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 |
