Financial StatementGlaxoSmithKline Operating and financial review and prospects

Avandia, GlaxoSmithKline’s new treatment for type 2 diabetes, achieved sales approaching half a billion pounds, the majority in the USA, where it was first launched in 1999. Avandia scripts now account for over half of the US thiazolidinedione market, a market which grew by 75 per cent in 2000. In April 2000 the US FDA approved Avandia in combination with a sulphonylurea, having previously approved it both as a monotherapy and in combination with metformin. Avandia will be rolled out into Europe and Rest of the World markets in 2001. In August 2000 Avandia received a positive recommendation in the UK from the National Institute for Clinical Excellence (NICE). Zantac continues to decline in the face of competition from generic products and alternative anti-ulcerant treatments. The rate of decline slowed to 11 per cent in 2000. Zantac’s largest market is now Japan, where sales remained stable.

Lotronex, a treatment for irritable bowel syndrome, was launched in the USA in March 2000 and generated sales of £36 million before being withdrawn in November 2000 following discussions with the US FDA over the interpretation of data relating to gastro-intestinal side effects. The company disagreed with the FDA’s assessment of the safety profile of Lotronex, but agreed to withdraw it from the US market and has also withdrawn all other regulatory submissions worldwide.

Vaccines sales reached £842 million, an increase of 11 per cent. In the hepatitis franchise, Engerix-B declined eight per cent due to lower sales in the USA, Havrix, for hepatitis A, grew slightly and Twinrix, a combined hepatitis A and B vaccine in both adult and paediatric strengths, grew five per cent to £95 million. Infanrix, GlaxoSmithKline’s range of combination vaccines for diphtheria, tetanus, and pertussis (whooping cough), grew 47 per cent. In October 2000 the European Commission approved Infanrix

PeNta, which provides additional protection for hepatitis B and polio and Infanrix HeXa which further adds protection against haemophilus influenzae type b disease.

Zofran, for emesis, a now well-established product and a leader in its sector, benefited from market growth in the USA, where over two-thirds of its sales are generated.

Cardiovascular sales were stable, with 11 per cent growth in Coreg and recent launches of Pritor for hypertension in European markets offsetting declines in older products. Future sales should benefit from new data showing Coreg’s effectiveness in treating severe heart failure.

The disposal of the anaesthesia franchise in the USA at the end of 1999 contributed to a fall in this therapeutic area of 21 per cent. In October 2000, Glaxo Wellcome’s US company also disposed of its portfolio of dermatological products, contributing to the four per cent decline in this sector.

Sales of anti-bacterial products increased by two per cent, with growth in Augmentin offset by flat sales of Zinnat/Ceftin and Amoxil and a decrease in Fortum. With sales reaching £1.2 billion, Augmentin continued to perform strongly. In the USA sales grew 13 per cent, with a market share of nearly a quarter. Solid growth was achieved in Latin America and South East Asia. In Europe sales were affected by generic competition.

Zinnat/Ceftin declined by seven per cent in its largest market, the USA, but this was offset by growth in the emerging markets of the Middle East, Africa, Latin America and Asia Pacific.

Growth in anti-viral sales of 14 per cent reflects strong growth in the HIV franchise, where the Group markets a range of reverse transcriptase inhibitors (RTIs) and a recently launched protease inhibitor, Agenerase, as well as steady growth in sales of herpes products and continued uptake of new products against other viral diseases.

Sales of RTIs increased by 12 per cent. Combivir again grew strongly, reflecting conversion of patients from its constituent single products, Epivir and Retrovir. In aggregate the three products achieved real growth of five per cent; excluding the effect of oneoff contracts in Brazil in 1999 which were not repeated in 2000, underlying growth was nearer eight per cent.

The newer RTI, Ziagen, grew by 75 per cent, reflecting continued uptake in the USA and in Europe. Trizivir, which combines Epivir, Retrovir and Ziagen, was launched in the USA in December 2000 and in the European Union (the UK and France) in January 2001.

The triple combination tablet simplifies the dosing regimen for patients who are often taking several tablets a day. The new protease inhibitor, Agenerase, also offers some improvement in dosing regimen. The majority of its sales were in the USA, where it has been available since May 1999. European Union approval was received in October 2000, and the product was launched in some markets, including the UK and France, before the end of the year.

The Group’s two herpes treatments, the newer Valtrex and the older Zovirax, grew at a combined rate of five per cent. Valtrex continues to protect the Group’s franchise in this area, with strong increases in all regions and a successful launch in Japan in August. Zeffix, for chronic hepatitis B, achieved sales of £70 million. First launched in the Asia Pacific region, it performed strongly in the Chinese and South Korean markets. Relenza, the new influenza treatment, doubled its sales to £32 million and, following launch in Japan in December, is now available in most major markets. http://www.gsk.com/financial/reports/ar/pdf_excel/report/p47-68.pdf  Go to Page 6

Good Shot…Prevnar Hits a Billion
[Published May 2002 Source Frost & Sullivan]

A novel vaccine for the prevention of pneumococcal disease in infants, entered the U.S market with a bang in February 2000, racking up sales of $461 million in the launch year, the most successful vaccine launch ever. The vaccine, known as Prevnar, is now the first blockbuster of the new millennium, having achieved sales of over $ 1 billion.

Background

Wyeth began development of Prevnar, a pneumococcal 7 valent conjugate in the early 1980s. It differs from other marketed pneumococcal vaccines in its ability to induce immunity in children under two years, who are susceptible to invasive pneumococcal disease.

Approved in 48 countries, Prevnar has thus far been launched in 24 countries, including most European countries. Although granted a coveted spot in the paediatric immunisation schedule in the U.S, European governments have been less hasty to implement a recommendation for mass immunisation of infants. While most paediatric vaccines now cost between $6 and $20 per dose, Prevnar, costs a substantial $60. In Europe, the vaccine commands a similar premium price compared to the U.S. For example, in the UK, the price of one dose equates to approximately $56.

The high price has been stipulated as one reason for the slower vaccine acceptance in Europe, when compared with the U.S and the limited recommendations granted. However, there is future potential for Wyeth as European governments discuss the implementation of recommendations similar to the U.S. And it does not stop there. The possibility of label expansion, covering the prevention otitis media, a highly prevalent ear infection, further boosts the potential revenues of this already highly successful vaccine.

Production Bottleneck

Prevnar sales fall by 29 percent in Q1of 2002. This sales shortfall has been attributed not to product demand, but to the production issues.

Because of expanded capacity and improvements in the actual process, Wyeth is optimistic that by the end of Q2, the gap between supply and demand would have decreased. This problem with production is certainly not a unique one. Many vaccine manufacturers have suffered similar 'interruptions' in production. For example, Merck temporarily ceased production of MMR and varicella vaccines to ensure quality. However, problems are caused when one manufacturer has a monopoly in a particular vaccine market, and supply problems often result in delays to scheduled immunisations.

Development Challenge

Despite production problems, Wyeth's grip on this market will not be threatened, atleast in the near future. Currently, clinical development for pneumococcal vaccines suitable for paediatric use is lacking. The realisation that any new vaccine would need to demonstrate equivalency to Prevnar in large scale clinical trials has led to many pharmaceutical companies shying away from this particular market, despite being highly lucrative. Nearly 38,000 children were involved in Phase III clinical trials and Phase IV post licence studies are ongoing, with a study group of 60,000 children. Because of the nearly 100 percent efficacy and good safety profile demonstrated by Prevnar in Phase III trials, establishment of clinical superiority by other pneumococcal vaccine candidates would be fraught with difficulties.

