The dearth of new drugs is one of the major challenges facing the pharmaceutical industry, with the number of new active substances launched dropping to a 20 year low of 36 in 2002. It is therefore not surprising that when a company does have a promising drug, it pulls out all the stops to promote it. Hence the publicity over products such as AstraZeneca's Crestor (rosuvastatin), and Zetia (ezetimibe) from Schering-Plough and Merck & Co. Abbott, the world's 12th largest pharmaceutical company in 2002 is putting its marketing muscle behind Humira (adalimumab), a new biological therapy for rheumatoid arthritis that received FDA approval earlier than expected, on New Year's Eve 2002.
Up to the launch of Humira, the biological response modifier sector was dominated by Amgen's Enbrel (etanercept), co-marketed by Wyeth. In second place in the M1C specific antirheumatic agent class, Aventis' Arava (leflunomide), a non-biological disease-modifying antirheumatic drug (DMARD). Third is Kineret (anakinra), a BRM also from Amgen, but an interleukin-1 receptor antagonist. In fourth place comes Sanofi-Synthelabo's Plaquenil (hydroxychloroquine), another non-biological DMARD. If included in the M1C class, Johnson & Johnson's (Centocor) Remicade (infliximab) would appear in fourth place; Humira was the first fully human monoclonal antibody approved for RA; It was co-developed by Cambridge Antibody Technology and BASF's Knoll unit, acquired by Abbott in March. Abbott has 100-200 sales representatives concentrating on its most important new drug. It is also developing Humira for Crohn's, psoriasis and psoriatic arthritis.
International company news in brief for May
Chiron launched a bid for Powderject to strengthen its presence in the US vaccine market. Aradigm acquired Intraject needle-free technology from the UK's Weston Medical. Solvay acquired the rights to Eli Lilly's antihypertensive Physiotens/Cynt. Bayer will market GW Pharmaceuticals' cannabis-based product Sativex for MS and neuropathic pain in the UK. Pfizer licensed a novel class of drugs for neurodegenerative diseases from Guilford. Yamanouchi acquired the rights to Phytopharm's experimental Alzheimer's drug for Japan and Asia. Lilly ended its agreement with Generex for an oral insulin product
There were a number of high-profile approvals, including AstraZeneca's Iressa for lung cancer, Millennium's Velcade for multiple myeloma, and Biomarin and Genzyme's Aldurazyme for mucopolysaccharidosis I, all by the US FDA. The EC cleared Roche and Trimeris' novel HIV drug Fuzeon. The FDA also approved Novartis' statin Lescol for the prevention of coronary events in patients with heart disease.
Genentech and Xoma discontinued research on Raptiva in rheumatoid arthritis but its application is pending approval for psoriasis. Wyeth's combination HRTs (Prempro) were linked to an increased risk of dementia and stroke. The Australian OTC market was thrown into turmoil by a mass withdrawal of products made by contract manufacturer PAN, which had its licence revoked after a safety inspection. Wyeth revealed that 90,000 users of its withdrawn diet drugs had opted out of a national settlement in the US - meaning it could have to pay out up to another $4 billion in damages
Spiriva, the first specific drug for COPD set to become a blockbuster
The COPD (chronic obstructive pulmonary disease) market is a complex one, as at the moment, many drugs of various types are used in the treatment of the condition. Some of these drugs are also used for asthma, another condition that requires brochodilation. In 2002, however, Boehringer Ingelheim launched the first specific drug for COPD - Spiriva (tiotropium bromide), which is co-marketed by Pfizer.
Analysts have estimated that the current annual global market for COPD drugs is worth about $3 billion, possibly tripling to over $9 billion by 2010, as safer and more convenient therapies for this mainly smoking related disease are introduced. Spiriva sales have already exceeded BI's expectations, and it looks set to become a blockbuster. Meanwhile, a number of agents from a completely new class of drugs, phosphodiesterase-IV inhibitors, are in the pipeline for COPD.
Boehringer Ingelheim is a major force in the treatment of COPD. It makes two of the older standard treatments: Atrovent (ipratropium bromide), and Combivent (ipratropium/salbutamol). These must be taken several times a day and offer only limited symptomatic relief. Spiriva is a long-acting anticholinergic drug with kinetic selectivity for muscarinic M1 and M3 receptors. Importantly, it is the first once-a-day inhaled bronchodilator for the maintenance treatment of COPD. Spiriva was first launched in the Netherlands, and has since been introduced in a number of European markets, Canada and Australia, with further launches planned in 2003. The drug was filed in the US in 2001 and could be launched there in 2004. A launch in Japan may also occur in 2004.
