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Kayıt Tarihi: 11-Haziran-2021
Gönderilenler: 49
Gönderen: 13-Ekim-2021 Saat 07:41 | Kayıtlı IP Alıntı upamfva

This Potential Indication Could Be a Winner for Novartis




Novartis (NYSE:NVS) announced earlier this month that the
U.S. Food and Drug Administration (FDA) accepted its
filing for tislelizumab to treat patients with
unresectable recurrent locally advanced or metastatic
esophageal squamous cell carcinoma (ESCC), which means
that a potential FDA approval could come sometime next
year. To get more
novartis
news
, you can visit shine news official website.

The news comes eight months after pharma stock Novartis
announced a collaboration deal to pay the Chinese biotech
Beigene (NASDAQ:BGNE) $650 million for commercialization
rights of the cancer drug tislelizumab in countries
outside of China, including the U.S., EU, and Mexico. The
deal also included royalties for tislelizumab sales
outside of China, as well as milestone payments to
Beigene.

Hearing pharma and FDA filings in the news triggers
investors to consider their portfolio holdings. Let's
take a look at why an eventual FDA approval could be in
the near future for Novartis, and how this could
translate into a winning deal for the company and its
investors.The encouraging news for esophageal cancer
patients is that there have been a number of advances in
treatment in the last few years, which could help to
raise survival rates. One of those is Novartis and
Beigene's drug tislelizumab.

The phase 3 results from tislelizumab's clinical trial
that were announced in June indicate that the drug is
quite effective as a monotherapy in treating patients
with unresectable recurrent locally advanced or
metastatic ESCC. An unresectable and recurrent esophageal
cancer is one that isn't able to be surgically removed,
which has returned after a period of remission.

Patients receiving tislelizumab as a sole treatment
experienced significant improvement in overall survival
to a median of 8.6 months compared to just 6.3 months in
those receiving chemotherapy. The risk of death in
patients receiving tislelizumab was also 30% lower
compared to those patients who received chemotherapy
treatment.

And not only did tislelizumab prove itself to be
effective in extending the lives of patients with
unresectable recurrent locally advanced or metastatic
ESCC, but it was also better tolerated by patients than
chemotherapy.

This was evidenced by the fact that the discontinuation
rate of treatment with tislelizumab due to treatment-
related adverse events was only 6.7%. That was less than
half of the 13.8% discontinuation rate of treatment for
chemotherapy, which means more patients can start and
stay on tislelizumab to benefit from the efficacy of the
treatment.

Simply put, tislelizumab is another option for
oncologists to help patients remain on an effective
treatment to combat their esophageal cancer.Tislelizumab
is an excellent treatment option, but what is its true
potential in the U.S. esophageal cancer market?

The American Cancer Society estimates that there will be
19,260 new cases of esophageal cancer in the U.S.
diagnosed this year. Coupled with the 20% overall five-
year survival rate for esophageal cancer, the market of
patients with recurrent esophageal cancer is likely at
least 20,000.

While it's unclear what the drug will net Novartis per
patient if ultimately approved in the U.S., I believe a
net annual price of $100,000 per patient should
appropriately factor in insurance adjustments and
Novartis' royalty payments to Beigene. Considering other
cancer treatments like Keytruda for example, yield annual
payments ranging from $100,000 to nearly $200,000 per
patient, my expectations for tislelizumab are fairly
conservative.

Assuming that Novartis can fetch 15% of the esophageal
cancer market or 3,000 patients (which seems doable given
the efficacy and tolerability of the drug), this would
work out to $300 million in potential annual revenue in
the U.S. alone from this indication.

While this amount of revenue is a fraction of a percent
of analysts' average $51.9 billion 2021 sales estimate
for Novartis, the U.S. market for esophageal cancer could
be just the beginning for tislelizumab. Overall, I
believe the drug has the potential to bring in billions
in annual revenue for Novartis.

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