Knight Therapeutics and Jaguar Health Announce Strategic Partnership

Knight Therapeutics Inc. (GUD.TO) (“Knight”), a Canadian-based specialty pharmaceutical company focused on acquiring, in-licensing, selling and marketing innovative prescription and over-the-counter pharmaceutical products, and Jaguar Health, Inc. (JAGX) (“Jaguar” or the “Company”), a commercial stage pharmaceutical company focused on developing novel, sustainably derived gastrointestinal products on a global basis, today announced that they have entered into a Distribution, License and Supply Agreement (the Agreement) that grants Knight the exclusive right to commercialize Mytesi® (crofelemer 125 mg delayed-release tablets) and related products in Canada and Israel and a right of first negotiation to commercialize Mytesi and related products in specified Latin American countries.

Mytesi is an FDA-approved product in the U.S. indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART). Jaguar is also pursuing possible follow-on indications for Mytesi in cancer therapy-related diarrhea (CTD), an important supportive care indication for patients undergoing cancer treatment; for rare disease indications for infants and children with congenital diarrheal disorders and short bowel syndrome (SBS); for irritable bowel syndrome (IBS); for supportive care for inflammatory bowel disease (IBD); and as a second-generation anti-secretory agent for use in cholera patients.

Under the terms of the Agreement, Knight will be responsible for all regulatory and commercial activities for Mytesi and related products in the licensed territories. Upon achievement of certain regulatory and sales milestones defined in the Agreement, Jaguar may receive payments from Knight Therapeutics in an aggregate amount of up to USD $18,019,743 (based on September 23, 2018 USD-CAD exchange rates) payable throughout the initial 15-year term of the Agreement.

“We are pleased to enter into this strategic transaction with Jaguar for Mytesi,” said Jonathan Ross Goodman, Chief Executive Officer of Knight.” Mytesi will strengthen Knight’s portfolio of GI products and will be an important treatment option for Canadian and Israeli patients, if Mytesi is approved in these markets.  We are excited to support Jaguar as they seek to develop Mytesi for follow-on indications such as cancer therapy-related diarrhea.”

“Our collaboration with Knight is an important step towards unlocking value and making our products available in global markets,” said Lisa Conte, president and chief executive officer of Jaguar. “The Knight team is highly experienced and has a strong track record of successful partnerships.”

https://finance.yahoo.com/news/knight-therapeutics-jaguar-health-announce-203628106.html

Elanco expands commitment to fight antimicrobial resistance

Elanco Animal Health updated its commitment to fighting antimicrobial resistance, which includes promoting responsible antibiotic use practices and policies while developing alternatives to medically important antibiotics. This latest move further refines Elanco’s aggressive, multifaceted 8-point plan announced in 2015 at the White House Stewardship Forum. Today’s commitments focus on three key areas of stewardship, including combating antimicrobial resistance through responsible antibiotic use, reducing the need for medically important antibiotics in livestock, and significantly investing in researching new alternatives. New commitments include: Investing at least half of Elanco’s food animal research and development budget in projects dedicated to developing alternatives to shared-class antibiotics; Increasing veterinary and professional oversight access in countries with limited resources through new partnerships; Expanding data collection and analytics to inform animal health professionals on best practices; Encouraging vaccination and nutrition programs that reduce the need for medically important antibiotics by preventing disease.
https://thefly.com/landingPageNews.php?id=2795327

Coherus Biosciences receives European Commission approval for UDENYCA

Coherus BioSciences announced the European Commission has granted marketing authorization to UDENYCA, a pegfilgrastim biosimilar. UDENYCA is one of the first pegfilgrastim biosimilars to gain marketing authorization in Europe. UDENYCA is currently under evaluation by the U.S. Federal Drug Administration with an action date of November 3, 2018.
https://thefly.com/landingPageNews.php?id=2795347

Glaxo vax helps prevent TB in HIV negative adults in phase 2

GSK and Aeras reported that GSK’s M72/AS01E[1] candidate vaccine significantly reduced the incidence of pulmonary tuberculosis disease in HIV-negative adults with latent tuberculosis infection[2] in an ongoing phase IIb clinical trial testing. These primary results published in the New England Journal of Medicine after two years of trial demonstrate an overall vaccine efficacy of 54%, with varied response rates observed in different demographic sub-groups. The candidate vaccine had an acceptable safety and reactogenicity profile.

Tuberculosis is the leading cause of death through infectious disease worldwide and represents a significant public health threat with 1.6 million attributed deaths in 2017. It is estimated that one-quarter of the global population has latent tuberculosis infection, of whom approximately 10% will develop active pulmonary tuberculosis disease. Currently, multi-drug resistant strains of tuberculosis are emerging globally, and the only currently available vaccine against tuberculosis, BCG, does not provide proven and consistent protection in adults in tuberculosis endemic countries. Without a more effective vaccine, it will not be possible to achieve the WHO target of decreasing the number of new cases by 90% and the number of tuberculosis deaths by 95% between 2015 and 2035.

