Press Release Details

NORTH BILLERICA, Mass.--(BUSINESS WIRE)--Apr. 2, 2019-- 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 it has entered into a strategic collaboration with Cerevast Medical, Inc. (“Cerevast”) for the treatment of retinal vein occlusion (RVO), one of the most common causes of vision loss worldwide. This collaboration fits squarely into Lantheus’ growth strategy to identify new applications for its microbubble franchise and expand into new disease areas, such as ocular diseases.

Under a development and commercial supply agreement, Lantheus’ microbubble will be used in combination with Cerevast’s ocular ultrasound device to target improving blood flow in occluded retinal veins in the eye. Cerevast’s RVO Technology will combine intravenous administration of Lantheus’ microbubbles with non-invasive ultrasound delivered across the closed eyelid. By treating the underlying cause of the disease as opposed to the symptoms, this therapy has the potential to reduce or eliminate the need for chronic maintenance therapy and improve the quality of life for those patients inflicted by RVO. Cerevast’s RVO Technology is expected to enter a Phase 2B clinical trial in the second half of 2019. Cerevast has received an investigational device exemption (IDE) from the U.S. FDA, which allows its investigational ocular ultrasound device to be used in a clinical study in order to collect safety and effectiveness data. If approved, the RVO Technology could be commercialized in 2023.

“We are excited to collaborate with Cerevast to extend our microbubble franchise into a new treatment modality that has the potential to help millions of patients suffering from RVO,” said Mary Anne Heino, President and Chief Executive Officer of Lantheus. “Our collaboration leverages both companies’ strengths as leaders providing novel, first-in-class solutions to the healthcare community. As the use of microbubbles in diagnostic and therapeutic applications gains more interest in the worldwide market, our collaboration with Cerevast demonstrates our commitment to have Lantheus’ microbubble franchise lead that evolution.”

“We are delighted to enter into this collaboration with Lantheus,” said Bradford Zakes, President and Chief Executive Officer of Cerevast. “Lantheus’ expertise in the field of microbubbles combined with Cerevast’s novel and proprietary ultrasound technology form the basis for a long-term, successful collaboration. We look forward to working with Lantheus to try to advance this promising technology to market and help patients that suffer from the debilitating disease of RVO.”

RVO is a chronic eye condition that occurs when blood clots form in the small veins that carry blood away from the retina. This condition affects approximately 16.4 million people worldwide, and that population is growing due to aging, resulting in 1.1 million new cases each year.^1-3 Left untreated, patients with RVO suffer a progressive, deterioration of vision that can significantly impair quality of life and may lead to permanent blindness. A new therapy that addresses the physical cause of RVO may potentially eliminate the need for long-term maintenance therapy.¹

“Microbubble-mediated ultrasound represents a novel approach to the treatment of RVO that could address the physical cause of the disease, said Dr. Mark Humayun, M.D., Ph.D., biomedical engineer, researcher and recognized thought leader in the field of ophthalmology. “Restoring blood flow to occluded veins offers the potential to reduce the need for long term intra-ocular injections and improve vision in patients afflicted with this disease. I look forward to the continued advancement of this exciting potential therapy.”

As part of the agreement, Cerevast will be responsible for regulatory filings and approvals in the U.S., Europe and China, as well as commercialization of the RVO Technology. Cerevast will have exclusive rights to commercialize Lantheus’ microbubble and activationdevice as part of its RVO Technology.

Lantheus will supply its microbubble vials and its activation devices at a predetermined transfer price. Additionally, Lantheus will receive royalties on sales of the RVO Technology after regulatory approval.

About Lantheus Holdings, Inc. and Lantheus Medical Imaging, Inc.
Lantheus Holdings, Inc. is the parent company of LMI, a global leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and products. The Company is headquartered in North Billerica, Massachusetts with offices in Puerto Rico and Canada. For more information, visit www.lantheus.com.

About Cerevast Medical, Inc.
Cerevast Medical, Inc. is a clinical-stage medical device company based in Bothell, Washington, USA. Leveraging its core expertise in the fields of ultrasound and microsphere technologies, Cerevast is committed to developing novel, first-in-class therapeutic solutions to restore health and improve the quality of life for patients that suffer from major diseases. The company’s lead clinical stage programs are for the treatment of ischemic stroke and retinal vein occlusion, two devastating diseases with limited treatment options that effect millions of patients worldwide each year. For more information, visit www.cerevast.com.

Safe Harbor for Forward-Looking and Cautionary Statements

This press release contains “forward-looking statements” as defined under U.S. federal securities laws, including statements about our future outlook. Forward-looking statements may be identified by their use of terms such as anticipate, believe, confident, could, has the potential to, estimate, expect, intend, may, plan, predict, project, target, will and other similar terms. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. 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 are 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).

¹ Cerevast
² American Academy of Ophthalmology (AAO) 2010
³ Laouri M, Chen E, Looman M, Gallagher M. The burden of disease of retinal vein occlusion: review of the literature. Eye. 2011;25(8):981-988. doi:10.1038/eye.2011.92.

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Source: Lantheus Holdings, Inc.

Media:
Meara Murphy
Director, Corporate Communications
978-671-8508

Investors:
Mark Kinarney
Director, Investor Relations
978-671-8842