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.
Friday, September 21, 2018
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.
Seattle Genetics announces Adcetris approval in Japan
Seattle Genetics (SGEN) announced that its collaborator, Takeda (TKPYY), has received approval from the Japanese Ministry of Health, Labour and Welfare for ADCETRIS in combination with doxorubicin, vinblastine and dacarbazine as a frontline treatment option for CD30-positive Hodgkin lymphoma patients in Japan. As a result, Seattle Genetics will receive a milestone payment from Takeda of $10M. The approval in Japan was based on the positive outcome from the phase 3 ECHELON-1 trial. Seattle Genetics and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs. Seattle Genetics is entitled to receive progress- and sales-dependent milestone payments. In addition, Seattle Genetics receives tiered double-digit royalties with percentages ranging from the mid-teens to mid-twenties based on net sales of ADCETRIS within Takeda’s territories.
Raymond James says Viking volatility on GTx trial failure would be chance to buy
Raymond James analyst Steven Seedhouse would be a buyer on any volatility in Viking Therapeutics (VKTX) after GTx (GTXI) announced its Phase 2 ASTRID study testing enobosarm in women with SUI failed to achieve its primary endpoint. Viking has not ever tested VK5211 in SUI, but there had appeared to be solid early clinical and preclinical rationale for the indication, Seedhouse tells investors. Viking is not yet developing its SARM VK5211 in SUI and VK5211 is not in his model for either SUI or hip fracture recovery, so the failure of ASTRID really doesn’t have immediate or direct negative readthrough to Viking, Seedhouse added. He maintains an Outperform rating and $43 price target on Viking shares, which are down 1% to $18.73 in early trading.
Johnson & Johnson’s Janssen discloses phase 3 study results of Esketamine
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced results from a Phase 3 clinical study of the investigational product esketamine nasal spray in patients with treatment-resistant depression. Janssen researchers presented these results at the Ninth Biennial Conference of the International Society for Affective Disorders (ISAD) and the Houston Mood Disorders Conference, taking place September 20-22, 2018 in Houston, TX. This clinical trial was a randomized, double-blind study of two fixed doses of esketamine, 56 mg and 84 mg. The study did not demonstrate statistical significance for the primary endpoint, change in a depression severity rating scale score from baseline to four weeks, for esketamine 84 mg plus oral antidepressant compared to oral antidepressant plus placebo. Therefore, based on the prespecified analysis plan, the esketamine 56 mg plus oral antidepressant group could not be formally evaluated in this study. Importantly, results of analyses of the primary endpoint and key secondary endpoints numerically favored both esketamine plus oral antidepressant treatment groups over the oral antidepressant plus placebo group.
https://thefly.com/landingPageNews.php?id=2794075
Exelixis Partner Ipsen Gets Euro Panel Nod on Liver Cancer Med
– In the phase 3 pivotal CELESTIAL trial, CABOMETYX demonstrated a statistically significant and clinically meaningful overall survival benefit –
Exelixis, Inc.(NASDAQ:EXEL) today announced that its partner Ipsen received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), for CABOMETYX® (cabozantinib) tablets as a monotherapy for the treatment of hepatocellular carcinoma (HCC) in adults who have been previously treated with sorafenib. The positive CHMP opinion will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union.
“This positive CHMP opinion represents significant progress for patients in Europe with this aggressive form of liver cancer who progress on prior systemic therapy, a large underserved patient population that currently only has one approved second-line treatment option,” said Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis. “We are excited about the potential therapeutic benefits CABOMETYX may offer the liver cancer community and look forward to the European Commission’s decision.”
Under the terms of the Collaboration Agreement with Ipsen, Exelixis is eligible to receive a milestone payment of $40 million for the approval of the second-line treatment of HCC. This milestone would be paid by Ipsen within 70 days of the approval decision by the European Commission.
CABOMETYX is currently approved in the European Union for the treatment of advanced renal cell carcinoma (RCC) in adults who have received prior VEGF-targeted therapy and for previously untreated intermediate- or poor-risk advanced RCC. The CHMP recommendation to expand the indication is based on results from the CELESTIAL trial of CABOMETYX in patients with advanced HCC who received prior sorafenib. In this phase 3 pivotal trial, CABOMETYX demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) versus placebo.
On May 29, 2018, Exelixis announced that the U.S. Food and Drug Administration (FDA) accepted for filing the supplemental New Drug Application (sNDA) for CABOMETYX for previously treated advanced HCC and assigned a Prescription Drug User Fee Act (PDUFA) action date of January 14, 2019. An sNDA is an application to the FDA that, if approved, will allow a drug sponsor to make changes to a previously approved product label, including modifications to the indication.
Please see Important Safety Information below and full U.S. prescribing information at https://cabometyx.com/downloads/CABOMETYXUSPI.pdf.
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