|
BLOOD CANCER
Dr. Reddy's Copies Roche Drug, Cuts Cancer Cure Cost (Update1) (Yahoo News -1/05/2007)
Dr. Reddy's Laboratories Ltd., India's third-biggest drugmaker, said its version of Roche Holding AG's rituximab will be 50 percent cheaper than the original, allowing more access to the cancer therapy.
Rituximab treats non-Hodgkin's lymphoma, a blood malignancy. Reddy's released Reditux on the weekend in Hyderabad, India, where the company is based. The generic-drug maker will also seek to sell the treatment elsewhere, including the U.S., spokeswoman Mythili Mamidanna said in a telephone interview yesterday.
Reddy's and bigger rivals Ranbaxy Laboratories Ltd. and Cipla Ltd. built billion-dollar businesses copying blockbuster medicines and selling them at a fraction of the price in the U.S. and Europe. They are developing the capability to produce complex drugs, known as biologics, whose sales are growing at 14 times the pace of traditional chemical compounds and are among the most expensive prescriptions.
``The door is wide open'' for Indian companies to produce biologic medicines, said Sarah E. Frew, a research associate at the University of Toronto's McLaughlin-Rotman Centre for Global Health. ``We're going to see more of this.''
Rituximab, approved to help fight non-Hodgkin's lymphoma in the U.S. almost a decade ago, generated more than $2 billion last year. U.S. companies Genentech Inc. and Biogen Idec Inc. market the drug as Rituxan in the U.S., and Basel, Switzerland-based Roche sells it in Europe under the name Mabthera.
Price Difference
Reddy's Reditux is priced at 10,000 rupees ($243) for a 100 milligram dose in a 10 milliliter vial, or about half the price Roche charges for Mabthera, Dr. Reddy's Mamidanna said. For a 500 miligram dose, it will cost 40,000 rupees, she said.
The injectable medicine is a monoclonal antibody designed by scientists to target a particular type of cell.
Reditux is the second product from Dr. Reddy's biologics unit, which is developing treatments for cancer and autoimmune diseases. Reddy's sells Grafeel, or filgrastim, to boost white blood-cell production. Filgrastim is marketed by Amgen Inc., based in Thousand Oaks, California, as
Neupogen. India has an estimated 40,000 sufferers of non-Hodgkin's lymphoma, a type of cancer arising in white blood cells, said Mamidanna.
Mabthera is patent-protected until 2013 and there are no immediate plans to change its price, said Roche spokeswoman Martina Rupp.
U.S. law allows the Food & Drug Administration to approve generic versions of conventional drugs, mostly made from chemical synthesis, after their patents expire. Congress is considering a law that would create a process to allow the FDA to approve generic versions of biotech medicines, sometimes known as ``biosimilars.''
Sales Plans
Dr. Reddy's plans to sell Reditux in other markets including the U.S., the world's biggest drug market, Mamidanna said. ``There is nothing actively being done about it at the moment.''
The Indian drugmaker doesn't expect charges of infringement of patent by Roche in Indian courts, she said.
Clinical trials generally aren't required for copies of conventional drugs, though for Reddy's to gain approval for its version of rituximab, it would have to undergo the years of testing that's required for any new medicine.
Conventional drugs are small molecules that generic makers can reproduce in versions that are almost identical to the original product, and vary little from batch to batch. Biotech medications use living cells to produce human proteins, and the final composition can vary, depending on the techniques used. Biotech companies say it is unlikely generic makers can easily reproduce the drug-making methods.
``New manufacturers would have to start again from scratch and would have to develop their own unique data to be able to be sure that the end product is not toxic and works in patients in the same way as the originator product,'' Roche's Rupp said in an e-mailed response to questions.
``The production needs the right production facilities and expert know-how,'' she said. ``Over the last 30 years, Roche has developed these molecules, learning about them very slowly.''