The unprecedented success of Prevnar in the U.S is set to be mirrored, although to a somewhat lesser scale in Europe. And with no competition on the horizon, Wyeth will continue to reap the success.

PowderJect reports healthy rise in profits
by Philip Howard
http://www.businessam.co.uk/BreakingNews/articles/0,1909,121992,00.html
Last update: 09:10, Nov 12, 2002

POWDERJECT Pharmaceuticals, the vaccines specialist, today posted a forecast-beating rise in first-half profit, strengthening its claim that a recent £455m bid approach was opportunistic.

The firm, which is being pursued by US pharmaceutical firm Chiron according to industry sources, said profit before tax leapt more than four-fold to £19.3m in the six months to 30 September, driven by strong sales of its Fluvirin flu vaccine. Analyst forecasts had ranged from £13m-£15m. "These results show what a strong business we've got and I can understand why competitors are interested," the chairman and chief executive, Paul Drayson, said. But he reiterated the bid approaches were "opportunistic", because they came at a time when the share price was at a four-year low.

It has been a roller-coaster year for PowderJect. In March it became only the second British biotech firm in history to post a profit as it cemented its switch from a needle-free drug delivery firm to a vaccines specialist. It then became caught up in a political row in April when it won a contract to supply smallpox vaccine to the UK just weeks after Mr Drayson had donated money to the Labour Party.

Worse came in August, when PowderJect's shares plunged after it withdrew a tuberculosis vaccine used to inoculate school children because it had found some faulty batches. But the shares bounced back last month when the firm said it had received a number of takeover approaches. Mr Drayson said there had still not been a formal offer for the business, and declined to comment on media reports that Chiron had dropped its verbal bid to 450p-per-share and that Shire Pharmaceuticals had pulled out of talks.

"The board will consider any offer properly, and consider whether it is in the interest of shareholders," he said.

Mr Drayson forecast a "modest" second-half profit, adding the company was on target to meet its goal of delivering a full-year pre-tax profit of over £20m. Revenues from PowderJect's Fluvirin flu vaccine are focused on the first-half of the fiscal year. They totalled £76.5m in the six months to 30 September.

 

11/25/2002 http://hoovnews.hoovers.com/fp.asp?layout=displaynews&doc_id=
NR20021206670.2_73970002018ad960

Aventis Pasteur is to spend $150 M on increasing its vaccines production capacities in France and USA. The company has vaccine plants at Marcy-l'Etoile in France and Swiftwater in Pennsylvania. A vaccines packaging and distribution depot costing EUR 8.5 M and employing staff of around 1000 has been in operation at Val-de-Reuil since Mar 2002. Aventis Pasteur has vaccines capacity in France of 370 M doses/y which is to be increased to 800 M doses/y by 2005. Pasteur Aventis produced 1.3 bn vaccines doses during 2001. These vaccines give protection against nineteen specific diseases including measles, rabies and poliomyelitis.

 

DECEMBER 9, 2002

NEWS: ANALYSIS & COMMENTARY

Vaccines Are Getting a Booster Shot

As their profit potential jumps, so does new investment in R&D


In the pharmaceutical industry, vaccines have long been poor stepsisters to big, glamorous drugs. Immunization campaigns have worked wonders, wiping out scourges such as polio. Yet annual global sales of vaccines are just $6 billion--about $1 billion less than what best-selling cholesterol drug Lipitor generates in one year. And the number of major companies selling vaccines has shrunk from 20 in the 1980s to just 4. For many years, "it wasn't an economic business to be in," says Dr. Paul Drayson, CEO of PowderJet Pharmaceuticals PLC, a vaccine maker in Oxford, England.

No more. In late November, Merck & Co. (MRK ) reported that its experimental vaccine could ward off infection from cervical cancer-causing human papillomaviruses (HPV). And GlaxoSmithKline PLC (GSK ) is working on one for herpes. If proven safe and effective in larger trials, both could become blockbusters, analysts say. And that's just the start. Company research-and-development pipelines are bulging with nearly 100 vaccines against infectious agents, with dozens more being engineered in academic and government labs against everything from Ebola virus to West Nile disease.

The surprising result: Annual growth for the vaccine industry will rise to the mid-teens per year, up from an historic average of 10%, according to a recent report commissioned by the Global Alliance for Vaccines &
Immunization (GAVI). "It's really a good time to be in the vaccine business," says Dr. Thomas P. Monath, research chief at Acambis Inc. (ACAM ) in Cambridge, Mass., which is churning out smallpox vaccine for the U.S. government.

Moreover, vaccines are becoming far more versatile. Traditional immunizations prime the immune system to fight off parasites, bacteria, or viruses such as flu. But increasingly, vaccines are tackling diseases beyond
the infection itself. Merck's HPV vaccine doesn't just prevent infection from HPV--it also holds the hope of eliminating the cervical cancer caused by the virus. Other experimental vaccines are aimed at prodding the immune system to eat away malignant tumors or chew up the brain tangles of Alzheimer's disease. "We are ready for a renaissance in the whole vaccine area," says Stephen A. Johnston, a biochemist at the University of Texas Southwestern Medical Center.

What explains the resurgence of vaccines? Credit a combination of smart policy moves, advances in science, and a big change in the economics of the business. Back in the 1980s, companies bailed out of vaccines because prices--and profits--were low, and because they faced huge legal threats from people harmed by vaccines. Congress largely solved the liability issue with a 1986 bill setting up a program to compensate victims. "That led to increased research, and we are seeing the fruits of that now," says independent drug analyst Hemant K. Shah.

The ability to command premium prices helped, too. In the late 1980s, Merck and SmithKline launched gene-spliced vaccines for hepatitis B. At $30 to $40 per dose, they cost well above what is charged for common childhood vaccines used to prevent measles, tetanus, or whooping cough. That marked the start of "increased interest in vaccines as a business as opposed to a public-health intervention," says Piers Whitehead, vice-president of biotech company VaxGen Inc. (VXGN ) in Brisbane, Calif., and co-author of the recent GAVI report.

Now, vaccines are racking up profits once seen only with blockbuster drugs. The best example is Wyeth Corp.'s (WYE ) Prevnar, a vaccine that helps protect children from the pneumococcal bacteria that cause meningitis. Prevnar's price is a lofty $232 for a four-dose course. Lehman Brothers Inc. analyst C. Anthony Butler predicts that the vaccine, with estimated sales of $625 million this year, could soon be a $1.5 billion product. "Wyeth's success has shown other companies that there is a potential for vaccine blockbusters," says Dr. Stanley A. Plotkin, consultant to Aventis Pasteur Ltd., one of the four big vaccine makers, and professor emeritus at the University of Pennsylvania.

Improved economics have prompted vaccine makers to boost R&D spending. The four industry leaders--Merck, GlaxoSmithKline, Aventis Pasteur (AVE ), and Wyeth--are estimated to spend more than $750 million a year on vaccine R&D--as much as a fivefold jump at some companies since '92. Scientific advances also are helping prompt renewed interest. One hot idea is to develop a basic vaccine that could be customized for a range of diseases. Acambis, for example, is using its yellow-fever vaccine as a way to deliver bits of other viruses--such as West Nile--to the immune system. Other drugmakers are creating vaccines made of DNA that could be spliced quickly with new genes when novel diseases or bioterror agents suddenly emerge (box).

