TOKYO & LONDON--(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 Headaches
Calcitonin
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 Migraine
Approximately 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 Sosei
Sosei 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 statements
This 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.