[Back]
Treatments target
sometimes-deadly side effects of bone marrow transplants-(The
Associated Press-15/11/2007)
WASHINGTON — Bone marrow transplants are one of cancer care’s striking
successes, but they have a dark side: The transplanted cells can turn on
patients, attacking their skin and organs. The potentially deadly side
effect with the unwieldy name of graft-versus-host disease, or GVHD,
strikes several thousand each year.“I love my doctors, but they throw up
their hands. They don’t know what to do,” laments Stephen Dugan, 54, of
Radnor, Pa., who longs for an alternative to the problematic steroid that
is today’s treatment mainstay.
His transplant four years ago saved Dugan from cancer. But two months
later he barely survived a harsh bout of GVHD; now he battles a less
severe but chronic form of the disease. When someone receives a
transplanted organ, the big fear is that the patient’s own immune system
will attack the new “foreign” tissue. GVHD is the opposite problem. It
occurs when patients receive donated bone marrow or the stem cells that
produce it. Sometimes the donor’s T cells, whose job is to hunt foreign
invaders, become super-aggressive and attack the recipient’s body.
It happens in at least half of the more than 6,000 Americans who receive
marrow or stem-cell transplants every year. Many times, GVHD is mild or
moderate, causing skin rashes or blistering, vomiting, liver or lung
damage. But one of every five cases is life-threatening. A particularly
dangerous form ravages the stomach and intestines, causing unremitting
vomiting and diarrhea. The only treatment: Super-high doses of the steroid
prednisone, to suppress out-of-control immune cells and the inflammation
they cause. But the side effects are severe, even deadly.
Now in advanced testing are treatments that aim to calm GVHD without that
body-wide steroid toxicity:
• OrBec is a milder kind of steroid, a pill version of the beclomethasone
that asthma patients have long inhaled. Dr. George McDonald of Seattle’s
Fred Hutchinson Cancer Research Center reformulated the drug to coat the
gastrointestinal tract, not roam the body.
• The experimental drug Prochymal aims to soothe the source of GVHD’s
inflammation without suppressing immunity.
[Back]
Thalidomide helps elderly cancer patients-(Yahoo
News)
LONDON (Reuters) - Elderly patients with an aggressive form of blood
cancer lived about 20 months longer when given the drug thalidomide as
part of their treatment, French researchers said on Friday.
The drug also slowed the spread of myeloma, a disease that accounts for
about 1-2 percent of all cancers, usually affects older people, and kills
its victims within three years, they reported in the Lancet medical
journal.
"The main message is the addition of thalidomide is able to improve
survival," Thierry Facon, a specialist in blood diseases at Lille
University in France who led the study, told Reuters.
The standard treatment, established 40 years ago, is a combination
chemotherapy of two drugs called melphalan and prednisone. In recent
years, some patients have also received bone marrow treatment that has
boosted survival, Facon said.
But bone marrow transplants are too harsh for frail, elderly patients, so
researchers turned to thalidomide, a drug used to fight nausea in pregnant
women in the 1950s and 60s until doctors found it caused limb deformity in
unborn children.
Once shunned, thalidomide is now considered a cancer fighter, with
scientists testing it on lung, blood and brain cancers. It has also been
approved to treat leprosy.
Facon and his colleagues analysed 447 untreated patients aged 65 to 75,
giving some the standard drugs and adding thalidomide into the mix for
others.
They used Pharmion's Thalidomide, currently under review by European
regulators for treating multiple myeloma, Facon said. Celgene sells the
drug in the United States under the brand name Thalomid.
In a follow-up nearly six years later, the researchers found those who
received thalidomide lived on average nearly 52 months, versus 33 months
for those on standard therapy.
Progression-free survival -- the time it takes before the disease worsens
-- also improved by about 10 months.
"After 50 years of unsuccessful attempts to find new and more effective
treatment approaches... we now have extensive evidence to support the
introduction of (thalidomide) as the standard of care for elderly patients
with multiple myeloma," Antonio Palumbo and Mario Boccadoro of the
University of Torino, wrote in a Lancet commentary.
