Life Science Compliance Update

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August 14, 2014

Antitrust Lawsuit Against Celgene Over Thalomid and Revlimid Focuses on REMS Requirements

Antitrust Revlimid

Celgene's successful cancer drugs Thalomid and Revlimid are at the center of an antitrust action. On April 3rd, Mylan Pharmaceuticals Inc. filed an antitrust lawsuit against Celgene Corporation in the U.S. District Court of New Jersey, accusing Celgene of blocking generic competition from Thalomid and Revlimid. Mylan accused Celgene of abusing their FDA Risk Evaluation and Mitigation Strategy requirements in order to monopolize the cancer drug market.

As a background, in 2007, the Food and Drug Administration Amendments Act (FDAAA) gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks. A REMS may be required by the FDA as part of the approval of a new product, or for an approved product when new safety information arises. According to FDA: "Essentially, a REMS is a safety strategy to manage a known or potential serious risk associated with a medicine and to enable patients to have continued access to such medicines by managing their safe use."

In Celgene's case, both their cancer drugs Thalomid and Revlimid have REMS attached to them that provide for restricted distribution due to safety concerns.

Among the 100-plus page REMS for Revlimid, the document states "Celgene will ensure that REVLIMID is only dispensed from REVLIMID REMS™ program certified pharmacies" (p. 3). In their complaint, Mylan accuses Celgene of using this REMS status as an excuse to prevent other companies from acquiring samples necessary to perform bioequivalence testing as part of the approval process for generic versions of the drugs.

Recognizing that certain REMS programs could be used to impede generic competition, Congress included language in FDAAA clarifying that REMS provisions may not be used for such purposes. FDAAA subsection f(8) states that no holder of a REMS-covered drug shall use an aspect of the REMS to "block or delay approval" of an ANDA. Consistent with subsection f(8), the FDA has stated publicly that REMS programs should not be used to block or delay generic competition.

Mylan Complaint

Thalomid is the branded version of the pharmaceutical thalidomide; Revlimid is the branded version of the pharmaceutical lenalidomide. Thalomid is used to treat multiple myeloma and lesions associated with complications from leprosy, while Revlimid is used to treat multiple myeloma and myelodysplastic syndromes, a group of blood disorders. According to Mylan's complaint, a monthly supply of Thalomid can cost between $5,000 and $9,000, while a monthly supply of Revlimid can cost up to $13,000, according to the complaint. Since 2006, Celgene has earned $20.9 billion from sales of the two drugs combined, comprising between 71 and 93 percent of its annual revenues (¶10).

In its complaint, Mylan states: "Celgene, a branded drug manufacturer, has used REMS as a pretext to prevent Mylan from acquiring the necessary samples to conduct bioequivalence studies, even after the FDA determined that Mylan's safety protocols were acceptable to conduct those studies."

Mylan claims that they had "contacted known wholesale distributors throughout the years, in an effort to obtain Thalomid and Revlimid samples," but those effort were not successful. "Throughout this entire period, Celgene has engaged in a scheme . . . to continuously prevent and/or stall all of Mylan's efforts to obtain samples of Thalomid and Revlimid." Eleven years after beginning efforts to develop generic Thalomid and five years after initiating efforts to develop generic Revlimid, Mylan has been unable to acquire any samples from Celgene.

"Such conduct harms consumers by denying them the substantial benefits of lower-priced generic competition and forces consumers and federal, state, and private payors to overspend on prescriptions for these products," Mylan argues.

In its Prayer for Relief, Mylan requested the Court (1) compel Celgene to sell Mylan sufficient quantities of Thalomid and Revlimid at market prices so that Mylan can perform bioequivalence testing; (2) Compensatory damages for Mylan's lost sales of generic thalidomide and lenalidomide, and profits on those sales, that are caused by Mylan's delay in submitting an Abbreviated New Drug Application; and (3) Treble damages.

Other Antitrust Actions Related to REMS

Last fall, Law 360 reported on a similar REMS issue in a lawsuit involving Apotex Corp. and Roxane Laboratories Inc., who were attempting to gain access to samples of Actelion Pharmaceuticals' high blood pressure medication, Tracleer. David Balto wrote: "Without these samples, Apotex and Roxane [would] not be able to demonstrate their generic versions of the drug are bioequivalent, a requirement for FDA approval."

In that case, Actelion sought declaratory judgment that Tracleer's REMS program—which, like Thalomid and Revlimid's REMS, required the drug only be sold and dispensed by certain certified pharmacies—prevented them from providing competitors with samples.


 

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