By Natalie Grover
Jan 4 (Reuters) - AXIM Biotechnologies Inc AXIM.PK , a
small, Manhattan-based company with ties to the Netherlands,
says it has a trump card in its quest to develop a
cannabis-based chewing gum to ease the symptoms of multiple
sclerosis.
The company says it will be able to price its gum cheaper
than a major competitor after securing a "significant" discount
on cannabis made available by the Dutch government, which has a
policy of promoting the drug for medicinal use.
To be sure, AXIM has a long way to go before its Medchew Rx
gum - still in the pre-clinical stage of development - will be a
viable alternative to an under-the-tongue spray developed by GW
Pharmaceuticals Plc GWP.L GWPH.O .
That spray, called Sativex, is already approved in 27
countries - though not the United States, where cannabis remains
prohibited under federal law.
There is no cure for multiple sclerosis, or MS, which
affects about 400,000 people in the United States. About 80
percent of patients suffer from spasticity, a condition often
treated with the muscle relaxant baclofen.
Existing oral therapies offer limited relief from spasticity
and pain and come with side-effects such as muscle weakness.
Botox, an injectable alternative, offers localized treatment and
is costly.
Provided treatment is regulated, cannabis could be
therapeutic for MS patients, said Dr. Paul Wright, chair of
neurology at North Shore University Hospital in Manhasset, New
York.
"I do believe that there's a role for it," he said, "but I
am fearful of the potential for abuse."
AXIM's gum and GW's spray are both designed to offer more
consistent relief than artisanal products derived from cannabis
that are smoked or eaten and are legal only in parts of the
United States.
A typical British patient takes four sprays of Sativex daily
at a cost of about 5.56 pounds ($8.24). But state health systems
in some countries, including GW's home market, do not consider
the drug sufficiently cost-effective to justify coverage.
urn:newsml:reuters.com:*:nL6N0S317M
Lekhram Changoer, AXIM's Dutch chief technology officer,
said the company would be able to pass on the discount from its
Dutch-sourced cannabis to customers. He declined to estimate an
exact price.
Dr. Marco van de Velde, head of the Dutch health ministry's
office for medicinal cannabis, said the government was making
the drug available to AXIM and other companies. He declined to
give further details.
For its part, GW - a pioneer in the development of natural
cannabis-derived medicine - has no immediate plans to source
cannabis from the Netherlands. The company grows its own plants
at a secret location in England.
"Breeding our plant is something that's absolutely essential
to our competitive position," said GW spokesman Stephen Schultz.
AXIM, which started out in the organic waste business before
reinventing itself last year, hopes its mint-flavored gum will
be on sale in the United States as early as 2017.
This will depend on whether the Food and Drug Administration
grants an accelerated development timeline that would allow it
to leapfrog GW, which is waiting to discuss with the agency if
and how a late-stage study for Sativex will proceed.
AXIM thinks its case could be bolstered by research already
undertaken by GW, which has established "evidence of safety" for
its drugs derived from natural cannabis.
The FDA said it would not comment on any specific drug.
($1 = 0.6745 pounds)
(Reporting by Natalie Grover in Bengaluru; Editing by Sayantani
Ghosh and Robin Paxton)
((natalie.grover@thomsonreuters.com;)(within U.S. +1 646 223
8780, outside U.S. +91 99 1694 7070; Reuters
Messaging:)(natalie.grover.thomsonreuters.com@reuters.net))
Keywords: CANNABIS AXIM/