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5111 Kali Era, Virodhi
Vikramarka Era, Virodhi
Year, Karthika month
Biologic industry is a fledgling industry in which more than 80 % of companies
have yet to make a profit. Research into biologics is an economically
risky business. Even among medicines that make it to the first stage of clinical
trial development, fewer than 20 % actually make it to the marketplace. Those
that emerge from that funnel face more hurdles. For example, among biologics
that made it to the marketplace as of the end of 2008, less than one-third
had recouped their research and development costs over a six-year period.
No doubt biologics are on the cutting edge of medical progress to find cures
for cancers, Alzheimer's, diabetes and other diseases. Biologics bring
hope for patients and for the US economy, but it may be threatened by the
proposed legislation that outlines the means for companies to sell similar
versions of innovative biologics, called "biosimilars." Committees in both
the House and Senate have passed, with bipartisan support, amendments that
would give innovators 12 years before having to share their data. That is
the minimum number suggested by an economic analysis that found that it takes
between 12.9 and 16.2 years for an innovator to recoup the return on their
investment on an innovative biologic product.
If innovators must share any successful research with competitors before a
reasonable amount of time has passed, investors are simply not likely to fund
more innovative research. Without investors, there are no companies, no jobs,
and no new medicines for anybody – rich or poor. Looming large is the
specter of industry job losses and curbs on innovation.
Although health reform may bolster drug industry sales over the next five
years, as cited in an IMS October report, the analysts still expect pharma
growth to be relatively low due to the global economic downturn, patent losses
and more intense pressure on prices. Industry executives insist that health
reform will be a wash in terms of revenue, especially if most of the added
sales involve discounts.
Job Cuts and Mergers
Some 233 mergers and acquisitions were announced in the healthcare industry
during the third quarter, and though volume was in line with the prior quarter,
the number of dollars spent rose 38 percent to $38.4 billion, according to
a recent report from Irving Levin Associates.
Johnson & Johnson announced global restructuring initiatives designed
to strengthen the company's position as the world's leading global health
care company. The company is taking steps to prioritize its innovation efforts
around the many growth opportunities in health care and to execute aggressively
on bringing key new products to market. The company said initiatives would
be implemented at the operating company levels to be certain the businesses
can meet the needs of the customers they serve on a day-to-day basis. The
company estimates that position eliminations will be in a range of 6-7 percent
of its global workforce, subject to any consultation procedures on these
plans in countries where required. For the third time in 13 months,
employees at Vacaville's ALZA Corp. faced another round of layoffs, this
time the result of the firm's parent company, Johnson & Johnson, reducing
its global workforce 6 to 7 percent.
Eli Lilly and Co. has notified the state that it will eliminate 191 sales
jobs as part of a company-wide restructuring announced in September that
ultimately will result in 5,500 job cuts by the end of 2011.
In a sweeping reorganization of its R&D operations following its merger
with Wyeth, Pfizer is closing six of its 20 research facilities while laying
out plans to restructure and consolidate others as it slashes 15 percent
of its R&D staff. The global giant will concentrate its R&D
operations around five key hubs while closing facilities in Princeton, NJ;
two sites in New York and North Carolina and one in the United Kingdom. It
intends to shutter a third of the 16 million square feet of space that it
has in R&D. http://www.fiercebiotech.com/story/pfizer-plans-massive-cuts-sweeping-r-d-reorg/2009-11-09?utm_medium=nl&utm_source=internal#ixzz0WP977DUB
Merck, which has averaged 50 biotech deals a year since 2003, says it plans
to keep up the pace and possibly double that number, even as it prepares
to cut around 16,000 jobs as part of its $41 billion merger with Schering-Plough.
In 1998, the U.S. Food and Drug Administration approved 147 new drugs.
Last year, just 11 new medicines were approved, continuing a downward trend
even as drug companies and the federal government spend more money than ever
on research and development. By some estimates it costs more than a
billion dollars or more to bring a drug from the laboratory into the clinic.
Key patent expiries within the pharmaceutical sector will intensify from
2011 onwards, affecting some of the biggest brands in the industry, such
as Pfizer's Lipitor (atorvastatin), driving down revenue growth for pharmaceutical
companies. As such, the reality is that revenue growth among Big Pharma will
flat-line at 0.2% between 2008 and 2014, leading Datamonitor to forecast
sales of $387 billion in 2014, about 50% less than what was projected.
