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Monday, May 28, 2018

Alibaba injects pharmacy assets into healthcare unit in $1.4 billion deal


Chinese e-commerce giant Alibaba Group Holding Ltd will inject some of its online pharmacy business into a listed unit in a deal valued at HK$10.6 billion ($1.35 billion), the firm said in a statement on Tuesday.
Alibaba Health Information Technology Ltd will buy Ali JK Nutritional Products Holding Limited, which controls sales of medical devices, healthcare products, adult products and healthcare services on Alibaba’s Tmall platform.
The deal will see parent Alibaba receive newly issued shares in Ali Health, taking its economic interest in the firm to 56.2 percent from 48.1 percent currently. Alibaba will also have a 67.5 percent voting interest in Ali Health after the deal.
The deal should bolster business for Ali Health amid a broader push into a fast-growing healthcare technology market by other firms in China, such as Tencent Holdings-backed WeDoctor and recently listed Ping An Healthcare.
Alibaba CEO Daniel Zhang said in a statement that healthcare was a “strategically important” business area for the firm and that the deal would help turn Ali Health into the country’s “best healthcare ecosystem”.
Ali Health’s CEO added that the deal would help the firm expand by adding new categories to its offering.
Chinese healthcare spending is set to hit $1 trillion by 2020, up from $357 billion in 2011, according to consultancy McKinsey & Co, with technology firms increasingly looking to break into a growing private healthcare market.
The business unit being injected into Ali Health generated a gross merchandise volume of around 20.56 billion yuan ($3.21 billion) in the financial year to March 31 and had over 3,300 related merchants, Ali Health said in a statement.
Alibaba said the deal was subject to approval from Ali Health shareholders and the Hong Kong stock exchange.

This Class of 2018 graduate is 66 and one of many older Americans pursuing a degree

For many newly minted college graduates, donning their caps and gowns this month will mark the beginning of their lives in “the real world.” But Larry Johnson, who graduated from Georgia State University last week, probably doesn’t need the life advice that commencement speakers are doling out — he’s already got a half century of experience.
The 66-year-old earned his bachelor’s degree on Thursday after decades of fits and starts in higher education. Johnson, whose tweet about the experience of achieving a “life milestone,” went viral, said his age wasn’t much of a deterrent when he set out for the final time to earn his bachelor’s degree five years ago.
“Rather than saying ‘Do I really have time to build a career at this age?’ my way of looking at is ‘What am I going to be doing otherwise?’” Johnson said.
And he’s not alone. About 512,000 students at least 50 years of age or older were enrolled in undergraduate institutions in the fall of 2015, according to government data analyzed by Robert Kelchen, a professor higher education finance at Seton Hall University. That’s about 2.9% of the total number of students enrolled in college.
Older Americans have accounted for roughly the same share of overall college students since 2003, but their patterns of enrollment do match other economic and educational trends. During the Great Recession, as more students entered college to retool, the ranks of older college students grew as well, topping 612,000 in the fall of 2009.
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Economic pressures combined with longer life spans have made college a more appealing prospect for students who might otherwise be thinking about retirement, said Lori Trawinski, the director of banking and finance at AARP’s Public Policy Institute.
These factors have also played into a “pretty significant disruption” of the traditional school to career to retirement life path that many Americans have grown accustomed to, said Jim Emerman, vice president of Encore.org, an organization focused on helping people ages 50 and older change careers or find new passions.
Many retirees want to go back to college to learn new skills
“The prospect of a 20- or 30 year-retirement starting in your late 50s or early 60s isn’t really appealing or affordable,” he said. That, combined with technological changes in many fields, has pushed many older adults to head to school to learn new skills for their current jobs or find a new passion, he said.
Nonprofit organizations, state and local governments and the colleges themselves are starting to step up with programs to serve this group. Though progress towards accommodating their needs — like flexible class schedules that complement full or part-time work — has been slow, Emerson said.
AARP’s Foundation works with community colleges and employers to help train workers 50 years of age and older for in-demand jobs in their region. Divinity schools have also increasingly been offering opportunities for older adults to take part in programs geared towards a paying or volunteer career working towards social good. Other programs at colleges across the country allow older students who are curious, but aren’t necessarily looking for a new degree, to audit courses as well.
For Johnson, the decision to go to college in his 60s came from a mix of motivations. Like many seniors entering college he was interested in a career change. After pursuing freelance journalism in addition to his day job of working in IT, Johnson said he decided he wanted to work in media full-time and thought the coursework would be useful. “I really wanted to learn the craft of journalism,” he said.
But “a little bit of ego” also played into his decision, Johnson said. His current wife, as well a former wife who passed away years ago and many of his friends all had some kind of degree, Johnson said. There was some “unfinished life business there,” he said.
And indeed, Johnson had been working towards the degree on and off his whole life. He first entered Georgia State in the fall of 1969, but because of his “unfocused” approach at the time, Johnson ultimately dropped out. He re-entered Georgia State in the late 1980s to study computer science and ultimately wound up being hired, first as a student and then full-time, to work in IT. But the combination of working and caring for his ailing wife left little time for school and so Johnson ultimately put his college career on hold again.
He finally returned to Georgia State for what would be the final time in his early 60s. Johnson attended journalism classes part-time while also running his hyper-local news site. Though “the professors tended to be about half my age and the students tended to be about a third my age,” Johnson said he generally got along well with both.
“The professors tended to be about half my age and the students tended to be about a third my age.”
Larry Johnson
“Some of the students might have been a little bit amused by me,” Johnson said, but given his ability to focus and the amount of time he put into his coursework — the recommended several hours per credit hour — they were always eager to work with him on group projects, he quipped.
Still, Johnson said he felt a little bit hesitant about taking full advantage of the programs the school offered, like opportunities to study abroad or participate in extracurricular activities. “I felt a certain amount of discomfort in terms of my reluctance to really get involved in activities that if I’d been in my twenties I would have had no questions about,” Johnson said.
Another major difference between Johnson and his classmates: He was able to attend the school for free. Students over the age of 62 in Georgia can get tuition remittancefor their college courses as long as they sign up during late registration — essentially when it’s clear that there’s extra space after paying students have enrolled.
Many older adults likely aren’t so lucky. The number of student loan borrowers over the age of 60 grew from 700,000 in 2005 to 2.8 million in 2015, according to data from the Consumer Financial Protection Bureau. Though it’s likely much of the debt held by baby boomers was taken on to help their children and grandchildren pay for school, some of them certainly borrowed on their own behalf.
The growth in student debt among older adults is fueled by many of the same factors as the increases in student debt overall, including lagging state investment in public higher education leading to rising college costs.
Johnson’s long higher education journey gave him some perspective on the way college financing has changed over the past several decades. When Johnson first started school in 1969, the cost was so minimal that “we were just basically handed college,” he said. At the time, his part-time job as a janitor provided enough money to pay the bills, Johnson said.
“For me, it was easy, for young people now, I think it’s horrendous,” he said.
https://on.mktw.net/2IShLk8

