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.
Friday, September 21, 2018
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.
Medtronic acquisition of Mazor not a surprise, says Piper Jaffray
Piper Jaffray analyst Matt O’Brien believes Medtronic’s (MDT) $1.64B acquisition of Mazor Robotics (MZOR) is not much of a surprise given the companies’ exclusive distribution arrangement and Medtronic’s existing minority stake. The deal will help Medtronic’s spine franchise business stay on the road to recovery, O’Brien tells investors in a research note. He keeps an Overweight rating on the shares with a $105 price target. Further, the analyst believes robot placements are “still in the early days” and that the acquisition will not “overly hurt” Globus Medical’s (GMED) ability to sell systems in coming quarters. As such, O’Brien thinks the Mazor Robotics takeover will unlikely have an impact on Globus’s Excelsius robot.
https://thefly.com/landingPageNews.php?id=2793565
BeiGene presents results on anti-PD-1 antibody tislelizumab at CSCO
BeiGene presented clinical data on tislelizumab, an investigational anti-PD-1 antibody, in Chinese patients with lung cancers, in two oral presentations at the 21st Annual Meeting of the Chinese Society of Clinical Oncology, or CSCO, in Xiamen, China. “Advanced lung cancer is one of our focus areas for development of tislelizumab, where we hope to have an impact on the way patients are treated both in China and worldwide. This complex and difficult-to-treat disease has proven to be susceptible to treatment with immunotherapies,” commented Amy Peterson, M.D., Chief Medical Officer, Immuno-Oncology, at BeiGene. “The preliminary data presented today demonstrate that tislelizumab is generally well tolerated and has antitumor activity both as monotherapy and in combination with several chemotherapy regimens used in small cell and non-small cell lung cancer patients. We are hopeful that further study of tislelizumab may lead to a new treatment option for a broad array of patients with lung cancers.” The multi-center, open-label Phase 2 trial in China of tislelizumab in combination with chemotherapy enrolled 54 patients with previously untreated locally advanced or metastatic lung cancer. All patients received tislelizumab at 200 mg every three weeks, plus platinum doublet until disease progression. Patients with non-squamous non-small cell lung cancer, or NSCLC, received pemetrexed plus platinum; patients with squamous NSCLC received either paclitaxel plus platinum or gemcitabine plus platinum; and patients with small cell lung cancer, or SCLC, received etoposide plus platinum. As of the June 5, 2018 data cutoff, 35 patients remain on treatment. Treatment discontinuation due to adverse events, or AEs, occurred in three patients. Fifty-one patients had at least one post-baseline tumor assessment and were evaluable for efficacy. Objective responses were observed in 56 percent of 16 evaluable patients with non-squamous NSCLC; 80 percent in 15 evaluable patients with squamous NSCLC, cohort A; 67 percent in six patients with squamous NSCLC, cohort B; and 82 percent in 17 evaluable patients with SCLC. Data continue to mature with follow-up. AEs were considered manageable and reversible, with chemotherapy dose modifications or tislelizumab dose holds, except for one fatal event of myocarditis/myositis. Five patients experienced at least one grade greater than or equal to3 AE that were considered to be possibly related to tislelizumab. Immune-related AEs occurred in 13 patients and included hypothyroidism, decreased tri-iodothyronine, hyperthyroidism, pneumonitis, pyrexia, and rash.
https://thefly.com/landingPageNews.php?id=2793569
Cara Therapeutics initiated at Cantor Fitzgerald
Cara Therapeutics initiated with an Overweight at Cantor Fitzgerald. Cantor Fitzgerald started Cara Therapeutics with an Overweight rating and $27 price target.
https://thefly.com/landingPageNews.php?id=2793573
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