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
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Issue 54

5110 Kali Era, Sarvadhari Year, Bhadrapada month
2066 Vikramarka Era, Sarvadhari Year, Bhadrapada month
1930 Salivahana Era
Sarvadhari Year, Bhadrapada month
 2008 AD, September





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Biotech Industry
Biotechnology companies have approximately 633 drugs in development, according to a report by the Pharmaceutical Research and Manufacturers of America.  Biotech drugs account for nearly one-third of the 2,000 drugs under development in the United States. Companies based or having branch offices in San Diego County playing a role in 44 of them, according to the report.  The number of biotech drugs in development nationally is nearly 50 percent greater than two years ago and nearly double the number in 2004, according to the report.  Biotech refers to the development of products from or by living creatures.

Cancer is the biggest disease target, with 254 biotech drugs under development, and the infectious diseases category ranks second, with 162 drugs.  Large pharmaceutical companies for years have looked to alliances with biotech companies to find new drugs. Biotechs are smaller and have less cash than big pharmaceutical companies, but they are renowned for their science and entrepreneurial spirit.

Pharmaceutical drugs with annual sales totaling $60 billion are due to come off patent by 2011 and thus face competition from generic drugs, adding urgency to the search for new medicines among big pharmaceutical firms, according to a report this year by IMH Health, a health care consulting firm in Fairfield, Conn. 

San Diego companies on the list include: BioVascular Inc., Cardium Therapeutics, Neurocrine Biosciences and Optimer Pharmaceuticals, Advantagene, Amylin Pharmaceuticals, Applied Molecular Evolution, Celladon, Ceregene, CovX, Ichor Medical Systems, Inovio Biomedical, Kirin Pharma USA, NexBio, NovaRx, Nventa Biopharmaceuticals, Pacira Pharmaceuticals, Pharmexa-Epimmune, Isis Pharmaceuticals, Orchestra Therapeutics and Vical.

According to another report, Georgia ranked first in the nation for medical scientists' salaries at $130,000, and salaries for animal scientists, zoologists, foresters and microbiologists were all in the top 10.  In terms of volume, metro Atlanta led the state with 213 biotech firms. Athens ranked second with 23, followed by metro Augusta with 16.  The report was released during the Georgia Life Sciences Summit.  Growth in the state's life sciences industry has until now outpaced expansion in the economy by two-to-one and supports nearly 15,200 private sector jobs, according to the report.

Biotechnology drugs that can be tailored more closely to individual patient needs and networks that speed drug development will become keys for big Pharma such as Lilly as the patents expire for several top sellers.  Biotechnology products already account for about a third of Lilly's annual revenue, which totaled $18.6 billion last year.  Broader problems like the cost of developing drugs and the decrease in new drug approvals play more of a role in pharmaceutical industry strategy.

Obama and McCaine presidential campaigns both pledged their support to help create a market for generic biologics, a long-sought goal of generic makers such as Mylan Laboratories and Teva Pharmaceuticals, which released a commissioned report. Biotechs, you may recall, do not face generic competition in the US, because the FDA lacks authority to approve copies. Three bills have been introduced, but behind-the-scenes bickering over immunogenecity and interchangeability has thwarted compromise. The generic and biotech industries, meanwhile, paid millions of dollars lobbying Congress over how generic biotech drugs should be approved. Perhaps the greatest disagreement is over how long a biotech drug should be on the market before a generic drugmaker can challenge its patent. The BIO trade group wants 14 years of data exclusivity, while generics say no more than five years.  Biotechs such as Amgen and Genentech will face strong push-back no matter which candidate next occupies the White House.

Biotech Patent System Broken
After conducting case studies in India, Brazil, Canada, Kenya the United States, the European Union, Japan and Australia, experts have said that the world’s biotechnology patent system is broken. The study by an international coalition of experts has claimed that the crisis in biotechnology has led not only to economic problems but to endemic mistrust among its various actors that is stopping lifesaving technologies from reaching the people who need them most in developed and developing countries.

Mini Antibodies
Today's monoclonal antibodies are large proteins that act as footsoldiers for the immune system. They are already the fastest-growing section of the global drugs market, with sales expected to hit $49 billion in 2013 compared with $26 billion in 2007, according to market analysis group Datamonitor.  And by the middle of the next decade, Genentech Inc and Roche AG's cancer drug Avastin is predicted by analysts to be the biggest-selling medicine of any type in the world.  But conventional antibodies, which must be injected, are limited in the parts of the body they can reach.

