The Andhra Journal of Industrial News
(An International Electronic Digest Published from the United States of America)
(dedicated to Andhra, My Mother's Homeland)

Chief Editor: Prof. Sreenivasarao Vepachedu
(Click here to subscribe to this free e-journal)

To join The Indian American Chemical Society (TIACS), please send an email to:

Issue 63

5111 Kali Era, Virodhi Year, Jyesta month
2067 Vikramarka Era, Virodhi Year, Jyesta month
1931 Salivahana Era
Virodhi Year, Jyesta month
 2009 AD, June





Vegetarian Links





More Links



Huntington’s Disease
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.

Originally 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 (
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%.

Combination Therapy
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. ( Wee, S. et al. Cancer Res. 69, 4286–4293 (2009)).

Alzheimer’s Disease
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 2009.

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 pain management.

Lilly Phenotypic 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 Lilly.

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 testing.

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 investment. 

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 said.

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 drugs.

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 ( 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 original (

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.

Source: The primary sources cited above,  BBC News, New York Times (NYT), Washington Post (WP), Mercury News,, Chicago Tribune, CNN, USA Today, Intellihealthnews, Deccan Chronicle (DC), the Hindu, Hindustan Times, Times of India, AP, Reuters, AFP,  Biospace etc.

Notice: The content of the articles is intended to provide general information. Specialist advice should be sought about your specific circumstances.

Copyright ©1998-2009
Vepachedu Educational Foundation, Inc
Copyright Vepachedu Educational Foundation Inc., 2009.  All rights reserved.  All information is intended for your general knowledge only and is not a substitute for medical advice or treatment for special medical conditions or any specific health issues or starting a new fitness regimen. Please read disclaimer.

Om! Asatoma Sadgamaya, Tamasoma Jyotirgamaya, Mrityorma Amritamgamaya, Om Shantih, Shantih, Shantih!
(Om! Lead the world from wrong path to the right path, from ignorance to knowledge, from mortality to immortality and peace!)
One World One Family

The Andhra Journal of Industrial News
The Telangana Science Journal
Mana Sanskriti (Our Culture) Journal
Disclaimer Solicitation