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Biotech / Medical : Ligand (LGND) Breakout! -- Ignore unavailable to you. Want to Upgrade?


To: JOEBT1 who wrote (11160)11/15/1997 2:22:00 PM
From: Henry Niman  Read Replies (1) | Respond to of 32384
 
JOEBT1, The LGND lawsuit against PFE was settled outside of court in LGND's favor. PFE agreed to pay LGND milestones on Droloxifene (some of which has already been paid) and to pay a royalty of 1% of gross worldwide sales of Droloxifene for breast cancer. If Droloxifene is approved for other indications (such as osteoporosis), the royalty rate will go up to 3% of sales for all indications, including breast cancer. The royalty rate on CP-366,156 is 6%. All other alliances that LGND has includes double digit royalty rates.

As far as the psoriasis trial is concerned, I think that Phase II is just about finished. Clinically, LGND is set to start Phase III. However, they have many promising trials and I'm not sure where psoriasis is on their priority list (Phase III trials are very expensive).



To: JOEBT1 who wrote (11160)11/15/1997 2:26:00 PM
From: Henry Niman  Read Replies (1) | Respond to of 32384
 
Here's the press release on the second milestone payment from PFE:
Ligand Receives Second Milestone in Stock from Pfizer for Continuance of Osteoporosis
Development; Ligand Retires Over 100,000 Shares

SAN DIEGO, Sept. 4 /PRNewswire/ -- Ligand Pharmaceuticals Inc.
(Nasdaq: LGND) today announced that it has received from Pfizer Inc
(NYSE: PFE) a milestone payment of $900,000 payable in 72,728 shares of Ligand
Common Stock on Sept. 1. The milestone is a result of Pfizer's continued
development of droloxifene for osteoporosis, in addition to breast cancer.
The milestone is the second of two milestones this year which Ligand has
elected to receive in Ligand Common Stock currently held by Pfizer. Ligand
received 28,283 shares in May, and confirms its intention to retire all
101,011 shares.
"It is good news for osteoporosis patients that a strong company like
Pfizer continues to develop this important product (droloxifene) in this
indication in addition to breast cancer," said David E. Robinson, Ligand
Chairman, President and Chief Executive Officer.
Droloxifene is a Pfizer compound worked on by Ligand at Pfizer's request
during the research phase of the Ligand-Pfizer collaboration. Droloxifene is
currently in Phase III clinical trials for breast cancer and Phase II clinical
trials for osteoporosis. Over 25 million Americans have osteoporosis, a
debilitating disease characterized by the depletion of bone mass which can
lead to increased risk of fractures.
Pfizer originally purchased 1,353,125 shares of Ligand Common Stock and
following this transaction now holds 1,252,114 shares. Under the terms of an
agreement settling a contract dispute, either Ligand or Pfizer may elect to
have milestone payments (up to $6,150,000) and royalty payments on droloxifene
or CP-336,156 made by Pfizer delivery of Ligand Common Stock valued at $12.375
per share, the market price on April 19, 1996, the date of the agreement. To
permit this election, Pfizer agreed to hold the Ligand Common Stock it
currently owns for a period of seven years from settlement or until it
discontinues development of all products that are eligible for milestone or
royalty payments, whichever occurs first.
CP-336,156 is an estrogen partial agonist resulting from the Pfizer-Ligand
research collaboration completed in November 1993. Preclinical studies in
vitro and in vivo conducted by Pfizer indicate that the compound retains the
bone-sparing and cardioprotective benefits of estrogen without the associated
increase in uterine cancer risk and has good oral bioavailability with a
suitable pharmacokinetic profile and excellent pharmacodynamic properties
(efficacy at inhibiting bone loss after estrogen withdrawal without causing
uterine proliferation) at very low daily doses.
Milestone and royalty payments for droloxifene are contingent upon
droloxifene's advancement toward regulatory approval and sales as a drug in
breast cancer, osteoporosis or other indications. The royalty rate will be 1%
on droloxifene worldwide sales for breast cancer. If Pfizer makes sales of
droloxifene for any indication other than breast cancer, including
osteoporosis, the royalty will then be 3% for all indications.
Ligand is also entitled to any remaining milestone payments, to the extent
not earned as a result of the development of droloxifene, and full royalties
of 6% on all indications for the Pfizer compound CP-336,156, if that compound
should also advance toward regulatory approval. Pfizer has confirmed that it
expects to initiate Phase I clinical trials with CP-336,156 in Europe in the
fourth quarter of 1996.
Ligand and Pfizer initiated their 1991 collaboration to apply Ligand's
intracellular receptor (IR) technology to the pursuit of drugs for the
treatment of osteoporosis. The research phase of the collaboration ended in
1993, with the announcement that the research objectives had been achieved and
a candidate had been identified for development by Pfizer. Ligand accepted
its first milestone in cash from Pfizer in 1993 for the identification of a
third generation osteoporosis compound.
Pfizer Inc is a diversified, research-based health care company with
global operations. The company reported sales of nearly $10.2 billion for
1995.
Ligand Pharmaceuticals Inc., founded in 1987, is a leader in gene
transcription technology, particularly intracellular receptor (IR) technology
and Signal Transducers and Activators of Transcription (STATs). Ligand
applies IR and STATs technology to the discovery and development of small
molecule drugs to enhance therapeutic and safety profiles and to address major
unmet patient needs in cancer, women's health and skin diseases, as well as
osteoporosis, cardiovascular and inflammatory disease.
This statement contains certain forward looking statements by Ligand and
actual results could differ materially from those described as a result of
factors, including, but not limited to the following. There can be no
assurance that droloxifene or CP-336,156, or any development candidate
identified as a result of the Ligand-Pfizer collaboration, will be
successfully developed, that regulatory approvals will be granted, or patient
and physician acceptance of these products will be achieved.

