Cowen cut their estimates because of Lutrin delay:
Headline: RESEARCH ALERT - Pharmacyclics (NASDAQ:PCYC) cut
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LOS ANGELES, July 7 (Reuters) - SG Cowen Securities Corp.
analyst David Stone on Tuesday reduced his earnings estimates
for Pharmacyclics Inc.
-- cut fiscal 2001 earnings estimate to $1.10/shr from
$2.50/shr and fiscal 2002 estimates to $3.25/shr from
$6.85/shr.
-- said trials of Lutrin, a photodynamic treatment for
cancer, have shown greater than expected levels of pain among
patients and that the company is starting a phase II trial of
the drug by the end of fiscal 1998.
-- said the company needs to find a trade-off between
efficacy and pain.
-- the phase II trial delays the new drug application and
launch of Lutrin by one year to 2001 and early 2002
respectively.
-- reduced first year expected sales of Lutrin by 55
percent because does not expect Lutrin to be embraced by
oncologists as widely as previously thought.
-- said fiscal 2003 earnings could reach $6.65/shr.
-- set a 12-month price target of $35 a share compared to a
prior estimate of between $35 and $40 by yearend.
-- shares of Pharmacyclics were 3-12/16 lower at $19-11/16
on Nasdaq.
Copyright 1998, Reuters News Service
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Here's the last word from the company on Lu-Tex (Lutrin). It's the
abstract from ASCO:
LUTETIUM TEXAPHYRIN (Lu-Tex) PHOTODYNAMIC THERAPY (PDT) OF PATIENTS
WITH REFRACTORY LOCALLY RECURRENT BREAST CANCER. T.J. Panella, T.J.
Wieman, S. Dougherty, A. Yuen, R. Carlson, L. Esserman, K. Woodburn,
J. Engel, R.A. Miller, M.F. Renschler. Thompson Cancer Survival
Center, Knoxville, TN; Univ. of Louisville, Louisville, KY; UCLA, Los
Angeles, CA; Stanford Univ., Stanford, CA; UCSF/Mount Zion, San
Francisco, CA, and Pharmacyclics, Sunnyvale, CA.
PDT of locally recurrent breast cancer has been limited to treatment
(tx) of small lesions because of non-selective necrosis of adjacent
normal tissues in the treatment field. Lu-Tex is a photosensitizer
with improved tumor localization that is activated by light (732 nm)
which can penetrate through larger tumors. We have evaluated Lu-Tex in
a Phase I trial and in an ongoing Phase II trial in patients with
large tumors who have failed radiation therapy. Patients (Pts)
received Lu-Tex IV 3 hours before illumination of cutaneous or
subcutaneous lesions. In Phase I, Lu-Tex doses were escalated from 0.6
to 7.2 mg/kg in 7 cohorts. 16 pts with locally recurrent breast cancer
lesions were treated. Dose limiting toxicities above 5.2 mg/kg were
pain in the tx field during tx, and dysesthesias in light exposed
areas. No necrosis of normal tissues in the tx field was noticed.
Responses were observed in 60% of evaluable patients (n = 15, 27% CR,
33% PR), with 63% of lesions responding (n = 73: 45% CR, 18% PR). In
Phase II, 19 patients have been studied to date, receiving two txs
ranging from 1.0 to 2.0 mg/kg at a 21 day interval. Tx fields up to
480 cm2 in size were treated successfully and activity has been
observed. Pts have experienced pain at the tx site but no tissue
necrosis. These studies demonstrate the feasibility of Lu-Tex PDT to
large chest wall areas in women who have failed radiation therapy for
the treatment of locally recurrent breast cancer. Treatment conditions
are currently being optimized in the ongoing Phase II trial.
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I've always thought the Lu-Tex timing has been too optimistic. I asume they are talking about an additional Phase II - it certainly would be nice to hear about this from the company rather than an analyst.
However I think Gd-Tex is an order of magnitude more important to the company than Lu-Tex. As long as there are no questions on that front, I remain a long-term bull.
Peter
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