Genentech lung cancer med meets Phase 3 primary endpoints

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III IMpower130 study met its co-primary endpoints of overall survival (OS) and progression-free survival (PFS). The combination of TECENTRIQ®(atezolizumab) plus chemotherapy (carboplatin and ABRAXANE® [albumin-bound paclitaxel; nab-paclitaxel]) helped people live significantly longer compared to chemotherapy alone in the initial (first-line) treatment of advanced non-squamous non-small cell lung cancer (NSCLC). In addition, the TECENTRIQ combination reduced the risk of disease worsening or death (progression-free survival; PFS) compared with chemotherapy alone. Safety for the TECENTRIQ and chemotherapy combination appeared consistent with the known safety profile of the individual medicines, and no new safety signals were identified with the combination. These data will be presented at an upcoming oncology congress.
“The results of the IMpower130 study add to the growing evidence showing the clinical benefit of TECENTRIQ-based combinations in the treatment of advanced non-squamous non-small cell lung cancer,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We will share these results with global health authorities with the goal of bringing this potential treatment option to people with this disease.”
Currently, Genentech has eight Phase III lung cancer studies underway evaluating TECENTRIQ alone or in combination with other medicines. This is the third positive Phase III study evaluating TECENTRIQ alone or in combination to demonstrate an OS benefit for people with NSCLC.
https://bit.ly/2xmEKyo