[Back]
Drug Discovery May Revolutionize Treatment Of Inflammatory Diseases And
Leukemia-(Science
Daily-21/09/2007)
If you found yourself on a run-away train, would you want
to switch on the brakes? Two Vancouver Coastal Health Research Institute (VCHRI)
and University of British Columbia investigators have found a way to turn
on the brakes of a cell, and thus halt abnormal blood-cell growth in a
range of inflammatory and autoimmune disorders and blood cancers.
The discovery was made by Drs. Alice Mui and Christopher Ong, two
assistant professors in the Dept of Surgery at UBC and researchers in the
VCHRI Immunity & Infection Research Centre and the Prostate Centre at VGH.
It is highlighted in the Sept. 15 edition of Blood, Journal of the
American Society of Hematology.
The immune system relies on white blood cells (leukocytes) to defend the
body against infectious pathogens such as bacteria and viruses. In a
healthy body, leukocytes are strictly controlled and turned off when no
longer needed. This off-switch is controlled by a protein called “SHIP” –
standing for SH2-containing inositol 5’phosphatase.
SHIP, which is only present in blood cells, was discovered in 1997 by Dr.
Gerald Krystal, a senior scientist at the BC Cancer Research Centre and a
professor of Pathology and Laboratory Medicine at UBC. It regulates the
PI3 kinase (PI3K) pathway which is essential for cell growth, survival and
immune cell activation. Inappropriate or persistent activation of the PI3K
pathway can result in serious inflammatory/immune diseases or blood
cancers such as multiple myeloma, leukemia and lymphoma.
With the aim of finding new drugs for treatment of blood borne diseases,
Drs. Mui and Ong collaborated with Dr. Krystal and Dr. Raymond Andersen, a
renowned natural products chemist and professor of Earth and Ocean
Sciences at UBC, to search for drugs that could modulate SHIP. The team
screened Dr. Andersen’s library of sea sponge extracts for molecule
compounds that can turn SHIP on.
“Sea sponges are a rich source of novel bio-active compounds, created by
nature, to protect themselves against marine predators, and interestingly
many of these compounds possess important medicinal properties,” says Dr.
Christopher Ong. “Dr. Andersen’s library has already produced other agents
with interesting biological properties on mammalian cells, some of which
are in clinical development as potential drugs for treatment of human
diseases, so we felt it would be an ideal place to look for drugs that
activate SHIP.”
Drs. Mui and Ong identified a compound, now known as AQX-MN100. It is able
to inhibit immune and blood cell activation both in the test tube and in
mouse models of human inflammatory disease and lymphoma by activating
SHIP.
“This is an entirely new paradigm for controlling run-away cells,” says
Dr. Alice Mui. “Previous research efforts were aimed at trying to control
the cells through blocking stimulation signals. In the run-away train
analogy, this would be like taking your foot off the accelerator and the
train will eventually stop when it runs out of fuel vs. this new approach
of directly applying the brakes. We are also excited because since SHIP is
only found in immune/blood cells, side-effects of SHIP-based therapy on
other cells of the body are expected to be limited.”
The AQX-MN100 discovery has been validated by proof-of-principal grants
from the Canadian Institutes of Health Research (CIHR) aimed at
translating basic research findings into clinically applicable therapy.
This past spring, in one of the largest early-stage financings in B.C.’s
recent biotech history, Vancouver based Aquinox Pharmaceuticals, the
exclusive licensee of the SHIP and AQX-MN100 technology, raised 14.5
million US in venture capital for the continued development and first
clinical trials of the drug for treatment of blood cancers and immune
disorders.
The research team has also received $250,000 from CIHR to support clinical
development, as well as funding from VGH & UBC Hospital Foundation,
through the fundraising efforts of the Sangara family of Vancouver, BC, to
help determine whether AQX-MN100 is active against multiple myeloma. Over
50,000 people are living with incurable multiple myeloma in North America.
New treatments for this disease are greatly needed.