None of this will make vaccines as glamorous--or as profitable--as drugs. For one thing, getting a vaccine approved can take longer than it does for drugs. The Food & Drug Administration wants proof that no serious side effects will appear even when the product is given to tens of millions of people. But that's tough, as evidenced by the current controversy over whether mercury in past children's vaccines could have caused autism.

Finally, scientists caution that they're still a long way from creating vaccines for viruses crafty enough to hide from the immune system, such as HIV. But with a host of important new vaccines now in companies' pipelines, this former poor stepsister is getting ready for the ball.


By John Carey in Washington, with Kerry Capell in London
 

http://www.guardian.co.uk/executivepay/story/0,1204,848541,00.html

Shareholders claim victory as Glaxo mothballs chief's £20m pay deal

Jill Treanor
Wednesday November 27, 2002
The Guardian

GlaxoSmithKline yesterday shelved a potential £20m pay deal for its chief executive Jean-Pierre Garnier after a furious backlash from City investors. Britain's biggest pharmaceutical company was forced to put the controversial plan on hold to avoid a full-scale battle with its shareholders, who do not believe the French-born executive deserves such a large pay rise.

GSK's retreat was heralded as one of the most significant victories by City investors. Two years ago shareholders exerted pressure on telecoms group Vodafone to reduce a £10m bonus for its chief executive Sir Christopher Gent, while earlier this year insurance company Prudential dropped a proposed pay deal for its top executives.

Mr Garnier, who took home £7m last year, demanded the increase to put his earnings in line with rivals in the United States, where he is based and where pay packets are more generous than those given to UK executives. Shareholders in GSK, who had made their opposition clear in a series of secret meetings with company chairman Sir Christopher Hogg last week, were elated.

However, some urged a note of caution amid fears that the company will try to secretly reintroduce the package in the coming months once the furore has died down. This is because GSK said that while it was postponing a decision on the deal, it remained "committed to aligning its incentive plans with those of its pharmaceutical peer group". 

A spokesman for the National Association of Pension Funds, whose members control around £650bn of pension fund assets, said: "Two cheers for Glaxo, one because they bothered to consult and the second because they listened to shareholders. But, we will be keeping a very close eye on them in the future."

At the Association of British Insurers, whose members control a third of the stock market, Peter Montagnon, head of investments, made it clear that any attempt to reintroduce the scheme would meet with further scrutiny from shareholder bodies.

"It remains very important that there must be a link between the remuneration and value generation for shareholders," Mr Montagnon said. The proposed pay deal for Mr Garnier was intricately structured, involving awards of US-listed shares known as American depository receipts, options over shares and "career performance shares".

This pushed the value of the deal to around £20m, according to the Guardian's calculations, after his base salary of £935,000 and other bonuses are added. The timing of the announcement, following a series of top-level crisis meetings at GSK, surprised the City as it appeared to contradict com ments made only yesterday by Sir Christopher Hogg in an interview with the Financial Times.

The planned rise for Mr Garnier was regarded as ill-judged by the City as it came after a 30% fall in the company's share price, a 25% slump in profits and a failure by the company's scientists to develop any
blockbuster drugs. It also came at a time when US-style pay deals are being discredited after a wave of corporate collapses across the Atlantic such as the oil company Enron.

One major shareholder, who asked not to be identified, said: "This is a tactical withdrawal, but in our view JP [Jean-Pierre] is unrepentant and undaunted and they remain committed to the US pay model." The City now believes that Mr Garnier's own job is on the line unless the company, formed through the merger of Glaxo Wellcome and SmithKline Beecham two years ago, starts to improve dramatically.

 

Monday, December 02, 2002
LAVAL, Que. (CP) - Shire Pharmaceuticals Group PLC will invest $28 million to build a new global vaccine research centre in Laval, where the British-based multinational company already has a research facility. Dr. Randal Chase, president of Shire Biologics, said Monday that federal government support through Technology Partnerships Canada was a significant factor in advancing the company's presence in Canada. Shire is eligible for $5 million in government money under the partnership program. "Our decision also serves to underpin Shire's strategic aim of becoming an even more significant player in the global vaccine market which is expected to grow from $5 billion annual sales to more than $10 billion sales within the next five years," Chase said in a release. Shire Biologics currently provides about half of the influenza vaccine used annually in Canada. The core of Shire's operations in Canada is the former BioChem Pharma Inc. of Laval, taken over by the British company in early 2001. Shire's Laval site is already home to its therapeutic research centre and.
Work on the addition is to begin immediately, with completion planned for mid-2004. Shire shares (TSX:SHQ) traded at $31.47 on Monday morning, off 29 cents. Shire, moving to expand its vaccines business, recently announced an agreement to supply its Fluviral influenza vaccine to Berna Biotech, for sale in international territories excluding Europe and North America. In return, Berna Biotech will supply its hepatitis B vaccines to Shire for sale in Europe.

Shire also has a marketing partnership with Baxter which involves the company's meningitis C vaccine in Canada.
 

Reuters
Vaccines Seen a $10 Billion Market by '06
Tuesday January 7, 5:42 am ET

LONDON (Reuters) - Sales of vaccines, once considered a commodity market, are booming with global revenues set to reach nearly $10 billion in 2006 from $5.4 billion in 2001, according to research published on Tuesday. Analysts at Merrill Lynch said the fastest growing section of the market would be for flu vaccines, sales of which are expected to more than double to $2 billion in the next five years.

Much of the flu vaccine market's 16 percent compound five-year growth will be driven by the entry of MedImmune Inc.'s premium priced nasal spray FluMist, which will be co-marketed by Wyeth.

The launch of FluMist later this year, coupled with increasing demand for pediatric jabs, could see the overall vaccine market leap by 20 percent in 2003 alone. Growth is then expected to moderate to an annual 10 percent from 2004 to 2006. Merrill's projection of 13 percent compound five-year sales growth for the total vaccine market compares with global drug sales of just eight percent in the year to October, 2002, according to healthcare information firm IMS Health.

The infant sector currently makes up the largest section of the vaccine market, with 2001 sales of $2.5 billion, but adult demand is growing as governments actively promote flu shots for the elderly and more vaccines are used by tourists. At the same time, the threat of bioterrorism in the wake of September 11, 2001 attacks on the United States has spawned a new business in supplying vaccines against smallpox following fears that the deadly virus might be used as a weapon.

The global vaccines market is currently dominated by four large pharmaceutical companies -- Aventis SA, GlaxoSmithKline Plc, Wyeth and Merck & Co Inc -- which together account for almost 85 percent of sales. But a number of smaller companies are also carving out a niche, including Britain's PowderJect Pharmaceuticals Plc and Acambis Plc, Switzerland's Berna Biotech and Chiron Corp of the U.S.

Merrill said it had initiated coverage of PowderJect with a "buy" recommendation, reflecting its strength in flu and travel vaccines, while Berna Biotech was started as "neutral." Acambis, however, was rated a "sell." The brokerage predicted it would revert to making a loss in 2005, after a period of profitability on the back of U.S. government contracts for smallpox vaccine.

CSR Finance - Market Advice You Can Trust
----- Original Message -----
From: The Investment U E-Letter
Sent: Saturday, December 14, 2002 11:00 AM
Subject: Media Confirms: Make 43% Off Smallpox Bio Terrorism Threat


      From The Desk of Julia C. Guth, Founder, Investment U
--------------------------------------------------------------------------

               Investment Alert for Investment U Readers

            Our Chicago-based colleague, Bryan Bottarelli, has come across one company positioned to eliminate two of the nation's most high-priority and urgent concerns: The eradication of Bio terrorism and the cure for West Nile Virus.