Next-generation antibody fragments, which are a fraction of the size, are potentially more flexible, cheaper to make and could lead to the development of drugs that are inhaled, used as eyedrops or given by mouth. A host of biotech companies are developing different technologies to shrink tomorrow's antibody drugs.  Among them are Bristol-Myers Squibb, Novartis AG, Wyeth, Boehringer Ingelheim, ESBATech, Trubion Pharmaceuticals Inc and Genmab. At the moment, the jury is out on how well the new generation of products will work, since even the most advanced are only now starting mid-stage Phase II clinical trials.

Encephalitis in India and Useless Vaccines
Encephalitis usually spreads in eastern parts of Uttar Pradesh during and after the June-to-September monsoon season, when pools of stagnant water provide breeding grounds for mosquitoes.  The mosquitoes transmit the virus from pigs and birds to humans. Since most infected people never develop symptoms, many adults are immune from earlier exposure — leaving young children most vulnerable.  Indian federal government sent thousands of ineffective vaccines to a northern Indian state, resulting in halting a planned immunization drive against the deadly outbreak of Japanese encephalitis that has killed more than 200 children since June.  The mistake, compounding delays in starting the immunizations, raises chances that hundreds more children could die of the disease this year.  Japanese encephalitis can be prevented by the vaccine, but stocks sent by the federal government to the state showed in testing that they were "unfit for human use."

Gardasil for Other Indications
The cervical cancer vaccine Gardasil also works to prevent cancers of the vagina and vulva, federal health officials said, as they approved expanding its use to protect against those diseases as well. The Food and Drug Administration first approved Gardasil in 2006 for the prevention of cervical cancer in girls and women ages 9 to 26. The vaccine works by protecting against strains of the human papillomavirus, or HPV, that cause about 70 percent of cervical cancers. The HPV virus, transmitted by sexual contact, causes genital warts that sometimes develop into cancer. The government estimates that there are 3,460 new cases of vulvar cancer and 2,210 new cases of vaginal cancer each year. Cervical cancer is more common, with an estimated 11,070 new cases each year and nearly 3,900 deaths.

Ranbaxy Under the Weather
The government is closing U.S. borders to more than 30 generic drugs, including popular antibiotics and cholesterol medicines, made by India's drug giant Ranbaxy Laboratories because of poor quality in two of its factories. The Food and Drug Administration says consumers who already have the drugs shouldn't worry: Repeated testing hasn't found any contamination, and Ranbaxy can continue selling medicines made at any of its other factories.

The showdown is over what the FDA says is Ranbaxy's failure to correct significant manufacturing problems that could lead to subpotent drugs, allergic reactions or other problems.  The move also may affect a U.S. program sending AIDS drugs to Africa, as Ranbaxy is a leading supplier.  The Indian generic drugmaker, which is under investigation for allegedly falsifying records that resulted in the production and sale of generic meds that didn’t meet FDA standards, has hired Rudy Giuliani “to provide advice and review compliance issues,” according to a statement.  This is the second time the former New York City mayor has acted as a paid consultant to a troubled drugmaker. He also worked for Purdue Pharma, which was fined for its Oxycontin marketing, and he helped negotiate a deal with federal prosecutors that kept company execs out of jail. Ironically, when he was a US Attorney in Manhattan, Rudy didn’t hesitate to send junk bond dealers to jail because they preyed on the system. Of course, Rudy is a private consultant now and paid to serve his clients.

The President's Emergency Plan for AIDS Relief suspended funding for three Ranbaxy generic drugs until the Food and Drug Administration says deficiencies have been resolved in one of the plants in India where they're produced, a spokeswoman for the program said. The program provided $8.9 million for Ranbaxy's AIDS drugs last fiscal year, according to the spokeswoman.

Indian drugmakers Aurobindo Pharma Ltd. of Hyderabad and Cipla Ltd. of Mumbai are among companies that have been cleared by the U.S. to supply the three AIDS drugs under the government program, according to the FDA's Web site. The program plans to provide $1.9 billion in support of antiretroviral treatment programs for AIDS during this fiscal year, according to the program spokeswoman.

Daiichi Sankyo agreed in June to buy the 34.8 percent stake held by Ranbaxy's founding family, and to make an open offer for a further 20 percent of Ranbaxy shares, as per Indian regulations, in a deal worth up to 198 billion Indian rupees ($4.3 billion). But payment for the stock purchase has been delayed until an unspecified time from an original deadline of Sept. 19 due to a delay in India's regulatory approval process.  Shares of Ranbaxy plunged last week after the United States banned dozens of its drugs because of procedural violations in manufacturing at Ranbaxy's plants in India.

