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PIP Awarded $195M, DEPO Expands Pain Management Portfolio, CRMD On Fast Track

Pharma 011615

Cantel Medical Corp.'s (CMN) subsidiary Mar Cor Purification Inc. has received FDA clearance for MINNCARE HD high level disinfectant, the first water system disinfectant granted a medical device clearance for use in hemodialysis application.

The product is expected to be available in early February 2015.

CMN closed Thursday's trading at $42.16, down 1.68%.

CorMedix Inc.'s (CRMD) lead product candidate Neutrolin Catheter Lock Solution has received Fast Track designation from the FDA.

Neutrolin is a catheter lock solution for the prevention of Catheter Related Bloodstream Infections (CRBI) and maintenance of catheter patency in Hemodialysis patients. The product is approved in Europe.

The company received approval from the FDA to initiate phase III clinical trials for Neutrolin in the U.S. last October.

CRMD closed Thursday's trading at $2.36, up 3.50%.

Depomed Inc. (DEPO) is all set to acquire the U.S. rights to the NUCYNTA franchise from Janssen Pharmaceuticals Inc. for $1.05 billion, which will become the flagship asset in its growing portfolio of pain and neurology specialty pharmaceuticals.

The NUCYNTA franchise includes NUCYNTA ER extended release tablets indicated for the management of pain, including neuropathic pain associated with diabetic peripheral neuropathy and NUCYNTA, an immediate release version of tapentadol, for management of moderate to severe acute pain in adults. NUCYNTA oral solution is an approved oral form of tapentadol that has not been launched.

The deal is expected to be immediately accretive to Depomed's non-GAAP EPS in 2015, with significant growth in net sales, EBITDA, non-GAAP earnings and cash flow beyond that timeframe.

DEPO closed Thursday's trading down 2.22% at $17.65. In after-hours, the stock gained 4.87% and was at $18.51.

OncoMed Pharmaceuticals Inc. (OMED) is all set to receive a $5 million milestone from its partner, GlaxoSmithKline (GSK), thanks to enrollment of the first biomarker-selected patient in its phase 1a solid tumor clinical trial with anti-Notch1.

Anti-Notch1 is being studied in two phase 1a clinical trials, one in patients with selected advanced solid tumors and one in select hematologic malignancies.

OncoMed's collaboration with GlaxoSmithKline is focused entirely on the development of two product candidates - Tarextumab (anti-Notch2/3, OMP-59R5) and anti-Notch1 (OMP-52M51).

OMED closed Thursday's trading at $23, down 0.86%.

PharmAthene Inc. (PIP) has been awarded $194.6 million plus a post-judgment interest of $30,663.89 per day by the Delaware Court of Chancery in the company's litigation against SIGA Technologies Inc.

The lawsuit dates back to 2006 when PharmAthene sued SIGA for breaching contractual obligations related to SIGA's smallpox antiviral drug Arestvyr. While Arestvyr is not yet approved by the FDA, it is being delivered to the Strategic National Stockpile under Project Bioshield.

The court's decision will remain subject to appeal by SIGA to the Delaware Supreme Court.

Seeking to ensure the supply of Arestvyr being delivered to the U.S. Strategic National Stockpile under the Project BioShield Act of 2004, SIGA filed for bankruptcy protection last September. Since SIGA has filed for protection under the Federal bankruptcy laws, PharmAthene is automatically stayed from taking any enforcement action in the Delaware Court of Chancery.

PIP closed Thursday's trading at $1.66, up 0.61%. In after-hours, the stock was up 10.84% at $1.84.

Pernix Therapeutics Holdings Inc.'s (PTX) supplemental New Drug Application seeking approval for its drug TREXIMET for use in adolescent patients, age 12 - 17, for the acute treatment of migraine with or without aura has been accepted for priority review by the FDA.

The regulatory agency's decision on the supplemental New Drug Application for TREXIMET is expected in 2Q 2015.

TREXIMET was first approved by the FDA in April 2008 for the acute treatment of migraine attacks, with or without aura, in adults.

Pernix acquired the U.S rights to TREXIMET from GlaxoSmithKline last year. Net sales of TREXIMET for the third quarter and year-to-date period of 2014 were $16.3 million.

PTX closed Thursday's trading at $7.64, down 5.21%.

Tonix Pharmaceuticals Holding Corp. (TNXP) has commenced a phase II trial of TNX-102 SL in post-traumatic stress disorder.

The trial, dubbed AtEase study, is expected to enroll approximately 220 participants, who will be randomized to receive either one 2.8 mg TNX-102 SL tablet and one placebo tablet or 5.6 mg of TNX-102 SL (2 x 2.8 mg tablets) in the two active arms. In the placebo comparator arm, participants will receive two placebo tablets.

TNXP closed Thursday's trading at $6.91, down 4.95%.

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