            The potential payoff for curing West Nile and eliminating the Bio terrorism threat could mean $1.2 Billion added to this small company's bottom line, and it could all start December 16th, the day the US invades Iraq. The profits to be made could be very explosive, so we're passing on the information as soon as we have it ourselves. Don't miss this opportunity...read below immediately.

            The Cure for West Nile virus...
            The Eradication of Bioterrorism...
            And a Safe 43% Gain Per Year, For the Next Three Years...
            ALL BY SIMPLY INVESTING IN THIS ONE COMPANY
            Dear Investor,

            Talk about being in the right place at the right time...

            The one company you'll learn about could soon be responsible for eliminating two of the world's most threatening and high-priority concerns:

              1.. The spread of West Nile virus
              2.. The threat of Biological Germ Warfare with Iraq (or any other rogue nation)
            Starting December 16th, for reasons you'll learn about in this letter, this company is poised to rally 43% per year, for each of the next three years. Those who invest in this company now could make handsome returns.

            Thanks to TWO exclusive contracts totaling $431 million with the U.S. Government and the Center for Disease Control and Prevention (CDC), this company has virtually zero competition. No other company is this close to delivering a West Nile virus cure. Plus, Big Pharma elected to abandon the threat of Bio-Terrorism years ago and focus their R&D money on more lucrative markets, like the cure for cancer. Given those facts, you could see why this company is in the best position of any healthcare company in the world.

            Nevertheless, this company maintains an extremely low profile. They've maintained a secretive place on Wall Street because they're based overseas (but trade publicly on the Nasdaq through an ADR, or American Depository Receipt) and have never once asked for a single dollar in venture capital. But this low profile will change starting December 16th, 2002, as you'll soon see.

            Since September 11th 2001, this stock has rallied 30%. Reasonable projections indicate that's just the beginning. The upcoming war with Iraq alone could add $343 million to the company's bottom line. Factor in the West Nile virus cure, and that could mean another $270 million in revenues, which could triple this stock's market cap. But although the market value of this stock could soar by three or four times, I'm estimating shares will increase 43% per year for the next three years. And you'll see it all start later this month.

            This company truly is in a unique position...and offers you a once-in-a-lifetime investment opportunity. The world needs a cure for West Nile virus and a way to eliminate the threat of bioterrorism...RIGHT NOW. This secretive company is the top bet to deliver both of these needs. Once the U.S. starts its assault with Iraq, this stock won't be a Wall Street secret for much longer. The clock is ticking...

            Even though it's Wall Street's "dirty word," you'll soon understand why this company will be the single best stock to actually "buy and hold" over the next three years. Here's their incredible story...

            SMALLPOX OUTBREAK COULD KILL ONE OUT OF EVERY THREE AMERICANS TODAY
            According to top political insiders, pentagon chiefs have pinpointed a six-week "window of opportunity" in which to launch a war against Iraq. If authorized, all signs point to December 16th. That's exactly why the U.S. Government is so concerned with a smallpox outbreak on U.S. soil. Consider the facts and you'll understand why...

            FACT: According to the CDC, smallpox represents the single largest threat aside from a biological attack.

            Why is smallpox such a threat right now?

            FACT: The New York Times reports that smallpox used to kill one in three people who were infected but not vaccinated. Although the highly contagious disease was declared globally eradicated in 1980, the U.S. stopped routine vaccinations in 1972. That means that most people today are considered vulnerable because immunity is believed to diminish with time.

            Does anyone possess smallpox that could potentially use it against us?

            FACT: The New York Times reports that the U.S. Government suspects Iraq of hiding mass quantities of smallpox for a biological germ warfare attack. If the U.S. starts attacking Iraq, there's no telling what Suddam Hussein will do. Exposing the U.S. to his stockpile of smallpox is a very legitimate threat. But how would this lead to revenues for this company?

            FACT: Forbes reports that in the wake of September 11th, there's no doubt the U.S. will increase spending on the detection and treatment of biological and chemical threats.

            Just how much money are we talking?

            FACT: The Nation reports that next year's budget for biological defense will increase 319% to $5.9 billion.

            The company you'll learn about will be a direct beneficiary of this increased budget due to the smallpox threat. In fact, a contract with the U.S. Government to provide a new, more powerful smallpox vaccination for every man, woman, and child in the entire country has already been signed.

            FACT: The U.S. Government gave this company a $428 million contract to supply them with a vaccine against smallpox, the number one threat to germ warfare in the U.S., over the next 20 years.

            This company currently has a market cap of $374 million. Their new $428 million dollar contract means this stock is trading below cash. Best of all, this promising company beat out some of the top pharmaceutical companies in the world for this contract. This stock could be in the infancy stages of becoming the next major player in the pharmaceutical and healthcare industry.

            FACT: The U.S. Government elected to issue the $428 million contract to this company, passing over industry giants Merck and GlaxoSmithKline.

            That's right. This company's vaccines are so advanced that the $428 million contract is done, locked up, and finished. The only thing left to happen is the proper media event to bring this company's story to the front pages. And that media coverage will begin the moment the U.S. invades Iraq.

            QUESTION: But what if the U.S. wins the war quickly, and Saddam doesn't release any of his deadly bioterrorism agents? Will this company still have a bright future?

            That's a very legitimate possibility...and if that's the case, this company is STILL a strong buy. Even if their smallpox vaccine never gets used, his company keeps the $428 million, and they still have a West Nile virus vaccine with a $270 million potential waiting in the wings. That's what puts this company in such a special position...

            IN THREE YEARS, 27 MILLION AMERICANS WILL NEED THIS COMPANY'S VACCINE
            According to experts at the CDC, West Nile virus is spreading at an alarming rate. In testimony in front of the Senate recently, Dr. Julie Gerberding, director of the CDC, said "our concern for the human toll (from West Nile virus) is enormous." When you consider the facts, you'll see why West Nile virus is fast-becoming such a serious health threat...

            FACT: West Nile virus is spreading faster than any experts expected. It surfaced for the first time in August of 1999...and has rapidly spread across the country...touching 42 states today. Total cases in the U.S. reached 2,072, with 98 deaths.

            What are the possible effects of West Nile?

            FACT: CDC researchers recently discovered that West Nile virus can cause disabling paralysis that resembles polio.

            How does West Nile virus get spread, and how long will it prevail?

            FACT:Experts believe that West Nile virus is here to stay. A mosquito gets the disease from feeding on infected birds, then passes it on when it bites humans or animals.

            How many people could be affected?

            FACT: A recent Business Week article estimates that 500 million people in the world travel each year, with 27 million Americans to tropical areas...all of whom could soon demand this company's vaccine.

            Assuming $10 per vaccination, that's $270 million in revenues from the West Nile virus vaccination per year. But how long will it take before they'll have a cure?

            FACT: Federal scientists told Congress that a West Nile virus cure could be available in three years.

            The same company I'm passing along to you will be a direct beneficiary of this West Nile virus threat. In fact, a contract with the National Institutes of Health to develop a West Nile virus cure has already been signed.

            FACT: The U.S. Government, in conjunction with the National Institutes of Health, gave this company a $3 million grant to develop a vaccine against West Nile virus, an emerging health threat within the U.S.

            It's widely rumored that the West Nile virus grant was to jump-start a fast-track research platform. The simple, sad fact is that vaccine development hasn't been a national priority...until just recently. As a result, the U.S. Government realizes that they have to spend much more on research, possibly underwriting the entire cost, just to get back on track.

