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Takeda to Partner with Altos Therapeutics to Develop Promising Compound for the Treatment of Gastroparesis

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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.

Contact information

For Altos Therapeutics LLC:
Joanna Denison
+1-650-948-1200
jlh@altostherapeutics.com
or
For Takeda Pharmaceutical Company Limited:
Tsuyoshi Tada – Japan
tsuyoshi.tada@takeda.com
+81 332 782 417
or
Sandra MacTavish – USA
sandra.mactavish@takeda.com
+1-224-554-2343

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