The pharmaceutical industry's US marketing application submissions for new molecular entities (NME) slipped again in 2003 While the 23 NME submissions filed in 2003 were off just slightly from the 24 submitted to the FDA a year earlier, industry submissions for this closely watched category of innovative drugs have fallen in six of the past seven years, and are now less than half the number submitted in 1995.
Annual Number of US marketing applications for NMEs filed with FDA
1995 48
1996 45
1997 42
1998 43
1999 38
2000 31
2001 30
2002 24
2003 23
Meanwhile, US drug submissions overall have increased over the last few years. In 2003, the pharma industry submitted 119 new drug applications (NDA) to the FDA, up for the second consecutive year and an increase of 21 per cent from 2001's 98 NDA submissions, the lowest figure in over a decade. NDA submissions, however, include filings not just for NMEs but for new esters, salts, derivatives, and formulations of previously approved drugs as well. Therefore, they are not as pure a measure of innovative drug output as NME submissions and launches.
NME Approvals
Although 2003's 21 NME approvals by the US FDA represented a modest rebound, that rebound comes following an almost unrelenting downturn in new drug clearances. 38 NMEs were approved in 2002 and 2003. These are less than the number that the FDA cleared in either 1996 or 1997.Increasingly over the last several years, the United States has been seen as the most important market for drug launches and industry profits. In 2003, the United States was the country with the most first new drug launches, notching 50 per cent of drug launches worldwide, according to IMS Health. Europe garnered 27 per cent of the first launches, while Japan managed barely 7 per cent. Interestingly, 10 per cent of the 2003 new drug launches were in Russia.
US NME Approvals, 1995-2003
1995 28
1996 53
1997 39
1998 30
1999 35
2000 27
2001 24
2002 17
2003 21
Worldwide New Drug Launches
On a worldwide basis, new drug launches appeared to stabilize in 2003. Pharma projects reported that 31 new active substances (NAS) were launched in 2003, up from 29 in 2002 but down significantly from the 43 introduced in 2000.
Biotech/Biological Launches Important Once Again
Following 2002, when only about 10 per cent of NAS launches comprised biotech/biological products, biopharmaceuticals were once again an important part of global NAS introductions in 2003. Overall, almost a third of 2003's NAS launches were biologicals. In the US, however, even new license application submissions for biologics have slumped. Biological license application (BLA) filings to the FDA have been slumping since the mid-1990s. In 2003, the agency received only 8 BLAs, roughly half the number submitted as recently as 2000 and about a third the number submitted in 1995.
Therapeutic Class Is A Critical Determinant Of Drug Development Cost And Time: Tufts Study
The cost and time required to develop a new drug and bring it to market is directly tied to the therapeutic category of that drug, according to a study completed by the Tufts Center for the Study of Drug Development. The study shows that analgesic/anesthetic drugs were the least costly to develop, requiring an average of $375 million for total out-of-pocket and time costs. This compares to an average of $466 million for all drugs, when phase attrition rates and clinical approval success rates are factored in. The most expensive category of drugs to develop includes medicines that treat diseases of the central nervous system - known as CNS drugs - which cost an average of $527 million. These figures exclude non-clinical research and development costs. The Tufts CSDD study examined four categories of drugs: analgesic/anesthetic, anti-infective, cardiovascular, and CNS. Average clinical and approval phase time for all drugs was 90.3 months.
Obesity/Diabetes Could Hit Life Expectancy: Experts
Twin global epidemics of obesity and diabetes are out of control and could reduce life expectancy in the future, health experts. Obesity, a major risk factor for diabetes, already affects 300 million people worldwide while an estimated 194 million suffer from diabetes. By 2025 the number of obese people is expected soar to 333 million. "I suspect that within a short period of time we will begin to see a reduction in life expectancy because of the twin epidemics," said Professor Claude Bouchard, president of the International Society for the Study of Obesity (IASO). As many as 80 per cent of cases of Type 2 diabetes are linked to overweight or obesity, particularly abdominal obesity. In the United States, the prevalence of excess weight and obesity in adolescents has nearly tripled in the past two decades. In 30 years time, the number of people in the U.S. with diabetes is expected to increase by 57 percent, according to Lefebvre. In some countries in the Middle East and Asia the number will double. The report described the twin epidemics as a global health crisis and stressed the importance of eating a low-fat healthy diet and getting plenty of exercise.
Could A Pill Prevent Grey Hair?
People with grey hair could one day pop a pill if they want to restore their hair to its natural colour. Scientists at French cosmetics giant L'Oreal have identified a pair of genes that may play a key role in turning hair grey. They say these genes may determine how long many of the cells that give hair its natural colour live. They believe that by targeting these genes they may be able to help these cells live longer, preventing grey hair. Hair turns grey when the cells that give it its colour die. However, the French scientists have found that some of these cells, which are called melanocytes, survive even when somebody's hair has turned grey.
Plant-Derived Estrogen Wins FDA Approval
US regulators have approved Barr Pharmaceuticals Inc.'s second plant-derived female hormone replacement tablet, an alternative to animal-derived products that have been linked to serious health risks. Enjuvia was cleared by the US Food and Drug Administration for treatment of moderate to severe symptoms associated with menopause that typically includes hot flashes, vaginal dryness and night sweats. Since 1999, the company has been selling Cenestin, another plant-derived estrogen product, which has annual U.S. sales of $50 million. Sales of Wyeth's Premarin, whose estrogen is derived from the urine of pregnant mares, have plunged in the past 2 years after a large, long-term federal study linked it to stroke and blood clots.
Compiled from WWW by Venkat Appaji Padmanabhuni appajipv@hotmail.com