On December 17, 2002, US FDA announced that its Vaccines and Related Biological Products Advisory Committee (VRBPAC) panel has recommended approving MedImmune’s flu vaccine FluMist for use in people of ages 5 to 49. If approved by the full FDA, it would be the first flu vaccine administered by nasal spray, avoiding the shots that could deter some individuals to take the vaccine.

FluMist is a live, attenuated, molecularly engineered vaccine with a tenuous development history (see drug profile on page 10). It has shown better efficacy than ... Read more

Frustrated with the slow pace of drug discovery research on rare diseases, due to limited economic incentive, some family groups and private foundations are taking the lead by partnering with small pharmaceutical companies in the search for treatments.

Families of Spinal Muscular Atrophy (FSMA) is a network of more than 5,000 families in the US and Europe with children now suffering or having previously suffered from the rare neurological condition that causes progressive muscle weakness and often death. It announced on Feb. 12, 2003 that it is to provide deCODE Genetics Inc. with $5.2 million in a determined effort to find a ... Read more

The US financial market continued its recovery in the period from mid-October to mid-November. Dow Jones Industrial Average, Nasdaq, and S&P 500 gained 4%, 10%, and 3%, respectively during the period. Biotech and biopharmaceutical companies faired worse than the overall market considering that most of them are traded in the Nasdaq while pharmaceutical companies performed slightly worse than the average (S&P 500).

Both biotech/biopharma and pharmaceutical groups underperformed compared with the overall market so far this year. For biotech/biopharma companies, underperformance was largely due to product disappointments and ... Read more

The Orphan Drug Act approved 20 years ago was one of the most successful legislations enacted in the USA. It is estimated that about 25 million people in the US suffer from one of the approximately 5,000 known rare diseases or “orphan diseases” designated by the US FDA as any disease that occurs in less than 200,000 people in the US.

The FDA has a different set of rules, incentives, and grants for the development and approval of orphan drugs. In the past 20 years, there were 231 orphan drugs approved which treated an estimated 11 million patients in the US ... Read more

U.S. financial markets accelerated on their downward trajectory in the period from mid-September to mid-October (2002). Dow Jones Industrial Average and S&P 500 reached their 5-year lows and the Nasdaq Composite Index touched a 6-year low. Investors fled from stocks like from the plague. Toward mid-October, U.S. shares rebounded strongly after mega-corporations like Citigroup, IBM, and Microsoft reported better than expected earnings and an affirmed outlook.

Biopharmaceutical companies “piggy-backed” the v-shaped ride along with the markets, with Amgen and Idec Pharmaceuticals leading the pack. Idec reported better than expected operational results on Oct. 16th owing to strong sales of its Rituxan, ... Read more

Johnson & Johnson and Boston Scientific reported on September 24, 2002 and September 26, 2002, respectively, that their drug-coated stents worked in large trial studies. Stents are metal-scaffold devices that can be inserted into narrowed arteries to keep them open. Restenosis, a process whereby the artery can narrow or even close again, can occur in 20-40% of patients treated with the bare metal stent, the only kind of stent currently available.

In the Johnson & Johnson study of 1,100 patients, 36% of the patients who were given the bare stent as controls had restenosis after 9 months compared to only 8.9% of ... Read more

On September 24, 2002, U.S. FDA’s oncology expert panel voted 11-3 to recommend the marketing approval of Iressa, an anti-lung cancer drug developed by AstraZeneca. The FDA usually (but is not obligated to) follows the panel’s recommendation. The Wall Street Journal described the development as “a rare victory at the FDA,” referring to FDA’s conservative stance towards approving new drugs in recent years.

The favorable recommendation came as a surprise to many in light of the recently well-publicized failure in two clinical trials when Iressa is used with other chemotherapy drugs as the front-line treatment for lung cancer. Without the long ... Read more

On October 21st, President Bush announced that his administration has proposed new rules to make it harder for brand-name drug makers to extend their patents and keep generic drugs off the shelves. The proposed rules are similar to a Bill passed by the U.S. Senate in July but then opposed by the President. The White House estimated that the new rules would cut brand-name drug makers $3 billion a year on prescription drug revenue. The Senate Bill would have cut twice as much.

As with the Senate Bill, the new rules will limit brand-name drug makers to extending their patents for ... Read more

In a pronounced backdrop of Wall Street sentiment that is obsessed with real and perceived worries, capital valuation of biotech and pharmaceuticals companies contracted last month (from August 15th to September 15th) (please see the table for sector indexes). Biotech and pharmaceutical companies were also confronted with their own problems. Product disappointments added to the negative tone.

On September 10, 2002, Genentech announced that its Avastin, a drug that targets the angiogenesis in tumors, failed to prolong the life of breast cancer patients in a large phase III pivotal trial. Genentech has looked upon the drug as the future engine for ... Read more

“Don’t confuse information with knowledge. The former may make you money today, but the latter is what helps you keep it tomorrow.”
Larry E. Swedroe, Buckingham Asset Management, Author of What Wall Street Didn’t Want to Tell You

“If you don’t know who you are, the stock market is an expensive place to find out.”
Adam Smith, Financial Advisor

“A money manager is a person who manages someone else’s money until it’s all gone.”
Woody Allen, Director/Actor/Writer/Filmmaker

“There’s a lot of stuff bubbling and much of it is sinister.”
MarketWatch.com

“October is one of the singularly most dangerous month to speculate in stocks. Others ... Read more