Pharmaceuticals in Drinking Water
The state of California has a warning for its 36 million residents: Do not flush pharmaceuticals down the toilet or drain, or they may end up in a river near you and even in the drinking water.
State and local officials are teaming with the U.S. Environmental Protection Agency for a "No Drugs Down the Drain Week," starting with events Oct. 2. The program recommends that drugs be dropped at special collection sites or tossed in the trash.  Researchers have found evidence that even extremely diluted concentrations of pharmaceutical residues harm fish, frogs and other aquatic species in the wild. Related research reports that human cells fail to grow normally in the lab when exposed to trace concentrations of certain drugs.

Reddy’s Promius
Dr. Reddy’s Laboratories formally announced its US Specialty Business with the launch of Promius Pharma, a wholly-owned subsidiary of Dr. Reddy’s Laboratories located in Bridgewater, NJ. Promius Pharma, which will initially focus on the branded dermatology market, is based on a platform of strategic licensing initiatives and internal product development activities undertaken over the last several years. Promius Pharma’s product portfolio currently comprises of three in-licensed and co-developed dermatological products that are scheduled to launch within calendar years 2008-09, and a pipeline of topical products being developed at the Integrated Product Development Facility in Hyderabad, India. Promius Pharma’s current portfolio contains innovative topical products for the treatment of psoriasis, atopic dermatitis and seborrheic dermatitis.

Outsourcing Drug Industry

 Food and Drug Administration Investigation
Drugs under investigation by the Food and Drug Administration, what they are used for and the potential problem:
_R-Gene 10, a growth hormone, pediatric overdose due to labeling/packaging confusion.
_Suprane, an anesthetic, cardiac arrest.
_Cymbalta, for depression and other conditions, urinary retention.
_Intelence, an HIV medication, bleeding into joints.
_Carac and Kuric, creams for skin conditions and fungal infections, name confusion.
_Heparin, a blood-thinner, serious allergic reactions.
_Extraneal, used in kidney dialysis, low blood sugars.
_Humulin R (U-500), insulin for diabetes, dosing confusion.
_Stromectol and Warfarin, an anti-parasite drug and a blood thinner, drug interaction.
_Tykerb, for advanced breast cancer, liver damage.
_Revlimid, for multiple myeloma, severe skin blistering and bleeding.
_Tysabri, for multiple sclerosis, skin melanomas.
_Nitrostat, for angina, overdose due to labeling confusion.
_Sandostatin LAR, for abnormal bone growth, bowel obstruction.
_Oxycontin, a pain killer, drug misuse, abuse and overdose.
_Definity, used in cardiac imaging, cardiopulmonary reactions.
_Dilantin injection, for epileptic seizures, serious skin reaction.
_Seroquel, for bipolar disorder, overdose due to sample pack labeling confusion.
_Tyzeka, for chronic hepatitis B, nerve damage.
_Tumor Necrosis Factor (TNF) Blockers, for juvenile arthritis, cancers in children and young adults.

Greed and Corruption
As America reels under a financial crisis, so does China under a food crisis, both resulting from greed and corruption.  While US is bailing out corrupt firms with trillion dollar package, the list of companies facing potential recalls grew as reports of foods tainted with the industrial chemical melamine, which has been blamed in the deaths of Chinese infants and sickness in several thousands of children, spread to a widening range of products - anything that should have protein in it.  Food companies around the globe are rushing to assess their products and in some cases setting new strategies to prevent problems. But many continued to disregard the risks.

Leaf v. Viagra
The soft green heart-shaped leaf of the horny goat weed could hold the key to a new drug for treating erectile dysfunction. Researchers say the Viagra alternative could be as effective as the famous blue pill, but have fewer side-effects.  Viagra's active compound, sildenafil, works by inhibiting an enzyme called phosphodiesterase-5 (PDE5). Because PDE5 helps control blood flow to the penis, inhibiting PDE5 promotes male erection.  Dell'Agli and his colleagues tested the four plants in vitro to see how efficient they were at inhibiting PDE5. Just one – Epimedium brevicornum, also known as horny goat weed and Bishop's Hat – had an effect. This confirmed previous studies showing that icariin, a compound found in the horny goat weed, is a PDE5 inhibitor. Horny goat weed is found in the wild in China, Asia and Europe.

Source: The primary sources cited above,  BBC News, New York Times (NYT), Washington Post (WP), Mercury News,, Chicago Tribune, 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 ©1998-2007
Vepachedu Educational Foundation, Inc
Copyright Vepachedu Educational Foundation Inc., 2007.  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!)
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