classification is changing around the world – it has already happened in Canada and will happen in more states in the US in due course," he said in a previous interview with Endpoints News. Feldmann also serves as CEO of CannBioRex, a Canada-based company that is developing synthetic cannabis-derived medicines.(Ver)

ARGENTINA: ANMAT aprueba primer producto cannabis

 

La ANMAT se mantuvo muy precavida y conservadora respecto de los criterios para aprobar tratamientos en base a cannabidiol en la Argentina.

Pero llegó el momento. Según pudo saber Pharmabiz falta apenas un click administrativo para que tenga luz verde Convupidiol, un cannabidiol registrado en el país por el Laboratorio Alef Medical Argentina. Ver disposición.

.../...

El producto será manufacturado en la Argentina y su certificado de inscripción en el Registro de Especialidades Medicinales (REM) tendrá una vigencia de cinco años. En esta primera instancia, la ANMAT está convalidando la inscripción del medicamento. Aunque claro, todavía faltan cumplimentar diferentes escalones. Antes de poder comercializarse, la empresa tiene que avisar cuándo arranca con la elaboración del «primer lote» para que luego el organismo le de la venia final.

Alef Medical deberá cumplir con el Plan de Gestión de Riesgo (PGR) que fuera aprobado a comienzos de septiembre. En caso de incumplimiento de esta obligación, la ANMAT podrá suspender la comercialización del producto cuando consideraciones de salud pública así lo ameriten. Además de ello, la agencia regulatoria capitaneada por Manuel Limeres estableció que en los rótulos y prospectos autorizados deberá figurar la leyenda “Especialidad Medicinal autorizada por el Ministerio de Salud Certificado nº”.

Alef Medical Argentina mantiene un nombre similar a Alef Biotechnology, una empresa con la que no la unía ningún vínculo, y que fue adquirida en 2018 por la canadiense Tilray mediante un desembolso de u$s 3.9 millones. De modo que la compañía que tiene como CEO global a Brendan Kennedy no es propietaria de la firma argentina. En la actualidad sin embargo, Tilray le vende a Alef Medical ciertos insumos. 

Ver:

Todo sobre Tilray en PHARMACOSERÍAS

Otra de las compañías que levantó la mano oficialmente a fin de operar en este micronicho es la multilatina Megalabs, que a fines de julio cerró un partnership con la norteamericana Medterra. Todo a fin de tener los derechos exclusivos para representar sus tratamientos en base a cannabis en la Argentina, México y Brasil. Ver Press Release.

Juán Abelló regresa...con Linneo Health SL

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Tras venderle su monopolio del opio, Alcaliber, el magnate crea junto al fondo británico GHO la sociedad Linneo Health, de la que su firma de inversiones, Torreal, controla un 40%

1973  

Se constituye Alcaliber, S.A. con el objetivo de garantizar el abastecimiento de Materias Primas Estupefacientes mediante el cultivo en España de la adormidera (Papaver somniferum) y su posterior transformación en Concentrado de Paja de Adormidera, así como la extracción de sus alcaloides.

Ver:
El empresario Juan Abelló entra en el negocio del cánnabis medicinal

 Juan Abelló pone en venta la joya de la corona de la familia: Alcaliber (40% de Sanofi)

El 60% restante pertenece a Alcaliber, vendido este año por Torreal y Sanofi a ese fondo londinense y propietario de la licencia para cultivar y comercializar la planta

El fondo londinense, especializado en el sector sanitario, controla Alcaliber a través de una firma radicada en el paraíso fiscal de Islas Caimán

Torreal, la firma de inversiones del multimillonario Juan Abelló, y el fondo británico GHO, nuevo propietario de Alcaliber (dueña del monopolio del opio en España y controlada por Abelló hasta hace unos meses), han unido fuerzas para cultivar y comercializar cannabis en España y poner en valor la licencia que la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) concedió en octubre de 2016 a Alcaliber para llevar a cabo esta actividad.

