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Biotech / Medical : Pharma News Only (pfe,mrk,wla, sgp, ahp, bmy, lly) -- Ignore unavailable to you. Want to Upgrade?

To: Anthony Wong who wrote (846)	9/28/1998 10:22:00 AM
From: Anthony Wong	Read Replies (1) \| Respond to of 1722

Osteoporosis Drugs in Development: a Glossary (Update1) Bloomberg News September 28, 1998, 6:20 a.m. ET (Updates item that ran Sept. 16 to incorporate changes in drugs under development from Novo Nordisk A/S, Astra AB and Allelix Biopharmaceuticals Inc.) London, Sept. 28 (Bloomberg) -- The following is a partial glossary of major osteoporosis drugs both on the market and in clinical development, and the broad classes to which they belong. Osteoporosis is also treated and prevented by the use of calcium, Vitamin D treatments and exercise and nutritional regimes. HORMONE REPLACEMENT THERAPY: The oldest class of osteoporosis drugs and made generically by many drug companies. HRT replaces natural hormones called estrogen and progesterone that decline in women in the years following menopause. HRT slows bone decay and has other positive effects, but may stimulate reproductive tissues, leading to period-like bleeding and breast pain. May increase risk of cancer of breast, uterus. Sold in tablets, skin patches, creams or gels. Premarin: Made by American Home Products Corp. Biggest-selling HRT, with sales of $1.3 billion in 1997, and the company's top selling drug. Derived from pregnant mare's urine, hence the name pre-mar-in. On market since 1941. Estraderm: Novartis AG. Transdermal patch launched in 1986. Others estrogen makers include Rhone-Poulenc Rorer Inc., Procter & Gamble Co., Novo Nordisk A/S, Akzo Nobel NV, Merck KGaA. SERMS: A class of drugs called selective estrogen receptor modulators, or Serms, which have been shown not only to prevent bone loss but also to lower cholesterol levels, and which may reduce incidence of breast and uterine cancers. Also shown not to stimulate reproductive tissues and cause bleeding and breast pain, as experienced by users of HRT. Evista (raloxifene): Eli Lilly & Co. The biggest-selling Serm in the U.S. and approved for the prevention of osteoporosis. Shown to reduce osteoporosis-related spinal fractures in women by about half compared to placebo. Side effects include leg cramps and hot flushes in some cases, dangerous blood clots in rare cases. Analysts forecast peak sales of $1 billion a year. Evista now has 19 percent of U.S. osteoporosis market, according to IMS Health, a market research firm. Idoxifene: SmithKline Beecham Plc. Now in phase 3 clinical trials for prevention of osteoporosis, phase 2 for treatment of advanced breast cancer. Merrill Lynch & Co. forecasts sales of $260 million by 2002. Levomeloxifene: Novo Nordisk. Denmark's biggest drugmaker, said Sept. 26, 1998, that it dropped late-stage clinical trials for levomeloxifene for treatment and prevention of osteoporosis due to ''substantially higher'' gynecological adverse effects than a placebo. HSBC James Capel had forecast peak sales of $370 million for the drug. Droloxifene: Pfizer Inc. Now in late-stage clinical trials. Merrill Lynch forecasts sales of $463 million in 2002. BISPHOSPHONATES: A class of drugs that have been shown to build bone mass by inhibiting the action of cells that cause bones to deplete. Used only for osteoporosis, not other post-menopausal disorders. Fosamax (alendronate): Merck & Co. The largest-selling osteoporosis-only drug in the U.S., with about half the market. Has been shown to reduce hip fractures in patients by about half. Side-effects include stomach irritation. J.P. Morgan forecasts sales of $2 billion in 2002. Bondronate (ibandronate): Roche Holding AG. In late-stage clinical trials as an injectable treatment for osteoporosis, requiring one dose every three months. Approved in Europe for some bone diseases. Salomon Smith Barney forecasts sales of 900 million Swiss francs ($640 million) by 2002. Didronel (etidronate): Procter & Gamble Co. Has about 2.3 percent of the U.S. market. Considered a first-generation bisphosphonate, with Fosamax and Bondronate more advanced. Actonel (risedronate): Hoechst AG, Procter & Gamble Co. Approved for Paget's disease (bone disorder) in U.S. In late-stage clinical trials for osteoporosis. Hoechst plans to launch drug in 1999. CALCITONINS: A class of drugs derived from naturally occurring hormones in fish, mammals or birds that slow the decline in bone-mass density with few side effects. Miacalcic, Miacalcin (salmon calcitonin): Novartis AG. The second- biggest selling osteoporosis treatment in the U.S. with 24.5 percent of the market. Available in nasal spray or injectable form. Recently released data shows the drug cut rates of spinal fractures by 36 percent in trials over four years, compared to placebo. Macritonin (salmon calcitonin): Cortecs Plc. Oral tablet formulation. Application submitted for approval in Europe for post-menopausal osteoporosis. Cortecs is seeking marketing partners to sell the drug. PARATHYROID HORMONES: A new class of hormonal medicines for osteoporosis farther away from introduction to the market. PTH: Eli Lilly. Now in clinical testing. J.P. Morgan analysts forecast first sales in 2002 of $25 million. ALX1-11: Allelix Biopharmaceuticals Inc. Astra AB said Sept. 24, 1998, that it dropped development of the drug, returning all rights to the drug to Allelix. The drug was in mid-stage clinical development. Allelix said it planned to continue developing the drug and said it is seeking a new corporate partner. STRONTIUM: A class of drugs, in early development, that may build bone faster than bisphosphonates. Now in development by Servier SA, a French drug company. --Dane Hamilton in the London newsroom (44-171) 330-7727/ab/ph