NOTE: If you would prefer to receive Ligand press releases via email
please inform us at investors@ligand.com and request to be placed on our
priority email list.

SOURCE Ligand Pharmaceuticals, Inc.

CONTACT: Susan E. Atkins of Ligand Pharmaceuticals, 619-550-7687



To: JOEBT1 who wrote (11160)11/15/1997 2:29:00 PM
From: Henry Niman  Respond to of 32384
 
Here's the announcement of the original suit:
LIGAND SUES PFIZER OVER DROLOXIFENE RIGHTS

SAN DIEGO, Dec. 21 /PRNewswire/ -- Ligand Pharmaceuticals Inc.

(Nasdaq-NNM: LGND) today announced that it has filed suit against Pfizer Inc
(NYSE: PFE) for breach of contract and for a declaration of future rights as
they relate to droloxifene, one of the compounds characterized by Ligand as
part of the Pfizer-Ligand corporate research collaboration in the field of
osteoporosis. The suit was filed today in the Superior Court of California
in San Diego County.

Droloxifene is an estrogen antagonist/partial agonist with potential
medicinal indications in the treatment of osteoporosis and breast cancer as
well as other potential applications. Pfizer licensed droloxifene from
Klinge Pharmaceuticals in Germany.

Ligand believes that the work performed in characterizing and evaluating
droloxifene which was completed by Ligand scientists during the term of the
collaboration under the terms of the Ligand-Pfizer contract qualify Ligand to
receive milestone payments and royalties.

According to recent announcements by Pfizer, droloxifene has entered Phase 3
clinical trials for breast cancer and would enter Phase 3 clinical trials in
osteoporosis in 1995.

Ligand and Pfizer began a strategic alliance in May 1991 to develop
better alternative therapies for osteoporosis. In November 1993, Ligand and
Pfizer announced the successful completion of the research phase of their
alliance with the identification of development candidates for the prevention
and treatment of osteoporosis which Pfizer intended to take to IND filing in
1995 if preclinical development were successful. More recently, Pfizer has
informed Ligand that Pfizer has selected a different development candidate
from the one initially selected. It is anticipated that this drug
development candidate could be the subject of an IND filing as early as 1996.

Ligand has taken this action after the failure of a dialogue between the
partners over the substance of Ligand's claim and after careful consideration
of all the relevant issues, including the seriousness of litigation with a
pharmaceutical partner and the potential value to Ligand shareholders of the
claim to milestone payments and royalties on droloxifene.

