Wednesday's positive recommendation for Onyx Pharma's (ONXX) Kyprolis gives the drug tailwinds ahead of the July 27 PDUFA date.
While the win was big for Onyx, investors exited Celgene (CELG) on concerns Kyprolis will eat into Revlimid market share and over worries surrounding Celgene withdrawing an EU application to expand Revlimid's use.
As I previously wrote in May, Celgene has a deep bench of late stage opportunities, suggesting short term selling provides a good opportunity to buy.
The impact of the application withdrawal is limited.
Celgene had hoped to expand Revlimid's use to newly diagnosed multiple myeloma patients and to make Revlimid available as a myeloma maintenance therapy. After concerns of secondary cancers were reported earlier this year, the European Medicine's Agency indicated it wanted more data, which prompted Celgene's withdrawal. It's likely we'll see Celgene resubmit later. And, in the meantime, expect Celgene to proceed with submissions in other core markets, like Australia.
While the withdrawal is a setback, it won't play a major role in de-railing the company's revenue or earnings. The company reiterated its forecast for $5.4-$5.6 billion in 2012 sales, rising to $8-$9 billion in 2015 and guided for earnings of $4.7-$4.8 this year and $8-$9 per share in 2015.
Pomalidomide provides a 2013 catalyst.
Celgene also reported it filed it's expected application for Pomalidomide with the European Medicine's Agency. The filing suggests the multiple myeloma drug, which is the same class as Revlimid, may be available for sale in Europe late this year or early next.
Here in the U.S., the FDA decided against priority review for Pomalidomide, which means they'll make their decision in February 2013.
If approved, Celgene will market the drug as an alternative therapy to Kyprolis in relapsed and refractory myeloma.
A Kyprolis and Revlimid Cocktail may mean both companies win.
Initial data from an ongoing Onyx trial combining Kyprolis with Celgene's Thalidomide and separately with Revlimid was presented at ASCO earlier this month.
The combination of Kyprolis, Revlimid and Dexa showed a 98% response rate and 92% progression free survival rate with a lower rate of side affects. If future data confirms this success, it's likely to provide tailwinds for both companies.
Celgene's opportunities beyond myeloma remain.
Beyond multiple myeloma, Celgene has opportunity to expand Revlimid's label to include lymphoma and CLL. And, its Abraxane, which is approved for the treatment of breast cancer, could see approval for non small cell lung cancer later this year. Abraxane may also have upside from treating pancreatic cancer and melanoma, with both in or entering phase III trials.
Investors will likely also see data from the company's Phase III study of Apremilast as a treatment for psoriatic arthritis this summer and for psoriasis by year end.
Despite the potential and the company's bullish 2015 guidance, shares have dropped 25% since spring. This suggests investors using this summer sell-off to buy may find themselves nicely rewarded over the coming 12 months.