Here's more on the SBH pipeline:
SMITHKLINE BEECHAM'S EXPANDING PORTFOLIO OF DRUGS AND
VACCINES -
'Deep, Diversified and Innovative'
NEW YORK, April 14 /PRNewswire/ -- SmithKline Beecham's (NYSE: SBH) expanding
portfolio of drugs and vaccines is "deep, diversified and innovative and will translate into
sustained growth for the company well into the next millennium," SB President and Chief
Operating Officer Dr. Jean-Pierre Garnier said today.
In an update to securities analysts covering an array of more than 60 new chemical entities,
new indications and vaccines in SB's pipeline, Dr. Garnier noted that "product candidates
now moving through clinical trials promise to sustain over the next several years the steady
flow of new pharmaceuticals that SB has introduced to the healthcare marketplace
throughout the 1990s. The pace at which these compounds are moving through the clinic
reflects SB's commitment to value creation in its drug-development program.
"Looking still further into the future, we see unprecedented drug-discovery opportunities
offered by rapid advances in molecular biology. To secure success, we have strengthened
not only our in-house capabilities, but also our network of alliances with both academic
institutions and biotechnology companies," Dr. Garnier said.
Product candidates currently moving through clinical trials include:
NEW CHEMICAL ENTITIES
-- Avandia (rosiglitazone), for treating type 2 diabetes.
Avandia, a potent and selective member of the glitazone drug class, has
progressed to Phase III in an extensive clinical program intended to
develop the drug for use both as first-line monotherapy and in
combination with conventional therapy. Avandia attacks the fundamental
defect underlying type 2 diabetes, the resistance of cells to the
action of insulin, by activating nuclear hormone receptors. In trials
to date, the drug has demonstrated sustained glycemic control without
drug-drug interactions and with no evidence of hepatic side effects.
New drug applications for Avandia are scheduled to be filed in the U.S.
and Europe within 12 months.
-- Idoxifene, a selective estrogen-receptor modulator (SERM). Idoxifene is in Phase III for
the prevention of osteoporosis and Phase II for the treatment of advanced breast cancer.
Preliminary studies suggest that idoxifene favorably influences lipid levels. Additional
studies will examine the potential benefits of idoxifene in treating or preventing cognitive
disorders. In clinical trials, idoxifene has been well tolerated after up to one year of
treatment with low incidence of hot flashes and no evidence of patterns of increased venous
thromboembolism or leg cramps.
-- Ariflo, for obstructive airways diseases. Ariflo is the most advanced member of a class
known as PDE4 (phosphodiesterase 4) inhibitors, which block an enzyme involved in the
airway inflammation process. Ariflo has demonstrated impressive results in chronic
obstructive pulmonary disease, a serious and common condition with few effective therapies
currently available. Ariflo also has considerable potential in asthma by ameliorating the
three components of the disease: inflammation, bronchoconstriction, and structural
modification of airways.
-- SB 265805, for bacterial infections, currently in Phase II. In vitro studies have
demonstrated that this compound is the most potent oral quinolone to emerge against a
variety of organisms including such common and increasingly resistant pathogens of the
respiratory tract as Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus
pneumoniae. The compound is being developed as oral, once-daily therapy with the
potential for shorter duration of dosing than current therapy.
-- Tranilast, for prevention of restenosis, or narrowing of arteries, following coronary
angioplasty. In preliminary studies involving 420 patients, tranilast has been associated with
reductions in the incidence of restenosis of up to 67 per cent. Additional studies are under
way to confirm these findings.
Also in clinical trials are a wide variety of drugs that SB is
progressing to meet unmet medical needs including migraine, irritable
bowel syndrome, rheumatoid arthritis, and thrombosis.
NEW INDICATIONS
The clinical program is also evaluating significant new
indications for several already-marketed drugs. In the 1998-2000
period, SB expects to file regulatory applications in support of using
Seroxat/Paxil (paroxetine) to treat social phobia, generalized anxiety
disorder, and post-traumatic stress disorder, significantly expanding
the potential market for the product (Paxil is currently approved for
use in depression, panic, and obsessive-compulsive disorder). Paxil is
also being studied in combination with pindolol to determine whether
the combination speeds onset of action.
-- Famvir (famciclovir), currently approved for treating shingles and recurring episodes of
genital herpes, is in trials to determine its effectiveness in preventing the establishment of
latent herpes infections and in treating chronic hepatitis B infection.
-- Baycol (cerivastatin). In trials at higher than currently approved doses, an enhanced
cholesterol-lowering capability has been recorded that is comparable to that of the market
leaders in its statin drug class. Further studies are ongoing to confirm these encouraging
results.
