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Biotech / Medical : AMLN (DIABETES DRUGS) -- Ignore unavailable to you. Want to Upgrade?


To: D.Right who wrote (1168)3/2/1998 6:28:00 PM
From: tonyt  Respond to of 2173
 
Here's the full story (I hate links):

Amylin Pharmaceuticals Announces That Johnson & Johnson Plans To
Withdraw from Collaboration in Six Months

=========================================================
Amylin Accelerates Filing of Pramlintide Marketing Application

SAN DIEGO, March 2 /PRNewswire/ -- Amylin Pharmaceuticals, Inc.
(NASDAQ:AMLN) today announced that Johnson & Johnson (NYSE:JNJ) has provided
six-months notice of its intention to terminate their collaboration. The
collaboration was formed to develop and commercialize pramlintide, a diabetes
drug candidate currently in Phase III clinical development. With all product
rights returning to Amylin, the Company is planning to accelerate by one year,
to the first half of 1999, the filing of pramlintide's European marketing
application for the treatment of type 1 diabetes. Amylin is also
restructuring its operations to ensure sufficient cash resources to operate
its research and development programs for at least one year without additional
funding. In the fourth quarter of this year, the Company plans to announce
additional pramlintide results from two ongoing, European Phase III clinical
studies in type 1 and type 2 diabetes.
Amylin was surprised by Johnson & Johnson's decision to withdraw. There
have been no new clinical results since August 1997, and the four ongoing
blinded Phase III studies are continuing as planned. Amylin believes that
Johnson & Johnson made a portfolio decision to invest resources elsewhere.
During the remaining six months of the collaboration, both companies will
continue to perform their obligations under the current agreement.

Amylin's Revised R&D Strategy
Until Johnson & Johnson's decision, the regulatory strategy for
pramlintide was based on plans for global filings in both type 1 and type 2
diabetes during the first half of 2000. However, as the Phase III trials have
proceeded, Amylin scientists and advisors have grown more confident that
available data support an earlier filing for use by type 1 patients. In the
major pharmaceutical markets, there are about two million type 1 patients for
whom the only important glucose-control drug is insulin.
The Company believes that Europe offers the earliest market opportunity.
Thus, Amylin aims to file its first marketing application in Europe for type 1
diabetes during the first half of 1999. The previously announced regulatory
filing for type 2 diabetes will remain on schedule for the first half of 2000.
In the United States, the plans to file a New Drug Application during the
first half of 2000 for type 1 and type 2 diabetes remain unchanged.
In a separate program, Amylin has begun clinical development of exendin, a
hormone-like drug candidate with promise for treating type 2 diabetes.
Exendin amplifies pancreatic insulin secretion in response to rising blood
glucose levels. The exendin program will stay on track, with human studies
planned to begin during the second quarter of 1998, thereby providing
two proprietary diabetes drug candidates in the clinic.
In light of Johnson & Johnson's decision, Amylin will restructure its
operations and reduce its workforce by approximately 25% to ensure that cash
is available for at least one year. The impact of this restructuring will
slow down other research programs, but the Company believes that they can be
restored to full funding levels when new data from the pramlintide Phase III
studies justify additional sources of cash.

Company Summary
Amylin Pharmaceuticals, Inc. is focused on developing novel medicines for
treating metabolic disorders. The Company has pioneered research of the
hormone amylin, which is believed to play an important role in metabolic
control and is missing or deficient in millions of people with diabetes. The
Company is developing pramlintide, a synthetic analog of human amylin, with
the aim of improving metabolic control for people with diabetes. Pramlintide
administration has resulted in clinically relevant improvement in glucose
control and other indicators of metabolic control, such as body weight and
cholesterol profiles, during Phase II and initial Phase III clinical testing
when used as an adjunct to insulin therapy in people with diabetes.
Four Phase III PARADIGM clinical studies are underway and are aimed at further
demonstrating pramlintide's ability to improve metabolic control, thereby
lowering the risk of degenerative complications. The Company has a research
and development pipeline within the field of metabolic disorders, including
preclinical programs for exendin and GLP-1 for type 2 diabetes and obesity,
lipid-lowering antioxidants for atherosclerosis and prevention of restenosis,
and several new drug targets for obesity, including mitochondrial uncoupling
proteins. Amylin Pharmaceuticals is headquartered in San Diego, California
and has European operations headquartered in Oxford, UK.
This press release contains forward-looking statements that involve risks
and uncertainties. Actual results may differ materially from those discussed
herein, due to, among other things, the research, development, financial and
market risks which could adversely affect the Company's timelines for clinical
trials, regulatory approval, and if such approval is received, time to market
thereafter. Additional risks and uncertainties are described in the Company's
most recently filed SEC documents, such as its Form 10-K for the fiscal year
ended December 31, 1996 and its most recent Form 10-Q.

