The US
Food and Drug
Administration on
Wednesday approved
the first new drug to
treat lupus in over 50
years,
Known as Benlysta,
the injectable drug is
designed to relieve
flare-ups and pain
caused by lupus, a
little-understood and
potentially fatal
ailment in which the
body attacks its own
tissue and organs.
Biotech drugmaker
Human Genome
Sciences Inc. spent 15
years developing
Benlysta and will co-
market it with
GlaxoSmithKline PLC.
The companies
estimate there are at
least 200,000 lupus
patients in the U.S.
who could benefit
from the drug.
But experts stress that
Benlysta is not a
miracle drug: It only
worked in 35 percent
of North American
patients tested and
was not effective for
patients with the
deadliest form of the
disease. Additionally, it
did not show positive
results in African
Americans, who are
disproportionately
affected by lupus.
FDA said in its news
release it would
require the drug
developers to conduct
another study
exclusively in African
Americans.
Dr. Betty Diamond,
who has studied lupus
for 30 years, said
Benlysta should
provide
encouragement to
researchers and drug
developers.
"It will send out the
message that it's
possible to conduct a
successful clinical trial
in lupus and that's
tremendously
important to keep the
pharmaceutical
industry interested in
this disease," said
Diamond, a researcher
at the Feinstein
Institute in New York.
Janice Fitzgibbon of
McLean, Virginia has
been taking Benlysta
for two years as part
of the drug's clinical
trial program.
"It's given me my life
back," she said, after
being so crushed by
pain that she couldn't
take her dog for a
walk or drive her
children to school.
"It's a bittersweet
thing for me because I
have friends with
lupus for whom this
drug won't work," said
Fitzgibbon, who is 54.
"There's no one-size-
fits-all for lupus and
I'm just extremely
fortunate that my
lupus is mild and is
helped by Benlysta."
FDA approved the
drug for systemic
lupus erythematosus,
the most common
form of the disease.
Ten-year survival for
patients diagnosed
with the illness is more
than 85 percent,
according to the
National Institutes of
Health.
Lupus patients have
long struggled to draw
attention to their
disease, which affects
women nine times
more than men.
African Americans are
three times more likely
to have the disease.
"I don't think there's a
conspiracy here, but it
just hasn't gotten a lot
of funding and it
hasn't gotten a lot of
attention from the
media," said Dr. Abby
Abelson, chair of the
Department of
Rheumatologic and
Immunologic Disease
at the Cleveland
Clinic.
Lupus causes fibrous
tissue and
inflammation of
internal organs, skin
rashes and joint pain.
Most of Benlysta's
benefit came from
relieving muscle
inflammation versus
organ problems, as
measured on a
comprehensive
checklist of lupus
symptoms.
The disease occurs
when the body's
protector cells, known
as antibodies, stop
differentiating
between foreign
invaders, like bacteria,
and healthy cells. The
cause of this
malfunction is not
understood.
Currently most
patients treat their
disease with a variety
of drugs that help
ease inflammation,
including painkillers,
steroids and
antimalarial drugs —
which were first
approved for lupus in
the 1955. Many
patients say the side
effects of those
treatments are nearly
as uncomfortable as
the disease itself.
Steroids can cause
bone fractures, weight
gain and infection.
Wednesday's approval
completes a
remarkable
turnaround for
Rockville, Md.,-based
Human Genome
Sciences which has
been developing
Benlysta since 1996
and has no other
products on the
market. The company
originally tested
Benlysta, known
generically as
belimumab, as a
treatment for
rheumatoid arthritis.
When a mid-stage trial
in lupus patients failed
to meet researchers'
goals in 2006, many
analysts wrote the
drug off and
downgraded the
company's stock. But
when scientists
reanalyzed the data
they found that the
drug helped block the
antibodies that cause
lupus symptoms in a
subset of patients.
Analysts estimate the
drug could reach
annual sales exceeding
$3 billion within five
years.