Remote-controlled capsules to diagnose and treat illnesses in the human gut
Once the stuff of science fiction, tiny, remote-controlled capsules could soon be used to diagnose and even treat illnesses anywhere in the human gut, according to researchers. . A wireless video-equipped capsule -- about half the size of a grape -- has been swallowed and tested in the first human volunteer. "It's the future of wireless capsule therapy," the scientists said.
Until recently, patients with unexplained gastrointestinal illness had only a few options when it came to diagnosis -- CT scans or MRI, endoscopy, or surgical interventions. Each has its limitations, and researchers have long sought a method of clearly viewing the inside of the entire length of the gastrointestinal tract without having to resort to surgery. Within the last decade, researchers developed tiny, video-equipped capsules that are swallowed and then passed through the body via the normal movement of the gut. But relying on the gut to propel the capsule forward has had its problems. What was needed was a method of controlling the capsule from the outside. Fritscher-Ravens and her colleagues say they have patented just such a method.
Using technology very similar to that found in TV remotes or electronic car-keys, they attached tiny electrodes to the front and rear portions of the video capsule, along with a tiny antenna. Using a drive/reverse switch, they have been 5 milli-amps of power The capsule, which is meant to be disposable, safely passes through the gut and is flushed away with a regular bowel movement. The scientists have high hopes for the capsule. Someday, the device might be made to travel through the gut and grab tiny pieces of tissue for biopsy. It might even be used to treat disease, possibly eliminating the need for surgery, according to the researchers. "Right now, with this capsule we can see (a lesion), but we can't treat it," Fritscher-Ravens said.
Spending on biotech medicines skyrockets
Spending on biotech drugs and treatments for rare diseases rose exponentially more than other types of medicines and were a significant factor in driving up overall pharmaceutical spending last year, according to a new report. In a study of its clients, pharmacy benefit management firm Medco Health Solutions Inc. found that spending on biotech and specialty drugs rose 40 percent last year. The second largest category was cholesterol-lowering drugs, which saw a 14 percent increase. Overall, drug spending by Medco's 63 million clients rose 12.9 percent to $33 billion. Biotech drugs are made from organisms such as proteins, which makes them more complicated and more expensive to produce than traditional drugs, which are made from chemicals. Biotech drugs often have to be administered in a doctor's office or hospital, driving up the cost. Treating a patient with a biologic drug costs between $1,000 and $2,000 a month compared with $600 for a traditional pharmaceutical. Spending on biotech and specialty drugs increased dramatically because 13 such products were approved last year and early this year, according to the report.
Laughter at dinner cuts blood sugar in diabetics
A small study shows that diabetics may be better able to process the sugar they consume during meals if they order a side of laughter with their food A group of researchers in Japan found that people with type 2 diabetes -- the most common form of the disease -- had a smaller rise in post-meal blood glucose (sugar) when they watched a comedy show than when they listened to a humorless lecture. The researchers, led by Dr. Keiko Hayashi from the University of Tsukuba, also found the same results in people without diabetes. Poorly controlled blood sugar can increase the risk of diabetes complications such as heart disease, kidney failure and blindness.
Hayashi said that people with diabetes have a lot to worry about -- diet, exercise and keeping their glucose and insulin levels in check. And stress is known to increase the risk of elevated blood glucose, the researcher noted. "If positive emotion such as laughter reduced blood glucose, both patients and medical providers would recognize the importance of it, and it would improve their mental health" and quality of life, Hayashi said. Plenty of studies have shown that laughter can combat many common ills. For instance, research suggests that humor may lower blood pressure and release endorphins. Laughter is also thought to improve circulation, stimulate the nervous system, heighten the immune system and make the heart stronger. All of the diabetic patients included in the study had type 2 diabetes, which occurs when the body fails to respond to insulin, the hormone that clears the blood of sugar after a meal and deposits it into cells to use for energy. Hayashi noted that the reasons why laughter might reduce blood glucose are not clear, but suggested that laughter could increase energy consumption by working the abdominal muscles. Alternatively, the researcher said, laughter might affect the neuroendocrine system, which controls glucose levels in the blood.
Major changes in the New Model List of WHO
Listed below are some major changes effected in the New Model List of Essential Drugs
1. Added:
amodiaquine tablet, 153 mg or 200 mg (base); azithromycin 250 or 500mg capsule, and suspension 200mg/5ml., 1.5 mg single levonorgestrel (new dosage form)
2. Rejected:
paediatric ibuprofen, porcine insulin suspension (insulin semilente), miconazole buccal tablets, misoprostol and valaciclovir.
