Pulmonary drug delivery has been used for several years for symptomatic relief and the treatment of patients suffering from asthma and chronic obstructive pulmonary disease (COPD). In addition, inhaled products are also being used for delivery of antibiotics for patients suffering from cystic fibrosis. Extensive research, spanning over many years has made possible development of products that can be delivered through the pulmonary route in many more specialties. Inhaled products pipeline includes products for diabetes, migraine, osteoporosis, hormones, and cancer therapies.Metered dose inhalers (MDIs), dry powder inhalers (DPIs), and nebulizers are the three available technologies within the pulmonary drug delivery.
Metered dose inhalers (MDIs) have been the most widely used devices for the delivery of medications through the lungs. Although the dry powder inhalers (DPIs) were introduced in the 1970s, their use has been limited due to overwhelming dominance of the MDIs. Due to concern over CFC based MDIs, companies have introduced new generation inhalers that utilize hydrofluoroalkane (HFA) as a propellant. A minimum of two products has been introduced in the U.S. market and more are expected to follow suite. Several other technologies are being developed for delivering medications effectively through the pulmonary route. Battelle Pharma is developing electrohydrodynamic aerosol delivery products for multiple indications. These devices are highly efficient and can deliver higher concentrations of the drugs to the lungs without the need for propellants. Inhale Therapeutics and Alkermes have developed dry powder inhalers that can deliver the drug much more effectively than the earlier available devices. Aradigm and Aerogen are developing electronic liquid aerosol inhalers that can deliver finer doses with precision. Many more technologies are being developed that are likely to overcome the shortcomings of the conventional pulmonary delivery technologies.
Italy cracks down on its drugs bill
The Italian government is cracking down on its spending on pharmaceutical drugs. Its ministry of health considers that 85 drugs are overpriced. Unless the drug companies reduce their prices for these drugs, the country's national health service will not reimburse pharmacists for the cost of them. As a direct consequence of the move, which involves drugs belonging to 41 therapeutic categories, public spending on drugs is expected to be reduced by 7.5%, The evaluation of each product's cost effectiveness by the ministry of health's pharmaceutical commission was based on the "defined daily dose," after the creation of homogeneous classes of substances "whose safety and efficacy profiles" were substantially the same. "These are drugs with the same mechanism of action, so it is very difficult to imagine a reason why a physician should prefer one to another," explained thedirector of Milan's Mario Negri Institute for Pharmacological Research and a member of the committee for proprietary medicinal products of the European Medicines Evaluation Agency. "This measure affirms the simple principle of having the same price for the same cost effectiveness. Now the manufacturers have to lower the prices of the named drugs or face exclusion from the list of drugs that can be reimbursed or to explain why in specific cases the proposed price would affect availability of medicines or distort consumption patterns. The list is expected to be released by the end of the year.
Piracy, prices delay China pay off, say Drug Firms
Pitfalls from piracy to pricing could mean a long wait before global drug firms make a profit in China. The world's most populous nation with 1.3 billion people, China is the world's seventh largest market for medicine valued at around $7 billion. It is set to overtake Italy and Britain and move into the number five spot with its market growing to $24 billion by 2010 China has made a series of promises to open this potentially massive market and protect intellectual property better after joining the World Trade Organisation last year. But top global drug firms like Pfizer, Aventis and AstraZeneca say they are tempering their enthusiasm for China because of rampant counterfeiting, copious red tape and pricing rules that squash their margins.Although laws protecting intellectual property rights are going into place, enforcement is patchy and a massive threat to profits, the foreign drugmakers say. China's WTO membership is expected to improve conditions for foreign drug firms, bringing down import tariffs to 4.2 percent on January 1 from an average of 9.6 percent and allowing them to wholesale their own drugs by December 2004.
Red tape is another problem; industry executives told of whole departments in their companies devoted to making photocopies and putting stamps on paperwork to participate in drug tenders at hospitals. Still, "the longer-term fundamentals are pretty darned good", Damond said, citing China's population, rising wealth in coastal cities and broader awareness of what they want from medicine.
Zetia (ezetimibe), the first cholesterol absorption inhibitor approved
The success of the statin product class can be attributed to the products' high efficacy in reducing the low-density lipoprotein cholesterol (LDL-C). The introduction of more potent statins like Zocor (simvastatin) and Lipitor (atorvastatin) has contributed to the meteoric rise in prescriptions within this market segment. Although, the statins are considered to be relatively safe, they do have some side effects, like muscle weakness and liver toxicity. Within the statin class of products, some products are considered to be safer than others are. Baycol (cerivastatin) had to be withdrawn from the market due to concerns regarding its safety. On similar grounds, the FDA has been carefully evaluating the approval of higher doses of Crestor (rosuvastatin).
Zetia works by absorbing cholesterol from the intestine and is also a weak anti-dyslipidemic agent on its own.. However, Zetia has synergistic effect when combined with statins. The addition of Zetia to a statin, significantly enhances the lipid-regulating efficacy, making it a worthwhile alternative The combination of Zetia and a statin is a much safer therapeutic alternative as it reduces the risk of liver toxicity and muscle weakness. This offers hope to a large number of dyslipidemic patients who were unable to tolerate high doses of the statins, and therefore failed to achieve the desired lipid goals.
The U.S. lipid regulators market is estimated to have generated approximately $13 billion in revenues in the year 2001, and is dominated by Lipitor (Pfizer) and Zocor (Merck). Zetia is likely to find it difficult to secure a place among the primary therapies used for cholesterol management. Instead, it will be used as a secondary therapy for those patients who are unable to tolerate high doses of statins.
