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SHPG

Shire

$176.90

-0.4 (-0.23%)

17:47
10/18/18
10/18
17:47
10/18/18
17:47

FDA advisory committee recommends Shire's Prucalopride for CIC

Shire announced that the FDA Gastrointestinal Drugs Advisory Committee voted unanimously 10 to 0 that the risk-benefit profile of prucalopride supports the approval of this New Drug Application. The FDA will take the advisory committee's recommendation into consideration when the agency makes a final determination. The Prescription Drug User Fee Act PDUFA action date for prucalopride is December 21, 2018. The advisory committee also voted unanimously 10 to 0 that the potential risk of cardiovascular adverse events with the use of prucalopride in adults with CIC has been adequately addressed by Shire. Prucalopride, a serotonin type 4 receptor agonist, is a gastrointestinal prokinetic agent that stimulates colonic peristalsis, increasing bowel motility. Drugs similar to prucalopride have been associated with adverse cardiovascular events in the past. Prucalopride has been studied in more than 90 clinical trials worldwide over the last 20 years, including six key studies by which the advisory committee made its recommendation today. The advisory committee reviewed data included in the prucalopride NDA, specifically five main Phase 3 and one Phase 4 double-blind, placebo-controlled clinical trials. An integrated analysis of these six main randomized, controlled clinical trials evaluated the global efficacy and safety of prucalopride 2 mg daily in men and women with chronic constipation; study designs across the trials were similar. Overall, there were 2,484 adult patients included in the integrated efficacy analysis and 2,552 adult patients included in the integrated safety analysis; all patients included received prucalopride less than or equal to 2 mg daily or placebo. There are an estimated 35M adults in the U.S. with chronic idiopathic constipation.

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SHPG Shire
$176.90

-0.4 (-0.23%)

05/09/18
LEER
05/09/18
NO CHANGE
LEER
Takeda/Shire transaction shows path for consolidation, says Leerink
Leerink analyst Geoffrey Porges notes that Takeda (TKPYY) confirmed its intention and agreement to purchase Shire (SHPG) for $62B in cash and stock. For the broader biopharma industry, the analyst believes Takeda's ability to lever up to an estimated 5.4x net debt/EBITDA suggests that investors are underestimating the ability of large cap biopharma companies to pursue large transactions. Nearly all of the large cap biopharma companies face looming growth issues or suffer under revenue-concentration risk discounts that could be mitigated by large-scale acquisitions, he contends. Porges believes that if Takeda can execute the Shire acquisition while checking the boxes of investor demands of a net positive ROIC, instant EPS accretion, maintaining an investment grade credit rating, and massive synergy savings, then others in the biopharma industry with stronger balance sheets and larger valuations can contemplate transactions that are substantially larger even than Shire.
09/04/18
BERN
09/04/18
DOWNGRADE
BERN
Market Perform
Shire downgraded to Market Perform from Outperform at Bernstein
09/04/18
09/04/18
DOWNGRADE

Market Perform
Shire downgraded to Market Perform as spread narrows at Bernstein
As previously reported, Bernstein analyst Aaron Gal downgraded Shire (SHPG) to Market Perform from Outperform. The analyst notes that he current controversy on Shire is the risk/reward into the closing of the Takeda (TKPYY) acquisition, and over the past few weeks deal spread narrowed, and the fundamentals have gotten a bit tougher in ADHD, HAE and Hemophilia.
09/07/18
BREN
09/07/18
DOWNGRADE
BREN
Hold
Shire downgraded to Hold from Buy at Berenberg
Berenberg analyst Klara Fernandes downgraded Shire (SHPG) to Hold saying the current valuation offers limited potential upside ahead of the pending takeover by Takeda Pharmaceutical (TKPYY).

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LOV

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ACA

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JNJ

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