CANADA: BAYER BIDS TO MARKET MARIJUANA-BASED MULTIPLE SCLEROSIS TREATMENT

TORONTO - Pharmaceutical giant Bayer HealthCare has applied to
market a marijuana-based drug in Canada. If approved, it would be the
first cannabis-based drug legally available in this country for the
relief of debilitating symptoms of multiple sclerosis and severe
neuropathic pain.

Bayer and GW Pharmaceuticals of Britain announced Tuesday they had
filed a new drug submission to Health Canada for Sativex, an oral
spray developed by GW Pharmaceuticals and licensed to Bayer.

A spokesperson for Health Canada said it typical takes about 18 months
for the department's therapeutic products directorate to review and
rule on a submission.

Bayer's vice-president for public policy and communication said the
companies are confident, based on early discussions with the
department, that the submission will be approved.

"It's our belief through our initial discussions that we hope to get
it through the regulatory process, and in as quick time as possible,"
Doug Grant said Tuesday.

"You can never tell with any drug once it gets into the regulatory
process, but they have been quite open in discussing this with us."

The companies describe the product as a whole plant medicinal cannabis
extract containing tetrahydrocannabinol, or THC, and cannabidiol as
its principal components.

There are other cannabis-based drugs available in this country. They
are used by cancer and AIDS patients to control nausea and vomiting
and to restore appetite as a means of combating the wasting effect of
those diseases.

But Sativex would be the first cannabis-derived drug aimed at MS
sufferers.

The head of the MS clinic at St. Michael's Hospital in Toronto said if
the drug is approved, it would be a welcome addition to the arsenal of
drugs available to alleviate the pain and spasticity experienced by
many patients with MS.

While there are other, non-cannabis based drugs on the market to treat
those symptoms of the disease, "there remains a subgroup of MS
patients who don't respond well or at all to the anti-pain,
anti-spasticity drugs. And that group would want to try this," said
Dr. Paul O'Connor, a neurologist.

"If it became an approved medication by the federal government, I
would certainly want to try it in certain patients and get some
first-hand experience as to how it works."

O'Connor said some of his patients use marijuana to control these
debilitating symptoms.

But users of medicinal marijuana complain the product available by
prescription from the federal government is of poor quality. And
O'Connor said many patients don't want to smoke.

"A lot of the patients that do smoke it wish that there was a more
convenient and non-smokeable but effective form of a cannabinoid
available," he said.

Approximately 50,000 people in Canada are diagnosed with MS.

British regulatory authorities are already working on a drug approval
submission for Sativex. Grant said the companies hope to have approval
shortly and to have the product on the market there by the end of this
year.