Testosterone Gel 1.62% CIII has annual sales of more than $911M in the U.S., according to IQVIA data as of February.
Thursday, April 11, 2019
Immuron receives U.S. patent on drug composition to treat clostridium difficile
Immuron announced the issuance of a patent by the United States Patent and Trademark Office for a method to treat Clostridium difficile infections. The patent entitled “Methods and compositions for the treatment and/or prophylaxis of Clostridium difficile associated disease” describes a targeted drug composition comprising an enriched, hyperimmune polyclonal antibody preparation of bovine colostrum for use in treating C. difficile, a bacterium that causes life threatening diarrhea. The company’s drug candidate IMM-529, which is based on this technology, is presently in a Phase 1/2a clinical trial in C. difficile patients.
Enanta presents new preclinical data on HBV, NASH targeting compounds
Enanta Pharmaceuticals announced that new preclinical data from Enanta’s wholly-owned development programs for hepatitis B virus, or HBV, and non-alcoholic steatohepatitis, or NASH, will be presented at The International Liver Congress. Jay Luly, President and CEO of Enanta, said, “Our extensive scientific research provides us the knowledge and confidence to move forward our best candidates with the highest likelihood of success. We look forward to announcing clinical results of EDP-305 in our ARGON-1 Phase 2 study in NASH patients in the third quarter and to initiating a phase 1 study with EDP-514 during the second half of 2019.”
https://thefly.com/landingPageNews.php?id=2891447
https://thefly.com/landingPageNews.php?id=2891447
Intercept falls after releasing ‘supportive data’ from Phase 3 NASH study
Intercept Pharmaceuticals overnight announced additional “supportive data” from its Phase 3 Regenerate study of obeticholic acid in patients with liver fibrosis due to nonalcoholic steatohepatitis. The new data based on additional analyses show that obeticholic acid “demonstrated robust efficacy across a range of additional histologic and biochemical parameters,” Intercept said in a statement. The data are being presented today at the International Liver Congress in Vienna, Austria. The primary efficacy analysis assessed efficacy at 18 months in 931 patients with stage 2 or 3 liver fibrosis due to NASH. Patients with biopsy proven NASH with fibrosis were randomized 1:1:1 to receive placebo, OCA 10 mg or OCA 25 mg once daily. A repeat biopsy was conducted after 18 months for histologic endpoint assessment. Overall, study discontinuations in the primary efficacy analysis population were balanced across treatment groups. As previously reported, in the primary efficacy analysis, once-daily OCA 25 mg met the primary endpoint of fibrosis improvement with no worsening of NASH in 23.1% of patients compared to 11.9% of placebo patients at the planned 18-month interim analysis, the company said. In the primary efficacy analysis, a numerically greater proportion of patients in both OCA treatment groups compared to placebo achieved the primary endpoint of NASH resolution with no worsening of liver fibrosis; however, this did not reach statistical significance. As agreed with the FDA, in order for the primary objective to be met, the study was required to achieve one of the two primary endpoints, it added. Additional supportive efficacy analyses were conducted using the per protocol population. Approximately three-fold more patients in the OCA 25 mg group achieved an improvement of fibrosis by greater than or equal to 2 stages compared to placebo, Intercept reported. The stock is down 12%, or $14.14, to $106.54 in morning trading.
Roth Capital doesn’t just like the new Intercept data, it loves it
“We don’t just like the new data, we love it,” Roth Capital analyst Yasmeen Rahimi writes in a research note following this morning’s data release from Intercept Pharmaceuticals Three-fold more patients in the 25mg obeticholic acid group achieved fibrosis improvements equal to or greater than two stages versus placebo, Rahimi points out. Some payers may grant higher pricing for drugs with strong potency, and further, this “one-line” efficacy data is going to drive adoption, contends the analyst. With that said, Rahim also found “more color for the angry bears.” Pruritus incidence across groups highest in first three months and decreased afterwards, she notes. Further, LDL-C peaked at week four of 22.6mg/dL but approached baseline at month 18. The analyst, however, calls this “no big deal.” She keeps a Buy rating on Intercept with a $192 price target. The stock in morning trading is down 12%, or $14.42, to $106.26.
WW dives as analyst sees user data tracking worse than bearish expectations
JPMorgan says DAU data implies that North America subscribers are around 2.5M, a drop of about 18% year over year
Shares of WW (WTW) are sliding after JPMorgan analyst Christina Brathwaite lowered her estimates and price target for the stock, saying daily active user data in the U.S. has tracked “even worse than her bearish expectations.” Further, the analyst argued that the “significant negative start to the year” will be extremely difficult for WW to overcome.
