AmeriCann To Operate Large-Scale Cannabis Manufacturing Unit in Mass.

Company to Produce Branded Cannabis Beverages, Vaporizer Products, Edible and Non-Edible Products and Concentrates

AmeriCann, Inc. (OTCQB: ACAN), an agricultural-technology company that is developing the next generation of eco-friendly start-of-the-art greenhouse cannabis cultivation and processing properties, has announced plans to own and operate a large-scale cannabis manufacturing and processing facility at its 52-acre Massachusetts Medical Cannabis Center (MMCC) in Freetown, MA.

The company has commenced construction on the first phase of the MMCC and recently released designs for the second phase. The second phase includes AmeriCann’s manufacturing facility which is designed to provide support to the entire MMCC project, as well as to other licensed cannabis cultivators throughout Massachusetts.

“Participating directly as an operator allows us to have a larger impact and greater flexibility in meeting consumer and patient demand throughout the country,” said Tim Keogh, CEO of AmeriCann.

AmeriCann’s manufacturing facility is designed to produce branded consumer packaged goods including cannabis beverages, vaporizer products, edible products, non-edible products and concentrates at the state-of-the-art facility.

The company plans to replicate the brands, technology and innovations developed at its MMCC project to new markets as a multi-state operator.

Infused products are becoming an increasingly larger segment of total cannabis sales in regulated markets. According to the Wall Street Journal, “Interest in cannabis as an ingredient in food and drinks in on an upswing; beer brewing giant Constellation Brands, Inc. (NYSE: STZ) recently took a $4 billion stake in Canadian marijuana grower Canopy Growth Corp., (NYSE: CPG) which makes cannabis infused drinks and other products.”

“In Colorado, consumers purchased 12.2 million marijuana infused products in 2017, stated Ben Barton, CFO of AmeriCann. “AmeriCann’s advanced processing and production facility in Massachusetts should play a large role in meeting similar levels of cannabis consumer’s needs in Massachusetts for a consistent supply of a variety of trusted, reliable branded products.”

Industry experts believe that the pending Massachusetts adult-use market, in conjunction with its existing medical program will exceed $1 billion by 2020. As the first approved adult-use cannabis market on the Eastern US, Massachusetts has the potential to become the epicenter for cannabis innovation and research.

About Massachusetts Medical Cannabis Center

Massachusetts Medical Cannabis Center (MMCC), a one million square foot sustainable greenhouse facility in Freetown, Mass. The first phase of the facility is scheduled to open and be ready for cannabis cultivation, processing, and infused product production in the spring of 2019. Once fully developed, the MMCC design calls for a research facility, a training center, corporate offices, a quality-assurance laboratory, and a facility for manufacturing cannabis-infused food, nutraceuticals and consumer packaged cannabis goods. AmeriCann intends to open similar facilities in states in which cannabis is legal for medical and adult use.

https://www.marketscreener.com/AMERICANN-INC-20954791/news/Americann-Inc-AmeriCann-To-Operate-Large-Scale-Cannabis-Product-Manufacturing-Facility-in-Massachu-27369129/

HIV Treatments That Could Make Redfield’s Prediction Reality to Beat AIDS

In April, Dr. Robert Redfield, the new head of the U.S. Centers for Disease Control and Prevention, boldly predicted that the AIDS epidemic can be defeated by 2025. This morning Merck, Janssen and Gilead Sciences all released clinical data for HIV treatments that could make Redfield’s prediction a reality.

Janssen released 96-week data for Symtuza, a triple-combination medication for HIV-1 that showed patients who are virologically suppressed and switched to Symtuza, maintained high virologic suppression for up to 96 weeks. Data showed that 91 percent of Symtuza patients were able to maintain that suppression. Only 1 percent of patients experienced low virologic failure at 96 weeks, Janssen reported. The positive 96-week data followed earlier reports that showed the single-pill treatment was effective at suppressing the virus for 24 and 48 weeks.

Joseph Eron, a professor of AIDS research at the University of North Carolina at Chapel Hill and a trial investigator, said the results from the Phase III study shows Symtuza “can offer clinically appropriate people living with HIV a single-tablet option that may help them maintain high rates of virologic suppression over time.”

Symtuza was well tolerated by patients, with only 2 percent of subjects experiencing an adverse event of Grade 3 or Grade 4.

Symtuza was approved by the U.S. Food and Drug Administration (FDA) in July for HIV-1 based on the 48-week data. Trial data showed that up to 95 percent of participating patients achieved or maintained virologic suppression.

Not to be outdone, Gilead Sciences released 96-week data from its Phase III study of Biktarvy that showed the medication was not inferior to a regimen of abacavir/dolutegravir/lamivudine. The patients in this late-stage trial were treatment-naïve adults. Data showed that at 96 weeks, 87.9 percent of patients taking Biktarvy showed non-inferiority against 89.8 percent of patients on the abacavir/dolutegravir/lamivudine arm. Biktarvy was well tolerated through Week 96, Gilead said. The company added that the study, known as 1489, will remain randomized and blinded through 144 weeks.

