NEW YORK—Celgene Corp. is planning to fight the recent generic challenge to its blood cancer drug, Revlimid, and has been plotting its strategy for years.
The drug, mainly used to treat multiple myeloma, is key to Celgene's growth and made up more than half of the Summit, N.J., drug maker's total revenue of $2.7 billion last year. Earlier this week, the Food and Drug Administration disclosed that an unnamed drug maker has applied for approval of a generic Revlimid.
A Celgene spokesman declined to comment beyond a statement released early Wednesday that it intends to "enforce its extensive intellectual property rights," but hasn't received official notice of the challenge. But earlier this year, the company's chief executive said the patent battle for a closely related drug was shaped by thinking ahead to the defense of Revlimid.
…Revlimid is covered by 12 patents, including a patent covering the composition of Revlimid that expires in 2019 and a polymorph patent, covering another form of the compound, that expires in 2026.
Jefferies analyst Thomas Wei believes it is the 2026 patent that is being challenged by the yet unnamed generic company and calculates that Celgene's share price implies a 2019 patent expiration.
"Because of the types of patents that expire beyond 2019 and the mixed track record of success with crystal polymorph patents, there is uncertainty on the exclusivity period for Revlimid beyond 2019," Wei wrote in a note to clients.
Revlimid is a more potent derivative of thalidomide, which Celgene has sold as Thalomid since 1998. Generic giant Teva Pharmaceutical Industries Ltd. withdrew a patent challenge to make a generic version of Thalomid in May, citing a "lack of commercial viability." The challenge was initiated by Barr Pharmaceuticals, which was later bought by Teva.
At a June industry conference, Chief Executive Robert Hugin cited the legal battle over Thalomid, which spanned three and a half years, as being preparation for any future challenge to Revlimid.
Hugin said the company would use the same legal team, made up of three law firms, in defending Revlimid. He called the case for Thalomid "only the initial battle" and Celgene instructed the legal team not to make any moves in defending Thalomid that could hurt the eventual defense of Revlimid.
"Everything we've done is to protect Revlimid and we feel as strong as we can about the patent estate," he said, stressing his confidence in the 2026 patent.
Furthermore, Celgene will likely argue that the FDA shouldn't allow generic versions of Revlimid because of the dangers associated with the drug.
Thalidomide was once used overseas to treat morning sickness during pregnancy but was banned in the early 1960s after causing devastating birth defects. Thalomid was approved under a strict distribution plan and Revlimid has similar restrictions.
The distribution plan for Thalomid, which was key to getting the FDA's approval, is covered by numerous patents, six of which are part of the Revlimid patent portfolio and expire in 2018 and 2020.
In a 2007 citizen's petition sent to the agency, Celgene argued that approval of generic Thalomid couldn't be reviewed like other drugs because just one pill can cause severe birth defects[lame].
It argued that allowing multiple companies on the market could raise issues such as cross-contamination in manufacturing, and increased risk of confusion and medication errors if there are multiple risk management plans for the branded and generic versions[even more lame, IMO].‹
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