“The work on SHIP promises to lead to great advances in the treatment of
blood cancers and disorders of the immune system,” says Dr. Clay Smith,
director of the Leukemia/BMT Program of VGH and British Columbia, and
professor in the Department of Hematology and Bone Marrow Transplant at
UBC. “It is doubly exciting that these advances came from a team of
researchers right here in BC and hopefully this research will lead to
better treatments not only in BC but throughout the world.”
[Back]
Obesity Found to be
a Risk Factor for Multiple Myeloma (Yahoo News)
PHILADELPHIA – An obese person is more likely than a lean person to
develop multiple myeloma, according to researchers from Brigham and
Women’s Hospital, Harvard Medical School, and Harvard School of Public
Health. Their findings indicate that Body Mass Index (BMI) – a statistical
measure that scales weight to height – provides an indicator for one’s
risk of developing multiple myeloma, a cancer of the blood cells that
produce antibodies. Multiple myeloma currently affects more than 50,000
people in the U.S., and the five-year survival rates of the cancer are
below 40 percent.
The study, published in the July issue of Cancer Epidemiology, Biomarkers
& Prevention, a journal of the American Association for Cancer Research,
takes its data from over 100,000 participants in the on-going Nurses’
Health Study and Health Professionals Follow-up Study, two similar
large-scale studies. The study findings were similar to those from
previously published studies that included smaller numbers of multiple
myeloma patients, and/or were based on a one-time recording of height and
weight.
“I find the results of these studies encouraging, since they show
consistent results about the first risk factor for multiple myeloma that
people can actually modify,” said the study’s lead author Brenda M.
Birmann, Sc.D., a researcher in the Department of Medicine at Brigham and
Women’s Hospital and Harvard Medical School. “Treatment options for this
disease are improving, but it is also important to identify risk factors
that could be modified. We would like to learn how to prevent its
occurrence.”
The Brigham and Women’s Hospital-based Nurses’ Health Study has followed
the health of female registered nurses since 1976, and the Health
Professionals Follow-up Study, based at Harvard School of Public Health,
has followed males from several health professions since 1986. These
studies recorded height, weight and physical activity for each person
enrolled, as well as diet, medications, smoking habits and other health
behaviors, and has updated that information every two to four years. Of
the 136,623 participants who qualified for their study protocol, Birmann
and her colleagues confirmed 215 cases of multiple myeloma.
Body Mass Index (BMI) is computed by dividing a person’s weight by the
square of their height. A BMI between 18.5 and 25 is considered optimal, a
BMI of 25-29 is considered overweight, and a BMI of 30 or higher is
considered obese.
The association between BMI and multiple myeloma was strongest among men
with a BMI of 30 or more. When compared with leaner men (those with a BMI
below 22), obese men, the researchers said, were over twice as likely to
develop multiple myeloma. The effect was less pronounced among overweight
or obese women, yet those women also had an increased risk.
The study also looked at whether regular exercise is related to risk of
multiple myeloma. There was not a clear effect of exercise on risk,
although the results among women suggested that those who exercise more
might have a lower risk. “We cannot say with certainty that exercise
reduces the risk of multiple myeloma, but there is ample evidence that
regular exercise offers many other health benefits,” Birmann said.
The study findings do show, however, that the effect of BMI on risk of
multiple myeloma is separate from any possible effect of physical
activity.
According to Birmann, previous research has identified possible biological
links between obesity and multiple myeloma. For example, adipocytes, cells
found in fat tissue, produce a cell signal, called interleukin-6 (IL-6),
which promotes the immune system’s inflammation response. In obese people,
this can cause an overproduction of IL-6, which in turn creates a cellular
environment that sustains multiple myeloma. “The IL-6 chemical pathway is
one possible way obesity could influence the risk of developing diseases
like cancer or cardiovascular disease, but the answer might also lie in
other relationships between obesity and cancer,” Birmann said.
