FDA To Rule On Elagolix In Q2, More Light From CELG's RADIANCE, TGTX On Watch

(RTTNews) - Today's Daily Dose brings you news about Neurocrine Biosciences' upcoming regulatory catalyst; Celgene's RADIANCE Part B trial results; tentative approval of Eagle Pharma's cancer drug Pemfexy; trial results of Kura's preclinical drug candidate, KO-539, and phase II drug candidate Tipifarnib; superiority of Roche's multiple sclerosis drug OCREVUS over EMD Serono's Rebif and additional encouraging results from TG Therapeutics' phase II trial of TG-1101 in relapsing forms of multiple sclerosis.

Read on...

The New Drug Application for Elagolix for the management of endometriosis with associated pain has been granted priority review - with a decision expected in Q2 2018.

Elagolix is developed by AbbVie (ABBV), in cooperation with Neurocrine Biosciences Inc. (NBIX).

The drug candidate is also being explored for the management of uterine fibroids, and phase III trials in this indication are ongoing.

NBIX closed Friday's trading at $62.14, up 4.70%.

Celgene Corp.'s (CELG) drug candidate Ozanimod has demonstrated superiority over Biogen Inc.'s (BIIB) approved multiple sclerosis drug Avonex in reducing annualized relapse rates and MRI brain lesions at two years in a phase III RADIANCE Part B trial.

The RADIANCE Part B is a pivotal, phase III, double-dummy, active-controlled trial evaluating the efficacy, safety and tolerability of two doses of oral Ozanimod (1 mg and 0.5 mg) against weekly intramuscular Avonex over a 24-month treatment period. The study included 1,320 people living with relapsing multiple sclerosis across 147 sites in 21 countries.

The incidence of adverse events and serious adverse events associated with oral Ozanimod were similar to Avonex, added the Company.

Celgene is planning to file regulatory submissions for Ozanimod in the U.S. by the end of 2017 and in the EU in the first half of 2018.

CELG closed Friday's trading at $98.17, down 1.82%.

The FDA has granted tentative approval for Eagle Pharmaceuticals Inc.'s (EGRX) PEMFEXY, a ready-to-dilute Pemetrexed Injection, for locally advanced or metastatic nonsquamous non-small cell lung cancer in combination with cisplatin; locally advanced or metastatic nonsquamous non-small cell lung cancer whose disease has not progressed after four cycles of platinum-based first-line chemotherapy, as maintenance treatment; locally advanced or metastatic nonsquamous non-small cell lung cancer after prior chemotherapy as a single agent; and malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery in combination with cisplatin.

Alleging that Eagle Pharma's PEMFEXY infringes a patent covering its chemotherapy drug Alimta, Eli Lilly and Co. (LLY) had sued Eagle in the District Court for the Southern District of Indiana on August 14, 2017 and in the District Court for the District of Delaware on September 11, 2017.

Alimta's patent in question is set to expire in the U.S. only on May 24, 2022. Alimta had annual global sales of $2.28 billion in 2016, including U.S. sales of $1.101 billion.

EGRX closed Friday's trading at $55.65, up 2.90%.

INSYS Therapeutics Inc.'s (INSY) founder and majority owner, John N. Kapoor, has stepped down from the Board of Directors, effective immediately. He was arrested last week for allegedly bribing doctors and pharmacists to prescribe "Subsys", a Fentanyl spray, intended for cancer patients experiencing breakthrough pain.

In his resignation letter Kapoor says that he has committed no crimes and that he believes he will be fully vindicated after trial. He further goes on to say that he plans to put his shares in a trust to be controlled independently and continue to have a long-term commitment to the company as a stockholder.

INSY closed Friday's trading at $5.74, unchanged from the previous day's close.

Kura Oncology Inc. (KURA) has announced that its preclinical drug candidate KO-539 has shown robust anti-tumor activity in NPM1- and DNMT3A-mutant acute myeloid leukemia.

A cancer that starts in the bone marrow and moves into the blood and spreads to other parts of the body is known as acute myeloid leukemia (AML). NPM1 and DNMT3A-mutants comprise approximately 45% of AML patients.

In other news, the Company announced updated preliminary results from its phase II open-label trial of Tipifarnib, which has confirmed the drug candidate's consistent clinical activity in patients with head and neck squamous cell carcinomas (HNSCC) with HRAS mutations.

KURA closed Friday's trading at $13.85, down 1.07%.

Roche's (RHHBY.OB) recently approved multiple sclerosis drug OCREVUS has demonstrated superiority over EMD Serono's Rebif in significantly reducing disability Progression Independent of Relapse Activity (PIRA) in people with relapsing multiple sclerosis in post-hoc analysis of phase III trials, dubbed OPERA I and OPERA II.

Specifically in the analysis, OCREVUS treatment reduced the risk of PIRA by 25 percent and 23 percent confirmed at 12 and 24 weeks, respectively, noted the Company.

Ocrevus was approved by the FDA in March of this year to treat adult patients with relapsing forms of multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS). Rebif, developed by EMD Serono Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, received FDA approval for the treatment of relapsing forms of multiple sclerosis in March 2002.

Rebif generated sales of 1.7 billion euros in 2016, down from 1.8 billion euros in 2015. Sales of Ocrevus were 308 million francs in Q3, 2017, up from 192 million francs in the previous quarter.

RHHBY.OB closed Friday's trading at $28.61, down 0.19%.

TG Therapeutics Inc. (TGTX), on Friday, announced additional encouraging results from its phase II trial of TG-1101 in relapsing forms of multiple sclerosis.

99% median B-cell depletion was observed at week 4 and maintained at week 24 with no additional infusions of TG-1101, reveals the data. B-cell depletion correlates with the clinical effectiveness of the drugs to treat autoimmune disorders like multiple sclerosis.

TG-1101 was well tolerated across all patients in the phase II trial, including those receiving 1 hour infusions of 450mg dose of TG-1101, noted the Company.

TGTX closed Friday's trading at $8.15, up 4.49%.