‘SIGNIFICANT NEGATIVE’ START TO THE YEAR: In a research note to investors on Thursday, JPMorgan’s Brathwaite lowered her estimates for WW and cut her price target on the shares to $12 from $14, saying DAU data in the U.S. has tracked even worse than her bearish expectations, contracting 40% year over year during the first quarter of 2019, according to SimilarWeb. By the analyst’s math, the data implies WW’s North America subscribers are around 2.5M, or down 18% year-over-year, which she says would put “significant pressure” on the company’s revenue for the year. While Brathwaite acknowledged that WW launched its new “It Works” marketing campaign prominently featuring Oprah on March 31, which could help improve recruitment trends sequentially, she believes it is still too early to tell if the marketing push is working. The “significantly negative start to the year” will be extremely difficult for WW to overcome, despite marketing investments during the second quarter and easier comparisons in the back half of the year, she contended. Additionally, given the declining profit, the analyst believes the company’s balance sheet is “coming into play” and WW’s leverage levels will trigger a mandatory 75% excess cash flow prepayment on its $1.5B term loan at the end of 2019. Brathwaite reiterated the stock as her Top Short Pick and keeps an Underweight rating on the shares.
FDA final rule on safety and effectiveness of consumer hand sanitizers
The U.S. Food and Drug Administration today issued a final rule designed to help ensure that hand sanitizers available over-the-counter (OTC) are safe and effective for those who rely on them. The rule establishes that certain active ingredients are not allowed to be used in OTC hand sanitizers, formally known as topical consumer antiseptic rub products, which are intended for use without water, that are marketed under the FDA’s OTC Drug Review. The final rule also seeks to ensure that the agency’s safety and effectiveness evaluations and determinations for consumer antiseptic rub active ingredients are consistent, up-to-date and appropriately reflect current scientific knowledge and increasing use patterns.
“Our action today aims to help provide consumers with confidence that the over-the-counter hand sanitizers they’re using are safe and effective when they don’t have access to water to wash with soap,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “In today’s final regulation we finalized the FDA’s previous determination that 28 active ingredients, including triclosan and benzethonium chloride, are not eligible for evaluation under the FDA’s OTC Drug Review for use in consumer antiseptic rubs. We’ve also reaffirmed our need for more data on three other active ingredients, including ethyl alcohol, which is the most commonly used ingredient in hand sanitizers, to help the agency ensure that these products are safe and effective for regular use by consumers. We believe industry has made good progress toward providing data and we will continue to provide updates to the public about the progress of collecting this data.”
Consumer antiseptic hand sanitizers provide a convenient alternative when hand washing with plain soap and water is unavailable. Millions of Americans use antiseptic rubs daily, sometimes multiple times a day, to help reduce bacteria on their hands. The Centers for Disease Control and Prevention advises that washing hands with plain soap and running water is one of the most important steps consumers can take to avoid getting sick and to prevent spreading infections to others. If soap and water are not available, the CDC recommends using an alcohol-based hand sanitizer that contains at least 60 percent alcohol.
As part of the June 30, 2016 proposed rule on consumer antiseptic rubs, the FDA requested additional scientific data to support the safety and effectiveness of active ingredients used in OTC consumer antiseptic rubs.
At this time, three active ingredients—benzalkonium chloride, ethyl alcohol, and isopropyl alcohol—are being deferred from further rulemaking to allow for the ongoing study and submission of additional safety and effectiveness data necessary to make a determination regarding whether these active ingredients are generally recognized as safe and effective for use in OTC consumer antiseptic rub products. Their status will be addressed either after completion and analysis of the studies or at another time, if these studies are not completed. At this time, the FDA does not intend to take action to remove hand sanitizers containing these three active ingredients from the market.
Less than 3% of the marketplace will be affected by the issuance of this final rule, as most OTC consumer antiseptic rubs use ethyl alcohol as the active ingredient.
The FDA is aware that retailers and pharmacies continue to market a very low number of consumer hand sanitizers containing benzethonium chloride, but that they stopped marketing hand sanitizers containing triclosan. Drug products containing any ineligible active ingredients will require approval under a new drug application or abbreviated new drug application prior to marketing.
This final rule completes a series of rulemaking actions in the FDA’s ongoing review of OTC antiseptic active ingredients to determine whether these ingredients are safe and effective for their intended uses. The FDA previously issued final rules on consumer antiseptic washes (Sept. 2016) and health care antiseptics (Dec. 2017).
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