BioCryst
Pharma‘s
(NASDAQ: BCRX) quarterly
conference call Thursday concluded with questions from analysts at BankAmerica,
Wells Fargo and other banks and funds.
The call and
slide deck followed the drug developer’s corporate report that morning.
For one, the
North Carolina company provided good detail on “pill burden” for a
hereditary angioedema drug candidate (five capsules three times a day for one
compound). “We are really committed to bringing the capsule count
down,” Jon Stonehouse, the CEO, said in answer to a question.
The pill
count or burden is relevant largely because medical practitioners like to
avoid multiple doses each day of any formula. “We have the high dose that
we need,” he said about the angioedema drug, which is in clinical trials.
Mr.
Stonehouse
said from the start that the company’s charter, or mission, includes making
small molecule “oral drugs” available in the form of inhibitors for a
range of diseases. For investors, this holds hope that the tiny drug developer
(total employees: 30 in North Carolina, Alabama) will continue to advance its
intravenous influenza treatment to oral acceptance in North America.
The
“oral” theme probably applies to each of BioCryst’s experimental
compounds for infectious disease and cancer.
“There
are people who just do not like needles,” Mr. Stonehouse said — referring
to trials of the angioedema drug.
Here is the
link: http://www.media-server.com/m/p/kg29pwih. Or simply www.biocryst,com. It is transpiring
now.
On Ebola,
Mr. Stonehouse said the strategic goal is “stockpiling” of any valid
treatment.
On
influenza, or flu, Mr. Stonehouse said federal regulators and the company are
in constant contact ahead of an anticipated deadline for an FDA decision on RAPIVAB
intravenous for severe influenza.
Those of us
who wish to deepen our understanding of BCRX’s hereditary angioedema candidate,
and of pandemics — influenza, Ebola, Marburg’s viruses — will find the
call and slide show worthy. The questions to follow at the close of the call
likely will ask about the expected federal funding for BioCryst’s Ebola
candidate, BCX4430, and the ramp-up to RAPIVAB (peramivir) if
the influenza treatment is FDA-approved in December.
BioCryst
said it anticipates filing a BCX4430 Investigational New Drug (IND) application
with the Food and Drug Administration this month for the Ebola
treatment. NIAID increased the BCX4430 development contract value to $28.7
million, if all options are exercised, the company said today.
All core
development programs of small-molecule drugs continue, BioCryst’s
executives said.
Finally,
BioCryst says it is “completing activities to make (intravenous) RAPIVAB
available in the U.S. during the upcoming influenza season, pending FDA
approval. Still in the works: “a satisfactory FDA general Good
Manufacturing Practice (GMP) inspection of the contract manufacturer’s
plant.”
“They
continue to remain under a warning letter,” Mr. Stonehouse said about the
factory for RAPIVAB. “The inspection process (by the FDA) is under way.”
TCR Take
I can say
BioCryst this year made great strides in simplifying its investor presentation
— mainly via Mr. Stonehouse’s deductive summary of his company’s three current
themes: hereditary angioedema, influenza, pandemic viruses (Ebola,
Marburg’s).
Little or no
discussion took place of its gout compound and of forodesine, the
leukemia treatment that already has Food & Drug Administration Orphan Drug
status for several indications. See: leukemia drug.
On the
promotional side, as usual, the closest these executives came to trumping or
heralding achievements or future activity came in a brief remark at the close.
Mr. Stonehouse said 2014 was all about setting up 2015 for multiple clinical
trials of small-molecule compounds.
TCR
family,
please keep our TCR Tradables page pinned to your
retinae. I added a small number of BCRX shares after the call Thursday; I
now own about 22,000+ shares and short-term call options on the stock.
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