September 19, 2020

Celgene accused of monopolizing market for cancer drug

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prescription_pillsBy Charles Toutant, from New Jersey Law Journal

An antitrust suit filed on behalf of a class of end payors alleges Celgene Corp. took steps to prevent the approval of generic versions of its cancer drugs Thalomid and Revlimid.

Celgene charges up to $500 per capsule for the drugs, and has taken in $17.1 billion selling them from 2009 to 2013, the suit says. The company has unlawfully perpetuated a monopoly by interfering with efforts to develop generic versions, according to the suit. The plaintiff, the city of Providence, Rhode Island, brought the suit on behalf of users and end payors of the drugs.

The suit, filed in the U.S. District Court for the District of New Jersey, brings claims for monopolization, attempted monopolization and unfair trade practices under the laws of various states, and seeks injunctive relief for violations of the Clayton Act. Also included is an unjust enrichment claim. The suit seeks compensatory and punitive damages and attorney fees and costs.

The suit claims Celgene uses a mandated restriction on access to Thalomid as a pretext to prevent generic companies from developing versions of the drug. To obtain approval from the U.S. Food and Drug Administration, a generic maker must obtain a sample of the drug it is seeking to replicate, to conduct bioequivalence testing, but Celgene refuses to sell its product, citing an FDA-mandated distribution program called Risk Evaluation and Mitigation Strategies (REMS), which requires pharmacists and patients to enroll in the program before receiving the drugs.

Thalomid is also known as thalidomide, which was developed in the 1950s as a treatment for morning sickness in pregnant women, but it was taken off the U.S. market in 1962 after it was found to cause severe birth defects. It was approved in 1998 as a treatment for leprosy, and more recently it was used in conjunction with steroids to treat multiple myeloma. Revlimid is similar to Thalomid and is also used for myeloma. The 1998 approval was contingent on participation in the REMS program to ensure pregnant women do not use the drugs.

Celgene, headquartered in Summit, N.J., has cited the REMS restrictions when it refused to sell samples of the drugs to Mylan Pharmaceuticals, Lannett Company and Dr. Reddy’s Laboratories, although the FDA has said such sales are not restricted under REMS, the suit claims. Mylan filed a separate suit in the District of New Jersey in April 2014, claiming Celgene used the REMS program as a pretext to obstruct approval of a generic version of its drugs, the suit says. In December 2014, Celgene’s motion to dismiss was denied, and an appeal is pending at the U.S. Court of Appeals for the Third Circuit.

The suit also claims Celgene fraudulently obtained six patents on its method of distributing the drug while preventing its exposure to fetuses, and has engaged in “sham litigation” to enforce the patents.

The suit also cites a separate case in which Celgene brought a suit over Barr Pharmaceutical’s application to make a generic version of Thalomid. The case ended in a confidential settlement, and the class complaint in the Providence case speculated that the terms might include a “reverse payment” or “pay for delay” deal. On information and belief, the deal had an anticompetitive effect, the suit says. At the same time, Celgene filed a petition with the FDA, urging it to deny Barr’s application based on alleged safety concerns that were poorly supported, the suit says.

Celgene maintains a monopoly through “willful exclusionary conduct, as distinguished from growth or development as a consequence of a superior product, business acumen or historic accident,” the suit claims.

James Notis of Gardy & Notis in Englewood Cliffs, N.J., representing Providence and the class, did not return a call seeking comment, nor did Celgene representatives.

For more on this story go to: http://www.njlawjournal.com/id=1202719766852/Celgene-Accused-of-Monopolizing-Market-for-Cancer-Drug#ixzz3TzhAc0bC

 

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