Thursday 10 March 2011
Friday 4 March 2011
Pfizer's Post Lipitor future
Pfizer the world largest pharmaceutical firm going through a critical period as patent protection of its blockbuster 'LIPITOR' is scheduled to expire in june 2011 Lipitor is chemicaly Atorvastatin a cholesterol lowering drug comes under HMG Coenzyme reductase category.It is one of the most widely studied medicine.
Lipitor is pfizer's biggest product making 11.4 billion US dollar in 2009.Lipitor's revenue is threatened by patient expiration in some markets such as US,Japan and UK and Ranbaxy is going to be a dominent force in us market with its generic lipitor.
Pfizer will lose 2% of its current sales over the next six years dropping to US$47.1 billion,as per reports.According to research by Evaluate pharma Pfizer will remain the no.1 seller of drugs over the next six years despite a drop in sales mainly because of its merger with Wyeth.
The patent expiration will be a huge blow for the company because its lipitor dominated the 20 bn statin market over the years.
Anticipating these set backs back in 2008 pfizer strategically delayed generic competition for its lipitor by some 20 months until november 2011 after threatened by Ranbaxy.
Pfizer will lay off more than 1000 employes at its Groton,Conn,research and development site to cut costs.They also announced that it would shuts its European research hub in Kent,Britian with the loss of around 2400 jobes.
Pfizer said cuts in R&D spending and other measures would help meet earing targets as it faces the expiry of patients on lipitor.
Now they focus on upcomimg products for alzheimer's,cancer and pain to reach blockbuster status.Pfizer has 30 new compounds in development for oncology and 10 in development for Alzheimer's.
One new class of drug candidate is CETP inhibitors but there has already been one major clinical failure with pfizer's torcetrapib failing in third phase.
Pfizer is going to focus on under tapped markets of asia and planning to increase research on asian population.All these to an extent help them to reduce their sales lose in upcoming years.
Lipitor is pfizer's biggest product making 11.4 billion US dollar in 2009.Lipitor's revenue is threatened by patient expiration in some markets such as US,Japan and UK and Ranbaxy is going to be a dominent force in us market with its generic lipitor.
Pfizer will lose 2% of its current sales over the next six years dropping to US$47.1 billion,as per reports.According to research by Evaluate pharma Pfizer will remain the no.1 seller of drugs over the next six years despite a drop in sales mainly because of its merger with Wyeth.
The patent expiration will be a huge blow for the company because its lipitor dominated the 20 bn statin market over the years.
Anticipating these set backs back in 2008 pfizer strategically delayed generic competition for its lipitor by some 20 months until november 2011 after threatened by Ranbaxy.
Pfizer will lay off more than 1000 employes at its Groton,Conn,research and development site to cut costs.They also announced that it would shuts its European research hub in Kent,Britian with the loss of around 2400 jobes.
Pfizer said cuts in R&D spending and other measures would help meet earing targets as it faces the expiry of patients on lipitor.
Now they focus on upcomimg products for alzheimer's,cancer and pain to reach blockbuster status.Pfizer has 30 new compounds in development for oncology and 10 in development for Alzheimer's.
One new class of drug candidate is CETP inhibitors but there has already been one major clinical failure with pfizer's torcetrapib failing in third phase.
Pfizer is going to focus on under tapped markets of asia and planning to increase research on asian population.All these to an extent help them to reduce their sales lose in upcoming years.
Thursday 3 March 2011
importance of plants as a drug source
Since ancient time mankind depended on plants as a remedy for their illness.At that times people or even the physician doesn't know about the constituents in that particular plant.The major reason for that is that the knowledge they had is simply trasmitted from generation to generation and they are simply using it.For example ayurveda, the ancient system of medicine in india.In this majority of drugs used are crude plants.
As time progressed,the search for new molecules resulted in screening of plants and which resulted in isolation of new lead compounds.And these compounds provide outstanding contribution to modern therapuetics.Examples for such discoveries include isolation of serpentine from roots of Rauwolfia serpentina in 1953.Similarly isolation of vincristine and vinblastine from Catharanthus roseus revolutionised the cancer therapy.These are a very few examples of plants that contributing to therapuetics.
