Oxygen Bio Breathes Anew, KERX Gets FDA Date, Rockwell Continues To Rock

(RTTNews) - Cardiome Pharma Corp.'s (CRME) (COM.TO) subsidiary, Cardiome International AG, has entered into a five-year agreement with Algorithm S.A.L., headquartered in Beirut, Lebanon, to sell and distribute BRINAVESS (vernakalant intravenous) exclusively in certain Middle Eastern and North African countries. The financial details of agreement, which begins November 1, 2013, have not been disclosed.

BRINAVESS (vernakalant IV) is approved in Europe and other territories for the rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults.

CRME closed Monday's trading 0.21% higher at $4.82.

Clovis Oncology Inc. (CLVS) has signed an agreement with QIAGEN (QGEN) to develop a companion diagnostic test to identify the T790M resistance mutation in patients with epidermal growth factor receptor (EGFR) driven non-small cell lung cancer (NSCLC) for CO-1686.

CO-1686 is under phase I/II testing for the treatment of NSCLC in patients with initial activating EGFR mutations as well as the dominant resistance mutation T790M.

Clovis intends to begin using the QIAGEN test in its Phase II expansion cohorts, the first of which is expected to begin enrolling in late 2013.

CLVS closed Monday's trading at $51.30, up 1.42%.

Cubist Pharmaceuticals Inc.'s (CBST) ENTEREG has received FDA approval in the expanded indication to accelerate the time to upper and lower gastrointestinal (GI) recovery following surgeries that include partial bowel resection with primary anastomosis (i.e., re-connection of the bowel following removal of the resected segment).

The FDA originally approved ENTEREG in 2008 to accelerate the time to upper and lower GI recovery following partial large or small bowel resection surgery with primary anastomosis.

CBST closed Monday's trading at $63.74, down 2.31%.

Keryx Biopharmaceuticals Inc.'s (KERX) New Drug Application for Zerenex has been assigned a decision date of June 7, 2014 by the FDA. The company is seeking approval of Zerenex for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with chronic kidney disease (CKD) on dialysis.

KERX closed Monday's trading down 3.46% at $10.87. In after-hours, the stock dropped another 3.31% to $10.51.

Oxygen Biotherapeutics Inc. (OXBT) rose more than 64 percent to $2.30 in extended trading on Monday after the company announced that it has signed a definitive agreement to acquire a phase III product Levosimendan from privately-held Phyxius Pharma.

Levosimendan is under development to prevent and treat cardiac surgery patients at risk for developing low cardiac output syndrome.

The transaction is valued at roughly $4.8 million in stock as of October 18, 2013, based on Oxygen Biotherapeutics issuing an aggregate of approximately 3.4 million shares of its common stock and securities convertible into common stock to Phyxius Pharma's stockholders in a private placement. Upon closing of the transaction, Phyxius Pharma Co-Founder and CEO, John Kelley is to become CEO of Oxygen Biotherapeutics.

PDL BioPharma Inc. (PDLI) has acquired the rights to receive royalties and milestones payable on sales of Type 2 diabetes products licensed by Depomed Inc. (DEPO) in exchange for a $240.5 million cash payment.

PDL will receive all royalty and milestone payments due under the agreements until it has received payments equal to two times the cash payment made to Depomed, after which all payments received, will be shared evenly between PDL and Depomed.

Rockwell Medical Inc. (RMTI) touched a new 52-week high of $13.20 on Monday before closing the day's trading at $12.47, following the announcement of positive safety results of its phase III short-term safety study of Triferic.

Triferic is the company's late-stage investigational iron-replacement drug for the treatment of iron deficiency in chronic kidney disease patients receiving hemodialysis.

The short-term safety study has concluded that Triferic is no different from placebo as regards the safety, and there has not been even a single acute safety signal or anaphylactic reaction when administered via dialysate.

Sucampo Pharmaceuticals Inc.'s (SCMP) subsidiary Sucampo AG has completed enrollment in a phase III study of Unoprostone isopropyl ophthalmic solution 0.15% for the treatment of retinitis pigmentosa. The study, which is being conducted in Japan, is expected to be completed by the end of 2014 with top-line results available in early 2015.

SCMP closed Monday's trading at $6.43, down 3.60%.

Seattle Genetics Inc. (SGEN) has initiated a phase I clinical trial of SGN-LIV1A for patients with LIV-1-positive metastatic breast cancer. LIV-1 is a protein which is expressed in most subtypes of metastatic breast cancer. The study is expected to enroll up to 70 patients at multiple centers in the United States.

SGEN closed Monday's trading at $40.04, unchanged from the previous day's close.

Biotech stocks can be risky as their fortunes depend on two key events namely clinical trial results and FDA decisions. Nevertheless, the returns can be impressive when the stocks are bought and sold at the right time.

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