            So what you have is a company on the fast-track to developing a cure for West Nile virus at the cost of the Government...while at the same time collecting $428 million over the next 20 years to produce a new smallpox vaccine to protect against a bioterrorism threat. It's truly a unique and unprecedented position.

            Again, this is an analysis on a single company. It trades on the Nasdaq. It has a virtual monopoly developing solutions for two of the world's biggest threats, bioterrorism and West Nile virus. And because of the U.S. military's involvements in Iraq, I can tell you exactly when and why this company's shares will start to rise later this month. What's the downside if I'm wrong? Well, not much, considering that this company has a 20 year gravy train of $431 million from the U.S. Government and the CDC. This could be the simplest, safest, and best stock to "buy and hold" over the next three years. And if that's not enough, get this...

            BIG PHARMA'S A NON-FACTOR
            In 2000, the worldwide market for vaccines was $2.97 billion. That's small potatoes for Big Pharma, which collectively decided to pour most of its research and development funding into cancert. Looking back, that was a huge oversight...

            FACT: Vaccines are currently the fastest-growing field among anti-infectives. With an estimated current market of $37 billion, they're expected to be a major driver of growth in the years ahead.

            Since the vaccine market jumpted from $2.97 billion in 2000 to $37 billion today, Big Pharma has become interested once again. The problem is, they're nearly three years behind. So what does that tell you?

            FACT: Since so many bigger pharmaceutical firms are ill-equipped to meet the challenge od delivering new vaccines, they have to look at smaller companies within this vaccine line of research to fill their gaping void.

            In addition to their two research grants, this company also stands the chance of getting taken over by a Big Pharma company at a steep premium. But here's the best part...

            THE COMPANY IS STILL A BUY EVEN IF EVERYTHING THUS FAR IS WRONG
            For argument's sake, how will this company look if smallpox turns out to be harmless, West Nile virus doesn't turn into a health problem for humans, and Big Pharma shomehow gets its act together and catches up with vaccine pipelines without any outside help?

            If everything thus far is completely wrong, this company could still be strong enough to gain 30% per year over the next three years.

            That's right. This company is in such a special position that it'll still be a buy if everything you've read thus far turns out to be 100% wrong. If tomorrow we make peace with Iraq, realize that West Nile virus can be cured by taking two Tylenol, and Big Pharma leapfrogs three years ahead with their vaccine research, this stock will still be capable of returning 30% over the next three years.

            Why? Because no matter what, cattle, horses, sheep, and even goats will all be seriously threatened by West Nile virus. Even if the human West Nile virus vaccine isn't needed, the veterinary application of the West Nile virus vaccine could have a significant effect on this company's earnings...starting this years.

            FACT: The Texas cattle industry, which includes cattle, horses, sheep, and goats, is prepared to spend millions on this company's West Nile virus vaccine to protect their livestock.

            Think about it. People can put on mosquito spray. Animals grazing in fields across the world cannot. That's why this company's veterinary application represents a $100 million market. That alone is enough revenue to push this stock up 15% over the next three years.

            But that's still not the end of this company's potential if everything thus far is wrong.

            In addition to the domestic demand for this company's smallpox vaccine, the overseas demand for this company's smallpox vaccine could provide them with another $343 million in revenue over the next 20 years.

            FACT: The U.S. is not the only country stockpiling this company's smallpox vaccine. The CBW Conventions Bulletin, a Harvard journal on chemical and biological weaponds that is regarded as authoritative, reported that Germany ordered 6 million doses, Ireland ordered 600,000, and Greece ordered 150,000.

            The 6.75 million orders from Germany, Ireland, and Greece are only the beginning. I have a hunch that even more countries across the world will start ordering their smallpox vaccines the moment Iraq starts feeling the heat.

            Factoring in just the estimated $100 million in revenues from the West Nile virus veterinary vaccine and the $343 million in revenues from the increased overseas demand for this company's smallpox vaccine, the stock price could go up 30% over the next three years. But when you also consider the U.S. smallpox contract and the West Nile virus human vaccine, I hope you're realizing that this company's "true" potential is easily ten times as great.

            Let me reiterate this opportunity.

            This company is positioned to solve two of the world's most threatening, urgent, and high-priority concerns: A defense against smallpox and the eradication of West Nile virus. Due to a contract with the U.S. Government and the CDC, this one company has a lock on the market to satisfy both needs.

            Their potential, but expected, revenue stream of $428 million over the next 20 years could conservatively make you 43% per year for the next three years. If all goes as expected, that revenue stream has the potential of topping $1.2 billion.   So, if this is such a great company, why is the stock not up more than 30% over the last year?

            Well for one, we haven't officially started a war with Iraq. Secondly, West Nile virus is still an emerging health threat. Also, Big Pharma spends millions upon millions to hide the fact that they were shortsighted years ago in researching vaccines. And lastly, this company has kept an extremely low profile, due in part to the fact that they operate overseas and have never once asked for a single dollar in venture capital. But if you look close enough, you'll notice that some ultra savvy insiders have picked up on the massive potential of this company.

            FACT: Armada Small Cap Growth Fund and Morgan Stanley Developing Growth Securities, arguably two of the best mutual funds at locating small-cap growth stocks, both own shares of this company's stock.

            FACT: This company ranked at the top of Time Magazine's annual "Europe's 50 Hottest Firms," which rates companies on their future potential, not present hype.

            SO...ARE YOU INTERESTED?
            Before I ask you if you're interested in this information, I must make one thing clear. I'm not a "high-powered" stock analyst. I don't work for any brokerage house. An I'm certainly not getting paid by this company to promote their stock. I'm an options trader who rarely even looks at stocks. But I'm drawing this opportunity to your attention because it's bar none the best positioned stock I've ever come across.

            I also must make it clear that there's no guarantee this stock will continue to go up. The risk that it could go down does exist. That's something for you to decide. But I can guarantee you that this stock is positioned to satisfy two of the world's most urgent needs: Providing a defense against smallpox and developing a cure for West Nile virus. In fact, if you're interested in getting in on this deal, I'll provide you with four special quarterly analysis reports that reveal the name of this company and prove everything you've read above is true. Your first of four reports will get sent to you today, and it'll reveal the name of this company and cover the following:

              a.. Details of the $428 million smallpox contract
              b.. Reports from the CDC about the seriousness of West Nile virus
              c.. Big Pharma's non-factor
              d.. The demand for the smallpox vaccine overseas
              e.. Veterinary West Nile virus vaccine applications
            A QUARTERLY ANALYSIS THAT COULD MAKE YOU 43% FOR EACH OF THE NEXT THREE YEARS
            This is going to be very easy for you. You don't have to follow a fast-moving trading system to make these profits. Nopee. I'll simply give you immediate access to four special reports, sent to you each quarter over the next year, detailing all the backup information you need to verify everything you've read about here. If you're interested, and you think the price is fair, all you need to do is say yes.

            You can start getting this analysis through the order link at the bottom of this page. You'll get instant access to the first report, which reveals the name of this company and tells you everything you need to get positioned for the rise. Then, over the next year, you'll receive quarterly updates via email on the performance of this company. You'll be "in the loop" throughout the entire process. I can't make it any easier for you.

            Let me repeat the offer. Thsi company, up 30% since September 11th, 2001, is in perfect position to solve two of the world's biggest threats: Bioterrorism and West Nile virus. Thanks to exclusive contracts with the U.S. Government and the CDC totaling $431 million over the next 20 years, this company could gain 43% per year for each of the next three years...and it could all start December 16th, the day the U.S. could start a war with Iraq. Savvy investors are getting positioned in this company's shares, and you can join them.

