Takeda to Acquire LigoCyte Pharmaceuticals, Inc.

Takeda to Acquire LigoCyte Pharmaceuticals, Inc.
Gains First-in-Class Norovirus Vaccine Candidate and Virus-Like Particle Platform, Advancing Takeda's Commitment to Vaccines and Global Public Health

Osaka, Japan, Oct. 5, 2012, Deerfield, Ill. and Bozeman, Mont., Oct. 4, 2012, – Takeda Pharmaceutical Company Limited (Takeda) and LigoCyte Pharmaceuticals, Inc. jointly announced today that Takeda's wholly-owned subsidiary, Takeda America Holdings, Inc. and LigoCyte Pharmaceuticals, Inc. have entered into a definitive agreement for Takeda to acquire LigoCyte for an upfront payment of $60 million, with future contingent consideration based on the progress of development projects LigoCyte is a privately-held biopharmaceutical company specializing in innovative vaccine products headquartered in Bozeman, Montana. Its lead product, a vaccine to prevent norovirus gastroenteritis, is in phase I/II of clinical development.

"Takeda's acquisition of LigoCyte is a major step forward in the expansion of Takeda's vaccine business, and    a demonstration of Takeda's dedication to preventing illness in children and adults around the world," said Rajeev Venkayya, M.D., executive vice president of Takeda's Vaccine Business Division (VBD), which was launched in January 2012. "Norovirus is the most common cause of outbreaks of gastroenteritis and foodborne illness in the U.S., and is responsible for 200,000 deaths each year, most of them in developing countries. With the only norovirus vaccine in clinical trials today, Takeda will be in a position to change this picture."

LigoCyte is focused on the development of innovative vaccine products based on its proprietary virus-like particle platform (VLP) technology. LigoCyte's lead product, the norovirus vaccine, uses VLP technology which enables the production of vaccines designed to cover multiple genetic varieties (or "strains") of norovirus. The vaccine candidate has been shown to confer protection in an initial human challenge trial. Approval for the vaccine will be sought in the United States, Europe and other countries based on disease burden.

"This milestone underscores Takeda's commitment to innovation and the advancement of global public health through the development of novel vaccines," said Tadataka Yamada, M.D., Takeda's chief medical and scientific officer and member of the Takeda board of directors. "Norovirus is responsible for a significant burden of disease around the world and is notoriously difficult to control. With this acquisition, Takeda will help to protect families and communities from this virus."

In recent years, norovirus has become recognized as the most common cause of outbreak and foodborne gastroenteritis in developed countries. Each year, outbreaks are reported on cruise ships, in health care and long-term care facilities and in child care settings, often requiring closure of facilities for cleaning, and resulting in significant disruption of operations and economic consequences. According to the Centers for Disease Control and Prevention, norovirus infects 21 million people in the United States each year.

In addition to the norovirus vaccine candidate, LigoCyte has also initiated preclinical development of vaccines against respiratory syncytial virus, influenza and rotavirus.
"LigoCyte is pleased to become a part of a leading research-based global pharmaceutical company with a commitment to vaccines and the resources to develop our pipeline," said Donald P. Beeman, chief executive officer, and member of the LigoCyte board of directors. "Together, we believe we have the right combination of expertise and dedication to bring our norovirus vaccine to market. We look forward to supporting Takeda's vaccine research and development efforts and contributing to the long-term success of Takeda's Vaccine Business Division."

To preserve continuity and build upon LigoCyte's success, Takeda will continue operating LigoCyte in Bozeman, Montana, for the foreseeable future and intends to retain the management team and its employees. Once the acquisition is complete, Mr. Beeman and his management team will become a part of Takeda's Vaccine Business Division. Pending the satisfaction of customary closing conditions, the deal is expected to close in the next several weeks.

