IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

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1 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA UNITED STATES OF AMERICA v. CRIMINAL NO. UCB, INC., Defendant. VIOLATION 21 U.S.C. 331(k), 352(f)(1), and 333(a)(1) (Causing drugs to be misbranded while held for sale after shipment in interstate commerce inadequate directions for use) INFORMATION The United States Attorney charges that COUNT ONE At all times material to this information BACKGROUND 1. Defendant UCB, Inc., formerly known as UCB Pharma, Inc., was a Delaware corporation, with its principal place of business located in Smyrna, Georgia. UCB, Inc. was a wholly owned subsidiary of UCB Holdings, Inc., a Delaware corporation formerly known as UCB, Inc., which in turn was a wholly owned subsidiary of UCB S.A., a global biopharmaceutical company headquartered in Brussels, Belgium. Defendant UCB, Inc. was engaged in the development, manufacture, promotion, and sale of pharmaceutical drugs intended for human use, including the drug Keppra. 2. UCB, Inc. promoted, sold, and distributed its pharmaceutical drugs, including Keppra, throughout the United States, including the District of Columbia. Throughout 2004, Defendant UCB, Inc. shipped Keppra in interstate commerce, and Keppra was held for sale

2 in warehouses, pharmacies, and other locations throughout the United States, including the District of Columbia. Throughout 2004, Keppra was prescribed by physicians and dispensed by pharmacies throughout the United States, including the District of Columbia. 3. Keppra was a new drug and a prescription drug within the meaning of the Federal Food, Drug and Cosmetic Act ( FDCA ), which, among other things, governed the interstate distribution of drugs for human use, as codified in 21 U.S.C. 301, et seq. The FDCA and its implementing regulations prohibited the distribution of any new drug in interstate commerce until the sponsor or manufacturer of that new drug had received approval from the United States Food and Drug Administration ( FDA ), based on an intensive application and review process. 21 U.S.C The FDCA required that the sponsor of a new drug submit a New Drug Application ( NDA ) to the FDA, which identified all of the uses of the drug intended by that sponsor, together with the proposed labeling for those uses and data, generated in well-controlled clinical trials, that demonstrated to the FDA s satisfaction that the drug would be safe and effective for those intended uses. 21 U.S.C. 331(d) and 355(b). 5. Until the FDA approved the NDA, including the proposed labeling for the drug, and found sufficient evidence of the drug s safety and efficacy for the uses intended by the sponsor, the FDCA prohibited the sponsor from promoting or marketing its drug. 21 U.S.C. 355(a). Uses not approved by the FDA, and not included in the drug's approved labeling, were known as unapproved uses or off-label uses. 6. The sponsor could not label or promote the drug for any new intended use without the prior approval of the FDA. The sponsor was first required to submit to the FDA for 2

3 approval each additional proposed use, together with evidence, in the form of well-controlled clinical studies, sufficient to demonstrate that the drug was safe and effective for each additional proposed therapeutic use. 7. The FDCA prohibited the doing of any act with respect to a drug, if the act was done while the drug was held for sale after shipment in interstate commerce and resulted in the drug being misbranded. 21 U.S.C. 331(k). Under the FDCA, a drug was misbranded if its labeling did not contain adequate directions for use. 21 U.S.C. 352(f)(1). Adequate directions for use meant directions under which a layperson could use a drug safely and effectively for the purposes for which it was intended. 21 C.F.R A prescription drug, by definition, could not bear adequate directions for use by a layperson, but an FDA-approved prescription drug, bearing the FDA-approved labeling, could be exempt from the adequate directions for use requirement if it was sold for an FDA-approved use. A prescription drug that was marketed for non-approved, off-label uses, did not qualify for this exemption and therefore was misbranded. 21 C.F.R Labeling included any written, printed, or graphic matter that accompanied a drug, and further included materials disseminated by or on behalf of a drug manufacturer or distributor that were descriptive of a drug. FDA APPROVAL AND REGULATORY ACTION REGARDING KEPPRA 9. On February 1, 1999, Defendant UCB, Inc. submitted an NDA to the FDA seeking approval of Keppra (also known by the chemical name levetiracetam) for use as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. FDA approved the NDA on November 30,

