Reports Q4 revenue $114.9M, consensus $244.01M.
https://thefly.com/landingPageNews.php?id=2875497
Wednesday, March 6, 2019
Gilead Presents New Data on Treatment of HIV-1 in Kids, Women, Seniors
Gilead Sciences, Inc. GILD, -2.28% today announced 48-week results from a Phase 2/3 study (Study GS-US-380-1474) evaluating the efficacy and safety of Biktarvy [®] (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, BIC/FTC/TAF), a once-daily single tablet regimen, in virologically suppressed adolescents and children at least 6 years of age who are living with HIV. Through Week 48, Biktarvy maintained high rates of virologic suppression with a low incidence of study drug-related adverse events and no treatment-emergent resistance. The data were presented at the 2019 Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle.
“These findings indicate that Biktarvy, an oral single-tablet regimen that can be taken with or without food, has the potential to be an effective and well-tolerated treatment option for some children and adolescents living with HIV,” said Aditya H. Gaur, MD, Clinical Director, Department of Infectious Diseases at St. Jude Children’s Research Hospital and lead study investigator. “Importantly, Biktarvy was not associated with any cases of treatment-emergent resistance through 48 weeks of treatment, a result observed consistently to date across the Biktarvy clinical research programs and a significant consideration for children and adolescents who are facing the prospect of long-term treatment.”
Biktarvy is indicated in the U.S. as a complete regimen for the treatment of HIV-1 infection in adults who have no antiretroviral treatment history. Biktarvy is also indicated to replace the current antiretroviral regimen in those adults who are virologically suppressed on a stable antiretroviral regimen for at least three months. Virologically suppressed adults must have no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy. Biktarvy carries a Boxed Warning in its U.S. product label regarding the risk of post-treatment acute exacerbation of hepatitis B. See below for Important Safety Information.
Few Seniors Receive Regular Brief Cognitive Assessments
Only 16 percent of seniors receive regular cognitive assessments, according to the Alzheimer’s Disease Facts and Figures report published March 5.
The authors of the report address the prevalence and risk of Alzheimer disease, as well as the impact of caregiving and national costs of care. In addition, the report focuses on attitudes toward cognitive assessment among seniors and primary care physicians (PCPs).
According to the report, an estimated 5.8 million Americans are living with Alzheimer disease in 2019; 5.6 million are aged 65 years and older. The number of people aged 65 years and older with Alzheimer disease is projected to reach 7.1 million and 13.8 million by 2025 and by 2050, respectively, barring the development of a medical breakthrough to prevent, slow, or cure the disease. Routine assessment is crucial for early detection of Alzheimer disease and other dementias and provides benefits including financial benefits. However, only half of seniors are being assessed, and only 16 percent get regular brief cognitive assessments. Half of seniors report sometimes or frequently noticing changes in their ability to think, understand, or remember, and 22 percent worry about these issues. Only 40 percent have talked to a health care provider about their concerns.
“The surveys highlight a number of educational opportunities for seniors and PCPs alike that have the potential to lead to the better utilization of brief cognitive assessments and the greater detection and diagnosis of cognitive impairment and dementia that are so urgently needed,” according to the report.
Gilead says DISCOVER trial met primary, secondary endpoints
Gilead Sciences announced results from the DISCOVER trial, a two-year Phase 3 randomized, controlled, double-blind study evaluating the safety and efficacy of the investigational use of once-daily Descovy for HIV pre-exposure prophylaxis, compared with Truvada, in men who have sex with men and transgender women at risk for sexually acquired HIV infection. In a late-breaker oral abstract presented today at the Conference on Retroviruses and Opportunistic Infections in Seattle, 5,387 study participants were randomized in a 1:1 ratio and received either Descovy or Truvada. Among the 2,694 participants who were at risk of HIV-1 infection and received once-daily Descovy, seven HIV infections were reported. Among the 2,693 participants who were at risk of HIV-1 infection and received Truvada, 15 HIV infections were reported. Descovy met the pre-established criteria for non-inferiority to Truvada using a stringent rate ratio statistical comparison, as demonstrated by the upper bound of the 95 percent confidence interval for HIV-1 infection rate ratio being less than the predefined non-inferiority margin of 1.62/100 PY. Additionally, statistically significant advantages with respect to bone and renal laboratory parameters were observed for participants receiving Descovy as compared with those receiving Truvada, which were pre-specified secondary endpoints. “As the largest HIV prevention trial conducted to date, the DISCOVER trial results clearly demonstrate Descovy for PrEP achieved a clinical profile similar to the high efficacy of Truvada and a more favorable bone and renal safety profile,” said John McHutchison, AO, MD, Chief Scientific Officer and Head of Research and Development, Gilead Sciences. “We look forward to filing regulatory applications for Descovy for the PrEP indication as a potential important new option to prevent individuals from becoming infected and contribute to the achievement of national and global HIV prevention goals.”