So these examples clearly indicate the importance of plants.So it is very important to screen those plants that are using in indigenous systems of medicine
Their is doubt that many asian,african and latin american countries have unexplored source of medicinal plants.Screening of such plants will obviously provide some lead compounds and that offer cure to many disease like cancer,AIDS etc.
One of the consistent challenges in screening of such plants is the incorporation from the peoples especially tribes using these plants.The WHO should take necessary measures on this matter.
There is no doubt in the importance of plants in future therapeutics.Plants will serve the humanity by providing lead compounds.
As time progressed,the search for new molecules resulted in screening of plants and which resulted in isolation of new lead compounds.And these compounds provide outstanding contribution to modern therapuetics.Examples for such discoveries include isolation of serpentine from roots of Rauwolfia serpentina in 1953.Similarly isolation of vincristine and vinblastine from Catharanthus roseus revolutionised the cancer therapy.These are a very few examples of plants that contributing to therapuetics.
So these examples clearly indicate the importance of plants.So it is very important to screen those plants that are using in indigenous systems of medicine
Their is doubt that many asian,african and latin american countries have unexplored source of medicinal plants.Screening of such plants will obviously provide some lead compounds and that offer cure to many disease like cancer,AIDS etc.
One of the consistent challenges in screening of such plants is the incorporation from the peoples especially tribes using these plants.The WHO should take necessary measures on this matter.
There is no doubt in the importance of plants in future therapeutics.Plants will serve the humanity by providing lead compounds.
Tuesday 1 March 2011
WHAT IS A DRUG PIPELINE?
in the pharmaceuticals sector, a drugs pipeline consists of the drugs that a company has under development or is testing. This includes completely new drugs, variants of existing drugs and new applications of existing drugs. The pipeline starts with new drug discoveries and it is important to assess companies' ability to discover new drugs as well as drugs that are currently in the pipeline. The early stage of the pipeline needs to be refilled as drugs move up. Good R & D is crucial. New drugs require extensive development, pre-clinical testing, three stages of clinical trials and then have to approved in each country the company wishes to sell the drug in. This means that many uncertainties lie between discovering a new drug and selling it. The uncertainties lessen as a drug moves along the pipeline . It is not uncommon for companies to buy and sell drugs that are in various stages of development, or to enter into agreements to jointly develop or market drugs. In these circumstances one company may receive milestone payments from another for completing particular stages of development, trials and approval, as well as royalties on the drug once it is marketed. Major pharmaceutical companies always have pipelines with many drugs in them. This may appear to spread the risk, but it is often the case that most of the value of the pipeline lies in a small number of drugs, or even in a single "blockbuster" drug Assessing the pipeline is often the most important part of valuing a pharmaceutical company, and the most difficult. The value of a pipeline is the sum of the values of each drug in the pipeline. To assess the value of a drug in the pipeline one needs to consider: the size of potential market for the drug how much market share the drug will be able to gain the risk that it will not be approved. The size of the potential market may be clear. If the drug is to treat a specific disease, recognised disease for which the need for treatment is accepted it may be easy. However if the diagnosis or treatment is a matter of controversy, if existing treatments are effective or if treatment is so expensive that health services or insurers may not pay for it, then the market size is less clear. How much market share a drug gains will depend on its cost and effectiveness compared to competitors. This includes not just the drugs already on the market, but others that are in development. The risk of failure to gain approval is the hardest thing to assess. It requires evidence of both effectiveness and safety. Effectiveness is generally demonstrated fairly early on (but not always). Safety problems may show up at any point in the clinical trials, although the risk diminishes in the later stages. Companies largely dependent on established products are easier to assess, and there are fewer uncertainties in the valuation. The best growth opportunities in the sector are small companies with a platform for developing new drugs. The valuations of these are, of course, very uncertain.
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