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发帖数: 4348 | 1 From cholesterol fighters to asthma relief, these treatments could earn Big
Pharma $170 billion
By Mike Tarsala | 24/7 Wall St.
Jul 22, 2009 | Updated: 12:29 p.m. ET Jul 22, 2009
Safety and efficacy data are critical to drug candidates. But what really
makes a potential drug attractive is strong top-line data, a new biotech-
based treatment, and a massive potential market.
With help from Thomson Reuters' SD Pharma database and our own backlog of
coverage, BioHealthInvestor.com, a 247wallst.com website, sought to find the
most promising biopharmaceutical candidate from both biotech and
pharmaceutical companies in each of the top 10 most prevalent medical
conditions in the U.S.
To do so, we reviewed data and Thomson Reuters revenue projections for 745
prescription drugs. We started by identifying the top sellers in each of the
top 10 conditions, then looked at promising candidates that threaten to one
day supplant the market leaders. All of these challenger treatments can
lead easily to a blockbuster drug status, meaning annual sales of $1 billion
or more.
Here are the top 10 medical conditions, sales estimates for the leading
drugs, and the up-and-coming biotech-based candidates:
1. CHOLESTEROL FIGHTERS:
Exercise. Lose weight. Avoid trans fats. Sound familiar? Millions in the U.
S. already have tried those things to some degree their bad cholesterol
still is not at reasonable levels. It's why cholesterol-lowering agents are
the No. 1 type of prescribed medication in the U.S., and are expected to
generate $27.4 billion in sales this year, according to Thomson Reuters SD
Pharma estimates.
Cholesterol-lowering agents are arguably the top U.S. lifestyle drug. An
American Journal of Medicine article in June suggested that Americans have
worse health habits than they did 18 years ago. Waistlines are expanding.
Physical activity has decreased, and so has healthy eating. It's why doctors
are apt to prescribe cholesterol-lowering drugs such as statins to patients
as young as their late-20s. The drugs have been shown to cut cholesterol,
and thereby reducing the risk of heart disease.
In the future, even patients with normal cholesterol levels may be
prescribed statins. An American Heart Association study in November showed
that AstraZeneca's statin Crestor dramatically cut deaths, heart attacks and
strokes in patients that had fine cholesterol levels, but high levels of a
heart disease-related protein.
There are about 34 million people in the U.S. that would benefit from taking
statins to cut their heart attack and stroke risk, the AHA says. But that
number could potentially increase by another 10 million if the new data were
to be adopted into the association's guideline.
The class-leading drug is Lipitor from Pfizer Inc., with about 41 percent of
the market, and expected sales of about $11.2 billion this year. Other
heavyweights include Crestor, with projected sales of $4.9 billion, and
Merck's cholesterol eating non-statin, Zetia, with projected sales of $2.1
billion.
The Potential Blockbusters:
The up-and-coming cholesterol-lowering candidate to watch is a potential
biopharmaceutical from Aegerion Pharmaceuticals called Lomitapide. It is a
small molecule drug that works to reduce blood levels of cholesterol and
triglycerides by limiting the production of lipoproteins from the intestine
and liver.
Privately held Aegerion Pharma released interim Phase III data for
Lomitapide in June. Among patients studied, Lomitapide reduced bad
cholesterol by 44 percent. Interestingly enough, Aegerion entered into
collaboration with Pfizer Inc. and the University of Pennsylvania for a
cross-license relationship covering a range of patents related to the use of
microsomal triglyceride transfer protein inhibitors.
2. INSULIN AND DIABETES TREATMENTS:
The U.S. Centers for Disease Control says that $116 billion was spent on
treating diabetes in the U.S. in 2007. And because it's a disease where a
quarter of the 23.6 million affected are unaware that they have it, sales of
these treatments may soon climb under proposed health care reform plans.
For many who have it, diabetes requires insulin or other daily medications.
Expected 2009 spending on those drugs is $23.3 billion, according to Thomson
Reuters' SD Pharma data, second only to cholesterol-fighting drugs.