            So, what's this information worth?

            Let's say you follow this advise and it's right on the money. A $10,000 investment before December 16th would be worth $29,242 in just three years. I know that a lot of you can afford to put a lot more than $10,000 on this kind of safe, high return play. But even if you have just $10,000 to invest, you could safely double your money over three years by simply "buying and holding" this stock. There's nothing else you'll have to do.

            So, what price do you think is fair for this kind of information? Many people spend $5,000 for investment trading services. Other services charge $2,500 for "insider trading" tips. Unfortunately, in order to participate in the profits of these trading services, you have to act fast. This offer is much simpler. All you need to do is elect to receive four quarterly reports detailing this special company. But after December 16th, this offer will not be made available again.

            So, what's a fair price? Quite honestly, I have no idea. It all depends on how much you're willing to invest in this company. A $10,000 investment could return $29,242 in three years, or a $100,000 investment could return $292,420 in three years. No matter how much you decide to invest, I'll give you instant access to what you need to know about this company for $299. For a quarterly analysis, that's not cheap. But if this company turns out to be a low-risk, high-return stock to own over the next three years, then it's well worth it.

            To get in on all the information about this company, simply follow this secure link:
            Click Here For The CSR Finance Secure Order Form

            After your order is complete, the first report will be immediately emailed to you within minutes. I hope you decide to use this information to your advantage.


            Sincerely,
                
                  Bryan Bottarelli 


            P.S. - As you read about this company in the news, you'll notice that they just hired a new public relations firm. It's no secret that this company wants to get its name out on Wall Street...so it won't be unknown for much longer. The clock is certainly ticking. Do yourself a favor and act now!

            Copyright © 2002 CSR Group, LLC. All Rights Reserved.
         
            
     <http://quote.bloomberg.com/fgcgi.cgi?ptitle=Hot%20Stocks&s1=blk,&s2=ad_right 1_topfin&tp=ad_topright_topfin&refer=topupdn&T=markets_bfgcgi_content99.ht&b
t=ad_position1_topfin&middle=ad_frame2_topfin&s=APf4LmBMUVmF4R2Vu>

VaxGen Shares Rise on Expedited Review for HIV Vaccine
By Angela Zimm

Brisbane, California, Dec. 16 (Bloomberg) -- VaxGen Inc. shares rose as much as 22 percent after the company said U.S. regulators designated its experimental HIV vaccines for fast review.

The shares rose $2.48 to $15.49 as of 12:01 p.m. New York time on the Nasdaq Stock Market after reaching $15.85.

The Food and Drug Administration agreed to consider VaxGen's AIDSVAX B/B and AIDSVAX B/E under a program designed to speed review of drugs for life-threatening diseases, VaxGen said in a statement. VaxGen's vaccines against the virus that causes AIDS are being studied in the last of three stages of human testing generally required for FDA approval. VaxGen may submit portions of its vaccine applications for FDA review instead of having to wait until it compiles complete data. Once VaxGen has turned in complete information, it may ask the FDA to review the applications in six months instead of the typical 12 months, said VaxGen spokesman Jim Key.

``We're confident we'll receive priority review,'' Key said.

Brisbane, California-based VaxGen said it expects to release results of its AIDSVAX B/B study in the first quarter of 2003 and AIDSVAX B/E results in the second half of the year.
 

Oh, but a drug company wouldn't do this - they really CARE about people's and children's health.
sheri

http://bernie.house.gov/documents/releases/20030110170032.asp
>From Bernie Saunders, Vermont's Independent Representative

For Immediate Release, 1/10/2003
Sanders: Drug Giant Glaxo Moves to Cut Off Supplies to Canadian Pharmacies Selling to Americans

Congressman calls for legislation to end Glaxo’s strong arm tactics

WASHINGTON – In a move that is sure to re-ignite the battle in Congress over Americans’ ability to purchase lower price prescription drugs from Canada, pharmaceutical giant GlaxoSmithKline has informed Canadian pharmacies and wholesalers who sell into the U.S. that they will no longer be able to buy Glaxo products after January 21, 2003. Rep. Bernard Sanders (I-VT) -- the first member of Congress to take constituents across the border to highlight the disparity in prescription drug prices between the United States and Canada -- responded sharply to Glaxo’s threat, calling it a “direct attack on the health of American prescription drug consumers.”

Glaxo sent letters to each of its wholesalers, distributors and retailers in Canada this week threatening to cut off their supply of life-saving drugs if they sell any of Glaxo’s products to U.S. consumers or to any one of 27 Canadian retailers who sell prescription drugs to U.S. consumers. It is rumored that similar letters from other pharmaceutical companies may be imminent.

While difficult to quantify, the Food and Drug Administration estimates that some two million prescriptions will be filled in Canada for American patients this year. Americans are increasingly looking to Canada to fill their prescriptions because drug companies charge consumers in the U.S. the highest prices in the world for the same medications, generally manufactured in the same plants.

Sanders said that Glaxo is trying to cut off Americans from reasonably priced medicines regardless of the impact on their health, “At a time when millions of Americans are struggling to afford the outrageously high price of prescription drugs in the U.S., Glaxo is trying to slam the door on a safe and affordable source of medicine for an increasing number of Americans, namely Canada. The outrage is that for some of these people this really is a matter of life and death. Once again, Glaxo is showing that for the pharmaceutical industry the health of their corporate coffers always comes before the health of American patients.”

In recent years, the U.S. House of Representatives has repeated voted in favor of preserving individual American’s ability to buy prescription medications for their own personal use in Canada. Just this week, Senator Daschle introduced a prescription drug bill that would fully authorize the purchase of prescription medicines from Canada.

Sanders predicted the U.S. House would act to protect Americans who buy medicines from Canada and pledged to introduce legislation to prevent Glaxo and other drug companies from strong arming Canadian pharmacies and wholesalers. “The U.S. Congress cannot sit idly by while Glaxo or any pharmaceutical company cuts off American consumers who are already getting safe, affordable prescription medications from Canada. The first bill I will introduce in the 108th Congress will put an end to this pharmaceutical company bullying.”

A copy of the Glaxo letter is available upon request.


For More Information:
Visit the PENSIONS section.
Contact:
Joel Barkin at (202) 225-4115 OR (202) 441-5247
 

http://www.coleypharma.com/wt/coley/pr_1039730845

Coley Pharmaceutical Group Awarded Defense Department
Contract to Develop CpG Immunostimulatory Oligos for
Enhancement of Vaccines

--DARPA awards $6MM in funding--

Wellesley, MA, USA,

December 13, 2002

Coley Pharmaceutical Group today announced that the US Defense Advanced Research Projects Agency (DARPA) has awarded $6MM to Coley to support the development of Coley’s CpG immunostimulatory oligonucleotides (CpG oligos) to enhance anthrax vaccines.

“This contract builds on our preclinical data showing that CpG oligos protect mice against a broad range of
pathogens, including Anthrax, as well as our human clinical data showing enhancement of the Engerix-B®
Hepatitis B vaccine when combined with our immunostimulatory oligos,” said Robert L. Bratzler, Ph.D., Coley President and Chief Executive Officer. “The DARPA contract and other development agreements with our partners, including Aventis and GlaxoSmithKline, give Coley the opportunity to realize the full potential of its immunostimulatory oligos to prevent or treat a broad range of diseases.” The current anthrax vaccine requires six doses and 18 months to produce immunity. Coley’s CpG oligos, used together with vaccines, have the potential to reduce the number of vaccine doses, induce protective antibody levels more quickly, produce higher affinity antibodies directed against a broader range of anthrax antigens, and to improve duration of protection.

