Sativex: Cuestión de pr_incipios?...No, de pr_ecios.

Almirall may pull Sativex in Germany

Spanish drugmaker Almirall has said it may decide to withdraw multiple sclerosis spasticity treatment Sativex from the German market after a breakdown in talks with the country's reimbursement authorities. 

 Sativex (nabiximols) is available in eight markets around the world - including six countries in Europe - but the pricing mandated by the German authorities undercuts the product's price elsewhere, according to its original developer GW Pharmaceuticals.

 Neither Almirall nor GW Pharma has disclosed the price mandated by Germany's Federal Joint Committee (G-BA) for Sativex after months of negotiations and arbitration proceedings, although GW Pharma said it was "unacceptable" and "significantly lower than the reimbursed Sativex price in other European countries". 

The Spanish company's German subsidiary Almirall Hermal GmbH has now indicated it may suspend or withdraw Sativex in Germany while it tries to reach an agreement with the authorities. 

Sativex is a cannabinoid treatment for moderate to severe spasticity in MS patients who cannot be treated with other drugs, and was deemed to offer an added benefit over existing therapies when the G-BA reviewed the product last year. 

The drug is reported to cost a little over 4 euros a day in other European markets, and to date is available in the UK, Spain, Germany, Denmark, Norway, Sweden, Canada and Israel. It is also approved for sale in Austria, Czech Republic, Belgium, Finland, Iceland, the Netherlands, Luxembourg, Poland, Portugal, Slovakia, New Zealand and Australia, with launches in the latter markets expected in the coming months. (Más)

España: Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs: Spain (I)

Cannabinoid Drugs

For the purposes of this topic shall mean any industrially produced medicinal product which contains cannabinoids.

1. Are Cannabinoid Drugs authorized in your country?

Cannabinoid Drugs may be authorized in Spain on the basis of scientific criteria on its quality, safety and efficacy. The foregoing is provided that applicable regulations on narcotics, such as Law 17/1967 on narcotics, and Royal Decree 2829/1977 on narcotics and its production, distribution, prescription and dispensation are observed.

2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?

The main Spanish authorities with jurisdiction over Cannabinoid Drugs are the Spanish Ministry of Health and the AEMPS.

3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs?

No. The general regulatory framework applicable for the authorization, pricing and reimbursement of medicinal products apply to Cannabinoid Drugs.

There are, however, specific regulations that may be applicable to other activities related to Cannabinoid Drugs such as manufacturing, distributing, prescribing, dispensing etc. (see, among others, Law 17/1967, Royal Decree 2829/1977 and Royal Decree 1675/2012 on prescribing and dispensing narcotics for both human and veterinary use).

4. Which are the cannabinoid drugs that have received market approval to date?

To date, only Sativex 2,7 mg / 2,5 mg Oromucosal spray solution (“Sativex®”) has received market approval in Spain. Sativex® is a Cannabinoid Drug which contains, per each single 100 microlitre spray, 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD) from Cannabis sativa L. 
The marketing authorization holder of Sativex is GW Pharma Ltd. 

Ver:
Todo sobre GW Pharma en PHARMACOSERÍAS

Sativex® has been classified as a hospital diagnosis drug, which means that it shall only be used for the treatment of diseases diagnosed either in hospitals or centers which have appropriate diagnosis means, or by specialized doctors (see art. 24.3.b of Royal Decree 1345/2007 on the procedure for authorization of industrially produced medicinal products for human use).

Likewise, according to section 4.1 of the technical sheet of Sativex®, Sativex® must only be used “to improve symptoms of adult patients with moderated or serious spasticity due to multiple sclerosis” if “other anti-spasticity medicines have not worked” and “a significant clinical improvement has been observed regarding the symptoms of spasticity after an initial trial period of the treatment”.

5. Who can prescribe Cannabinoid Drugs?

Doctors, odontologists and veterinaries, each of them in the field of its competence, can prescribe narcotic drugs.

6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?

There is not a list of doctors authorized to prescribe Cannabinoid Drugs. Doctors, provided that they comply with the applicable requirements and procedures (which include the need to use the appropriate prescription forms), can prescribe Cannabinoid Drugs without need to be previously registered in any official list. It is to be noted that doctors holding prescription forms for narcotic drugs may be controlled (and, therefore, somehow listed) but these are lists relating to the prescription forms (holders of such forms are listed) and not related to the doctors themselves.

7. What approvals or notifications are required to prescribe Cannabinoid Drugs?

Provided that applicable regulations are complied with (including the use of the appropriate prescription forms), doctors themselves do not have to ask for any specific approval or make any specific notification each time they prescribe Cannabinoid Drugs.

8. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?

Cannabinoid Drugs can be dispensed to the public by authorized pharmacy offices/services.

Cannabinoid Drugs can be distributed (that is, sold to either other authorized distribution entities or pharmacy offices/services) by any of the following entities provided that they comply with all applicable regulations on medicinal products and narcotics (such as Law 17/1967, Royal Decree 2829/1977 -and its complementary regulations- and Royal Decree 1675/2012):

Pharmaceutical laboratories; Distribution entities duly authorized to distribute medicines for human use (see Royal Decree 782/2013 on distribution of medicinal products for human use); and/or Distribution entities duly authorized to distribute veterinary medicines (see Royal Decree 109/1995 on veterinary medicinal products).