-- Coreg/Kredex (carvedilol), currently marketed for treating heart failure and hypertension,
is being studied as a therapy to immediately follow heart attacks.
-- Hycamtin, currently approved for second-line therapy of ovarian cancer, is in Phase II
trials as a therapy for myelodysplastic syndrome. An application for another indication,
small-cell lung cancer, has already been filed. Additionally, Hycamtin, now an intravenous
product, is being studied as an oral formulation to improve convenience and possibly its
safety profile.
VACCINES
Reviewing the company's extensive vaccines portfolio, Jean
Stephenne, Senior Vice President and General Manager, SmithKline
Beecham Biologicals, expressed confidence that SB will build on its
leadership position with new breakthrough vaccines for prophylaxis and
therapy and more convenient combination products, especially for
children.
-- A regulatory filing for a Lyme disease vaccine is under evaluation at the FDA. Lyme
disease is a tick-borne bacterial infection presenting risk of serious disabling conditions
that is present in 46 U.S. states. Trials involving over 10,000 subjects provide strong
evidence of efficacy, compliance and tolerance.
-- A prophylactic genital herpes vaccine has advanced into Phase III trials that have enrolled
more than 10,000 subjects.
-- Prophylactic vaccines to prevent malaria and diseases caused by rotavirus and
respiratory syncytial virus are in Phase II.
-- Infanrix combination pediatric vaccines against hepatitis B, polio and Haemophilus
influenzae type b as well as diphtheria, tetanus and pertussis continue to be developed.
-- A vaccine against measles, mumps and rubella with an improved safety profile has
received its first worldwide approval. The vaccine is also being studied in combination with a
varicella vaccine.
-- Therapeutic vaccines, or "pharmaccines." In clinical trials are vaccines aimed against
hepatitis B, melanoma, human papilloma virus, genital warts, and food and hay fever
allergies.
GROWING PRODUCTIVITY AND OPPORTUNITY
One measure of the activity in the SB clinical program is the
number of patients currently enrolled--approximately 18,000, exclusive
of patients in vaccine trials, up from a range of 8,000 to 12,000
earlier this decade. Dr. David U'Prichard, Chairman, Research and
Development, noted that this accelerating activity has been accompanied
by accelerating productivity. "SB's stated goal has been to shorten the
time required to take a compound from discovery to regulatory
submission by 44 per cent during this decade -- to 2,000 days on
average by the year 2,000, down from 3,600 days in 1991," Dr.
U'Prichard said. As of 1997, the company was already nearing this
goal, having cut the average development time to 2,200 days.
At the same time, SB has assembled the discovery technologies essential to providing
novel compounds to be tested in the clinic: DNA sequencing, bioinformatics, functional
genomics, combinatorial chemistry and fast- throughput screening. Whereas fewer than
500 drug targets were available to the entire pharmaceutical industry up to 1995, SB alone
was working on some 200 targets in 1997. "Genomics has changed our ability to identify
new targets for drug action; we have gone from famine to feast," said Dr. Peter Goodfellow,
Senior Vice President, Discovery Worldwide. A bacterial genomics initiative has identified
new drug targets in pathogenic bacteria such as S. pneumoniae and Staphylococcus
aureus which provide opportunities for discovering novel classes of antibiotics.
Concluding the presentations, Dr. Garnier reaffirmed the growing value of SmithKline
Beecham's drug and vaccines portfolio and the healthy state of its R&D organization. "Even
after taking into account the inherent risks of drug development, our expanding portfolio of
drugs and vaccines makes us optimistic about the future," Dr. Garnier said.
SmithKline Beecham (NYSE: SBH) -- one of the world's leading healthcare companies --
discovers, develops, manufactures, and markets pharmaceuticals, vaccines,
over-the-counter medicines, and health-related consumer products, and provides healthcare
services including clinical laboratory testing, disease management, and pharmaceutical
benefit management. For company information, visit SmithKline Beecham on the World
Wide Web at sb.com.
SOURCE SmithKline Beecham
04/14/98 /CONTACT: Media, Jeremy
Heymsfeld, 215-751-5166, or Richard Koenig, 215-751-3415, or Investors,
Richard Williams, 215-751-7002, all of SmithKline Beecham/
/Company News On-Call: prnewswire.com or fax, 800-758-5804,
ext. 801350/
/Web site: sb.com (SBH)
CO: SmithKline Beecham ST: Pennsylvania IN: MTC SU: |
