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Friday, July 12, 2019

Neovasc to pursue humanitarian path for Reducer angina device

Neovasc (NASDAQ:NVCN) announces its U.S. regulatory approval plan for Neovasc Reducer, a stent-like device used to treat refractory angina (chest pain caused by inadequate blood flow to the heart).
Per FDA guidance, it will pursue the Humanitarian Device Exemption (HDE) pathway for class IV angina patients (chest pain with any level of physical exertion), the quickest way to enable access for this population, while exploring an alternate clinical trial design aimed at broadening the patient population [class III (chest pain with mild exertion) and IV] and eliminating the restrictions associated with HDE status.
The Reducer is currently CE Mark certified.
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ICER still skeptical on efficacy of Sarepta, PTC exon-skipping therapies for Duchenne

The Institute for Clinical and Economic Review (ICER), a Boston-based non-profit that evaluates the cost of medical treatments, has just published an Evidence Report assessing the comparative clinical benefit and value of Sarepta Therapeutics’ (SRPT -0.8%) Exondys 51 (eteplirsen) and golodirsen and PTC Therapeutics’ (PTCT -1.9%) corticosteroid Emflaza (deflazacort) for the treatment of Duchenne muscular dystrophy (DMD). The report will be reviewed at a public meeting of the New England Comparative Effectiveness Public Advisory Council in Cambridge, MA on Thursday, July 25.
The report cites the absence of “persuasive evidence” that exon-skipping therapies improve outcomes that matter to patients, including functional status, quality of life or length of life. The limited data that exists show that both drugs modestly increase dystrophin levels but the clinical significance of this is “uncertain.”
As far as cost is concerned (more than $1M/year in its model), eteplirsen would still be over-priced even if it restored DMD patients to perfect health for additional 40 years, adding that it is unable to calculate value-based price benchmarks for either medication due to the paucity of efficacy data.
It says that there is evidence that deflazacort, a corticosteroid developed years ago, delivers greater benefits with less risk than prednisone, but the U.S. price is way out of line, 50x higher than prices in other countries.
The value-based price benchmark range is no higher than $19,000 – 31,700 per year. Conceptually, the company would have to discount the wholesale cost as much as 83% to be in line with the model (price assumption: $81,400).
According to Endpoints News, representatives from both companies stated that they have not raised the prices of their medications and are unclear on the assumptions ICER used in its calculations.
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FDA tentatively OKs Yabao’s generic Nexavar

The FDA has tentatively approved Chinese drug maker Yabao Pharmaceutical Group Limited’s sorafenib tosylate. Sorafenib is the active ingredient in Bayer’s (OTCPK:BAYRY -0.7%) cancer med Nexavar (sorafenib).
Tentative approval means that the application met the criteria for approval but patent issues need to be resolved before full approval is granted.
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J&J to launch study of HIV vaccine this year

CNBC reports that Johnson & Johnson (JNJ -1.2%) plans to initiate a clinical in the U.S. and Europe evaluating an experimental HIV vaccine.
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Illumina Slumps on Q2 Sales Miss

Illumina Inc (NASDAQ:ILMN) shares are trading lower Friday, after the company reported preliminary second-quarter sales below analyst estimates.
The genetics company expects to report second-quarter revenue of approximately $835 million, compared to $830 million in the second quarter of 2018.
The company reports approximately $10 million lower revenue than expected is due to ongoing weakness in the direct-to-consumer market, primarily impacting array services.
“We are obviously disappointed with our second-quarter financial results. Our preliminary analysis suggests that these challenges are transitory and do not reflect a macro change to the fundamentals of our business,” said CEO Francis deSouza.
“Despite our shortfall this quarter, we remain as enthusiastic about the long-term growth prospects for our markets as we have ever been, and are committed to setting the industry’s bar for consistency and execution in the dynamic and rapidly growing world of genomics.”
Illumina now expects fiscal year revenue growth of approximately 6%, primarily associated with lower near-term expectations in DTC, a more conservative assumption about the speed with which certain population genomics initiatives ramp, and lower non-high-throughput sequencing systems and consumables, including a delay in a partner program that is now expected to ramp in 2020.
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Alder Presents New Data on Migraine Med Eptinezumab

Alder BioPharmaceuticals, Inc. (NASDAQ: ALDR), a biopharmaceutical company focused on developing novel therapeutic antibodies for the treatment of migraine, today announced new data from post-hoc analyses of its PROMISE-1 and PROMISE-2 Phase 3 clinical trials for eptinezumab, an investigational monoclonal antibody developed for the prevention of migraine.
Detailed data will be shared at the American Headache Society’s (AHS) 61st Annual Scientific Meeting in Philadelphia that further support eptinezumab’s clinical profile, including data on migraine-free months, migraine severity and quality of life.
‘These new data analyses further validate our belief that, if approved, eptinezumab can provide clinically meaningful improvements for people living with migraine, which is considered the most disabling disease of people in the most productive years of their lives,’ said Roger K. Cady, M.D., vice president, neurology of Alder BioPharmaceuticals. ‘With these new data showing the clinical effects of rapid, robust and sustained suppression of CGRP, we are excited about the potential of eptinezumab to be a compelling new treatment option for migraine prevention.’
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Quest, Novartis Offers Free Genetic Mutation Test in Advanced Melanoma

The Know Now Testing Program, a Novartis initiative in collaboration with Quest Diagnostics, offers genetic mutation testing at no cost for all patients with stage III or stage IV melanoma.
Melanoma is an aggressive and often deadly form of skin cancer. Nearly 100,000 adults in the United States will be diagnosed with melanoma this year and approximately seven percent will die from melanoma1. Nearly half of all advanced melanoma patients carry a specific mutation, called BRAF. It’s important for patients to get tested and know their BRAF status as it is a key piece of information when evaluating treatment options2.
Results from tests completed under the Know Now Testing Program are available approximately 48 hours after a Quest Diagnostics laboratory receives a sample, which could lead to timely and optimal treatment decisions. To access the Know Nowprogram and its no-cost testing, healthcare professionals should visit http://www.knownowbraf.com and download the BRAF Test Request Form.
‘At Novartis, we know that understanding potential mutations is critical for melanoma patients and their doctors to make informed treatment decisions,’ said Ameet Mallik, Executive Vice President and Head, US, Novartis Oncology. ‘We recognize the barriers that often keep patients from being tested. That’s why we’re empowering the melanoma community with this Know Now Testing Program.’
People diagnosed with stage III or stage IV melanoma can ask their doctor about BRAF testing and the Know Now Testing Program to access its no-cost testing benefit.
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