Pfizer Inc is a diversified, research-based health care company with
global operations. The company reported sales of nearly $7.5 billion for
1993.

Ligand Pharmaceuticals Inc., founded in 1987, is a leader in gene
transcription technology, particularly intracellular receptor (IR) technology
and Signal Transducers and Activators of Transcription (STATs). Ligand
applies IR and STATs technology to the discovery and development of small
molecule drugs to enhance therapeutic and safety profiles and to address
major unmet patient needs in cancer, women's health and skin diseases, as
well as osteoporosis, cardiovascular and inflammatory disease.

/CONTACT: Susan Atkins of Ligand, 619-550-7687/ (LGND PFE)

CO: Ligand Pharmaceuticals Inc.; Pfizer Inc.

ST: California

IN: MTC

SU:

Transmitted: 94-12-21 00:00:00 EST



To: JOEBT1 who wrote (11160)11/15/1997 2:32:00 PM
From: Henry Niman  Respond to of 32384
 
Here's the settlement:
PFIZER AND LIGAND END LITIGATION OVER DROLOXIFENE CP-336,156 TO
ENTER CLINICAL TRIALS IN 1996 SAN DIEGO, April 23 /PRNewswire/
-- Ligand Pharmaceuticals Inc. (Nasdaq-NNM: LGND) today
announced that it has settled its lawsuit against Pfizer Inc
(NYSE: PFE) for breach of contract. The lawsuit, filed in
December 1994, claimed that, under the terms of the LigandPfizer
collaborative agreement initiated in 1991, Ligand was entitled
to certain milestone payments and royalties in connection with
droloxifene. Droloxifene, a compound Pfizer licensed from Klinge
Pharmaceuticals in Germany, is currently in Phase III clinical
trials for breast cancer and Phase II clinical trials for
osteoporosis. In order to end the costs and avoid the risks
inherent in litigation, Ligand and Pfizer settled the lawsuit
and reached agreement that Ligand will be eligible to receive
certain milestones and royalties in connection with droloxifene.
Ligand is deemed to have earned a second milestone payment of
$350,000 and is expected to receive a further milestone payment
of $900,000 on Sept. 1, 1996 with respect to droloxifene if
droloxifene continues to be under development for osteoporosis
or other indications. Future milestone and royalty payments
are contingent upon droloxifene's advancement toward regulatory
approval and sales as a drug in breast cancer, osteoporosis or
other indications. The royalty rate will be 1% on droloxifene
worldwide sales for breast cancer. If and when Pfizer makes
sales of droloxifene for any indication other than breast
cancer, including osteoporosis, the royalty rate will be 3% for
all indications including breast cancer. Although not at
issue in the lawsuit, the parties have reaffirmed that Ligand
will be entitled to any remaining milestone payments, to the
extent not earned as a result of the development of droloxifene,
and full royalties of 6% on all indications for the Pfizer
compound CP-336,156, identified as a result of the Pfizer/Ligand
osteoporosis collaboration, if that compound should also advance
toward regulatory approval. Pfizer has confirmed that it
expects to initiate Phase I clinical trials with CP-336,156 in
Europe in the fourth quarter of 1996 and expects to begin U.S.
trials in the second quarter of 1997. Under the original
terms of the collaborative agreement, Pfizer would fund and has
exclusive rights to conduct the development, manufacture and
commercialization of collaborative products. Ligand would
receive milestone payments of up to $7.5 million as development
objectives are achieved, and royalties of 6% on sales of
successful drug(s) that emerge from the alliance. A first
milestone payment of $100,000 was earned by Ligand in l993 as
well as a bonus of $400,000. Under the terms of the
settlement, Ligand or Pfizer may elect to have the milestone
payments arising under the settlement, and the remaining
developmental milestone payments ($6,150,000) and royalty
payments on droloxifene or CP-336,156 made by Pfizer delivery of
Ligand stock valued at the market price on the date of
settlement, April 19, 1996 ($12.375). Pfizer has agreed to hold
the Ligand Common Stock it currently owns for a period of seven
years from settlement or until it discontinues development of
all products that are eligible for milestone or royalty
payments, whichever occurs first. Pfizer will fund and has
exclusive rights to conduct the development, manufacture and
commercialization of collaborative products. "We are pleased
to bring an end to this litigation and restore a normal business
relationship with Pfizer, Ligand's first collaborative partner,"
according to David E. Robinson, Ligand President and Chief
Executive Officer. "We value our relationship with Pfizer in
the development and commercialization of these compounds for
osteoporosis, one of the truly exciting growth markets, as well
as for other women's health indications. The terms of this
settlement, and the elimination of uncertainty it brings,
clarifies our business relationship on two potentially important
drugs in major markets allowing Ligand shareholders the
opportunity to share in the results of Pfizer's development and
commercialization efforts." Ligand and Pfizer began a
strategic alliance in May 1991 to apply Ligand's intracellular
receptor (IR) technology to the pursuit of drugs for the
treatment of osteoporosis. The research phase of the
collaboration ended in 1993, with the announcement that the
research objectives had been achieved and a candidate had been
identified for development by Pfizer. Pfizer Inc is a
diversified, research-based health care company with global
operations. The company reported sales of more than $10.02
billion for 1995. Ligand Pharmaceuticals Inc., founded in
1987, is a leader in gene transcription technology, particularly
intracellular receptor (IR) technology and Signal Transducers
and Activators of Transcription (STATs). Ligand applies IR and
STATs technology to the discovery and development of small
molecule drugs to enhance therapeutic and safety profiles and to
address major unmet patient needs in cancer, women's health and
skin diseases, as well as osteoporosis, cardiovascular and
inflammatory disease. This statement contains certain forward
looking statements by Ligand and actual results could differ
materially from those described as a result of factors,
including, but not limited to the following. There can be no
assurance that droloxifene, or any development candidate
identified a result of the Pfizer/Ligand collaboration, will be
successfully developed, that regulatory approvals will be
granted, or patient and physician acceptance of these products
will be achieved. -0- 4/23/96

