|Healthcare Review: Navidea Biopharma, Insmed, Forest Labs, Prana Biotechnology, Chelsea Therapeutics International|
|By Staff and Wire Reports|
|Tuesday, 18 February 2014 15:15|
Navidea Biopharma ($NAVB) says the FDA granted a priority review for an expanded use of its Lymphoseek drug for sentinel lymph node detection in patients with head and neck cancer. The FDA grants priority review status to drug applications that may offer a significant improvement in treatment over existing options; Lymphoseek is already approved for use in lymphatic mapping procedures performed to aid in the diagnostic evaluation of lymph nodes draining a primary tumor in patients with breast cancer and melanoma.
Piper's Josh Schimmer says that a key opinion leader will soon publish data that will get Insmed's ($INSM) Arikace lung-infection treatment approved based on a primary end-point. Piper is as confident of Arikace's speedy approval as it was with the prospect of Vanda receiving FDA authorization for its Hetlioz sleep-wake disorder drug - the therapy was approved at the end of January.
Actavis ($ACT) will pay $89.48 per share, comprised of $26.04 in cash and 0.3306 of an Actavis share. The price represents a premium of 25% over Forest Labs' (FRX) close on Friday of $71.39.The merger would create a company with combined forecast revenues of $15B in 2015 and free cash flow of over $4B.The firms project potential operating and tax synergies of $1B, not including manufacturing or revenue synergies. Actavis CEO Paul Bisaro will lead the new firm, while Forest CEO Brent will join Actavis' board. In total, three
Prana Biotechnology's ($PRAN) PBT2 treatment for Huntington disease met its primary endpoints of safety and tolerability in a Phase II study of 109 patients.PBT2 also statistically improved executive function among early-stage Huntington's patients who received a 250 mg dose - but not the whole population - was associated with "a favorable signal in functional capacity" and a reduction atrophy of brain tissue. However, the drug didn't bring about any significant improvements in other secondary efficacy measures in the study, including motor, functional and behavioral assessments.
Shares of Chelsea Therapeutics International Ltd. ($NASDAQ:CHTP) are trading higher by 9.30% to $5.16 on high volume ahead of a critical FDA’s decision. The company issued the following statement regarding the FDA Prescription Drug User Fee Act action date for the Company’s NORTHERA New Drug Application:
“As a result of severe weather conditions leading to an office closure, FDA today notified Chelsea Therapeutics that the goal date for the Company’s NORTHERA NDA has been extended to the next business day, or Tuesday, February 18, 2014.”