This research at Coley stems from a grant awarded in 1999 to Arthur Krieg, M.D., then a professor of
Internal Medicine at the University of Iowa, a Coley founder and currently the company’s Chief Scientific
Officer. Commenting on this new contract, Dr. Krieg said, “ I am delighted that our progress since we
began this program in 1999 has been so rapid, and that DARPA has selected this program to transition from the preclinical phase to the clinical phase as a high priority.”

About B Class CpG Oligonucleotides Coley has specifically optimized CpG 10103, a B Class oligo for vaccine applications. CpG 10103, acting through the TLR9 receptor present in B-cells and plasmacytoid dendritic cells, potently stimulates human B-cell proliferation, enhances antigen- specific antibody production and induces Interferon-a production, Interleukin-10 secretion, and Natural Killer Cell (NK cell) activity. These broad immunostimulatory actions are required to improve the immune response to vaccines.

CpG 7909, Coley’s lead drug candidate, is also a B Class oligo. CpG 7909 significantly increased antibody
responses when administered to normal human volunteers in combination with Engerix-B, GlaxoSmithKline’s marketed prophylactic Hepatitis B vaccine. The approved dosing of Engerix-B requires three vaccinations over six months but fails to induce protective antibody levels in 5-10% of normal healthy individuals. In a clinical study conducted by Coley in normal healthy volunteers, individuals given the Engerix-B vaccine (without CpG 7909) rarely had any detectable antibody response within two weeks of the first vaccine dose, but almost 60% of subjects given the vaccine together with CpG 7909 had protective antibody levels within just two weeks of the first dose, and 100% of subjects receiving CpG 7909 did within six weeks.

 

This article from NYTimes.com
has been sent to you by dfoster@ucsd.edu.

Drug Makers Battle Plan to Curb Rewards for Doctors

December 26, 2002
By ROBERT PEAR

WASHINGTON, Dec. 25 - Drug companies and doctors are fighting a Bush administration plan to restrict gifts and other rewards that pharmaceutical manufacturers give doctors and insurers to encourage the prescribing of particular drugs. In October, the Department of Health and Human Services said many gifts and gratuities were suspect because they looked like illegal kickbacks. Since then, a few consumer groups, including AARP, have voiced support for the restrictions. But they are outnumbered by the drug makers, doctors and health maintenance organizations that have flooded the government with letters criticizing the proposal.

In contending that the proposed federal code of conduct would require radical changes, those opposing the change discuss their tactics with unusual candor and describe marketing practices that have long been shrouded in secrecy. Drug makers acknowledged, for example, that they routinely made payments to insurance plans to increase the use of their products, to expand their market share, to be added to lists of recommended drugs or to reward doctors and pharmacists for switching patients from one brand of drug to another.

Insurers, doctors and drug makers said such payments were so embedded in the structure of the health care industry that the Bush administration plan would be profoundly disruptive. Moreover, doctors said that drug companies were a major source of money for their professional education programs, and that the administration proposal could drastically reduce such subsidies. "Without financial support from industry, medical societies would most likely be forced to curtail or stop offering these important educational activities," said Dr. Michael D. Maves, executive vice president of the American Medical Association.

Doctors of all types echoed that concern.

The arguments were made in a public comment period. The administration said it was considering those comments and expected to issue final guidelines in a few months. In its guidance to the industry, the government warned drug makers not to offer financial incentives to doctors, pharmacists or other health care professionals to prescribe or recommend particular drugs. The government said the industry's aggressive marketing practices could improperly drive up costs for Medicare and Medicaid, the federal health programs for 75 million people who are elderly, disabled or poor. But a coalition of 19 pharmaceutical companies, including Pfizer, Eli Lilly and Schering-Plough, said the Bush administration proposal was "not grounded in an understanding of industry practices." The payments and incentives to which the government objects are standard in the drug industry, they said.

Merck & Company said it routinely gave discounts and payments to health plans to reward "shifts in market share" favoring its products. Merck complained that the administration proposal would "criminalize a wide range of commercial conduct" that the industry regards as normal and entirely proper. The Pharmaceutical Research and Manufacturers of America, the chief lobby for brand-name drug companies, acknowledged that these payments created a strong incentive to prescribe certain drugs, or to shift patients from one drug to another. But, it said, that did not make the payments "illegal kickbacks."

Solvay Pharmaceuticals of Marietta, Ga., told the government: "We understand that bribes and other hidden remuneration should be prohibited. However, a policy statement that declares well-established commercial practices potentially criminal creates a chilling effect on commerce and ultimately harms all consumers." The American Association of Health Plans, which represents most of the nation's H.M.O.'s, said the proposed standards "cast doubt on the propriety of many well-established practices undertaken by health plans to develop and administer their drug benefits."

Drug manufacturers said they often encouraged the use of their products by making payments or giving discounts to H.M.O.'s and to the specialized companies that manage drug benefits for millions of Americans. Such companies, known as pharmacy benefit managers, can exert immense influence over what drugs are prescribed and dispensed. H.M.O.'s and pharmacy benefit managers said they typically received money from the manufacturer of a drug if sales of that drug reached a certain level - say 40 percent of all the prescriptions for cholesterol-lowering agents. The manufacturer may agree to a higher payment if the drug achieves a larger share of the market.

While describing such arrangements, the drug companies, doctors and insurers did not divulge who received how much for promoting a specific drug, nor did they provide details of individual marketing campaigns. The Bush administration proposal received support from one H.M.O., the Great Lakes Health Plan, which serves more than 90,000 Medicaid recipients in Michigan.

Eric J. Wexler, general counsel of the Great Lakes plan, said pharmacy benefit managers sometimes sent letters to doctors recommending that they shift Medicaid patients from generic drugs to brand-name medicines. In many cases, Mr. Wexler said, the brand-name drugs cost more, but are less effective.
For each letter sent to a doctor, Mr. Wexler said, "the pharmacy benefit manager receives an administrative fee, and it may get additional remuneration for converting patients from one drug to another." AdvancePCS, a pharmacy benefit manager based in Irving, Tex., confirmed that it received payments from drug companies for letters sent to doctors and patients urging them to use particular drugs.

But it said the payments - typically a flat fee for each letter - were for educational services that could help
control drug spending. Kaiser Permanente, a nonprofit H.M.O. based in Oakland, Calif., said the administration plan would impair its ability to negotiate lower drug prices for its 8.5 million members because it suggested that discounts and rebate payments create "a prosecutorial risk" under the kickback law.  The Blue Cross and Blue Shield Association said the proposal would impede what it described as legitimate cost-control measures.

"Pharmaceutical companies may be less willing to offer large discounts if those discounts cannot be tied to
movements in market share," said Alissa Fox, policy director for the association, whose members insure more than 84 million people.  LaVarne A. Burton, president of the Pharmaceutical Care Management Association, which represents pharmacy benefit managers like Express Scripts and AdvancePCS, said that "manufacturers may cease offering discounts," rather than run the risk of liability under the proposed guidelines.

But the Food Marketing Institute, whose members operate 12,000 supermarket pharmacies, applauded the proposal. "Pharmacy benefit managers routinely refuse to disclose their financial arrangements with drug companies," said Tim Hammonds, president of the institute, "and they do not wish to be subjected to any kind of accountability, such as an annual audit." As a result, Mr. Hammonds said, "it is not possible to know with any certainty whether P.B.M.'s are helping to control drug costs for the federal government or if these middlemen are contributing to skyrocketing drug costs."

