The Andhra Journal of Industrial News, December 2005, Issue 21, Vepachedu Educational Foundation

Contents

Chilling Down the Generic Enthusiasm
Cephalon v. Ranbaxy
AIDS Drug
Too Much of a Good Thing!
Barley
Femara(R) (letrozole)
Five Important Advances in Nanotech
The Year 2005 in Biology and Medicine

Chilling Down the Generic Enthusiasm
The generic drug industry has been increasingly bold in its legal maneuvers in recent years. Pfizer's victory in the Lipitor trial may bring a chill to the generic drug industry. Pfizer Inc. won a court ruling blocking generic competition for cholesterol-lowering Lipitor, the world's best-selling prescription drug, until 2011. Judge Joseph J. Farnan held that Ranbaxy’s atorvastatin infringes Pfizer’s U.S. Patent No. 4,681,893, and at the same time upheld the validity of another, Pfizer U.S. Patent No. 5,273,995 which Ranbaxy had claimed was invalid. The ruling followed a hearing in the U.S. District Court of Delaware, which took place in December 2005. Ranbaxy plans to begin the appeals process immediately.

Cephalon v. Ranbaxy
Pharmaceutical company Cephalon Inc. dropped its lawsuit against generic drug maker Ranbaxy Laboratories Ltd. over the sleeping disorder treatment Provigil. In connection with the settlement, Cephalon will grant Ranbaxy a non-exclusive royalty-bearing right to market and sell a generic version of PROVIGIL in the United States . Ranbaxy’s license will become effective in October 2011 absence of a pediatric extension for PROVIGIL, which would delay the entry date by six months (to April, 2012). An earlier entry by Ranbaxy may occur based upon the entry of another generic version of PROVIGIL.

AIDS Drug
A generic version of a pediatric AIDS drug received preliminary approval from the Food and Drug Administration. The FDA said it was giving tentative approval for Stavudine, an antiretroviral drug considered child-friendly that is manufactured by Aurobindo Pharma Ltd. of Hyderabad, India. Stavudine for oral solution is the first generic version of the previously approved Zerit for oral solution manufactured by Bristol-Myers Squibb. The generic version meets FDA manufacturing, safety and efficacy standards but will not be marketed in the United States for patent exclusivity reasons, the agency said. The approval does means that the generic version can be used by relief organizations outside the United States funded by President Bush's $15 billion AIDS relief plan.

Too Much of a Good Thing!

Use it correctly and acetaminophen, best known by the Tylenol brand in US and Crocin brand in India, lives up to its reputation as one of the safest painkillers. It's taken by some 100 million people a year in the US, not to mentions 100s of millions in the Indian Continent, and liver damage occurs in only a small fraction of users. But it's a damage that can kill or require a liver transplant, damage that liver specialists insist should be avoidable.

The problem comes when people willingly or unwittingly take too much, not realizing acetaminophen is in hundreds of products, from the over-the-counter remedies Theraflu and Excedrin to the prescription narcotics Vicodin and Percocet.

Paracetamol, an old drug used mainly for treatment of fever, has been in use the world over for several decades now. In most countries the drug is sold as an OTC product and is usually taken with no medical supervision. India and China are probably the two largest producers of this drug. And there are a number of brands and generics of the drug available in the market today. In India, amongst paracetamol brands and generics, the market leader, undoubtedly, is Crocin. Until recently, the maximum strength of a paracetamol formulation used to be 500 mg including that of Crocin. SmithKline Beecham which owns this brand, has recently introduced an extension of this brand namely Crocin 1000 containing 1000 mg of paracetamol in one tablet. Crocin 1000 is being promoted as a pain reliever for chronic conditions like osteoarthritis, rheumatic arthritis, headache, toothache, period pain and muscle pain on the label of the bottle. The label does not carry any warning on the hazards of an overdose or prolonged usage on vital human organs. At the same time the label assures that Crocin 1000 does not irritate the stomach and the maximum daily dose can go upto 4000 mg.

