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5111 Kali Era, Virodhi
Vikramarka Era, Virodhi
Now researchers at Johns Hopkins University in Baltimore say they have finally
worked out why the huntingtin protein accumulates in cells everywhere, but
only kills cells in the part of the brain that controls movement. They
said in a study published in Science magazine that the tiny protein, Rhes,
only found in the brain cells which cause movement seemed to be to blame.
It's always been a mystery why, if the protein made by the HD gene is seen
in all cells of the body, only the brain, and only a particular part of the
brain, the corpus striatum, deteriorates.
Developed and Acquired Drugs
AVOS Life Sciences has analysed the revenue contribution of organically developed,
licensed or co-developed, acquired and joint venture products to the major
Rx drug portfolios (MRDPs: the collection of branded drugs that are each
predicted to generate at least US$500 million in annual sales) of the top
14 pharmaceutical companies (http://www.nature.com/nrd/journal/v8/n6/suppinfo/nrd2912.html)
For the group overall, organic products — drugs that have been internally
discovered and developed through to registration without the assistance of
an external partner — accounted for 45.3% of MRDP revenue in 2008. This share
declines to 39.7% in 2013E as companies increasingly turn to licensing and
acquisitions to generate new products, with the proportion of revenue from
licensed products growing from 29.2% to 30.8%, and that from acquired products
growing from 22.4% to 25.8%. http://www.nature.com/nrd/journal/v8/n6/pdf/nrd2912.pdf
On 1 June, AstraZeneca, based in London, and Merck & Co., headquartered
in Whitehouse Station, New Jersey, announced plans to collaborate to test
a combination therapy comprising two early-stage cancer drug candidates.
The therapy will combine AstraZeneca's AZD6244, which targets a protein called
MEK and is in phase II clinical trials, and Merck's MK-2206, a compound that
blocks a protein called AKT and has just completed a phase I clinical trial.
The two proteins are involved in separate pathways and genetic mutations
in either pathway can promote cancer. But the two pathways communicate with
one another, and blocking one can simply stimulate the other. Preliminary
work has suggested that blocking both pathways simultaneously could overcome
this problem1. In recent years, companies have been pursuing cancer therapies
that block specific proteins or pathways that help cancer cells to thrive.
In the process, researchers have also gained an appreciation of how wily
tumours can escape such therapies. One particularly vexing problem is the
wide variety of mutations that can be found within a single tumour. (http://www.nature.com/news/2009/090602/full/news.2009.536.html
Wee, S. et al. Cancer Res. 69, 4286–4293 (2009)).
The formation of insoluble deposits of tangled proteins is a characteristic
of several neurodegenerative diseases, including Alzheimer's disease, although
its contribution to pathogenesis remains controversial. Serum amyloid P (SAP)
has previously been shown to bind to amyloid deposits and protect them from
proteolytic degradation, suggesting that inhibiting or reducing the levels
of this glycoprotein might be an effective strategy to promote the degradation
of these protein aggregates and potentially combat Alzheimer's disease.
SAP levels in the serum correlate with amyloidogenesis in animal models.
Several studies have suggested that SAP could also have direct neurotoxic
effects, as it induces apoptosis in neurons and can trigger the release of
proinflammatory cytokines from microglia. Proc. Natl Acad. Sci. USA 16 Apr
Dr. Reddy’s Laboratories
Dr. Reddy’s Laboratories announced a partnership with GlaxoSmithKline plc
(GSK) to develop and market select products across emerging markets outside
India. Under the terms of the agreement, which is effective immediately,
GSK will gain access to Dr. Reddy’s rich and diverse portfolio and future
pipeline of more than 100 branded pharmaceuticals in fast growing therapeutic
segments such as cardiovascular, diabetes, oncology, gastroenterology and
Drug Discovery Initiative
Through a new drug discovery initiative, Eli Lilly & Co. is hoping to
engage researchers in searching for new drug candidates to treat Alzheimer’s
disease, cancer, diabetes and osteoporosis. The initiative, called the Lilly
Phenotypic Drug Discovery Initiative, or PD2 (pronounced PD-squared), uses
Lilly-developed disease-state assays and a secure Web portal to evaluate
the therapeutic potential of compounds synthesized in university and biotechnology
laboratories. Findings from this initiative could ultimately form the basis
for collaboration or licensing agreements between Lilly and external institutions.
The PD2 initiative is designed to provide a more convenient point of entry
for global external researchers into Lilly’s drug discovery and development
process. By doing so, PD2 allows for the establishment of productive relationships
with institutions and organizations that may not previously have worked with
Through the automated PD2 interface, researchers confidentially submit a
structure of their compound for an initial computational evaluation using
a set of proprietary Lilly algorithms focused on drug-like properties and
structural novelty. If the compound structure meets certain specified criteria,
the researcher is then invited to submit a physical sample for biological
All testing by Lilly is free, and all intellectual property rights remain
with the submitting researcher and/or institution at this stage. An objective
of PD2 is not to promote a random, high volume submission of compounds, but
rather to encourage the testing of molecules that represent novel structural
diversity and hypotheses that are thoughtfully considered in light of the
biology associated with each assay module.
