Hoechst, Astra, Others Race to Make New Drugs for Bone Disease
Bloomberg News September 15, 1998, 5:15 a.m. ET
Hoechst, Astra, Others Race to Make New Drugs for Bone Disease
Berlin, Sept. 15 (Bloomberg) -- Eli Lilly & Co. and Merck & Co. grabbed the spotlight with positive news on new drugs at Europe's biggest gathering of osteoporosis experts, but other companies will soon have their turn with even newer drugs.
The two U.S. drugmakers released new data showing how well their drugs build bone mass and prevent fractures in a disease that affects 200 million women worldwide. Doctors said these and even newer treatments now give them an unprecedented range of treatment options for the illness.
Soon, Hoechst AG, Novo Nordisk A/S, Astra AB, SmithKline Beecham Plc, Roche Holding AG and Servier SA could release data on more advanced drugs in treating osteoporosis. The global drugmakers are looking to grab a chunk of a $2.3 billion market that experts predict will soar as more people live longer and elect to take new drugs for what is now considered a widely undertreated illness.
''These new treatments are extremely welcome to meet the diversity of osteoporosis,'' said Pierre D. Delmas, president of the European Foundation for Osteoporosis, speaking at the European Congress on Osteoporosis. ''Four years ago, the only treatment that was shown effective was hormone replacement therapy.''
After menopause, women can lose a third or more of their bone mass, sometimes within five years, leaving them susceptible to bone breaks. The World Health Organization says a woman's risk of an osteoporosis fracture are greater than her combined risk of breast, cervical and ovarian cancer.
New Drugs
For years, women took American Home Products Corp.'s Premarin or other estrogen drugs to replace lost natural production of hormones following menopause. While effective in treating post-menopausal disorders such as osteoporosis and pain, HRT can cause vaginal bleeding and breast pain while slightly increasing risk of breast and uterine cancer. Doctors say a majority of women quit using estrogens within two years after starting.
In recent years, new drugs called bisphosphonates found a ready market for women at risk from osteoporosis, particularly those who couldn't tolerate HRT. The top seller is Fosamax, seventh-biggest selling drug at Merck, the world's largest drugmaker. New data released at the Berlin conference showed that Fosamax reduced hip fractures by 56 percent and spinal fractures by 49 percent in a major clinical trial. Fosamax, however, causes gastrointestinal difficulties that prompt many patients to quit, doctors say. Germany's Hoechst, the world's No. 9 drugmaker, aims to surmount that with Actonel, a drug discovered by Procter & Gamble Co. that Hoechst says may get U.S. approval next year.
''This drug is going to be the major competitor to Fosamax,'' predicted David Hosking, a bone specialist at Nottingham City Hospital, central England, who directed clinical trials of Actonel. He said Actonel acts like Fosamax in building bone and may not give stomach problems.
''Fosamax's Achilles heel is that the incidence of gastrointestinal side-effects is quite high,'' agreed Michael McClung, a Portland, Oregon, physician who also tested Actonel, chemically called risedronate. ''We saw no gastrointestinal intolerance in risedronate.'' He added that early clinical trials found no stomach problems with Fosamax either, however.
Roche Version
Roche Holding AG of Switzerland, Europe's fifth-biggest drugmaker, said it hopes to trump Merck and Hoechst with a new bone-building bisphosphonate called Bondronate. Roche aims to make a version of the drug that can be taken by injection every three months, avoiding stomach problems entirely. One doctor said that method may not find favor with patients, however.
''It will be a very individual decision whether a woman wants to be injected or take a pill every day,'' said Steven R. Cummings, assistant dean of research at the University of California, San Francisco, and a women's health expert. ''I think it will be great when they make a weekly dosing version of Fosamax.''
Eli Lilly's new high-tech estrogen drug Evista, which was hailed by some doctors as a major advance in treating osteoporosis, could also face competition in coming years with other hormone drugs coming to market. Both Danish drugmaker Novo Nordisk and SmithKline Beecham are in late-stage clinical trials of so-called selective estrogen receptor modulators, or serms.
SmithKline, the world's eighth-biggest drugmaker, counts its idoxifene serm as one of four major products that will drive future growth for the London-based drugmaker. Like Lilly's Evista, idoxifene has the potential not only to protect against osteoporosis, but also lowers levels of cholesterol and may protect against breast cancer, both major killers of women.
Those drugs could soon face competition from other drugs called parathyroid hormones in late-stage clinical development from Lilly, the world's 10th-biggest drugmaker, and Swedish drugmaker Astra AB. The European Foundation for Osteoporosis' Delmas said the drugs appear to have a much greater ability to stimulate bone-building cells than any previously.
Also moving into the osteoporosis market is French drugmaker Servier, which is in clinical tests of another kind of drug called strontium, which also may have the effect of building bone.
--Dane Hamilton in the London newsroom (44-171) 330-7727/ph
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