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发帖数: 1072 | 1 September's BioPharma Catalyst Calendar
By Lisa LaMotta Sep 01, 2010 2:40 pm
This month could be full of opportunities for biotech and pharmaceutical
investors who know where to look.
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VVUS 6.33 +0.61 (+10.75%)
FRX 29.20 +1.55 (+5.61%)
CBST 22.52 -0.09 (-0.40%)
ABT 50.53 +0.26 (+0.52%)
ARNA 6.72 +0.15 (+2.28%)
September has historically been a dismal time for the stock market, but if
you play your cards right and know what to look for, this autumn month is
ripe with opportunities. The biotech and pharmaceutical sectors will be
particularly hot with news coming out of the FDA and medical meetings. Here
are a few of the dates to watch to make sure your portfolio doesn’t cool
down with the weather.
Early September
Vivus (VVUS) is expected to announce data from its two-year Sequel clinical
trial. The 650-patient study included three treatment arms -- two that were
taking doses of Vivus' obesity drug Qnexa and one that was a placebo. The
patients were originally enrolled in Vivus Conquer study and then continued
for an extra year. The biotech claims that the study will enhance the safety
and efficacy data of the drug, but it doesn't include data on
teratogenicity or cardiovascular risks.
September 7
Forest Laboratories (FRX) faces an FDA Advisory Committee for its antibiotic
ceftaroline that's meant for the treatment of skin and soft-tissue
infections. Oppenheimer analyst John Newman estimates the biotech’s shares
could swing as much as $2 to $3 in either direction depending on the outcome
of the panel. “We remain cautious heading into the panel and expect the
FDA's briefing documents to shed light on potential efficacy and safety
analysis. Given the limited safety data available, we remain cautiously
positive and look ahead for further clarity provided by FDA briefing docs.
We believe recently updated FDA guidance increases ceftaroline risk since
endpoints suggested by FDA are different than those used in FRX's phase III
program,” Oppenheimer wrote in a recent note.
September 12-15
Infectious-disease experts will be congregating in Boston for the
International Conference of Antimicrobial Agents and Chemotherapy annual
meeting. Investors of Cubist Pharmaceuticals (CBST) should be watching out
for further data on CXA-101, a drug the company acquired last year. A
glimpse of top-line results for the treatment of complicated urinary tract
infections was released in June, but the company will be expanding on what
looks like positive results. This is important to Cubist’s CXA-201 program,
which is a combination of CXA-101 and another agent. The company has
recently begun a mid-stage study for CXA-201.
September 15
Abbott Laboratories’ (ABT) obesity drug Meridia will be reviewed by an FDA
Advisory Committee in regards to concerns about its safety -- particularly
cardiovascular risks. This meeting comes just months after European
regulators pulled the drug form the market. Abbott stands to lose $300
million in revenues if the drug gets yanked off the US market.
(Minyanville will be live-blogging the Abbott Meridia Advisory Committee
meeting; join us for up-to-the-minute coverage.)
September 16
Arena Pharmaceuticals (ARNA) will face the Endocrinologic and Metabolic
Drugs Advisory Committee where a panel of experts to the FDA will scrutinize
the company's obesity drug lorcaserin. Analysts and investors believe that
lorcaserin will have better luck than Vivus -- the safety profile has been
shown to be far better than Qnexa. Yet some people worry that the committee
will get hung up on the efficacy of the drug.
(Minyanville will be live-blogging the Arena Lorquess Advisory Committee
meeting; join us for up-to-the-minute coverage.)
AstraZeneca (AZN) is waiting on a decision for its blood thinner Brilinta.
The FDA is set to decide by September 16 whether or not the drug will hit
the US market and be a competitor to Plavix (the second best-selling drug in
the world with revenues over $6 billion annually). Brilinta has been shown
to be more effective than Plavix in studies, but questions were raised about
its effectiveness in North Americans – ultimately, an FDA advisory
committee gave the go-ahead (but the FDA isn’t required to follow that
decision).
Alkermes (ALKS) expects an approval decision for its opioid addiction
treatment Vivitrol by October 12, but before this it will have to get past
an FDA Advisory Committee on September 16. The drug is already approved as
an injectible treatment for alcohol dependence. In November, the biotech
announced positive results of a phase III study that showed Vivitrol helped
patients stay off opioids, but the study was conducted in Russia and the FDA
has concerns about how that will translate to US patients. But investors
shouldn’t be too worried; this doesn’t seem like a large hurdle to
overcome.
September 20-24
Bristol-Myers Squibb (BMY) and AstraZeneca will be in focus at the annual
meeting of the European Association for the Study of Diabetes in Stockholm
this year. The Big Pharma companies are expected to present late-stage data
for their diabetes drug dapagliflozin. Hapoalim Securities analysts write,
“The EASD meeting released a Phase III abstract for dapagliflozin versus
glipizide, showing that, as add-on therapy, in patients with type 2 diabetes
, dapagliflozin was non-inferior to glipizide at lowering HbA1c.
Dapagliflozin continues to impress, and in our view will be the next major
new way to treat type 2 diabetes." |
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