CAMBRIDGE, Mass. (
first-quarter earnings failed to meet Street expectations on disappointing sales of its multiple sclerosis drug Tysabri.
Adjusted earnings for the quarter were $1.08 a share, below the consensus estimate of $1.13 a share. Biogen said it took a $13 million charge in the quarter due to passage into law of the healthcare reform legislation.
On a GAAP basis, Biogen's earnings fell 5% to 80 cents a share.
Total revenue in the quarter was $1.11 billion up 7% year over year but just a tad below investors' consensus estimate of $1.12 billion. More worrisome were worldwide Tysabri sales of $292 million, well below consensus estimate of $306 million. Approximately 146 new patients per week began Tysabri treatment during the first quarter, down from net new patients adds of 177 per week during the fourth quarter.
Sales of Avonex, Biogen's other multiple sclerosis drug, totaled $593 million in the first quarter, in line with consensus estimates.
Berwick: ObamaCare's Major Coup (Forbes)
In April, Biogen said its board authorized a new $1.5 billion share repurchase program. The company did not update its 2010 financial guidance.
Biogen shares were up one cent to $54.80 in pre-market trading.
Human Genome's Lupus Drug Wanes Over Time
(Updated at 8:48 am EDT)
The beneficial effect of
Human Genome Sciences'
experimental lupus drug Benlysta wanes over time, according to updated results from a phase III study released Tuesday.
Human Genome said 38.5% of patients responded to treatment with a high dose of Benlysta after 76 weeks compared to 32.4% of patients treated with a placebo, a difference that was not statistically significant.
were first announced in November, the high-dose Benlysta patients reported a 43.2% response rate after 52 weeks of treatment compared to a 33% response rate for placebo -- a result that was statistically significant.
The primary endpoint of this phase III study was designed to measure the effect of Benlysta after one year of treatment, so the study was a success. The waning benefit of Benlysta for lupus patients measured 18 months after treatment, however, could influence doctors to treat lupus patients for a shorter period of time with Benlysta. That might affect the drug's commercial sales potential.
Human Genome shares were down 5% to $29.75 in Tuesday's pre-market trading.
Human Genome and partner
are expected to seek regulatory approval for Benlysta later this year. The approval applications are based on two positive phase III studies of Benlysta.
"A positive overall picture has emerged from our pivotal Phase 3 studies of Benlysta, including its achievement of statistical significance on the primary efficacy endpoint at Week 52 with a favorable safety profile in both BLISS-52 and BLISS-76," said Thomas Watkins, Human Genome's CEO, in a statment. "We view the results of these studies as strongly supportive of our view that Benlysta has the potential to become the first new approved drug in more than 50 years for people living with systemic lupus."
-- Reported by Adam Feuerstein in Boston.
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