Torreal y GHO han constituido Linneo Health, SL, una sociedad con domicilio en el número 27 de la calle Génova de Madrid (donde está la sede de Alcaliber), que comenzó sus operaciones el pasado 27 de julio y tiene como objeto social:

"la realización, tanto en España como en el Extranjero, de las actividades de cultivo, producción, fabricación, importación, exportación, distribución y comercio de cannabis y sus productos para fines médicos y científicos, así como la investigación ligada al desarrollo de estas actividades", según el Registro Mercantil.(...)

Alcaliber fue la primera empresa española que, en octubre de 2016, logró licencia de la Agencia del Medicamento para el cultivo, producción, fabricación, importación, exportación, distribución y comercialización de cannabis. Un año después, firmó un acuerdo de suministro con la canadiense Canopy Growth (la mayor compañía del sector en el mundo) para cultivar sus semillas en España.

En Portugal, otra firma canadiense del sector, Tilray (que desde que salió a Bolsa en julio pasado ha llegado a multiplicar por nueve su valor), va a invertir 20 millones en la macroplantación que pondrá en marcha cerca de Coimbra, al norte del país, según publicó el pasado fin de semana Jornal de Negòcios (Empresa de canábis mais valiosa do mundo produz em Portugal e já vê futuro de 100 mil milhões).(Más)

Ver: 
SANDOZ con Tilray (pioneros) y la marijuana "no cumbustible"

Juán Abelló (408 mill €)
Por supuesto, tambien tiene parte de su capital en importantes farmacéuticas internacionales, como Pfizer. 

No en vano, Abelló comenzó a forjar su gran imperio en el sector farmacéutico. 

Cual frio estratega tomó el control junto a Mario Conde de Antibióticos S.A., y a finales de los 80 protagonizó la operación más espectacular de venta de una empresa española a una multinacional. (Ver)

Taller de prensa sobre cannabis medicinal

 

Taller de prensa sobre cannabis medicinal: evidencia científica, regulación y contexto europeo

El Congreso de los Diputados aprobó, recientemente, la creación de una subcomisión, que formará parte de la Comisión de Sanidad en el Congreso, que analizará las experiencias europeas en la regulación del cannabis medicinal. A la espera de que esta comisión inicie su funcionamiento, cuyo trabajo durará seis meses, en principio, y culminará con la redacción de un informe que será remitido al Gobierno, desde la Asociación Nacional de Informadores de la Salud creemos que es más necesario que nunca clarificar conceptos y resolver dudas sobre lo que significa e implica realmente el uso médico del cannabis.

Para ello, el próximo 27 de septiembre, a las 16:00h, te invitamos a un taller de prensa virtual, en el que analizaremos la evidencia científica y el proceso de investigación y desarrollo que se encuentra detrás de estos productos, realizaremos un análisis del contexto regulatorio europeo, y debatiremos con expertos del ámbito médico las garantías que serían necesarias en el caso de una eventual regulación del cannabis medicinal en España.

Para ahondar en estos temas, contaremos con Vasco Bettencourt, director de Unidad de Licencias del Departamento de Inspección y Licencias de la Autoridad Nacional de Medicamentos y Productos Sanitarios de Portugal (INFARMED), el Dr. Juan Pablo Leiva, presidente de la Sociedad Española de Cuidados Paliativos (SECPAL); el Dr. Jesús de Santiago, coordinador del Grupo de Interés en Cannabinoides de la Sociedad Española del Dolor (SED); y José Tempero, director médico de Tilray.

 

Ver:

Tilray: A Pioneering Medical Cannabis Cultivator

Marijuana green grey zone...patients, Dr´s & pharmaceuticals.

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If you live in one of the 20 states where marijuana is legal but only for medical use, access to the drug begins at the doctor's office. But unlike most other treatments, it is not granted via a prescription pad.

That's because marijuana remains a schedule 1 substance. (Physicians can only write prescriptions for schedule 2 drugs or higher.) This classification encapsulates a wider paradox: marijuana is defined as a drug with no medical value and a high potential for abuse by the federal government, but it is now legal for medical use in most states. Once dismissed as a drug for slackers, marijuana has entered the mainstream so completely it's been embraced by wellness enthusiasts. Sixty-one percent of Americans support its legalization.

