Transcept And Shin Nippon Biomedical Laboratories Announce Global Licensing
Agreement For Advanced Acute Migraine Treatment
TO-2070 is new migraine treatment with a profile promising meaningful
therapeutic advantages in an easy-to-use, self-administered dosage form
POINT RICHMOND, Calif. and TOKYO, Sept. 25, 2013
POINT RICHMOND, Calif. and TOKYO, Sept. 25, 2013 /PRNewswire/ -- Transcept
Pharmaceuticals, Inc. (NASDAQ: TSPT), and Shin Nippon Biomedical Laboratories,
Ltd ("SNBL"), today announced that the companies have entered into an
exclusive worldwide licensing agreement for a novel, rapidly absorbed
treatment for acute migraine incorporating dihydroergotamine (DHE) as the
active drug. The agreement grants Transcept the global development and
commercialization rights to the product candidate, designated TO-2070, which
is expected to offer a new and potentially improved approach to the treatment
of acute migraine. Preclinical data suggest that TO-2070 may offer
significant migraine treatment benefits beyond those provided by less
convenient and more invasive DHE drug delivery methods, such as injection,
liquid nasal sprays or pulmonary inhalation. TO-2070 is designed to provide
these benefits at a relatively low cost via a unique and proprietary nasal
powder drug delivery system that can be easily self-administered by patients.
Under the terms of the agreement, Transcept has agreed to pay SNBL an upfront
technology license fee of $1 million, development milestones totaling $6.5
million through New Drug Application (NDA) approval and, following the launch
of the product, commercialization milestones tied to the achievement of
specified annual sales levels totaling up to $35 million. Additionally,
Transcept will pay tiered, low double-digit royalties on annual net sales.
The parties anticipate entering into further agreements under which SNBL would
supply Transcept with nasal powder delivery devices and would provide
Transcept with certain preclinical and clinical services to support TO-2070
Glenn A. Oclassen, President and CEO of Transcept, stated as follows: "For
more than 55 years, SNBL has been a leader in the field of biopharmaceutical
research, and this nasal powder drug delivery system is the latest example of
its innovative spirit. Our TO-2070 agreement enables Transcept and SNBL to
work together to develop a potentially important new therapeutic for acute
migraine, which is among the most common neurological disorders. There are
approximately 30 million migraine cases each year in the United States alone,
and we estimate that the worldwide therapeutic market is over $3 billion.
However, current treatment options are not adequate to meet the needs of
patients. We believe that TO-2070 represents a significant potential
therapeutic advance that could offer patients and physicians rapid and
meaningful relief of migraine symptoms. TO-2070 will offer these advantages in
a DHE treatment system that does not have the problems associated with
intranasal liquid, injectable or pulmonary delivery, that can be conveniently
self-administered, and that has a relatively low manufacturing cost."
DHE is a well-established acute migraine treatment, especially among migraine
specialists, and has been approved for use in the United States since 1946.
However, it has poor oral bioavailability and is not available in an oral
dosage form. Instead, DHE is generally administered via subcutaneous (SC),
intramuscular (IM) or intravenous (IV) injection. It is also available as a
liquid nasal spray; however, the performance of that product is limited by an
inconvenient administration regimen, slow onset of relief, inconsistent
absorption, post-nasal drip and bitter taste. A DHE product that is delivered
via pulmonary inhalation is under review by the Food and Drug Administration.
TO-2070 is based on a novel nasal powder drug delivery technology created by
SNBL that combines a muco-adhesive drug carrier with a proprietary nasal
powder drug delivery device. This system is the product of a decade-long SNBL
internal development program with the objective of unlocking the significant
market potential for nasal drug delivery by overcoming many of the obstacles
that have limited its application to date. Unlike previous nasal drug
delivery technologies, the SNBL system is able to consistently deliver drug
into the nasal cavity with each administration and hold it in place on the
nasal mucosa to enable enhanced absorption into the bloodstream. Delivery of
the dry powder drug formulation to the nasal mucosa via the specially designed
device nozzle is achieved by simply squeezing the device. Animal model data
have shown pharmacokinetic (PK) results that are similar to subcutaneous and
intramuscular drug administration of DHE, suggesting the potential for
migraine relief heretofore achievable only with injectable DHE dosage forms.
Furthermore, the easy-to-use delivery device allows patients to
self-administer their treatment without the need to manipulate complicated
devices, or to visit their physician or emergency room.
"The decision by Transcept to license this promising new migraine therapeutic
provides an important validation for our breakthrough drug delivery platform,
which we believe is positioned to trigger a renewed focus on the broad
potential of nasal drug delivery. We believe that this new relationship with
Transcept, with its track record of successfully advancing a neuroscience
product all the way through NDA approval, provides an ideal opportunity to
bring our novel technology to market," said Ryoichi Nagata M.D. Ph.D., SNBL
CEO and President.
Alan Rapoport, M.D., Clinical Professor of Neurology at the David Geffen
School of Medicine at UCLA, Los Angeles, CA, and President of the
International Headache Society commented: "DHE has proven to be an excellent
treatment for many of the migraine patients who have tried it. This
medication can work quickly depending on how it is administered, provides
long-lasting relief, has demonstrated a low migraine recurrence rate and can
be effectively administered late in the migraine process. Despite these
important advantages, the therapeutic impact of DHE has been somewhat limited
by challenges associated with the effective delivery of the drug. With this
in mind, a novel delivery system that enables the administration of DHE in a
convenient way and offers patients rapid and sustained migraine relief, would
represent an important advance in the treatment of migraine."
