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Daily Dose: HALO Shines, TSPT Fails, HZNP, ALXA, NPSP, CEMI Get Thumbs Up


Shares of Halozyme Therapeutics Inc. (HALO) rose as much as 30 percent in intraday trading on Friday before closing nearly 27 percent higher at $7.01 after the company announced that it has entered into a worldwide collaboration and license agreement with Pfizer Inc. (PFE) to develop and commercialize subcutaneous biologics.

Under the terms of the agreement, Halozyme has granted to Pfizer a worldwide license to develop and commercialize products combining its rHuPH20 enzyme with Pfizer proprietary biologics directed to up to six targets.

Besides getting an initial payment of $8 million, Halozyme is entitled to receive up to $507 million upon Pfizer's achievement of specified development, regulatory and sales-based milestones.

Transcept Pharmaceuticals Inc. (TSPT) announced that its phase II clinical trial of TO-2061 as an adjunctive therapy for obsessive compulsive disorder, or OCD, failed to meet the primary endpoint of improvement in OCD symptoms.
Shares lost 6% to close at $4.85.

Horizon Pharma Inc. (HZNP) is all set to receive approval for DUEXIS from the United Kingdom Medicines and Healthcare products Regulatory Agency, or MHRA.
The approval of DUEXIS is for the treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis and to decrease the risk of developing upper gastrointestinal ulcers.

The approval of DUEXIS in the UK will facilitate progressive approval of the product across Europe. The drug was approved by the FDA last year and is available in the United States.

Coronado Biosciences Inc. (CNDO) has entered into a clinical trial agreement with the National Institute of Allergy and Infectious Diseases for the conduct of a phase II study to evaluate the potential of TSO (Trichuris suis ova or CNDO-201) as a treatment for ulcerative colitis. The trial is planned to begin during Q1, 2013.

Raptor Pharmaceutical Corp. (RPTP) now will have to wait until April 30, 2013 to know the FDA's decision on its New Drug Application for RP103 (PROCYSBI) for the potential treatment of nephropathic cystinosis. The decision date was originally set for January 30, 2013, but has been extended by 3 months to provide more time to the regulatory agency to complete the review. However, the company has not been requested to conduct any additional studies. Shares were down more than 12% to $5.03 in after-hours trading.

Alexza Pharmaceuticals Inc.'s (ALXA) ADASUVE Inhalation Powder won the FDA approval on Friday for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.

The product, which will be available for commercial launch early in the third quarter of 2013, will carry a boxed warning about bronchospasm and increased mortality in elderly patients with dementia-related psychosis.

The company is required to conduct a large observational clinical trial designed to gather patient safety data based on the real-world use of ADASUVE, as well as a clinical program addressing the safety and efficacy of ADASUVE in agitated adolescent patients.

Last week, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended ADASUVE to be authorized in the EU for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder. A decision is expected from the European Commission in the first quarter of 2013.

Shares were down more than 10% to $5.19 in after-hours trading.

NPS Pharmaceuticals Inc. (NPSP) announced Friday that its short bowel syndrome treatment Gattex has been approved by the FDA for use in adult patients who are dependent on parenteral support.

According to the company, Gattex is the first major long-term treatment advance for short bowel syndrome in nearly 40 years. The product is expected to be launched in the U.S. in Q1, 2013.

NPSP closed Friday's trading 0.44% higher at $9.10 on a volume of 8.4 million shares.

Shares of Chembio Diagnostics Inc. (CEMI) rose more than 14% on Friday to close at $5.25 following the receipt of FDA approval for its DPP(R) HIV 1/2 Assay.

The assay is intended to be used in the preliminary diagnosis of patients with HIV in point-of-care settings such as public health and other clinics, hospital emergency rooms and physician offices, and is expected to be launched during the second half of 2013.

According to the company, its DPP(R) point-of-care HIV 1/2 Assay detects antibodies to HIV-1 and HIV-2 in oral fluid, fingerstick whole blood, venous whole blood, serum or plasma samples, and provides a simple "reactive/non-reactive" result.

Chembio plans to submit Clinical Laboratory Improvement Amendments, or CLIA, waiver trials in order to establish the quality standards for its laboratory testing that provide for the accuracy, reliability and timeliness of patient tests results regardless of where the tests are performed during the first half of 2013.

Cubist Pharmaceuticals Inc. (CBST) is seeking expanded FDA approval for its drug ENTEREG to be used in accelerating gastrointestinal recovery following any surgery that includes a bowel resection with primary anastomosis. The supplemental new drug application for ENTEREG has been submitted by the company.

Currently ENTEREG is approved by the FDA to accelerate gastrointestinal recovery in patients requiring surgery for colorectal disease.

ENTEREG, which came into Cubist's fold following the acquisition of Adolor Corp. in December 2011, raked in net product revenue of $10.1 million in Q3, 2012.

Spectrum Pharmaceuticals Inc. (SPPI) announced that Belinostat, its investigational drug for the treatment of patients with relapsed/refractory peripheral T-cell lymphoma, achieved the primary endpoint in a pivotal, registrational phase II trial.

According to the company, the Belinostat trial, dubbed BELIEF, surpassed an objective response rate of at least 20% in relapsed/refractory peripheral T-cell lymphoma patients.

The company expects to file a New Drug Application for Belinostat by mid-2013, and if all goes well as planned, anticipates an FDA decision in 2014.
SPPI closed Friday's trading 3.72% higher at $11.72.

by RTTNews Staff Writer

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