Mundipharma Wins Approval for Antineoplastic Agent mundesine(R) as Treatment for Relapsed/Refractory

Mundipharma today announced that mundesine®, a Purine-nucleoside phosphorylase (PNP) inhibitor, has been approved for the treatment of relapsed/refractory PTCL by the Ministry of Health, Labor and Welfare in Japan. The Minister's decision follows successful clinical trials and makes Japan the first in the world to make mundesine® available for treatment.

PTCL is a group lymphoma that develops from mature T-cells and NK-cells, where cancerous T/NK cells can cause infiltration into various organs. mundesine® is the first PNP inhibitor to be approved for treatment featuring a novel action mechanism -- by inhibiting PNP, and accumulating plasma 2'-deoxyguanosine (dGuo) in cells, it eliminates the environment necessary for T-cells to grow. Accumulated dGuo induces apoptosis (cell death), reducing the proliferation of cancerous T-cells. mundesine® is also the first single agent oral treatment for this indication.

"Our team at Mundipharma K.K. in Japan have worked hard for early approval of this treatment to give patients and medical practitioners additional support in the fight against lymphoma," said Raman Singh, President Mundipharma Asia Pacific, Latin America, Middle East and Africa. 

Mr Singh added that since the beginning of 1990s when combination chemotherapy CHOP became established as the frontline treatment regimen for intermediate grade non-Hodgkin lymphoma, little progress has been made in terms of additional treatment options. Further, there is no standard second line treatment for PTCL where the median overall survival rate among patients that relapse after chemotherapy is 6.5 months.

"We would like to express our gratitude to the patients and medical practitioners who participated in our clinical trials and enabled us to make this treatment available for the first time globally," said Mr Singh. 

"In working to ensure that patients in Japan receive access to mundesine® as early as possible, Mundipharma K.K has delivered to our patient-first vision and delivered to the standards we set ourselves. This represents another positive step forward as we strive to deliver more treatment options for cancer patients in Japan as part of our mission to address the unmet patient need in emerging markets." 

Product Details

Name                                           Mundesine® Capsule100mg

Generic Name                              Forodesine Hydrochloride

Indication                                     Relapsed/Refractory Peripheral T-cell Lymphoma

Dosing and Administration          Oral administration 300mg, twice daily for an adult. Reduce amount in relation to patient conditions.

Manufacturing and Marketing

Approval Date                               30 March, 2017

Manufacturer                                 Mundipharma K. K.

About mundesine®

mundesine® (Forodesine Hydrochloride) is a low molecular weight compound that inhibits PNP, discovered by BioCryst Pharmaceuticals Inc (USA, trades on the NASDAQ Global Select Market as BCRX). In Japan, forodesine hydrochloride was designated in Japan as "orphan drug" for relapsed/reflactory PTCL in 2008.

Promoting Proper Usage

To promote proper usage of mundesine® since the number of cases in clinical trials was limited, per condition for approval, we will conduct treatment outcome study for all cases until there is certain amount of data for safety and efficacy collected and take necessary actions.

About Mundipharma

Mundipharma's independent associated companies are privately owned entities covering the world's pharmaceutical markets. Mundipharma is a prime example of a company that consistently delivers high quality medicines while standing by the values that represent the company. Our mission is to alleviate the suffering of patients with cancer and non-cancer pain and to substantially improve their quality of life. Mundipharma is dedicated to bringing to patients the benefit of novel treatment options in fields such as pain, oncology, oncology supportive care, ophthalmology, respiratory disease and consumer healthcare.