Novartis bolsters Neuroscience pipeline with in-licensing of PTC518 for Huntington’s disease

Dec 02, 2024

Novartis today announced that it has entered into a global license and collaboration agreement with PTC Therapeutics for PTC518, an HTT mRNA splice modulator with the potential to become the first oral disease-modifying therapy for Huntington's disease.

The agreement bolsters the company’s Neuroscience pipeline and reflects its strategic focus on neurodegenerative diseases with high unmet needs.

Novartis will assume responsibility for PTC518’s development, manufacturing and commercialization following the completion of the placebo-controlled portion of the ongoing Phase II PIVOT-HD study, expected in H1 2025.

Under the terms of the agreement, Novartis will pay USD 1.0 billion upfront and up to $1.9 billion in development, regulatory and sales milestones. Novartis will also share profits in the US and pay tiered royalties on ex-US sales.

The transaction is subject to customary closing conditions.

Disclaimer:

This investor 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 any investigational or approved products resulting from the global license and collaboration agreement with PTC Therapeutics for PTC518, or regarding potential future revenues from such collaboration. 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 any investigational or approved products resulting from the collaboration with PTC Therapeutics, in particular PTC518, will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Neither can there be any guarantee expected benefits or synergies from this transaction will be achieved in the expected timeframe, or at all, nor can there be any guarantee that the collaboration with PTC Therapeutics will be commercially successful in the future. In particular, our expectations regarding the collaboration with PTC therapeutics described in this investor update could be affected by, among other things, the process of satisfying the customary closing conditions for the proposed transaction may be delayed or may not be possible (or may result in the imposition of conditions that could adversely affect the proposed collaboration); 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; 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 investor update as of this date and does not undertake any obligation to update any forward-looking statements contained in this investor update as a result of new information, future events or otherwise.

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Novartis bolsters Neuroscience pipeline with in-licensing of PTC518 for Huntington’s disease

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