Here's the Droloxifene info:
Pfizer Shifts Droloxifene Development Program to Prevention of
Osteoporosis; Dofetilide Regulatory Filing on Schedule for First Quarter
Thursday, January 22, 1998 05:25 PM
> NEW YORK -- Pfizer Inc (NYSE:PFE) said today that due to interim clinical trial results, it is
shifting the focus of its developmental program for droloxifene, an estrogen agonist/antagonist, from
treatment of advanced breast cancer to prevention of osteoporosis.
Interim results from the world-wide clinical trial of droloxifene for the treatment of advanced
(metastatic) estrogen-receptor-positive breast cancer have shown that at the dose studied,
droloxifene offers no benefit beyond the current therapy. The company said that it will therefore not
submit the droloxifene New Drug Application (NDA) for treatment of breast cancer in the fourth
quarter of 1998 as originally anticipated.
Preliminary data regarding the efficacy and safety of droloxifene in osteoporosis, however, are
encouraging, especially when compared to currently available products, and Pfizer will now
accelerate development efforts in this therapeutic area. The company also plans to investigate the
use of droloxifene in the prevention of breast cancer and other potential health issues of
post-menopausal women.
Pfizer confirmed it will file an NDA with the U.S. Food and Drug Administration (FDA) for
dofetilide in March. Dofetilide is a selective potassium-channel blocker for the treatment of atrial
fibrillation (AF). Clinical data indicate that dofetilide is effective in controlling AF, a type of heart
arrhythmia, and is better tolerated than older drugs. More than 10 million patients worldwide suffer
from AF, which accounts for 15 percent of all strokes in the U.S. and can contribute to heart failure.
Approval of Viagra could come soon, the company said, noting that the NDA was filed in
September 1997, and FDA has granted it priority review. Pfizer is devising tactics to meet
anticipated high patient demand by accelerating the availability of the drug upon approval.
Viagra is a type 5 phosphodiesterase inhibitor for the treatment of erectile dysfunction (ED). It
works by blocking the activity of phosphodiesterase, an enzyme that inhibits blood flow to the
genital area. An estimated 140 million men worldwide (between 20 million and 30 million in the
U.S.) suffer from ED. Twenty clinical trials including 4,500 patients demonstrated high efficacy in
patients with organic, psychological or mixed ED.
Finally, the company said exploration of the anti-arthritic agent, tenidap, for possible future
development as a disease-modifying agent for osteoarthritis, has now been discontinued. Future
research will focus on back-up anti-arthritis compounds with potentially enhanced safety and
efficacy characteristics.
Pfizer Inc is a research-based, global health-care company. In 1997, the company reported
revenues of more than $12.5 billion and research and development spending of more than $1.9
billion.
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