FDA Nod For Label Expansion Of Sutent, Egalet Flies, Double Blessing For Roche

(RTTNews) - Today's Daily Dose brings you news about Aerie's progress in phase II trial of glaucoma drug in Japan; phase III results of Egalet's pain pill; FDA approval of GlaxoSmithKline's COPD drug; expanded labeling for Pfizer's kidney cancer drug Sutent and Roche's double blessing on Thursday.

Read on...

Aerie Pharmaceuticals Inc. (AERI) has commenced patient dosing in its phase II clinical trial of Netarsudil ophthalmic solution in Japan.

The study will include three arms of about 60 patients each - a netarsudil ophthalmic solution 0.02% arm, a netarsudil ophthalmic solution 0.04% arm, and a placebo arm, all taken once daily in the evening.

This Phase 2 study will be conducted in the United States, enrolling Japanese and Japanese-American subjects as a precursor to Phase 3 trials that are expected to be subsequently conducted in Japan, noted the Company.

Netarsudil ophthalmic solution 0.02% is known by the name Rhopressa in the United States, and is under FDA review for the proposed treatment of glaucoma - with a decision expected by February 28, 2018.

AERI closed Thursday's trading at $59.70, up 0.67%.

Alkermes plc's (ALKS) New Drug Application for Aripiprazole Lauroxil NanoCrystal Dispersion for initiation onto ARISTADA extended-release injectable suspension for the treatment of schizophrenia, has been accepted for review by the FDA.

The regulatory agency's decision on the NDA will be known by June 30, 2018.

ALKS closed Thursday's trading at $47.75, down 0.69%.

Shares of Egalet Corp. (EGLT) soared more than 38% on Thursday, following positive top-line results from a phase III safety study of Egalet-002, an abuse-deterrent, extended-release oxycodone, in opioid-experienced patients with moderate-to-severe chronic noncancer pain.

According to the Company, Egalet-002 was generally well-tolerated and the incidence of adverse events reported was generally consistent with outcomes expected following treatment with an extended-release oxycodone formulation.

A phase III trial evaluating the safety and efficacy of Egalet-002 in patients with moderate-to-severe chronic pain is expected to be completed by year end.

EGLT closed Thursday's trading at $1.15, up 38.55%. In after-hours, the stock was up another 17.39% to $1.35.

The European Commission has approved GlaxoSmithKline PLC (GSK) and Innoviva Inc.'s (INVA) Trelegy Ellipta, a once-daily single inhaler triple therapy, as a maintenance treatment for appropriate patients with chronic obstructive pulmonary disease.

Trelegy Ellipta is a combination of an inhaled corticosteroid (ICS), a long-acting muscarinic antagonist (LAMA), and a long-acting beta2-adrenergic agonist (LABA), delivered once-daily in GSK's Ellipta dry powder inhaler.

The first European launch of Trelegy Ellipta is expected to take place before the end of the year.

Trelegy Ellipta was approved by the FDA as recently as September, and it is expected to be launched in the US in the middle of November.

INVA closed Thursday's trading at $12.97, down 0.15%.

The FDA has approved Pfizer Inc.'s (PFE) SUTENT for a new indication, i.e., as an adjuvant treatment for adult patients who are at high risk of their renal cell carcinoma returning after surgery.

Since its approval in 2006, SUTENT has been a standard of care for the treatment of advanced renal cell carcinoma, the most common type of kidney cancer.

The expanded approval of SUTENT comes nearly 2 months ahead of the FDA's decision date, which was originally scheduled for January 2018.

The drug logged global sales of $805 million in the first nine months of 2017 compared to $823 million in the year-ago period.

PFE closed Thursday's trading at $35.56, up 0.57%.

The FDA has approved Roche's (RHHBY) Gazyva in combination with chemotherapy for people with previously untreated advanced follicular lymphoma.

Follicular lymphoma, the most common slow-growing form of non-Hodgkin's lymphoma is incurable and becomes harder to treat each time it returns.

The drug is already approved in combination with chlorambucil, for people with previously untreated chronic lymphocytic leukaemia (CLL), and in combination with bendamustine for people with certain types of previously treated follicular lymphoma.

In the first nine months of 2017, Gazyva recorded sales of 202 million Swiss Francs, up 40% over the comparable year-ago period.

Thursday was a day of double blessing for Roche as yet another drug of the Company, Hemlibra, too received the FDA nod.

Hemlibra, previously known as emicizumab-kxwh, has been approved for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with haemophilia A with factor VIII inhibitors.

Hemlibra is the first new medicine in nearly 20 years to treat people with haemophilia A with inhibitors.

RHHBY.OB closed Thursday's trading at $28.89, up 0.57%.

Shares of Vascular Biogenics Ltd. (VBLT) were down more than 7% in extended trading on Thursday, following its proposed public offering of 2.5 million ordinary shares.

The Company intends to use the net proceeds from the offering for the advancement of clinical programs, product development, and for working capital and other general corporate purposes.

Near-term catalysts:

-- Initiate a phase III study of VB-111 in ovarian cancer by year-end 2017. -- Top-line results from phase III study of VB-111 in recurrent glioblastoma, dubbed GLOBE, are expected to be available in the first quarter of 2018.

VBLT closed Thursday's trading at $9.00, up 17.26%. In after-hours, the stock was down 7.78% to $8.30.