FDA updates on asbestos contamination in certain cosmetic products
Each day, cosmetic products are sold to consumers across the U.S. – some to children under the age of 18, still in the formative years of development. These products are used as part of daily beauty and cleansing routines, often times on the skin’s most sensitive areas, like the face, eyelids and lips. That’s why it’s so important that cosmetic products are safe, properly labeled and free of contamination. It’s also why when we hear about reports of contamination, like the 2017 reports of asbestos contamination in certain cosmetic products sold by Claire’s and Justice retailers, we’re especially concerned.
Today, we’re providing an update on our assessment of the contaminated Claire’s and Justice products. This includes the release of new independent testing results and an associated safety alert that warns consumers against the use of certain cosmetics sold by Claire’s. We’re also announcing new steps that the FDA is taking, given existing limitations on our cosmetic oversight authority, to better ensure the safety of the cosmetic products men, women and children use every day. Our goal is to help ensure the safety of the products that consumers use and pursue steps that modernize our pursuit of that mission.
The cosmetics industry is undergoing rapid expansion and innovation. These changes help bring new opportunities and choices to consumers. There are now more varieties of cosmetic products available to consumers than ever before. But they can also bring new uncertainty, complexity and risks. And at the same time, the provisions in the Federal Food, Drug, and Cosmetic Act (FD&C Act) – the law governing the FDA’s oversight of cosmetic products — have not been updated since it was first enacted in 1938. The current law does not require cosmetics to be reviewed and approved by the FDA prior to being sold to American consumers. There are reasons why the FD&C Act doesn’t require prior approval of cosmetics before marketing. Our statute is based on risk, and many cosmetics do not pose the same risks as medical products that require prior approval before they can be lawfully marketed. Our regulatory approach across our broad portfolio is not a one-size-fits-all approach.
But at the same time, when it comes to cosmetics, our authority hasn’t changed in many years even as the industry has undergone rapid evolution. Right now, when it comes to cosmetics, companies and individuals who market these products in the U.S. hold the responsibility for the safety and labeling of their products. This means that ultimately a cosmetic manufacturer can decide if they’d like to test their product for safety and register it with the FDA. To be clear, there are currently no legal requirements for any cosmetic manufacturer marketing products to American consumers to test their products for safety.
Although the FDA doesn’t have pre-market review authority, there are other tools besides the requirement for approval that the FDA uses to ensure the safe marketing of products. In the case of cosmetic products, the FD&C Act imparts the responsibility on us to monitor the cosmetics market and take action to protect consumers, if needed, in the post-market setting. Cosmetics must not be “adulterated” or “misbranded,” meaning they must be safe for consumers when used according to directions on the label, or in the customary or expected way, and they must be properly labeled. The FDA’s current work focuses on reviewing scientific literature; reviewing reports of adverse events involving cosmetics that we receive from consumers and health professionals; research; surveillance; education and outreach; and pursuing enforcement action against products on the market that are not in compliance with the law, or against firms or individuals who violate the law.
Update on 2017 Finding
As part of our work to protect consumers from unsafe cosmetics on the market, the FDA routinely monitors the market for cosmetic products that may pose a public health risk. This is how the FDA, in 2017, first became aware of reports of asbestos contamination in certain cosmetic products sold by Claire’s and Justice retailers. On Sept. 5, 2017 Justice voluntarily recalled its Just Shine Shimmer Powder and seven additional cosmetic products including: Just Shine Bronzer Brush, Makeup Palette Pinks, Blues and Glitter Cream, and Eye Shadow Palette Cool, Pinks, Eye Shadow and Glitter Cream. For its part, on Dec. 22, 2017 Claire’s removed from its stores the following products: Ultimate Mega Make Up Set, Metallic Hot Pink Glitter 48-Piece Makeup Set, Bedazzled Rainbow Heart Makeup Set, Rainbow Bedazzled Star Make Up Set, Rainbow Glitter Heart Shaped Makeup Set, Mint Glitter Make Up Set, Rainbow Bedazzled Rectangle Make Up Set, and Pink Glitter Palette with Eyeshadow & Lip Gloss.
