Pubdate: Sun, 14 Aug 2016
Source: Orange County Register, The (CA)
Copyright: 2016 The Orange County Register
Author: Brooke Edwards Staggs


At least once a week, Steve McDonald drives from his home in Irvine 
to an industrial stretch of Santa Ana filled with auto shops and 
home-improvement wholesalers.

Inside a beige storefront, McDonald consults with young budtenders 
about the jars of raw cannabis flowers and rows of infused edibles 
that fill the shelves at From the Earth medical marijuana dispensary.

The 40-year-old said cannabis products help him avoid prescription 
medications for pain from severe burns he suffered in a fire two 
years ago, as well as lingering back trouble and anxiety that plague 
him from his days as a paratrooper in the Army's 82nd Airborne Division.

"Some days are better than others," he said. "Cannabis isn't a 
cure-all ... But it has a lot of benefits  more than negatives."

Two miles to the west, in a Costa Mesa high-rise with views of the 
Segerstrom Center for the Arts, a team of doctors and executives also 
discuss ways in which patients like McDonald can be helped using 
marijuana. Only, they never say that word.

"We don't talk about marijuana or cannabis," said Dr. Brian Murphy, 
CEO of Nemus Bioscience. "We talk about cannabinoids."

Those are the chemical compounds in marijuana that have both 
psychoactive and therapeutic effects. And they are enticing 
pharmaceutical companies to spend years and millions of dollars 
pursuing government approval of new drugs inspired by the plant.

The United States' conflicted history with marijuana regulation has 
caused it to lag behind countries such as Israel and Canada in 
developing pharmaceutical-grade drugs based on cannabis. But as 
public support and legalization of medical marijuana spread, a 
growing number of cannabis biotech companies are joining Nemus in 
Southern California, including two in Irvine, two more in San Diego 
and one each in Los Angeles and Manhattan Beach.

The sector has surged over the past 18 months, said Scott Greiper, 
president of New York-based Viridian Capital Advisors, which tracks 
the cannabis industry. More than half of all investments in the 
marijuana industry are now going to biotech companies seeking the 
"next billion-dollar drug" based on cannabis, he said, with three 
such companies trading on the Nasdaq and many more on the penny stock 
exchange. And he predicts the market for such drugs could reach $20 
billion by 2020.

Just last week, the federal government promised to expand the number 
of suppliers permitted to provide researchers and drugmakers with 
government-approved marijuana.

"It is profound that we have this opportunity to be right in the 
middle of such powerful changes in the pharmaceutical industry," said 
Raymond Dabney, who recently moved his firm, Cannabis Science, from 
Colorado to Irvine.

The companies are developing products for patients who don't feel 
comfortable buying flowers in dispensaries that can smell like weed, 
but would buy a cannabis-inspired syrup from their local pharmacist.

They're also hoping to persuade patients relying on California's 
20-year-old medical marijuana community and other entrenched markets 
across the country to switch from smoking Bubba Kush and Maui Gold to 
filling prescriptions for drugs named Syndros, Epidiolex and the like.

That may be a tough sell. Many medical marijuana users view cannabis 
the way McDonald does: as a holistic alternative to pharmaceuticals 
with far fewer side effects. Moreover, in states such as California, 
patients can legally grow medicinal pot in their backyards.

But with medical cannabis a $2.7 billion-a-year industry in 
California alone, drug companies see a major opportunity for new 
products that are rigorously tested, will likely be covered by 
insurance and  unlike traditional marijuana plants  can be patented.


There are 173 ailments, from arthritis to epilepsy, that patients say 
they've treated by smoking, vaping or otherwise ingesting marijuana, 
according to the advocacy organization United Patients Group. 
Extensive studies back up some of those claims, while others rely 
only on anecdotal evidence.

Skeptics say pot is no "miracle plant" and question the rigor of 
existing research on its medical use. But scientists working to 
develop drugs based on marijuana have faith in its pharmaceutical potential.

"The tricky bit is getting the drug in the body correctly," said Nemus' Murphy.

Take glaucoma.

Research dating back to the 1970s shows THC (the cannabinoid in 
marijuana that makes users feel high) can ease symptoms of the 
disease by relieving eye pressure. But the benefits of smoking 
marijuana last only a few hours, meaning consistent relief may 
require burning through eight joints a day.

Decades ago, researchers sought a solution via an eyedrop. They 
extracted THC from marijuana and placed a liquid version in the eye, 
but nothing happened. That's because THC is fat-soluble, meaning it 
binds to fat and not liquid  a problem considering the constant 
wetness of the eye. Plus the cornea is good at keeping foreign substances out.

Nemus is now manipulating THC molecules in hopes of making a version 
that's more easily absorbed. And since many people struggle to get 
drops in their eyes, the company is also developing an implant that 
would steadily release synthetic THC.

That drug and others Nemus is planning are in the preliminary phase 
of seeking U.S. Food and Drug Administration approval.

Already, federal regulators have approved three cannabis-based drugs 
to treat nausea and promote weight gain for cancer and AIDS patients.

Edmond Arlington took one such drug  the "pot pill" Marinol  for 
several years after he injured his back lifting heavy equipment. The 
Riverside native first tried smoking marijuana to combat nausea 
caused by the "arsenal" of painkillers he was taking. But the 
accompanying high interfered with his ability to function, he said. 
Marinol, which delivers a dose of pure THC, calmed his stomach 
without making him stoned, he added.

