Fri Feb 7, 2014 4:17am EST
<span id="articleText"/>* Vyvanse fails to help patients in two depression trials
<span id="midArticle_0"/>* Shire pushing ahead with developing drug for binge eating
<span id="midArticle_1"/>* 2013 sales of Vyvanse in ADHD expected to be about $1.2 billion
<span id="midArticle_2"/>* Shares down 2 percent
<span id="midArticle_3"/>By Ben Hirschler
<span id="midArticle_4"/>LONDON, Feb 7 (Reuters) - Pharmaceuticals group Shire has halted development of its top-selling hyperactivity drug Vyvanse as a treatment for depression after it failed to treat patients successfully in two late-stage clinical trials.
<span id="midArticle_5"/>The news sent the drugmaker's high-flying shares down by about 2 percent to 30.80 pounds by 0830 GMT, though they remain within a whisker of this week's record high of 31.53 pounds, reflecting investor confidence in Shire's underlying growth.
<span id="midArticle_6"/>Amphetamine-based Vyvanse, prescribed to U.S. students to control attention deficit hyperactivity disorder (ADHD), did not ease symptoms significantly when given as an add-on therapy for adults who had responded inadequately to two common types of antidepressants, Shire said in a statement late on Thursday.
<span id="midArticle_7"/>As a result, London-listed Shire said it would no longer pursue the clinical development programme for major depressive disorders.
<span id="midArticle_8"/>Chief Executive Flemming Ornskov said the news was "disappointing" but pointed out that Vyvanse remains a leading treatment for ADHD and that the company would also be filing it for U.S. approval this year as a treatment for binge-eating disorders.
<span id="midArticle_9"/>Industry analysts estimate that Vyvanse sales totalled about $1.2 billion last year, reflecting its popularity as an ADHD treatment in the United States, the main market for such therapies.
<span id="midArticle_10"/>Some analysts were surprised by the negative results in depression, which had been considered a more promising new use for the medicine than the untested field of treating binge eating.
<span id="midArticle_11"/>Analysts at Jefferies said that Vyvanse as a depression treatment had accounted for 85 pence per share in its sum-of-the-parts valuation of the company based on anticipated annual sales of about $350 million by 2018.
<span id="midArticle_12"/>Berenberg analyst Alistair Campbell said the loss of Vyvanse as a depression treatment would result in a 3 percent cut to his 2018 earnings estimate for Shire. As a consequence, Berenberg no longer expects double-digit earnings growth through to 2018, lowering its forecast to 9 percent from 10 percent.
<span id="midArticle_13"/><span id="midArticle_14"/>PIPELINE FOCUS
<span id="midArticle_15"/>The setback for Vyvanse follows mixed late-stage results in December for another drug, lifitegrast, as a treatment for dry eye, putting Shire's ability to deliver on its pipeline of experimental medicines under scrutiny.
<span id="midArticle_0"/>"Pipeline focus is now increasingly on rare orphan diseases, potentially putting pressure on management to execute more business development deals and/or M&A, in our view, with ophthalmology and blood cancers possible targets," Jefferies said in a note.
<span id="midArticle_1"/>Shire is a serial acquirer of other drug companies. It struck its biggest deal yet in November, when it agreed to buy rare diseases specialist ViroPharma for $4.2 billion.
<span id="midArticle_2"/>Shares in Shire, which will report full-year results on Feb. 13, have outperformed the market strongly in the past year thanks to strong growth on the back of treatments for rare diseases and ADHD.
<span id="midArticle_3"/>It is a firm favourite among pharmaceutical analysts, with 20 of 25 sell-side analysts tracked by Thomson Reuters rating it either a "strong buy" or a "buy".
<span id="midArticle_4"/>
<span id="articleText"/>* Vyvanse fails to help patients in two depression trials
<span id="midArticle_0"/>* Shire pushing ahead with developing drug for binge eating
<span id="midArticle_1"/>* 2013 sales of Vyvanse in ADHD expected to be about $1.2 billion
<span id="midArticle_2"/>* Shares down 2 percent
<span id="midArticle_3"/>By Ben Hirschler
<span id="midArticle_4"/>LONDON, Feb 7 (Reuters) - Pharmaceuticals group Shire has halted development of its top-selling hyperactivity drug Vyvanse as a treatment for depression after it failed to treat patients successfully in two late-stage clinical trials.
<span id="midArticle_5"/>The news sent the drugmaker's high-flying shares down by about 2 percent to 30.80 pounds by 0830 GMT, though they remain within a whisker of this week's record high of 31.53 pounds, reflecting investor confidence in Shire's underlying growth.
<span id="midArticle_6"/>Amphetamine-based Vyvanse, prescribed to U.S. students to control attention deficit hyperactivity disorder (ADHD), did not ease symptoms significantly when given as an add-on therapy for adults who had responded inadequately to two common types of antidepressants, Shire said in a statement late on Thursday.
<span id="midArticle_7"/>As a result, London-listed Shire said it would no longer pursue the clinical development programme for major depressive disorders.
<span id="midArticle_8"/>Chief Executive Flemming Ornskov said the news was "disappointing" but pointed out that Vyvanse remains a leading treatment for ADHD and that the company would also be filing it for U.S. approval this year as a treatment for binge-eating disorders.
<span id="midArticle_9"/>Industry analysts estimate that Vyvanse sales totalled about $1.2 billion last year, reflecting its popularity as an ADHD treatment in the United States, the main market for such therapies.
<span id="midArticle_10"/>Some analysts were surprised by the negative results in depression, which had been considered a more promising new use for the medicine than the untested field of treating binge eating.
<span id="midArticle_11"/>Analysts at Jefferies said that Vyvanse as a depression treatment had accounted for 85 pence per share in its sum-of-the-parts valuation of the company based on anticipated annual sales of about $350 million by 2018.
<span id="midArticle_12"/>Berenberg analyst Alistair Campbell said the loss of Vyvanse as a depression treatment would result in a 3 percent cut to his 2018 earnings estimate for Shire. As a consequence, Berenberg no longer expects double-digit earnings growth through to 2018, lowering its forecast to 9 percent from 10 percent.
<span id="midArticle_13"/><span id="midArticle_14"/>PIPELINE FOCUS
<span id="midArticle_15"/>The setback for Vyvanse follows mixed late-stage results in December for another drug, lifitegrast, as a treatment for dry eye, putting Shire's ability to deliver on its pipeline of experimental medicines under scrutiny.
<span id="midArticle_0"/>"Pipeline focus is now increasingly on rare orphan diseases, potentially putting pressure on management to execute more business development deals and/or M&A, in our view, with ophthalmology and blood cancers possible targets," Jefferies said in a note.
<span id="midArticle_1"/>Shire is a serial acquirer of other drug companies. It struck its biggest deal yet in November, when it agreed to buy rare diseases specialist ViroPharma for $4.2 billion.
<span id="midArticle_2"/>Shares in Shire, which will report full-year results on Feb. 13, have outperformed the market strongly in the past year thanks to strong growth on the back of treatments for rare diseases and ADHD.
<span id="midArticle_3"/>It is a firm favourite among pharmaceutical analysts, with 20 of 25 sell-side analysts tracked by Thomson Reuters rating it either a "strong buy" or a "buy".
<span id="midArticle_4"/>
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