Shire’s growth during the period was driven by a solid increase in total revenues, which jumped 23% to $411 million, as product sales leapt 28% to $346 million and royalty income climbed 5% to $61 million.
Product sales were propelled by strong performances from: Adderall (mixed amphetamine salts), for attention-deficit hyperactivity disorder, leaping 42% to $206 million; the hyperphosphataemia drug Fosrenol (lanthanum carbonate), rocketing 59% to $7.8 million; the ulcerative colitis therapy Pentasa (mesalamine), up 7% to $28.1 million; and newcomer Replagal (agalsidase alfa) - for the treatment of Fabry disease - which entered the group’s portfolio through its purchase of Transkaryotic Therapies last year and brought in first-quarter revenues of $25.8 million.
On the downside, a reduction in turnover was booked for US sales of Agrylin/Xagrid (anagrelide) for thrombocythemia, which plummeted 93% to $1.4 million on mounting generic competition (rest of world sales were flat at $12.1 million) and Carbatrol (carbamazepine), which fell 17% to $14.1 million, due to “limited promotion and supply constraints” in the US.
But the news looks set to be positive over the coming months, with several filings and potential approvals in the pipeline. “In Q2, we expect a response from the US Food and Drug Administration for Elaprase (idursulfase), our treatment for Hunter syndrome, and later in the year we are expecting the first response from the European authorities. Mesavance (mesalamine), for ulcerative colitis is now filed with both the European and the US agencies,” Emmens noted.
Furthermore, Shire recently received a green light from US regulators to market Daytrana (methylphenidate), the first transdermal patch for the treatment of attention-deficit hyperactivity disorder. According to Shire, “the US ADHD market is performing as expected, with prescription growth at around 5%,” and it is planning to launch the drug mid-year.
With regard to the firm’s near-term performance, Emmens remarked: “We have a strong pipeline and are planning for the roll-out of five new products by mid-2007. There is good momentum in the business and we continue to anticipate revenue growth for 2006 in the low double-digit range.”
Meanwhile, Shire noted it is in talks with Barr Laboratories, which is angling to bring a generic version of Adderall XR to market by breaking Shire's patent on the ADHD drug in the courts.
The company is hoping to agree an out-of-court settlement with Barr, which would minimise the risk to Adderall XR and give the firm time to switch patients to NRP104, a drug it is developing for ADHD that could reach the market next year and has been tipped to make sales in excess of $1 billion.