|
 The drug, tested on early stage prostate cancer that does not
respond to hormonal therapy, was shown to be safe to use with only
fatigue as the most serious side effect, Bayer said on Thursday,
citing a phase-three study that could be decisive for regulatory
approval.
Given the cancer is not yet spreading and patients are still
relatively unburdened by the disease, a drug's tolerability is a key
concern for the generally elderly men taking it, said Robert LaCaze,
Bayer's head of oncology.
"Patients may be on this drug for two to three, maybe four years ...
it really does fit this patient population, we feel, much better
than maybe some of the alternatives available today," he said.
Some initial results of the phase three trial were released earlier
this week and sparked disappointment. Shares in Finland's Orion,
which sold certain rights to the drug in a collaboration deal with
Bayer in 2014, fell as a result.
The details showed darolutamide held off metastases for nearly two
years when compared to a placebo but analysts doubted this would
give darolutamide an edge over approved drugs Xtandi by Astellas and
Pfizer as well as J&J's Erleada.
Bayer is in discussions with regulators about a request for
marketing approval and estimates annual peak sales of at least 1
billion euros ($1.13 billion).
Analysts at UBS and Jefferies said the side effect profile was
favorable but questioned whether that would suffice to set the drug
apart from its established rivals because efficacy data was roughly
on par.
[to top of second column] |
Full details on the darolutamide study are being presented at the
American Society of Clinical Oncology Genitourinary Cancers
Symposium on Thursday.
An ongoing trial
https://clinicaltrials.gov/
ct2/show/NCT03314324 comparing Xtandi directly with darolutamide,
with patients first taking one and then the other, may provide more
clarity in about three years.
Among the 160,000 new cases of prostate cancer diagnosed per year in
the United States roughly 15,000 fall under the category that was
tested in the trial, LaCaze said.
Darolutamide is also being tested on advanced prostate cancer with
metastases, a potentially bigger market.
Bayer is under pressure to strengthen its drug development pipeline
as its pharmaceuticals division faces falling sales from 2024 amid
likely competition for its two bestselling drugs.
Shares in the German company, which acquired seed maker Monsanto,
have fallen amid U.S. lawsuits claiming its Roundup weed-killer
played a role in the plaintiffs' cancer.
(Editing by Alexandra Hudson)
[© 2019 Thomson Reuters. All rights
reserved.] Copyright 2019 Reuters. All rights reserved. This material may not be published,
broadcast, rewritten or redistributed.
Thompson Reuters is solely responsible for this content.
 |
