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Nov. 24, 2006
Summit Pharmaceuticals International Corporation
Sumitomo Corporation

Summit Pharmaceuticals International Corporation Begins Phase II Clinical Study for a Plasma Volume Expander, Hextend®

Summit Pharmaceuticals International Corporation (President and C.E.O. Masahiro Sasaki; Headquarters: Harumi, Chuo-ku, Tokyo, Japan; hereinafter "SPI"), one of the companies of the Sumitomo Corporation Group, has been involved in the joint development of Hextend®, a plasma volume expander under license of BioTime, Inc. (Office of the President: Judith Segall, Hal Sternberg, Harold Waitz; Headquarters: California, USA; hereinafter "BioTime"), along with Maruishi Pharmaceutical Co., Ltd. (President: Keiichi Inoue; Headquarters: Tsurumi-ku, Osaka, Japan; hereinafter "Maruishi").

SPI was recently able to confirm the safety and pharmacokinetic and pharmacodynamic properties of Hextend® through a Phase I Clinical Study on healthy Japanese adult males. In order to further evaluate the efficacy and safety of Hextend®, SPI has now embarked on its Phase II Clinical Study on patients who are undergoing surgery and require treatment for hypovolemia, a condition in which the volume of circulating blood is insufficient.

A plasma volume expander is an infusion solution which is administered to patients with decreased circulating blood volume due to surgery or injury to recover and maintain the circulating blood volume. This infusion solution is also referred to as a plasma substitute preparation. According to "Guidelines for Usage of Blood Products (revised version)" (Blood and Blood Products Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare, September 2005), the recommended therapeutic intervention in the event of decreased circulating blood volume is infusion of extracellular fluid (lactate Ringer's solution, acetate Ringer's solution, etc.) followed by infusion of artificial colloid solution and albumin preparation with the increase of bleeding volume.

Hextend®, which is an artificial colloidal solution consisting mainly of high-molecular weight hydroxyethyl starch as a colloid, has been marketed in the United States since 1999. High-molecular weight hydroxyethyl starch is formulated in Hextend® with the expectation that the circulating blood volume can be maintained for a longer period. Hextend® is a lactated electrolyte solution including calcium with a composition similar to that of plasma, and it is regarded as a remarkably safe product which has limited side effects on the blood coagulation system and renal function. Although artificial colloidal solutions containing low-molecular colloids have been marketed in Japan, introduction of plasma volume expanders that enable prolonged maintenance of circulating blood volume is keenly awaited.

During the period from 1999 to 2002, a survey (Japanese Journal of Transfusion and Cell Therapy, Vol. 51. No. 1 51 [1]: 23-31, 2005) of 800 medical institutions certified by the Japanese Society of Anesthesiologists found that anesthesiologists took part in 4.3 million operations. Based on this survey, Hextend® is potentially expected to be prepared for approximately 1 million surgeries a year. Hextend® is expected to safely maintain circulating blood volume for a longer period, and it can be widely used here for patients with hypovolemia, which may also contribute in the reductions of blood products use.

SPI is a wholly owned subsidiary of Sumitomo Corporation. As a company specializing in the support of research and development activities of pharmaceutical companies and bioventures, SPI has achieved noteworthy successes in various stages/aspects in the pharmaceutical industry. SPI is designated as an exclusive agency in Japan for American Type Culture Collection (ATCC), the world's largest gene/cell bank for research purposes, and actively works to promote ATCC activities. Furthermore, SPI supports research activities for drug discovery by providing compounds from chemical library suppliers for high-throughput screening (HTS, a technology that enables rapid screening to find candidate compounds for new drugs). SPI also mediates in the licensing of various opportunities such as technologies, research & development projects, products, etc., from Japan to foreign companies and vice versa.

In April 2005, a revision to the Pharmaceutical Affairs Law that enables corporations without manufacturing facilities to market pharmaceuticals provided that they have established quality assurance and safety management systems for product distribution and acquire the necessary manufacturing and marketing approval was made. SPI established the department of pharmaceutical development in April 2004 to obtain rights and have its own pharmaceutical development projects.

Currently, SPI places particular focus on pharmaceuticals in wide use in the United States and Europe that are needed by many patients here but have not been developed by domestic pharmaceutical companies due to concerns over marketability, etc. SPI decided to add such a new activity to contribute in the improvement of the medical environment by promptly delivering pharmaceuticals that are urgently required in clinical settings.

Hextend® is the first product for SPI to develop. Within the co-developmment with Maruishi, SPI took the lead in implementing Phase I of the Hextend® Clinical Study, which confirmed the safety and pharmacokinetics of Hextend® among Japanese subjects. It is also playing a major role in Phase II, which will see the safety and efficacy of Hextend® evaluated in patients in an exploratory manner. In collaboration with Maruishi, SPI will also conduct a Phase III Clinical Study to verify efficacy and safety of Hextend® in settings that will closely mirror actual clinical environments.

Maruishi has constantly provided high-quality products since its establishment in 1888, as a leading company specializing in the manufacture of pharmaceuticals listed in Japanese Pharmacopoeia and a specialty pharmaceutical company in the disinfection/sterilization-related field. In 1990, well ahead of overseas pharmaceutical companies, Maruishi acquired approval in Japan for the general inhalation anesthetic sevoflurane, a general inhalation anesthetic used in more than 100 countries that commands a considerable market share. Accordingly, Maruishi has since worked to actively promote research and development as a specialty pharmaceutical company in surgery- and anesthesia-related fields.

BioTime (established in 1990) is a venture company involved in the development of plasma volume expander, tissue preservative solution and blood substitution solution used in hypothermia surgery. Hextend®, the first product to be licensed by BioTime, is marketed in the United States and Canada by Hospira and in South Korea by CJ Corp.

SPI will continue to make efforts to investigate and explore for promising pharmaceuticals that are needed by patients here but whose development has been delayed in Japan, and accelerate their introduction so that they can be used promptly in a clinical setting. In this way SPI is actively promoting development of such products and contributing to improvements in the medical environment.



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Sumitomo Corporation

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