The vast majority of Americans diagnosed with the disease have Type 2
diabetes, a condition where insulin levels rise because the body fails to
properly use it. Over time, the disease can cause malfunctions of the eyes,
kidneys, nerves and heart. It's a main reason diabetes is the seventh-
leading cause of death.
Daily medications are a fact of life for the majority of patients with Type
1 diabetes, which used to be called juvenile diabetes. And it is creating
billions in profit for drug companies that treat patients with Type 2
diabetes, as well.
Leading diabetes drugs include several long-acting insulins. Once-weekly
dosing is a huge opportunity, considering the daily needle-pricks required
for many with both Type 1 and Type 2 diabetes. The best-seller is the Sanofi
-Aventis drug Lantus, with expected revenue in 2009 of more than $4 billion.
Yet the current drug to beat for long-lasting insulin may be from Novo-
Nordisk, following recent data that showed a potential link to cancer risk
among Lantus patients.
The Potential Blockbusters:
The true up-and-comer, however, may be an inhalable biopharmaceutical
insulin candidate from Mankind Corp. called Afresa. It's true that inhalable
insulin has been under development for a long time that has had issues from
the start. But MannKind shares recently posted a new 52-week high on Afresa
study data. In a late-stage study, the Valencia, Calif.-based company said
Afresa's performance was shown to be comparable to injectable insulin.
Expectations are rising that Mankind may soon secure a worldwide marketing
and development partner for Alfresa, and that it likely will be an approved
product by next spring.
One possible partner might be Pfizer Inc., which started switching its
Exubera inhaled-insulin patients to MannKind's experimental product. The
companies had been partners until Pfizer pulled Exubera from the market in
2007 after showing poor sales.
3. BLOOD PRESSURE
High blood pressure has become the norm for U.S. seniors; two-thirds of
Americans age 60 or older have the condition. It's one of the most prevalent
health plagues in the country, affecting men and women equally.
Overall, 29 percent of adults age 18 or older have hypertension, including
about 7 percent of those who do not know they have the condition, according
to the CDC. And 68 percent of those with the condition are taking
medications to bring their BPs down. It's why spending on blood pressure
meds is expected to top $21.4 billion this year, according to Thomson
Reuters SD Pharma data.
High blood pressure boosts the risk of heart attack, heart failure, stroke,
and kidney disease. On the other hand, a common factor for those over 80,
worldwide is normal or low blood pressure.
The CDC's facts and figures do not include an additional 28 percent of the U
.S. adult population that has pre-hypertension, a diagnoses that raises the
chances of a person developing high blood pressure.
The top-selling blood pressure drug is Novartis AG's Diovan. It is expected
to post 2009 sales of about $5.9 billion, according to Thomson Reuters data.
But that number could fall dramatically when the pill's patent expires in
2012. The other big high-blood pressure treatment is Merck's drug Cozaar,
with expected sales this year of about $4.4 billion. Its patent is set to
expire in 2010.
The Potential Blockbusters:
Although some concerns have been raised about its side effects, especially
at high doses, the up-and-coming candidate to watch for high blood pressure
is a biopharmaceutical from Gilead Sciences Inc. called Darusentan.
In May, the company announced data from one of its two Phase III clinical
trials of the candidate in patients with resistant hypertension. The drug
showed significant improvements in both systolic and diastolic blood
pressures vs. placebo. Provided the second Phase III study backs up the
efficacy data and raises no new safety concerns, the drug could receive FDA
approval as early as 2011.
4. IMMUNE SYSTEM BOOSTERS/SUPRESSANTS
One giant category of drugs that covers everything from vaccines to anti-
rejection transplant drugs is called immunomodulators — drugs that either
stimulate or suppress the body's immune system.
A growing number of the immunomodulators in development are
biopharmaceutical compounds, such as recombinant proteins and peptides,
monoclonal antibodies, and vaccines that are being used to fight multiple
types of conditions and diseases, including some types of cancer.
The biggest drugs in the category are designed at least partially as a
treatment for arthritis, the leading cause of disability in the U.S, and one
that affects more than half of seniors. The CDC projects that the number of
people age 65 or older who have arthritis or chronic joint symptoms will
nearly double from 21.4 million in 2001 to 41.4 million in 2030, as more
people are living longer.
