Healthcare Review: Galectin Therapeutics, Intercept Pharmaceuticals, Galena Biopharma, Alimera Sciences, Merck Print E-mail
By Staff and Wire Reports   
Monday, 13 January 2014 14:38
U.S. stocks were flat in early trading Monday as gains in drugmaker Merck were offset by investor concern over valuations. Investor concern may be increasing as stocks have become expensive, with the S&P above the mean forward price-to-earnings ratio and at its highest level in nearly seven years. The benchmark S&P 500 surged almost 30 percent in 2013. According to Thomson Reuters data, fourth-quarter earnings are expected to grow 7.3 percent over the year-ago period. However, the 9.8 ratio of negative guidance to positive outlooks is currently the largest on record.

Galectin Therapeutics ($GALT) is having a rough session. The shares rose 76% late last week, as investors clamored for liver disease plays in the wake of Intercept Pharmaceuticals' monumental rally. Today, the company announced the completion of patient enrollment "in the first cohort of a Phase 1 trial of GR-MD-02."The study will evaluate the "safety, tolerability, and exploratory biomarkers for efficacy for single and multiple doses of GR-MD-02 when administered to patients with fatty liver disease with advanced fibrosis."

Shares of Intercept Pharmaceuticals ($ICPT) are off their, but are still sharply lower coming off last week's improbable run. Count Summer Street's Bart Classen among those not too concerned with the "bad" cholesterol chatter that's at least partly responsible for today's sell-off. Classen reportedly thinks that due to the seriousness of NASH, a potential rise in LDL likely won't be enough to deter many people from using OCA.

Galena Biopharma ($GALE) rallies on news the company is buying Mills Pharmaceuticals, giving GALE rights to GALE-401 (CR anagrelide), a treatment for Essential Thrombocythemia. In GALE's estimation, the drug "meets the qualifications for orphan drug status [and] has an estimated peak market size of approximately $200M in the U.S." The company says a Phase 2 study should begin in "mid-2014."GALE made an upfront payment to Mills' owners who are also eligible for stock grants and a milestone payment, the latter is contingent upon FDA approval of an NDA for '401.

Alimera Sciences ($ALIM) says it has begun shipping the first orders of Iluvien to U.K. NHS facilities. The company also says "the first NHS patient received an implant for the treatment of DME" on January 10.For reference: NICE guidance allows for patients with a pseudophakic eye to receive Iluvien when their chronic DME is "considered insufficiently responsive to available therapies."

Merck ($MRK) is considering its options for its animal health and consumer-care operations and plans to carry out any moves this year. The pharmaceutical company said it "could reach different decisions" about the businesses. Merck's comments follow reports last week that the company is in talks with Novartis about the Swiss pharmaceuticals company swapping its animal-health and human vaccines businesses for the U.S. drug maker's over-the-counter health-products unit.

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