Eisai Inc. to Promote Pfizer's Anti-Seizure Medicine, Cerebyx -Fosphenytoin Sodium Injection-, in the United States.

Business Editors/Health & Medical Writers

TEANECK, N.J. & NEW YORK--(BUSINESS WIRE)--July 25, 2002

Eisai Inc. and Pfizer Inc. today announced a collaborative agreement in which Eisai has acquired exclusive U.S. rights to promote Pfizer's Cerebyx(R) (fosphenytoin sodium injection).

Cerebyx is a water-based injectable anticonvulsant used in the hospital setting to control generalized convulsive status epilepticus (SE), to prevent and treat seizures occurring during neurosurgery and as a short-term replacement for oral phenytoin when other means of phenytoin are unavailable, inappropriate or deemed less advantageous. Following intravenous or intramuscular administration of Cerebyx, fosphenytoin is converted to the anticonvulsant phenytoin.

Under the terms of the agreement, Eisai Inc. will develop educational, promotional and training materials as well as promote the product to medical professionals. Cerebyx has been available in the United States since 1996 and was acquired by Pfizer through its merger with Warner-Lambert in 2000.

Status epilepticus is a condition in which one major attack of convulsions succeeds another with little or no intermission. SE affects approximately 195,000 people annually, and each year, an estimated 42,000 people die from it.

Cerebyx(R) (fosphenytoin sodium injection) is contraindicated in patients who have demonstrated hypersensitivity to Cerebyx or its ingredients, or to phenytoin or other hydantoins. The safety and effectiveness of Cerebyx has not been systematically evaluated for more than five days.

Most common side effects are involuntary eye movements, dizziness, itching, tingling sensation, headache, sleepiness and lack of coordination. The tingling of the skin and itching, which usually occur around the face or groin areas, are seen more frequently with Cerebyx than with IV phenytoin administration, mainly with intravenous administration. They do not appear to be allergic reactions and typically resolve within 10 minutes after completion of infusion. Cerebyx should be discontinued if a skin rash appears.

Cerebyx should be used with caution in patients with low blood pressure and severe heart failure. Cerebyx is contraindicated in patients with slow heart rate, sinoatrial block, second- and third-degree AV block and Adams-Stokes syndrome (blockages of electrical impulses that regulate heartbeat). Careful cardiac monitoring is needed when administering intravenous loading doses of Cerebyx. The phosphate load provided by Cerebyx should be considered when treating patients with severe renal impairment.

Incidence of adverse effects was dose and rate related, increasing with higher doses and rates. Cerebyx is not approved for use in patients under 18 years old.

Throughout all Cerebyx(R) product labeling, the amount and concentration of fosphenytoin is expressed in terms of phenytoin sodium equivalents (PE). Fosphenytoin's weight is expressed as phenytoin sodium equivalents to avoid the need to perform molecular weight-based adjustments when converting between fosphenytoin and phenytoin sodium doses. Cerebyx(R) (fosphenytoin sodium injection) should always be prescribed and dispensed in phenytoin sodium equivalent units (PE).

This is the second collaboration between Pfizer and Eisai. Pfizer co-promotes the Alzheimer's disease medicine Aricept(R) (donepezil HCl tablets) with Eisai Co., Ltd., which discovered and developed donepezil HCl.

"This agreement is an important step toward strengthening Eisai's strategic focus on specialty products in the key therapeutic areas of neurology and acute care," said Eisai Inc. President Bill Sheldon. "The quality of our partnership with Pfizer is reflected in the success of Aricept the leading prescription drug worldwide for Alzheimer's disease. We are pleased to broaden our relationship with a valued partner."

Eisai Inc., based in Teaneck, New Jersey, is a U.S. pharmaceutical subsidiary of Eisai Co., Ltd. of Japan, a research-based human health care company that discovers, develops and markets products in more than 30 countries. Established in 1995, Eisai Inc. began marketing its first product in the U.S. in 1997 and has rapidly grown to become an integrated pharmaceutical business with sales of more than $1 billion in fiscal year 2001 (ending March 31, 2002). Areas of therapeutic focus include neurology, gastroenterology, oncology and acute care.

Eisai employs more than 600 people at the headquarters in Teaneck, N.J., at a state-of-the-art R&D and production facility in Research Triangle Park, N.C., and in the field. Between 1998 and 2001, Eisai Inc. moved up in the rankings of U.S. pharmaceutical companies (based on revenues) from No. 44 to 23.

Pfizer Inc. discovers, develops, manufactures and markets leading prescription medicines for humans and animals and many of the world's best-known consumer brands.

Full prescribing information for Cerebyx(R) (fosphenytoin sodium injection) is available at http://www.pfizer.com/hml/pi's/cerebyxpi.pdf.