U.S. Food and Drug Administration has Granted Orphan Drug Designation to XOMA’s Licensed anti-TGFβ Asset NIS793
July 28 2021 - 7:30AM
XOMA Corporation (NASDAQ: XOMA), announced today NIS793 in
combination with standard of care chemotherapy has been granted
Orphan Drug Designation in pancreatic cancer by the U.S. Food and
Drug Administration. NIS793 is a potential first in class
novel antibody specific for Transforming Growth Factor Beta
(TGFβ). An Orphan Drug Designation grants special status to a
drug that treats a rare disease or condition and provides companies
certain benefits to encourage the continued development of
medicines that bring novel solutions to patients with these severe
diseases1.
“Pancreatic cancer is a particularly difficult diagnosis for a
patient to receive. The statistics clearly demonstrate
pancreatic cancer is an unmet medical need, and we are highly
supportive of Novartis’ efforts to bring NIS793 to this patient
population,” said Jim Neal, Chief Executive Officer at
XOMA.
Under the terms of the 2015 agreement between XOMA and Novartis,
XOMA has the potential to earn up to $445 million in additional
milestone payments. Upon receipt of regulatory approval to
commercialize NIS793, XOMA will receive tiered royalties on any net
product sales that range from the mid-single digits to the low
double digits.
NIS793 is an investigational compound. Efficacy and safety
have not been established. There is no guarantee that NIS793
will become commercially available.
About XOMA Corporation XOMA is a biotechnology
royalty aggregator playing a unique role in helping biotech
companies achieve their goal of improving human health. XOMA
acquires the potential future economics associated with
pre-commercial therapeutic candidates that have been licensed to
pharmaceutical or biotechnology companies. When XOMA acquires
the future economics, the seller receives non-dilutive,
non-recourse funding they can use to advance their internal drug
candidate(s) or for general corporate purposes. The Company
has an extensive and growing portfolio with more than 70 assets
(asset defined as the right to receive potential future economics
associated with the advancement of an underlying therapeutic
candidate). For more information about the Company and its
portfolio, please visit www.xoma.com.
Safe Harbor Statement Certain statements
contained in this press release are forward-looking statements
within the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934, including
statements regarding the potential of XOMA’s portfolio of partnered
programs and licensed technologies generating substantial milestone
and royalty proceeds over time, creating additional value for the
stockholders, cash sufficiency forecast, economic outlook, and
potential impact of the COVID-19 pandemic. These statements
are based on assumptions that may not prove accurate, and actual
results could differ materially from those anticipated due to
certain risks inherent in the biotechnology industry, including
those related to the fact that our product candidates subject to
out-license agreements are still being developed, and our licensees
may require substantial funds to continue development which may not
be available; we do not know whether there will be, or will
continue to be, a viable market for the products in which we have
an ownership or royalty interest; if the therapeutic product
candidates to which we have a royalty interest do not receive
regulatory approval, our third-party licensees will not be able to
market them, and the impact to the global economy as a result of
the COVID-19 pandemic. Other potential risks to XOMA meeting
these expectations are described in more detail in XOMA's most
recent filing on Form 10-K and in other SEC filings. Consider
such risks carefully when considering XOMA's prospects. Any
forward-looking statement in this press release represents XOMA's
views only as of the date of this press release and should not be
relied upon as representing its views as of any subsequent
date. XOMA disclaims any obligation to update any forward-
looking statement, except as required by applicable law.
EXPLANATORY NOTE: Any references to “portfolio” in this press
release refer strictly to milestone and/or royalty rights
associated with a basket of drug products in development. Any
references to “assets” in this press release refer strictly to
milestone and/or royalty rights associated with individual drug
products in development. References to royalties or royalty
rates strictly refer to future potential payment streams regardless
of whether or not they are technically defined as royalties in the
underlying contractual agreement; further, any rates referenced
herein are subject to potential future contractual adjustments.
As of the date of this press release, all assets in XOMA’s
milestone and royalty portfolio are investigational
compounds. Efficacy and safety have not been
established. There is no guarantee that any of these assets
will become commercially available.
Investor contacts: |
|
Gitanjali Jain |
Juliane Snowden |
Solebury Trout |
XOMA |
+1-646-378-2949 |
+1 646-438-9754 |
gogawa@soleburytrout.com |
juliane.snowden@xoma.com |
|
|
Media contact: |
|
Kathy Vincent |
|
KV Consulting & Management |
|
310-403-8951 |
|
kathy@kathyvincent.com |
|
1
https://www.fda.gov/industry/developing-products-rare-diseases-conditions/designating-orphan-product-drugs-and-biological-products
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