The administration proposal says that when drug executives discover evidence of illegal conduct, they should report it to federal authorities within 60 days. Also, it said, drug makers should consider offering rewards to whistle-blowers and should prominently display the phone number for reporting Medicare fraud to the government (1-800-447-8477).

The coalition of drug makers objected to these recommendations, saying they would undercut the companies' efforts to police themselves.  The American Medical Association said drug companies should not be forbidden to give doctors pens, notepads and other items of nominal value that have "no correlation to any service provided by the physician to the pharmaceutical company." Such "giveaway items" are harmless, it said. But the Massachusetts Medical Society suggested that "these items would not be so readily produced if they were not an effective form of advertising."

The society asked: "Is the physician who writes a prescription with a company's logo on the pen more likely
to write a prescription for that advertiser? Are patients more likely to request a certain drug because they see the notepad on the doctor's desk?"

http://www.nytimes.com/2002/12/26/politics/26DRUG.html?ex=1041929155&ei=1&en
=c09
ed9fd20c3d089

 

Pricey vaccines for kids still public health bargains

Researchers say advance budgeting for the increased costs of childhood immunization is a wise move.

By Susan J. Landers, AMNews staff. Feb. 17, 2003. Additional information

Washington -- The cost of childhood vaccines has risen over the past 26 years from $10 per child in 1975 to $385 in 2001, and those costs could take a giant leap upward when vaccines now in the pipeline become available. The cost per child for recommended vaccines at public-sector prices may triple over the next two decades, warned a new vaccine study published in the December 2002 American Journal of Public Health.

The study was done, not to question the cost effectiveness of vaccines, but to serve as a warning to policy-makers that they should make sure there is enough money in the coffers to continue to cover the price tags of these valuable public health tools. "In the past, vaccines were less expensive, and there may have been some impression on the part of officials that they would remain inexpensive," said Matthew Davis, MD, the study's lead author and an assistant professor of pediatrics and communicable diseases at the University of Michigan Medical School in Ann Arbor.

"Our analysis suggests that vaccines may be more expensive in the future than they have been in the past," said Dr. Davis. "But that's not to say that they are no longer an excellent investment in our children's health." As the number of recommended vaccines for children has grown over the years, the role of the state and federal governments in financing their purchase for children who were in danger of going without has also increased. Currently, state and federal programs buy more than half of the vaccines sold in this country.

Childhood vaccines were 38 times more expensive in 2001 than in 1975.

The study by Dr. Davis and colleagues is the first analysis of vaccine cost trends to try to put some parameters around the possibilities of what lies ahead. It was inspired in part by the introduction in 2000 of the pneumococcal conjugate vaccine for children, marketed by Wyeth Pharmaceuticals as Prevnar.

The drug's cost, at about $46 per dose for four doses, is more than four times that of the DTaP series and was alone responsible for doubling the total cost of childhood vaccines. The high cost of Prevnar is due, in part, to its inclusion of the seven most common serotypes that cause 80% of pneumococcal infections in very young children, said Margaret Rennels, MD, a professor of pediatrics at the University of Maryland School of Medicine in Baltimore. "So, unquestionably it is a more difficult vaccine to manufacture [than a vaccine] which is just one serotype."

Another factor driving up prices is the more stringent regulatory climate in which the new vaccines are being developed, said Dr. Rennels. "The paperwork, the regulatory requirements, the quality monitoring, the time to get something approved by an Institutional Review Board, the length of the  consent forms, everything has gotten more and more complicated," she said. While Dr. Davis' study focused on the costs of vaccines in the public sector, he noted that vaccines purchased in the private sector are usually at least 20% higher.

Worth every penny

Although vaccines may fall under heightened scrutiny by both public and private purchasers, their value can not be overestimated, said Louis Cooper, MD, interim director of National Network for Immunization Information and a past president of the American Academy of Pediatrics.

When asked about the high cost of vaccines, Dr. Cooper responds with additional questions. "How can the public and the profession be so distorted about the value of prevention compared to what they are willing to spend on treatment? Why is it we spend more on Claritin and Viagra than we do on vaccines?"

Dr. Cooper attributes the costs to the fact that there are more and better vaccines now available, and he believes there will be little or no change in the willingness of payers to continue to cover them. "People who make the health decisions at the federal and state levels know that vaccines are a  bargain. There is nothing we do in medicine that matches the return on investment from our vaccines."

And despite the withdrawal of some manufacturers from the vaccine marketplace, there are new vaccines in the pipeline, including a nose spray influenza vaccine, a conjugate meningococcal vaccine and a combination conjugate meningococcal and pneumococcal vaccine, said Dr. Rennels.

 

PUBLIC HEALTH

Vaccines Seen a $10 Billion Market by '06

  story.news.yahoo.com/news?tmpl=story&u=/nm/20030107/bs_nm/health_vaccines_dc
_1

      Reuters - Sales of vaccines, once considered a commodity market, are booming with global revenues set to reach nearly $10 billion in 2006 from $5.4 billion in 2001, according to research recently published.       Analysts at Merrill Lynch said the fastest growing section of the market would be for flu vaccines, sales of which are expected to more than double to $2 billion in the next five years.

      Much of the flu vaccine market's 16 percent compound five-year growth will be driven by the entry of MedImmune Inc.'s premium priced nasal spray FluMist, which will be co-marketed by Wyeth.  The launch of FluMist later this year, coupled with increasing demand for pediatric jabs, could see the overall vaccine market leap by 20 percent in 2003 alone. Growth is then expected to moderate to an annual 10 percent from 2004 to 2006.

      Merrill's projection of 13 percent compound five-year sales growth for the total vaccine market compares with global drug sales of just eight percent in the year to October, 2002, according to healthcare information
firm IMS Health.  The infant sector currently makes up the largest section of the vaccine market, with 2001 sales of $2.5 billion, but adult demand is growing as governments actively promote flu shots for the elderly and more vaccines are used by tourists.

      At the same time, the threat of bioterrorism in the wake of September 11, 2001 attacks on the United States has spawned a new business in supplying vaccines against smallpox following fears that the deadly virus might be used as a weapon. The global vaccines market is currently dominated by four large pharmaceutical companies -- Aventis SA, GlaxoSmithKline Plc, Wyeth and Merck & Co Inc -- which together account for almost 85 percent of sales. But a number of smaller companies are also carving out a niche, including Britain's PowderJect Pharmaceuticals Plc and Acambis Plc, Switzerland's Berna Biotech and Chiron Corp of the U.S.
* * *

 

Aventis Reports Full-Year Results for 2002
Wednesday February 5, 8:00 am ET

* Aventis meets ambitious growth targets for third consecutive year despite a more challenging market and industry environment in 2002: Core business sales activity rises 11.6% and net income climbs 28% Core business EPS rises 27% to 2.62 euros (2.48 USD) [3.31 euros (3.13 USD) before goodwill amortization] U.S. sales activity increases 21.4%, strategic brands sales activity rises 28.3%

* Product leadership reinforced in key therapeutic areas and complemented by successful introduction of future growth drivers: Lantus and Ketek continue successful roll-out in key markets Aventis plans to submit several new drugs for approval in 2003/2004 New products expected to contribute significantly to sales growth between 2002 and 2007

* Aventis expects continued strong earnings growth in 2003 and beyond Financial flexibility to further strengthen the pharmaceutical business of Aventis