CHMP Says Yes To CLVS, No To PTLA, NVCN Put On Notice, OGEN To Report Data In Q2

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Today's Daily Dose brings you news about Oragenics' progress in its phase II oral mucositis trial; Nasdaq notification for Neovasc; approval of TiGenix and Takeda's Alofisel in Europe, and CHMP opinion on Portola's Betrixaban, and Clovis' Rubraca.

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The Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the granting of a conditional marketing authorization for Clovis Oncology Inc.'s (CLVS) Rubraca as monotherapy for treatment of women with advanced BRCA mutant ovarian cancer with platinum-sensitive, relapsed or progressive disease, who are unable to tolerate further platinum based chemotherapy.

A formal approval of Rubraca by the European Commission is anticipated in the second quarter of 2018.

In the United States, Rubraca was granted accelerated approval by the FDA for treatment of patients with deleterious BRCA mutation associated advanced ovarian cancer who have been treated with two or more chemotherapies in December 2016. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

The Company's supplemental New Drug Application for Rubraca for a second-line or later maintenance treatment indication in ovarian cancer is under FDA review in the U.S., with a decision expected on April 6, 2018.

The annual Rubraca U.S. sales totaled $55.5 million in 2017 compared to $78 thousand in 2016.

CLVS closed Friday's trading at $57.27, down 0.07%.

Neovasc Inc. (NVCN) (NVCN.TO) has been notified by the Nasdaq of not being in compliance with the minimum market value requirement for continued listing.

According to Nasdaq Listing Rules, the companies are required to maintain a minimum market value of US$35 million, and a failure to meet the market value requirement exists if the deficiency continues for a period of 30 consecutive business days.

In the case of Neovasc, its market value has been below US $35 million for 30 consecutive business days from February 6, 2018 to March 21, 2018.

The Company has time until September 18, 2018, to regain compliance with Nasdaq Listing Rules.

NVCN closed Friday's trading at $0.11, down 2.99%.

Oragenics Inc. (OGEN) has completed enrollment of the interim analysis cohort of 20 patients in its phase II clinical trial of AG013 for the treatment of oral mucositis (OM).

The purpose of the phase II study is to evaluate the efficacy, safety and tolerability of topically administered AG013 compared to placebo in reducing Oral Mucositis in patients undergoing chemoradiation for the treatment of head and neck cancer, as measured by the duration, time to development, and overall incidence of Oral Mucositis during the active treatment phase, beginning from the start of chemoradiation therapy (CRT) until 2 weeks following its completion.

The preliminary data on the initial 20 enrolled patients is expected to be reported during the second quarter of 2018, with top-line results of the trial expected in 2019.

OGEN closed Friday's trading at $1.88, unchanged from the previous day's close.

Portola Pharmaceuticals Inc. (PTLA) Betrixaban, proposed for the prevention of venous thromboembolism, or VTE, in adult patients hospitalized for an acute medical illness with risk factors for VTE, including VTE-related death, has received a negative opinion from the Committee for Medicinal Products for Human Use (CHMP).

The Company intends to appeal the opinion and seek a re-examination by the CHMP.

In the U.S., Betrixaban was approved by the FDA in June 2017 under the trade name Bevyxxa, and its commercial launch was initiated in January 2018.

PTLA closed Friday's trading at $30.57, down 3.56%.

TiGenix NV (TIG) and Takeda Pharmaceutical Company Ltd.'s Alofisel has been approved in Europe to treat complex perianal fistulas in Crohn's Disease.

Alofisel, formerly known as Cx601, becomes the first allogeneic stem cell therapy to receive central marketing authorization (MA) approval in Europe.

Alofisel has been licensed to Takeda for the exclusive development and commercialization outside of the US. Following the approval in Europe, TiGenix is entitled to receive a milestone payment of 15 million Euro from Takeda.

In the U.S., Alofisel is under phase III development.

TIG closed Friday's trading at $42.44, down 1.82%.

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