LLY Fixing Depleted Pipeline, AMGN's Prolia Outdoes Rival, Opdivo In The News

(RTTNews) - Allergan plc's (AGN) supplemental New Drug Application for single-dose administration of DALVANCE for the treatment of acute bacterial skin and skin structure infections in adults caused by designated susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus, has been accepted for review by the FDA.

DALVANCE, given by injection into a vein, was first approved by the FDA last May as a two-dose regimen of 1000 mg followed one week later by 500 mg, each administered over 30 minutes, for the aforementioned indication. The drug is marketed in the European Union as XYDALBA.

AGN closed Friday's trading at $274.84, down 0.48%.

Amgen's (AMGN) injectable osteoporosis drug Prolia scored over the most-frequently used intravenous bisphosphonate zoledronic acid in improving bone mineral density in postmenopausal women with osteoporosis following previous treatment with oral bisphosphonates in a phase 4 study.

In the 12-month study, which enrolled 643 women 55 years or older who had postmenopausal osteoporosis and had been taking oral bisphosphonate therapy for two or more years, the change from baseline in lumbar spine bone mineral density (BMD) at 12 months was significantly greater in participants who received subcutaneous Prolia every six months plus intravenous placebo once yearly compared to participants who were administered intravenous zoledronic acid once yearly plus subcutaneous placebo every six months.

The Prolia group also had significantly greater improvements than the zoledronic acid group in secondary and exploratory study endpoints, including BMD changes in the total hip, femoral neck, and 1/3 radius, according to the company.

Prolia sales totaled $340 million in the second quarter of 2015, an increase of 29% over the comparable year-ago period.

AMGN closed Friday's trading at $149.59, down 0.21%.

Bristol-Myers Squibb Co.'s (BMY) cancer drug Opdivo, also known chemically as nivolumab, has received FDA approval for yet another indication - this time, for the treatment of patients with metastatic non-squamous non-small cell lung cancer whose disease progressed during or after platinum-based chemotherapy.

The expanded approval was based on results from a phase III trial, dubbed CheckMate-057, where Opdivo demonstrated superior overall survival in previously treated metastatic non-squamous NSCLC patients compared to standard chemotherapy drug Docetaxel, with a 27% reduction in the risk of death.

The median overall survival was 12.2 months in the Opdivo arm and 9.4 months in the Docetaxel arm. The approval comes nearly three months ahead of the FDA's scheduled decision date of January 2, 2016.

Opdivo was first approved for the treatment of advanced melanoma by the FDA last December. On March 4, 2015, Opdivo received its second FDA approval for the treatment of patients with advanced squamous non-small cell lung cancer with progression on or after platinum-based chemotherapy.

Early this month, Opdivo in combination with Yervoy was approved by the FDA for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma. The drug is also approved in Japan for the treatment of patients with unresectable melanoma, and in Europe for advanced melanoma and advanced squamous non-small cell lung cancer.

Opdivo raked in sales of $162 million for the six months ended June 30, 2015.

BMY closed Friday's trading at $61.44, up 1.54%.

Eli Lilly and Co. (LLY), which has been facing a tough time due to patent expirations of its key blockbuster drugs, has acquired worldwide rights to intranasal glucagon, a potential treatment for severe hypoglycemia in people with diabetes treated with insulin, from privately held Locemia Solutions.

Intranasal glucagon is currently in phase III clinical trial testing, and if approved, could be the first needle-free rescue treatment for severe hypoglycemia. Financial terms have not been revealed.

LLY closed Friday's trading at $86.14, up 2.83%.

Health watchdog NICE has recommended Merck & Co.'s (MRK) KEYTRUDA as a first-line treatment option for adults with advanced melanoma.

Last week, NICE had issued final guidance recommending KEYTRUDA for the treatment of advanced melanoma after disease progression with ipilimumab.

It is binding on part of the National Health Service in England and Wales to fund medicines and treatments recommended by NICE for eligible people.

Keytruda was approved as monotherapy for the treatment of adult patients with advanced melanoma that cannot be surgically removed or where the cancer has spread to other parts of the body (unresectable or metastatic melanoma) in May of this year.

The drug is currently approved in 39 countries, including the United States.

MRK closed Friday's trading at $50.95, down 0.14%.

MediciNova Inc. (MNOV) is all set to initiate a phase II clinical trial of MN-001 to treat moderate to severe idiopathic pulmonary fibrosis this fall.

The trial is designed as a double blind 6-month study followed by an open-label extension phase and will enroll fifteen qualifying subjects.

MNOV closed Friday's trading at $2.82, down 1.05%.