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To: J.Y. Wang who wrote (78)10/11/1999 5:27:00 AM
From: Wolff  Respond to of 96
 
Glaxo says to Britain sell our drug or we will fire your citizens!

Companies Protest Flu Drug Call
By BRUCE STANLEY
AP Business Writer
LONDON (AP) -- A government proposal to discourage the state-run health service from prescribing a new influenza drug has raised the ire of Britain's three largest pharmaceutical companies.

AstraZeneca PLC and SmithKline Beecham PLC joined Glaxo Wellcome PLC [NYSE:GLX - news] in writing to Prime Minister Tony Blair, warning that their industry could suffer if government doctors were barred from prescribing Glaxo's flu drug, Relenza.

The companies said the government's National Institute for Clinical Excellence, which is understood to be discouraging use of Relenza, represents an additional hurdle for British drug makers seeking to win approval for new medicines. They sent their letter late Tuesday.

''This has potentially devastating consequences for the future of the British-based pharmaceutical industry,'' said the letter, which was signed by Tom McKillop, chairman of the British Pharma Group, a trade organization comprising the three firms. He also is chief executive of AstraZeneca.

Relenza was approved for sale in the United States in July, though a government advisory panel had previously advised against it.

NICE chief executive Andrew Dillon refused Wednesday to say whether his agency has actually advised against the use of Relenza by doctors in Britain's National Health Service. He dismissed press reports about the agency's recommendation as ''speculation.''

However, Glaxo Wellcome spokeswoman Nancy Pekarek said a so-called rapid review committee within NICE has in fact rejected the drug. The agency's final decision against Relenza was leaked later to the press, she said.

NICE was set up April 1 to assess new drugs and medical equipment and issue guidelines for their use by the NHS.

The agency's rejection of Relenza would effectively block use of the drug by the majority of people in the United Kingdom who receive medical care through the state-funded NHS -- though it still would be available from doctors in the private sector.

Glaxo Wellcome had been alone in expressing its displeasure. But the company drew the support of competitors AstraZeneca and SmithKline Beecham because they felt that NICE also poses a threat to their own efforts to bring new drugs to market.

''We feel that the U.K. is becoming a more hostile environment for the launch of a new drug,'' said Chris Strutt, head of the British Pharma Group.

In a sign of what could be at stake, Glaxo Wellcome announced Tuesday that it plans to lay off 6 percent of its work force, or 3,400 employees, as part of an effort to restructure in the face of intense global competition. Half the jobs lost would be British.

Pekarek said Relenza is the first anti-viral treatment ever developed for flu, a disease that killed 29,000 people in Britain in 1989-90.

Relenza costs $40 for a five-day treatment. It is the first drug for which NICE has issued a recommendation.

If doctors in the National Health Service were to prescribe the drug, patients would pay less than $10 for it, with the government picking up the remaining cost, Pekarek said.

''There needs to be some consideration for the number of deaths and hospitalizations and the amount of suffering that can be reduced'' through its use by the NHS, she argued.

Dillon of NICE said his agency's recommendation on the drug is expected to lead to a government decision some time before flu season starts in November.

''Clearly, if it's no more effective and costs more than what's already available, we would want to look very closely before making any recommendation to the National Health Service,'' he warned.

In their letter, the three pharmaceutical firms said they were ''appalled'' at NICE's apparent recommendation against Relenza.

''The emergence of NICE as a new obstacle to market entry serves to wipe out, at a stroke, a key element of the U.K.'s competitive advantage,'' the letter said.

In fact, NICE was founded partly to speed up access by government doctors to new drugs and technologies.

The NHS, Dillon said, ''tends to be rather cautious about taking up new technologies.''



To: J.Y. Wang who wrote (78)10/21/1999 2:57:00 PM
From: Wolff  Read Replies (1) | Respond to of 96
 
Biocryst Reports Third Quarter 1999 Financial Results

BIRMINGHAM, Ala., Oct. 21 /PRNewswire/ -- BioCryst Pharmaceuticals, Inc.
(Nasdaq: BCRX) today announced financial results for the third quarter ended
September 30, 1999. The Company reported revenues for the third quarter of
$335,000, compared to $6,249,000 in the third quarter of 1998. The net loss
for the quarter ended September 30, 1999 was $2,206,000, or $0.15 per share,
compared to net income of $2,667,000, or $0.19 per share, for the same period
last year.

Revenues for the nine months ended September 30, 1999 were $3,376,000,
compared to $6,920,000 in the nine months ended September 30, 1998. The net
loss for the nine months ended September 30, 1999 was $4,857,000, or $0.32 per
share, compared to a net loss of $3,320,000, or $0.24 per share, for the same
period last year. As of September 30, 1999, the Company had cash, cash
equivalents and investments of $23.9 million.