Machines Screen for Melanoma

study suggests that a machine-learning algorithm may be just as good as trained dermatologists for determining whether suspect lesions are melanomas or not. In this 150-Second Analysis, F. Perry Wilson, MD, looks to a future where these algorithms are as ubiquitous at CT scanners are today.
Is this a melanoma?
Is this?
What about this?
Telling the difference between a benign mole (the first and third images) and a melanoma like image number two requires significant training.
And even the best dermatologists make mistakes. But rapidly developing research in the field of computer vision may give us a new weapon in the fight against this deadly disease. The most compelling data to date, comes from this paper, appearing in the Annals of Oncology.
Let’s go through the basics of this paper before we get to the really interesting implications for the future.
Researchers curated a set of 100 dermoscopy images of suspect lesions — like the ones I showed you earlier. These were deliberately chosen to be difficult to diagnose. Of the 100 images, 20 were melanomas and 80 were benign melanocytic nevi. The pictures were sent to 58 dermatologists, who made their diagnoses.
But there was a 59th reader of the images, though: an algorithm called a convolutional neural network. A convolutional neural network is a type of machine-learning algorithm particularly suited to image recognition — it’s what powers much of the optical character and facial-recognition software bouncing around Silicon Valley and, presumably, the optic systems of your standard Cylon.

In any case, applying convolutional neural networks to medical image classification is, pardon the pun, a no-brainer.
How’d the computer do?
Alan Turing would be proud.
The algorithm missed only one of the 20 melanomas. The average dermatologist missed three. The neural net had a bit of an itchy trigger finger though, identifying 29 of the 80 benign lesions as melanomas compared to 23, on average, for the humans. Here’s one of the lesions it got wrong, courtesy of the lead author, Dr. Holger Haenssle (© Prof. Dr. H. Haenssle, Dept. Dermatology, University of Heidelberg, Germany).
Overall, only 13 of the 58 dermatologists had better diagnostic performance than the neural network.
Basically, the neural network detected more melanomas, at the price of a few more false-positives as you can see here.
This is actually ideal for a screening test, which is where I think algorithms like this really shine. Convolutional neural networks are really hard to build, but once that step is done, they can be widely deployed and don’t require more computational power than what you have on your smartphone. This means that primary care or even self-directed screening of suspicious skin lesions may become a reality soon.
But let’s not all board the hype train right away. This was only 100 images; there was limited representation of all the varieties of lesions and skin types. In a real-world setting, the algorithm may suffer.
Still, I think it’s clear that algorithms like these are the next wave of medical advancement, similar to ultrasound, CT scan, and genetic testing before them. Provided the machines don’t, you know, rise up and destroy us all, these brains in silico are coming soon to a clinic near you.
F. Perry Wilson, MD, MSCE, is an assistant professor of medicine at the Yale School of Medicine. He is a MedPage Today reviewer, and in addition to his video analyses, he authors a blog, The Methods Man