About $20.7 billion is expected to be spent on immune system modulators in
2009, a number that is expected to grow as the number of treatments that
work with the body's immune system increases.
One of the top immune system suppressants — and the top-selling
immunomodulator overall — is the Abbott Laboratories Inc. drug Humira,
which works to shut down the body's inflammatory response for patients with
arthritis and Crohn's disease. It was created using a particular type of
human immune cell, which was a clone of a single parent cell. Popular
competing drugs are Johnson & Johnson's Remicade, with expected sales of
about $4.3 billion this year, and Amgen Inc. and Wyeth's Enbrel, with
expected sales of about $3.4 billion.
The Potential Blockbusters:
The company to watch in immunomodulation is Array Biopharma Inc., which has
five total MEK inhibitor candidates, and two that could eventually find
markets in both cancer and rheumatoid arthritis — ARRY-162 and ARRY-300.
The furthest along of the two early candidates is ARRY-162, which is now in
a Phase II trial in 200 patients with rheumatoid arthritis. So far, the
candidate has been well tolerated and with no patients that discontinued the
study due to an adverse event. The efficacy data in that trial is expected
to be released in September, an event that's a likely catalyst for the
company's stock.
Meanwhile, ARRY has a Phase I of ARRY-300 in rheumatoid arthritis under way,
and in mid-July filed an investigational new drug application for ARRY-162,
in anticipation of a Phase I cancer trial.
5. ASTHMA
One type of trauma that will get you in to see an emergency room doctor than
most any other is an asthma attack. The reason is simple: breathing is the
most critical necessity of life.
The CDC says that about 7.3 percent of adults and 9.1 percent of children
have asthma, the most common respiratory disease other than sinusitis. In
2004, the most recent CDC data available, some 4.2 percent of people in the
U.S. had at least one asthma attack. The disease leads to nearly 2 million
emergency room visits a year, and tens of thousands of missed days of school
and work. It's the reason that about $20.2 billion will be spent on asthma
medications in the U.S. this year, according to Thomson Reuters SD Pharma.
The most commonly prescribed asthma drug is GlaxoSmithKline's Advair, with
projected sales of $7.4 billion. It works to boost lung function by opening
restricted airways and tamping down inflammation. Another popular drug is
Merck & Co's Singular, which helps to block genetic signals that trigger
airway constriction.
The Potential Blockbusters:
Perhaps the asthma drug to watch is fluticasone furoate, developed by
GlaxoSmithKline, in partnership with Theravance Inc. The two companies are
working on a potential follow-up to Advair.
Glaxo and Theravance announced results of three separate Phase IIb studies
of the candidate across a range of eight doses in more than 1,800 patients.
Fluticasone furoate was effective in all but the lowest dose tested. Only
the highest dose showed a statistically significant boost in a side effect
typical of its type of inhaled steroid. A Phase III trial could start early
next year.
6. ANTIPSYCHOTICS
Mental illnesses might not be top of mind when it comes to a list of top
medical conditions. Yet one in four adults in the U.S. has a diagnosable
mental disorder in a given year. About 6 percent have a serious mental
illness, according to the National Institute of Mental Health.
One of the top mental illnesses being treated with prescription drugs is
bipolar disorder, a disease that can cause extreme mood swings, from
infrequent manic highs to more common depressive lows. It is the leading
mental health diagnosis that contributes to lost work productivity. The
median age for the disease's onset is 25 years, which is why many with
bipolar disorder are on antipsychotic medications for most of their adult
lives.
Nearly $16.7 billion will be spent in the U.S. this year on medications to
treat mental illnesses including bipolar disorder, according to Thomson
Reuters SD Pharma. The top drug in the category is the bipolar disorder drug
Seroquel, made by AstraZeneca plc, with expected sales of $5.4 billion,
accounting for about a third of all antipsychotic drug sales. The No. 2 drug
in the category is Eli Lilly & Co.'s Zyprexa, for treating bipolar
disorder and schizophrenia. Expected sales this year are $4.6 billion.
There are other potential markets for drug manufacturers, and for some drugs
already in the category. Mental illnesses that may require antipsychotics
include major depressive disorder, anxiety disorder, panic disorder, and
obsessive-compulsive disorder. Many affected by mental illness have multiple
disorders and phobias.
