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Articles on Pharmacy Benefit Management
Featured Health Business Daily Story December 7, 2007
Six Therapeutic Drug Categories That
Could See Important New Drugs Emerge From the Pipeline in 2008
Reprinted from DRUG
BENEFIT NEWS, biweekly news, data and business strategies for health
plans, PBMs and pharmaceutical companies.
While many pharmaceutical industry observers are expecting a weak Rx
pipeline in 2008, that doesn't mean it will be completely dry. The following
are some therapeutic categories and key drugs that will keep pharmacy
and therapeutic committees busy next year:
- Osteoporosis: Amgen Inc. is expected to file a new
drug application (NDA) for denosumab — a twice-yearly injectable
treatment to increase bone-mineral density and help prevent fractures
— with the FDA in the second half of 2008, says Brian Kolling,
Pharm.D., chief pharmacy officer of UnitedHealth Pharmaceutical Solutions.
The early trials seem to indicate denosumab works a little better
than Merck & Co., Inc.'s Fosamax (alendronate), Kolling says.
Fosamax, which had 2006 U.S. sales of $1.4 billion, is set to go generic
in February 2008. "That's a category where you're going to benefit
from generic Fosamax, but then Amgen brings out denosumab, [so] you
could end up with a very interesting market dynamic in the next couple
of years."
- Blood clotting: The pharmaceutical industry is keen
on developing the next generation of antithrombotic and antiplatelet
drugs, Kolling explains. One promising product in this area is prasugrel,
a compound developed by Eli Lilly and Co. and Daiichi Sankyo Co. On
Nov. 4, Lilly released results of a Phase III head-to-head clinical
trial that found prasugrel produced a 19% reduction in relative risk
for the endpoints of cardiovascular death, non-fatal heart attack
or non-fatal stroke when compared with Plavix (clopidogrel bisulfate).
The results, however, also showed that prasugrel had more side effects
than Plavix, Kolling says. "But the question on the table is,
are the side effects worth the risk to have a better outcome or lower
mortality?" Plavix, marketed by Bristol-Myers Squibb Co. (BMS)
and sanofi-aventis, has annual sales of roughly $2 billion.
- Cancer therapies: Chris Peterson, Pharm.D, director
of emerging therapeutics at Express Scripts, Inc., says up to 20 specialty
oncology compounds could be approved next year. Key products include
Dendreon Corp.'s Provenge (sipuleucel-T), Cephalon, Inc.'s Treanda
(bendamustine) BMS's ipilimumab, Novartis and Schering-Plough Corp.'s
vatalanib, and GlaxoSmithKline's pazobanib, says Mark Gruenhaupt,
clinical consultant for Argus Health Systems.
- Cholesterol: While no new statins are expected on
the market in 2008, there will be activity in the cholesterol space,
says Kolling. This includes Merck's Cordaptive, a combination of niacin
and laropiprant, he explains. "It's not on the scale of a statin,
but it's Merck, and Merck has a lot of experience marketing cholesterol
drugs," he says. Cordaptive contains a "flushing inhibitor,"
says Peterson. Flushing is the main reason patients discontinue niacin
therapy, he adds, noting that the product is expected to be a direct
competitor of Abbott Laboratories' Niaspan (niacin). Another cholesterol
candidate to watch is Abbott's Simcor, which combines the company's
Niaspan with generically available simvastatin. The product has been
shown to elevate "good" HDL cholesterol and lower "bad"
LDL cholesterol, says Peterson who projects the drug could have sales
of $400 million by 2010.
- Rheumatoid arthritis: Johnson & Johnson unit Centocor,
Inc. is expected by the end of 2007 to file an NDA for Golimumab,
a follow-on to the company's Remicade. Golimumab is a fully humanized
subcutaneous injection. By contrast, Remicade has mouse components
in the antibody, which can cause a potential allergic reaction, says
Peterson. Another difference is that Golimumab will be self-administered.
"That will allow the product to more adequately compete"
with Humira (adalimumab), marketed by Abbott, and Enbrel (etanercept),
marketed by Amgen and Wyeth Pharmaceuticals, says Peterson.
- Diabetes: This category could see some significant
changes over the next few years, says Kolling. An NDA for Saxagliptin,
developed by BMS and AstraZeneca, could be filed in the first half
of 2008. The once-daily product has the same mechanism of action as
Merck's Januvia (sitagliptin, which was approved last year, Kolling
says. Another candidate is Novo Nordisk's once-daily Liraglutide,
which has a similar profile to Amylin Pharmaceuticals, Inc.'s twice-daily
Byetta. Following that is Amylin's Byetta LAR (exenatide), which is
a once-weekly formulation of Byetta.
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