Biktarvy, a once-per-day treatment, was approved by the FDA in February as a complete regimen to treat HIV-1 in adults who haven’t been treated with antiretrovirals or to replace the current antiretroviral regimen in patients who are virologically suppressed on a stable antiretroviral regimen for at least three months.

UNC scientist David Wohl, the lead author of the study, said the Phase III data “underscores the role of Biktarvy as a first-line treatment option for appropriate adults living with HIV who are new to therapy. In addition, Biktarvy was shown to have less nausea with a similar bone and renal safety profile to the comparator through 96 weeks.”

Merck also showcased data from its study of HIV patients who switched to Delstrigo, its once-per-day triple combination treatment. The Phase III DRIVE SHIFT trial included HIV-1 adults who demonstrated virological suppression for at least six months on a stable antiretroviral treatment regimen. Merck said the study met its primary endpoint of non-inferiority as measured by the number of patients who switched to Delstrigo compared to those who remained on the baseline treatment.

Princy Kumar head of Georgetown University School of Medicines’ Division of Infectious Diseases, said the Phase III data builds on the existing profile of Delstrigo as a therapy for treatment-naïve patients. Kumar said the data suggests that Delstrigo has the potential to address a broader population of HIV-1 patients.

The FDA approved Delstrigo in August, alongside another HIV treatment, Pifeltro. Clinical data showed that patients who took Delstrigo, which is a combination of doravirine, lamivudine and tenofovir disoproxil fumarate, demonstrated sustained viral suppression through 48 weeks. Data showed that 84 percent of the patients on Delstrigo achieved viral suppression.

https://www.biospace.com/article/hiv-treatments-that-could-make-redfield-s-prediction-a-eality-/

Guardant Health indicated to open at $26.50, IPO priced at $19.00

Guardant Health (GH) priced 12.5M shares at $19.00. The deal priced above the $15.00-$17.00 range, as expected. JPMorgan and BofA/Merrill acted as joint book running managers for the offering.
https://thefly.com/landingPageNews.php?id=2799867

Novo Nordisk pullback on Lilly data likely overdone, says Deutsche Bank

Deutsche Bank analyst Tim Race noted that Novo Nordisk (NVO) shares have reacted to “strong” diabetes trial data from competitor Eli Lilly (LLY), but at first glance he thinks the move seems overdone. While a potential meaningful competitor creates a new overhang, the risk needs to be placed in to context, said the analyst, who noted the Phase 2 data will need to be confirmed in extensive Phase 3 trials before it is able to impact Novo’s growth prospects. From what he understands, Phase 3 trials would commence in 2019, suggesting a potential 2023 launch of Lilly’s LY3298176, which should give Novo time to adjust and react, Race tells investors. He maintains a Buy rating on Novo Nordisk shares.
https://thefly.com/landingPageNews.php?id=2799911

Why Traders Are ‘Whispering’ About A 500,000 Jobs Print Tomorrow

The key economic catalysts for yesterday’s dramatic spike in Treasury yields was the two-punch combo of surprisingly strong September ADP payrolls which came in at 230K (184K expected), and a blowout ISM non-manufacturing report, which printed at 61.6 (58.0 expected) – the highest reading since August 1997 – but it was the employment component which was the highlight of the report, and stunned traders: at 62.4, it printed at the highest level on record.

Between the blockbuster ADP and ISM reports, and together with Fed Chair Powell’s surprisingly hawkish speech after hours, it is hardly a surprise that yields moved up as much as they did: after all, if accurate these numbers suggest that the US economy is now well into “overheating” territory.

This morning, SocGen’s FX strategist Kit Juckes tried to put some numbers to this qualification, and in highlighting the ISM employment print, writes that “there’s a strong positive correlation between changes in private sector payrolls and the ISM non-manufacturing employment sub index, though the monthly miss can still be huge too.”

Putting the two series side by side, Juckes observes that “yesterday’s record 62.4 reading for the ISM employment component would ‘imply’ a 500k increase in private sector jobs, which would be the best since 1983.”

This is shown in the chart below.

The SocGen analyst summarizes the potential for a blockbuster jobs report tomorrow as follows:

I don’t think we’re supposed to rush out and revise our forecasts for tomorrow’s data as a result, but the market will be braced for a strong outcome despite the potential drag from Hurricane Florence, and the underlying message is that the US economy isn’t just in fine fettle, it’s on fire. That has been enough to take 10year Note yields out of their recent range and to levels (2.23% and still rising) that we haven’t seen since 2011. Ed Chairman Powell acknowledges that the funds rate is likely to get above ‘neutral’ (i.e., above 3%) at some point, albeit slowly.

