Arthritis drugs:

Arthritis is inflammation of one or more
joints, which results in pain, swelling,
stiffness, and limited movement. There
are over 100 different types of arthritis.

The most common form, osteoarthritis
(degenerative joint disease) is a result
of trauma to the joint, infection of the
joint, or age. Other arthritis forms are
rheumatoid arthritis, psoriatic arthritis,
and autoimmune diseases in which the
body attacks itself. Septic arthritis is
caused by joint infection



PFIZER'S TOFACITINIB IS EFFECTIVE
IN  PHASE 3 TRIAL
At least one analyst thinks Pfizer has
hit a home run with tofacitinib.
Catherine Arnold told Bloomberg that
the new drug is a “game-changer,” and
may bring in more than $2.6 billion a
year. She emphasized the estimate
could be conservative given the
current market for rheumatoid arthritis
is $22 billion. The Pfizer treatment
offers a dosing advantage because it’s
given orally instead of injected like the
other drugs on the market.

In October 2011 new data from a trial
of tofacitinib showed the medicine was
as effective as Abbott’s  blockbuster
injectable Humira, which will generate
sales approaching $8 billion this year.
The only potential sticking point was
that proportion of patients who
developed serious side effects, though
small, was higher in the tofacitinib
groups.

Pfizer said the company believes the
risk-benefit profile supports regulatory
submission for both the 5- and 10-
milligram dose. “We are looking
forward to filing in the U.S., EU and
Japan by the end of 2011” company
spokesperson Victoria Davis said.

Analysts think both doses of the drug
will get Food and Drug Administration
approval in 2012. But it will probably
be a few years before the drug should
materially hit Humira sales because the
Pfizer treatment will initially be
prescribed mainly for patients who
have failed to benefit from standard
treatments. This should change as
Pfizer moves its use to earlier treatment

In addition to Humira, the other
injectable drugs that dominate the
market include Remicade from
Johnson & Johnson and Enbrel from
Amgen  which Pfizer shares.

Tofacitinib is the most-advanced pill in
a family of experimental drugs to target
a protein, called JAK, which leads to
joint destruction in 1.3 million
Americans with rheumatoid arthritis.
Three biotechnology companies are
working to catch up to Pfizer with
similar treatments: Rigel
Pharmaceuticals , Incyte and Vertex.
However, all these drugs are in earlier
stages of development.



VERTEX HAS A PROMISING DRUG TO
TREAT RHEUMATOID ARTHRITIS
Vertex is  seeing positive trial results
for its VX-509 drug, used to treat
rheumatoid arthritis ("RA"), which
affects about 1.5 million adults in the
United States.

In a Phase 2a study, 66% of patients
taking a twice-daily 150mg dose and
65% of those taking a 100mg dose
saw a 20% or greater improvement in
signs and symptoms. Only 29% of
those on placebo saw such gains.

Competitors also have similar drugs for
RA in their pipeline, including Pfizer's  
tofacitnib. But VX-509 hasn't shown
any decrease in white blood cells,
which could give Vertex an advantage.

The overall market for RA drugs is
expected to be in blockbuster territory,
well above $1 billion a year, which
suggests plenty of room for Vertex to
carve out growth.

For investors sitting on the sidelines
worried Vertex doesn't have
opportunity beyond Incivek, market
potential for its VX-770 and VX-509
provide incentive to buy shares into
quarter end volatility.


PLANNED  IMPROVEMENTS  FOR
HUMIRA TO MEET COMPETITION
Abbott Laboratories'  anti-inflammatory
drug Humira may be poised to become
the top-selling drug in the world next
year, but with new competition looming
the company is planning improvements
to the product.

Among potential changes in the offing:
a thinner needle to reduce patient
discomfort during injections; a once-a-
month dose, versus the current
regimen of every other week; and
widening the drug's approved uses to
treatment of the gastrointestinal
disorder colitis and other conditions.

Humira, which treats forms of arthritis
and the skin condition psoriasis, faces
competition from newer injectable
drugs as well as experimental, oral pills
that could hit the market beginning
2012. Analysts believe the oral pills,
including Pfizer Inc.'s  tofacitinib, could
take market share from Humira and
drugs like it.

But there are limitations to how much
better Abbott can make Humira. A
clinical study of a once-monthly dose
failed to reach its primary goal of
showing comparable efficacy to the
standard regimen, according to data
posted on the government database
clinicaltrials.gov.

Sales of Humira more than doubled
between 2007 and 2010, to $6.5 billion
globally. Next year, sales are expected
to hit $8.7 billion, which should be
enough to earn the No. 1 spot for
prescription sales, according to
EvaluatePharma. Today's No. 1,
Pfizer's cholesterol pill Lipitor, will lose
U.S. market exclusivity in November
2011, clearing the way for sales-
eroding generic versions.

