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News Breaks
July 17, 2014
13:34 EDTSHPGShire reports results from Vyvanse vs. Concerta studies in adolescents with ADHD
Shire announced top-line results from two Phase 4 efficacy and safety studies of Vyvanse compared with Concerta with a placebo reference arm in adolescents aged 13-17 diagnosed with Attention-Deficit/Hyperactivity Disorder. In SPD489-406, the forced-dose titration study, Vyvanse was found to be statistically superior to Concerta on the primary efficacy analysis with mean reductions on the ADHD RS-IV total score of 25.4 and 22.1 points, respectively. In SPD489-405, the dose optimization study, neither Vyvanse nor Concerta was found to be statistically superior to the other on the primary efficacy analysis, with a larger mean improvement found for Vyvanse than Concerta. The primary efficacy endpoint for both studies was defined as the change from baseline in ADHD-RS-IV total score at Week 6 and Week 8, respectively. In both studies, the types of adverse events appear to be generally consistent with the known safety profile for Vyvanse established in studies of adolescents with ADHD. Shire plans to submit the efficacy and safety data from the two studies for presentation at a future scientific congress.
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April 23, 2015
09:20 EDTSHPGCelgene patent latest to be challenged by Hayman Capital's Bass
The Coalition For Affordable Drugs, a group linked to Hayman Capital's Kyle Bass, has requested an Inter Partes Review of Claims 110 of U.S. Patent No. 6,045,501 held by Celgene (CELG), according to a USPTO filing. The 501 patent claims methods for delivering a drug, including a teratogenic drug, to a patient while preventing the exposure of a fetus or other contraindicated individuals to the drug. The patent is related to the company's Revlimid drug. BACKGROUND: Previously, the same coalition requested an Inter Partes Review of patents held by Pharmacyclics (PCYC), Acorda Therapeutics (ACOR), Shire (SHPG) and Jazz Pharmaceuticals (JAZZ). On January 7, Reuters reported that Bass planned to take "around 15 pharmaceutical companies with a combined market capitalization of $450B" into an Inter Partes Review for extending patents in questionable ways, citing a presentation made by Bass in Oslo. PRICE ACTION: Shares of Celgene are down 0.5% to $114.92 in pre-market trading.
April 22, 2015
07:07 EDTSHPGEuropean Association for the Study of the Liver to hold annual meeting
50th Annual Meeting of EASL will be held in Vienna, Austria on April 22-26.
April 20, 2015
14:32 EDTSHPGPharmacyclics patent for Imbruvica challenged by Hayman Capital's Bass
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April 13, 2015
07:20 EDTSHPGShire price target raised to $288 from $267 at JPMorgan
JPMorgan raised its price target for Shire to $288 after lifting its estimates for Lifitegrast in dry eye following the FDA's Priority Review designation. The firm believes the FDA is very likely to approve the application in October of this year, without waiting for the third Phase III study late 2015. It upped its 2020 Lifitegrast forecasts by $600M to $900M and reiterates an Overweight rating on Shire.

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