The Potential Blockbusters:
There are a number of seemingly promising antipsychotic drug candidates, but
one at the top of the list is paliperidone palmitate for treating
schizophrenia. The drug is being developed by Johnson & Johnson, with
NanoCrystal technology from Elan Corp.
The FDA in August 2008 asked for more data on the drug before allowing it on
to the U.S. market. But it has not asked for additional trials. The drug
was effective in studies, with only 10 to 15 percent of patients relapsing,
vs. 40 percent in the placebo group.
The main advantage of paliperidone palmitate could be in its delivery. It's
an injection taken once monthly, which in theory could make it much easier
for schizophrenics to stay on their medications.
7. HEARTBURN DRUGS
Heartburn, or acid reflux, is very common, very uncomfortable, and a
condition that can lead to more serious medical conditions if left untreated
. It's why $13.1 billion will be spent this year on a particular class of
prescription acid reflux medications, according to Thomson Reuters SD Pharma
data.
Roughly 60 million adults report suffering from acid reflux at least once a
month, according to the American College of Gastroenterology. And about 20
percent of those people develop a more serious condition associated with
immune system weakness and a higher esophagus cancer risk.
The most common prescription treatment for acid reflux is a class of drugs
called proton pump inhibitors. They work to block the production of stomach
acid that causes heartburn. Unlike fast-acting medications like over-the-
counter antacids, proton pump inhibitors take much longer to work, but they
offer long-lasting relief.
The top prescription heartburn treatment by far is AztraZeneca plc's "purple
pill" Nexium, with 2009 expected revenue of about $5.6 billion, and more
than 40 percent market share. The No. 2 is Takeda Pharmacetical's Prevacid,
with roughly 17 percent share, and projected revenue of about $2.2 billion.
The Potential Blockbusters:
There appear to be few significant near-term challengers on the horizon to
the Nexium; the drug does not start coming off patent until 2015. But one
company with a candidate that could be a contender is Orexo AB, with its
OX17 proton pump inhibitor. It is being developed for the treatment of
gastro esophageal reflux disease, the most serious form of acid reflux. It
combines two substances in an effort to provide both long-lasting and fast-
acting heartburn relief.
In a Phase II trial last year, OX17 quickly proved effective in working fast
and continuing to work to reduce stomach acid. Earlier this year, Orexo
signed an exclusive development deal with a yet-to-be-named partner. The
company expects to announce a licensing deal for its OX17 program this year,
as well.
8. ANTI-CANCER ANTIBODIES:
Cancer kills about 1,500 people a day in the U.S., more all conditions other
than heart disease. And according to the American Cancer Society, it
accounts for nearly one of every four deaths. That said, there are more
than 3 times the number of cancer survivors in the U.S. today than in 1970,
largely due to advances in anti-cancer antibodies that are prolonging lives.
About $13 billion will be spent on the drug class this year, according to
Thomson Reuters SD Pharma. There are many targeted cancer treatments, so
our focus is on cancer treatments which have been indicated to have a
broader use.
Modern cancer treatments are antibodies that target tumor cells, and have
far less of an impact on healthy cells. The scientific names of all drugs in
the class end in the letters "mab", for monoclonal antibodies. Most either
bind to tumor cells and release toxins, or work at the cellular level to
halt the growth of tumors.
The most popular drug in the class is owned by Roche's Genentech in
Herceptin, which blocks chemical signals that can stimulate breast cancer
growth. Expected sales are $4.4 billion in 2009. Breast cancer is the No. 1
cancer in women, with an expected 192,370 cases this year, according to the
National Cancer Institute.
The second-best selling cancer drug is Genentech's Avastin also now under
Roche after it acquired Genentech, which is used to shut off the blood
supply in cancer cells that have spread to other parts of the body. It's
approved in small-cell lung cancer, as well as colon and breast cancers.
Expected sales this year are about $3.2 billion.
