ACHN On Track, AMAG Fortifies Patent, CMXI Pockets $5Mln, SUPN In Legal Fight

(RTTNews) - Achillion Pharmaceuticals Inc. (ACHN) expects to report initial results from a phase II trial of Sovaprevir and ACH-3102 with Ribavirin for treatment-naive HCV patients as planned during the third quarter of 2013, as well as sustained viral response results in the fourth quarter of 2013.

Meanwhile, the company is finalizing the data requested by FDA in order to release the clinical hold, which was placed on Sovaprevir last month, and anticipates learning of their response to that data submission in September.

ACHN closed Wednesday's trading at $6.81, down 1.87%.

AMAG Pharmaceuticals Inc.'s (AMAG) lead anemia drug Feraheme (ferumoxytol) has been issued another U.S. patent that will expire in 2020. Feraheme now has four Orange Book listed patents, with patent protection through 2020, without patent term extension.

AMAG has sought to lengthen the patent term for Feraheme through June 2023.

AMAG shed 0.17% on Wednesday to close at $23.23.

Amicus Therapeutics (FOLD) expects 12-month data from one of the two phase III studies of migalastat HCl monotherapy for Fabry disease, dubbed Study 011, in the fourth quarter of this year. Top line data from the second phase III study, known as Study 012, are expected in the second half of 2014.

The company intends to begin a phase II chaperone-ERT co-administration study for Pompe disease in the second half of this year.

FOLD closed Wednesday's trading 1.55% higher at $2.62.

Cardiovascular Systems Inc. (CSII) said that its orbital atherectomy system to treat calcified coronary arteries could be approved in late calendar 2013 or early 2014, primarily depending on whether or not a full advisory panel is required by the FDA.

The company completed the submission of Premarket Approval application for the orbital atherectomy system to the FDA on March 15, 2013.

CSII closed Wednesday's trading at $19.63, down 0.76%.

Cardium Therapeutics Inc. (CXM) has entered into a distribution agreement with Kasiak Holdings AG for the marketing and sale of Excellagen advanced wound care product in Germany and Switzerland.

Cardium's Excellagen is FDA-cleared for the treatment of neuropathic and diabetic foot ulcers, pressure ulcers, venous ulcers, surgical wounds, and other dermal wounds.

CXM closed Wednesday's trading at $1.23, down 1.60%.

Cytomedix Inc. (CMXI.OB) is pocketing a $5 million upfront payment, and stands to receive royalties in a five-year worldwide licensing agreement with Arthrex Inc., a privately held global leader in orthopedics.

Under the terms of the agreement, Cytomedix has granted Arthrex exclusive worldwide rights to develop, manufacture, and commercialize Angel Concentrated PRP System.

Angel is Cytomedix's cPRP device and associated disposable products used in surgical settings for the separation of concentrated platelets from whole blood or bone marrow aspirates.

CMXI.OB closed Wednesday's trading at $0.43, down 4.42%.

Cytori Therapeutics (CYTX) announced that its Celution System for autologous re-implantation or re-infusion of a patient's adipose-derived regenerative cells has been approved in Australia. The Celution System is CE marked and is also available in Europe, the Middle East, and Asia.

CYTX gained 1.89% on Wednesday to close at $2.69.

ImmunoCellular Therapeutics Ltd. (IMUC) expects top-line read-out of data from a phase II trial of its cancer vaccine ICT-107 in patients with newly-diagnosed glioblastoma to be available in the fourth quarter of 2013 or the first quarter of 2014.

IMUC was up 3.24% in after-hours on Wednesday at $3.50.

Sucampo Pharmaceuticals Inc. (SCMP) announced Wednesday that its phase Ia trials of Cobiprostone and SPI-3608 demonstrated the two investigational drugs to be generally well-tolerated.

Cobiprostone is being developed for the prevention and/or treatment of oral mucositis and SPI-3608 for the treatment of mild to moderate lumbar spinal stenosis.

The company intends to begin a phase 1b trial is of Cobiprostone in the fourth quarter of 2013 while the next phase of development for SPI-3608 is expected to begin in the first quarter of 2014.

SCMP closed Wednesday's trading at $6.16, down 0.96%.

Supernus Pharmaceuticals Inc. (SUPN) has sued generic drug makers Actavis Inc. and Watson, alleging patent infringement, for seeking approval for a generic version of its antiepileptic drug Oxtellar XR, whose patents do not expire until April 13, 2027.

Supernus launched Oxtellar XR in the U.S. in February of this year.

SUPN closed Wednesday's trading at $6.58, down 0.60%.