Here's the complete text of the Pfizer release. It's a MYSTERY as to why price dropped today on scant volume. Perhaps shaking loose a few fleas before the feeding frenzy...
Ed
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Pfizer Moves Droloxifene Forward in Osteoporosis & Breast Cancer CP336,156 Completes Phase I
in Europe, IND in United States
PR Newswire, Tuesday, July 08, 1997 at 16:19
SAN DIEGO, July 8 /PRNewswire/ -- Ligand Pharmaceuticals Inc.
(NASDAQ:LGND) today announced that Pfizer Inc. (NYSE:PFE) has confirmed the
initiation of advanced randomized, double-blind, placebo controlled clinical
trials to study the effects of droloxifene in the treatment of osteopenic
postmenopausal women and continues on schedule its Phase III trials for
droloxifene in breast cancer. If Phase III trials are successful, Pfizer says
it is on track for New Drug Application (NDA) filings in 1998 and 2002 for
droloxifene in breast cancer and osteoporosis, respectively. Additionally,
Pfizer confirmed that CP336,156 is expected to complete Phase I trials during
2Q97 and is scheduled for an investigational new drug application (IND) filing
in the United States in June of this year.
"According to their report to Ligand in June, Pfizer initiated in 1Q97 two
advanced multi-dose trials with droloxifene in the treatment of osteopenic
postmenopausal women. A second set of advanced multi-dose trials with
droloxifene targeting the prevention of bone loss in recently postmenopausal
women is scheduled to begin in 1Q98 completing the Phase III program. We are
pleased with the progress both droloxifene and CP336,156 are making in the
clinic. If successful, royalty revenue from sales of droloxifene for breast
cancer could begin for Ligand as early as 1999," 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. CP336,156 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 CP336,156 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 or
breast tissue proliferation) at very low daily doses. According to the
National Osteoporosis Foundation more than 28 million Americans have or are at
high risk for osteoporosis, a debilitating disease characterized by the
depletion of bone mass which can lead to increased risk of fractures.
According to the American Cancer Society, breast cancer is the second leading
cancer killer among women with more than 180,000 cases diagnosed in the U.S.
in 1997.
TERMS OF THE AGREEMENT
In accordance with an agreement between Ligand and Pfizer, Ligand earns a
$900,000 milestone payment when Pfizer initiates Phase III trials with
droloxifene in osteoporosis. Ligand has elected to receive this payment in
72,728 Ligand shares which Pfizer owns and expects to retire the shares when
this milestone is triggered.
Pfizer originally purchased 1,353,125 shares of Ligand Common Stock and
following this transaction will hold 1,179,386 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 CP336,156 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.
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 compound CP336,156, if that compound should
also advance toward regulatory approval. Pfizer has confirmed that it expects
to complete Phase I clinical trials with CP336,156 during 2Q97 and has
scheduled an IND submission in the U.S. in June of this year.
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 (and a back up 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, and accepted
its second milestone of $350,000 payable in 28,283 shares of Ligand Common
Stock in May 1996 and a third milestone payment of $900,000 payable in 72,728
shares in September 1996.
Pfizer Inc. is a diversified, research-based health care company with
global operations. The company reported sales of more than $11 billion for
1996.
Since 1989, Ligand Pharmaceuticals Inc. has established a leadership
position 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, inflammatory and metabolic
diseases.
This statement may contain 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 CP336,156, or any development candidate
identified as a result of the Ligand-Pfizer collaboration, will be
successfully developed, that regulatory approvals will be granted, or that
patient and physician acceptance of these products will be achieved. |
