Thursday, December 6, 2018
Sensus Healthcare’s radiation therapy shows low 3% keloid recurrence in study
Sensus Healthcare announced positive results of a multicenter case series of patients treated with the SRT-100 Image-Guided Superficial Radiation Therapy following complete surgical keloidectomy. Of the 297 keloidectomy patients treated post-operatively with superficial radiation, there were only nine cases of observed clinical keloid recurrences, or a recurrence rate of 3%. The results of the study were published in the November issue of SKIN, The Journal of Cutaneous Medicine.
https://thefly.com/landingPageNews.php?id=2832985
Teladoc refutes SIRF report claims
Teladoc Health is issuing the following statement in response to a report published referencing an incident from 2016. “We take workplace conduct matters very seriously. The SIRF report contains several factual inaccuracies. When we were made aware of the allegations against Mark Hirschhorn in 2016, we engaged an outside law firm to investigate the claims. That investigation found violations solely of our workplace relationship policy, and our board of directors took swift and appropriate disciplinary action to address the violations. This matter was handled in a prompt, thorough and fair manner. We are deeply committed to ensuring a safe, respectful work environment where all individuals are treated fairly and equally.”
https://thefly.com/landingPageNews.php?id=2832605
Tabula Rasa price target raised to $80 from $72 at Piper Jaffray
Piper Jaffray analyst Sean Wieland raised his price target for Tabula Rasa HealthCare to $80 after the company at its analyst day reiterated its 25% revenue growth outlook and target EBITDA margins of 20% but noted incremental investments in 2019 will keep EBITDA margins flat over the next 12 months. The analyst boosted his target multiple up to 5.5 times enterprise value to 2020 estimated revenue to “account for the success in the EMTM pilot and sustainability of revenue growth.” He reiterates an Overweight rating on Tabula Rasa shares. https://thefly.com/landingPageNews.php?id=2832607
Xofluza (Baloxavir), The New, Single Oral-Dose Antiviral for Influenza
Hello. I’m Dr Arefa Cassoobhoy, a primary care internist, Medscape advisor, and senior medical director for WebMD. Welcome to Medscape Morning Report, our 1-minute news story for primary care.
For the first time in 20 years, we have a new antiviral drug to battle influenza A and B. It’s different from other antivirals, such as oseltamivir. The new drug, baloxavir (with the brand name Xofluza), has a novel mechanism of action: It’s a selective inhibitor of the enzyme influenza cap-dependent endonuclease; it blocks viral replication by preventing mRNA synthesis.
In clinical trials, a single oral dose of baloxavir significantly reduced the duration of flu symptoms and fever compared with placebo. The patients’ symptoms resolved 23-28 hours sooner. Its efficacy in symptom reduction is similar to that of oseltamivir. Like the older drug, it must be given within 48 hours of symptom onset and is more effective if given within 24 hours of flu symptoms.
Baloxavir seems well tolerated. The most common adverse reactions were diarrhea and bronchitis.
As far as differences when compared with oseltamivir, patients with uncomplicated influenza who received baloxavir had a shorter duration of viral shedding.
As the new drug becomes available, researchers will follow to see if resistance emerges with this one-dose drug, and to see if combination therapy with baloxavir and oseltamivir may be useful for some groups of patients.
For now, baloxavir is approved for patients over age 12.
GENFIT: Positive Phase 2 Results in Study of Elafibranor in Biliary Cholangitis
- Elafibranor successfully meets primary endpoint with high statistical significance of p<0.001* Substantial reductions in alkaline phosphatase in patients receiving elafibranor; 52% (80 mg) and 44% (120 mg) when compared to placebo* Significant response rate on composite endpoint used for regulatory approval, with 67% (80 mg) and 79% (120 mg) responders vs 6.7% for placebo (p</=0.001)* Potential for improved efficacy and tolerability compared to existing second-line PBC therapy, supports advancement to the next stage of developmentGENFIT(Euronext: GNFT – ISIN: FR0004163111), a biopharmaceutical company focused on discovering and developing drug candidates and diagnostic solutions targeting liver diseases, in particular those of metabolic origin, and hepatobiliary diseases, today announced positive results from its Phase 2 study of elafibranor in patients with primary biliary cholangitis (PBC), a chronic liver disease.This trial was a multicenter (US and Europe), double-blind, randomized, placebo- controlled, 12-week treatment, Phase 2 study to evaluate the efficacy and safety of elafibranor (80 mg and 120 mg once-daily) in adult patients with PBC who had an inadequate response to ursodeoxycholic acid (UDCA).The primary endpoint of “Change at week 12 in serum alkaline phosphatase (ALP) from baseline” was met. Both elafibranor doses demonstrated significant decrease in mean ALP: -48% for 80 mg -41% for 120 mg with +3% increase for placebo leading to highly significant treatment effect versus placebo: -52% for 80 mg (p<0.001) and -44% for 120 mg (p<0.001).A key secondary endpoint was the responder rate for patients achieving the composite endpoint of serum ALP <1.67xULN, an ALP decrease >15%, and total bilirubin (TB) <ULN. On this endpoint, elafibranor achieved the substantially higher response rates of 67% for 80 mg and 79% for 120 mg as compared to 6.7% for placebo (p=0.001 and p<0.001, respectively). ALP is an established surrogate marker of disease progression in PBC, and this composite endpoint has been previously used for regulatory approval.Alongside substantial reductions in ALP, in both elafibranor-treated groups, patients showed improvement in other PBC markers such as gamma-glutamyl transferase and metabolic markers such as total cholesterol, low-density lipoprotein-C, and triglycerides. Improvement in pruritus was observed and will be confirmed in a study of longer duration. Treatment with elafibranor was generally well-tolerated, with similar adverse events across the treatment and placebo groups.
