- September 12, 2011
- Taiho Pharmaceutical Co., Ltd.
Taiho Pharmaceutical to Launch a New Anti-tumor Agent,
ZOLINZA® capsules 100mg, on September 14
Taiho Pharmaceutical Co., Ltd. (HQ: Tokyo, President: Toru Usami, hereafter Taiho) announced today that a new anti-tumor agent, ZOLINZA® capsules 100mg (generic name: Vorinostat, hereafter ZOLINZA) will become available in Japan for the oral treatment of cutaneous T-cell lymphoma (CTCL) on September 14.
MSD K.K. (HQ: Tokyo, President: Tony Alvarez, hereafter MSD) was granted a Japanese marketing approval for this product on July 1, 2011, and the drug price in Japan was listed on September 12.
Taiho will promote and distribute ZOLINZA in Japan on the basis of the distribution agreement signed by MSD and Taiho. ZOLINZA , which is a novel anti-tumor agent, has a new mechanism of action to down-regulate cancer related genes by inhibiting histone deacetylase. It was granted an orphan drug designation by the Japanese Ministry of Health, Labour and Welfare on June 2010.
Taiho expects ZOLINZA® will be a useful agent for the treatment of CTCL that it could contribute to the patients and medical professionals by meeting unmet medical needs arose from the limited treatment options.
About cutaneous T-cell lymphomas (CTCL)
- CTCL is a type of non-Hodgkin lymphoma among malignant lymphomas, which often occurs in organs other than lymph nodes, such as the gastrointestinal tract, skin, and brain. Out of the type of malignant lymphoma without lesions observed in the organs except the skin at the initial visit, called primary cutaneous lymphoma, CTCL is the acronym for cutaneous T-cell lymphomas, the general term for a group of diseases.
- CTCL is a rare disease associated with persisting refractory skin lesions, such as multiple occurrence and repeated recurrence, and includes mycosis fungoides and Sezary syndrome.
|Product name (English)||ZOLINZA® Capsules 100mg|
|Effects and indications||Cutaneous T-cell lymphoma|
|Dosage and administration method||400 mg orally once daily with food. The dose may be decreased if patient is intolerant to therapy.|
|Marketing authorization date||July 1, 2011|
|Drug price listing date||September 12, 2011|
|Launch date||September 14, 2011|
|Packaging||ZOLINZA® Capsules 100mg Press-through packaging, 28 capsules (14 capsules × 2)|
|Drug price||,462.80 per capsule|
|Distributor||Taiho Pharmaceutical Co., Ltd.|
|Marketing authorization holder||MSD K.K.|
Information in this news release was current as of the original release date.