October - December 2012
October 5, 2012
Takeda Pharmaceutical Company Limited
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.
Takeda expects the acquisition of LigoCyte will:
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.
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.
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.
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 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.
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.
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; the transaction may not be consummated; the anticipated benefits of the transaction may not be realized; the transaction could disrupt relationships with employees, licensees, customers and other business partners or governmental entities; future sales could be adversely affected by competition or other factors; and integration costs may exceed current expectations. In addition, the combined business could be adversely affected by industry, economic or political conditions outside of LigoCyte’s or Takeda’s control, including general economic conditions in Japan, the United States and worldwide; 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 LigoCyte 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.
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