Biopeer

FDA approves generic AIDS drugs

The morale of people fighting against Acquired Immuno Deficiency Syndrome (AIDS) got a boost when the USFDA (Food and Drug Administration) gave its tentative approval for three generic AIDS drugs.

Aurobindo Pharma Ltd, of Hyderabad, India has been authorized to manufacture the generic version of Abacavir Sulfate Oral Solution with 20 mg (base)/mL. The drug is otherwise sold by GlaxoSmithKline under the name of Ziagen Oral Solution. The formulation is intended for children between the ages of three months and 13 years who are infected with the Human immunodeficiency virus (HIV). The approval is a good news as it means that thousands of children covered by the US President's Emergency Plan for AIDS Relief (PEPFAR) will now get access to the drug.

Aurobindo Pharma was granted tentative approval by the USFDA also for stavudine 15 and 20 mg capsules. The drug is a generic version of Zerit, sold by Bristol Myers-Squibb. As in the case of abacavir, the tentative approval does not allow the drug to be marketed in the US. because of existing patents and/or exclusivity rights. Stavudine fights AIDS by preventing the virus from reproducing.

However, Aurobindo is receiving stiff competition from Cipla Ltd. Cipla has got tentative approval from the USFDA for its abbreviated new drug application (ANDA) for anti-HIV/AIDS drug Slamivudine. The approval is for the oral solution of strength 10 mg per ml. The active ingredient in the formulation is lamivudine. The announcement caused Cipla’s shares to rise 1.6 per cent.

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Vaccines and lifting import ban make some positive avian flu news

Russian scientists have announced the commencement of the second phase of a clinical trial for H5N1 virus vaccine. Investigators from the Research Institute of Influenza in St. Petersburg said that the first injection had not caused any side effects 28 days after it had been administered. One hundred and twenty volunteers between 18 and 50 years have been enrolled for the repeat vaccination. Blood tests of the volunteers after 28 days will determine the efficacy of the vaccine. The vaccine was manufactured at the Russian enterprise Mikrogen.

Two unnamed vaccine makers will supply eight million doses of a ‘pre-pandemic’ vaccine to the government of Switzerland. The vaccine is intended to protect against the H5N1 and other variants of the avian flu virus. The Federal Council announced that the stock will be ready by next year. The vaccine will act as an initial layer of protection for the citizens of Switzerland till a proper vaccine is developed.

Poultry from two Malaysian states can now be exported to Singapore. Following Malaysia’s declaration that it is free from avian flu, the Agri-Food and Veterinary Authority (AVA) of Singapore has lifted the ban on Malaysian poultry. Poultry from the northern states of Perak and Selangor will now regain entry in the neighboring country. AVA issued a statement saying that it found the disease control and prevention measures taken by Malaysia’s Department Veterinary Services (DVS) to be in compliance with international standards. The ban will be lifted from  June 30.

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Prostate cancer drug approved in UK

Men suffering from prostate cancer in UK can heave a sigh of relief. The National Institute for Health and Clinical Excellence (NICE) in UK has approved the use of docetaxcel for the treatment of late-stage prostate cancer.

Docetaxcel is sold under the brand name Taxotere by Aventis Pharmaceuticals Inc. NICE has proposed that it should be made available to all patients in need in England and Wales on the National Health Service (NHS). Experts like Chris Hiley, of the Prostate Cancer Charity, hailed the decision as a “major step forward in prostate cancer treatment.” However, they agreed that further research is necessary to test the efficacy of the drug in the earlier stages of aggressive prostate cancer in younger men.

Prostate cancer is treated with hormonal therapiess that stop testosterone from aiding the cancer. However, in the later stages, patients stop responding to this treatment. Docetaxcel is a chemotherapy drug originally used in the treatment of breast cancer. But a study published in the New England Journal of Medicine in 2004 proved that it extended the lives of late-stage prostate cancer patients by 18.9 months. It fights cancer by obstructing the means by which tumor cells divide. By reducing the pain and weight loss, it also enhances the quality of life.

In the UK, prostate cancer is the most common cancer in men and accounts for almost 1 in 4 of all new male cancers diagnosed. It is also the cause of 14 per cent of male deaths from cancer.

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Hope floats with vaccine trials and GIS

After the success of the phase I trial of the human vaccine to fight bird flu, scientists from Perth, Australia are set to start the phase II trial. The vaccine developed by a Melbourne pharmaceutical manufacturer, CSL has proved safe and effective in the initial trial. Scientists will now test it in larger doses. 150 adults will be recruited as part of the phase II trials. The focus of the new trial will be to determine the quantity of vaccine needed to provide protection against bird flu. Trial participants will receive two doses of the vaccine, three weeks apart.