Humira belongs to a class of drugs that
block tumor necrosis factor, a
substance in the body implicated in
inflammatory diseases. Other top-
selling anti-TNFs include Remicade, co-
marketed by Johnson & Johnson and
Merck & Co.  

Newer anti-TNFs have hit the market in
recent years, including UCB SA's
Cimzia. Most are either injected or
given by intravenous infusion.

The drugs carry safety risks, including
infections and the potential for
lymphoma and other cancers in
children and adults.

On another competitive front, Pfizer
hopes its tofacitinib will have
comparable safety and efficacy to anti-
TNFs, but with greater appeal and
convenience for patients because it
can be taken as a pill twice daily.

HORIZON PHARMA SUBMITS ITS  
DRUG LODOTRA FOR FDA
APPROVAL
In Sptember  2011 Horizon Pharma,
Inc. announced the submission of New
Drug Application or NDA to the United
States Food and Drug Administration
for its Lodotra for the treatment of
active rheumatoid arthritis. Lodotra is a
proprietary delayed-release
formulation of low-dose prednisone.

The submission was primarily based
on a Phase 3 trial, 12-week, double-
blind, placebo-controlled study
involving 350 rheumatoid arthritis
patients. The study revealed a
statistically significant improvement in
primary study endpoint, compared to
the placebo group.




NOVARTIS HAS POTENTIAL  DRUG
FOR JUVENILE ARTHRITIS
In October 2011 Swiss drug maker
Novartis announced a potential
treatment for a severe form of juvenile
arthritis at the 2011 European
Pediatric Rheumatology Congress in
Belgium.

The drug, which goes by the generic
name canakinumab, did better than a
placebo in a late-stage study
measuring system improvements.

Almost 84 percent of patients who took
the compound, labeled ACZ885,
experienced at least a 30 percent
improvement in symptoms. That
compares with nearly 10 percent who
took a placebo.

The study focused on patients with
systemic juvenile idiopathic arthritis, a
rare condition marked by possibly life-
long and recurrent arthritis flares that
can involve a skin rash, fever and joint
pain and sweeting, according to the AP.

Canakinumab is approved in the U.S.,
the European Union and other markets
as a treatment for cryopyrin-
associated periodic syndromes, a
group of conditions including joint pain,
rash, fever, and fatigue.




ANTIBODY  FOUND
Scientists found an antibody which
treats the cause of the pain rather
than just the symptoms. University of
Lisbon in Portugal tests have shown
that anti-CD4 antibodies attack the
white blood cells that cause the
debilitating disease without affecting
other cells.






ALTERNATIVE:
GLUCOSAMINE TRIAL: The GAIT
Under the direction of the  National
Institutes of Health, 13 universities in
the U.S. performed a randomized,
double-blind, placebo controlled study
on more than 1,500 people diagnosed
with osteoarthritis. Each participant
was given a daily dose of either
glucosamine hydrocloride or
chondroitin sulfate, a combination of
the two, 200 mg of the painkilling drug
Celebrex, or a placebo for 24 weeks.
Pain levels of each participant were
evaluated at the beginning and again
at the end of each four week period.

The scientists found that the
combination of glucosamine and
chondriotin significantly reduced pain
compared to Celebrex.

This finding confirms what many
people already know about the
combination of glucosamine and
condroitin. Together these substances
produce better results than if used
separately. And these results are
achieved without side effects or
damage to stomach, intestinal tract or
liver.
The GUIDE trial
As the GAIT results were being
released in the U.S., results of a study
involving 13 hospitals in Europe were
hitting the news. Scientists conducting
the Glucosamine Unum-in-Die (once a
day) Efficacy Trial (GUIDE) found that
glucosamine was the preferred
treatment in knee arthritis. This was a
randomized, placebo and reference
controlled, double-blind study.
The GUIDE compared a 1,500 mg  
daily dose of glucosamine sulfate and
a large 3,000 mg dose of
acetaminophen (found in Tylenol,
Excedrin and others) to a placebo in
318 patients across the 13 hospitals
participating in the study. After 24
weeks of monitoring, it was clear that
glucosamine showed superior
effectiveness for pain and movement.

As the results of these studies show,
glucosamine in two different forms
(hydrocloride and sulfate) and
chondroitin sulfate have been proven
to work in combination to alleviate joint
pain at least as well as painkilling
drugs. The  Joint Rescue (90) brand
combines both of the proven forms of
glucosamine with condroitin sulfate to
provide broad spectrum joint pain relief.
Glucosamine is a glucose-based
substance produced naturally in
healthy joints where it is used to repair
and maintain cartilage. Condroitin is a
naturally occurring substance in the
body responsible for elasticity of
cartilage. As the body ages, levels of
these substances drop and need to be
replaced.

However:
Some disappointing news for those
who suffer from chronic lower back
pain: Glucosamine, a widely used
nutritional supplement, is no better
than a sugar pill at relieving pain and
disability in the lower back, according
to a study published in the Journal of
the American Medical Association.