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11.01.2017 07:27:47

So Long DSCI, MRK Seeks New Use For Old Drug, VRX Does It Again, PSTI On Watch

(RTTNews) - Coherus BioSciences Inc. (CHRS) on Tuesday reported positive results from part 2 of its phase III clinical study of CHS-1420, a biosimilar candidate to AbbVie's blockbuster drug, Humira, in psoriasis patients.

The Part 2 of the study focused on maintenance of response through Week 24. This is a 3-part study and data from this study are scheduled to be presented at an upcoming scientific conference. The company currently anticipates filing the Biologic License Application for CHS-1420 in the first half of 2017.

CHRS closed Tuesday's trading at $28.00, up 1.27%.

Derma Sciences Inc. (DSCI) is all set to be acquired by Integra LifeSciences Holdings Corp. (IART) for $7.00 per share of common stock in cash or a total value of approximately $204 million.

Integra will also offer $32.00 per share for Derma's outstanding shares of Series A Convertible Preferred Stock and $48.00 per share for its Series B Convertible Preferred Stock.

The purchase price represents a 40% premium to Derma's share price at close on January 10, 2017.

The transaction is expected to close in the first quarter of 2017.

DSCI closed Tuesday's trading at $5.00, unchanged from the previous day's close. In after-hours, the stock was up 2% to $5.10.

Merck's (MRK) supplemental Biologics License Application for KEYTRUDA in combination with chemotherapy for first-Line treatment of metastatic non-squamous non-small cell lung cancer has been accepted for priority review by the FDA. The regulatory agency's decision is set for May 10, 2017.

KEYTRUDA is already approved for the treatment of metastatic melanoma, metastatic non-small cell lung cancer, and recurrent or metastatic head and neck squamous cell carcinoma.

The drug brought home sales of $919 million in the first nine months of 2016, up 161% over the comparable year-ago period.

MRK closed Tuesday's trading at $59.92, down 1.93%.

Pluristem Therapeutics Inc.'s (PSTI) Phase III study of its PLX-PAD cells in the treatment of critical limb ischemia has been cleared by the FDA.

The company expects to begin enrolling patients in the Phase III study in both the U.S. and Europe during the first half of 2017. The study will enroll about 250 patients with critical limb ischemia Rutherford Category 5 who are unsuitable for revascularization, and its primary endpoint is time to amputation or death.

PSTI closed Tuesday's trading at $1.62, up 10.20%.

Valeant Pharmaceuticals Intl Inc.'s (VRX) second confirmatory pivotal phase III trial of IDP-118 lotion in the treatment of plaque psoriasis has met the primary endpoint.

The primary endpoint of the study was achievement of a "clear" to "almost clear" score and at least a 2 grade improvement based on an Investigator Global Assessment at 8 weeks, which IDP-118 successfully demonstrated.

The treatment success rate at 8 weeks with IDP-118 is 35.76% compared to vehicle's 6.98%.

Last month, Valeant announced results of its first phase III study of IDP-118 in moderate to severe psoriasis. In that study, IDP-118 showed statistical significance to vehicle with a treatment success rate at 8 weeks of 45.33% to 12.51%.

VRX closed Tuesday's trading at $16.40, up 6.84%.

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