Japanese drug discovery companies spend a fraction compared to US counterparts

Drugs developed in Japan accounted for 13 per cent of the new drugs approved in the U.S. over the past five years, compared to 8 per cent between 1989 and 1993. One of those drugs, Abilify, from Otsuka resulted in a record licencing deal between the drugmaker and Bristol-Myers Squibb, which agreed to give Otsuka 35 per cent royalties on the drug's revenue. Other drugs discovered in Japan, which hit the U.S. market this year are Crestor, which was discovered by Shionogi, and licensed to AstraZeneca, and an incontinence drug that GlaxoSmithKline licensed from Yamanouchi, which Glaxo believes holds promise. Takeda and Eli Lilly entered into a co-promotional agreement for the diabetes drug Actos. The success that Japanese drug companies are having in drug discovery belies their R&D budgets, which are a fraction of those of Western drugmakers. Otsuka spends $300 million a year on R&D compared with Bristol-Myers' R&D budget, which is about $2.2 billion

Polypill for preventing heart attacks and stroke

The inventors of a so-called polypill that combines six medications to be taken once a day for the prevention of heart attacks and strokes have begun negotiations with U.K. health officials and regulators on producing the pill a news source reports

Researchers from the Wolfson Institute of Preventive Medicine, who say the pill would prevent 80 per cent of heart attacks and strokes, presented their proposal to senior members of the health department and discussed licensing requirements with the Medicines and Healthcare products Regulatory Agency. Regulators may require a large trial comparing the polypill to its individual components taken separately, a process that could take as long as six years, the news source reports. The pill would contain aspirin to prevent blood clots, a statin to lower cholesterol, three blood-pressure-lowering agents at half the standard dose and folic acid to reduce homocysteine, which causes furring of the arteries

Statins to become non prescription drugs in UK

The U.K.'s Medicines and Healthcare products Regulatory Agency published a report proposing that pharmacists be able to sell statins such as Pfizer's Lipitor and Merck's Zocor over-the-counter within six months. Many people could benefit greatly if statins were made more widely available, possibly saving hundreds of lives per year and preventing a higher incidence of coronary heart disease. Merck's Zocor would likely be the first to hit the OTC market. Merck is also pushing for statins to be made available over-the-counter in the U.S., something the FDA is expected to consider in the near future

GSK loses claim on U.S patent for Augmentin

A U.S. appeals court ruled that GlaxoSmithKline's U.S. patents on Augmentin are invalid, closing a 19-month court battle during which Glaxo tried to quell generic competition to its drug, once a top-selling product with nearly $1 billion in sales in 2001. The win is a victory for Novartis, which will sell its generic form of the popular antibiotic through its U.S. subsidiary Geneva Pharmaceuticals. GlaxoSmithKline is turning its attention to its new antibiotics Augmentin ES and XR, which it says already comprise nearly 35 per ent of total prescriptions written for both branded and generic versions of Augmentin

Long-term approach to pharmaceutical R&D

Across the industrialised world, the pharmaceutical industry is considered to be one of the most highly R&D-intensive technology sectors. In 2000, around US$58 billion was invested in pharmaceutical R&D by companies worldwide and between 1990 and 2000, investment increased by 121 The competitive and overcrowded nature of the pharmaceutical market means that companies are under pressure to make help them outperform their rivals. An increasing number of companies have sought collaborations with other companies in order to spread the risks and costs involved in drug development and also to gain access to new technologies and expertise that can drive innovation.

In 1977, the US pharmaceutical industry invested around US$1.3 billion in R&D, but in 2000 this figure had risen to US$32 billion As a result of this commitment eight of the current top ten worldwide prescription pharmaceutical products have their origins in US R&D and that since 1990, the US pharmaceutical industry has grown twice as fast as the overall national economy. Due to these efforts despite several odds the total global pharmaceutical sales reached $430 billion in 2002 - an 8 per cent increase over the previous year. The continued growth of the pharmaceutical market, particularly the dominant North American region, provides a continuing incentive for companies to invest in R&D for new medicines on a proactive basis.

FDA's fast track initiative cut total drug development time by three years.

The U.S. Food and Drug Administration's (FDA) fast track program to speed new drugs to market has saved nearly three years time According to a recently completed analysis by the Tufts Center for the Study of Drug Development. The study found that clinical development time for fast track drugs approved between 1998 and 2003 was, on average, 2 to 2.5 years shorter than for non-fast track drugs. "The fast track program has had a significant public health impact by speeding access to new drugs, particularly those that treat AIDS, breast cancer, leukemia, and other diseases that afflict millions of patients and result in the loss of tens of thousands of lives every year in the U.S."

The Tufts Center examined implementation of the fast track program since it took effect in late 1997. The fast track program aims to expedite development and approval of drugs that address unmet medical needs for serious or life-threatening conditions. The fast track designations for products aimed at treating diseases other than cancer and HIV/AIDS grew from more than 30 in 2001 to more than 50 in 2003.