4 10. In 2000, Defendant UCB, Inc. initiated a pilot proof-of-concept trial ( Study N01014") to study the potential safety and efficacy of Keppra in preventing migraine attacks (referred to as migraine prophylaxis ) in adults. This 18-week multi-center, randomized, double-blind, placebo-controlled study enrolled 80 patients. Defendant UCB, Inc. planned to conduct further clinical trials based on the results of Study N01014 to seek FDA approval for Keppra for migraine prophylaxis. Defendant UCB, Inc. never carried out this plan. 11. In November of 2001, Defendant UCB, Inc. learned that Study N01014 had failed to show that Keppra was effective in preventing migraine attacks. In fact, the study results showed no statistically significant difference in migraine attacks between the group who received Keppra and the placebo control group. Following this failed study, Defendant UCB, Inc. ceased clinical development of an indication for Keppra for migraine prevention. 12. Defendant UCB, Inc. never submitted an NDA for the use of Keppra in preventing migraine attacks or otherwise for use in treating migraine. The FDA never approved Keppra for use in preventing migraine attacks or otherwise for use in treating migraine. UCB, INC. S OFF-LABEL PROMOTION AND SALES PRACTICES 13. From approximately January of 2004 through December of 2004, Defendant UCB, Inc. unlawfully promoted Keppra for use in treating migraine. This intended use was not approved by the FDA. In promoting Keppra for this off-label use, Defendant UCB, Inc. caused the drug to be misbranded under 21 U.S.C. 352(f)(1) while it was held for sale following shipment in interstate commerce, in violation of 21 U.S.C. 331(k). 4

5 14. Defendant UCB, Inc. prepared business plans which observed that the markets for Keppra to treat off-label uses, including migraine, offered a much higher sales potential than the epilepsy market. Defendant UCB, Inc. was aware of the competitive pressures from other rival drugs, including Neurontin, and noted that UCB, Inc. was being outspent by competitors who were aggressively pursuing off-label business. Defendant UCB, Inc. s business plans projected that off-label sales of Keppra would grow substantially in the coming years and cited the need to put structures and budgets in place now to fully exploit the current and future market potential for Keppra within and outside epilepsy. 15. In furtherance of its business plans to pursue the off-label market for Keppra, Defendant UCB, Inc. prepared marketing plans citing the need to seed the market for the off-label use of Keppra by generating and disseminating data supporting the use of Keppra to treat migraine. Defendant UCB, Inc. s management developed marketing strategies to promote Keppra for the off-label use of treating migraine by seeding the market. These strategies included Defendant UCB, Inc. s sponsorship of purported Keppra investigator initiated studies, ( KIIS ) and retrospective studies aimed at generating off-label sales of Keppra by creating publications, posters, and oral presentations to spread information about the supposed benefits of Keppra for migraine. 16. Acting at the direction of Defendant UCB, Inc. s management, the company s medical science liaisons ( MSLs ) recruited and paid physicians to participate in KIIS and retrospective studies regarding the use of Keppra to treat migraine. UCB, Inc. s marketing department provided the funding to support these KIIS and retrospective studies. These studies were not double-blind, placebo-controlled clinical trials and lacked the scientific rigor required to 5

6 support FDA approval for Keppra to treat migraine. UCB, Inc. s MSLs supported and participated in the preparation of posters representing that Keppra was safe and effective in treating migraine (the Migraine Posters ). The Migraine Posters failed to disclose the results of Defendant UCB, Inc. s failed pilot Study N01014 showing that Keppra was not effective in preventing migraine. The Migraine Posters also failed to disclose UCB, Inc. s sponsorship or financial support, despite Defendant UCB, Inc. s role in generating the posters. 17. Defendant UCB, Inc. s sales managers provided reprints of the Migraine Posters to UCB, Inc. s sales representatives and directed them to disseminate the posters to physicians in order to encourage them to prescribe Keppra for treating migraine. UCB, Inc. s sales representatives promoted the off-label use of Keppra to treat migraine to health care providers throughout the United States and widely disseminated the Migraine Posters to persuade doctors to prescribe Keppra for migraine. 18. Defendant UCB, Inc. also used the Migraine Posters to promote the offlabel use of Keppra in treating migraine by recruiting and paying physicians to present the Migraine Posters to other physicians during peer-to-peer sessions. HARM CAUSED BY UCB, INC. S OFF-LABEL PROMOTION 19. The promotion of an off-label use for a prescription drug can interfere with the proper treatment of a patient. Off-label promotion can lull a physician into believing both that the drug being promoted is safe and effective for the intended off-label use, and that the FDA has approved the drug for that use. Thus, off-label promotion can cause a doctor and patient to forgo treatment with an FDA-approved drug that has been proven to be safe and effective, and instead to 6

