Celgene Corp. gave an initial glimpse at sales for its recently launched Pomalyst (pomalidomide) to treat multiple myeloma, revealing early revenues that surpassed analyst expectations.

After FDA approved the drug Feb. 8, Pomalyst’s first-quarter sales were $29 million. Of that, $22 million was in the U.S., while $7 million came from early access programs in Europe. Wall Street consensus for Pomalyst sales during the quarter was $8 million. Celgene expects a regulatory decision on Pomalyst from EU’s CHMP in the third quarter of 2013 ([A#14130208006]).

Investors have driven up Celgene shares about 46% this year. That brings its market cap up to almost $50 billion. The biotech is confident Pomalyst “will become our next blockbuster hematology brand,” Celgene CCO and EVP Mark Alles said on an April 25 earnings call.

Keeping Pomalyst’s sales momentum going is just one of Celgene’s top priorities. The biotech is also trying to continue expanding sales of the blockbuster MM treatment Revlimid (lenalidomide) by adding new indications and geographies. But Celgene’s plans for Revlimid as a frontline and maintenance MM therapy have already been delayed due to safety concerns.

Considering New Combinations

The Pomalyst launch followed the approval last July of another multiple myeloma treatment, Kyprolis (carfilzomib) from Onyx Pharmaceuticals Inc. The two have different mechanisms of action and delivery. Pomalyst is an oral immunomodulator, while Kyprolis is a proteasome inhibitor given by intravenous infusion ([A#14130315004]).

Celgene’s Alles said most of the Pomalyst patients are third or fourth line, which is within the approved label. In addition, he said, “patients are either finishing or switching from Kyprolis to Pomalyst.” It’s typical for MM patients to cycle through a series of treatments to delay disease progression and eventual mortality. Alles noted that almost all of the Pomalyst patients had previously received Revlimid, another oral immunomodulator.

He said Celgene hasn’t seen combination use of Pomalyst and Kyprolis, but added that “investigator interest is high.” He said several investigators at the XIVth International Myeloma Workshop in Kyoto in April were interested in determining if a combination of Pomalyst, Kyprolis and dexamethasone (PKD) might be superior to what’s been seen with Revlimid, Kyprolis and dexamethasone (RKD) Also see "Onyx’s Transformative Year: From Productive Partner To Big Cap Contender?" - In Vivo, 19 March, 2013..

The combinations of MM treatments in the clinic and used by physicians are rapidly evolving. RKD could “end up being the top regimen especially for high risk patients or in the setting of newly-diagnosed myeloma,” said Alles. Currently, Revlimid, Velcade (bortezomib) and dexamethasone (RVD) is a common combination used to treat frontline MM, despite the fact that Revlimid is only approved for second-line or later treatment. Velcade is marketed by Takeda Oncology

Revving Up Revlimid

Celgene hopes to gain an FDA approval for Revlimid to treat frontline MM patients. “There is no greater corporate priority for us than to expand the clinical benefit of Revlimid to patients with newly diagnosed multiple myeloma,” said Alles on the call.

But last June, Celgene withdrew its EU application for approval in this indication as well as for maintenance therapy on concerns about second primary cancers, including acute myeloid leukemia and myelodysplastic syndromes Also see "Counting The Cost Of Delay For Revlimid Front-line Myeloma Approval" - Pink Sheet, 25 June, 2012.. At that time, it also postponed an FDA submission but said it expected one in 2013.

The company didn’t lay out a timeline for regulatory submissions during the call. Celgene does plan to update data for a Phase III trial of Revlimid in newly diagnosed MM patients, MM-015, at the American Society of Hematology meeting in December. It will also discuss these data with regulatory agencies “in the coming months,” Alles said. Celgene could provide further details on its regulatory plans for frontline and maintenance use of Revlimid at an analyst day on May 6, which will include a five to seven year plan for its hematology oncology franchise.

Revlimid was recently approved by SFDA in China for second-line and later MM patients. Celgene CFO and EVP Jacqualyn Fouse said the opportunity for Revlimid in China would be worth more than $100 million within several years. Revlimid also has a June 5 PDUFA date for Revlimid to treat relapsed and refractory mantle cell lymphoma (MCL) after prior therapy that included bortezomib.

Revlimid had more than $1 billion in sales in the first quarter, including $568 million in the U.S. and $435 million in international markets. U.S. Revlimid sales were up 16% from 1Q12, while international sales added 17% during that period. The company said all the Revlimid growth could be attributed to an increase in volume, while the negative impact of currency exchange and the positive impact of price increases offset one another.

Expectations for 2013

Sequentially, from the fourth quarter of 2012, Celgene’s product and total revenues declined by 1%. The biotech attributed the change to the Medicare Part D coverage gap rebates of $15 million in the first quarter of this year; they were only $4 million in the 2012 fourth quarter and $2 million in the first quarter of 2012.

Celgene reaffirmed 2013 guidance for total net product sales of $6 billion, up 11% from 2012, and Revlimid net product sales of $4.1 to $4.2 billion, up 10% from 2012. It raised earnings per share guidance to $5.55 to $5.65 per share from $5.50 to $5.60. That accounts for the potential entrance of a generic Vidaza (azacitidine) during the second half; the drug’s first quarter 2013 sales were $204 million Also see "Celgene Lays Out Catalysts For Strong 2013, Highlights Apremilast" - Pink Sheet, 25 January, 2013..

The biotech also expects the U.S. budget sequestration could have a “slightly positive impact on orals” through Oct. 1 and added that only half of 1% of Celgene’s revenue would be impacted by President Obama’s current budget proposal.

Upcoming Celgene milestones include submissions in the second half of this year to FDA for apremilast to treat moderate-to-severe plaque psoriasis and to EMA for psoriatic arthritis and psoriasis Also see "Apremilast Efficacy Results Disappoint But May Be Enough For Commercial Success" - Pink Sheet, 4 March, 2013.. The biotech will also have more than 50 abstracts at the AmericanSociety for Clinical Oncology (ASCO) meeting on May 31 to June 4. Alles said five of these abstracts will have “important and immediate clinical considerations.” ASCO is slated to release most full abstracts on May 15; it has already posted abstract titles.

Celgene Has A Swift Start For Pomalyst Launch

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