The testing could lead to some moments of serendipity for those involved.
After biological testing is completed, Lilly provides the external researchers
a data report with a complete biological profile of the compound across the
four assay modules mentioned earlier (Alzheimer’s disease, cancer, diabetes
and osteoporosis). Because these data are derived from sophisticated and
systematic in vitro model systems, they provide researchers with broader
assessments of a compound’s biological profile than what is generally available
today in academic or government laboratories.
In return for these data, Lilly has first rights to exclusively negotiate
a collaboration or licensing agreement with submitters of those compounds
that demonstrate biological activity that Lilly would like to further explore.
If there is no agreement within a defined time period, the researcher is
granted no-strings-attached ownership of the data report and can choose to
use it in publication or grant proposals, or to further refine structural
hypotheses, all of which may advance scientific discovery.
Biologics are man-made forms of human proteins that are tougher to produce
than traditional, chemical-based medicines. The drugs treat conditions ranging
from anemia and rheumatoid arthritis to cancer. The amount of protection
for brand-name companies is a sticking point among lawmakers working to set
up a legal pathway for approval of generic forms of biotech drugs. The brand-name
versions can cost tens of thousands of dollars per year, because development
of a new biotech drug involves years of research and at least $ 1.2 billion
Making biologics is complicated and very expensive work, and that’s one reason
the biotech industry has voiced caution about legislation to allow generic
versions of the medicines. Waxman, chairman of the House of Representatives
Energy and Commerce Committee, has written legislation providing up to five
years of protection from rivals for brand-name drugs. Waxman, in a
statement, said the Obama administration "has made clear that the president
does not support the lengthy monopoly periods sought by the drug industry
and instead wants a bill, as I do, that will bring real competition and will
not unduly prolong the monopolies on biotech drugs." White House officials,
in a letter to Representative Henry Waxman, said seven years "strikes the
appropriate balance between innovation and competition by providing for seven
years of exclusivity."
The Biotechnology Industry Organization, which represents brand-name companies,
"is extremely concerned" that seven years would be a "risky short cut," BIO
President Jim Greenwood said in a statement. "We believe this abbreviated
period will undermine the incentives necessary for continued biotech research
into breakthrough medicines and cures for diseases such as cancer, multiple
sclerosis, Alzheimer's and HIV/AIDS as well as unmet medical needs," Greenwood
Biogen is just one of several examples of life sciences companies that are
taking an interest in biogenerics as a potential revenue stream. Many already
have the infrastructures and the internal brainpower to produce original
biotech or biologic drugs. And a barrier to entering the business of making
biogenerics is the huge investment required to build biotech drug plants,
which must also be approved by regulators before the facilities can market
products manufactured there. There are also businesses, such as Merck &
Co.’s GlycoFi, of Lebanon, NH, where innovative technology has overcome some
of the technical challenges of making copies of biotech drugs.
Biotech companies fear an invasion of biogeneric drugs into the marketplace
that could hurt their ability to fund the development of novel biotech drugs.
But some lawmakers see the approval of these copycat treatments as important
to controlling the rising cost of drugs. And at the center of the current
biogeneric debate is how to formulate a regulatory pathway to approve these
Some of the key issues in the biogenerics debate are related to the inherent
differences between biologics and small-molecule drugs. Biologics, typically
made in processes that involve living cells and bioreactors, are often protein-based
drugs with complex structures that cannot be duplicated like small-molecules.
This means that biogeneric drugs aren’t exact copies of the originals, raising
questions about whether the knockoffs should be required to undergo additional
clinical trials to prove their safety and effectiveness.
The FTC recommended that the government not grant biotech companies 12 to
14 years of exclusivity on each biotech drug (http://www.ftc.gov/os/2009/06/P083901biologicsreport.pdf).
The Biotechnology Industry Organization (BIO) says that 12 to 14 years of
exclusivity would be needed to recoup a company’s investment to develop the
Generic Plan B
Watson Pharmaceuticals, Inc. announced that its subsidiary, Watson Laboratories,
Inc., has received approval rom the United States Food and Drug Administration
on its Abbreviated New Drug Application (ANDA) for levonorgestrel tablets,
0.75 mg, for women seventeen years and younger. Levonorgestrel is the generic
equivalent to Duramed Pharmaceuticals' PLAN B(R), which is indicated for
the prevention of pregnancy following unprotected intercourse or contraceptive
failure. This product is approved for prescription use only. The Company
intends to market the product under the trade name Next Choice(TM) and plans
to launch the product shortly. For the 12-months ending March 2009, PLAN
B(R) had total U.S. sales of approximately $123 million, of which approximately
ten percent are attributable to prescription sales, according to IMS sales
data. PLAN B(R) over-the-counter (O.T.C.) new product exclusivity expires
on August 24, 2009.
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, AFP,
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