Altus Formulation Signs Agreement With Zogenix for Development of Abuse
Deterrent Formulations of Zohydro(TM) ER
MONTREAL, Nov. 4, 2013 (GLOBE NEWSWIRE) -- Altus Formulation Inc. ("Altus"), a
private Montreal-based drug formulation and development company today
announced that it has entered into a Development and Option Agreement ("D&O
Agreement") with Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company
developing and commercializing products for the treatment of central nervous
system disorders and pain, to develop abuse deterrent formulations of Zohydro™
ER using Altus's proprietary, clinically validated Intellitab drug delivery
platform. Altus and Zogenix have initiated development of Intellitab abuse
deterrent formulations of Zohydro ER with the entry into the agreement.
Zohydro^TM ER (hydrocodone bitartrate) extended-release capsules, an opioid
agonist, is the first approved extended-release oral formulation of
hydrocodone without acetaminophen, for the management of pain severe enough to
require daily, around-the-clock, long-term opioid treatment and for which
alternative treatment options are inadequate. In 2012, existing hydrocodone
products generated $3.5 billion in sales on approximately 131 million
prescriptions and are the most commonly prescribed pharmaceutical products in
the United States (Source® PHAST Prescription January 2012 - December
2012).Zogenix expects to launch Zohydro ER in the United States in
approximately four months.
Under the D&O Agreement, Altus has granted Zogenix an option (subject to the
terms and conditions of the D&O Agreement) to enter into an exclusive license
on mutually agreed terms to develop and commercialize abuse deterrent
formulations of Zohydro ER in the United States.In connection with the
transaction, Zogenix will pay Altus a technology access fee in the amount of
$750,000.Zogenix will fund all development activities and Altus may earn an
additional $3.5 million in development and regulatory milestones through to
submission of a New Drug Application.Following exercise of the option, Altus
will be eligible to receive additional regulatory and sales milestone payments
and royalties based on net sales of the licensed product.
"We are extremely pleased that Zogenix has chosen Altus and Intellitab
technology to develop abuse deterrent formulations of Zohydro ER^TM," said Dr.
Damon Smith, President and CEO of Altus.Smith continued, "We believe that
Zohydro ER fulfills a critical need among people living with chronic pain and
are delighted to now be playing a part in its development. We look forward to
working closely with the Zogenix team to rapidly bring this important new
product to the market."
Dr. Stephen Farr, president, Zogenix, added, "We conducted an extensive review
of available abuse deterrent technologies and chose Intellitab because of its
versatility, demonstrated abuse deterrent features, and Altus' intellectual
property portfolio. Of equal importance, Intellitab can be customized to match
the current pharmacokinetic profile of Zohydro ER, which we believe, in turn,
will allow us to bridge to the current product's safety and efficacy
established in the recently approved NDA and streamline overall development
About Altus Formulation
Altus Formulation is a Quebec-based drug formulation and development company
using its proprietary and patent protected drug delivery technologies to
generate novel, differentiated and cost effective new products for its
clients. With a focus on an improved patient experience Altus technologies
include Intellitab tamper and abuse resistant technologies, Contramid^® for
high dosage product delivery, MicroSpheres Plus for taste-masked controlled
release liquids and the PNDS micellar technology platform that enables
delivery of insoluble small and large molecules via both oral and parenteral
routes to achieve increased bioavailability and low volume intravenous
administration; More information regarding Altus Formulation may be found at
Zogenix, Inc. (Nasdaq:ZGNX), with offices in San Diego and Emeryville,
California, is a pharmaceutical company committed to developing and
commercializing therapies that address specific clinical needs for people
living with CNS and pain-related conditions who need innovative treatment
alternatives to help them return to normal daily functioning.Zogenix
developed and commercialized the first needle-free subcutaneous injection,
SUMAVEL^® DosePro^® (sumatriptan injection) for migraine and cluster headache.
Zogenix recently received FDA approval for Zohydro ER (hydrocodone bitartrate)
extended-release capsules, the first extended-release oral formulation of
hydrocodone without acetaminophen.The development pipeline for Zogenix
includes a once-monthly subcutaneous injection for schizophrenia.
Contramid^®is a licensed trademark of Altus Formulation Inc.
Zohydro^TM ER is a trademark and SUMAVEL^® and DosePro^® are registered
trademarks of Zogenix, Inc.
CONTACT: Dr. Damon Smith
Tel : 514-883-344 7
Web site: www.altusformulation.com
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