6 Biotechs Launch IPO Plans in Last Days of May; Iterum Adjusts IPO Goals


It’s been a busy month for IPOs. Numerous biotech companies announced their intentions to publicly list their stock on an exchange in the U.S. or abroad in order to gain new funding to advance developmental programs.
BioSpace put together a list of some of the most recent announcements. In the last week alone six companies have announced their IPO intentions before the month of May ends.
AvroBio – Cambridge, Mass.-based AvroBio, a leader in lentiviral-based gene therapies, filed a preliminary prospectus with the U.S. Securities and Exchange Commission on May 25 to raise $86 million in an initial public offering. In its S-1 filing, the company said it intends to use the proceeds to advance its lead clinical product, AVR-RD-01, for the treatment of Fabry disease.  AVR-RD-01 is being pushed into Phase II testing. Additional funding will be used to support the ongoing investigator-sponsored Phase 1 trial, the company said. The company also intends to use proceeds for other candidates. It will advance AVR-RD-02 for the treatment of Gaucher disease into Phase I/II clinical trials, push AVR-RD-03 for Pompe disease further into preclinical development and finally to advance AVR-RD-04 for the treatment of cystinosis. AvroBio intends to trade under the symbol AVRO.
Kezar Life Sciences – On May 24 Bay Area-based Kezar Life Sciences, with a focus on developing treatments for autoimmune diseases, filed a preliminary prospectus with the SEC to raise $80 million in an IPO. In its S-1 filing, Kezar said it intends to use the funds raised through the IPO to advance its KZR-616 drug candidate, a first-in-class selective immunoproteasome inhibitor, through the clinic for the treatment of lupus and lupus nephritis. That program is currently in a Phase Ib/II trial. Additionally, the company said it will use the funds to study KZR-616 for the treatment of idiopathic inflammatory myopathies, as well as up to three additional autoimmune indications into a Phase Ib or Phase II clinical trial, the company said in its prospectus.
Kezar closed out its first quarter of 2018 with $47.1 million in cash and cash equivalents.  The company filed its IPO plans weeks after it strengthened its leadership team with a new chief medical officer and a new chief financial officer. The company intends to list under the ticker symbol KZR.
Xeris Pharmaceuticals – Chicago-based Xeris Pharmaceuticals also filed its preliminary prospectus for an IPO on May 24, less than one month after it secured $55 million in fundingfrom a Series C and a loan agreement. The funds raised earlier in May will be used to prepare a New Drug Application for its ready-to-use glucagon rescue pen to treat severe low blood sugar in diabetes patients. Xeris intends to file its NDA next quarter. Additionally, the company said it intends to use the funds for potential commercialization. With the IPO, Xeris intends to raise $75 million to further support the planned commercial launch of the G-Pen device, the company said in its filing with the SEC. In February the U.S. Food and Drug Administration (FDA) granted its Orphan Drug Designation for the ready-to-use device for the treatment of Hyperinsulinemic Hypoglycemia.
At the end of the first quarter of the year, Xeris said it had $58.1 million in cash or cash equivalents. Xeris plans to list under the ticker XERS.
Magenta Therapeutics – Cambridge, Mass.-based Magenta Therapeutics said it intends to use the expected $100 million from an IPO to advance its portfolio of bone marrow transplant medications. Magenta filed its preliminary prospectus on May 24. The filing comes weeks after securing $52 million in a Series C financing. In its S-1 filing with the U.S. Securities and Exchange Commission, the company said it intends to use the funding to specifically advance the development of two clinical assets, MGTA-456 and MGTA-145. The Phase II MGTA-456 is the company’s most advanced asset. Magenta in-licensed MGTA-456 last year from Novartis. MGTA- 456 is a first-in-class allogeneic stem cell therapy consisting of a single umbilical cord blood unit expanded with an aryl hydrocarbon receptor (AHR) antagonist. Magenta believes MGTA-456 has the potential to treat patients with higher cell doses than otherwise possible and to have access to better HLA-matched cord blood units. In April the company dosed the first patient in Phase II MGTA-456 trial. The patient has an undisclosed inherited metabolic disorder, the company said at the time. Magenta will trade on the Nasdaq under the symbol MGTA.
Aptinyx – On May 23, one day after strengthening its relationship with Allergan, the company set its sights on an $80 million IPO. The company is looking to raise funds to support its NMDA programs to treat neurological disorders, including depression. The lead product for Aptinyx, NYX-2925, in two Phase II studies in chronic pain. One study is testing the therapeutic in patients with painful diabetic peripheral neuropathy and the second is for the treatment of fibromyalgia. Aptinyx anticipates topline data from these two studies in the first half of 2019. The company also has a second candidate, NYX-783, for the treatment of post-traumatic stress disorder. Additionally, the company intends to move NYX-458 into the clinic for the treatment of cognitive impairment associated with Parkinson’s disease.
As of the end of March, Aptinyx had $82.4 million in available funds. The company said those funds are not sufficient enough to take NYX-2925 through Phase III studies. The company will trade under the symbol APTX.
Verrica Pharmaceuticals – On May 22 West Chester, Penn.-based Verrica Pharmaceuticals planned an IPO with the hopes of raising $86 million. The company intends to use funds gained from the IPO to advance its lead product, VP-102, a proprietary topical therapy for several common skin conditions, including Molluscum contagiosum (warts) and Verruca Vulgaris (plantar warts). It is launching two Phase III trials with top-line results expected next year. It the results are positive, the company anticipates filing a New Drug Application with the FDA. Verrica intends to trade under the symbol VRCA on the Nasdaq.
Iterum Therapeutics — Earlier in May Iterum Therapeutics announced its intentions for an IPOwith the hope of raising $92 million. However, on May 25 the company said priced its IPO at $13 per share, which was lower than expected. Now the company anticipates raising $80 million. The funds will be used to advance the Phase III clinical trials of both oral and IV formulations of sulopenem, the company’s lead compound, which is a novel penem anti-infective with oral and IV formulations. Iterum acquired sulopenem, which is in the same class of antibiotics as penicillin, from Pfizer in 2015.
Those companies filed IPOs within the last week, however, Bay Area-based GRAIL, Inc., is rumored to be looking at filing an IPO on the Hong Kong Exchange. Last week the company secured $300 million in an oversubscribed Series C financing from Chinese investors. The company, which merged with Hong Kong-based Cirina, Ltd. last year, intends to launch a screening test for the early detection of nasopharyngeal cancer this year in the area.

