Sosei Regains Worldwide Rights from Teva to Develop & Commercialize Novel Small Molecule CGRP Antagonists for Migraine & Othe...
13 Marzo 2018 - 8:35AM
Business Wire
Sosei Group (“Sosei” or the “Company”; TOKYO Mothers Index:
4565), the world leader in GPCR medicine design and development,
announced that it has regained worldwide rights from Teva
Pharmaceutical Industries Ltd. (“Teva”) to develop and
commercialize lead candidate HTL0022562 and other novel small
molecule CGRP antagonists for the treatment of migraine and other
severe headaches.
HTL0022562 is a novel, potent, and highly selective small
molecule CGRP antagonist designed by Sosei’s wholly-owned
subsidiary Heptares Therapeutics (“Heptares”) using its proprietary
structure-based drug design platform. The candidate emerged from a
rigorous selection process under the alliance with Teva based on
its highly differentiated preclinical data. The first dosing in a
Phase 1 clinical trial in healthy volunteers was expected in late
2018. Sosei will now undertake a detailed review of the programs
and update the market later this year on the new expected timing
for HTL0022562’s entry into Phase 1 clinical trials following a
formal handover from Teva.
The termination of the 2015 licensing and drug discovery
agreement between Heptares and Teva is a result of Teva’s recent
portfolio prioritization. All licensed rights relating to the CGRP
antagonist programs will be returned to Sosei. As part of the
reversion package, Sosei will also receive the full preclinical
data set generated by Teva under the partnership. In regaining the
worldwide development and commercialization rights there is no
immediate or material financial impact to Sosei. Going forward, as
a wholly-owned pipeline program, Sosei will be responsible for the
costs associated with developing HTL0022562 or any other small
molecule CGRP antagonists.
“Heptares’ technologies and know-how provided unique structural
insights concerning the interaction between CGRP and its receptor,
enabling the design of a portfolio of differentiated, potent and
selective small molecule CGRP antagonist candidates. The joint
project activities of both companies have led to the selection and
progression through preclinical development of HTL0022562 as the
preferred candidate,” commented Dr. Malcolm Weir, Chief R&D
Officer of Sosei. “Thanks to this excellent work by the combined
teams under the alliance, and following the return of the assets,
we are now well positioned to rapidly progress HTL0022562 into the
clinic as part of our wholly-owned pipeline. HTL0022562 has very
interesting and differentiated properties compared to other small
molecule and antibody antagonists, and we look forward to
continuing its development.”
“Sosei is extremely pleased to regain worldwide rights for the
development and commercialization of HTL0022562 and the CGRP
program,” said Peter Bains, CEO of Sosei. “It provides Sosei with
another high-quality preclinical candidate to add to our expanding
wholly-owned development pipeline. With c.$280 million of cash on
balance sheet1, we are well positioned to take this candidate
forward and capture greater value for our shareholders.”
1 As at 31 December 2017
Notes to Editors
About CGRP Antagonists for Migraine and Other Severe
HeadachesCalcitonin gene related peptide (CGRP) is released
during migraine attacks and can trigger migraine in patients. CGRP
is found in small to medium sized neurons in the trigeminal
ganglion of the brain and mediates its activity through G
protein-coupled receptors located throughout the body. Elevated
levels of CGRP are found in people with migraine during an attack
and blocking CGRP activity is a validated mechanism of action for
relieving pain, and also for preventing migraine.
About MigraineApproximately 36 million people in the
United States and 8 million people in Japan suffer from migraine.
Migraine is three times more common in women than in men and
affects more than 10 percent of people worldwide. Migraine is
defined as recurring attacks of moderate to severe headache pain,
typically one-sided, throbbing and worse with activity. The
International Headache Society defines chronic migraine as more
than 15 headache days per month over a three-month period of which
more than eight are migraine, in the absence of medication over
use. Episodic migraine is the other migraine sub-type, which is
defined as less than 15 headache days per month. During migraine,
people can experience varying characteristics such as being very
sensitive to light and sound, or experiencing nausea and vomiting.
There is no absolute cure for migraine since its pathophysiology
has yet to be fully understood.
About SoseiSosei is an international biopharmaceutical
company focused on the design and development of new medicines
originating from its proprietary GPCR-targeted StaR® technology and
structure-based drug design platform capabilities. The Company is
advancing a broad and deep pipeline of partnered and wholly owned
product candidates in multiple therapeutic areas, including CNS,
cancer, metabolic diseases and other rare/specialty indications.
The Company’s leading clinical programs include a proprietary Phase
2 candidate for dementia with Lewy bodies (DLB) in Japan, together
with partnered candidates aimed at the symptomatic treatment of
Alzheimer’s disease (with Allergan) and immuno-oncology approaches
to treat cancer (with AstraZeneca). Sosei’s additional partners and
collaborators include Novartis, Teva, Pfizer, Daiichi-Sankyo,
PeptiDream, Kymab and MorphoSys. The Company is headquartered in
Japan with R&D facilities in the UK.
Sosei is listed on the Mothers Index of the Tokyo Stock Exchange
(ticker: 4565). For more information, please visit
http://www.sosei.com/en/.
Forward-looking statementsThis press release contains
forward-looking statements, including statements about the
discovery, development and commercialisation of products. Various
risks may cause Sosei’s actual results to differ materially from
those expressed or implied by the forward-looking statements,
including: adverse results in clinical development programs;
failure to obtain patent protection for inventions; commercial
limitations imposed by patents owned or controlled by third
parties; dependence upon strategic alliance partners to develop and
commercialise products and services; difficulties or delays in
obtaining regulatory approvals to market products and services
resulting from development efforts; the requirement for substantial
funding to conduct research and development and to expand
commercialisation activities; and product initiatives by
competitors. As a result of these factors, prospective investors
are cautioned not to rely on any forward-looking statements. We
disclaim any intention or obligation to update or revise any
forward-looking statements, whether as a result of new information,
future events or otherwise.
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Contact informationSosei Group CorporationChris Cargill,
+44 (0)7912 892 199Head of Investor Relations and Corporate
Communicationsccargill@sosei.comorSosei Group CorporationHarumi
Banse, +81 3 5210 3399Corporate Communications
(Japan)hbanse@sosei.comorCitigate Dewe Rogerson (for International
media)Mark Swallow / David Dible, +44 (0)20 7638
9571sosei@citigatedewerogerson.com