Pharma in Focus After Hours: Kythera (NASDAQ:KYTH), La Jolla Pharmaceutical (NASDAQ:LJPC), Medifast (NYSE:MED)

Kythera (NASDAQ:KYTH) and Bayer ADR (OTCMRKTS:BAYRY) announced that Kythera acquired all rights outside of the U.S. and Canada to ATX-101, a proprietary formulation of a purified synthetic version of deoxycholic acid currently in late-stage development for the reduction of submental fat (double chin). In 2010, KYTHERA (NASDAQ:KYTH) licensed the commercial rights to ATX-101 outside of the U.S. and Canada to Bayer Consumer Care AG.

Under the new agreement, Kythera Holdings, a wholly-owned Bermuda subsidiary of Kythera Biopharmaceuticals, acquired rights to develop and commercialize ATX-101 outside the U.S. and Canada. Bayer will receive $33M in KYTHERA (NASDAQ:KYTH) common stock, plus a $51M note, payable no later than 2024. Bayer is also eligible to receive certain long-term sales milestone payments on annual sales outside of the U.S. and Canada.

La Jolla Pharmaceutical (NASDAQ:LJPC) announced top-line results from its randomized, placebo-controlled Phase 2 trial of GCS-100 in chronic kidney disease. The trial met its primary efficacy endpoint of a statistically significant improvement in kidney function. Specifically, a dose of 1.5 mg/m2 led to a statistically significant increase in estimated glomerular filtration rate (eGFR) compared to placebo between baseline and end of treatment. At the 30 mg/m2 dose, there was no statistically significant difference.

Key secondary endpoints were also met, and the effect on circulating galectin-3 levels was consistent with the effect on eGFR. For the 1.5 mg/m2 dose, there was a statistically significant reduction in circulating levels of galectin-3, while there was no significant difference at the 30 mg/m2 dose level. GCS-100 was well-tolerated.

Out of 121 patients enrolled, 117 completed treatment, including all 41 patients treated at the 1.5 mg/m2 dose. There were no serious adverse events in the 1.5 mg/m2 dose group compared to two in the placebo group and two in the 30 mg/m2 group. All SAEs were deemed by the investigators as not drug-related. “We are obviously delighted with the results,” said George Tidmarsh, President and CEO of La Jolla Pharmaceutical (NASDAQ:LJPC). “We hope to use these results as a platform for further investigation not only in chronic kidney disease but also in other diseases where tissue fibrosis plays a central role.”

Medifast (NYSE:MED) is lower in late trading Monday after the company reported mixed financial results for Q4, and provided Q1 guidance below analysts’ expectations, plus a mixed FY14 outlook. Shares are down 1.84% at $24.50, with a 52-week range of $21.75 – $29.47. Medifast (NYSE:MED) reported Q4 earnings of $0.39 per share, compared with the prior-year period’s $0.13 per share. Revenue was $77.3 million, down from $83.24 million in the same quarter last year. Analysts polled by Capital IQ were expecting EPS of $0.37 on revenues of $80.57 million. The company expects Q1 EPS of $0.32 – $0.35 on revenues of $86 million – $88 million. The Street view is EPS of $0.49 on revenues of $96.79 million. For fiscal 2014, Medifast (NYSE:MED) said it sees EPS of $1.80 – $1.90, versus the Street view of $1.96, and revenue of $340 million – $380 million, versus the consensus of $372.49 million.



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