Further research, she said, will uncover more about the relationships
between obesity and cancers such as multiple myeloma. The researchers
believe their findings may lead to examination in greater detail of the
BMI/multiple myeloma link, including the role of IL-6 and other chemical
signals, energy metabolism, and other risk factors such as weight change
or weight cycling.
This research was funded through grants from the Dana-Farber/Harvard
Cancer Center Specialized Program in Research Excellence in Multiple
Myeloma, the National Cancer Institute and the National Institutes of
Health.
[Back]
2
New Drugs for Blood Cancer Show Promise in Clinical Trials-(Yahoo News-06/12/2004)
Two
experimental drugs are showing strong early results in treating patients
with a blood cancer that has grown resistant to the most commonly prescribed
medicine, doctors reported. The
existing drug, Gleevec, has been widely hailed as a wonder drug because
it prolonged lives and is directly aimed at the aberrant enzyme that causes
chronic myeloid leukemia, a disease marked by an overgrowth of certain
white blood cells. But the majority of patients with the most advanced
form of the disease become resistant to Gleevec, and even 16 percent of
those given the drug when the disease is first diagnosed become resistant
by 40 months, said Charles L. Sawyers, a professor at the University of
California, Los
Angeles.
Two new drugs, one
from Bristol-Myers Squibb and the other by Novartis, which also developed
Gleevec, might pick up where Gleevec leaves off, doctors reported at the
American Society of Hematology meeting here.
The Bristol drug,
known now as BMS-354825, returned white blood cell counts to normal in
86 percent of 36 patients with the early phase of the disease, Dr. Sawyers
said. Such a response makes people feel normal though it does not wipe
out the underlying cause of the disease. In 29 patients with more advanced
stages of disease, a majority had blood cell counts improve or return
to normal, but it was too soon to tell how long the improvements would
last.
"Some of them
have one or two weeks to live," said Dr. Moshe Talpaz of the M. D.
Anderson Cancer Center in Houston,
who helped conduct the trial. "To see them improve is very dramatic."
To be sure,
the test had small numbers of patients, without a control group, and was
the first stage of clinical trials. But promising cancer drugs for which
there is no alternative can reach the market after only two stages of
trials instead of the usual three, making it conceivable the drug could
reach the market in a couple of years, Dr. Talpaz said.
The new Novartis
drug, AMN107, is also in the first phase of testing. Of 65 patients with
chronic myeloid leukemia or a related disease called acute lymphocytic
leukemia, more than 50 percent have had some response to the drug, according
to the M. D. Anderson Cancer Center.
[Back]
Umbilical
cord blood can cure adult leukemia-(Times of India-27/11/2004)
Umbilical
cord blood now used mostly to treat children with leukemia could save
thousands of adults with the disease every year who cannot find bone marrow
donors, two large studies indicate. A European study found that those
who got cord blood were just as likely to be free of leukemia two years
later as those who got marrow. A US study looking at 3 year survival
yielded results almost as promising.
Cord
blood offers an important advantage over marrow that makes it particularly
valuable for use in transplants-its stem cells are less likely to attack
the recipients body. That allows a greater margin of error in matching
donor and recipient. Until now cord blood has been considered suitable
only for children because each donation has only about one tenth the
number of stem cells in a marrow donation. The new studies suggest that it
is not a serious impediment.
In the
European study involving 682 patients, about a third of both those who
got matched marrow and those who got cord blood that did not quite match
their own tissues were alive after two years.
[Back]
Mumbai gets ready for first bone marrow list-(Mumbai
Newsline-17/09/2004)
The
Indian Society of Organ Transplantation (ISOT) will set up Mumbai's first
(there is one in Delhi) bone marrow registry at the Tata Memorial
Hospital, Parel where donors can be matched with patients. With state of
the art equipment, lab and a data base available to Indian patients
globally, the registry will be launched on September 30th.
TMH
carried out India's first bone marrow transplant in 1983. Most patients
who require a bone marrow transplant suffer an extreme paucity of donors
who are relatives. The patient needs bone marrow transplant from a HLA
match (Human Leucocyte Antigen) sibling, but there is only a one in four
chance of a match. With the size of the average family decreasing, finding
a genotypically identical sibling is very difficult.
