Lantheus Enters into Strategic Collaboration with Insightec for Use of Microbubbles in Combination with MR-Guided Focused Ultrasound for Treatment of Glioblastoma and Neurodegenerative Conditions

Lantheus Holdings, Inc. (the "Company”) (NASDAQ: LNTH), parent company of Lantheus Medical Imaging, Inc. ("LMI”), a global leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and products, today announced a strategic collaboration with Insightec Ltd., a global healthcare company focused on the therapeutic power of acoustic energy. Under the agreement, Lantheus’ microbubbles will be used in combination with Insightec’s investigational MR-guided Focused Ultrasound (MRgFUS) platform to evaluate treatment of glioblastoma and neurodegenerative conditions. The collaboration directly aligns with key Lantheus growth strategies of pursuing new applications for its microbubble franchise and expansion into oncology.

Under the terms of the agreement, Lantheus’ microbubbles will be used together with Insightec’s MRgFUS platform designed to deliver ultrasound energy deep in the brain with no incisions. The microbubbles, combined with the application of focused ultrasound, are being investigated in the temporary disruption of the blood brain barrier to potentially allow for more effective delivery of chemotherapeutic agents in the treatment of glioblastoma patients. Glioblastoma is the most aggressive malignant primary brain tumor affecting 3.19 Americans per one hundred thousand and has a less than 5% five-year survival rate.¹

Lantheus will supply its microbubbles and activation devices while Insightec will be responsible for future regulatory submissions and commercialization. The deal terms include a transfer price and royalties.

"We are thrilled to partner with Insightec to further expand our microbubble franchise within oncology and potentially neurodegenerative conditions,” said Mary Anne Heino, President and Chief Executive Officer of Lantheus. "Our collaboration with Insightec could help change the paradigm in glioblastoma, an aggressive cancer for which patients and clinicians unfortunately have few options, and where the unmet medical need is truly significant.”

"Focused ultrasound has strong potential to transform the treatment of diseases that currently have poor outcomes and few options. Partnerships, like this one with Lantheus, will help Insightec’s future customers push the boundaries of what is possible in providing care to patients with neurooncologic as well as neurodegenerative diseases,” said Maurice R. Ferré MD, Chairman and CEO of Insightec.

About Glioblastoma

There are approximately 12,500 new cases of glioblastoma in the United States each year. Glioblastoma is the most commonly occurring primary malignant brain tumor, accounting for over 48% of all malignant tumors.² Overall, median survival for glioblastoma patients is 12-15 months. Glioblastoma has a poor prognosis due to its high rate of tumor recurrence, which has been described clinically as inevitable.³ Worldwide, there are more than 240,000 estimated deaths from brain and central nervous system cancers each year, and glioblastoma represents one of the most common and lethal forms of these cancers.⁴

About Lantheus Holdings, Inc.

Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc., and EXINI Diagnostics AB, and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY^® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; TechneLite^® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA^® for the treatment of certain rare neuroendocrine tumors; and RELISTOR^® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Puerto Rico, Canada and Sweden. For more information, visit www.lantheus.com.

Safe Harbor for Forward-Looking and Cautionary Statements

This press release contains "forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by their use of terms such as "anticipate,” "believe,” "confident,” "could,” "estimate,” "expect,” "intend,” "may,” "plan,” "predict,” "project,” "target,” "will” and other similar terms. Such forward-looking statements are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include (i) regulatory risks related to our DEFINITY^® modified formulation candidate; (ii) expectations for future clinical trials, the timing and potential outcomes of clinical studies and filings and other interactions with regulatory authorities; (iii) the impact of legislative, regulatory, competitive and technological changes; (iv) Insightec’s ability to successfully launch its MRgFUS platform with our microbubble as a commercial product; and (v) the risk and uncertainties discussed in our filings with the Securities and Exchange Commission (including those described in the Risk Factors section in our Annual Reports on Form 10-K and our Quarterly Reports on Form 10-Q).

¹Tamimi AF, Juweid M. Epidemiology and Outcome of Glioblastoma. In: De Vleeschouwer S, editor. Glioblastoma [Internet]. Brisbane (AU): Codon Publications; 2017 Sep 27. Chapter 8.
²National Brain Tumor Society Statistics accessed at: https://braintumor.org/brain-tumor-information/brain-tumor-facts/ on October 16, 2020.
³van Linde ME, Brahm CG, de Witt Hamer PC, et al. Treatment outcome of patients with recurrent glioblastoma multiforme: a retrospective multicenter analysis. J Neuro oncol. 2017;135(1):183-192.
⁴Bray, F. et al. Global Cancer Statistics 2018: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA. Cancer, J Clin: 2018: 68: 394-424.

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