A Voluntary Recall of a Specific Batch of “Vesanoid Capsule,” a Treatment for Acute Promyelocytic Leukemia

TOKYO, August 3, 2007 - Chugai Pharmaceutical Co., Ltd (Head office: Chuo-ku, Tokyo; President: Osamu Nagayama, hereafter, “Chugai”) announced today that it has begun a voluntary recall of “Vesanoid® Capsule,” a treatment for acute promyelocytic leukemia, that Chugai manufactures and markets.

With a specific batch (K0156X1) of “Vesanoid® Capsule” imported from F. Hoffmann-La Roche Ltd. (Head office: Basel, Switzerland; Chairman & CEO: Franz B. Humer, hereafter, “Roche”), it was discovered that some bovine-derived materials sourced from Canada were used for gelatin which was used as a raw material of the capsules. Use of bovine-derived material sourced from Canada is approved overseas, however, Japan had decided to require a partial amendment to the approval document in order to use such raw materials, in conjunction with the partial amendment to the criteria on biologically-derived raw materials enacted on March 30, 2004.

Accordingly, Chugai and Roche were in agreement not to export to Japan, “Vesanoid Capsule” which uses bovine-derived material sourced from Canada. However, the batch in question was exported to Japan due to a misunderstanding by Roche that its use in Japan had been approved. As a result of this discovery, Chugai has decided to voluntarily recall the shipped product in question.

Chugai has submitted a notification to the authorities, and on August 2, started to recall the products that have already been supplied to medical institutions and distributors by the below method.

The bovine-derived raw material sourced from Canada used in the products has been officially certified by the European Directorate for the Quality of Medicines (EDQM), and its use is permitted in Europe and other countries since no problem is said to exist with its safety, and Chugai believes the same.

Chugai wishes to express its sincere apologies for having caused inconveniences to patients and healthcare professionals. In collaboration with Roche, Chugai intends to do its utmost to strengthen its setups to prevent similar incidents from recurring in the future.

The details of this incident are as follows:

1. The business entity conducting the recall

Name of company: Chugai Pharmaceutical Co., Ltd.

Location of the head office: Nihonbashi Mitsui Tower, 1-1 Nihonbashi-Muromachi 2-Chome, Chuo-ku, Tokyo

Type of pharmaceutical business: Manufacture and sale of pharmaceuticals, Type 1 Business license number: 13A1X00056

2. Overview of the product

1) Name, etc.

Commercial name: Vesanoid® Capsule

Generic name: Tretinoin

Approval No.: 20700AMY00010000

Date of approval: January 20, 1995

Date of launch: March 22, 1995

2) Usage, etc.: Used for the treatment of acute promyelocytic leukemia

3. Overview of the item targeted for the recall

1) Target medical institutions: 740 institutions

2) Batch to be recalled, volume and day of shipment

4. Reason for the recall

It was agreed with Roche that for gelatin used as raw material of capsules for Vesanoid Capsule, bovine-derived raw material sourced from Canada should not be used, however, it was discovered that such raw material was mistakenly used in the batch in question. Chugai has decided to voluntarily recall the product as the use of bovine-derived material sourced from Canada is not permitted in principle according to the criteria on biologically-derived raw materials.

5. Possible health damages

The bovine-derived raw material sourced from Canada has been officially certified by the European Directorate for the Quality of Medicines (EDQM), and its use is permitted in Europe and other countries since no problem is said to exist with its safety, and Chugai believes the same.

6. Method of the recall, etc.

1) Method of the recall

Chugai will send a written document to medical institutions, etc., to which Vesanoid® Capsule had been supplied, and inform them about recalling the products in question. Chugai recalls and collects the products in the batch in question from medical institutions through its distributors, and the collected items will be brought to Chugai Pharmaceutical’s East Japan Distribution Center by the distributors, and will be disposed of.

2) Date to start the recall

From August 2, 2007

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