NORTH BILLERICA, Mass.–(BUSINESS WIRE)–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 activation device
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.
Contacts
Media:
Meara Murphy
Director, Corporate Communications
978-671-8508
Investors:
Mark Kinarney
Director, Investor Relations
978-671-8842