SOURCE Amylin Pharmaceuticals, Inc.
-0- 03/02/98
/NOTE TO EDITORS: Amylin Pharmaceuticals issued two press releases today.
The other press release is entitled: Amylin Pharmaceuticals Reports 1997
Financial Results./
/CONTACT: Richard W. Krawiec, Ph.D., Director of Corporate Communications
of Amylin Pharmaceuticals, 619-552-2200/
/Web site: amylin.com



To: D.Right who wrote (1168)3/2/1998 6:29:00 PM
From: tonyt  Read Replies (2) | Respond to of 2173
 
Amylin Pharmaceuticals Reports 1997 Financial Results

=================================================
SAN DIEGO, March 2 /PRNewswire/ -- Amylin Pharmaceuticals, Inc.
(NASDAQ:AMLN) today reported a net loss of $21.5 million, or $0.67 per share,
for the fourth quarter ended December 31, 1997, as compared to a net loss of
$15.7 million, or $0.51 per share, for the 1996 fourth quarter. For the
fiscal year ended December 31, 1997, the Company posted a net loss of
$54.6 million, or $1.70 per share, as compared to a net loss of $37.8 million,
or $1.31 per share, for 1996. Cash equivalent and short term investments were
$52.7 million at the end of 1997.
The increases in Amylin Pharmaceuticals' net losses were primarily
attributed to increases in product and clinical development efforts for
pramlintide, the Company's lead product candidate for improving metabolic
control in diabetes. In this regard, increases included expenses for an
expanded Phase III clinical program, product development activities,
intensified medical education efforts, and additional staffing to support
these activities.
Higher expenditures for the fiscal year were offset partially by increased
revenues received from Johnson & Johnson based on their co-funding of the
pramlintide development program and their decisions to broaden the scope of
their ongoing collaboration with the Company in the first and second quarters
of 1997. In addition, in 1997 Amylin Pharmaceuticals received proceeds
totaling $30.6 million from a draw-down under a development loan facility from
Johnson & Johnson.
Amylin Pharmaceuticals, Inc. is focused on developing novel medicines for
treating metabolic disorders. The Company has pioneered research of the
hormone amylin, which is believed to play an important role in metabolic
control and is missing or deficient in millions of people with diabetes. The
Company is developing pramlintide, a synthetic analog of human amylin, with
the aim of improving metabolic control for people with diabetes. Pramlintide
administration has resulted in clinically relevant improvement in glucose
control and other indicators of metabolic control, such as body weight and
cholesterol profiles, during Phase II and initial Phase III clinical testing
when used as an adjunct to insulin therapy in people with diabetes.
Four Phase III PARADIGM clinical studies are underway and are aimed at further
demonstrating pramlintide's ability to improve metabolic control, thereby
lowering the risk of degenerative complications. The Company has a research
and development pipeline within the field of metabolic disorders, including
preclinical programs for exendin and GLP-1 for type 2 diabetes and obesity,
lipid-lowering antioxidants for atherosclerosis and prevention of restenosis,
and several new drug targets for obesity, including mitochondrial uncoupling
proteins. Amylin Pharmaceuticals is headquartered in San Diego, California
and has European operations headquartered in Oxford, UK.
This press release contains forward-looking statements that involve risks
and uncertainties. Actual results may differ materially from those discussed
herein, due to, among other things, the research, development, financial and
market risks which could adversely affect the Company's timelines for clinical
trials, regulatory approval, and if such approval is received, time to market
thereafter. Additional risks and uncertainties are described in the Company's
most recently filed SEC documents, such as its Form 10-K for the fiscal year
ended December 31, 1996 and its most recent Form 10-Q.

AMYLIN PHARMACEUTICALS, INC.

Consolidated Balance Sheets Data December 31,
(in thousands) 1997 1996

Assets
Cash, cash equivalents and
short term investments $52,748 $62,123
Other current assets 2,264 3,231
Property & equipment, net 8,610 6,754
Other assets 1,716 1,425
Total assets $65,338 $73,533

Liabilities & Stockholders' Equity
Current liabilities $23,709 $18,664
Other liabilities 36,980 6,335
Stockholders' equity 4,649 48,534
Total liabilities &
stockholders' equity $65,338 $73,533

Consolidated Statements of Operations Data
(in thousands, except per share data)

Three Months Ended Twelve Months Ended
December 31, December 31,
1997 1996 1997 1996
(unaudited)
Revenues under
collaborative
agreements from
related party $11,147 $11,880 $42,609 $35,803

Expenses
Research &
development 26,261 24,853 82,281 64,998
General &
administrative 5,900 3,230 15,592 10,420
Total expenses 32,161 28,083 97,873 75,418

Interest income
(expense), net (523) 502 637 1,828
Net loss ($21,537) ($15,701) ($54,627) ($37,787)

Net loss per
share - basic
and diluted ($0.67) ($0.51) ($1.70) ($1.31)

Shares used in
calculation of
net loss per
share - basic
and diluted 32,337 30,552 32,156 28,745

SOURCE Amylin Pharmaceuticals, Inc.
-0- 03/02/98
/NOTE TO EDITORS: Amylin Pharmaceuticals issued two press releases today.
The other press release is entitled: AMYLIN PHARMACEUTICALS ANNOUNCES THAT
JOHNSON & JOHNSON PLANS TO WITHDRAW FROM COLLABORATION IN SIX MONTHS./
/CONTACT: Richard W. Krawiec, Ph.D., Director of Corporate Communications
of Amylin Pharmaceuticals, 619-552-2200/
/Web site: amylin.com