Shire Just Took Another Step Forward With Its ADHD Drug

BTIG's Timothy Chiang said Shire PLC (ADR)

moved one step closer to satisfying the FDA's request for clinical data with its SHP465 (a three-bead formulation of mixed amphetamine salts) compound for the treatment of ADHD (Attention-Deficit Hyperactivity Disorder). The company announced positive results of SHP465 safety and efficacy study in children and adolescents with ADHD and said the study addresses key U.S. Food and Drug Administration (FDA) requirement, keeping SHP465 on track for potential 2017 U.S. launch. http://finance.yahoo.com/news/shire-announces-positive-results-shp465-110000088.html "While we are currently forecasting $50M of sales in 2018 for SHP465, we do think our estimates could be conservative, given Shire's dominant presence in the ADHD treatment space," Chiang noted. "Assuming SHP465 is approved and launched in 2H17, we expect a potentially long runway of patent protection (up to May 2029). We believe SHP465 could offer a longer duration of coverage vs. Adderall XR," Chiang added. Chiang continued: "Our analysis of prescription trends for Vyvanse and Adderall XR suggest that there are ~1.2M Rx's dispensed per month on these two treatments in the US, with Vyvanse volumes up ~9% in the Jan-Feb time frame." "Currently, our CY16 and CY17 Vyvanse sales forecasts are $1.93B and $2.2B, respectively, with Shire's total ADHD franchise making up ~one-third of the Co.'s total revenues. With additional generics expected in Adderall XR, most of the sales growth is tied to Vyvanse which is patent protected until June 29, 2023." Chiang remains positive SHPG shares and reiterated its $230 price target. ADRs of Shire closed Monday's regular trading session up 1.54 percent at $177.51.