But Dr. Allan Frankel, a Santa Monica internist focused on medical 
marijuana treatments, said he's never had a patient who thought 
Marinol worked better than cannabis.

"The whole plant is tremendously different than a single molecule," he said.

That's why pharmaceutical companies are experimenting with a variety 
of cannabis compounds as they develop new products.

There's a mouth spray that aims to ease muscle spasms in people with 
multiple sclerosis. There's a patch that's said to dull chronic pain; 
another could treat osteoporosis. There's a gel that promises to 
treat issues triggered by Fragile X syndrome, a rare condition that 
can cause serious intellectual disabilities.

If these drugs get FDA approval, patients could save a lot of money, 
Murphy argues. As it stands, they might spend $500 or more to buy a 
month's supply of marijuana at a dispensary. If they could buy a 
marijuana-based mouth spray at CVS, they might instead face a $10 
copay from their insurance company.


Several hurdles have kept pharma giants such as Pfizer or Novartis 
from developing major cannabis drugs.

The federal government recently reaffirmed its ranking of marijuana 
alongside heroin as a Schedule I drug, a classification reserved for 
substances that have no proven medical use and are highly addictive. 
Doctors can't write prescriptions for Schedule I drugs  or any 
controlled substance that isn't FDA- approved. So in California and 
the other 24 states where medical marijuana is legal, doctors write 
"recommendations" for patients to use the plant.

The Schedule I designation makes research more challenging and can 
make it difficult for drug companies to attract investors. But Murphy 
notes the FDA can change the classification of individual 
cannabis-related pharmaceuticals if they're approved for patient use. 
Marinol, for example, is a Schedule III drug, akin to Tylenol with 
codeine. And a similar pill, Cesamet, is Schedule II, which includes 
oxycodone and Ritalin.

Another hurdle for developing pharmaceutical marijuana drugs has been 
the limited supply of federally approved cannabis, some experts say.

For nearly 50 years, the only sanctioned source for federally 
regulated research and drug manufacturing has been a pot farm 
maintained by the University of Mississippi. The Drug Enforcement 
Administration this week announced it will allow more growers to 
supply marijuana for research and commercial production of approved 
drugs, though it's expected to be some time before those new 
pipelines are open.

The three companies with FDA approval for cannabis-based drugs 
bypassed that supply hurdle by creating synthetic THC in labs. But a 
British company with U.S. headquarters in Carlsbad is close to 
developing the first federally sanctioned drugs extracted directly 
from marijuana plants.

GW Pharmaceuticals is in the final stages of clinical trials on 
Epidiolex, a syrup that contains pure CBD, the compound in marijuana 
thought to have the most medical benefits without getting users high. 
In tests with some 2,000 patients, Epidiolex has helped reduce 
seizures in children with two of the rarest forms of epilepsy, 
according to CEO Justin Gover.

The company grows its strain of organic cannabis in a greenhouse in 
England and imports the CBD syrup to the United States. Gover said it 
hopes to get FDA approval for Epidiolex in 2017 and start selling it 
by early 2018.

For its supply, Nemus has inked a deal with Teewinot Life Sciences 
Corp. The Florida company takes DNA from cannabis plants, implants it 
in microorganisms and grows colonies that can produce cannabinoids it 
says are genetically identical to those found in marijuana plants. 
But rather than waiting 12 weeks to harvest the plant, Teewinot says 
it can grow the compounds in a lab in 48 hours.


Given such advances, experts believe it's inevitable that more 
cannabis-inspired drugs will hit pharmacy shelves.

That's a scary prospect for many medical marijuana patients, who 
worry about Big Pharma squeezing out their favorite dispensaries and 
then hiking the cost of replacement drugs.

"The trust of pharma just isn't there," said McDonald, the veteran from Irvine.

A spokeswoman for Pharmaceutical Research and Manufacturers of 
America or PhRMA, a trade group representing drug companies, said the 
organization doesn't have a position on how the federal government 
classifies marijuana. But Aaron Herz berg, who runs the Costa Mesa 
investment firm CalCann Holdings, is among the many marijuana 
advocates who blame drug companies for keeping the plant illegal.

The Arizona company Insys Therapeutics, for example, petitioned 
against a Department of Health and Human Services recommendation to 
reclassify naturally derived THC as a Schedule III drug. And 
investigations by Vice and The Nation suggest pharmaceutical 
companies pay leading anti-marijuana academic researchers and support 
groups that lobby to keep cannabis in Schedule I.

In states where medical marijuana is legal, a recent

University of Georgia study showed prescriptions for painkillers and 
seizure medicines dropped significantly. In the 17 states studied, 
Medicare expenses for those drugs fell by $165 million, which critics 
say points to the motivation for pharmaceutical companies to fight 
federal reclassification of marijuana.

Even if more FDA-approved cannabis drugs come to market, John Hudak 
with the Brookings Institution doesn't believe the current medical 
marijuana industry will be wiped out. He argues the federal 
government never will sanction patient use of cannabis plants. 
Rather, he predicts pills and patches will be sold through pharmacies 
while flowers and edibles will still be sold at dispensaries.

Frankel, a physician, bets that herbal marijuana will come out on 
top. But if biotech companies manage to produce affordable drugs that 
capture the plant's benefits without introducing new side effects, he 
sees it as a win-win.

"If it's better medicine and people get treated ... ," he said. "Hey, 
I'm a doctor, and that's what I want."
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MAP posted-by: Jay Bergstrom