For
persons residing abroad, the chances of finding a compatible Indian origin
donor is one in a million due to ethnic differences. Even if a matching
donor is found, the transplant can only be performed outside India at an
exorbitant price. The registry will be electronically linked to
international registries.
Earlier efforts to form the registry failed because of lack of funding,
but this time many non resident Indians in the US who have formed their
own ethnic Indian registry are helping with funding.
[Back]
Patents
controller fired over EMR to Novartis-(Economic Times-08/09/2004)
India's first exclusive
marketing right (EMR) in the pharma sectorgiven to Novartis for its anti
blood cancer drug Glivec in November last year has cost the Controller-General
(C-G) of patents and trademarks his job. The EMR has been fiercely challenged
in courts by generic producers of the drug on the grounds that the compound
being a derivative of a molecule known prior to 1995, did not satisfy
the novlety criterion in the Patents Act.
Following the grant
of EMR, Novartis had obtained an ex parte injunction from Madras High
Court barring six companies-Ranbaxy, Cipla, Sun Pharma, Camlin, Emcure
and Intas from selling generic versions of the drug. However, at least
three companies, including Hyderabad based Natco and Shanta Biotech continue
to market their versions of the drug even as a Novartis plea for ex parte
injunction is oending in the Bombay High Court. Natco Had moved the Supreme
Court also seeking nullification of the EMR to Novartis.
Sources in the C-G's
office said that they would now stick to the Act and refrain from discretionary
interpretation to the extent possible. The Patent Act is allegedly ambiguous
on definitions of patentability with terms like "novelty", "industrial
application", "prior art" etc left for the patent giving
authority to draw conclusions on. The domestic pharma industry wants these
terms to be deconstructed in patent amendment bill which has recently
been referred to a group of ministers for fine tuning.
[Back]
Allergy
link to blood cancer risk-(Yahoo News-06/11/2004)
Scientists found people with hives had an
increased risk of leukaemia, while those who had childhood eczema were at
higher risk of non-Hodgkin's lymphoma. The
research, by Sweden's Karolinska Institute, is published in the journal
BMC Public Health. UK experts have
questioned whether the findings are robust, and advised people with
allergies not to be alarmed. Other
allergic conditions, such as hay fever, did not appear to increase risk of
cancer.
The researchers followed 16,539 twins for
31 years and recorded whether they were diagnosed with a blood cancer
during that time. All the people who
took part in the study had answered a questionnaire sent out by the
Swedish Twin Registry in 1967, which included questions about allergies.
Researcher Dr Karin Söderberg said: "An
important strength of our study is that the information about allergic
conditions was collected prior to the individuals being diagnosed with
cancer. This prevents the bias that may
arise if people, who have already been diagnosed with cancer, are asked to
remember whether or not they have ever suffered from an allergy."
The researchers believe the key may be
chronic stimulation of the immune system caused by allergic conditions.
This leads to the formation of increased
numbers of white blood cells, increasing the risk that cancer-causing
mutations occur within the white-blood cell population. Some experts
believe that allergic conditions might actually protect against cancer by
enhancing the ability of the immune system to detect and eliminate
malignant cells. But the Karolinska
team said their findings suggest there is little truth in this hypothesis.
They stress that although childhood eczema
appeared to increase the risk that individuals will suffer from
non-Hodgkin's lymphoma by around two-fold, it was important to realise the
likelihood of any individual suffering from this condition is still
remote.
Hazel Nunn, of the charity Cancer Research
UK, said: "Although some aspects of this study are well designed
we must be careful when interpreting the results. They
do not show a convincing link between allergies and blood cancers.
The interpretations of the results of this
study are questionable because the apparent link between allergies and
cancer that have been identified are most likely to be due to chance.
This is an area where further research is
welcomed and allergy sufferers should not be alarmed."
[Back]
|