Key Strategic Benefits
Takeda expects the acquisition of LigoCyte will:
•    Advance Takeda's presence in the global vaccine market, and demonstrate Takeda's commitment to global public health
•    Expand Takeda's development pipeline and R&D capacity, and position Takeda to bring a "first-in-class" vaccine for an unmet health need to populations around the world
•    Contribute to Takeda's long-term commercial objectives Acquisition Summary
(1)    Acquiring company: Takeda America Holdings, Inc. (2)    Shareholders of LigoCyte Pharmaceuticals, Inc.: Forward Ventures, JAFCO, Novartis
Venture Fund, Fidelity Biosciences, MedImmune Ventures, Athenian Venture Partners and MC Life Sciences Ventures (Mitsubishi International Corporation). GlaxoSmithKline is also a shareholder of the company.
(3) (4)
(6) (7) (8) (9) (10)
Payment: Cash Number of common and preferred stock equivalent to common outstanding shares: 121,761,569 Acquisition amount: $60 million i.    In addition to this acquisition amount, the deal consideration includes future
contingent consideration based on the progress of development projects. Other
economic provisions are not disclosed. Planned date of completion: Next several weeks (by end of November 2012) Financial advisor to Takeda: None Legal advisor to Takeda: Polsinelli Shughart PC Financial advisor to LigoCyte: Sagent Advisors, LLC Legal advisor to LigoCyte: Cooley LLP
Profile of LigoCyte Pharmaceuticals, Inc.:
(1) Corporate Name: LigoCyte Pharmaceuticals, Inc. (2) Location of executive offices: Bozeman, Montana (3) Representative: Donald P. Beeman, CEO and Member of the Board of Directors (4) Year of establishment: 1998 (5) Common Stock Equity: $10,000 (6) Additional Paid-in Capital: $1,371,516 (7) Shares: Non-listed (8) Number of employees: Approximately 40 employees. (9) Relationship with Takeda: No matters to report regarding capital, personal and
transactional relationship between Takeda and LigoCyte.
The impact from this acquisition on Takeda's consolidated financial statements of fiscal 2012 is limited, and Takeda does not find it necessary to revise the financial forecasts of fiscal 2012 at this point of time.

About Virus-Like Particle Technology
LigoCyte has developed core technologies used in a wide range of virus-like particle vaccines. Virus-like particles, or VLPs, mimic the external protein structure of a virus without including the genetic material (DNA or RNA) necessary for viral replication. The human immune system responds to a VLP vaccine as if it is encountering the live virus, which allows the body to build immune defenses capable of fighting infections. Without genetic material, VLP vaccines are incapable of causing infections themselves while at the same time presenting viral antigens in the most authentic configuration possible.

About LigoCyte
LigoCyte is a private, clinical-stage biopharmaceutical company focused on developing novel vaccines for gastrointestinal and respiratory indications. LigoCyte's expertise in virus-like particle technology supports a pipeline of enhanced product candidates, including vaccines against norovirus, influenza, respiratory syncytial virus and rotavirus. LigoCyte has funded its product development efforts through a mix of private investment as well as grants and contracts administered through the National Institutes of Health and the U.S. Department of Defense. For more information about LigoCyte, visit www.ligocyte.com.

Takeda's Vaccine Business Division
Takeda's history in providing vaccines dates back more than 60 years, during which the company has established itself as an important supplier of pediatric vaccines in Japan. In January 2012, Takeda announced the launch of its Vaccine Business Division to enhance its presence in the global vaccine market. This division's recent efforts include clinical testing of the Haemophilus Influenza type b (Hib) vaccine and development of a combination vaccine containing a Sabin-inactivated poliovirus (s-IPV) vaccine, which could play an important role in polio eradication. Takeda is also developing a cell culture pandemic and seasonal influenza vaccine, in partnership with Baxter.

Takeda Pharmaceutical Company Limited
Located in Osaka, Japan, Takeda 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 patients worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.

Suggested Articles

UCB’s bispecific antibody recently beat Johnson & Johnson’s Stelara at clearing psoriasis symptoms, and now it has bested AbbVie’s Humira, too.

FDA staff took the action in response to cases of early growth plate closure in children on the retinoic acid receptor gamma agonist.

The CTAD presentation cleared up some questions about the data set without delivering a telling blow for either side of the debate.