/CONTACT: Susan Atkins of Ligand Pharmaceuticals, 619-550-7687/
/Ligand Pharmaceuticals press releases are available through
Company News On-Call by fax, 800-758-5804, extension 509313, or
prnewswire.com



To: JOEBT1 who wrote (11160)11/15/1997 2:33:00 PM
From: Henry Niman  Read Replies (1) | Respond to of 32384
 
Here's the press release on the first milestone payment:
LIGAND ELECTS TO RECEIVE MILESTONE PAYMENTS FROM PFIZER IN

LIGAND COMMON STOCK; LIGAND COULD RETIRE OVER 101,000 SHARES

SAN DIEGO, May 7 /PRNewswire/ -- Ligand Pharmaceuticals Inc.

(Nasdaq: LGND) today announced that it has elected to have its
next two

milestone payments from Pfizer Inc (NYSE: PFE) paid in Ligand
stock,

currently held by Pfizer.

Under the terms of a recently settled lawsuit, Ligand has
been

deemed to have earned a second milestone payment of $350,000
(payable by

May 7, 1996) and will receive a further milestone payment of
$900,000 on

Sept. 1, 1996 with respect to droloxifene if droloxifene
continues to be

under development for osteoporosis and other indications except
breast

cancer.

Pfizer currently holds 1,353,100 shares of Ligand Common
Stock, and

under the terms of the settlement, either Ligand or Pfizer may
elect to

have these two milestone payments and subsequent developmental
milestone

payments (up to $6,150,000) and royalty payments on droloxifene
or

CP-336,156 made by Pfizer delivery of Ligand stock valued at the
market

price on the date of settlement ($12.375). To permit this
election,

Pfizer has agreed to hold the Ligand Common Stock it currently
owns for

a period of seven years from settlement or until it discontinues

development of all products that are eligible for milestone or
royalty

payments, whichever occurs first.

At a price of $12.375 per share, the first two milestones
will

amount to 101,009 shares of Ligand stock which the Company
intends to

retire. The first milestone will amount to 28,272 shares. If

droloxifene continues to be developed in indications in addition
to

breast cancer, Ligand will receive the second milestone which
would

amount to 72,727 shares. Ligand will record the milestone
payment at

the closing price of the stock on the date the stock is received.

