EXPOSING the FDA and the USDA - Broad Casting here the things that they would prefer us NOT to know about our FOOD & DRUGS & Farming.

Thursday, June 25, 2009

Gov't Bails Out Failing BioTech Firm with 35M Contract

Facing angry creditors, Protein Sciences wins $35M contract
By John Carroll

A day after creditors went to federal court in a bid to push the financially shaky vaccine maker Protein Sciences into bankruptcy liquidation, the company won a $35 million federal contract to push a faster and more efficient approach to making pandemic vaccines.

The bulk of the $11.7 million that the creditors are demanding is owed to Emergent Biosolutions, which lent the company $10 million to help seal a buyout deal. But the acquisition deal fell apart, leaving executives on both sides engaged in an angry round of accusations and counter-accusations.

Andrew Pollack at The New York Times asked the government if officials were entrusting the country's pandemic defenses to "a financially shaky or untrustworthy company." But an official at HHS says that audits demonstrated that Protein Sciences is financially healthy enough to do the work.

Daniel Abdun-Nabi, the president of Emergent, tells the Times that a forced bankruptcy wouldn't destroy Protein Sciences' technology. That could be acquired by a company like, say, Emergent.

From the NY Times;

Vaccine Maker Facing Possible Bankruptcy Wins Contract

Published: June 23, 2009
A small biotechnology company facing possible bankruptcy and liquidation has been awarded a $35 million federal contract to develop a faster way to make vaccines for pandemic influenza.

The award of the contract to the Protein Sciences Corporation of Meriden, Conn., was announced on Tuesday by the Department of Health and Human Services. But only a day earlier, creditors filed a petition in federal bankruptcy court in Wilmington, Del., seeking to force Protein Sciences into bankruptcy and liquidation, saying they were owed $11.7 million.
Almost all of that money is owed to Emergent BioSolutions, a vaccine company in Rockville, Md., that lent Protein Sciences $10 million last year in advance of the pending acquisition of virtually all the assets of Protein Sciences by Emergent. The acquisition deal fell apart, and Emergent sued Protein Sciences and its top executives, accusing them of fraud and breach of agreements.

The series of events raises questions about whether the government is entrusting part of the nation’s influenza defense to a financially shaky or untrustworthy company. Conversely, the award of the contract could put Emergent into an uncomfortable light for trying to force into bankruptcy a company with promising vaccine technology.

Robin Robinson, director of the branch of Health and Human Services that will administer the contract, said the government had spent months doing “two very thorough financial audits” of Protein Sciences. “It was determined that they were healthy enough to go forward with development of this vaccine,” he said.

Health authorities are scrambling to come up with enough vaccine to protect the world’s population against the recently declared pandemic of swine flu, which has killed more than 230 people worldwide and sickened more than 52,000. They are worried that the death toll from the strain might rise sharply this winter.

“I can’t imagine what legitimate purpose can be served by trying to close the company,” Daniel D. Adams, the chief executive of Protein Sciences, said in an interview on Tuesday. Mr. Adams said that Emergent’s suit was without merit and that its actions were making it difficult for Protein Sciences to attract new investors.

But Daniel J. Abdun-Nabi, president and chief operating officer of Emergent, said that bankruptcy “doesn’t destroy the product, and it doesn’t destroy the technology.” It might result in the technology’s being sold to a stronger company, like his own or others, he said. Emergent, which makes the anthrax vaccine used by the armed forces, says it has been more than patient in giving Protein Sciences a chance to pay back the loan.

Protein Sciences is one of several small companies trying to make influenza vaccines by methods that are faster than growing them in chicken eggs, the technique now generally used.

Instead of growing whole viruses, Protein Sciences produces just a protein from the virus and it does so in genetically modified insect cells.

The company, which is privately held, has already applied to the Food and Drug Administration for approval of a seasonal flu vaccine. And last week, Mr. Adams said, the company made its first 100,000 doses of a vaccine against the new swine flu.

The federal contract will help Protein Sciences develop its technology and obtain F.D.A. approval. It can be extended up to five years for a total cost of $147 million.

If the technology is proved safe and effective and is licensed by the F.D.A, the contract calls for Protein Sciences to establish domestic manufacturing capacity, to provide a finished vaccine within 12 weeks of the onset of a pandemic and to produce at least 50 million doses of a pandemic flu vaccine within six months.

Mr. Robinson of Health and Human Services said that for the current pandemic, the Protein Sciences vaccine might be used as a backup to those being supplied by larger companies.

