AMRI Opens Wallet, IDIX To Fight Back, QRxPharma Awaits FDA Panel Verdict

(RTTNews) - Albany Molecular Research Inc. (AMRI) has agreed to acquire Cedarburg Pharmaceuticals Inc., a contract developer and manufacturer of technically complex active pharmaceutical ingredients, for $38.2 million in cash.

The transaction is expected to close in early April 2014. Based on the anticipated timing of the close, the acquisition is expected to add between $13 million and $14 million to AMRI's revenue in 2014.

AMRI closed Monday's trading at $18.91, up 2.55%.

ARIAD Pharmaceuticals Inc. (ARIA) has initiated a pivotal global phase II trial of AP26113 in patients with locally advanced or metastatic non-small cell lung cancer who were previously treated with Pfizer Inc's crizotinib (Xalkori). Xalkori is an approved drug for lung cancer.

The phase II trial of AP26113 is designed to enroll approximately 220 patients. Full patient enrollment in the trial is expected in the third quarter of 2015, and first data from the trial is expected to be reported at a medical meeting in 2015.

Arrowhead Research Corp. (ARWR) has begun patient dosing in a phase IIa clinical trial of ARC-520, its RNAi therapeutic for the treatment of chronic hepatitis B virus (HBV) infection. The study is planned to enroll up to 16 chronic HBV patients in two dose cohorts with patients receiving either ARC-520 or placebo in combination with approved drug Baraclude (entecavir).

ARWR shed 16.09% on Monday to close at $17.37. In after-hours, the stock gained 1.27% to $17.59.

Cellular Biomedicine Group Inc.'s (CBMG.OB) phase I clinical trial of TC-DC (Tumor Stem Cell Specific Dendritic Cell) therapy for hepatocellular carcinoma (HCC), the most common type of liver cancer, has demonstrated safety profile. Accordingly, the company plans to advance the compound to a phase II trial to further test its safety and efficacy.

CBMG.OB closed Monday's trading 5.66% lower at $5.00.

CytRx Corp. (CYTR) has initiated a pivotal global phase III clinical trial with Aldoxorubicin for the second-line treatment of patients with soft tissue sarcoma.

The trial designed to enroll approximately 400 patients is expected to complete enrollment in 2015.

CYTR closed Monday's trading at $3.99, up 4.45%.

Idenix Pharmaceuticals Inc. (IDIX) intends to file an appeal to challenge the Oslo, Norway District Court's decision regarding patent invalidity of certain 2'-methyl-2'-fluoro nucleoside compounds useful in the treatment of the hepatitis C virus and other flaviviridae infections.

In September 2012, Gilead Sciences Europe Ltd., a subsidiary of Gilead Sciences, Inc. (GILD) filed a lawsuit in Norway District Court claiming that Idenix's Norwegian patent NO 330 755 is invalid. Idenix subsequently filed a counter claim that a patent owned by Gilead covering similar subject matter (Norwegian patent NO 333 700) is invalid and unenforceable.

The lawsuit has gone in favor of Gilead with the Court, last week, determining that Idenix's patent is invalid and that Gilead's patent is valid.

IDIX closed Monday's trading at $6.70, down 5.77%.

Kamada Ltd. (KMDA) has initiated a new phase II U.S. clinical trial of its proprietary inhaled Alpha-1 Antitrypsin (AAT) therapy for the treatment of Alpha-1 Antitrypsin Deficiency (AATD, or Inherited Emphysema). The company has completed a phase 2/3 multicenter of inhaled formulation of human AAT to treat AATD in more than 165 patients in Europe and Canada, and expects to report top-line results by the end of April or the beginning of May 2014.

KMDA closed Monday's trading at $15.13, down 2.26%.

QRxPharma Ltd.'s (QRXPY.OB) resubmitted New Drug Application for Moxduo for the treatment of moderate to severe acute pain is all set to be reviewed by FDA's Advisory Committee on April 22, 2014.

MoxDuo is an immediate-release Dual Opioid pain therapy comprised of a patented 3:2 fixed ratio combination of morphine and oxycodone.

The FDA usually follows the recommendations of its advisory panels, although it is not required to do so. The final decision of the regulatory agency is scheduled for May 25, 2014.

MOXDUO NDA was issued a complete response letter twice - on June 27, 2012 and on August 28, 2013.

QRXPY.OB closed Monday's trading at $4.02, down 0.99%.

Rexahn Pharmaceuticals Inc.'s (RNN) phase I dose-escalation clinical trial of Supinoxin (RX-5902) in cancer patients with solid tumors is expected to be completed in the fourth quarter of 2014.

Earlier this year, a phase Ib clinical trial of RX-3117 in cancer patients with solid tumors was initiated, and the company expects to complete patient enrollment in the fourth quarter of 2014 or early 2015.

RNN closed Monday's trading at $1.29, down 0.77%.