Bayer Takes On Investor Worries
Germany’s Bayer AG Wednesday laid out ambitious sales and profit targets in its latest effort to convince the market it is serious about boosting profits, reducing debt and stopping a downward spiral in its stock price that has put management under heavy pressure.
The chemicals and pharmaceuticals company is dealing with a string of long-term challenges and the fallout from its recent acquisition of Monsanto Co., a deal that was designed to strengthen Bayer’s strategic position but ended up spooking investors.
“We are not happy at all with the recent development of the company and the stock,” Chief Executive Werner Baumann said in London at the company’s first gathering with investors since taking over Monsanto this summer. “Your disappointment is our disappointment and all of us will do everything we can to bring the value of our company back into the stock.”
Investors and analysts had been waiting for Wednesday’s event to offer details about how Bayer planned to fix operational problems in its drugs businesses and reap the benefits of its $63 billion acquisition of Monsanto.
An August jury verdict granting a plaintiff high damages against Monsanto raised doubts in some investors about the appeal of the deal. Bayer shares have lost roughly 30% since the jury ruled Monsanto weedkillers containing the chemical glyphosate had caused the plaintiff’s cancer. Investors fear a protracted legal battle with an uncertain outcome will consume time and resources and end up in costly payouts for Bayer.
Mr. Baumann, who brokered the Monsanto acquisition just days after becoming CEO in 2016, said Bayer would face roughly a dozen new trials in 2019 and reaffirmed the company’s conviction that glyphosate was safe to use and that Bayer stood good chances of winning in court. But he was quick to move on to topics whose resolutions aren’t in the hands of U.S. jurors.
Shares took some respite on Wednesday as analysts were positively surprised by some of Bayer’s medium-term targets. In early afternoon trade, shares were trading 1.3% higher against a lower DAX index.
Bayer said it aimed to grow sales by 4% next year and between 4% and 5% in the following two years as it turns around its consumer-care business, overhauls research and development at its prescription drugs business and integrates Monsanto into its crop-science business. The target excludes currency shifts.
The company, based in Leverkusen, Germany, also wants to boost earnings before interest, taxes, depreciation and amortization, excluding one-off items, to EUR16 billion ($18.2 billion) in 2022 from a pro-forma of EUR11.5 billion this year and grow free-cash-flow generation by 18% on average each year to a total of about EUR23 billion between 2019 and 2022, two goals that beat consensus expectations.
Markus Mayer, analyst at Baader Bank AG, said the free-cash-flow target was a positive surprise.
Bayer’s targets assume drastic cost-cutting measures the company announced last month. The company caught investors by surprise in late November with a plan to cut 10% of its global workforce, which Mr. Baumann said was the most comprehensive job-cutting plan in the company’s 155-year history. Bayer also plans to sell its animal-health business and foot-care brand Dr. Scholl’s and sunscreen products Coppertone as it wants to focus resources on its core drugs and agriculture operations.
Bayer said it would use the higher cash flow and some proceeds from asset sales to increase dividends in the future and would even consider share buybacks, independent of how the glyphosate cases turn out. The group also wants to bring down net debt, which is expected to reach EUR36 billion by the end of the year due to the Monsanto purchase.
Welltower price target raised to $76 from $72 at MUFG
MUFG analyst Karin Ford maintained an Overweight rating on Welltower, and raised her price target on shares to $76 from $72, following Welltower’s 2018 Investor Day. Ford said of the meeting, “We were encouraged by management’s 12.7% 5-year total annualized return forecast. Moreover, average annual organic cash flow growth of 5.6% and a 5.0% dividend yield implies a double-digit return for shareholders without any incremental capital activity. Management seemed bullish on investments, which are supported by a strong balance sheet and data analytic platform, as well as on senior housing prospects, where the impact of supply may decline 23% next year.”
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