The U.S. Gets 2nd Biosimilar, ORMP Awaits Data This Qtr, PFE Hits Mark In OPAL

(RTTNews) - Advaxis Inc. (ADXS) and Merck & Co. Inc. (MRK) have launched the third dose-escalation cohort in their phase 1/2 study evaluating the combination of product candidate ADXS-PSA and Merck's approved drug KEYTRUDA in patients with previously treated, metastatic castration-resistant prostate cancer.

The trial, dubbed KEYNOTE-046, is the first-in-human study of ADXS-PSA, Advaxis' immunotherapy candidate for prostate cancer. It is the second study initiated to evaluate the use of KEYTRUDA in the treatment of advanced prostate cancer.

ADXS closed Tuesday's trading at $9.28, unchanged from the previous day's close.

With enrollment in its phase III trial of Plazomicin in patients with complicated urinary tract infections, dubbed EPIC, expected to be completed ahead of schedule, Achaogen Inc. (AKAO) now looks to release top-line results from the trial in the first quarter of 2017, two quarters ahead of initial estimates.

If all goes well as planned, the company plans to submit a New Drug Application for Plazomicin in the second half of 2017.

AKAO closed Tuesday's trading at $2.72, down 0.73%.

The FDA has approved South Korea-based Celltrion Inc.'s INFLECTRA, which is a biosimilar to Johnson & Johnson's (JNJ) Remicade.

In February of this year, an FDA panel voted 21 to three, recommending approval of INFLECTRA. It has been approved across all eligible indications of the reference product, Remicade, namely for the treatment of a variety of serious autoimmune diseases, including rheumatoid arthritis, adult ulcerative colitis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and adult and pediatric Crohn's disease.

The product will sport a Boxed Warning, alerting health care professionals and patients about the serious side effects associated with its use. INFLECTRA has been available in the European markets since February 2015.

INFLECTRA is now the first and only biosimilar monoclonal antibody (mAb) therapy, and only the second biosimilar, to be approved in the U.S. Novartis' Zarxio, which is a biosimilar to Amgen's Neupogen, is the first biosimilar to be approved by the FDA.

Hospira, now a Pfizer company, entered into an agreement with Celltrion Inc. and Celltrion Healthcare, Co., Ltd. in 2009 for several potential biosimilar products, including INFLECTRA. Pfizer holds exclusive commercialization rights to INFLECTRA in the U.S. and certain other jurisdictions.

Remicade had worldwide sales of $6.56 billion last year compared to $6.87 billion in 2014.

PFE closed Tuesday's trading at $31.36, up 2.08%.

Ironwood Pharmaceuticals Inc. (IRWD) has decided to discontinue its phase IIa study of IW-9179 for gastroparesis as topline data indicated that IW-9179 did not meaningfully reduce the severity of symptoms in patients with diabetic gastroparesis.

IRWD closed Tuesday's trading at 10.79, down 3.92%.

Nivalis Therapeutics Inc. (NVLS) has reached the halfway point in dosing of the 135 patient phase II trial of N91115 in cystic fibrosis.

The study is evaluating two doses of N91115, 200mg and 400mg, administered twice daily versus placebo in adult patients with CF who are homozygous for the F508del-CFTR mutation and being treated with Orkambi. The company expects to report results from the study in the fourth quarter of this year.

NVLS closed Tuesday's trading at $4.14, down 3.94%.

Oramed Pharmaceuticals Inc. (ORMP) has completed its phase IIb study of oral insulin capsule, ORMD-0801, in patients with type 2 diabetes.

The study, involving 180 was patients, was initiated on June 30, 2015 and conducted at 33 clinical sites in the United States. Top-line results are expected later this quarter.

ORMP closed Tuesday's trading at $7.95, up 4.19%.

Pfizer Inc.'s (PFE) first phase III study investigating Tofacitinib for the treatment of psoriatic arthritis has met its primary efficacy endpoints.

The trial, dubbed OPAL Broaden, tested Tofacitinib 5 mg and 10 mg twice daily in adult patients with active psoriatic arthritis who had an inadequate response to at least one conventional synthetic disease-modifying antirheumatic drug (csDMARD) and who were tumor necrosis factor inhibitor (TNFi)-naïve.

Another phase III study of Tofacitinib in psoriatic arthritis, dubbed OPAL Beyond, is underway, and results are anticipated in the first half of 2016.

PFE closed Tuesday's trading at $31.36, up 2.08%.