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Takeda and Nanotherapeutics Announce Agreement

Wednesday, August 26, 2015  
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Takeda and Nanotherapeutics Announce Agreement to Expand Takeda's Commercialization and Technology Access Rights in Support of Influenza and Other Vaccine Programs

ALACHUA, Fla. & OSAKA, Japan--(BUSINESS WIRE)--Takeda Pharmaceutical Company Limited (Takeda) (TOKYO: 4502) and Nanotherapeutics, Inc., announced an agreement providing Takeda with expanded commercialization and technology access rights related to Nanotherapeutics’ Vero cell technology platform – a cell culture-based platform for vaccine production which Nanotherapeutics acquired from Baxalta, formerly Baxter International’s BioScience division. Financial terms of the agreement were not disclosed.

In 2010, Takeda and Baxter entered into an agreement in which Takeda licensed from Baxter certain exclusive rights to the technology for the development of pandemic and seasonal influenza vaccines for the Japanese market. Takeda’s cell culture-based H5N1 and prototype vaccine for pandemic influenza was developed on this platform and was approved in Japan in March 2014. Takeda is currently developing a cell-based seasonal flu vaccine (TAK-850) on the same platform for use in Japan.

The agreement with Nanotherapeutics extinguishes Takeda’s remaining financial obligations under the initial agreement with Baxter. Additionally, Takeda gains rights to commercialize its pandemic and seasonal influenza vaccine products, based on the Vero cell technology platform, in certain regions outside of Japan and will have access to Vero cell technology and reagents for the development of vaccines beyond influenza.

“We are delighted to partner with Nanotherapeutics to create the opportunity to expand the reach of Takeda’s pandemic and seasonal flu vaccines to other parts of the world,” said Rajeev Venkayya, M.D., President of Takeda’s Vaccine Business Unit. “Today’s agreement reinforces Takeda’s commitment to its global vaccine business and our goal of reaching as many people as possible with vaccines that address important unmet needs in global public health.”

James Talton, Ph.D., President and Chief Executive Officer of Nanotherapeutics, noted, "Our acquisition of the Vero cell technology has meaningfully strengthened and increased our core capabilities and internal product portfolio. That said, we are very pleased to be able to partner with global pharmaceutical leader, Takeda, to expand their access to the technology for further expansion of their vaccine pipeline, thereby also allowing Nanotherapeutics to align itself with a company which has approved and late-stage products in development based on this proven technology platform.”

About Nanotherapeutics

Nanotherapeutics, based in Alachua, FL, is an integrated biopharmaceutical company with a focus on development and manufacturing. The Company has expertise in preclinical and clinical development, formulation optimization, and cGMP manufacturing of biopharmaceutical products and medical devices. The Company's proprietary platform technologies can be used with all drug types, ranging from small molecules to proteins and vaccines. For more information, visit the Company website at www.nanotherapeutics.com

About Vero cell technology

On December 9 2014, Baxter International Inc. announced that it has entered into a definitive agreement to sell its proprietary Vero cell technology and related assets, including its production facility in Bohumil, Czech Republic, to Nanotherapeutics, Inc. The Vero cell platform is an advanced, cell-based technology for vaccine production. The agreement with Nanotherapeutics includes all assets related to the platform, including vaccines for H5N1, H1N1 and seasonal influenza. The agreement also includes investigational vaccine programs for Ross River virus, Chikungunya disease and West Nile virus.

About Takeda Pharmaceutical Company Limited

Located in Osaka, Japan, Takeda (TSE: 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.

About Takeda’s Vaccine Business Unit

Takeda has supplied vaccines to protect the health of people in Japan for more than 60 years. Launched in 2012 and headquartered in Deerfield, Illinois, Takeda’s global Vaccine Business is tackling some of the world’s most challenging infectious diseases for which vaccines do not exist, such as dengue and norovirus.

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, 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: 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 Nanotherapeutics nor Takeda undertake 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.

Contacts

For Nanotherapeutics, Inc.:
Nanotherapeutics, Inc.
Gary Ascani, 386-462-9663
Vice President of Business Development
gascani@nanotherapeutics.com
For Takeda Pharmaceuticals Company Limited:
Takeda Pharmaceuticals Company Limited
Nanako Nakamura, +81 3 3278 2229
Corporate Communications Dept.
nanako.nakamura@takeda.com
Takeda Pharmaceuticals Company Limited
Julia Ellwanger, +1-224-554-7681
R&D Communications
julia.ellwanger@takeda.com

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