Cancer Suppression Gene Identified
Scientists have identified one of the genes that may be responsible for stopping the spread of some cancer cells. The gene, known as RhoGDI2, is missing or present in low levels in invasive, metastatic cancer, says a study by University of Virginia researchers This finding could lead to new tests to help doctors determine the best way to treat individual cancers, and eventually could lead to gene therapy to treat aggressive forms of cancer. To isolate the gene responsible for metastasis, Theodorescu and his team compared two types of bladder cancer -- one aggressive and invasive, the other a localized, non-spreading cancer. They found the aggressive form of cancer expressed low levels of RhoGDI2.
Cancer can develop only when the body's functions go awry. Normally, human cells grow to replace old, dying cells. If new cells form when the body doesn't need them and older cells don't die off, a tumor develops from all those extra cells. Some tumors are benign and generally don't cause problems. Others are malignant; these tumors can invade and damage other cells and travel to other parts of the body via the bloodstream. For that whole process to occur, however, numerous genes have to be altered or destroyed. According to the researchers, replacing even the function of one of those damaged genes may stop the process that lets tumors spread. Theodorescu says it could be possible to develop a test to look for levels of RhoGDI2 in tumors, which would let doctors treat their patients more accurately and effectively. .Theodorescu and his colleagues are studying RhoGDI2 to see if they can learn how it controls metastasis, because, he says, if they know how it works, they may be able to manipulate it and develop new treatments for cancer patient.
Valdecoxib Label With New Warnings
US FDA and Pharmacia are advising health care professionals about new warnings and information in the product labeling of the drug Bextra (valdecoxib), a drug approved for treatment of osteoarthritis, rheumatoid arthritis and dysmenorrhea (menstrual pain). The labeling is being updated with new warnings following postmarketing reports of serious adverse effects including life-threatening risks related to skin reactions -- including Stevens Johnson Syndrome, and anaphylactoid reactions (serious allergic reactions). In addition, the labeling will state that the drug is contraindicated-- not to be used -- in patients allergic to sulfa containing products.
Pharmacia, the manufacturer of Bextra sent letters to health care professionals advising them of postmarketing reports and new warnings that will be included in the drug label. Since the firm began marketing the drug in March of 2002, cases of the serious skin and hypersensitivity reactions have been reported.. Although these adverse events are rare, some of these patients required hospitalization. Based on these reports, As these reactions can be life threatening, people who use valdecoxib and experience a rash should discontinue the drug immediately.
Lilly gets European Approval of Impotence Drug Cialis
Eli Lilly. won approval from European regulators to sell the impotence treatment Cialis, one of the company's biggest products in development. Worldwide sales of Cialis, which the drugmaker is developing with biotechnology company Icos ., may reach $750 million .Indianapolis-based Lilly said earlier this year that the U.S. Food and Drug Administration wants more studies on the drug, and the company expects U.S. approval in the second half of 2003. Cialis would give Lilly a rival to Pfizer 's Viagra and Levitra, a medicine Bayer and GlaxoSmithKlineare planning to introduce in the U.S. next year.
US FDA approves Repaglinide in combination with insulin sensitisers
The FDA has approved a new indication for use of Prandin (repaglinide), a meglitinide, in combination therapy with rosiglitazone or pioglitazone (insulin sensitisers), for the treatment of Type II diabetes. Prandin, an insulin secretagogue, was previously approved for use as monotherapy or in combination with metformin, another type of insulin sensitiser. Developed in collaboration with Boehringer Ingelheim, the agent is in-licensed by Novo Nordisk for worldwide development and marketing. Prandin rapidly stimulates insulin secretion, whereas insulin sensitisers primarily improve the body's response to the hormone. The product is indicated as monotherapy or in combination with metformin, rosiglitazone or pioglitazone for individuals with Type II diabetes whose hyperglycaemia cannot be controlled by diet and exercise alone plus monotherapy with metformin, sulphonylureas, repaglinide or thiazolidinediones (rosiglitazone/pioglitazone). While it improves overall glycaemic control, including fasting blood glucose (FPG) levels, Prandin was developed specifically for dosing at mealtime, to control postprandial hyperglycaemia as well.
Painless Inflammation Triggers Heart Attacks
Despite their seemingly healthy cholesterol levels, new research shows many people are at high risk of heart attacks because of painless inflammation in the bloodstream. The inflammation comes from many sources and triggers heart attacks by weakening the walls of blood vessels, making fatty buildups burst. A large study published Thursday concludes it is twice as likely as high cholesterol to trigger heart attacks. Over the past five years, research by Dr. Paul Ridker of Boston's Brigham and Women's Hospital has built the case for the "inflammation hypothesis." With his latest study, many believe the evidence is overwhelming that inflammation is a central factor in cardiovascular disease, by far the world's biggest killer. Inflammation can be measured with a test that checks for C-reactive protein, or CRP, a chemical necessary for fighting injury and infection. Diet and exercise can lower CRP dramatically. Cholesterol-lowering drugs called statins also reduce CRP, as do aspirin and some other medicines.
Doctors believe the condition often begins when the fatty buildups that line the blood vessels become inflamed as white blood cells invade in a misguided defense attempt. Fat cells are also known to turn out these inflammatory proteins. Other possible triggers include high blood pressure, smoking and lingering infections, such as chronic gum disease. Doctorsrecommend a CRP check for almost anyone getting a cholesterol test. "The CRP test can predict risk 15 to 25 years in the future," Ridker said. Dr. Wayne Alexander of Emory University in Atlanta said he already uses CRP testing to help make treatment decisions, such as whether to prescribe statins for people with borderline high cholesterol.
Compiled from WWW by Dr. Venkat Appaji Padmanabhuni
email : appajipv@hotmail.com