Melinta Therapeutics announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, has adopted a positive opinion recommending Vabomere for approval as a treatment for adult patients with complicated intra-abdominal and urinary tract infections, hospital-acquired pneumonia including ventilator associated pneumonia, bacteraemia that occurs in association with any of these infections, and infections due to aerobic Gram-negative organisms where treatment options are limited. The CHMP’s opinion will be reviewed by the European Commission, or EC, which is expected to make a final decision regarding marketing authorization within 67 days of receiving the CHMP opinion. If approved by the EC, marketing authorization for Vabomere will be granted in all 28 countries of the European Union, Norway, Iceland and Liechtenstein. Milestone payment obligations related to Vabomere’s European approval would not take effect until marketing authorization is granted by the EC.
Friday, September 21, 2018
Eli Lilly receives positive CHMP opinion for Emgality
Eli Lilly announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion for Emgality for the prophylaxis of migraine in adults who have at least four migraine days per month. In June 2018, Lilly announced the intended brand name, Emgality, was conditionally accepted by the U.S. FDA.
GTx: placebo-controlled ASTRID trial did not meet primary endpoint
GTx announced that the ASTRID Trial, a Phase 2 double-blind, placebo-controlled clinical trial of orally-administered enobosarm in post-menopausal women with stress urinary incontinence, did not achieve statistical significance on the primary endpoint of the proportion of patients with a greater than 50% reduction in incontinence episodes per day compared to placebo. The percentage of patients with a greater than 50% reduction after 12 weeks of enobosarm treatment was 58.9% for 3mg, 57.7% for 1mg and 52.7% for placebo. Enobosarm was generally safe and well tolerated. Reported adverse events were minimal and similar across all treatment groups. “We are very disappointed that the ASTRID Trial did not achieve its primary endpoint,” said Robert Wills, executive chairman of GTx. “We plan to conduct a full review of all the data. We want to thank the patients, physicians, study coordinators and the entire GTx team for their support of this novel study. We have an ongoing preclinical program assessing the potential of SARDs, our novel selective androgen receptor degrader technology, to treat castration-resistant prostate cancer. We are currently on target to have development candidates by year end, which we potentially plan to take into IND-enabling studies.”
Clovis price target lowered to $71 from $87 at JPMorgan
JPMorgan analyst Cory Kasimov lowered his price target for Clovis Oncology to $71 after “reigning in” his ovarian expectations but keeps an Overweight rating on the shares. With the European Society of Medical Oncology meeting coming up in October, Kasimov is previewing the first look at data from Clovis’s Triton-2 study in prostate cancer. The analyst is “quite confident” that the company’s PARP inhibitor rucaparib should produce response rates that are well above chemotherapy and anti-androgens, at least in third line BRCA positive patients. He views the Triton-2 update as an important event for Clovis and believes “promising results could represent a step towards restoring more favorable sentiment.” A response rate of at least 30% is the lower bar for share appreciation, Kasimov tells investors in a research note. He keeps an Overweight rating on Clovis.
United Natural Foods profitability pressures on the rise, says RBC Capital
RBC Capital analyst William Kirk kept his Underperform rating on United Natural Foods after its Q4 earnings and revenue miss. The analyst adds that the company’s organic net sales growth of 10.7% was below 11.5% consensus and down from 11.8% last quarter. With gross margins also shrinking, Kirk points to United Natural Foods’ declining profitability and maintains that the cost of servicing Whole Foodsis rising. The analyst adds that the company’s synergy of its Supervalu deal has underperformed while its leverage increased.
Mylan announces U.S. launch of generic Ampyra tablets
Mylan (MYL) announced the U.S. launch of Dalfampridine Extended-Release Tablets, 10 mg, the authorized generic version of Acorda’s (ACOR) Ampyra, which is indicated to improve walking in adult patients with multiple sclerosis. The launch comes after the United States Court of Appeals for the Federal Circuit upheld the United States District Court for the District of Delaware’s decision to invalidate four Ampyra patents: U.S. Patent Nos. 8,663,685, 8,007,826, 8,440,703, and 8,354,437. Acorda’s U.S. Patent No. 5,540,938, previously upheld by the District Court, expired on July 30, 2018.
Takeda Pharmaceutical receives positive CHMP opinion recommending Alunbrig
Takeda Pharmaceutical announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion, recommending the full approval of ALUNBRIG as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase-positive advanced non-small cell lung cancer previously treated with crizotinib. ALUNBRIG is a tyrosine kinase inhibitor designed to target and inhibit the ALK mutation in NSCLC. Approximately three to five percent of NSCLC patients globally have the ALK mutation. If the CHMP opinion is affirmed, and the European Commission approves ALUNBRIG, it will become the only ALK inhibitor available in the European Union as a one tablet per day dose that can be taken with or without food. The randomized, global Phase 2 ALTA trial was designed to investigate the efficacy and safety of ALUNBRIG in patients with locally advanced or metastatic ALK+ NSCLC who had progressed on crizotinib. Patients were randomized to receive one of two regimens of ALUNBRIG: 90 mg of ALUNBRIG once daily or 180 mg once daily with seven-day lead-in at 90 mg once daily. As part of this submission, the CHMP also reviewed data from the first interim analysis of the Phase 3 ALTA-1L trial, which met its primary endpoint, as supportive evidence. In ALTA-1L, treatment with ALUNBRIG resulted in a statistically and clinically significant improvement in PFS versus crizotinib as assessed by a blinded independent review committee. The safety profile associated with ALUNBRIG was generally consistent with prior studies and approved U.S. and Canadian labeling. The CHMP positive opinion for ALUNBRIG will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 28 member states of the European Union, as well as Norway, Liechtenstein and Iceland.
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