3. Deleted:
ethinylestradiol + levonorgestrel tablet, 50 micrograms + 250, micrograms (pack of four) nonoxinol and spermicides with condoms and diaphragms, chloral hydrate,
dextromethorphan, fludrocortisone, folic acid injection, ipecacuanha syrup,
human immunoglobulin,- pethidine, cyclophosphamide in section 2.4 trimethoprim injection, iron dextran injection, , prazosin, hydralazine, reserpine,- desmopressin
4. Changes ; :
ORS: to 75 mEq/l sodium (sodium chloride 2.6 g/liter) and 75 mmol/l. (13.5 g/liter) glucose, - - streptokinase: dosage changed to powder for injection 1.5 million IU
in vial.
5. Combined list ;
The Committee recommended that the core and complementary list be combined as one, with medicines on the complementary list printed in italics or otherwise identified.
6. Moved from the core list to the complementary list:
amphotericin-B, aminophylline, azathioprine, clomifene, diethylcarbamazine, dopamine, ethosuximide, hydrocortisone rectal preparations, intraperitoneal dialysis solution, methotrexate, penicillamine, pentamidine, pyridostigmine, sulfadiazine and
sulfasalazine.
7. Moved from the complementary list to the core list:
amoxicillin/clavulanic acid, chloramphenicol oily solution, epinephrine, (adrenaline) injection, levonorgestrel, mannitol and norethisterone, enantate.
Sesame oil lowers blood pressure
Using sesame oil instead of other cooking oils helps reduce high blood pressure and lower the amount of medication required to control high blood pressure, says a study by researchers in India. The study looked at the effect of sesame oil on 328 people with hypertension who were taking 10 to 30 milligrams a day of the calcium channel blocker drug nifedipine, which lowers blood pressure by relaxing arterial membranes.
The average age of the people in the study was 58, and they had moderate to severe long-term hypertension but no history of stroke or heart disease. They consumed an average of 35 grams of sesame oil a day for 60 days. Their blood pressure was measured at the start of the study, every 15 days during the study and on day 60. The study found using sesame oil as their sole cooking oil lowered their blood pressure levels from 166 mm Hg systolic to 134 mm Hg and from 101 mm Hg diastolic to 84.6 mm Hg. The average dose of nifedipine taken by the people in the study was reduced from 22.7 milligrams per day to 7.45 milligrams per day by the end of the study.
Japanese domestic industry prepare for global competition
In recent years Japan has steadily eased regulations that limited foreign competition in its pharmaceutical market, and Japanese drug makers are being forced to establish a global presence in order to survive. The gates will open wide in 2005 when Japan drops the requirement that companies must own a production facility in the country to sell drugs there. This will allow multinationals such as Pfizer, Roche, Novartis and Merck to grab a piece of the country's $50 billion pharmaceutical market, the world's second largest.
Companies such as Takeda Chemical Industries and Fujisawa Pharmaceutical are pumping money into R&D and developing a greater presence in U.S. and global markets. Fujisawa made the first move in 1994, introducing organ-transplant drug Prograf to the U.S. market. Today the drug is administered to 70 percent of liver-transplant patients and 50 percent of kidney recipients. Takeda has sought strategic partners such as Abbott Laboratories to help market its products overseas and has seen 25 percent sales growth over the last year for its four top drugs. Other companies are also expected to endure, including Sankyo and Kyowa Hakko Kogyo, which has pared down its operations and in February launched a biotechnology firm in Princeton, N.J., to develop a new cancer drug.
New malaria drug combo promising
Vietnamese researchers reported that a new drug combination for malaria, costing about one euro per treatment, is fast acting, highly effective and well tolerated. A spokeswoman for the World Health Organization (WHO) said the drug combination, from a collaboration of Chinese and Vietnamese groups, was an impressive development. At the European Congress of Clinical Microbiology and Infectious Diseases, the Vietnamese researchers reported on a trial comparing the new CV8 combination -- containing dihydroartemisinin, piperaquine, trimethoprim and primaquine -- against Malarone, a combination of atovaquone and proguanil currently used to fight malaria. In the study, a total of 161 patients with malaria caused by the Plasmodium falciparum parasite received either four doses of CV8 or three doses of Malarone, over three days. CV8 and Malarone are found equally effective, fast acting and tolerable. CV8 can be used in developing countries due to its low cost.