Only days after Celgene dodged a patent attack on its megablockbuster drug Revlimid in the U.S., a copycat has rolled on to the market in Europe.
Alvogen launched its generic in several small European countries, including Romania, Croatia and Bulgaria, and says other rollouts are on track for this year. Revlimid racked up $1.8 billion in EU sales in 2017, Alvogen has said, which makes a very big bullseye for generics to target.
The generic launch might come as a surprise to Celgene investors, considering the drugmaker said in its most recent quarterly filing (PDF) that it believes Revlimid is protected by patents in Europe until at least 2022. Celgene previously inked a settlement with Accord Healthcare allowing the company to launch its generic in certain European markets in 2022. Celgene declined to comment to FiercePharma on the launch.
Indeed, Jefferies analyst Michael Yee wrote Thursday that Celgene investors were taken "off guard" because of a lack of communication from Celgene about the launch. The analyst said his team fielded questions "all day" Wednesday "regarding the confusion and uncertainty" around the generic rollout. Celgene didn't provide updates, the analyst said, so "investors were unclear as to what the impact was and why there was no prior commentary from [Celgene] management that an EU generic launch could be possible."
For its part, Celgene wasn't surprised about the launch because it previously inked a "confidential agreement" with Alvogen for the rollout, Yee wrote. Celgene management also told the analyst that Alvogen's comment about a 2019 global launch was used "very loosely," and that they doesn't expect a broad European launch. Celgene doesn't expect Alvogen's launch to materially affect its sales for Revlimid.
The news comes only days after the U.S. Patent and Trademark Office declined Dr. Reddy's request to review three Revlimid patents standing in the way of U.S. copycat launches. That decision means it’s likely Revlimid will keep its lock on the U.S. market for several more years, analysts said, barring challenges in court.
For now, Revlimid is expected to start facing U.S. competition in 2022 under a limited settlement that Celgene previously inked with Natco Pharma. The drug pulled in $6.47 billion in the U.S. in 2018.
The PTO’s decision marked an important win for both Bristol-Myers Squibb and Celgene, which last month inked one of biopharma’s biggest-ever merger agreements. After the $74 billion buyout, the combined company will be a leader in oncology and cardiovascular diseases and a top 5 player in inflammatory diseases, executives have said.
But threats to Revlimid were at the top of investor concerns following the deal. The drug generated almost two-thirds of Celgene’s sales last year.
Aside from Revlimid, Bristol executives said they’re excited about the “doubling” of the company’s pipeline with the deal. The combined drugmaker would have 10 phase 3 programs, six near-term potential launches and a broad early-stage pipeline, executives said.
Editor's note: This story was updated with comments from Jefferies analyst Michael Yee.