CorMedix Inc. Receives Positive Feedback from FDA for Neutrolin® Clinical Trial Protocol for Oncology Patients

BEDMINSTER, N.J., June 17, 2015 -- CorMedix Inc. (NYSE MKT: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardiac, renal and infectious disease, today announced that the U.S. Food and Drug Administration (FDA) has provided positive feedback regarding a second pivotal clinical trial protocol.  The new Phase 3 protocol is designed to assess the use of Neutrolin^® as a catheter lock solution in oncology patients who require total parenteral nutrition (TPN) to support filing of a New Drug Application with the FDA. The comments provided by the FDA should enhance the quality of the proposed study.

Allergan to Acquire KYTHERA Biopharmaceuticals

- Complements Allergan's Existing Position in Facial Aesthetics -
- Lead Product KYBELLA™ the First and Only Approved Non-surgical Treatment for Reduction of Submental Fullness -
- Enhances Allergan's Long-term Growth Profile -

DUBLIN and WESTLAKE VILLAGE, Calif., June 17, 2015 -- Allergan plc (AGN), a leading global pharmaceutical company, and KYTHERA Biopharmaceuticals, Inc. (KYTH), a biopharmaceutical company focused on the discovery, development and commercialization of novel prescription products for the aesthetic medicine market, today announced that they have entered into a definitive agreement under which Allergan has agreed to acquire KYTHERA in a cash and equity  transaction valued at $75 per KYTHERA share, or approximately $2.1 billion, subject to the fulfillment of certain customary conditions summarized below.  The fixed-value transaction consideration will be payable 80 percent in cash and 20 percent in new AGN shares issued to KYTHERA shareholders.  Allergan's 2015 earnings-per-share forecast provided on May 11, 2015 is unchanged as a result of the acquisition.  The acquisition is expected to be breakeven in 2016 and accretive thereafter.  The Company remains committed to de-levering to below 3.5x debt to Adjusted EBITDA by the end of the first quarter of 2016.

Synergy Pharmaceuticals Announces Positive Results in the First Phase 3 Trial of Plecanatide in Patients with Chronic Idiopathic Constipation (CIC)

NEW YORK-- -- Synergy Pharmaceuticals Inc. (SGYP) today announced positive top-line results from the first of two pivotal phase 3 clinical trials evaluating the efficacy and safety of two different plecanatide treatment doses (3.0 mg and 6.0 mg), taken as a tablet once-a-day, in 1,346 adult patients with chronic idiopathic constipation (CIC).

Preliminary analysis of the data indicates that both plecanatide 3.0 mg and 6.0 mg doses met the study’s primary endpoint and demonstrated statistical significance in the proportion of patients in the intention-to-treat population who were durable overall responders compared to placebo during the 12-week treatment period (21.0% in 3.0 mg and 19.5% in 6.0 mg dose groups compared to 10.2% in placebo; p<0.001 for both doses).