- Production and phased deliveries of patient doses resumed in early June
- Screening and enrollment have restarted for 177Lu-PSMA-617 and Lutathera® clinical trials
- Expanding radioligand therapy manufacturing capacity globally to support demand
Basel, June 30, 2022 — In early June, Novartis restarted radioligand therapy (RLT) production at its sites in Ivrea, Italy, and Millburn, New Jersey, and resumed delivery of doses to patients in a phased approach, ahead of the expected six-week timeframe. The company has remediated the issues that led to the temporary, voluntary suspension of production in May. These issues did not affect patient safety, and no risk to patients from the doses previously produced at these sites was identified.
Novartis has also restarted screening and enrollment for clinical trials with 177Lu-PSMA-617 (INN: lutetium (177Lu) vipivotide tetraxetan), marketed as Pluvicto™ (lutetium Lu 177 vipivotide tetraxetan) in the US, in most countries globally, and clinical trials with Lutathera® (USAN: lutetium Lu 177 dotatate; INN: lutetium (177Lu) oxodotreotide) in the US and Canada.
In addition, to support the growing demand for our RLT platform, Novartis is investing in the expansion of RLT production capabilities in both Millburn and Ivrea, as well as building a new radioligand manufacturing facility in Indianapolis, Indiana that will be operational in 2023.
We recognize that this situation has affected – and is still affecting – patients, their families and care teams. Product quality and patient safety remain the company’s top priorities. We expect that product supply may be initially limited, and we are working hard to resume full production capacity and meet patient demand as quickly as possible. We continue to communicate with health authorities, and they are aware that we have restarted production and that the delivery of patient doses has resumed.
This media update contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this media update, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this media update will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this media update as of this date and does not undertake any obligation to update any forward-looking statements contained in this media update as a result of new information, future events or otherwise.
Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 108,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com.
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