ACAD Gets FDA Nod, High-Five For ABBV's Imbruvica, NLNK Waits To Impress

(RTTNews) - AbbVie's (ABBV) blood cancer drug Imbruvica has moved one step closer to getting approved for the fifth treatment indication in the EU - now that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion for the use of the drug as a first-line treatment for chronic lymphocytic leukemia patients. The European Commission will review the CHMP opinion and is expected to render a final decision later this year.

The other indications for which Imbruvica is already approved in Europe are to treat adult patients with relapsed or refractory mantle cell lymphoma (MCL), adult patients with CLL who have received at least one prior therapy or who have del 17p or TP53 mutations, adult patients with Waldenström's macroglobulinemia (WM) who have received at least one prior therapy, or as a first-line treatment for WM patients unsuitable for chemo-immunotherapy.

Last month, the FDA approved Imbruvica for the first-line treatment of patients with chronic lymphocytic leukemia.

Imbruvica is jointly developed and commercialized in the U.S. by Pharmacyclics LLC, an AbbVie company and Janssen Biotech Inc., a Johnson & Johnson (JNJ) subsidiary. In Europe, Janssen-Cilag International NV holds the marketing authorization and its affiliates market Imbruvica in EMEA (Europe, Middle East, Africa), as well as the rest of the world.

AbbVie reported sales of $754 million for Imbruvica while Johnson & Johnson recorded sales of $689 million for the drug for full year 2015.

ABBV closed Friday's trading at $61.00, down 0.33%.

ACADIA Pharmaceuticals Inc.'s (ACAD) NUPLAZID has been approved by the FDA for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. NUPLAZID, which becomes the first and only medicine to be approved by the FDA for this indication, is expected to be launched in the U.S. next month.

In March, an FDA panel had voted 12 to 2 recommending approval of NUPLAZID.

ACAD closed Friday's trading at $32.30, down 0.31%. In after hours, the stock was up 0.31% to $32.40.

NewLink Genetics Corp. (NLNK) expects to report top line results from its phase III study of Algenpantucel-L in patients with resected pancreatic cancer, dubbed IMPRESS, in the second quarter of 2016.

At the upcoming American Society of Clinical Oncology Annual Meeting from June 3 to 7, 2016 in Chicago, NewLink Genetics expects to report the following:

- Interim data update from a phase II trial evaluating the addition of Indoximod to gemcitabine/nab-paclitaxel for patients with metastatic pancreatic cancer, and

- Mid- trial and safety data update from a phase II trial of Indoximod and ipilimumab or PD-1 inhibitors for patients with stage 3 or 4 advanced or metastatic melanoma.

NLNK closed Friday's trading at $16.21, up 2.08%.

Ocera Therapeutics Inc.'s (OCRX) phase 2b study of OCR-002 in patients with acute hepatic encephalopathy has enrolled about 165 patients. The study, dubbed STOP-HE, is on target to complete enrollment in the fourth quarter of 2016, with top-line results to be published soon thereafter.

Initiation of an additional oral phase I study of OCR-002 in patients with cirrhosis is also on the cards for the company.

The study will be conducted in two parts- with Part A evaluating the pK and bioavailability of a single oral dose of OCR-002 in cirrhotic patients dosed under certain conditions, and Part B is expected to be a multi-dose study which will include the evaluation of steady state pK and the formation of phenylacetylglutamine (PAGN), the end-product responsible for clearing ammonia.

The company expects enrollment in Part A of the study to begin in the third quarter of 2016 with data anticipated by year-end 2016.

OCRX closed Friday's trading at $2.92, down 3.95%.