Revenues decreased in the third quarter of 1999 over the comparable period
in 1998, primarily due to the $6.0 million license fee during the third
quarter of 1998 from Ortho-McNeil Pharmaceutical, Inc. The decline in total
expenses for the 1999 third quarter compared to the comparable period in 1998
was generally due to a decline in clinical trial expenses, a reduction in
outside contract research, and a decrease in general and administrative
expenses, primarily due to one-time expenses incurred in the third quarter
1998 in connection with the license agreement signed in the third quarter.
These items tend to fluctuate from quarter to quarter depending on the status
of the Company's research programs and collaborative efforts.

The decrease in revenues for the nine months ended September 30, 1999 from
the nine months ended September 30, 1998 is primarily due to the Company
receiving a $2.0 million milestone payment from Ortho-McNeil in
June 1999, compared to the $6.0 million license fee from Ortho-McNeil in
September 1998. Both amounts were pursuant to the Company's worldwide license
agreement with Ortho-McNeil and The R. W. Johnson Pharmaceutical Research
Institute, or PRI, both Johnson & Johnson (NYSE: JNJ) companies, for the
development and commercialization of BioCryst's influenza neuraminidase
inhibitor.

During the quarter, BioCryst announced preliminary results from a Phase II
clinical study of RWJ-270201, an influenza neuraminidase inhibitor which was
licensed by BioCryst in 1998 to Ortho-McNeil and PRI. PRI conducted a Phase
II placebo-controlled randomized study of healthy volunteers infected with a
susceptible strain of Influenza A and provided preliminary results to
BioCryst. The primary efficacy endpoint was the reduction in viral titers in
infected subjects. Preliminary results showed a statistically significant
result for the primary endpoint and evaluation of safety showed that the drug
was well-tolerated at all dosage levels. These results are preliminary only
and subject to further analysis.

Founded in 1986, BioCryst Pharmaceuticals, Inc. focuses on the design and
development of small-molecule pharmaceuticals for the treatment of infectious,
T-cell mediated and cardiovascular diseases and disorders using structure-
based drug design, an approach to drug discovery that integrates advanced
biology, biophysics and medicinal chemistry.

This press release contains projections or other forward-looking
statements regarding future events or the future financial performance of the
Company. These statements are only predictions and the actual events or
results may differ materially. Some of the factors that could affect the
forward-looking statements contained herein include, without limitation, that
either the Company's or its collaborative partners' research or product
development efforts as to any particular compound may not be successfully
completed, that the agreements with the Company's collaborative partners may
be breached or otherwise terminated, that research and testing may not result
in milestone or royalty payments under the agreements with collaborative
partners, and products may not be cleared for marketing in a timely fashion or
at all, the compounds currently under development may not be safe or
effective, or that required regulatory clearances may not be obtained from the
U.S. Food and Drug Administration. Please refer to the documents BioCryst
files from time to time with the Securities and Exchange Commission,
specifically BioCryst's most recent Form 10-K and Form 10-Q. These documents
contain and identify important factors that could cause the actual results to
differ materially from those contained in projections or forward-looking
statements.

BIOCRYST PHARMACEUTICALS, INC.

FINANCIAL SUMMARY

Statement of operations data (in thousands, except per share)

Three Months Ended Nine Months Ended

September 30, September 30,

1999 1998 1999 1998

Revenues:

Collaborative and other research

and development $48 $6,000 $2,456 $6,000

Interest income and other 287 249 920 920

Total revenues 335 6,249 3,376 6,920

Expenses:

Research and development 1,889 2,353 5,895 7,706

General and administrative 651 1,226 2,334 2,521

Interest 1 3 4 13

Total expenses 2,541 3,582 8,233 10,240

Net (loss)/income $(2,206) $2,667 $(4,857) $(3,320)

Net (loss)/income per share:

Basic $(.15) $.19 $(.32) $(.24)

Diluted (.15) .19 (.32) (.24)

Weighted average shares

Outstanding:

Basic 15,119 13,952 15,028 13,932

Diluted 15,119 14,303 15,028 13,932

Balance sheet data (September 30, 1999 and December 31, 1998) (in thousands)

1999 1998

(Unaudited) (Audited)

Cash, cash equivalents and securities $23,864 $27,012

Total assets 26,391 29,100

Accumulated deficit (58,027) (53,170)

Stockholders' equity 24,872 27,682

SOURCE BioCryst Pharmaceuticals, Inc.

CO: BioCryst Pharmaceuticals, Inc.; Ortho-McNeil Pharmaceutical, Inc;
The R. W. Johnson Pharmaceutical Research Institute; Johnson & Johnson

ST: Alabama

IN: MTC

SU: ERN

10/21/1999 13:48 EDT prnewswire.com