But because the federal government continues to classify marijuana as a schedule 1 drug, along with heroin and LSD, it's very difficult for researchers to study its health effects. While the available evidence suggests marijuana can be an effective treatment for chronic pain, the body of studies is far from robust.

Meanwhile, doctors are barred from prescribing cannabis products. Instead, certified physicians in states where the drug is legal can provide patients with a medical marijuana card.

The disconnect likely contributes to the overall confusion and lack of information surrounding marijuana's medical benefits. Patients are increasingly curious about the drug, but doctors often don't have answers. In a recent survey of oncologists published in the Journal of Clinical Oncology, around 80% said they've discussed marijuana with their patients in the past year, but only 30% felt they have enough information to advise patients on its medicinal use.

Even for providers who are informed about the drug and can talk knowledgeably about treatment options, such guidelines aren't easily integrated into a patient's health records. Because of the drug's scheduling, doctors can suggest dosages and products (most doctors likely won't recommend that a lung cancer patient smokes a joint, for example), but they can't prescribe anything specific. Instead, patients visit a dispensary, card in hand, and select what they want.

“Physicians are cut out of the loop,” said W. David Bradford, a professor of public policy at the University of Georgia. Rescheduling marijuana would allow physicians to write cannabis prescriptions, and “integrate it into a care plan.” It would open the door, albeit a crack, for pharmaceutical companies to work with dispensaries to create more uniform doses of the product, as Sandoz has done in Canada. Patients, particularly those with complex drug regimens, could benefit from an added layer of coordination and precision.

Ver: 
Sandoz / Novartis y la marijuana (no "combustible")...

Dr. Andrew Epstein, an oncologist with Memorial Sloan Kettering Cancer Center in New York City, supports marijuana's use to help with pain, nausea, and fatigue after more traditional medical treatments have been tried and exhausted. But unlike Bradford, he does not feel the drug is not ready for the prescription pad treatment.

Researchers simply don't know enough about what marijuana can – and can't – do to justify having doctors prescribe the drug in specific dosages, he said. “I'm concerned it would add to the confusion.” (...)

Impact on pharma

Despite doctor's inability to prescribe the drug, medical marijuana is nonetheless having an effect on prescribing patterns.

In every state where medical cannabis has been legalized it has “this benefit of people being able to use less prescription medication,” said Jessica Gelay, a policy manager at the Drug Policy Alliance. Indeed, a recent study published in JAMA Internal Medicine by Bradford and colleagues found that after states legalized medical marijuana, opioid prescriptions under Medicare Part D declined significantly. 

Ver

In those states that introduced a system of dispensary outlets, opioid prescriptions under Medicare Part D dropped by 14.5% following legalization. “People are reacting to the availability of cannabis as if cannabis was medicine,” Bradford said. “They're doing exactly what they would do if a pharma company introduced a new blockbuster drug.”

Bradford estimates that if every state were to turn on a dispensary-based cannabis program, Medicare and Medicaid spending would drop by around $4 billion to $6 billion. Legalization represents a potentially significant “reduction in the revenue flowing to prescription drugmakers.” 

Which hasn't gone unnoticed by manufacturers. Some have publicly lashed out: Insys, an opioid maker, contributed $500,000 to an anti-legalization campaign in Arizona, for example. 
Others (including, ironically, Insys again) have invested in harnessing elements of the drug to create FDA-approved treatments.

The FDA is expected to green light an epilepsy medication from GW derived from marijuana later this summer. If the decision goes through, it would be the first cleared drug made from the marijuana plant, although the agency has already approved a few drugs derived from synthetic cannabinoids.

The approval would open the door for other medications derived from marijuana, particularly those, like GW's epilepsy drug, that do not contain properties that make users high. For broad, lucrative categories such as pain management, however, marijuana-based medications could lack the financial windfall necessary to justify heavy R&D investment.

“You can't patent the cannabis plant,” Bradford said. Were a manufacturer to invest heavily in determining the most effective strains and dosages for treating chronic pain, “everyone could just go buy it from their local dispensary instead.” (Más)

Ver también:

USA: FDA aprueba EPIDIOLEX primer cannabinoide
SANDOZ con Tilray (pioneros) y la marijuana "no cumbustible"