Acetaminophen bottles in the US currently recommend that adults take no more than 4,000 milligrams a day, or eight extra-strength pills. Just a doubling of the maximum daily dose can be enough to kill, warns Dr. Anne Larson of the University of Washington Medical Center. The Food and Drug Administration has long wrestled with the liver risk, warning two years ago that more than 56,000 emergency-room visits a year are due to acetaminophen overdoses and that 100 people die annually from unintentionally taking too much. Acetaminophen was to blame for 28 percent of the liver poisonings in 1998, but caused 51 percent of cases in 2003. That makes acetaminophen the most common cause of acute liver failure, the researchers report in the journal Hepatology. 63 percent of unintentional overdoses involved narcotics like Vicodin and Percocet that contain from 325 mg to 750 mg of acetaminophen inside each pill.

Read drug labels and add up all your acetaminophen, avoiding more 4,000 mg a day. For extra safety, it is advised no more than 2,000 to 3,000 mg for more vulnerable people, who regularly use alcohol or have hepatitis.

Barley
Breakfast cereals and other foods that contain barley also will be able to start claiming they can reduce the risk of coronary heart disease that kills 500,000 Americans a year. Labels on whole barley and dry milled barley products, including flakes, grits, flour and meal, are expected to start making the claim, the Food and Drug Administration said Friday in announcing its ruling. The claim is identical to that already made on many oat products. The FDA estimates a quarter of the hot breakfast cereals, and another 5 percent of the cold cereals, sold in the United States will start boasting their health benefits. The breakfast cereal market is worth $7.1 billion a year, according to the FDA. Products must provide at least 0.75 grams of soluble fiber per serving to make the health claim, the FDA said. Scientists believe a high-fiber diet helps lower cholesterol levels.

Femara(R) (letrozole)
Novartis announced today the US regulatory approval of Femara(R) (letrozole) in a new indication as a treatment for use after surgery in postmenopausal women with hormone-sensitive early breast cancer (adjuvant setting). The US approval was based on results of the Breast International Group (BIG 1-98) study, which were published for the first time in the December 29 issue of The New England Journal of Medicine (NEJM). BIG 1-98 compared the effectiveness and tolerability of Femara versus tamoxifen when used as initial therapy after surgery (adjuvant setting) in postmenopausal women with hormone- sensitive early breast cancer. The study included an analysis of disease-free survival in patients treated for a median of 24 months and followed for a median of 26 months. The BIG 1-98 study is ongoing, and further analyses on safety and efficacy are planned. Femara reduced the risk of breast cancer returning by an additional 21% (p=0.002) over the reduction offered by tamoxifen. Further, patients taking Femara showed a 27% (p=0.0012) reduction in the risk of the cancer spreading to distant parts of the body. While no survival advantage has been demonstrated, this is clinically relevant because women whose disease does spread to other sites (metastases) may be at greater risk of dying from their disease. In addition to the overall findings, Femara demonstrated its greatest benefit in two groups of women at increased risk of recurrence. Femara reduced this risk by 29% in women whose breast cancer had already spread to the lymph nodes at the time of diagnosis and by 30% in women who had undergone chemotherapy. The data also showed that in these high-risk subgroups, Femara reduced the risk of cancer spreading to distant parts of the body by 33% and 31%, respectively.

The approval of Femara for adjuvant use in the US was based on a six-month priority review. The FDA grants priority review to products that could potentially offer a significant improvement compared to marketed products in the diagnosis, treatment or prevention of disease, increased compliance or demonstrated efficacy in subgroups. Novartis recently received approval for this indication in the UK. Femara has also been submitted in the EU, Japan, and other countries. Additional approvals in other countries are expected in 2006.

Five Important Advances in Nanotech
Technology Review picks five important advances in nanotechnology and materials science in 2005 -- and one policy issue that could decide the future of the entire field.
1) Harvesting Energy from the Sun
2) The Lithium Economy
3) Toward Self-Assembling Devices
4) Nanomedicine and
5) Universal Memory
Nanotechnology is leaping technical hurdles -- but ultimately its success will depend on winning over consumers. And that will mean assuring the public that nano-scale materials are safe.
See for more: http://www.technologyreview.com/NanoTech/wtr_16096,318,p1.html

The Year 2005 in Biology and Medicine
Major breakthroughs in 2005 included the publishing of several complete genomes, including a dog called Tasha, the chimpanzee, three human parasites, ancient cave bears, as well as a map of genetic variations called SNPs in the human genome. The year also saw the world’s first human face transplant by French surgeons – one of several international teams vying to achieve this high-profile goal. Visit for more: http://www.newscientist.com/article.ns?id=dn8512

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