Dr Emmanuel Hanon, Senior Vice-President and Head of R&D, Global Vaccines GSK, said: ‘These initial findings represent a significant innovation in the development of a new and much-needed vaccine and advance the scientific understanding of tuberculosis. This scientific breakthrough – one of the very few in tuberculosis vaccine development for almost 100 years – has been made possible by our strategic partnership with Aeras, in which GSK is providing the innovation expertise and technology platforms, such as the proprietary AS01 adjuvant.’

The study assesses the safety and efficacy of M72/AS01E protecting adults with latent tuberculosis infection against developing pulmonary tuberculosis disease. The ongoing trial is conducted in tuberculosis endemic regions (Kenya, South Africa and Zambia) and involves 3,573 HIV-negative adults. For this analysis, participants who received two doses of either M72/AS01E or placebo 30 days apart have been followed up for at least 2 years to detect evidence of pulmonary tuberculosis disease. In the vaccine group, 10 participants developed active pulmonary tuberculosis compared to 22 participants in the placebo group.

Jacqui Shea, Chief Executive Officer of Aeras, which contributed to the partnership their decades long experience in tuberculosis vaccine clinical development, clinical operations capabilities and strong links with African clinical sites and patient communities, said: ‘This ground-breaking study shows – for the first time – that a subunit vaccine can significantly reduce the incidence of pulmonary tuberculosis in healthy, HIV-negative adults with latent tuberculosis infection, and that more effective vaccines against tuberculosis are achievable. Given the overwhelming public health need, the importance of these promising results, which need to be confirmed through additional clinical research, cannot be overstated. An effective vaccine, able to reduce transmission, would be by far the most impactful new intervention to end the global tuberculosis epidemic’.

The study is still ongoing and a final analysis including all efficacy, safety, reactogenicity and immunogenicity data will be performed in 2019 after all participants have completed three years of follow up.

https://www.marketscreener.com/GLAXOSMITHKLINE-9590199/news/GlaxoSmithKline-GSK-candidate-vaccine-helps-prevent-active-pulmonary-tuberculosis-in-HIV-negative-27316016/

Health-Care Stocks Lead This Leg of Rally, After Tech Giants’ Stumbles

Health-care stocks have emerged as market leaders in the third quarter, helping push major U.S. indexes to new highs.

One reason: money managers are embracing the sector as a safety play, particularly after big technology stocks stumbled in September.

The S&P 500’s health-care sector is the best performer of the index’s 11 groups in the third quarter, up 13% and on pace for its strongest showing in more than five years. On a year-to-date basis, health-care stocks are trailing only the technology and consumer-discretionary sectors.

Hedge funds have built up their biggest position in health-care shares of the past five years. About 17% of their assets are in the sector, second only to shares of tech companies, according to Goldman Sachs Group Inc. data through June. Mutual-fund managers have also been shifting into health-care stocks, with many building outsize positions, according to Goldman’s data.

And flows into health-care-focused mutual funds and exchange-traded funds, which are popular with retail investors, are at their strongest in three years, according to Morningstar LLC.

Rising interest in the stocks coincides with surging profits across the industry. Plus, the health-care needs of an aging population are expected to insulate the companies from a downturn, and investors searching for attractively valued stocks after a nine-year bull market in the U.S. have embraced the shares.

The sector’s rally has been broad, with shares of pharmaceutical giants like Merck & Co. and Pfizer Inc., insurers including Humana Inc. and UnitedHealth Group Inc., and equipment suppliers like Abiomed Inc. and Align Technology Inc. all rising at least 20% in 2018.

“These stocks had been out of favor for a while,” said Tom Hancock, head of focused equity at Grantham, Mayo, Van Otterloo & Co., the Boston-based money-management firm founded by famed investor Jeremy Grantham.

“But we’ve been trying to find stocks that aren’t being inflated by this rising tide of economic good news,” Mr. Hancock added, referring to the strong U.S. growth that has helped fuel a broad stock-market upswing in recent years. “When that tide recedes, we’re looking for companies that will be OK in that environment.”

Big tech stocks that have led much of this year’s rally, including Amazon.com Inc., Google parent Alphabet Inc. and Apple Inc., which each fell more than 3% in September. Investors have cut their exposure amid concerns about new regulations in the wake of Facebook Inc.’s data mishap.

At firms like GMO, investors have been trimming their technology holdings to help fund their shifts into health care. GMO’s funds recently initiated a position in Merck, Mr. Hancock said, as the pharmaceutical giant has focused on further developing cancer-treatment drug Keytruda, which accounted for about 9% of the company’s total revenue last year. Merck shares have surged 26% this year and 17% in the third quarter alone.

GMO funds, meanwhile, trimmed stakes in Alibaba Group Holding Ltd. and Microsoft Corp. in the past six months, according to FactSet.

Similarly, hedge-fund manager Tudor Investment Corp. increased its stake in health insurer Aetna Inc. and initiated new positions in drugmakers Shire PLC and AbbVie Inc. all in the last six months, according to fund-holdings data compiled by FactSet. Millennium Management LLC, another hedge fund, added to its positions in medical-device makers Medtronic PLC and Boston Scientific Corp.

