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EW Gets FDA Nod, BMRN's Achondroplasia Trial Promising, Watch Out For POZN

Pharma 061715

Arrowhead Research Corp. (ARWR) has received regulatory clearance in Germany for two additional phase 2b multiple-dose studies of ARC-520 in patients with chronic HBV infection to be conducted in parallel.

The studies, titled Heparc-2002 and Heparc-2003, are planned to enroll up to 60 and 90 patients, respectively. In each study, patients will be randomized to receive four doses, once every 4 weeks, of either 1 mg/kg ARC-520, 2 mg/kg ARC-520, or placebo at a ratio of 1:1:1, according to the company.

The primary objective of the studies is to evaluate the depth of hepatitis B surface antigen (HBsAg) decline in response to multiple doses of ARC-520 compared to placebo as a measure of drug activity.

ARWR closed Wednesday's trading 7.62% higher at $7.20.

BioMarin Pharmaceutical Inc.'s (BMRN) phase 2 proof-of-concept and dose finding study of Vosoritide in children with achondroplasia has demonstrated a 50% increase in mean annualized growth velocity in 15 ug/kg/daily dose group. Achondroplasia is the most common form of human dwarfism.

Based on the promising results, the company intends to move into pivotal registration study discussions with health authorities with a dose of 15 micrograms per kilogram daily.

Vosoritide has Orphan designation in both the United States and Europe.

BMRN closed Wednesday's trading 2.06% higher at $123.60. In after-hours, the stock was up 6.43% at $131.55.

CorMedix Inc. (CRMD) has received positive feedback from the FDA regarding the company's Neutrolin clinical trial protocol for oncology patients.

The new phase III protocol is designed to assess the use of Neutrolin as a catheter lock solution in oncology patients who require total parenteral nutrition to support filing of a New Drug Application with the FDA.

Neutrolin received QIDP and Fast Track designations earlier this year.

CRMD closed Wednesday's trading 6.72% higher at $5.08.

Edwards Lifesciences Corp.'s (EW) most advanced transcatheter aortic heart valve - the Edwards SAPIEN 3 valve with the Commander Delivery System - for the treatment of high-risk patients suffering from severe, symptomatic aortic stenosis, has received FDA approval, earlier than anticipated.

The launch of the product is expected to be largely completed by the end of the year.

The SAPIEN 3 valve has been commercially available in Europe since January 2014. The SAPIEN family of valves has been used in the treatment of more than 100,000 patients globally, according to the company.

EW closed Wednesday's trading at $141.60, up 2.68%.

The early results from Endologix Inc.'s (ELGX) clinical study of Nellix EndoVascular Aneurysm Sealing System for the endovascular repair of infrarenal abdominal aortic aneurysms have been promising.

Abdominal aortic aneurysms, or AAA is a weakening of the wall of the aorta, the largest artery in the body, resulting in a balloon-like enlargement. Once AAA develops, it continues to enlarge and, if left untreated, becomes increasingly susceptible to rupture. The overall patient mortality rate for ruptured AAA is approximately 70%, making it a leading cause of death in the U.S, according to Endologix.

The company revealed that the results from the trial, dubbed EVAS FORWARD-IDE clinical study, demonstrated 100% procedural technical success with few device-related serious adverse events, low 30-day mortality (0.7%) and overall major adverse events (2.7%), with no aneurysm rupture or conversion to open repair, low incidence of any endoleak on the 1-month CTA scan (6%) and no lumen thrombosis or occlusions or other device integrity issue.

ELGX closed Wednesday's trading at $16.35, down 0.06%.

Shares of Synergy Pharmaceuticals Inc (SGYP) soared as much as 72% on Wednesday following positive results from the first of two pivotal phase III clinical trials evaluating the efficacy and safety of two different doses of investigational oral drug Plecanatide in chronic idiopathic constipation.

According to the trial results, Plecanatide at 3.0 mg and 6.0 mg doses 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. Plecanatide also proved to be safe and well tolerated at both doses in the study.

*A durable overall responder is defined as a patient who fulfills both greater than or equal to 3 complete spontaneous bowel movements, or CSBM, per week plus an increase of greater than or equal to 1 CSBM from baseline in the same week, for 9 out of the 12 treatment weeks. In addition, the same patient must be an overall responder for at least 3 of the last 4 treatment weeks in order to be considered a durable overall responder.

The top-line data from the second phase III trial of Plecanatide in chronic idiopathic constipation are expected to be announced in the first half of the third quarter of this year. The company plans to file its first new drug application with Plecanatide in the chronic idiopathic constipation indication in the fourth quarter of this year.

SGYP closed Wednesday's trading at $7.78, up 67.67%.

Shares of Tribute Pharmaceuticals Canada Inc. (TBUFF.OB) (TRX.V) touched a new high on Wednesday following the company's acquisition of privately owned Medical Futures Inc., a specialty pharmaceutical company, in a transaction valued at $25 million.

The acquisition, which is said to further diversify Tribute's product portfolio in Canada through the addition of 13 marketed and 2 pipeline products, is also expected to be immediately accretive.

Tribute is itself set to be acquired by Pozen, Inc. (POZN) at approximately US$146 million. Upon completion of the transaction, which is expected to occur in the fourth quarter of 2015, subject to satisfaction of various conditions, the combined company will be named Aralez Pharmaceuticals plc. Upon closing, Aralez is expected to trade on NASDAQ and Toronto Stock Exchange.

POZN touched a new high of $10.90 on Wednesday before closing the day's trading 5.49% higher at $10.57.

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