OSAKA, Japan & LOS ALTOS, Calif.--(BUSINESS WIRE)--Takeda Pharmaceutical Company Limited (TOKYO:4502) and Altos Therapeutics LLC today jointly announced the companies have entered into a definitive agreement to further the development of Altos’s proprietary compound ATC-1906. Additionally, the agreement includes an exclusive option for Takeda to acquire Altos beginning on the date of the agreement and continuing for a period of time following the completion of ongoing Phase 1 studies of ATC-1906. The parties envision future development of ATC-1906 for the treatment of gastroparesis (GP) and its symptoms.
GP is a chronic gastric motility disorder characterized by delayed gastric emptying. Symptoms include early satiety, post-prandial fullness, nausea, vomiting, and abdominal discomfort.i Diabetic gastroparesis and idiopathic gastroparesis have high unmet need.
Altos Therapeutics, a single asset company, is developing the ATC-1906 compound as an oral dopamine D2/D3 receptor antagonist that addresses the symptoms of nausea and vomiting in GP patients. As part of the agreement, Takeda will provide Altos an upfront payment for the option to acquire Altos. If Takeda elects to exercise the option, Takeda would make an additional payment to acquire Altos, and would then assume control over development and commercialization of ATC-1906. Altos would be eligible to receive additional payments linked to clinical development and achievement of key commercial milestones. No further details of the agreement were disclosed.
In patients with GP, the activation of dopamine receptors drives an emetic response, also commonly known as vomiting. Altos & Takeda will seek to develop ATC-1906 and its dopamine receptor antagonist mechanism of action as an alternative treatment to target the symptoms of nausea and vomiting to relieve patient suffering with an improved safety profile.
“There is a significant unmet need for a treatment to help patients with gastroparesis, and developing novel and innovative treatments for patients suffering from gastrointestinal disorders is a top priority for Takeda’s global R&D strategy,” said Dr. Asit Parikh, senior vice president and head of Takeda’s Gastroenterology Therapeutic Area Unit. “This agreement reinforces Takeda’s commitment to developing highly differentiated medicines to improve the health and quality of life of patients around the world.”
“Altos’s main goal has been to develop ATC-1906 for the treatment of gastroparesis. We are delighted to have Takeda, with its expertise in gastroenterology, involved as Altos continues to develop ATC-1906 through Phase 1 clinical trials,” said Dr. Roger Whiting, CEO of Altos Therapeutics, LLC. “We believe that this agreement will expedite the development of this important medicine.”
Oppenheimer & Co. acted as exclusive financial advisor, and Cooley LLP acted as legal counsel to Altos. Polsinelli acted as legal counsel to Takeda.
i http://iffgd.org/upper-gi-disorders/gastroparesis.html. Accessed May 20, 2016
About Altos Therapeutics
Altos Therapeutics is a private
pharmaceutical company located in Los Altos, California. Its main focus
has been to develop ATC-1906 for gastroparesis. The company has
performed all the necessary studies to successfully obtain an IND and
continues to develop ATC-1906 into Phase 1 clinical trials.
About Takeda
Located in Osaka, Japan, Takeda (TOKYO:4502)
is a research-based global company with its main focus on
pharmaceuticals. As the largest pharmaceutical company in Japan and one
of the global leaders of the industry, Takeda is committed to strive
towards better health for people worldwide through leading innovation in
medicine. Additional information about Takeda is available through its
corporate website, www.takeda.com.
Takeda’s Commitment to Gastroenterology
Takeda is a global
leader in gastroenterology. With expertise spanning more than 25 years,
the company’s dedication to innovation continues to evolve and have a
lasting impact. ENTYVIO® (vedolizumab) demonstrates Takeda’s
global capabilities and expansion into the specialty care market in
gastroenterology and biologics. Designed and developed specifically to
target the gastrointestinal (GI) tract, ENTYVIO was launched in 2014 for
the treatment of adults with moderate to severe ulcerative colitis and
Crohn’s disease. TAKECAB® (vonoprazan fumarate) is Takeda's
potassium-competitive acid blocker and was launched in Japan in
2015. Takeda also markets motility agent AMITIZA®
(lubiprostone), which originally launched in 2006 for the treatment of
chronic idiopathic constipation, and received subsequent approval to
treat irritable bowel syndrome with constipation and opioid-induced
constipation. Preceding these notable launches, Takeda pioneered
gastroenterological breakthroughs in proton pump inhibitors beginning in
the 1990’s with lansoprazole. Through specialized and strategic in-house
development, external partnerships, in-licensing and acquisitions,
Takeda currently has a number of promising early stage GI assets in
development, and remains committed to delivering innovative, therapeutic
options for patients with gastrointestinal and liver diseases.
Takeda’s Forward-Looking Statements
This press release
contains “forward-looking statements.” Forward-looking statements
include all statements other than statements of historical fact,
including plans, strategies and expectations for the future, statements
regarding the expected timing of filings and approvals relating to the
transaction, the expected timing of the completion of the transaction,
the ability to complete the transaction or to satisfy the various
closing conditions, future revenues and profitability from or growth or
any assumptions underlying any of the foregoing. Statements made in the
future tense, and words such as “anticipate,” “expect,” “project,”
“continue,” “believe,” “plan,” “estimate,” “pro forma,” “intend,”
“potential,” “target,” “forecast,” “guidance,” “outlook,” “seek,”
“assume,” “will,” “may,” “should,” and similar expressions are intended
to qualify as forward-looking statements. Forward-looking statements are
based on estimates and assumptions made by management that are believed
to be reasonable, though they are inherently uncertain and difficult to
predict. Investors and security holders are cautioned not to place undue
reliance on these forward-looking statements.
Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Some of these risks and uncertainties include, but are not limited to: required regulatory approvals for the transaction may not be obtained in a timely manner, if at all; the conditions to closing of the transaction may not be satisfied; competitive pressures and developments; applicable laws and regulations; the success or failure of product development programs; actions of regulatory authorities and the timing thereof; changes in exchange rates; and claims or concerns regarding the safety or efficacy of marketed products or product candidates in development.
The forward-looking statements contained in this press release speak only as of the date of this press release, and neither Altos Therapeutics LLC nor Takeda undertakes any obligation to revise or update any forward-looking statements to reflect new information, future events or circumstances after the date of the forward-looking statement. If one or more of these statements is updated or corrected, investors and others should not conclude that additional updates or corrections will be made.