See Also, "Studies Show & Doctors Agree, Ignore Pandemic, Say no to Tamiflu (vaccines);

A ProMED-mail post

ProMED-mail is a program of the
International Society for Infectious Diseases

Date: Fri 19 Jun 2009
From: Julian Tang

Some follow-up comments on the question posed by
Dr Rau in the ProMED-mail post titled: Influenza
A (H1N1) - worldwide (67): comments on 1918
virus, archive number 20090618.2251.
I think Dr Rau has raised a valid point, and one
that I have also commented on previously (1);
i.e., it is difficult to assess how accurate the
estimated number of deaths due to the 1918
influenza A(H1N1) virus can be -- especially
without any laboratory confirmation of the causal
agent. The influenza virus was only formally
discovered in 1933 by Smith and colleagues (2),
so before that it would have been difficult to
definitively relate the cause of death to this
unknown pathogen.

Mathematical modellers tend to argue that the
number of excess deaths in what we now know are
fairly predictable influenza seasons (at least in
temperate countries) are almost certainly due to
influenza. Admittedly this may be more true
nowadays because we can control the other causes
of death with clean water, effective sanitation,
modern medicine and vaccination programmes.
However, in 1918, many of these excess deaths
(the death certificates would hardly have been
very accurate at that time) may have been due to
other infectious agents such as TB, cholera,
typhoid (many of which may have gone undiagnosed
in the community and may have presented with
flu-like illness) and bacterial pneumonias. As
pointed out in several recent articles (3,4),
secondary bacterial infection may well have been
the direct cause of death during this 1918
pandemic -- particularly since penicillin was
also not available as a recognised antibiotic
then either. In fact, this also raised the more
philosophical question of exactly how do you
define the cause of death? In such cases,
influenza becomes just a contributing factor,
perhaps like any other lung condition that may
predispose to bacterial infection. So how
meaningful is the stated cause of death on any of
the death certificates during that time?

The oft cited paper on the Copenhagen data (5)
again suffers from the limitations noted above --
that no definitive diagnosis of influenza could
have been made in any of the cases at that time,
since the virus itself had not been discovered
yet. It's quite amazing how one study on the data
from the 1918 pandemic from one city has created
such concerns about the so-called 'lethal 2nd
wave', which may be totally irrelevant to the
modern society in which we now live, with modern
medicine (reducing case fatality rates -- when
widely accessible), influenza vaccination (which,
admittedly, still has a poor uptake rate), rapid
modern travel (perhaps most important, which may
disseminate the virus to multiple locations
worldwide providing rapid herd immunity -- as we
are seeing now with the new H1N1/2009 virus).

In fact, in their abstract, the authors of this
article actually state that the rapid spread of
the milder summer wave may have protected against
a higher mortality in the following fall wave.
So, if we are using the conclusions of this paper
to guide current public health policy with this
new influenza A(H1N1/2009) virus, to provide
greater protection against any potentially more
"lethal fall wave," it seems that we should allow
this current, relatively mild A(H1N1/2009)
influenza virus to disseminate as widely as
possible and not attempt to contain it at all
with isolation/quarantine or the widespread use
of oseltamivir (Tamiflu).
But how likely are
governments and public health teams to follow
such a suggestion? Probably not very.

The Copenhagen summer wave may have been caused
by a precursor A/H1N1 pandemic virus that
transmitted efficiently but lacked extreme
virulence. The R measured in the summer wave is
likely a better approximation of transmissibility
in a fully susceptible population and is
substantially higher than that found in previous
USA studies. The summer wave may have provided
partial protection against the lethal fall wave".

Perhaps, some comment from the authors of this
paper would be useful to clarify things.

(1) Tang JW. Pandemic influenza forecasting: does
past performance indicate future performance? Am
J Infect Control. 2008 Sep;36(7):466-7.
(2) Smith W, Andrewes CH, Laidlaw PP. A virus
obtained from influenza patients. Lancet 1933;
222: 66°V68.
(3) Morens DM, Taubenberger JK, Fauci AS.
Predominant role of bacterial pneumonia as a
cause of death in pandemic influenza:
implications for pandemic influenza preparedness.
J Infect Dis. 2008 Oct 1;198(7):962-70.
(4) Brundage JF, Shanks GD. Deaths from bacterial
pneumonia during 1918-19 influenza pandemic.
Emerg Infect Dis. 2008 Aug;14(8):1193-9.
(5) Andreasen V, Viboud C, Simonsen
L.Epidemiologic characterization of the 1918
influenza pandemic summer wave in Copenhagen:
implications for pandemic control strategies. J
Infect Dis. 2008 Jan 15;197(2):270-8.

Communicated by:
Dr Julian W Tang PhD, MRCP, FRCPath
Consultant/ Virologist
Division of Microbiology/Molecular Diagnostic Centre
Department of Laboratory Medicine
National University Hospital
5 Lower Kent Ridge Road
Singapore 119074

[Another relevant factor might be the therapeutic
interventions available at that time. See for
example: Aspirin in the 1918 pandemic, Tsunetoshi
Shimazu, British Medical Journal, 17 June 2009;
338 b2398
- Mod.CP]

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