Based on the long history of use and established safety profile of DHE, and
the data from the animal model PK study indicating that TO-2070 has the
potential to deliver therapeutic doses of DHE as rapidly as an IM or SC
injection, Transcept is planning the first human PK study for the second half
of 2014. This study is expected to be followed by a meeting with FDA to
discuss how Transcept intends to pursue a 505(b)(2) regulatory pathway for
TO-2070. Transcept believes that this regulatory strategy provides key
development benefits associated with reduced cost, mitigated risk and
potentially expedited approval.
In addition to TO-2070, Transcept and SNBL are evaluating further potential
opportunities for new neuroscience products incorporating the SNBL technology
that would deliver meaningful clinical benefits to patients.
Transcept Pharmaceuticals, Inc. is a specialty pharmaceutical company focused
on the development and commercialization of proprietary products to address
important therapeutic needs in the field of neuroscience. The company's lead
development candidate is TO-2070, a novel, rapidly absorbed treatment for
acute migraine incorporating dihydroergotamine (DHE) as the active drug.
Preclinical data suggest that TO-2070 may offer significant migraine treatment
benefits beyond those provided by less convenient and more invasive DHE drug
delivery methods, such as injection, liquid nasal sprays or pulmonary
In addition to advancing TO-2070, Transcept is continuing to evaluate
opportunities to supplement its development pipeline with new programs
appropriate to its area of expertise. The company's management team developed
Intermezzo^® from concept to its approval by the FDA in 2011. Purdue holds
commercialization and development rights for Intermezzo in the United
States.For further information about Transcept, please visit
www.transcept.com. For information about Intermezzo, please visit
About Shin Nippon Biomedical Laboratories (SNBL)
For more than 55 years, SNBL has been a leader in providing development
services to biopharmaceutical companies, generating high quality data with the
exceptional precision needed to rapidly advance new medical therapies and
innovations that improve patients' lives.
In addition to providing services, SNBL has a Translational Research business,
which utilizes its development capabilities to develop value-adding
technologies and provides them to the pharmaceutical and medical industry.
Under such business, SNBL has developed μco™ System, a novel intranasal drug
delivery technology platform, to provide effective delivery solutions to
pharmaceutical products. For further information about SNBL, please visit
http://www.snbl.com. For information about SNBL's nasal drug delivery
technology, please visit http://www.snbl-nds.co.jp/en/.
Forward Looking Statements
This press release contains forward-looking statements that involve
substantial risks and uncertainties regarding Transcept. All statements,
other than statements of historical facts, included in this press release
regarding Transcept's strategy, future operations, future financial position,
future revenues, projected expenses, prospects, plans and objectives of
management are forward-looking statements. Examples of such statements
include, but are not limited to, statements relating to the following:
TO-2070 offers a new and improved approach to the treatment of acute migraine;
the potential for TO-2070 to be superior to existing migraine treatments,
including by offering significant benefits at relatively low cost; the
benefits and nature of SNBL's nasal drug delivery system with respect to
TO-2070 and as compared to existing delivery systems, including convenience,
cost, ease of self-administration, safety and speed; the amount, timing and
nature of payments by Transcept to SNBL under the TO-2070 licensing agreement;
the nature of Transcept's relationship and collaboration with SNBL and market
opportunities pursuant to such relationship; Transcept's estimates regarding
the potential size of the market for migraine treatments; beliefs regarding
the inadequacy of existing treatment options for migraine; the potential
market importance of TO-2070 and SNBL's nasal drug delivery system; the
occurrence and timing of Transcept's planned FDA meeting and initial human PK
study relating to TO-2070; and the potential benefits of Transcept's
regulatory strategy. Transcept may not actually achieve the plans, carry out
the intentions or meet the expectations or projections disclosed in its
forward-looking statements and you should not place undue reliance on these
forward-looking statements. Actual results or events could differ materially
from the plans, intentions, expectations and projections disclosed in the
forward-looking statements. Various important factors relating to Transcept
could cause actual results or events to differ materially from the
forward-looking statements that Transcept makes, including the following:
achieving acceptance of Intermezzo by physicians, patients and third party
payors; Transcept's dependence on its collaboration with Purdue; supplying
sufficient quantities of Intermezzo from third party manufacturers and
suppliers to meet anticipated market demand; the impact of competitive
products and the market for Intermezzo generally; obtaining, maintaining and
protecting regulatory exclusivity and intellectual property protection for
Intermezzo; Transcept's ability to identify and finance additional product
candidates for in-licensing or acquisition; and the ability of Transcept to
obtain additional funding, if needed, to support its business activities.
These and other risks are described in greater detail in the "Risk Factors"
section of Transcept periodic reports filed with the SEC . Forward-looking
statements do not reflect the potential impact of any future in-licensing,
collaborations, acquisitions, mergers, dispositions, joint ventures, or
investments Transcept may enter into or make. Transcept does not assume any
obligation to update any forward-looking statements, except as required by
Transcept Pharmaceuticals, Inc. Vida Strategic Partners (media)
Leone Patterson Tim Brons
Vice President, Chief Financial Officer Executive Vice President
(510) 215-3500 (415) 675-7402
Shin Nippon Biomedical Laboratories, Ltd.
Shunji Haruta, Ph.D.
General Manager, NDS Division
SOURCE Transcept Pharmaceuticals, Inc.
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