The Potential Blockbusters:
The monoclonal antibody candidate to watch is a candidate from Bristol-Myers
Squibb via its recently acquired ImClone Systems and its IMC-1121b, which
is in an ongoing Phase III trials and might some day be a rival to Herceptin
for breast cancer treatment. It's designed to block a signaling pathway
that's key to new blood vessel formation in growing tumors. It aims to stunt
tumor growth by starving off the blood supply. The candidate had favorable
safety and efficacy data in an early trial. It may have potential to also
treat melanoma, renal and liver cancers.
There are many potential interesting anti-cancer candidates and/or new drugs
, including Genentech's breast cancer candidate Omnitarg. But the reason IMC
-1121b is of particular interest is that it targets patients that cannot
receive Herceptin. It also represents a bold move for ImClone if it can move
into an area of biopharma where Roche's Genentech now dominates.
9. ANTI-CLOTTING DRUGS
Blood clots are a leading killer. The CDC says about 350,000 to 600,000
Americans have a clot or one that leads to a pulmonary embolism each year,
and that at least 100,000 people die as a result. The trouble with clots is
that half the people who have them do not know it; they find out when they
start having chest pains labored breathing, a rapid heart rate, and seek
emergency medical attention.
Anti-clotting drugs are expected to be a $10.9 billion enterprise this year,
according to Thomson Reuters SD Pharma estimates. One main reason is that
it is often prescribed as a preventive measure to those most prone to a clot
, such as people who have had recent surgery, or ones that have had an
artery blockage in the past, and need to be especially careful to avoid
clotting.
The top name in the anti-clot game is Bristol Myers' Plavix, with expected
revenue of $9.5 billion this year, making it the No. 2 prescription drug in
the U.S., second only to Lipitor. Plavix has about 86 percent market share.
There are few noteworthy challengers, but one Ono Pharmaceuticals in Japan,
with a drug called Limaprost, marketed as Opalmon.
The Potential Blockbusters:
The contender here is Eli Lilly & Co. with its Effient, which was approved
in July 2009. It was more effective than Plavix in preventing heart attacks.
The trouble is that it also is more likely to cause problems with dangerous
and sometimes fatal bleeding. As a result, Effient carries a strong black
box warning. The label recommends against its use in patients with a history
of heart attack or stroke. And it's not generally recommended for anyone
over age 75. Plavix may be the older drug, and it even may be less
effective, according to the study data. But it carries no such warning.
10. MULTIPLE SCLEROSIS
Unlike most diseases in the top 10, multiple sclerosis is a killer only in
its most severe forms. The chronic disease affects the brain, nerves and
spinal cord can affect muscle coordination and speech, making basic
activities like walking and talking extremely difficult. In its most severe
form, it can cause paralysis, blindness, tremors and extreme fatigue.
About 400,000 Americans have MS, and every week about 200 people are
diagnosed, according to the National Multiple Sclerosis Society. About $9.5
billion will be spent this year on prescription medications to help patients
deal with MS symptoms, according to Thomson Reuters SD Pharma data.
The two top names in MS drugs are neck-and-neck, each with 2009 estimated
sales of about $2.5 billion about 26 percent market share. One is Avonex, an
immunomodulator made by Biogen Idec Inc. It seeks to slow progression of
physical disability and reduces the number of relapses by helping to limit
the body's immune response and limit damage to nerve cells. The other is
generic manufacturer Teva Pharmaceutical Inc.'s Copaxone, also an
immunomodulator. Biogen's TYSABRI, its other MS treatment on the market,
has been hamstrung due to the number of PML incidents that prompted the
company to even pull TYSABRI off the market for a period.
The Potential Blockbusters:
Biogen Idec is the multiple sclerosis leader, and the candidate to watch
from them is called PEGylated interferon beta-1a. The company announced
earlier this month that it is enrolling patients in a global Phase II study
for it, testing the safety and efficacy of bi-weekly and once-monthly
injections.
Early-stage clinical trials suggest that the new candidate has the potential
to offer less frequent dosing without compromising efficacy, which would be
an advance over many existing drugs, including others from Biogen. The
Phase III study will examine if, over time, treatment with PEGylated
interferon beta-1a can slow disease progression and lead to a decrease in
the number of T2 hyperintense brain lesions commonly seen in MS patients.
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