Technology is being called to play an increasing part in bird flu monitoring. Experts believe that geographic information system (GIS) can be effectively used to track the spread of diseases like avian flu. Using GIS, the exact location of residential and office buildings, produce markets, chicken farms and any other sites where infections might have occurred can be mapped. This will provide valuable inputs in terms of tracking the pattern of the disease spread.

A study by the European Commission estimates that bird flu pandemic among humans could cost upwards of 180 billion euros in lost economic output in the European Union in the year that it strikes. According to the study, an avian influenza pandemic would reduce economic output by 1.6 per cent. Supply-side damage mainly in terms of work hours lost through death and sickness would account for about two-thirds of the total impact of the pandemic.

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Preventive measures and a possible vaccine against avian flu

Following the detection of the avian flu virus in Hungary, Russia has banned imports from Hungary. The agricultural ministry announced that the ban would cover related products like live poultry, poultry meat and poultry products that have not undergone thermal treatment, hatching eggs, fodder and fodder additives. Poultry management equipment too has been prohibited. Japan and China too have imposed restrictions on Hungarian poultry.

Bangladesh is continuing its efforts against bird flu. The government has started an emergency program to fight bird flu. The emergency program is estimated to cost around USD 61 million. Fisheries and Livestock Secretary, Quamrul Hasan notified livestock officers at a daylong training program that the government has taken up inter-ministerial programs to execute the national strategy to fight avian influenza. Even the World Bank is favorably considering the Bangladeshi government’s request for assistance of around USD 28.6 million.

Meanwhile, US scientists have found another possible way to combat an avian flu epidemic. Researchers from the University of Massachusetts Medical School have formulated a vaccine for bird flu using the DNA of the virus. The vaccine would be administered using a pressurized gun that penetrates the skin, thus eliminating the need for needles. According to Dr Shan Lu, it is necessary to prepare ourselves against the spread of the virus. The testing of the vaccine on animals will take place soon. Human trials are expected to commence in around six months. A British drug company is also involved in the development of the vaccine.

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New alliances for developing diabetes products

Two major pharmaceutical companies have separately entered into agreements that will see them take a major step into the field of diabetes drugs.

The drug delivery technology maker Nastech Pharmaceutical Co announced its pact with drug maker Amylin Pharmaceuticals Inc to develop a nasal spray for diabetes. The main ingredient in the spray will be exenatide. Preclinical studies of the formulation show positive results and preparations are underway for commencing studies to verify its feasibility in human subjects. The drug will be developed by Amylin and marketed by Nastech. Nastech will also receive the royalty and milestone payments from the end product. Through the collaboration, both companies aim to provide therapeutics that facilitate a healthier life. The announcement lead to Nastech shares rising to USD 15.38 in afternoon trading on the Nasdaq, while Amylin shares rose up to USD 46.87.

Meanwhile, Metabolex, Inc has decided to address metabolic diseases in collaboration with Ortho-McNeil, Inc, a Johnson & Johnson company. The focus will be on type 2 diabetes, obesity and dyslipidemia. Metabolex's two clinical compounds, metaglidasen and MBX-2044, and additional follow-on compounds are included in the agreement. The two companies will work together to screen metabolic disease targets identified by Metabolex. According to Harold E Van Wart, Ph D, President and CEO, Metabolex, the deal will aid the development and commercialization of its lead best-in-class type 2 diabetes products and will also enhance the company’s capability to produce future first-in-class therapies. The contract will equip Metabolex with USD 40 million in equity and convertible financing.

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Avian flu in Azerbaijan; EU, West Africa continue brainstorming

Avian flu continued its spread with cases being reported from Azerbaijan. Four people have died after contracting the virus from infected swans. The victims appear to have been infected after they plucked the feathers of the swans to sell for pillows. Andreas Gilsdorf, an epidemiologist at the Robert Koch Institute in Berlin, whose team made the discovery, said that it is the first time a case involving wild birds has been reported. Three other people who were infected by the swans have survived.

Ministers of various West African nations came together to discuss bird flu measures. The one-day meeting of the Economic Community of West African States (ECOWAS) saw ministers in charge of departments like agriculture, livestock and health discuss the need for coordination among the nations to prevent and control bird flu. According to the Nigerian president, the agricultural sector was important for the region, as it was a major employer of labor. However, the avian flu outbreak was having negative effects on the sector, and consequently, food security.

A major safety body of the European Union (EU) is continuing its efforts to evaluate scientific evidence regarding avian influenza. The scientific panel of the European Food Safety Authority (EFSA) has published a report called “Food as a possible source of infection with highly pathogenic avian influenza viruses for humans and other mammals”. The paper analyses the possibility of mammals contracting the virus through the consumption of contaminated food. Though it comes to the conclusion that there is no definite proof of such transmission, it does advise the proper cooking of poultry to avoid food poisoning.

