Genentech [DNA], which co-developed Raptiva (Efalizumag) with Xoma is expected to start the product's distribution by mid-November 2003. The relatively large size of the psoriasis market and the need for novel therapies that work with highly specific mechanisms of action have created an unprecedented amount of interest in the biotechnology area. Amgen's anti-TNF-a drug Enbrel, (etanercept) already marketed for arthritis, is in phase III for psoriasis. Remicade (Infliximab), Johnson & Johnson's anti-TNF-a product, is in phase III and Abbott's Humira (adalimumab) another anti-TNF-a biologic could complete phase III in 2004.
A highly effective and convenient formulation would command pricing power that could reach $8,000-12,000 a year per patient. Amevive (alefacept) which was approved by the FDA for the treatment of psoriasis in January 2003, and Raptiva are the cheapest biological psoriasis therapies, with annual costs in the range of $8,500-9,000. Enbrel and Humira will cost over $11,000 per patient.
In terms of clinical efficacy, 27-28 per cent of Raptiva's patients could achieve a 75 per cent improvement in PASI scores, compared with 14-21 per cent for Amevive. Meanwhile, Enbrel and Remicade have shown some impressive results. Some 50 per cent of patients treated with Enbrel could achieve a 75 per cent improvement in PASI scores, as could 73-82 per cent of patients treated with Remicade. Given Enbrel's strong clinical profile and the fact that Remicade's annual cost per patient will not be higher than that of Raptiva, the two drugs could provide strong competition for Raptiva.
Amevive, as the first biologic on the market, will attract a high degree of brand loyalty among dermatologists, with sales forecast at $231 million in 2005 and $421 million in 2008. Two market segments are likely to be captured first - Medicare patients and cyclosporin-treated patients. Raptiva will also initially target these two market segments and is expected to overtake Amevive by 2008 with sales forecast to increase from $170 million in 2005 to $566 million in 2008.
Potential heart disease breakthrough
An amazing new treatment promises to unclog arteries -- even in people with advanced heart disease. It's called ApoA-I Milano. The original molecule was found in the blood of an Italian family with unusually healthy arteries -- despite high levels of fats in their blood and low levels of protective "good" HDL cholesterol. Now a genetically engineered version of this "good" HDL cholesterol protein has been tested in a small human trial.
The results -- published in the Journal of the American Medical Association --astounded even the doctors who performed the trial. The unprecedented nature of the human study is the rapid plaque regression in just five weeks. It's never been seen before the fact that plaque can so quickly be removed from arteries means a sea change in treatment. Now, doctors treating patients with serious heart disease think only about trying to keep arteries from getting more clogged. Now they can think about unclogging them -- without a risky operation. The idea is called reverse-cholesterol transport. And ApoAI Milano may be only the tip of the iceberg.
Brain may control type 2 diabetes
The key to curing type 2 diabetes may be in our heads, or at least in the heads of mice. A new study shows that altering a single gene in the brains of obese mice bred to have type 2 diabetes helped them completely normalize blood sugar levels. Researchers say that it's the first study to show that glucose control may be regulated by the brain. If further research confirms these results, it could open a whole new approach to treating type 2 diabetes. In the study, published in the November issue of Diabetes, researchers looked at the effect of manipulating a gene in the brain known as POMC in mice bred to be obese with type 2 diabetes. Previous studies have shown that POMC production is reduced in the brains of obese and diabetic mice. People with mutations in this gene are also obese and diabetic. But because many genes are implicated in obesity and diabetes, it's not clear which genes, if any, play a role in regulating glucose levels. Drugs that mimic POMC are already being studied for the treatment of obesity, but it may turn out that these drugs will be even more effective in treating type 2 diabetes.
International agencies meet to discuss ways to combat problem of counterfeit medicines
The World Health Organisation (WHO) and other international agencies, including Interpol, are meeting in Vietnam to discuss ways to combat the growing problem of counterfeit prescription medicines in Asia. It is estimated that as much as 25 per cent of the prescription drugs taken in developing countries are counterfeit, a news source says citing WHO. "A WHO survey between January 1999 and October 2000 found that 60 per cent of fake medicine cases occurred in developing countries and 40 per cent in industrialised nations." And while for the most part, the drugs are often those used to treat epidemics such as malaria, tuberculosis and AIDS, Viagra is one of the most popular counterfeited drugs.
