Thursday, October 4, 2018
Titan Medical achieves Q3 milestones for SPORT Surgical System
Titan Medical announced that the company has achieved all of its publicly stated Q3 development milestones for the SPORT Surgical System. It completed the improved camera insertion tube engineering confidence build. Titan Medical also completed design enhancements of both the surgeon workstation and patient cart in anticipation of system engineering confidence build by year-end. The company completed and demonstrated full suite of simulation training software for beta testing and filed three Q-submissions containing detailed protocols for animal, cadaver and human confirmatory studies for review by the FDA, approximately one year ahead of plan.
https://thefly.com/landingPageNews.php?id=2799759
Halozyme’s PEGPH20 data featured in Clinical Cancer Research publication
Halozyme announced the publication of nonclinical data for PEGPH20 in Clinical Cancer Research, an American Association for Cancer Research journal. PEGPH20 is the PEGylated version of Halozyme’s proprietary recombinant human hyaluronidase enzyme, rHuPH20. The paper demonstrates an association with increased collagen content, high tumor interstitial pressure, vascular collapse, hypoxia, drug resistance and increased metastatic potential. Treatment with PEGPH20 at the human equivalent dose degraded HA in the TME reversing these changes, and also depleted an important proangiogenic growth factor, VEGF-A165, suggesting that treatment with PEGPH20 may diminish the angiogenic potential of the TME. The accumulation of HA is common in many cancers, particularly in pancreatic cancer. A Phase 3 study evaluating the ability of PEGPH20 plus Abraxane and gemcitabine to increase Progression Free Survival and Overall Survival versus Abraxane and gemcitabine alone in metastatic pancreatic ductal adenocarcinoma patients, is under way.
https://thefly.com/landingPageNews.php?id=2799783
Adamas Pharmaceuticals publishes Phase 3 Gocovri Parkinson’s data
Adamas Pharmaceuticals announced that pooled Phase 3 data of Gocovri extended release capsules were published online in Parkinsonism and Related Disorders. Results from pooled Phase 3 ADS-5102 clinical trials, concluded that dyskinesias in people with Parkinson’s disease can impact a patient’s activities of daily living, or ADLs, across multiple tasks and that treatment with Gocovri can help ameliorate the impairment. Gocovri is the first and only medicine approved by the FDA for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. It is also the only drug approved by the FDA to treat dyskinesia in people with Parkinson’s disease on levodopa therapy, as well as demonstrate a secondary benefit in reducing off time in that population. In the pooled Phase 3 analysis, most adverse reactions were of mild to moderate intensity, and the most common adverse reactions were hallucination, dizziness, dry mouth, peripheral edema, constipation, falls, and orthostatic hypotension. https://thefly.com/landingPageNews.php?id=2799797
Horizon Pharma to hold a webcast
Management provides an overview of the clinical data for Teprotumumab as presented at the Annual Meeting of the American Thyroid Association on a webcast to be held on October 4 at 10:30 am.
Webcast: https://edge.media-server.com/m6/p/azkcmuon
https://thefly.com/landingPageNews.php?id=2799807
https://thefly.com/landingPageNews.php?id=2799807
Lannett Launches Five New Products in Fiscal 2019 First Quarter
Lannett Company, Inc. (NYSE: LCI) today announced that it commenced marketing five new products in its recently completed fiscal 2019 first quarter, bringing to 12 the total number of products launched since January 1, 2018.
The five products, all launched in the quarter ended September 30, 2018, include Methylphenidate ER Capsules (the authorized generic equivalent of Metadate CD), Esomeprazole DR Capsules, Buprenorphine plus Naloxone Sublingual Tablets and two pain management products. The five products have an estimated IMS market value of approximately $1.6 billion, although actual generic market values are expected to be lower. From January 1, 2018 to June 30, 2018, the company launched seven new products.
‘Adding products to our offering is a key component of our growth plan,’ said Tim Crew, chief executive officer of Lannett. ‘We still have as many as 20 products, of which eight have already received FDA approval, that we anticipate we will launch over the next 12 months. In addition, we are in active discussions to acquire and/or in-license products from various partners. Thus, our goal is to maintain this recent cadence of product launches for the foreseeable future.’