Big Pharma could potentially offset sales growth decline by diversification,
the resulting fall in operating margin would act to reduce operating profit
and somewhat negate the benefits of diversification. While cost-cutting
and restructuring, together with merging with and acquiring other pharmaceutical
companies and biotechs to gain access to their drug development pipelines
seems to be a strategy to endure the upcoming patent cliff.
India Looses to China
India is not conducive for R&D investment in innovation and drug discovery,
according to Novarttis. "The intellectual property (IP) protection
was not up to the mark in India. In principle you can discover in India,
you can do research. There has been some progress on the protection of intellectual
property but its not up to the standard that I would expect to make an investment
into discovery led research," said Novartis' Vasella. Novartis was
denied patent of its blockbuster cancer medicine Glivec by Bombay and Madras
High Courts which prompted the company to move to the Supreme Court. According
to Mr Vasella, the Supreme Court verdict on the Glivec case might be the
turning point for Indian R&D.
Many in the industry, including Novartis, think that there is a significant
difference between India and China - in the political system, in the decision
making processes, in the complexities of the processes and in the continuity.
India has potential but things take longer to get done. Mr Vasella said IP
protection is the crux of any investment for pharma companies. “IP is very
fundamental to our business and any investment we make without it is a no
go. Now Indian companies are also investing in research and I believe they
would create something more of an intellectual basis.”
Novartis announced a USD 1 billion investment over the next five years, increasing
R&D activities in China and confirming Novartis' long term commitment
to China's further economic development, health reform and improving the
health care of the Chinese people. The Novartis investment will include a
significant expansion of The Novartis Institute of BioMedical Research (CNIBR)
in Shanghai. Novartis investments will expand The Novartis Institute for
BioMedical Research in Shanghai (CNIBR) which is currently located in Zhangjiang
High-tech Park. The Institute specializes in basic research and development
of new drugs including small molecule and biological medicines to treat diseases
that are highly prevalent in China. To allow for this large expansion, the
BioMedical Research Institute will relocate to a new state of the art campus
in Shanghai. Its activities are expected to span work in analytics and biomarkers,
in vivo pharmacology, protein production, characterization and scale-up screening
and chemistry and proteomics, genomics and imaging. CNIBR is expected to
extend and increase its collaborations with institutions in China and is
committed to cultivating local R&D talent, sharing the world-leading
development technology platform of Novartis and years of drug development
experience. CNIBR is expected to be the third largest R&D center for
Novartis, after the R&D center in Cambridge, Massachusetts, USA and the
facility at the Novartis headquarters in Basel, Switzerland, and to become
the largest comprehensive R&D center in China. Estimates are that the
number of R&D associate positions will increase from 160 today to about
1,000. Novartis also announced that it has invested USD 250 million in a
new global technical center which is opening in Changshu, focused on technical
research, development and manufacturing activities of APIs (active pharmaceutical
ingredients). The synergies gained from the co-location of both technical
R&D and manufacturing enable significant pharmaceutical process improvements
and operational efficiencies. The number of high quality jobs at the new
center is projected to nearly double, and the facility is expected to be
a critical part of the global production and supply chain network.
Demand for healthcare in China is growing rapidly. In addition, the burden
of disease now includes more chronic diseases associated with lifestyle choices.
The government is working to expand access to affordable, basic medical services
to all citizens by 2020, and recently announced that it will spend approximately
USD124 billion over the next three years to further build the nation's health
system. Government efforts are expected to extend to expanding insurance
coverage, updating public hospitals and training community healthcare workers.
Activities are also anticipated to help improve health IT systems and strengthen
the quality and safety of pharmaceutical production capabilities, improving
access to innovative treatments. Novartis aims to support the government's
health reform by sharing knowledge and best practices.
In addition, Hard To Treat Diseases (HTDS.PK) www.htdsmedical.com, announced
that Novartis is acquiring an 85% stake in HTDS' H1N1 Vaccine partner, Zhejiang
Tianyuan Bio-Pharmaceutical Co., Ltd., for US$125 million. Novartis of Switzerland
will begin a five-year, $1 billion China initiative with two aims: the company
will dramatically increase its investment in its China R&D facility,
and it will seek to make China one its top three markets worldwide.
Novartis reports that it has made the purchase of a majority interest in
Zhejiang Tianyuan to expand its human vaccines presence in China. Zhejiang
Tianyuan is a privately-held vaccines company providing a competitive product
portfolio and pipeline in China, where Novartis has a limited vaccines presence.