New rheumatoid arthritis drug holds promise
An experimental drug that blindfolds immune system cells that attack the body is better than conventional care for rheumatoid arthritis, new research finds. The drug, a protein called CTLA4Ig, prevents T-cells from "seeing" and going after their targets in joint tissue. People who took CTLA4Ig in addition to the conventional therapy for rheumatoid arthritis (RA) were nearly twice as likely to show a 20 percent reduction in joint pain and swelling, among other symptoms, as those on the usual treatment alone. Those on the drug -- which prevents T-cells from binding with one of two molecules that activate them -- were also more likely to experience more dramatic improvement, though the number of patients who did so was small. The drug is being developed by Bristol-Myers Squibb Co., which funded the latest research. It has not yet been approved for sale in the United States or abroad.
Tuberculosis "superbugs" resistance may wreak health havoc in South Africa
Scientists have sounded the alarm over Tuberculosis "superbugs" stalking communities across the Western Cape that could wreak health havoc throughout South Africa. One variant, called DRF150, is resistant to almost all the front-line antibiotics used to treat drug-resistant TB, which means hundreds of thousands of rands may be needed to bring the mini-epidemic under control. The emerging mutant strain, which has not been identified anywhere else in the world, brings a formidable new enemy into the South Africa's Western Cape's battle with tuberculosis prevalence that is already at record levels. The Victor team's findings have been published in the European International Journal of Tubercle and Lung Disease, and have been accepted for publication in the Journal of Clinical Microbiology in the United States
Vitamin C may ward off stroke
People who eat a diet rich in vitamin C may be at lower risk of suffering strokes, and smokers who do so may benefit the most. A new Dutch study finds people with the lowest amount of vitamin C in their diets were 30 percent more likely to have a stroke than people with the highest amount of it. Smokers with diets high in vitamin C were more than 70 per cent less likely to have a stroke than smokers with diets low in vitamin C.
Antioxidants such as vitamin C may protect cells from oxidative stress, which plays a role in stroke, the researchers say. The study also found smokers benefited from high levels of vitamin E in their diets. They were more than 20 per cent less likely to have a stroke than those with diets low in vitamin E. Ironically, nonsmokers with high vitamin E levels didn't enjoy similar protection. The study cautions that vitamin C alone may not be responsible for the results of the study.
Tea may offer treatment to fight AIDS virus - Japan study
Japanese researchers said that they had discovered a molecule in tea that could block the spread of the AIDS virus. The lab findings could offer a novel way to combat the HIV infection by preventing the virus from spreading throughout the body, scientists said. Current treatments that target HIV fight the infection after it has spread. Scientists at the University of Tokyo, led by Kuzushige Kawai, found a compound called epigallocatechin gallate (EGCG) the element believed to contain most of the health benefits found in green tea, rapidly attaches to the doorways that the AIDS virus uses to invade cells.
Three genes may explain psoriasis cause
Researchers have discovered a trio of genes that likely help provide the complex origins of psoriasis, the itchy skin disease triggered when the immune system runs amok. Researchers have discovered a trio of genes that likely help provide the complex origins of psoriasis, the itchy skin disease triggered when the immune system runs amok. The genes, when defective, increase a patient's susceptibility to the incurable disease. The genes are considered low risk for psoriasis, meaning it is likely that many other genes -- as well as environmental factors such as stress -- play a role in increasing susceptibility to the disease. Drug companies recently have introduced some new treatments for psoriasis that work by tinkering with the body's immune system. They include two shots that recently received Food and Drug Administration approval. Psoriasis is marked by red or white patches of scaly skin that burn and itch. In about 30 per cent of cases, it is accompanied by debilitating arthritis-like symptoms.
Quitting smoking after a heart attack reduces risk of early death by at least a third
According to a Cochrane review, quitting smoking after a heart attack or cardiac surgery can reduce the risk of death from heart disease as much as cholesterol-lowering drugs. In the UK, about 40 per cent of heart disease can be attributed to smoking, but that rate can be even higher in areas where there are more smokers Cochrane reviewers found 20 studies that could help answer this question. The studies included over 12,600 smokers. People's risk of dying after a heart attack or cardiac surgery drops quickly after they quit. Within two years, people who have quit are dying less than people who keep smoking. For every 100 who quit, 12 will avoid an early death.
Compiled from WWW by Dr Venkat Appaji Padmanabhuni
E mail: appajipv@hotmail.com