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News Release

FOR IMMEDIATE RELEASE
June 11, 2010
For Print (PDF 95KB)

Pfizer, Eisai to launch postherpetic neuralgia drug Lyrica® Capsules on June 22

Pfizer Japan Inc.
Eisai Co., Ltd.
Tokyo, Japan, June 11, 2010 — Pfizer Japan Inc. (Head Office: Tokyo; President: Ichiro Umeda) and Eisai Co., Ltd. (Headquarters: Tokyo; President & CEO: Haruo Naito) announced that the two companies will launch postherpetic neuralgia treatment Lyrica® Capsules (generic name: pregabalin) on June 22, 2010.

Lyrica® was approved in Japan on April 16 of this year and was today listed in the NHI drug price list. Pfizer Japan and Eisai are jointly promoting sale of the drug and work together to ensure the provision of information regarding its proper usage.

Developed by Pfizer Inc. (USA), Lyrica® is currently approved in over 105 countries worldwide. Its major mechanism of action is thought to express its analgesic effects by suppressing the output of various neurotransmitters from overexcited nerves. The efficacy and safety of Lyrica® have already been proven in a number of clinical trials. Lyrica® is also listed as a first-line drug in the treatment guidelines / algorithm for neuropathic pain (including postherpetic neuralgia) in the United States and Europe.

Postherpetic neuralgia (PHN) is a disorder representative of peripheral neuropathic pain caused by nerve damage. Herpes zoster appears when viral resistance is lowered due to latent neuromuscular infection by varicella / herpes zoster viruses following first infection with chicken pox. PHN is considered an intractable pain, and symptoms include continued burning or electric shock-like pain after skin symptoms of herpes zoster have healed.

Lyrica® has a new mechanism of action that is completely different from existing analgesic treatments, and domestic phase III trials have confirmed the efficacy and safety of its analgesic effects. The drug is also under review for indication approval for peripheral neuropathy, and development is underway to secure indication for fibromyalgia.

Both Pfizer Japan Inc. and Eisai Co., Ltd. will contribute to the QOL improvement for patients with PHN by providing Lyrica® Capsules as a new treatment.



Media Inquiries:
Product Communications, Pfizer Japan Inc. +81-(0)3-5309-6719
Public Relations Department, Eisai Co., Ltd. +81-(0)3-3817-5120

Contact for healthcare professionals and consumers (Toll-free numbers):
Product Information Center, Pfizer Japan Inc. 0120-664-467
Customer Hotline, Eisai Co., Ltd. 0120-419-497



Outline of Lyrica® Capsules

Product name:Lyrica® Capsules (25mg, 75mg, 150 mg)
Generic name:Pregabalin
Approval date:April 16, 2010
Launch date:June 22, 2010
Manufactured/sold by:Pfizer Japan Inc.
Co-promotion with:Eisai Co., Ltd.
Effect/efficacy:Postherpetic neuralgia
Administration/dosage:Normally, adults are orally administered an initial dosage of 150mg of pregabalin in two divided doses per day. The daily dosage is then titrated to 300mg over one week. The dosage may need to be adjusted depending on age and symptoms. However, daily dosage should never exceed 600mg and should always be orally administered in two divided doses per day.
Property: 1. Abundant evidence
Approved in 105 countries and regions around the world (as of April 2010).
Recommended by the International Association for the Study of Pain and various other overseas academic societies as a first-line drug in the treatment of postherpetic neuralgia.

2. New mechanism of action
Unlike existing analgesic treatments, Lyrica® has a new mechanism of action in which it binds to calcium ion channel alpha2delta sub-units which are distributed in the nervous system.

3. Superior analgesic effect
Takes effect from the first week of administration
Effect maintained even for long-term administration

4. Safety profile
In a domestic dose-response trial, a domestic long-term administration trial, a foreign late stage phase II trial, a foreign phase III trial and a foreign long-term administration trial, adverse events (including an abnormal clinical laboratory test results) were found to have occurred in 1,084 cases (64.5%) of 1,680 cases. The most common adverse events were floating dizziness (393 cases, 23.4%), somnolence (267 cases, 15.9%), and edema (179 cases, 10.7%) (Based on the total of investigation data collected prior to approval). Severe adverse events reported were heart failure, lung edema, loss of consciousness, rhabdomyolysis, renal failure, and blood vessel edema.
Formulation/Price:
Lyrica® Capsules 25 mg:¥100.50 per capsule
Lyrica® Capsules 75 mg:¥167.10 per capsule
Lyrica® Capsules 150 mg:¥229.00 per capsule
Packaging:
Lyrica® Capsules 25 mg:30 capsules per pack
Lyrica® Capsules 75 mg:100/700 capsules per pack
Lyrica® Capsules 150 mg:100 capsules per pack