Tianyuan and Novartis are to collaborate on building a vaccines industry
leader targeting unmet medical needs in China, the world's third-largest
vaccines market. Acquisition of 85% stake in Tianyuan for approximately US$125
million will require Chinese regulatory and government approvals.
Novartis Opens New Facility in the US
Novartis officially opened the first next-generation flu vaccine plant in
the United States. The factory in Holly Springs, North Carolina, will
use batches of dog cells to grow influenza vaccine, instead of the chicken
eggs widely used now. While the cell method is only slightly faster, it can
be scaled up more quickly. Federal advisers to the U.S. Food and Drug
Administration last week asked for more safety data on another cell-based
vaccine, one made by privately held Protein Sciences Corp.
The United Stae Health and Human Services (HHS) spent $487 million helping
Novartis build the plant, which was planned before the current pandemic of
H1N1 swine flu. The U.S. government is struggling to vaccinate enough
Americans against H1N1. The Centers for Disease Control and Prevention estimates
22 million Americans have been infected, and it wants to vaccinate at least
160 million people. But just over 50 million H1N1 vaccines have been distributed.
In 2011, the Novartis Holly Springs facility will be able to make 50 million
doses of seasonal flu vaccine a year and up to 150 million doses of pandemic
vaccine within six months of a pandemic being declared.
Working in India is Difficult
“The nail that sticks out gets hammered down” is a Japanese saying. Like
it or not this is the way many societies behave, including the American work
Recently, Prime Minister Dr Manmohan Singh extended an invitation to return
to India to all Indian Americans and nonresident Indians. However,
the Indian Americans, moving to India hoping for better life, surprisingly
met India’s notoriously inefficient government. The repatriates complained
about traffic and congestion, lack of infrastructure, bureaucracy and pollution,
although India never promised anything different. Things went downhill
for many Indian Americans, as the Indian workplace cultures felt unexpectedly
foreign to them.
In India, one might see disorganization, intimidation, and a culture where
top directors’ decisions are rarely challenged. These situations exist
in the West as well, but maybe not to the extent as in India. What
is unique to India is that meetings deliberately start hours late and sometimes
go on for hours without any clear agenda or purpose. Corruption and
crime exist in the West at high places, if not in day-to-day life.
However, it is simply unacceptable that some very simple practices that are
often taken for granted in the US, such as being ethical in day-to-day situations
and believing in the rule of law in everyday behavior, are surprisingly absent
in India. It is an unnecessary drain on the bodies and souls of many.
In addition, there are so many things that are tricky about doing business
in India that it takes years to figure it out.
The best bet for the returning Indian American, having high moral values,
ethics, and wish to work in India, maybe an American multinational company
that plays by the Indian laws and retains American values. Read an article
on this topic:
Duke University and Jubilant Organosys Limited, the largest integrated Custom
Research and Manufacturing Services (CRAMS) and leading Drug Discovery and
Development Services (DDDS) company in India, through its subsidiary, Jubilant
Biosys Limited, signed a Letter of Intent to develop a multi-faceted partnership
that will expedite translation of discoveries by Duke scientists into clinical
therapies. The proposed partnership will also advance both organizations’
mutual commitment to reducing global health disparities. The Parties shall
complete definitive agreements by the first quarter of 2010. In addition,
Jubilant and Duke will collaborate on two innovative biomarker studies to
be conducted in Kolkata, India. One will be the development of a cohort to
gain insights into the clinical and molecular characteristics of several
chronic diseases highly prevalent in the Indian population and to better
understand these diseases in the context of transitioning rural to urban
populations. The second study will validate in an Indian population, with
heart disease and diabetes, metabolomic biomarker signatures found to be
associated with insulin resistance and cardiovascular disease in Caucasian
populations. Jubilant will fund the pilot phase of these studies in India
and both studies will be led by Duke University School of Medicine and the
Duke Global Health Institute.
Also, Jubilant Organosys, the University of Alabama at Birmingham (UAB),
and Southern Research Institute announced a joint venture that will focus
on leveraging their collective innovation and enabling technologies in the
areas of Oncology, Metabolic Disease and Infectious Diseases.
New Medicine for
Heavy menstrual bleeding (Menorrhagia) is reported each year by about 3
million U.S. women of reproductive age. Women with uterine fibroids
may experience heavy menstrual periods. But in most cases, there is no underlying
health condition associated with the condition. Heavy menstrual periods
can cause pain, mood swings, and disruptions to work and family life.
