AMGN To Face FDA, BDSI Fails To Deliver, 'Twas A Merger Monday

(RTTNews) - Amgen's (AMGN) supplemental New Drug Application of Kyprolis for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy has been accepted for priority review. Accordingly, the regulatory agency's decision date is set for July 26, 2015.

Kyprolis is currently approved by the FDA for the treatment of patients with multiple myeloma who have received at least two prior therapies, including bortezomib and an immunomodulatory agent (IMiD), and have demonstrated disease progression on or within 60 days of completion of the last therapy.

Kyprolis recorded sales of $331 million in the full year of 2014.

AMGN closed Monday's trading at $164.30, up 1.05%.

Argos Therapeutics Inc.'s (ARGS) pivotal phase III trial of AGS-003 for the treatment of metastatic renal cell carcinoma is nearing completion of enrollment. The initial interim data analysis of the study, dubbed ADAPT, by the Independent Data Monitoring Committee is planned for late May.

ARGS closed Monday's trading at $9.52, up 3.82%. In after-hours, the stock was down 2.84% to $9.25.

Shares of BioDelivery Sciences International Inc. (BDSI) plunged over 24% on Monday after the company announced that a phase 3 clinical study of Clonidine Topical Gel compared to placebo for the treatment of painful diabetic neuropathy did not meet statistical significance.

BioDelivery Sciences gained rights to Clonidine Topical Gel under a worldwide licensing agreement with privately held Arcion Therapeutics signed in March 2013.

However, certain secondary endpoints showed statistically significant improvement over placebo, in addition to a strong safety profile. The results of the trial provide data that will help to better refine the protocol criteria to capture a more "enriched" patient population and target site selection, noted the company.

BDSI closed Monday's trading at $10.51, down 24.33%.

Celladon Corp. (CLDN) is on track to un-blind data and announce top-line results from its phase 2b clinical trial, dubbed CUPID2, evaluating the efficacy of product candidate MYDICAR in reducing the frequency of, or delaying heart failure-related hospitalizations in late April 2015.

CLDN closed Monday's trading at $21.67, up 2.75%. In after-hours, the stock was up 5.21% at $22.80.

Shares of Intellipharmaceutics International Inc. (IPCI) rose more than 10% on Monday following positive topline data from a series of phase I clinical trials of its abuse-deterrent Rexista Oxycodone XR tablets.

Rexista Oxycodone XR is a non-generic extended release formulation intended for the management of moderate to severe pain when an around-the-clock analgesic is required.

The results of three studies in which Rexista Oxycodone XR was compared to Oxycontin under single dose fasting, single dose steady-state fasting and single dose fed conditions in healthy volunteers showed that it met the bioequivalence criteria.

The company also reported that its request for a Pre-IND Meeting with the FDA, focused on the proposed phase III clinical program for its once-a-day Regabatin XR non-generic controlled release version of pregabalin, has been granted.

IPCI closed Monday's trading 10.59% higher at $2.82.

Luminex Corp. (LMNX) has commenced clinical and analytical studies to evaluate its ARIES System and ARIES HSV 1&2 Assay.

The company expects its FDA submission for ARIES and the HSV 1&2 Assay to occur in the summer of 2015. Luminex also plans to seek CE IVD marking this year.

LMNX closed Monday's trading at $16.04, down 0.37%.

Sanofi's (SNY) subsidiary Genzyme has won marketing approval for Cerdelga , the only first-line oral therapy for Gaucher disease type 1 patients, in yet another country - this time, in Japan.

Cerdelga was approved by the FDA in August 2014, the European Commission in January 2015, and the Australian Therapeutics Goods Administration in February 2015.

Sales of Cerdelga were €4 million in the fourth quarter of 2014.

Cerdelga is priced at $310,250 per year in the U.S., slightly higher than intravenous enzyme replacement therapy for Gaucher disease Cerezyme, which costs $300,000 per year. Cerezyme is also developed by Genzyme, and it raked in sales of €715 million in the full year of 2014, up 8.3% over 2013.

SNY closed Monday's trading 0.54% higher at $50.24.

Synthetic Biologics Inc. (SYN) has initiated a phase 2a clinical trial to evaluate the gastrointestinal (GI) antibiotic-degrading effects and the safety of SYN-004, its investigational oral beta-lactamase enzyme designed to protect the microbiome and prevent C. difficile infection.

The company anticipates reporting topline results from this Phase 2a clinical trial during the second quarter of 2015, and initiating the Phase 2b clinical trial in the second half of this year.

SYN closed Monday's trading at $2.29, down 1.29%.

It was a Merger Monday for the Biotech sector - with two deals being announced.

Horizon Pharma plc (HZNP) is all set to acquire Hyperion Therapeutics Inc. (HPTX) for $46.00 per share or $1.1 billion in cash.

The per share consideration represents a premium of approximately 35 percent to Hyperion's volume weighted average price for the trailing 60-days. The transaction is expected to close in the second quarter of 2015.

Another deal of the day is the acquisition of Auspex Pharmaceuticals, Inc. (ASPX) by Teva Pharmaceutical Industries Ltd. (TEVA) for $101.00 per share in cash. The deal represents a total consideration of approximately $3.2 billion in enterprise value and approximately $3.5 billion in equity value.

Teva expects the transaction to close in mid-2015.