Because the 2017 testing was done by third-party laboratories, the agency believed it was important to scientifically confirm that these reports were accurate. That’s why after Claire’s withdrew and Justice recalled suspect products from the market, the FDA began the process of conducting independent tests to determine if some of these products did in fact contain asbestos. In late February of this year, we received the results of this testing initiative.
The FDA is today announcing the results of these tests. Those tests confirmed the presence of asbestos in three of the product samples collected from Claire’s and one of the product samples collected from Justice. All suspect Justice products, including the one testing positive for asbestos, were previously recalled from the market in 2017. The FDA issued a Safety Alert today warning consumers to not use three of Claire’s products: Claire’s Eye Shadows – Batch No/Lot No: 08/17; Claire’s Compact Powder – Batch No/Lot No: 07/15; and, Claire’s Contour Palette – Batch No/Lot No: 04/17 because they tested positive for asbestos.
The FDA requested that Claire’s recall the products because they should not be used by consumers. Claire’s has refused to comply with the FDA’s request, and the agency does not have authority to mandate a recall. The FDA is therefore warning consumers not to use these products and will continue to communicate our safety concerns about them. We strongly encourage consumers and health care providers to report cosmetic-related adverse reactions to the FDA’s MedWatch reporting system or a consumer complaint coordinator.
DBV loses regulatory, R&D executives ahead of peanut drug refile
Two of the leaders responsible for regulatory and product development at DBV Technologies are set to leave the company this month. The departures deprive DBV of senior members of its regulatory team as it gears up to refile for FDA approval of its peanut allergy drug.
COO Charles Ruban and CDO Laurent Martin are both set to leave their positions at the end of next week, although Martin will remain as DBV’s responsible pharmacist for the purposes of French rules until a replacement is found. DBV said Ruban is leaving to pursue new opportunities but offered no explanation for Martin’s departure.
Both men were central to the development of Viaskin Peanut and its submission to FDA. Ruban’s role gave him oversight of areas including regulatory and product development. Martin worked on the same areas as chief development officer.
DBV framed the changes as a way to “flatten the organizational structure” in support of its planned evolution into a commercial-stage company. For that evolution to happen, DBV needs to persuade FDA to approve its peanut allergy drug.
Viaskin Peanut has hit bumps in the road on its path to market, from its inability to hit the primary endpoint in phase 3 through to DBV’s need to pull the original filing after the FDA identified gaps in the manufacturing and quality control sections. Three of the people involved in those events, Ruban, Martin and former CMO Lucia Septién-Velez, have left DBV this year.
DBV is yet to replace any of the departing executives, although it did hire ex-Alexion Pharmaceuticals EVP Julie O’Neill to direct “all product development, manufacturing, supply chain, quality assurance and end-to-end process optimization” at the start of the year. O’Neill will take on Martin’s primary responsibilities.
Given the mess DBV made of the original filing, the overhaul of the regulatory leadership could be seen as a positive. But it leaves DBV without the experience of several people who were central to the development of Viaskin Peanut and with unfilled gaps in its leadership team.
DBV needs the new-look team to nail the filing this time around. With DBV planning to refile for FDA approval months before its money runs out in the fourth quarter, there is little margin for error, particularly as the earlier setbacks have diminished its ability to raise more cash.
Shares in DBV have risen by more than 60% since the stock cratered following the filing withdrawal late last year but remain well down on the heights they scaled before the clinical and regulatory setbacks.
Sarepta selloff on short report a buying opportunity, says Piper Jaffray
A short report on Sarepta Therapeutics was published this morning and appears to be the reason for today’s selloff, Piper Jaffray analyst Danielle Brill tells investors in a research note. After going through the report, however, the analyst found “no salient points to consider,” and she remains confident in her Overweight thesis on the shares. The LGMD-2E data presented last week sufficiently demonstrated proof-of-concept and further de-risked Sarepta’s muscle targeted gene therapy platform, says Brill. She believes the company’s fundamentals remain intact and would be a buyer on today’s selloff. The analyst reiterates an Overweight rating on Sarepta with a $200 price target. The stock in midday trading is down 9%, or $13.21, to $135.38. The short report, while not mentioned by name in Piper’s research note, is said to be from Elliot Favus of Favus Institutional Research. In addition, a secondary offering of 2.6M Sarepta shares priced last night at $144.00.
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