Merck Research

 

 

(Fortune)---Rat No. 3 is determined. He lumbers straight to an

octagon in the corner of the pen and runs his white whiskers over

its edges. In another corner is a white ball. It holds little interest for

No. 3--exactly the result Merck researcher Rebecca Dias is hoping

for. The rat has a few micrograms of Merck's memory-enhancing

compound coursing through its tiny veins, a prototype medicine

that might someday treat Alzheimer's patients or people who have

suffered a stroke. How does Dias know the serum is working?

Rats can only remember what's happened to them in the past four

hours. No. 3 spends more time investigating the octagon, says

Dias, because he recalls seeing the ball the previous day--and

he's bored with it. 

 

The medicine Dias and her team are testing, at Merck's Terlings

Park labs just outside London, still has some seven years of lab

work and clinical trials to go before the company can send it to the

FDA for approval. The odds that any test compound will make it to

market are incredibly low. It's a fact Dias and her colleagues are

painfully aware of. At 29, and at the beginning of her career with

Merck, Dias will be lucky if she sees one test compound reach

pharmacists' shelves before she retires. Even so, she is excited by

her findings. "It's so novel we can't really talk about it right now,"

says Dias. "But imagine if you were able to turn a 70-year-old's

memory into that of a 50-year-old." 

 

Unfortunately, Merck investors don't need a pill to remember

happier times. Back in 2000, the Whitehouse Station, N.J.,

behemoth's revenue growth was tops in the drug industry.

Between 1994, when Ray Gilmartin got the CEO job, and 2000,

Merck's annual earnings growth averaged 17%; in the 1990s,

Merck's shares rose 600%. But those days have faded. Following

a raft of patent expirations on some of Merck's biggest drugs, the

$48-billion-a-year company will have no earnings growth at all in

2002. Since December 2000, the stock has fallen 43%, vs. 21% for

the S&P; Merck shares recently traded for $53 each. 

 

What's odd about Merck's predicament is that its scientists have

been demonstrably more innovative than the competition. Since

1996, Merck researchers have patented 1,933 new compounds,

400 more than second-place Pharmacia. Certainly not all newly

discovered compounds lead to viable products, but patents are a

prime indicator of research productivity. Even more impressive,

Merck's scientists do more with less. Their discoveries cost an

average of $6 million per patent, the lowest in the industry.

Competitors like Pfizer, Eli Lilly, and Pharmacia plow about 20% of

drug revenues back into R&D, while Merck reinvests just 12%. 

 

Exceptional science is nothing new for Merck. The company traces

its roots to 1668, the year Friedrich Jacob Merck took over the

Angel Drugstore in the German town of Darmstadt. By the 1860s,

Merck was the most powerful drug firm on the Continent, the first

to commercially produce morphine, codeine, and cocaine, then

considered medicinal. Thirty years later scion George Merck

crossed the Atlantic to build a North American plant in Rahway,

N.J., where the company still maintains a research facility. In the

1930s, Merck led the industry in synthesizing vitamins like B-1 and

B-12, and in 1949 it worked with Nobel Prize-winning biochemists

Edward Kendall and Phillip Hench to produce the first commercial

batch of arthritis-reliever cortisone. 

 

That focus on breakthrough medicine is the main reason Merck

continues to attract the world's leading biochemists and engineers--

people like Dennis Choi, former head of neurological research at

Washington University in St. Louis. Last spring he left the cozy

confines of academia to join Merck as executive vice president of

neuroscience. "I was having a ball in St. Louis; I had tenure. But I

came here because Merck enjoys a widespread reputation for

sustained application of the best science," says Choi. Does he feel

pressure to produce a big drug? Sure he does. "But this is a

singular moment in medical history,'' he says. "Things are definitely

going to happen." 

 

The question is when. Despite the company's edge in innovation

and efficiency, Merck hasn't been able to churn out enough new

products to offset shrinking sales from drugs losing patent

protection. The malaise isn't unique to Merck, of course. Beset by

cutthroat competition from generic drugmakers, pricing constraints

imposed by managed care, threats of government price regulation,

and more intense FDA scrutiny, most brand-name drugmakers are

struggling. Merck's problems are complicated by its decision last

winter to spin off Medco, the prescription-benefits-management

firm that provided more than half of Merck's revenues. As a result,

the company's future depends more than ever on blockbuster

drugs--at a time when the entire pharmaceuticals industry is having

difficulty delivering them. 

 

That's been the case for a while now. During the 1990s only 15%

of the 1,035 major drugs approved by the FDA used new active

ingredients or treated illnesses in original ways. The majority of

approvals were modifications of existing medicines, so-called me-

too drugs. Even without much innovation, the cost of ushering a

new medicine to market has risen 60% since 1990, to more than

$800 million. 

 

In this difficult environment, a drugmaker's pipeline of soon-to-be-

released medicines is critical. Patents give companies exclusive

sales rights for an average of 11 to 12 years, but once that period

expires, generic drugmakers enter the market and begin selling the

medicine at cut-rate prices. Within a month or two the name-brand

company can lose as much as 80% of its sales to generic

replacements. In order to stanch that revenue drain, name-brand

companies must generate a constant flow of new products. Yet

their pipelines are just about tapped out. 

 

No company illustrates Big Pharma's woes better than Merck. Last

month the patent on its $1.1 billion Prinivil ran out, ending a spate

of recent expirations that included Mevacor, Vaseretic, and Pepcid-

-together representing annual sales of roughly $4.5 billion, or 10%

of Merck's total. Another potential weak spot is Merck's Prilosec, a

heartburn remedy developed in a joint venture with AstraZeneca

PLC. The world's second-bestselling drug, Prilosec garners $3

billion a year in U.S. sales, a third of which goes to Merck. But the

FDA has just awarded a generic maker the right to market a form

of the drug. Merck and AstraZeneca are fighting to extend the

patent. 

 

When Merck executives talk about promising new drugs, they point

to Arcoxia, an arthritis pain reliever; Zetia, a cholesterol medicine;

and something the company calls Substance P, a drug to prevent

nausea and vomiting in chemotherapy patients. The company is

loath to mention, though, that it pulled its FDA application for

Arcoxia last spring for additional review, and that Substance P has

run into snags in clinical testing. The release dates for both have

been pushed back. Even so, Merck claims its pipeline beyond

those drugs is among the strongest ever, with future medicines like

a diabetes drug called KRP297, a human papilloma virus vaccine,

and an HIV vaccine that is in phase I of clinical testing. 

 

Wall Street isn't convinced. Says Robertson Stephens analyst

Robert Hazlett: "Are these new drugs enough to keep substantial

growth? No. Until we see proof, there's going to be skepticism." 

 

The disbelief sounds awfully familiar to Merck's old guard. Ed

Scolnick joined the company in 1982 as a research scientist and

achieved a place in the Merck pantheon when he led the team that

developed the cholesterol reducer Mevacor in the mid-1980s. Now

executive vice president of science and technology, he's seen

Merck endure many feast/famine cycles. "We went through the