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Ranbaxy's generic form of Zocor approved by USFDA

In a major boost to Indian pharmaceutical companies, the US Food and Drug Administration (USFDA) granted Ranbaxy Laboratories Ltd the right to produce and market cholesterol-lowering Simvastatin Tablets in the US market.

Ranbaxy stated that the USFDA approval includes a 180-day exclusivity for marketing the drug in the strength of 80mg and will launch the product almost immediately. The company expects its formulation of simvastatin to give considerable benefits and value to the patients. Generic forms will mean lower costs for US insurance companies, employers and patients as competition drives down a drug's price by 80 per cent. Israel-based Teva Pharmaceuticals too has been granted exclusive permission to produce the drug for a period of six months.

However, the approval comes as a major blow to drug giants Merck & Co and Pfizer. Merck was selling simvastatin under the name of Zocor in the United States. But now, on losing its patent protection, it is open to generic competition that will cost Merck an estimated USD 2 billion this year. Pfizer’s rival cholesterol drug, Lipitor is also expected to bear the brunt.

In order to minimize its loss, Merck has signed a deal with another Indian pharmaceutical company, Dr Reddy’s Laboratories. The deal will allow Dr Reddy’s to market authorized generic versions of Merck’s Zocor and Proscar tablets across all dosage forms. Also, Merck has plans to sell Zocor at a price lower than that of its generic versions. The decision is being seen as an attempt to fend off the generic competition by instigating a price war.

Simvastatin is used in the treatment of patients with coronary heart disease, hypercholesterolemia requiring modifications of lipid profiles and adolescent patients with Heterozygous Familial Hypercholesterolemia (HeFH).

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Probable treatment for rheumatoid arthritis

A new study by Dutch researchers has found the drug methotrexate to be beneficial for people suffering from rheumatoid arthritis.

Henrike Van Dongen and colleagues at Leiden University conducted a study on patients with undifferentiated arthritis who are positive for the anticyclic citrullinated peptide (anti-CCP). The study aimed to find out the benefits, if any, of the drug methotrexate for such patients. The study called Probable rheumatoid arthritis: Methotrexate versus Placebo Treatment (PROMPT) is a double-blind placebo controlled randomized multi-center trial. The trial enrolled hundred and ten patients who were either given methotrexate or a placebo. The researchers concluded that when compared to the placebo group, fewer patients receiving methotrexate developed rheumatoid arthritis and more of them reached remission. The findings were presented at the meeting of the Annual European Congress of Rheumatology (EULAR 2006) in Amsterdam, Netherlands.

At the same meeting, it was also reported that rheumatoid arthritis patients also benefited from a combination treatment of methotrexate and etanercept. The 52-week TEMPO extension trial involved 227 subjects who had completed the 3-year double-blind TEMPO trial. Subjects who had received only either one of the drugs were now switched to a combination of both. Those who were anyway receiving the combination therapy were continued on the same regimen. Fifty per cent of patients taking the combination for all four years achieved clinical remission. For those who had received methotrexate monotherapy for the first three years, the addition of etanercept brought about a response achieved by the former group. Those who had received etanercept during the first three years also showed improvements with the addition of methotrexate.

With rheumatoid arthritis affecting approximately 0.5 to one per cent of the adult population worldwide, the findings presented at the Annual Congress are a significant breakthrough.

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Avian flu continues to create news waves in Asia

Indonesia’s efforts against bird flu hit a roadblock with the World Health Organization (WHO) announcing the possibility of human-to-human transmission of the virus. The WHO has established that the deaths of seven members of a family most likely occurred due to one member transmitting the virus to the other six. The case findings were distributed at a closed meeting in Jakarta attended by some of the world's top bird flu experts. However, WHO officials emphasized that the virus had not undergone any mutation and the chances of a global pandemic had not increased.

An avian flu vaccine made in China is being seen as probably a better alternative to western vaccines. The Chinese H5N1 flu vaccine is reportedly stimulating a good immune response at lower dosages compared to western vaccines. This is allegedly because the Chinese vaccine is being made using whole viruses while the western manufacturers are using viruses broken into particles. Sinovac, the company making the vaccine, announced that its trials had shown that subjects who had received two 10-microgram doses of the vaccine made with whole virus and alum, showed protective responses. The finding is significant as it would help to stretch the vaccine supply in case of a global pandemic.

The Indian government has decided not to lift the ban on the retail sales of the avian flu drug, Tamiflu. Drug giants Cipla and Roche had sought a review of the ban and permission to sell the drug commercially to private hospitals and organizations. However, officials of the taskforce on avian influenza met at New Delhi and asserted that public health was of greater importance than business considerations and refused to lift the ban. The ban had been declared earlier to prevent panic buying of the drug.

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