9. Is there a list of retailers/distributors authorized to sell Cannabinoid Drugs?

Retailers. The AEMPS, with the cooperation of the regional authorities, publishes lists including all pharmacy offices opened to the public in Spain. Such pharmacy offices can dispense Cannabinoid Drugs if they comply with applicable regulations (please refer to Question 8). Distributors. 
The AEMPS publishes lists including all entities authorized to distribute veterinary medicines and medicines for human use in Spain. All entities authorized to distribute Cannabinoid Drugs must be included in such lists.

10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?

We are not aware of any proposal to significantly reform the regulation of Cannabinoid Drugs in Spain.

11. When are they likely to come into force?

N/A

Cannabinoid drugs, medicinal cannabis and opioid drugs in Spain – a legal guide. 
Prepared in association with Faus & Moliner Abogados, a leading law firm in Spain, this is an extract from 
The Pharma Legal Handbook: Spain

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)

Jazz Pharmaceuticals compra GW.

 

Jazz Pharmaceuticals paga 6.000 millones de euros para comprar GW, que comercializa fármacos contra la esclerosis múltiple o la epilepsia con derivados de cannabis

Nuevo salto de Jazz Pharmaceuticals. La compañía, que a finales de 2019 selló un contrato milmillonario con Pharma Mar para comercializar el antitumoral Zepzelca en Estados Unidos, ha anunciado que desembolsará un total de 7.200 millones de dólares (unos 6.000 millones de euros al cambio actual) para hacerse con el control de GW Pharmaceuticals. 

Ver:

Pharma Mar: Goldman Sachs también quiere pescar...en Galicia 

La adquisición se articulará a través de un pago de 200 dólares por acción y la entrega de 20 dólares en acciones. Según asegura Jazz Pharmaceuticals, el acuerdo está previsto que se cierre a lo largo del segundo trimestre y permitirá elevar la facturación de Jazz a un ritmo de doble dígito tras pasar a hacerse con el control de fármacos como el Nabiximoles o el Epidiolex. Se trata de dos de los fármacos estrella de GW Pharmaceuticals.

El primero está dedicado al tratamiento de la esclerosis múltiple y fue primer derivado natural de la planta de cannabis en recibir este tipo de autorización en todo el mundo. El segundo, por su parte, está enfocado al tratamiento de la epilepsia en niños. (Más)

NICE: SATIVEX ok en MS

The National Institute for Health and Care Excellence (NICE) has recommended Bayer’s Sativex (delta-9 tetrahydrocannabinol (THC) cannabidiol (CBD)), for spasticity in people with multiple sclerosis (MS).

Ver:

SATIVEX: Esplendor en la "yerba" para Bayer

The cannabis-based medicinal product has been approved within its licensed indication, as the organisation deemed it clinically and cost effective at its current list price. NICE also updated the MS Guideline to state that Sativex should be offered to treat spasticity in people with the disorder.

The news follows a previous positive health technology appraisal of the treatment in spasticity by the All Wales Medicines Strategy Group (AWMSG).

Sativex, developed by GW Pharma and marketed in the UK by Bayer, has been approved for use in the United Kingdom since June 2010 for the treatment of some symptom improvement in adult patients with moderate to severe spasticity due to MS.

Ver también:

Sativex: Cuestión de pr_incipios?...No, de pr_ecios.

The new guideline has been hailed as “very positive for people living with moderate to severe MS spasticity who are not responding to their current medication.”

Dr Jackie Napier, medical director, neurology at Bayer explained that the company “looks forward to the rapid implementation of this guideline to broaden the range of treatment options currently available.”

It is estimated that MS affects 100,000 people in the UK with spasticity a common symptom and major contributor to disability. Spasticity can range from mild muscle stiffness to severe, painful and uncontrollable muscle spasms, and as a consequence an individual may have difficulty in walking, picking up objects, washing, dressing and other everyday activities involving movement. Ver

Ver:
Todo sobre SATIVEX en `PHARMACOSERÍAS

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

.

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"

Marijuana M&A sizzled in 2021 and is poised for a hot 2022

 

Marijuana merger and acquisition activity proceeded at a torrid pace in 2021 – and could accelerate in 2022 – thanks to lower interest costs and pressure on larger companies to expand their footprints and boost revenue.

New York-based Viridian Capital Advisors counted 306 M&A transactions through Dec. 17, up well over threefold from the 86 recorded for the same period of 2020.

That included 209 in the U.S. totaling $10.1 billion in value – with both the numbers and amount exceeding what was recorded in 2019 and 2020 combined.

The year included a couple of blockbuster, multibillion-dollar deals:

_Dublin-based global pharma company Jazz Pharmaceuticals agreed to buy United Kingdom-based GW Pharmaceuticals, one of the largest medical cannabinoid companies in the world, for $7.2 billion.

_Florida-based multistate marijuana operator Trulieve Cannabis acquired Arizona-based Harvest Health & Recreation in a deal initially valued at $2.1 billion.

Más