Pfizer on saanut luvan markkinoida lääkevalmiste Lyricaa fibromyalgian aiheuttamaan kipuun ja uupumukseen. Tätä ennen lääkettä on käytetty esim. diabeteksen aiheuttamaan hermosärkyyn. Pfizer tarvitsi lääkkeen myyntiin lisäpotkua ja sitä se sai fibromyalgiaa sairastavien kautta. Lyrican myynti nousi viisinkertaiseksi viime vuoden aikana. Osakkeen hinta nousi 21:stä 25:een dollariin. Pfizer käytti 12 v. lääkkeen kehittelyyn ja testaukseen. Eläinkokeissa korkeiden lääkeannosten todettiin aiheuttavan kasvainten muodostumista.
Pfizer Wins Clearance to Sell Lyrica for Fibromyalgia (Update2)
By Shannon Pettypiece
June 21 (Bloomberg) -- Pfizer Inc. won U.S. approval to sell its pain pill Lyrica to treat fibromyalgia, making it the only drug approved for a condition that affects 1 in 50 Americans.
The clearance allows Pfizer to market Lyrica to alleviate the muscle pain and fatigue caused by fibromyalgia, the Food and Drug Administration said today in an e-mailed statement. The disorder affects mostly middle-aged women. Lyrica was approved in the U.S. in 2004 to treat nerve pain from diabetes and shingles. Lyrica was Pfizer's first company-developed drug to reach $1 billion in annual sales since the impotence pill Viagra. Pfizer, the world's largest drugmaker, is seeking additional uses for its medicines to help replace $21 billion in annual sales it will lose to generic competition by 2011.
``Pfizer needs the fibromyalgia indication to stimulate Lyrica growth,'' said Bear Stearns & Co. analyst John Boris in a research report. Lyrica sales increased fivefold to $1.2 billion last year and may reach $3.4 billion by 2012, analysts said.
Shares of New York-based Pfizer rose 21 cents to $25.92 at 4 p.m. in New York Stock Exchange composite trading. The shares have increased 14 percent in the past 12 months.
Other drugmakers are racing to win approval of their treatments for the condition. Eli Lilly & Co. said it plans to file for its antidepressant Cymbalta in the second half of the year. Wyeth and Forest Laboratories Inc. have also said they are testing medicines for the condition.
Not Well Understood
Scientists don't fully understand what causes the hard-to- treat disorder. One theory is that the neurons in the brain that are responsible for the transmission of pain are overactive, causing patients to feel pain from light touches such as a hug, said Steve Romano, the company's vice president for global medical research.
Studies showed Lyrica cut pain during six months by more than 30 percent in two-thirds of patients with fibromyalgia, suggesting it may be more effective for many patients than current treatments, which include pain pills and antidepressants.
Pfizer bought the rights to Lyrica's chemical compound, pregabalin, in 1992 from Northwestern University, near Chicago, where it was discovered in 1989 by chemist Richard Silverman.
Lyrica was intended to replace Pfizer's Neurontin epilepsy drug, which had $2.7 billion in sales in 2004 before cheaper generic copies came on the market. A study sponsored by the National Institutes of Health this month found that Neurontin also treats fibromyalgia.
How It Works
The drug works by binding to a channel in the central nervous system responsible for muscle contractions, the release of hormones and regulating production of chemicals responsible for sending messages among cells.
The company spent 12 years developing the drug and testing it in animals and humans.
Lyrica almost didn't make it to the market in the U.S. After at least 10 years of animal testing, Pfizer began experimenting with it in humans only to have to halt the clinical trials in 2000 when tumors showed up in lab mice given large doses.
After a year, Pfizer was able to convince the FDA that the problem reflected the dosage given to the lab animals, and it was allowed to proceed with human testing.
Pfizer said earlier this year it is also seeking approval to market Lyrica for generalized anxiety disorder. It is studying Lyrica for nerve pain from colon cancer and HIV and for anxiety from dental work, according to a government database of clinical drug trials.
To contact the reporter on this story: Shannon Pettypiece in Washington at firstname.lastname@example.org