The launch of “TORAYMYXINTM” (PMX-05R) in EU market

Tokyo, June 21, 2019 - Toray announced that a small size of TORAYMYXIN^TM (PMX-05R) had obtained EC certificate and is launched in the EU market on this month.

TORAYMYXIN^TM is indicated for use in the treatment of patients¹⁾ with sepsis²⁾ or septic shock caused by gram-negative bacteria. The small size had been developed for patients with low body weight, who may not have enough blood volume to perform blood purification therapy with a regular size of TORAYMYXIN^TM (PMX-20R). In Japan, we already had been launched PMX-05R. For overseas, Toray has decided to launch PMX-05R in response to strong requests from clinical sites in EU.

Sepsis is a global health crisis. According to Global Sepsis Alliance, it affects 27 to 30 million people every year and 7 to 9 million die – one death every 3.5 seconds. Toray expects the launch of PMX-05R in EU market can be one of the opportunities and choices for the treatment of more sepsis patients.

Toray strives for sustained growing along with social contribution by realizing our corporate philosophy, “Contributing to society through the creation of new value with innovative ideas, technologies and products”, by developing high-value added materials for medical applications using advanced technology.

Table: TORAYMYXIN^TM Specifications

Product type	PMX-20R	PMX-05R
Length	225 mm	133 mm
Diameter (max)	63 mm	55 mm
Priming volume	135 ± 5 ml	40 ± 3 ml
Launch year in EU market	2002	2019

<Glossary>
1)	TORAYMYXINTM is indicated for use in the treatment of patients with sepsis or septic shock caused by gram-negative bacteria, who usually meet the following conditions.
	・	Endotoxemia or suspected gram-negative infection, and
	・	Systemic Inflammatory Response Syndrome (SIRS), as defined by the presence of at least two of the following four conditions:
		>	Fever or hypothermia (body temperature of above 38°C or below 36°C)
		>	Tachycardia (heart rate of above 90 bpm)
		>	Tachypnea [(respiratory rate of above 20 breaths/min, or PaCO2 below 4.3 kPa (32 mmHg)]
		>	White blood cell count of above 12,000 cells/mm3, below 4,000 cells/mm3 or above 10% immature (band) forms.
2)	Sepsis arises when the body’s response to an infection injures its own tissues and organs. It may lead to shock, multi-organ failure, and death - especially if not recognized early and treated promptly. Sepsis is the final common pathway to death from most infectious diseases worldwide.