Takeda Pharmaceutical Company Limited (Takeda) and Dainippon Sumitomo Pharma Co., Ltd. (DSP) announced that they have entered into an exclusive license agreement for the development, manufacturing and commercialization of ceftaroline fosamil (Takeda’s development code: TAK-599, “ceftaroline”), a cephem antibiotic developed originally by Takeda, in Japan.

Under terms of the agreement, DSP will make an upfront payment of 500 million Japanese Yen and milestone payments up to 2.5 billion Japanese Yen in accordance with the progress of the development. After commercialization, DSP will pay royalty and milestone to Takeda based on net sales. DSP will cover all the costs necessary for non-clinical and clinical development, submission of a new drug application, and for sales and marketing activities in Japan.

“We are very pleased to enter into this agreement for ceftaroline, which was discovered by Takeda and has strong anti-bacterial activities against MRSA (methicillin-resistant Staphylococcus aureus). It is expected to become a potential treatment option for MRSA infection that is now showing an increasing tendency in Japan,” said Yasuchika Hasegawa, President & CEO, Takeda Pharmaceutical Company Limited. “DSP has well-established franchise in severe infectious diseases, and with DSP having an exclusive right in Japan, we expect that ceftaroline will be successfully developed, approved and launched as a treatment that can satisfy unmet medical needs in this area.”

“Treatment of infectious disease is one of our company’s core therapeutic areas for domestic business, and we sell “Meropen”, “AmBisome”, etc.” said Masayo Tada, president and chief executive officer, Dainippon Sumitomo Pharma Co., Ltd. “We intend to develop ceftaroline to satisfy the high unmet medical need existing in the areas of hospital-acquired bacterial pneumonia, sepsis and other MRSA infections. We aim to offer this treatment to patients as soon as possible and contribute to the treatment of severe infectious diseases in Japan.”

Takeda will record an upfront payment from DSP this fiscal year ending March 31, 2011, but without revising its financial forecast for this fiscal year announced on October 29, 2010. As for DSP, that payment will be recorded this quarter (Jan 1 - Mar 31, 2011), and revisions to the financial forecast for this fiscal year in regards to other license agreements and recent achievement trends are announced.

Discovered by Takeda, ceftaroline is a cephem antibiotic, and has strong activities against gram-positive bacteria including MRSA and multiply-resistant Streptococcus pneumonia and also gram-negative bacteria. Takeda executed an agreement with Peninsula Pharmaceuticals, Inc. that time (currently, Cerexa, Inc., a wholly-owned subsidiary of Forest Laboratories, Inc.) in September 2003, granting exclusive rights to develop and market ceftaroline in all territories outside Japan.

Forest Laboratories obtained an approval from the US FDA of the product for the treatment of Acute Bacterial Skin and Skin Structure Infection (ABSSSI) and Community-Acquired Bacterial Pneumonia (CABP) on October 29, 2010. The product is now being marketed by Forest as “Teflarotm” in the US

In August 2009, Forest Laboratories and AstraZeneca entered into a definitive collaboration agreement to co-develop and commercialize ceftaroline in all markets outside the US, Canada and Japan, and AstraZeneca submitted a Marketing Authorization Approval to the European Medicines Agency during the quarter of Oct. – Dec. 2010.

Takeda is a research-based global company with its main focus on pharmaceuticals.

Dainippon Sumitomo Pharma (DSP) is a pharmaceutical company with a diverse portfolio of pharmaceutical, animal health, food and specialty products and aims to produce innovative pharmaceutical products in the Central Nervous System (CNS) field, designated as a key therapeutic area, and other specialty areas.