DPLO To Dispense Breast Cancer Drug, New Use For Old Drugs Sought, CANF On Watch

(RTTNews) - Actavis plc.'s (ACT) supplemental New Drug Application to expand the label for TEFLARO in cases of acute bacterial skin and skin structure infections with concurrent bacteremia has been accepted for review by the FDA.

The regulatory agency's decision is expected in Q3 2015.

Concurrent bacteremia is a secondary infection that occurs when bacteria spreads from the primary site of infection to the blood stream. Concurrent bacteremia complicates infection treatment and in the most serious cases can be fatal.

TEFLARO is already approved for the treatment of community-acquired bacterial pneumonia (CABP), including cases caused by Streptococcus pneumoniae bacteremia, and acute bacterial skin and skin structure infections (ABSSSI), including cases caused by methicillin-resistant Staphylococcus aureus (MRSA).

ACT closed Wednesday's trading at $266.23, down 0.79%.

Can-Fite BioPharma Ltd. (CANF) has completed a phase II/III psoriasis trial for its drug candidate CF101. The top line results from the study are expected by the end of March 2015.

Interim results from the phase II/III trial and final results from a prior phase II trial for CF101 in psoriasis were both positive, noted the company.

CANF closed Wednesday's trading 7.40% higher at $3.63.

Starting Thursday, Diplomat Pharmacy Inc. (DPLO), a specialty pharmacy, will dispense Pfizer Inc.'s (PFE) new breakthrough medication, IBRANCE.

IBRANCE, in combination with Novartis' letrozole (Femara), is approved for first-line treatment of postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) metastatic breast cancer.

DPLO closed Wednesday's trading at $24.19, down 1.10%.

Tekmira Pharmaceuticals Corp. (TKMR) (TKM.TO) has sought to voluntary delist its common shares from the Toronto Stock Exchange as the company believes that the limited trading volume of its shares on the TSX no longer justifies the expense and administrative complexity of maintaining the dual listing.

The delisting from the TSX is anticipated at the close of trading on or about Tuesday, March 3, 2015, and shares will continue to be listed and trade on NASDAQ.

TKMR closed Wednesday's trading at $23.19, down 4.29%. TKM.TO closed the day's trading at C$29.08, down 2.64%.

KYTHERA Biopharmaceuticals Inc. (KYTH) has sought approval from Australia's Therapeutic Goods Administration for ATX-101, an injectable treatment for the reduction of submental fat.

Submental fullness or "double chin" can be a tell-tale sign of aging, negatively impacting overall appearance.

The company has also submitted regulatory applications seeking approval for ATX-101 in the U.S., Canada and Switzerland, and additional submissions to regulatory authorities in other countries are planned during the remainder of this year.

In the U.S., the New Drug Application for ATX-101 is scheduled to be reviewed by an FDA panel on March 9, 2015, and the FDA's final decision is slated for May 13, 2015.

KYTH closed Wednesday's trading 1.53% higher at $38.33.

Pfizer Inc. (PFE) is seeking approval for XELJANZ 5 mg and 10 mg tablets in the additional indication of treating adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.

The FDA is expected to announce its decision in October 2015.

In the United States, XELJANZ 5 mg tablets are approved for the treatment of adults with moderate to severe rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate (MTX).

PFE closed Wednesday's trading at $32.07, up 1.04%.

OncoMed Pharmaceuticals Inc. (OMED) has initiated dosing in a phase II clinical trial of its drug candidate Demcizumab for the treatment of patients with first-line advanced-stage non-small cell lung cancer.

The trial, known as "DENALI" is the first of two randomized phase 2 trials being conducted for Demcizumab in collaboration with Celgene Corp. (CELG). Patient dosing for the second Demcizumab randomized phase 2 trial in pancreatic cancer should also begin shortly, said the company.

Results from the phase 2 studies of Demcizumab are expected in the 2016-2017 timeframe.

OMED closed Wednesday's trading at $22.32, down 1.67%.