The U.S. Food and Drug Administration approved Lysteda tablets (tranexamic
acid), the first non-hormonal product cleared to treat menorrhagia. Lysteda
works by stabilizing a protein that helps blood to clot.
Tranexamic acid was first approved by the FDA in 1986 as an injection, under
the brand name Cyklokapron, and is used to reduce or prevent bleeding during
and following tooth extraction in patients with hemophilia, a hereditary bleeding
disorder caused by the lack of a blood clotting factor. The most common
adverse reactions reported during clinical trials by patients using Lysteda
included headache, sinus and nasal symptoms, back pain, abdominal pain, muscle
and joint pain, muscle cramps, anemia, and fatigue. There was a statistically
significant reduction in menstrual blood loss in women who received Lysteda,
compared with those taking an inactive pill (placebo). Use of Lysteda
while taking hormonal contraceptives may increase the risk of blood clots,
stroke, or heart attack. Women using hormonal contraception should not take
Lysteda, unless there is a strong medical need, and only if the benefit of
treatment will outweigh the potential increased risk. Lysteda is manufactured
by Xanodyne Pharmaceuticals of Newport, Ky.
The Desire Drug
World’s population continue to grow, because births outnumber deaths, to
an unsustainable level indicating human desire for sex is undiminished at
least among people of reproductive age. However, a Boehringer survey
of 31,000 U.S. women aged 18 and above found that one in 10 expressed distress
because of diminished sex drive. As humans age, especially women, diminished
desire occurs for many reasons. In 2003, an article in the British
Medical Journal identified female sexual dysfunction as a disease created
by pharmaceutical companies to make healthy people think they need medicine.
Now, the German drugmaker is putting the finishing touches on a pill designed
to reawaken desire by blunting female inhibitions. While Viagra, Cialis and
Levitra target the mechanics of sex by boosting blood flow to the penis,
this drug works on the brain – the desire drug may prove sex really is all
in her head, which has the potential to revolutionize sexual medicine much
as Pfizer Inc.’s blue pill did a decade ago. The medicine is a chemical
shortcut around a complex dysfunction involving body and mind or whether
disinterest in sex is a legitimate medical condition. Flibanserin works
on the brain by putting “two feet on the brakes” to block the release of
a chemical called serotonin, which regulates mood, appetite, sleep and memory.
In time, the process should trigger the production of dopamine, a chemical
that, among other jobs, helps stimulate desire. The drug differs
from testosterone, a hormone that’s also been tested to reawaken women’s
If flibanserin makes it to market, it will be the first success after a
series of failures from drugmakers including Procter & Gamble Co. and
Pfizer. The New York-based maker of Viagra abandoned efforts to adapt its
pill for women in 2004 and closed sex-health research at the end of last
year. The only female sexual dysfunction therapy approved in the U.S.
is Eros-CTD, from NuGyn, Inc., a suction pump that fits over the clitoris
much like the erection pumps that predated Viagra. Intrinsa, a testosterone
patch from Noven Pharmaceuticals Inc. licensed by Procter & Gamble, is
sold in Europe for women whose uteruses have been removed. A U.S. version
was put on hold in 2004 on concern about whether it is safe for long-term
use. Still in clinical trials are a new version of the P&G patch; LibiGel,
a testosterone gel from BioSante; and bremelanotide, an injected therapy
from Palatin Technologies.
In addition, according to the Massachusetts Male Aging Study (MMAS), ED
affects an estimated 52 percent of men between the ages of 40 and 70.
There seems to be a need for better ED drugs for millions of men living with
ED, searching desperately for new treatment options. Avanafil (a phase
3 candidate developed by Vivus) is a next-generation, highly selective oral
phosphodiesterase type 5 (PDE5) inhibitor therapy being investigated for
the treatment of ED. Studies to date have demonstrated that avanafil has
a fast onset of action, with activity apparent in 30 minutes or less after
administration. The unique profile of avanafil suggests that the compound
may be more selective than other PDE5 inhibitors, potentially resulting in
lower incidence of the side effects most commonly associated with PDE5 inhibitor
therapies. Data suggests that avanafil achieves a full effect in 30 minutes
or less, with a window of opportunity for intercourse extending beyond six
primary sources cited above,
BBC News, New York Times (NYT),
Washington Post (WP), Mercury News,
Bayarea.com, Chicago Tribune, CNN, USA
Today, Intellihealthnews, Deccan
Chronicle (DC), the Hindu, Hindustan
Times, Times of India, AP, Reuters,
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