into the Merger pricing period and Gilead's
average daily close is $52.0375. The stock has been very
resilient (sp?) especially at the close. Next week could be
interesting with all the economic figures that will be
released. Personally, I have no doubt that we will stay
above $51.50 for the next 10 trading
Hopefully, everyone has received (and will return) their
Proxy statement. I found it interesting that Gilead
first began looking at NeXstar early in 1997. I'm also
happy to see they included patent expiration dates as
I was wondering if any of you had thoughts about
using NeXstar's liposomal technology to enhance
Gilead's drugs? Being that most of them are small-molecule
orally dosed medicines, I wouldn't expect that to be the
case. However, perhaps the safety and therapeutic value
of injectibles (Vistide, PMPA) could be enhanced.
I'm really enjoying this year. I
hope you all are, too.
The FDA requested more data from Glaxo as a
result of the comments from the Advisory Committee
meeting to address the concerns raised. The Advisory
Panel is just that, a group of expert advisors. I think
what happened in this case is that a concern was
identified and the FDA allowed Glaxo more time to address
it. It is not uncommon within the US regulatory
process for this to occur. Let's just hope Gilead is
successful as well!
Washington, July 27 (Bloomberg) -- Glaxo Wellcome
Plc won U.S. Food and Drug Administration approval to
sell Relenza, the first new flu drug in six years and
the only drug that can treat both strains of
The FDA approval overrules the recommendation of an
agency advisory panel, which advised against approving
the product five months ago, saying the company
failed to prove the Relenza inhalant was effective, even
though it was safe.
Relenza will be the first
entrant into the a market that analysts say could be
worth between $500 million and $2 billion in annual
Relenza could be face competition for the
market as soon as next year from a drug being developed
by Foster City, California- based Gilead Sciences
Inc. and Switzerland's Roche Holding AG.
drugs act by blocking an enzyme the virus needs to
replicate. Roche's drug, currently under review by the FDA,
comes in a pill rather than an inhaler. Both drugs
could be on the U.S. market by next winter, when the
flu season is at its peak.
Because Relenza is
most effective within 36 hours of the onset of flu
symptoms, the challenge for London-based Glaxo in selling
Relenza will be in getting people to visit a doctor at
the first sign of the flu. Patients will miss much of
the drug's benefit if rely first on traditional
treatments for the flu -- over-the-counter drugs, rest and
plenty of fluids. Educating consumers about Relenza is
likely to involve a heavy advertising campaign and that
will take time, analysts said. The drug isn't expected
to hit its sales peak for at least three years, when
Relenza could see sales of $300 million.
the expert advisory panel recommended against FDA
approval for the drug, analysts widely expected the FDA to
approve the drug.At the meeting in February, panel
members voiced support for the science behind the drug,
though they said problems with a final-stage study in
North America raised doubts about whether the drug was
effective in reducing recovery time.
The FDA said
the drug cuts the average duration of the flu when it
is taken within 2 days of the onset of symptoms.
That could limit the suffering of the 30 million
Americans who come down with the virus each year.
addition, a study published in the Journal of the American
Medical Association earlier this month, suggested that
the drug can prevent -- as well as treat -- the flu.
The 1,107- person study found that the drug was 67
percent effective at preventing flu infection during an
outbreak. Still, that use hasn't been established as safe
or effective, the FDA said.
we're down today. An FDA decision will be made on
Glaxo's Relenza tomorrow.
Being that GS4104 goes
before the FDA panel in September, and approval would be
by October 29, our drug would also be available for
the upcoming flu season in the U.S..
if you would, please ask Dr. Martin if the
company is pursuing (or has any plans to pursue)
liposomal technology for GILD's proprietary drugs. Also,
try to gauge management's optimism about their
Antibacterial Program and other preclinical drugs in
I'm sure Dr. Martin will say if they are planning to
present data on PMPA at ICAAC. Any reply about their
enthusiasm will be appreciated.
After last year's
meeting, Mark Perry drove me to the Company; and Bill
Strong treated me to lunch in the Company's cafeteria,
as well as giving me a tour of the facilities (and a
tee-shirt, a sweatshirt and a coffee mug). I DID ask a lot
of questions, however, I haven't worn the shirts or
used the mug. This Sunday-Tuesday the CVS/pharmacy
Charity Golf Classic will be held at the Rhode Island
Country Club (about a block from my house). I believe the
event will be televised on ESPN, and I will proudly
wear my 't' then. I will baptize the mug with a
champagne toast upon GS4104's approval.
I dearly would
have loved to attend this year's meeting. However,
Friday also happens to be the closing date for the sale
of my mother's house. With all the packing and
moving going on, Sunday will be the first chance I get
I know I had stated that I didn't wish
to "steal GILD's thunder" about GS4104, but with the
annual meeting at hand, what the heck. Roche has a
trademarked name for the drug and has received fast-track
designation from the FDA. The panel will convene September
14-15, and the action date is October 29,
Pharma...please give my warm regards to Dr. Martin, Mark Perry,
and Susan Hubbard. They are wonderful
My sincerest thanks to you.
Here is a good queston of concern to all.
Re: the management of NXTR, Who is going to stay with
in what capacity will they be used? Who is
NXTR has a lot going for it now but in the past year
stock languished in a trading range. Many
management for failure to improve
shareholder value at a faster
pace. [ Check yahoo bb
before date of merger announcement. ]
Ask Mark Perry this important question. Is there
any pending litigation from other companies or from
former employees that could impact the merger or the
I was just listening to a CD of
Tami Wynet. I just love Tami.
Ask him about the dosages of PMPA. PMPA is the
drug of the future. They are testing at 300 mg and it
has shown no real safety concerns yet. They have a
1.22 log drop at that level. When they had the IV
formulation it was the equivelant of 900 mg and showed a 4
log drop. They have done some prelim testing at a
higher dose. Will phase 3 be at 300 mg or higher dose. I
would like to see 600 mg tested.
Try to run into
Hiedi and Susan. Tell them I said hello and give me a
good description. I picture them both as very
attractive intelligent women. I would like to see them to
verify this belief.