Tudor declined to comment through a spokesman. Millennium didn’t respond to a request for comment.

Some investors, though, question the timing of health care’s sudden appeal, citing its bouts of volatility when political debates over how Americans pay for health care intensify. The sector will likely see another jolt should Republicans retain control of Congress in November’s midterm elections and resume talks of a health-care overhaul, said Lewis Piantedosi, a vice president and portfolio manager for Eaton Vance Investment Managers, which has kept its allocation toward health-care stocks below its benchmark.

Still, the broader shift into health-care stocks suggests investors are eschewing risk after a long rally. Although the tax cut enacted in December led to an explosion in corporate profits that fueled the latest leg of the rally, Wall Street analysts and economists are increasingly convinced that the U.S. economy will start contracting as early as 2020.

Investors tend to view health-care stocks as a defensive investment because health insurers, pharmaceutical companies and medical-device makers usually hold up better in times of economic turbulence. That is because most medical expenses can’t be put off in a recession, and economic swings don’t typically curb the rollout of new drugs and devices. Valuations are also enticing, investors said, with health-care stocks in the S&P 500 trading at 16 times future earnings, compared with 17 times for the S&P 500 and 19 times for the tech sector, according to FactSet.

Biotech firms, however, are viewed as riskier and aren’t getting nearly as much attention from big money managers, some investors said, because those stocks can move dramatically based on drug approvals. Biotech shares in the S&P 500 aren’t seeing the same bump as pharmaceutical giants, insurers and medical suppliers.

“Not to say it can’t continue, but we’re in the longest bull market ever, ” said Matthew Watson, a portfolio manager and assistant vice president at James Advantage Funds, a mutual-fund manager that has boosted its positions in health-insurer Anthem Inc. and drugmaker Pfizer. “So from a risk standpoint, getting into health-care stocks, which tends to be defensive, makes sense for us too.”

https://www.marketscreener.com/GOLDMAN-SACHS-GROUP-12831/news/Health-Care-Stocks-Lead-This-Leg-of-Rally-After-Tech-Giants-Stumbles-27312148/?countview=0

Can Artificial Intelligence Make Us Smarter Traders?

There are some who would have you believe that trading is 80+% a function of your psychology.  All you need to do is sustain your mindset and discipline and remove your emotional blocks and you, too, can find the success of Market Wizards.

As a psychologist, a psychologist who has worked full-time with traders on trading floors, a psychologist who has consulted to trading firms across different markets and strategies, and as one who has traded himself for decades, I can assure you that there is a helluva lot more to success in markets than maintaining the right psychology.

A good way to put it is that the wrong psychology can derail anyone, but the right psychology does not substitute for insight, skill, and experience.  Psychology is necessary for success in any performance field–from athletics to trading–but it is not sufficient.

One of the most powerful observations I’ve encountered in my work with traders and portfolio managers is that cognitive skills and development account for as much success in markets as personality variables.  Superior traders have superior information processing skills.  Show me a good trader, and I will show you someone who–in some way–processes information more effectively and uniquely than his or her less successful counterparts.

I was part of a meeting recently in which a money management firm discussed the idea of requiring programming knowledge from all new hires.  Years ago, that could never have been a topic for discussion.  Now it is a serious proposal.

It makes sense.  When I look at the traders who have been particularly successful over the past couple of years, the majority are either entirely algorithmic or manage capital with a hybrid, “man-machine” interface.  Many make discretionary decisions–aided by signals generated by the machines.

Quite simply, machines–used properly–can process more information, more quickly than we can.  They can find patterns in multidimensional space that evade our naked eyes–and they can ensure that these patterns are not merely curve-fit.

It’s not that artificial intelligence (AI) necessarily succeeds by giving us better trades.  It is valuable in giving us more hypotheses to consider in framing trade ideas.  It identifies patterns that have set up in the most recent past so that we can make an informed judgment as to the potential for those patterns continuing into the immediate future.  It vastly expands our cognitive bandwidth.  For that reason, AI can help us more quickly adjust to shifting patterns in the instruments and markets that we trade.

On Saturday, October 20th, I’ll be in San Diego with the folks at Trade Ideas and several experienced market participants to discuss the potential for partnering with machines for better trading.  We’ll take a look at trading processes, as well as trading psychology, and how those can make the most of increased information bandwidth.  The automobile greatly expanded our travel capacity relative to the horse-and-buggy.  So, too, in the machine age, can we greatly enhance our decision making with a superior flow of supporting information.

http://traderfeed.blogspot.com/2018/09/can-artificial-intelligence-make-us.html

Sage depression drug to get FDA panel review on Nov. 2

The FDA earlier today announced a forthcoming public advisory committee meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The committees will discuss the efficacy, safety, and benefit-risk profile of Sage Therapeutics’ new drug application for brexanolone for the proposed indication of postpartum depression on November 2.
https://thefly.com/landingPageNews.php?id=2795297