Earlier this year, the company acquired Metadate CD from UCB, S.A.
CVS pledges Aetna will remain in Hartford for least 10 years
Connecticut officials have received official assurances that CVS Health Corp. will keep Aetna Inc. in Hartford for at least the next decade.
The pledge is included in a commitment letter CVS delivered Wednesday to the Connecticut Insurance Department.
CVS had said in January that it had no plans to move Aetna, reversing last year’s announcement by the insurance giant that it would move its headquarters to another state. Hartford has been Aetna’s home since 1853.
CVS announced last December that it was buying Aetna.
Wednesday’s commitment letter also promises employee levels at Aetna will remain at approximately 5,291 for at least the next four years. CVS also will continue to honor civic contributions of the Aetna Foundation and a promised $50 million payment to the city of Hartford over five years.
Shionogi: Positive Results for Phase 3 Flu-Related Complications Study
Shionogi Presents Positive Results for Baloxavir Marboxil Phase III Study (CAPSTONE-2) in Individuals at High Risk for Influenza-Related Complications at IDWeek 2018
Shionogi & Co., Ltd. (Head Office: Osaka, Japan; President and CEO: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) has announced that the results from the global phase III study (CAPSTONE-2) assessing baloxavir marboxil in individuals at high risk for influenza-related complications are being presented at IDWeek 2018, held in San Francisco on October 3-7, 2018.
Key results from CAPSTONE-2 are as follows:
Baloxavir marboxil significantly reduced the time to improvement of influenza symptoms (TTIIS, the primary endpoint) compared with placebo (median time of 73.2 hours versus 102.3 hours; p<0.0001) and met the study’s primary objective. In analysis for each influenza virus subtype, baloxavir marboxil significantly reduced TTIIS in influenza type A/H3N2 (median time of 75.4 hours versus 100.4 hours; p<0.05) and type B (median time of 74.6 hours versus 100.6 hours; p<0.05) compared with placebo.
Baloxavir marboxil demonstrated superior efficacy compared with placebo for important secondary endpoints:
- ・ Significantly reduced the length of time the virus continued to be released from the body (viral shedding; median time of 48.0 hours versus 96.0 hours; p<0.0001).
- ・ Significantly reduced the usage of antibiotics for infections secondary to influenza infection (3.4% versus 7.5%; p=0.01).
- ・ Significantly reduced the incidence of influenza-related complications (2.8% versus 10.4%; p<0.05)
Baloxavir marboxil was also shown to be effective compared with oseltamivir for key endpoints:
- ・ Numerically reduced the TTIIS (median time of 73.2 hours versus 81.0 hours; p=0.8347). In analysis for each influenza subtype, TTIIS was significantly reduced in influenza type B (median time of 74.6 hours versus 101.6 hours; p<0.05)
- ・ Significantly reduced the length of time the virus continued to be released from the body (viral shedding; median time of 48.0 hours versus 96.0 hours; p<0.0001)
- ・ Numerically reduced the incidence of influenza-related complications (2.8% versus 4.6%)
Baloxavir marboxil was well tolerated and no new safety signals were identified. Baloxavir marboxil had a numerically lower overall incidence of reported adverse events (25.1%) compared with placebo (29.7%) or oseltamivir (28.0%). The most common adverse events reported following treatment with baloxavir marboxil were bronchitis (2.9%), diarrhoea (2.7%), nausea (2.7%) and sinusitis (1.9%), all observed at a lower frequency than placebo.
The data from CAPSTONE-2 demonstrate that baloxavir marboxil provides a clinically meaningful benefit for patients who are most susceptible to influenza-related complications. There are no other medicines which have demonstrated clear benefit specifically in high-risk populations in clinical studies. It is remarkable that baloxavir marboxil demonstrated superiority to oseltamivir in shortening the duration of virus shedding and in resolving the symptoms of influenza B virus infection. Based on these results, Shionogi believes that baloxavir malboxil will become a promising treatment option for influenza A and B, not only for otherwise healthy patients but also for those with risk factors for influenza complications.
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