May 20, 2011
Press Release
Mitsubishi Tanabe Pharma CorporationApproval for Additional Indication of Anti-D Human Immunoglobulin
I.M.1000-BENESIS (Dry anti-Rho(D) Immune Human Globulin)
Osaka, Japan, May 20, 2011---Mitsubishi Tanabe Pharma Corporation (President & CEO:Michihiro Tsuchiya) announced today that its consolidated subsidiary, Benesis Corporation(Head office: Osaka; President: Junichi Watanabe) obtained approval for additional
indication of “the sensitization risk due to the D(Rho) factor around the 28th week ofpregnancy, or after miscarriage or artificial abortion.” for Anti-D Human Immunoglobulin
I.M.1000-BENESIS (dry anti-Rho(D) immune human globulin) as of May 20, 2011.
When a woman with D(Rho) negative blood becomes pregnant and gives birth to aD(Rho) positive child, the red blood cells of the D(Rho) positive baby will enter thematernal circulation of the D(Rho) negative mother through transplacental hemorrhage. Asa result, anti-D(Rho) antibodies may be generated in the mother’s body. If this woman
becomes pregnant a following time, anti-D(Rho) antibodies will be transmitted via theplacenta to the baby in the womb, causing hemolytic disorder in the newborn baby.
This drug inhibits the generation of anti-D(Rho) antibodies in the body of a D(Rho)negative mother who has delivered a D(Rho) positive baby, if administered within 72 hours
after delivery. For this indication, the Health, Labor and Welfare Ministry has already given
approval, and its efficacy has been widely recognized.
Based on reports, however, that the rate of sensitization to the D(Rho) factor further
decreases upon administering this drug around the 28th week of pregnancy, medicalguidelines in the United States, Europe and Japan recommend that the drug beadministered during the pregnancy itself (around the 28th week of pregnancy). Moreover,medical treatments such as amniocentesis and external versions of the fetal position,
miscarriage and ectopic gestation also carry a risk of sensitization due to the D(Rho) factor,
medical guidelines in the United States, Europe and Japan recommend that the drug beadministered after treatment, operation or miscarriage.
Under these circumstances, the Japan Society of Obstetrics & Gynecology filed a request
with the Ministry to review the drug based on the List of Unapproved Drugs/Off-Label
Prescription Drugs with High Medical Needs in 2009. In October 2010, the First Committee
on Pharmaceutical Products of the Pharmaceutical Affairs and Food Sanitation Council
issued a pre-assessment report that an “application for approval of additional indication for a-1-

publicly known prescription” may be filed with the Ministry. Based on this pre-assessment
report, Benesis Corporation filed an application for approval of additional indication for a
publicly known prescription in November 2010, and the approval was obtained for thesensitization risk due to the D(Rho) factor around the 28th week of pregnancy, or after
miscarriage or artificial abortion. .
Mitsubishi Tanabe Pharma and Benesis expect that, by the acquisition of this approval for
additional indication, Anti-D Human Immunoglobulin I.M.1000-BENESIS will contribute
greatly to the prevention of hemolytic disorders among newborns in pregnancies with rhesus
incompatibility.

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