7 substitute a treatment urged by the sales representative that is not known to be safe and effective, and that may in fact be harmful. 20. Defendant UCB, Inc. s off-label promotion of Keppra undermined the FDA drug approval process, thereby affecting the treatment of patients. Defendant UCB, Inc. undertook this illegal off-label promotion for its own financial gain and despite data from its own clinical trials indicating that Keppra was ineffective for migraine prevention. GAIN TO UCB, INC. 21. Defendant UCB, Inc. received a gain in the amount of $5,394,470 by causing Keppra to be misbranded while it was held for sale following shipment in interstate commerce between January 2004 and December of 2004 by promoting Keppra for the unapproved use of treating migraine. 22. From in or about January of 2004 through in or about December of 2004, in the District of Columbia and elsewhere, Defendant UCB, INC. promoted the prescription drug Keppra for the treatment of migraine, a condition for which it was not approved by FDA, while the drug was held for sale after shipment in interstate commerce, which resulted in the drug being misbranded within the meaning of 21 U.S.C. 352(f)(1) and 21 C.F.R , in that its labeling did not bear adequate directions for use. (In violation of Title 21, United States Code, Sections 331(k), 352(f)(1), and 333(a)(1)) 7

8 FORFEITURE ALLEGATION 1. The allegations set forth in Count One of this Information are re-alleged as though set forth fully herein and incorporated by reference for the purpose of alleging forfeiture to the United States of America pursuant to the provisions of Title 28, United States Code, Section 2461(c), and Title 21, United States Code Sections 334 and 853(p). 2. As a result of the offense alleged in Count One of this Information, the defendant, UCB, Inc., shall forfeit to the United States, a money judgment in the amount of $ 1,078,894, as a value of a quantity of the drug, Keppra, that it misbranded and distributed in interstate commerce. 3. By virtue of the commission of the offense charged in this Information, any and all interest that defendant UCB, Inc., has in the amount of $ 1,078,894, as a value of a quantity of the drug, Keppra, that it misbranded and distributed in interstate commerce, is vested in the United States and hereby forfeited to the United States pursuant to Title 28, United States Code, Section 2461(c), and Title 21, United States Code, Sections 334 and 853(p). If, as a result of any act or omission of defendant UCB, Inc., the property identified above 1. cannot be located upon the exercise of due diligence; 2. has been transferred or sold to, or deposited with, a third person; 3. has been placed beyond the jurisdiction of the Court; 4. has been substantially diminished in value; or 5. has been commingled with other property that cannot be subdivided without difficulty; it is the intention of the United States, pursuant to Title 28, United States Code, Section 2461(c), and Title 21, United States Code, Sections 334 and 853(p), to seek forfeiture of 8

9 any other property of said defendant up to the value of said property listed above as being subject to forfeiture. (Criminal Forfeiture, in violation of Title 28 United States Code, Section 2461(c), and Title 21, United States Code, Sections 334 and 853(p)). Respectfully submitted, RONALD C. MACHEN JR. UNITED STATES ATTORNEY Matthew C. Solomon Matthew C. Solomon Assistant United States Attorney 555 Fourth St, N.W., Fifth Floor Washington, DC N.Y. Bar Number Sondra L. Mills Sondra L. Mills Trial Attorney D.C. Bar Number United States Department of Justice Office of Consumer Protection Litigation 450 Fifth Street, N.W., Room 6400 South Washington, D.C

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