ARRY Working Its Way, Be All Ears For Auris, BGNE Inks Deal With CELG

(RTTNews) - Today's Daily Dose brings you news about Array's progress in melanoma clinical program; Auris Medical's upcoming clinical trial catalyst; BeiGene's collaboration with Celgene; Merck's disappointing KEYNOTES; Prothena's PASADENA trial and Vivus' patent suit related to weight-loss drug Qsymia.

Read on...

Array BioPharma (ARRY) has submitted two New Drug Applications to the FDA to support use of the combination of binimetinib 45 mg twice daily and encorafenib 450 mg once daily for the treatment of patients with BRAF-mutant advanced, unresectable or metastatic melanoma.

In a pivotal phase III study, dubbed COLUMBUS, patients with locally advanced, unresectable or metastatic melanoma with BRAF V600 mutation who received binimetinib and encorafenib had a significantly longer progression free survival (PFS) compared to patients receiving vemurafenib.

ARRY closed Wednesday's trading at $8.99, up 3.33%.

Auris Medical Holding AG (EARS) has completed patient enrollment in its phase III clinical trial of AM-111 in idiopathic sudden sensorineural hearing loss, also known as sudden deafness.

This is the first of two pivotal trials in Auris Medical's phase III clinical development program for AM-111, and is known by the name HEALOS. Top-line results from the study, dubbed HEALOS, are expected in the fall of 2017.

The second phase III trial, known as ASSENT, is set to enroll patients, and top-line results from this study are expected in the second half of 2018.

EARS closed Wednesday's trading at $0.75, up 3.13%.

Celgene Corp. (CELG) and BeiGene Ltd. (BGNE) have entered into a strategic collaboration to develop and commercialize BeiGene's investigational BGB-A317, for patients with solid tumor cancers in the United States, Europe, Japan and rest of world outside Asia.

BGB-A317 is currently in two pivotal trials in China - one in patients with bladder cancer and another in patients with relapsed or refractory classical Hodgkin lymphoma. Global pivotal studies of BGB-A317 are planned for initiation in 2018.

BeiGene is set to receive $263 million in upfront license fees and Celgene will acquire an equity stake of 5.9% in BeiGene, which equals to a $150 million equity investment. BeiGene is eligible to receive up to $980 million in development, regulatory and sales milestone payments and royalties on future sales of BGB-A317.

As part of the agreement, BeiGene will acquire Celgene's commercial operations in China and gain an exclusive license to commercialize Celgene's approved therapies in China namely, ABRAXANE, REVLIMID and VIDAZA.

BGNE closed Wednesday's trading at $52.27, down 3.84%.

The FDA has placed Merck's (MRK) three multiple myeloma studies evaluating KEYTRUDA in combination with Pomalidomide or Lenalidomide, dubbed KEYNOTE-183, KEYNOTE-185 and KEYNOTE-023.

A review of data by Data Monitoring Committee revealed that there were more deaths in the KEYTRUDA arms of KEYNOTE-183 and KEYNOTE-185, which led to the pause in new patient enrollment, as announced on June 12, 2017.

The FDA has determined that the data available at the present time indicate that the risks of KEYTRUDA plus pomalidomide or lenalidomide outweigh any potential benefit for patients with multiple myeloma.

MRK closed Wednesday's trading at $64.16, down 0.17%.

Pieris Pharmaceuticals Inc. (PIRS) is making a steady progress with its drug candidates PRS-343 for HER2-positive solid tumors; PRS-080, an anti-hepcidin Anticalin to address functional iron deficient anemia and PRS-060 for asthma.

The Company filed an IND for PRS-343 and has been engaged in discussions with FDA to finalize the clinical trial protocol for this first-in-patient study.

Separate clinical trial applications have been filed with the German and Czech Republic regulatory authorities to conduct a multi-dose trial for PRS-080 in FID anemia patients. If all goes well as planned, enrollment in the trial may commence in the third quarter across several sites.

As for PRS-060, the Company plans to initiate and dose healthy subjects in the fourth quarter of 2017 in a single ascending dose trial followed by a multi-ascending dose trial in Australia. The dosing of the first subject would trigger a milestone payment of $12.5 million by AstraZeneca to Pieris.

PIRS closed Wednesday's trading at $5.44, up 6.04%.

Prothena Corp. plc (PRTA) announced that a global phase II study of PRX002/RG7935 in patients with early Parkinson's disease has been initiated.

The study, dubbed PASADENA, is a two-part trial, and is being conducted by Roche. The start of the study triggered a $30 million milestone from Roche to Prothena, which was earned in the second quarter of 2017. Prothena had previously received $45 million in upfront and development milestone payments.

PRTA closed Wednesday's trading at $57.58, up 3.65%.

VIVUS Inc. (VVUS) has resolved the patent litigation with Actavis Laboratories FL related to weight-loss drug Qsymia.

Actavis is seeking approval to market generic versions of Qsymia. Now, that a settlement has been reached, Actavis can begin selling a generic version of Qsymia on December 1, 2024, or earlier under certain circumstances.

In the event of a launch earlier than December 1, 2024, VIVUS will receive a royalty on sales of the generic version of Qsymia.

The net product revenue of Qsymia for Vivus was $48.5 million in 2016, down from $54.6 million in 2015.

VVUS closed Wednesday's trading at $1.23, up 0.82%.