The first chewable oral contraceptive tablet

The US FDA has approved Ovcon 35, an oral, spearmint-flavored contraceptive tablet that can be chewed and swallowed. This new version of Ovcon 35, indicated for the prevention of pregnancy, provides one more alternative to the many types of oral contraceptives currently on the market. It contains a progestin (norethindrone) and an estrogen (ethinyl estradiol). The directions for use tell women that the pill may be swallowed whole or chewed. The product is manufactured by Bristol Myers Squibb Company USA.

FDA authorized to ask for tests on paediatric use of new drugs

Legislation that would give the US FDA the authority to require drug makers to test new medicines in children passed Congress and will go to President Bush for signing into law. While hailed as landmark legislation, some say it will be detrimental to the drug industry. Under the new law, along with granting the regulatory agency the power to require the testing of new drugs in children, it could require tests of older drugs if they are widely prescribed for this patient group. The FDA's director of paediatric drug development said that while the existing voluntary programme is successful, it has only led to the testing of 91 out of some 400 medicines on which the agency requested studies

US patent for decongestant nasal spray

The object of the invention is to provide a nasal spray that eases congestion of the nasal passages, in particular, congestion due to decreased ciliary function, swelling, fluid retention, increased mucus secretion and/or mucus buildup. A further object of the invention is to provide a method for manufacturing such a nasal spray. A still further object of the invention is to provide method of treating the nasal passages. The invention meets these and other objects by providing a composition for osmotic decongestion and moisturization of the nasal passages comprising water, a ciliary stimulant, a mucus thinning agent, an osmotic agent, glycerin, and a preservative. The invention provides a method of preparing an alkaline, hypertonic composition for use in osmotic decongestion of the nasal passages. The patent was granted in November 2003.

US patent for immune stimulating dietary supplement

The immune system of middle aged and elderly individuals is stimulated with a dietary supplement. The dietary supplement includes Vitamin E, Vitamin B6 and conjugated linoleic acid. The dietary supplement can further include glutathione alone or in combination with Vitamin C, folic acid, zinc, selenium, Vitamin D, copper and Vitamin B12. The dietary supplement is administered to middle aged and elderly individuals in a suitable form for consumption by the individual. Suitable forms of consumption can include a snack bar, tablet, capsule, powder, drink, or dairy products. US patent no PCT PUB.NO WO00/67596 was granted to Trustees of Tufts College (Medford, MA) in November 2003.

Third new drug for erectile dysfunction wins US FDA approval

Eli Lilly's and Icos' Cialis (Tadalafil) won US FDA approval for the treatment of erectile dysfunction. Cialis joins Bayer's and GlaxoSmithKline's Levitra (Vardenafil) and Pfizer's Viagra (sildanafil citrate) in competition for the U.S. erectile dysfunction market share Viagra has worldwide sales of $1.7 billion, with the U.S. accounting for $1 billion in sales. Cialis, already approved in Europe and other countries, had sales of $109 million so far this year, and analysts predict that once established in the U.S. its sales should top $1 billion. Analysts consider Eli Lilly's new drug pipeline as one of the strongest in the industry. "It has now seen three drugs approved recently, cleared up manufacturing issues with the FDA, and expects four more approvals in the next 12 months," a news source reports.

Late stage trial of the promising diabetes drug halted

Merck stopped a Phase III trial of its experimental type 2 diabetes treatment MK-767, which is licensed from Kyorin Pharmaceutical, because it was linked to tumour development in mice. The drug was considered one of Merck's more promising in its late-stage pipeline Last week Merck announced it was stopping Phase III development of an antidepressant which was considered as a potential blockbuster. Failure of MK-767, which had a sales potential of $500 million in 2007, could also have fallout for Bristol-Myers and AstraZeneca, which are developing similar drugs. Of the three, Merck's drug was furthest along.

Inhaled insulin

Most people using inhaled insulin for diabetes in trials prefer it to relying on injections according to a Cochrane review. People with type 1 diabetes and many with type 2 rely on several injections of insulin every day to control their diabetes. A new option, currently available only in trials, is inhaled insulin. This involves an inhaler, with either a dry powder or aerosol. It replaces most injections, but not all of them. Cochrane reviewers concluded that while it is early days in assessing this new method, so far it appears to be as effective as injected insulin. Most people find it more convenient than injections. Of those people in trials who have had the option to continue with inhaled insulin or return to injections, 80 per cent choose to stay with inhaled insulin. Research is still needed on the safety of inhaled insulin for people with asthma. Research is needed, too, on use of inhaled insulin by smokers. Cochrane reviewers report that while it appears to be safe on the lungs, it will be 10 years before we can be confident about the long-term safety of inhaled insulin.

South Africa approves mass HIV/AIDS drug treatment

South Africa approved a comprehensive drug treatment program to tackle the world's highest AIDS caseload, bending to pressure to act against an epidemic which kills an estimated 600 South Africans each day. With in a year there would be a network of centers to distribute anti-retroviral drugs, which the government previously resisted providing to the public sector. Nearly five million of South Africa's 45 million people have AIDS or HIV, the virus which causes it, giving it the world's highest caseload.