And with emerging markets cracking again as the dollar surges and yields soar sending EM currencies plunging, the cost of gasoline soaring and capital flowing out at an accelerating pace, tomorrow’s jobs report may just be one of the most important, if not for the US economy – which is still basking in the soft glow of Trump’s $1.5 trillion fiscal stimulus – then for the rest of the world, where any print even remotely close to 500,000 will unleash a new market tantrum and economic turmoil.

https://www.zerohedge.com/news/2018-10-04/why-traders-are-whsipering-about-500000-jobs-print-tomorrow

Lilly’s diabetes drug data impresses, hurts rival Novo

Eli Lilly and Co (LLY.N) said on Thursday its new two-in-one diabetes drug was successful in lowering blood sugar and reducing weight, sending its shares to a record high and weighing on those of arch-rival Novo Nordisk (NOVOb.CO).

The novel drug targets two key gut hormones at the same time, and could pose a threat to currently available single-hormone drugs, which form a large and growing part of Novo’s business.

Lilly’s treatment reduced blood sugar levels in type 2 diabetes patients by up to 2.4 percent and produced an average weight reduction of up to 12.7 percent in a mid-stage study by targeting the GLP-1 and GIP hormones.

The trial results set a new industry gold standard versus marketed GLP-1s, including Novo’s Ozempic for both blood sugar lowering and weight loss, Citi analyst Andrew Baum said.

Lilly’s shares were rose 6.5 percent to a record high of $115.68 in early trading, while those of Novo fell nearly 8 percent.

Novo’s existing GLP-1 products include Victoza and Omzepic, and the company is also developing an oral version of semaglutide, the active ingredient in Ozempic.

Lilly said it intends to complete its late-stage study for the drug in late 2021, and is also evaluating the drug for treating obesity, among other conditions.

BMO Capital Markets analyst Alex Arfaei said the treatment provides Lilly with a reasonable shot at the large obesity market and should meaningfully strengthen the company’s position in the rapidly growing GLP-1 market.

Eli Lilly and Co113.05

LLY.NNEW YORK STOCK EXCHANGE

+4.43(+4.08%)

• LLY.N
• NOVOb.CO

About 30 million adults in the United States have diabetes, with 90 percent to 95 percent of them suffering from type 2 diabetes.

Obesity is a major risk factor for developing type 2 diabetes, and weight loss as little as 5 percent of the total body weight has been found to help improve type 2 diabetes in patients who are obese or overweight, according to American Society for Metabolic and Bariatric Surgery.

Lilly’s wide portfolio of diabetes drugs, including GLP-1 drug Trulicity, contributed at least 38 percent to its total sales of $6.36 billion in the latest reported quarter.

“With Trulicity representing a core growth driver for Lilly and competitive concerns regarding Ozempic and oral semaglutide causing an overhang on shares over the past year, we see today’s results as a clear positive for the Lilly story,” JP Morgan analyst Chris Schott said in a note.

https://www.reuters.com/article/us-lilly-study/lillys-diabetes-drug-data-impresses-hurts-rival-novos-shares-idUSKCN1ME11Z

Eli Lilly presents phase 2b trial data of dual GIP, GLP-1 receptor agonist

Results from a phase 2b clinical trial of Eli Lilly’s dual GIP and GLP-1 receptor agonist showed strong and clinically meaningful blood sugar reduction and weight loss in people with type 2 diabetes. The six-month data, showing average HbA1c reductions of up to 2.4 percentage points and an average weight reduction up to 11.3 kg ,were presented at the 54th annual meeting of the European Association for the Study of Diabetes and simultaneously published in The Lancet. The weekly dual glucose-dependent insulinotropic polypeptide, or GIP, and GLP-1 receptor agonist integrates the action of both incretins into a single novel molecule, aiming to build upon the clinical benefits seen with a selective GLP-1 RA. Two statistical approaches were used to evaluate the efficacy of four doses of GIP/GLP-1 RA compared to placebo and dulaglutide 1.5 mg in people with type 2 diabetes. The first was a dose response model evaluating the effect regardless of discontinuation of treatment and use of rescue medication. An additional analysis identified the effect while on treatment and without use of rescue medication. At 26 weeks, the primary analysis showed a robust dose response compared to placebo throughout the entire dose range of GIP/GLP-1 RA included in the study. The safety profile of GIP/GLP-1 RA was similar to the GLP-1 RA class. The most commonly reported side effects were gastrointestinal-related, and dose-dependent. These events included nausea, diarrhea and vomiting which were mild to moderate and generally temporary, most often occurring during the titration period. Dulaglutide 1.5 mg had a similar side effect profile to previous studies. No participants in any of the treatment groups experienced severe hypoglycemia. A further study examining an optimal titration schedule to help manage GI side effects was conducted and will be presented next year. The safety and efficacy of Lilly’s GIP/GLP-1 RA are being studied further in a large phase 3 clinical program that will be referred to as the SURPASS program. Phase 3 studies for type 2 diabetes are expected to begin no later than early 2019 and complete in late 2021. Lilly is evaluating next steps in the study of GIP/GLP-1 RA for obesity and other conditions.

https://thefly.com/landingPageNews.php?id=2799531