PHARMACEUTICALS: Pfizer counts on antiseizure drug

Researchers at Pfizer Inc.'s labs in Ann Arbor could have found the son of Lipitor -- a billion-dollar blockbuster that could further elevate Michigan's reputation within the drug giant while strengthening Pfizer in an industry where one drug can make or break a company.

Pfizer, which employs more workers in Michigan than any other state, asked U.S. regulators Friday to approve its new antiseizure medication Pregabalin.

Such approval would allow Pfizer to sell the drug to treat pain associated with diabetes, anxiety and epilepsy seizures. If all goes well, the drug could be on the market by 2005.

"It is always a remarkable feat to get a new drug submission to the Food and Drug Administration," said Toni Hoover, who has led the Pregabalin team since 1998. "We are trying to bring a new medication to caregivers for the relief of pain and for the improvement in fighting seizures."

The drug, Hoover said, reduces the dull throbbing pain diabetics sometimes feel in their hands and feet, reduces anxiety and helps improve medications individuals are taking to fight seizures.

Experts say Pregabalin could easily become a multibillion-dollar drug based on the growing number of people who suffer from diabetes worldwide and the few drugs to treat their ailments. By 2025, a projected 300 million people worldwide will have diabetes. The global market for drugs fighting epilepsy seizures is estimated to be $6.7 billion.

"Pfizer needs new business badly and any new discovery will help cash flow," said Dr. Michael Anisfeld of the Deerfield, Ill.-based consultant Globepharm. "Most of the drugs are facing going generic."

In the pharmaceutical world, Pfizer spends about $20 million each business day on research and drug development. The company recoups its expenses and generates revenue by exclusively selling its drugs for a certain number of years. Once the patent expires, generic drug makers can step in and sell the same drug, which cuts Pfizer's profits.

Pfizer faces that situation with at least six of its top billion-dollar-selling drugs.

Generic drugmakers are battling with Pfizer to get their cheaper versions of Neurontin on the U.S. market since the patent expired in April 2000. Neurontin, which helps treat epilepsy, generated sales of $2.27 billion for Pfizer in 2002.

Other Pfizer drugs that are coming off patent protection include Diflucan in 2004, Zithromax in 2005 and Zoloft in 2006. The three drugs posted combined sales of $5.37 billion in 2002.

In addition to securing a new source of revenue, Pregabalin would become the second blockbuster to come out of Ann Arbor since the launch of cholesterol-lowering drug Lipitor in 1997.

The drug is taken by more than 18 million people across the country and generated $7.97 billion in revenue for 2002.

Pregabalin has been in development since 1990 when pharmaceutical company Parke-Davis licensed the compound from Northwestern University. Parke-Davis was later purchased by Warner Lambert and then Pfizer.

Hoover said one of the biggest hurdles in Pregabalin's development is that it caused tumors in mice.

Hoover said researchers embarked on an extensive investigation and compiled hundreds of pages of research that showed that the tumors appeared only in certain types of mice and were not a risk to humans.