FDA Rejects IPCI's Painkiller, GNCA Bleeds On Herpes Vaccine News, PRQR Abuzz

(RTTNews) - Today's Daily Dose brings you news about FDA approval of Amphastar's generic Bloxiverz; Arbutus' positive Cohort 4 results from phase II study of ARB-1467 in chronic HBV patients; the upcoming catalyst of Catalyst Biosciences; Genocea's decision to cease development of genital herpes drug candidate GEN-003 and Intellipharmaceutics' Complete response Letter for investigational opioid painkiller Rexista.

Read on...

The FDA has approved Amphastar Pharmaceuticals Inc.'s (AMPH) abbreviated new drug application for Neostigmine Methylsulfate Injection, USP, 1mg/mL, 10mL, and 0.5mg/mL, 10mL vial.

The approved product is therapeutically equivalent to Bloxiverz sold in the United States by Avadel, which is used for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery.

According to IMS Health data, the U.S. brand and generic sales of Neostigmine Methylsulfate Injection, USP, 1mg/mL, 10mL, and 0.5mg/mL, 10 mL were about $185 million for the 12 months ended June 30, 2017.

Amphastar anticipates launching its product in the fourth quarter of 2017.

AMPH closed Monday's trading at $16.27, up 1.06%. In after-hours, the stock was up 6.33% to $17.30.

Arbutus Biopharma Corp.'s (ABUS) topline results of bi-weekly dosing segment of Cohort 4 of its phase II study of ARB-1467 in chronic HBV patients on stable nucleotide therapy have demonstrated greater reduction in serum HBsAg levels with a favorable safety profile.

According to the trial results, all twelve patients in Cohort 4 experienced reductions in serum HBsAg levels, whose average reduction in serum HBsAg was greater than that observed with monthly dosing in Cohorts 1 through 3.

The Company is planning to initiate a new study of ARB-1467 next quarter to evaluate longer dosing of ARB-1467 combined with interferon.

ABUS closed Monday's trading at $6.75, up 3.05%.

Catalyst Biosciences Inc.'s (CBIO) collaborator ISU Abxis has completed dosing of the first subcutaneous cohort in an ongoing phase 1/2 proof-of-concept clinical trial of CB 2679d/ISU304 in individuals with severe hemophilia B. This cohort represents the second of up to five patient cohorts.

The companies plan to have interim top-line data from the trial by the end of 2017.

The positive results from Cohort 1 of the trial were reported earlier this month.

CBIO closed Monday's trading at $5.09, up 5.60%.

Shares of Genocea Biosciences Inc. (GNCA) plunged nearly 52% in extended trading on Monday after the Company announced that it is ceasing spending and activities for GEN-003, its Phase 3-ready investigational immunotherapy for the treatment of genital herpes.

In July of this year, positive 12-month top-line data from phase IIb trial of GEN-003 in genital herpes were reported. The Company is exploring strategic alternatives for GEN-003, and is trimming its workforce by approximately 40 percent.

Genocea added that it plans to initiate a Phase 1 clinical trial for GEN-009 in a range of tumor types in the first half of 2018 and expects to report initial immunogenicity data in the first half of 2019.

GNCA closed Monday's trading at $5.31, up 0.38%. In after-hours, the stock plunged 51.97% to $2.56.

The FDA has refused to approve Intellipharmaceutics International Inc.'s (IPCI) (IPCI.TO) Rexista, an abuse and alcohol-deterrent controlled-release formulation of oxycodone hydrochloride, proposed for the relief of moderate to severe pain.

In its Complete Response Letter, the FDA provided certain recommendations and requests for information, including the relevant Category 2 and Category 3 studies, the Company needs to complete to assess the abuse-deterrent properties of Oxycodone ER by the oral and nasal routes of administration.

The FDA also requested additional information related to the inclusion of the blue dye in the Oxycodone ER formulation, which is intended to deter abuse.

The FDA's decision was not surprising because Rexista was voted down by an FDA panel in July of this year. The panel had recommended against approval stating that the Company failed to demonstrate that Rexista has properties that can be expected to deter intravenous abuse.

IPCI closed Monday's trading at $1.01, up 18.52%.

Infinity Pharmaceuticals Inc. (INFI) has expanded its existing clinical collaboration with Bristol-Myers Squibb (BMY) evaluating IPI-549 in combination with Opdivo to include patients with triple negative breast cancer who have not been previously exposed to anti-PD-1 or anti-PD-L1 therapy.

A phase 1/1b study of IPI-549 as a monotherapy and in combination with Opdivo in approximately 200 patients with advanced solid tumors, being conducted by Infinity, is underway.

The study includes four parts - monotherapy and combination dose-escalation components, in addition to monotherapy expansion and combination expansion components. Patient enrollment is complete in monotherapy dose-escalation, and monotherapy expansion is ongoing. Combination dose-escalation is also ongoing, and combination expansion is expected to begin in the second half of 2017, noted the Company.

INFI closed Monday's trading at $1.20, up 5.26%.

ProQR Therapeutics N.V. (PRQR) has reported positive preliminary top-line results from a Phase 1b safety and tolerability clinical trial of QR-010 in cystic fibrosis patients with F508del mutation.

The study primarily assessed safety, tolerability and pharmacokinetics of QR-010, and a number of exploratory efficacy endpoints including sweat chloride, weight gain, change in CFQ-R Respiratory Symptom Score and FEV1. The study was not powered for statistical significance on the exploratory efficacy endpoints.

Commenting on the results, Stuart Elborn, the principal investigator of the study, added, "QR-010 exceeded expectations in this study as an innovative investigational therapy for the treatment of cystic fibrosis for which the need remains high. The improvements demonstrated in reduction of respiratory symptoms are very encouraging and intriguing and of course of enormous importance to people with CF. The results of this study together with the previous proof of concept study are strongly supportive of the further development of QR-010."

PRQR closed Monday's trading at $6.45, up 4.03%. In after-hours, the stock was up another 6.98% to $6.90.