AMGN's Endeavor Awaits Verdict, NVS Scripts History, OTIC Is Not Music To Ears

(RTTNews) - Today's Daily Dose brings you news about encouraging preliminary data of Immune Design's phase II trial of CMB305 in soft tissue sarcoma; Novartis scripting history - with the FDA approval of its CAR-T therapy; FDA approval of Medicines Co.'s VABOMERE and Teva's AUSTEDO; disappointing results from Otonomy's phase III clinical trial of OTIVIDEX; the seventh FDA approval Roche's Actemra and Vivus resolving the pending lawsuit related to its weight-loss drug.

Read on...

Amgen Inc.'s (AMGN) supplemental New Drug Application to add overall survival results to KYPROLIS' label has been accepted for review by the FDA - with a decision date set for April 30, 2018.

In a phase III head-to-head trial, dubbed ENDEAVOR, KYPROLIS and dexamethasone reduced the risk of death by 21 percent and increased overall survival by 7.6 months compared to Velcade and dexamethasone in patients with relapsed or refractory multiple myeloma.

KYPROLIS was approved in the U.S. in 2012 and in Europe in 2015. The drug netted total sales of $692 million in 2016, up 35% over the prior year.

AMGN closed Wednesday's trading at $173.65, up 0.82%.

An interim analysis of Immune Design Corp's (IMDZ) phase II trial evaluating CMB305 in combination with Roche's Tecentriq in soft tissue sarcoma patients has shown that there is a greater clinical benefit and immune response with CMB305 plus Tecentriq than with Tecentriq alone.

The trial, which is fully enrolled is comparing the safety, immunogenicity and efficacy of CMB305 in combination with Tecentriq against Tecentriq alone, in a total of 88 patients with locally advanced, relapsed, or metastatic NY-ESO-1+ synovial sarcoma or myxoid/round-cell liposarcoma.

Immune Design intends to present survival data from the trial in 2018 once all patients have at least one year of follow up.

IMDZ closed Wednesday's trading at $10.10, up 2.02%.

The Medicines Co.'s (MDCO) VABOMERE has been granted accelerated approval by the FDA for the treatment of adult patients with complicated urinary tract infections, including pyelonephritis.

VABOMERE addresses gram-negative bacteria that produce beta-lactamase enzymes that have spread in the United States and Europe, particularly the Klebsiella pneumoniae carbapenemase (KPC) enzyme, the Company noted.

The drug is expected to be available in the fourth quarter of 2017. The FDA approval of VABOMERE triggered a $40 million milestone payment obligation to the former security holders of Rempex Pharmaceuticals Inc., which the Medicines Co. acquired in December 2013.

MDCO closed Wednesday's trading at $36.43, down 5.96%.

The FDA has approved Novartis AG'S (NVS) Kymriah for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia. The approval was expected as an FDA panel unanimously endorsed the drug in July of this year.

Kymriah, previously known as CTL019, is a chimeric antigen receptor T cell (CAR-T) therapy for the treatment of patients up to 25 years of age with B-cell precursor ALL that is refractory or in second or later relapse. It is the first gene therapy to become available in the United States.

Gene therapies have already been approved in China, Russia and Europe.

A one-time treatment that uses a patient's own T cells to fight cancer, Kymriah will reportedly cost $475,000 per treatment.

Since treatment with Kymriah has the potential to cause severe side effects, the drug sports a boxed warning for cytokine release syndrome (CRS), which is a systemic response to the activation and proliferation of CAR T-cells causing high fever and flu-like symptoms, and for neurological events.

NVS closed Wednesday's trading at $82.74, down 1.05%. In after-hours, the stock was up 1.52% to $84.00.

Shares of Otonomy Inc. (OTIC) plunged over 82% on Wednesday as the first of its two phase III clinical trials of OTIVIDEX in patients with Ménière's disease failed to achieve the primary endpoint.

Ménière's disease is a disorder of the inner ear characterized by acute episodes of vertigo, fluctuations in hearing, tinnitus and aural fullness. The underlying cause of Ménière's disease is unknown and there are currently no FDA-approved drug treatments. According to the National Institute on Deafness and Other Communication Disorders (NIDCD), approximately 615,000 individuals have been diagnosed with Ménière's disease in the United States.

The study, dubbed AVERTS-1, was a 16-week, prospective, randomized, double-blind, placebo-controlled trial that enrolled a total of 165 patients with unilateral Ménière's disease in the United States.

Patients in both the OTIVIDEX and placebo groups showed similar reductions in the number and severity of vertigo episodes during the three month observation period. OTIVIDEX patients reported a 58% reduction from baseline in vertigo frequency in Month 3 vs. 55% for placebo patients.

Based on the AVERTS-1 data, the Company is immediately suspending the ongoing AVERTS-2 trial too.

OTIC closed Wednesday's trading at $3.57, down 82.81%.

Roche's (RHHBY.OB) rheumatoid arthritis blockbuster drug Actemra has secured FDA approval for yet another indication - this time, for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in patients two years of age and older.

Cytokine release syndrome, which is caused by an overactive immune response, has been identified as a potentially severe and life-threatening side effect of CAR-T cell therapy for certain cancers.

This is the seventh FDA approval for Actemra since its U.S. launch in 2010.

Actemra is already approved for the treatment of moderate to severe rheumatoid arthritis in adults, and the treatment of active systemic juvenile idiopathic arthritis (SJIA) and polyarticular juvenile idiopathic arthritis (PJIA) in patients two years of age and older.

The drug generated total sales of CHF 922 million in the first half of 2017, up 13% over the comparable year-ago period.

RHHBY.OB closed Wednesday's trading at $31.38, down 1.29%.

TearLab Corp. (TEAR) has been given time until November 6, 2017 to regain compliance with all applicable criteria for continued listing on The Nasdaq Capital Market, including the $2.5 million stockholders' equity requirement.

TEAR closed Wednesday's trading at $1.36, down 0.73%.

Teva Pharmaceutical Industries Ltd. (TEVA) has received FDA approval for AUSTEDO for the treatment of tardive dyskinesia in adults. AUSTEDO was previously approved for the treatment of chorea associated with Huntington's disease in April 2017.

Tardive dyskinesia is a debilitating and often irreversible movement disorder characterized by repetitive and uncontrollable movements of the tongue, lips, face, trunk and extremities. The condition affects about 500,000 people in the United States and can be caused by certain medications used to treat mental health conditions or gastrointestinal conditions.

TEVA closed Wednesday's trading at $15.46, down 1.97%.

VIVUS Inc. (VVUS) has resolved a pending lawsuit with Dr. Reddy's Laboratories S.A. and Dr. Reddy's Laboratories Inc by entering into a settlement agreement.

The lawsuit, which dates back to 2015, resulted from Dr. Reddy's seeking approval to market generic versions of VIVUS' weight-loss drug Qsymia.

The settlement agreement permits Dr. Reddy's to begin selling a generic version of Qsymia on June 1, 2025, or earlier under certain circumstances. In the event of a launch earlier than June 1, 2025, VIVUS will receive a royalty on sales of the generic version of Qsymia.

Sales of Qsymia were $48.5 million in 2016 compared to $54.6 million in 2015.

VVUS closed Wednesday's trading at $0.89, down 0.52%. In after-hours, the stock was up 4.42% to $0.93.