FDA Action Alert: TherapeuticsMD and Kitov Pharmaceuticals


The Memorial Day Holiday is making the U.S. Food and Drug Administration (FDA)’s schedule a bit more complicated, although the agency approved BioMarin Pharmaceutical’s Palynziq (pegvaliase-pqpz) for phenylketonuria (PKU) just before the holiday. PKU is a rare genetic disease, observed at birth and can cause seizures and neurological and neuropsychiatric problems. The company expects to launch the drug commercially in the U.S. by the end of June. It is also being evaluated by the European Medicines Agency.
And although it had a PDUFA action date of Monday, May 28 (Memorial Day in the U.S.), the agency approved Amgen’s supplemental BLA (sBLA) for Prolia (denosumab) to treat patients with glucocorticoid-induced osteoporosis (GIOP) a week early, on Monday, May 21. This was the fifth indication approved for Prolia, which was originally approved in 2010 for osteoporosis.
Here’s a look at two more FDA decisions coming up this week.
1.TherapeuticsMD. Headquartered in Boca Raton, Florida, TherapeuticsMD is expecting a decision on its resubmission of its New Drug Application (NDA) for TX-004HR, an investigational applicator-free estradiol vaginal softgel capsule to treat moderate-to-severe vaginal pain during sex (dyspareunia) due to menopause. The PDUFA date is Tuesday, May 29. The resubmission is a complete, class 2 response to a Complete Response Letter (CRL) the company received on May 5, 2017. The company submitted additional endometrial safety information on September 14, 2017, outside of an official review cycle. If approved, the company hopes to launch the drug in the third quarter of this year.
“The acceptance of the NDA resubmission for TX-004HR is an important milestone for TherapeuticsMD and this PDUFA target action date will allow us to maintain our timelines for launch as early as July 2018,” said Robert Finizio, the company’s chief executive officer, in a statement in December 2017. “If approved, TX-004HR has the potential to be a highly differentiated treatment option for the 32 million postmenopausal women in the United States who suffer from symptoms of VVA.” VVA is vulvar and vaginal atrophy.
2. Kitov Pharmaceuticals. Kitov, based in Tel Aviv, Israel, expects the FDA to approve its KIT-302 by May 31. The NDA was filed in October 2017. KIT-302 is a patented combination of celecoxib and amlopidine to treat osteoarthritis pain and hypertension simultaneously. If approved, the drug will be marketed under the brand name Consensi.
Both components of the drug are FDA approved. Pfizer’s Celebrex (celecoxib) is a COX-2 inhibitor to treat osteoarthritis. Pfizer’s Norvasc (amlodipine besylate) is a calcium channel blocker for lowering blood pressure.
“The acceptance of filing of our NDA for KIT-302 represents a key achievement toward commercialization of our lead drug candidates,” said J. Paul Waymack, the company’s chairman and chief medical officer, in a 2017 statement. “We intend to work closely with FDA as it reviews the NDA. We look forward to FDA rendering a decision on approval for marketing of KIT-302 during the second quarter of 2018.”

Exercise helps treat addiction by altering brain’s dopamine system


New research by the University at Buffalo Research Institute on Addictions has identified a key mechanism in how aerobic exercise can help impact the brain in ways that may support treatment—and even prevention strategies—for addiction.
Also known as “cardio,” aerobic exercise is brisk exercise that increases heart rate, breathing and circulation of oxygen through the blood, and is associated with decreasing many negative health issues, including diabetes, heart disease and arthritis. It also is linked to numerous mental health benefits, such as reducing stress, anxiety and depression.
“Several studies have shown that, in addition to these benefits, aerobic exercise has been effective in preventing the start, increase and relapse of substance use in a number of categories, including alcohol, nicotine, stimulants and opioids,” says Panayotis (Peter) Thanos, PhD, RIA senior research scientist and senior author of the study. “Our work seeks to help identify the underlying  driving these changes.”
Using animal models, Thanos and his team of researchers found that daily  altered the mesolimbic dopamine pathway in the brain. Dopamine is a key neurotransmitter associated with , playing an important role in reward, motivation and learning.
“Current work is looking at whether exercise can normalize dopamine signaling that has been changed by chronic drug use, as this may provide key support of how exercise could serve as a treatment strategy for ,” he says.
“Further studies that focus on people with substance use disorders should help researchers develop new methods to integrate  into treatment regimens that may help prevent relapses,” Thanos adds.