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Case 1:04-cv—00833-KAJ Document 257-7 Filed 06/27/2006 Page1 0f3

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IN THE UNITED STATES DISTRICT COURT
I FOR THE DISTRICT OF DELAWARE
PHARMACIA & UPJOHN COMPANY, LLC,
Plaintiff, A
V C.A. No. O4-833-KAJ
SICOR, INC., and
SICOR PI-IARMACEUTICALS, INC.,
Defendants.
EXPERT REPORT OF JACOB H. BEIJNEN
I, JACOB H. BEIJNEN, being over the age of eighteen and competent in all respects to
testify, hereby declare as follows:

A Case 1 :04-cv—00833-KAJ Document 257-7 Filed 06/27/2006 Page 3 of 3
of the molecules. Finally, Iwill discuss available formulations of anthracycline glycosides and
other antineoplastic agents as of 1985. V if
A 1. Injectable Products _
Inj ectable products are part of the parenteral class of pharmaceutical products. A
"parenteral" is a product that is administered under or through one or more layers of the skin or I
mucous membrane. In 1985, injectable formulations of certain cytotoxic drugs were available as
lyophilized products; injectable formulations of other cytotoxic drugs were available as ready-to-
use solutions. Absent other issues, health professionals would always prefer ready-to-use
solutions, particularly when dealing with cytotoxic drugs. However, as I will explain later,
anthracycline glycosides were available only as lyophilized products as of 1985.
Lyophilized products are distributed and marketed as vials of freeze-dried powder. They
A are typically reconstituted with an appropriate physiologically acceptable solvent prior to use. A
lyophilized product is made by first dissolving the drug (and, generally, a bulking agent) in a
suitable solvent. The resulting solution is then filtered to sterilize the drug solution. Dosage
form containers (such as vials) are filled with the sterile solution, and the solution is then freeze-
dried in the vials. The freeze-drying process drives off the solvent, leaving the drug and bulking
agent in the containers in a sterile environment. The vials are then sealed and packaged for _
distribution and sale. ‘
The use of lyophilized cytotoxic drug products poses several difficulties in the clinic or
hospital owing to the fact that the drug must be reconstituted prior to administration to a patient.
The lyophilizate is reconstituted by piercing the seal of the vial with a hypodermic needle,
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