"We are pleased at the prospect of retiring over 100,000
shares this

year and hope that, if these compounds progress through clinical
and

commercial development, we will be able to continue to retire

substantial additional shares," according to Paul V. Maier,
Ligand Chief

Financial Officer. "We are especially pleased with progress in
the

development and commercialization of these compounds,
particularly for

osteoporosis, one of the truly exciting growth markets of the
1990s and

the next century."

Ligand and Pfizer announced that effective April 19, 1996
they

settled the lawsuit brought by Ligand against Pfizer for breach
of

contract. The lawsuit, filed in December 1994, claimed that,
under the

terms of the Ligand-Pfizer collaborative agreement initiated in
1991,

Ligand was entitled to certain payments and royalties in
connection with

droloxifene. Droloxifene, a compound Pfizer licensed from Klinge

Pharmaceuticals in Germany, is a compound Ligand worked on at
Pfizer's

request during the research phase of the Ligand-Pfizer
collaboration.

Droloxifene is currently in Phase III clinical trials for breast
cancer

and Phase II clinical trials for osteoporosis.

Under the original terms of the 1991 collaborative
agreement, Pfizer

would fund and have exclusive rights to conduct the development,

manufacture and commercialization of collaboration products.
Ligand

would receive milestone payments of up to $7.5 million as
development

objectives were achieved, and royalties of 6% on sales of
successful

drug(s) that emerged from the alliance. A first milestone
payment of

$100,000 was earned by Ligand in 1993.

Milestone and royalty payments for droloxifene are
contingent upon

droloxifene's advancement toward regulatory approval and sales
as a drug

in breast cancer, osteoporosis or other indications. The
royalty rate

will be 1% on droloxifene worldwide sales for breast cancer. If
Pfizer

makes sales of droloxifene for any indication other than breast
cancer,

including osteoporosis, the royalty will then be 3% for all
indications.

Although not at issue in the lawsuit, the parties have
reaffirmed

that Ligand will be entitled to any remaining milestone
payments, to the

extent not earned as a result of the development of droloxifene,
and

full royalties of 6% on all indications for the Pfizer compound

CP-336,156, identified as a result of the Ligand-Pfizer
osteoporosis

collaboration, if that compound should also advance toward
regulatory

approval. Pfizer has confirmed that it expects to initiate
Phase I

clinical trials with CP-336,156 in Europe in the fourth quarter
of 1996

and expects to begin U.S. trials in the second quarter of 1997.

Ligand and Pfizer initiated their 1991 collaboration to apply

Ligand's intracellular receptor (IR) technology to the pursuit
of drugs

for the treatment of osteoporosis. The research phase of the

collaboration ended in 1993, with the announcement that the
research

objectives had been achieved and a candidate had been identified
for

development by Pfizer.

Pfizer Inc is a diversified, research-based health care
company with

global operations. The company reported sales of nearly $10.2
billion

for 1995.

Ligand Pharmaceuticals Inc., founded in 1987, is a leader in
gene

transcription technology, particularly intracellular receptor
(IR)

technology and Signal Transducers and Activators of Transcription

(STATs). Ligand applies IR and STATs technology to the
discovery and

development of small molecule drugs to enhance therapeutic and
safety

profiles and to address major unmet patient needs in cancer,
women's

health and skin diseases, as well as osteoporosis,
cardiovascular and

inflammatory disease.

This statement contains certain forward looking statements
by Ligand

and actual results could differ materially from those described
as a

result of factors, including, but not limited to the following.
There

can be no assurance that droloxifene, or any development
candidate

identified as a result of the Ligand-Pfizer collaboration, will
be

successfully developed, that regulatory approvals will be
granted, or

patient and physician acceptance of these products will be
achieved.



CONTACT: Paul Maier of Ligand Pharmaceuticals, 619-550-7573





To: JOEBT1 who wrote (11160)11/15/1997 2:52:00 PM
From: Henry Niman  Respond to of 32384
 
JOEBT1:
You can view a year's worth of press releases at:
prnewswire.com
Moreover, their latest Annual Report is now online at that site
(it even has pictures!)