Novartis AG. (1/24/23). "Press Release: Sandoz Announces Agreement to Acquire Leading Antifungal Agent Mycamine from Astellas, Reinforcing Hospital Offering and Leading Anti-infectives Portfolio". Basel.

	Region	ALL
	Organisation	Sandoz (division of Novartis)
	Group	Novartis (Group)
	Organisation 2	Astellas Pharma Inc. (TSE: 4503)
	Group	Astellas (Group)
	Product	Mycamine®
	Product 2	cefalosporin
	Index term	Novartis–Astellas: micafungin, 202110– acquisition of ww product rights to Mycamine/Funguard by Sandoz from Astellas SIGNED
	Index term 2	Novartis–GSK: cephalosporin, 202110 acquisition of GSK’s global cephalosporins portfoloio by Sandoz
	Person	Saynor, Richard (Novartis 2019Q1– CEO of Sandoz)
	Person 2	Adomakah, Nicholas (Novartis 202301 Sandoz Anti-infectives Global Medical Lead)

> Sandoz plans to acquire worldwide product rights for Mycamine®(micafungin sodium) from Astellas

> Acquiring leading global echinocandin, one of three major antifungal classes, will significantly reinforce Sandoz hospital offering and leading anti-infectives portfolio

> Addition of Mycamine® will support Sandoz global program to combat antimicrobial resistance (AMR) by targeted use of most appropriate therapies

Sandoz, the global leader in off-patent (generic and biosimilar) medicines, has signed an agreement to acquire worldwide product rights for leading systemic antifungal agent Mycamine® (micafungin sodium, Funguard® in Japan) from Astellas.

Closing is anticipated in the course of H1, 2023, subject to standard conditions and regulatory approvals.

Astellas reported Mycamine® sales of JPY 18.9 billion (USD 135 million) for the year ending March 31, 2022. The announcement comes after Sandoz successfully completed the acquisition of GSK’s global cephalosporins portfolio in October 2021.

Sandoz CEO Richard Saynor said: “Acquiring this leading and respected global brand will significantly reinforce the Sandoz global hospital offering, as well as complement our existing global leadership position in generic antibiotics.”

He added: “This will also be an important addition to our growing portfolio of anti-infective therapies aimed at combatting the spread of antimicrobial resistance, by providing the right drug to the right patient at the right time.”

Sandoz Anti-Infectives global medical lead Nicholas Adomakoh said: “Modern medicine is increasingly characterized by the need for complex interventions involving highly vulnerable patients. This welcome and timely portfolio addition will allow us to respond even better to the needs of patients and clinicians across the healthcare continuum.”

Mycamine® is a leading global echinocandin, one of three major classes of antifungal agents, with a global patient base of well over two million. It is a therapy of choice in hospitals and intensive care units worldwide, a proven prophylactic in hematology and oncology patients, and widely used in organ transplants.

Mycamine® is indicated for treatment of invasive candidiasis and espophageal candidiasis, which are currently both on the rise with a higher occurrence of associated hospital outbreaks, as well as prevention of candida and aspergillus infections in patients undergoing hematopoietic stem cell transplantation.

Disclaimer

This press release 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 press release, 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 press release 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 that, if approved, such generic or biosimilar products will be approved for all indications included in the reference product’s label. 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; the particular prescribing preferences of physicians and patients; competition in general, including potential approval of additional generic or biosimilar versions of such products; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit Sandoz from selling its products; 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 press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

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About Sandoz

Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. Our purpose is to pioneer access for patients by developing and commercializing novel, affordable approaches that address unmet medical needs. Our ambition is to be the world’s leading and most valued generics company. Our broad portfolio of high-quality medicines, covering all major therapeutic areas, accounted for 2021 sales of USD 9.6 billion.

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Record changed: 2024-01-06