EU approves high intensity sweetener

Holland Sweetener company, DSM's joint venture with Japan-based Tosoh launched its high intensity sweetener Twinsweet on to the European market First patented in 1995 the low calorie product - a sweetener-sweetener salt of aspartame and acesulfame - received approval from the European Parliament at the end of October. The decision supercedes the temporary approval already granted in the UK and the Netherlands and paves the way for access to the growing European low calorie market. "Twinsweet links the two sweeteners at molecular level as an iconic salt. It is a flexible product that allows manufacturers to use one product only." The product flows well, dissolves rapidly and is non-hygroscopic."

Uganda to launch door to door anonymous testing for HIV

Uganda will soon launch a door to door blood testing survey to get a more accurate picture of the number of Ugandans with HIV or AIDS. An estimated 100 000 people in Uganda have AIDS, out of a population of 25 million. Many are in urgent need of antiretroviral drugs. The exercise is planned to take place between March and June next year and will be carried out by the Ugandan health ministry, with the support of the US Agency for International Development, the US Centers for Disease Control and Prevention, and the World Health Organization. Other organisations involved include the Joint UN Programme on HIV/AIDS (UNAIDS), Unicef, the UN Population Fund, and the Uganda National Bureau of Statistics. The teams will test people of both sexes in two age groups: 0 to 5 years and between 15 and 59 years. People aged between 5 and 15 years have been left out because health experts believe that this group has few HIV positive people. Uganda is one of the leading countries in Africa in promoting awareness of HIV and AIDS.

New wave of HIV therapies

Existing therapies for combating AIDS appear to be reaching their limit of efficacy The newest wave of therapies being developed, however, are entry inhibitors, which work differently from the older drugs in that they attempt to attack the virus before it attaches itself to CD4 cells Bristol-Myers Squibb is researching compounds that target a protein called viral gp120. An early study by Progenics, which is also working on a similar compound, found it is successful in tamping down viral levels in the blood. Tanox is working on a drug that targets the CD4 receptor, and so far, this compound has not met with the side effects found with other compounds working in this way. Several drugmakers are working on CCR5 blockers. Schering is testing compound SCH-D, which in vitro appears more potent and does not have the adverse side effects that go along with blocking the CD4 receptor. "Clinical data are expected to show big drops in viral levels in patients." Pfizer's CCR5 blocker, UK 427-857, was shown in an initial 10-day trial to result in a 10- to 100-fold drop in viral load. Roche's and Trimeris' recently approved Fuzeon works after the virus has docked to the cells. Though it's difficult to make and must be injected twice a day. Trimeris is now testing a second-generation version.

Pfizer's acquired new drug shows efficacy in slowing vision loss

A Phase III trial of Pfizer's and Eyetech's 'pegaptanib sodium' (Macugen) found that the drug appears to be effective in limiting vision loss due to the wet form of age-related macular degeneration. Based on the results of the current study, Pfizer and Eyetech are expected to apply for FDA approval in the first half of 2004. The results are similar to a Phase III trial for Novartis' and QLT's Visudyne. Pfizer paid $745 million for the rights to Macugen, an amount that suggests the drugmaker believes it will become a bestseller. Also in the wings is Genentech's Lucentis, which is currently in late-stage trials.

Is smallpox behind AIDS immunity?

A new research suggests the tiny number of people who are immune to AIDS are the descendants of Europeans who developed resistance to smallpox in the Middle Ages."Smallpox has left a signature on our genetic makeup, providing a benefit to us 700 years later," says study coauthor Alison P. Galvani, an epidemiologist at the University of California at Berkeley. If Galvani is correct, she may have punctured the prevailing wisdom that the prime suspect behind AIDS immunity is bubonic plague, the deadly disease that wiped out a third of Europe in the 14th century. Unfortunately, the findings may reveal more about the past than the future. Experts don't expect their research to have any effect on treatment of people with AIDS. The existence of AIDS immunity itself isn't new. Researchers discovered it in the 1980s during the early years of the AIDS epidemic, when they noticed that some people were repeatedly exposed to the virus but didn't get infected. The prevailing theory is those who had the gene mutation were spared infection by one or more diseases and lived to pass the mutation to future generations. In the new study, published in the issue of the Proceedings of the National Academy of Sciences, researchers argue that the clues point to smallpox, and not plague as supposed earlier. Smallpox makes more sense for a variety of reasons, the researchers say, including its stubbornness. While plague came and went in huge waves, smallpox was always around and influencing the genetics of humans.

GSK's Fluticasone (Advair) get's new indication approval for smoker's cough

Europe's biggest drugmaker, GlaxoSmithKline, said that U.S. regulators had approved its Advair (Fluticasone) for treating patients with severe cases of the smoker's lung disease known as COPD. The drug, GSK's biggest seller, is already widely used in the treatment of asthma. The new approval covers its use as a maintenance treatment for chronic obstructive pulmonary disease (COPD) patients who suffer from chronic bronchitis. Some estimates suggest that 15-20 percent of all Advair sales currently go to treating the condition, which is also known as smoker's cough. COPD -- which is mainly caused by smoking -- kills an estimated 2.9 million people each year, according to the World Health Organization.

Compiled from WWW by Venkat Appaji Padmanabhuni appajipv@hotmail.com