Psoriasis Drug Trial Meets Goals, Reimbursement Rate For Cologuard Finalized

(RTTNews) - Amgen Inc. (AMGN) and AstraZeneca plc's (AZN) phase III trial of psoriasis drug candidate Brodalumab has met its primary endpoint of achieving total clearance of skin disease when compared with placebo as well as Janssen Biotech Inc.'s approved drug Stelara.

The trial, dubbed AMAGINE-2, is the third and final pivotal study in the companies' phase III psoriasis program. Brodalumab is being co-developed by Amgen and AstraZeneca.

Top-line results from AMAGINE-1, comparing Brodalumab with placebo, were released in May 2014 while top-line results from AMAGINE-3, comparing Brodalumab with Stelara and placebo, were announced as recently as November 11, 2014.

The trials AMAGINE-2 and AMAGINE-3 are identical in design.

AMGN closed Tuesday's trading at $162.24, down 1.18%.

Exact Sciences Corp.'s (EXAS) Cologuard will be reimbursed at $502 per test, according to the final payment decision issued by the Centers for Medicare & Medicaid Services.

Cologuard is the first and only FDA-approved noninvasive stool DNA colorectal cancer screening test.

EXAS closed Tuesday's trading at $24.90, up 2.55%.

Intra-Cellular Therapies Inc. (ITCI) has enrolled the first patient in its phase III trial of ITI-007 for the treatment of schizophrenia.

The trial, dubbed ITI-007-301, is designed to enroll over 400 patients with an acutely exacerbated episode of schizophrenia who will be randomized to receive one of three treatments namely, 60 mg ITI-007, 40 mg ITI-007, or placebo in a 1:1:1 ratio. Top-line results from this trial could be available as early as the fourth quarter of 2015.

Another phase III trial of ITI-007 in schizophrenia, designated as ITI-007-302 trial, is expected to be initiated in the first half of 2015.

ITCI closed Tuesday's trading at $14.99, down 0.86%.

Isis Pharmaceuticals Inc. (ISIS) has initiated a pivotal phase III study of its experimental, antisense-based drug ISIS-SMNRx in non-ambulatory children with spinal muscular atrophy.

The trial, dubbed CHERISH, is the second phase III study involving ISIS-SMNRx.

Following the dosing of the first patient in this study, Isis earned a $27 million milestone payment from its development partner, Biogen Idec Inc. (BIIB).

The first phase III study of ISIS-SMN Rx in infants with spinal muscular atrophy, known as ENDEAR, was initiated in August of this year, and is currently underway.

ISIS closed Tuesday's trading at $51.51, down 1.74%.

Vascular Solutions Inc. (VASC) has received FDA clearance for Gel-Block 10x embolization pledgets for use in the treatment of hypervascular tumors and arteriovenous malformations. The product will be launched in the U.S. this week.

As the name suggests, Gel-Block 10x consists of ten pre-formed, ready-to-use gelatin foam pledgets supplied in a vial with a delivery syringe.

The original Gel-Block embolization device, which is packaged with two pledgets per device, was launched in the U.S. in July 2012.

VASC closed Tuesday's trading at $25.57, down 0.35%.

Valeant Pharmaceuticals International Inc. (VRX) (VRX.V) has received FDA approval for its ONEXTON Gel for the treatment of acne vulgaris in patients 12 and older. The company plans to launch ONEXTON in early 2015.

Acne vulgaris is a common skin disorder that affects 40 to 50 million people in the United States.

VRX closed Tuesday's trading at $144.76, up 1.54%.