U.S. Food and Drug Administration has Granted Orphan Drug Designation to XOMA’s Licensed anti-TGFβ Asset NIS793
XOMA Corporation (NASDAQ: XOMA) has announced that NIS793, an investigational antibody targeting Transforming Growth Factor Beta (TGFβ), has received Orphan Drug Designation from the FDA for pancreatic cancer treatment. This designation provides various benefits to encourage drug development for rare diseases. Upon regulatory approval of NIS793, XOMA could earn up to $445 million through milestone payments and receive tiered royalties on net product sales. However, efficacy and safety of NIS793 have not yet been established, and commercialization is not guaranteed.
- NIS793 has received Orphan Drug Designation from the FDA, potentially facilitating its development.
- XOMA can earn up to $445 million in milestone payments from Novartis if NIS793 progresses.
- XOMA will receive tiered royalties on net product sales of NIS793 upon commercialization.
- Efficacy and safety of NIS793 are not yet established, posing commercial risk.
- There is no guarantee that NIS793 will become commercially available.
EMERYVILLE, Calif., July 28, 2021 (GLOBE NEWSWIRE) -- 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
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 |
FAQ
What is NIS793 and its significance for XOMA (XOMA)?
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