Tuesday, March 19, 2019
Hikma upgraded to Buy from Neutral at Citi
Citi analyst Peter Verdult upgraded Hikma Pharmaceuticals to Buy from Neutral saying the company’s stronger growth deserves a premium multiple relative to European pharma peers and U.S. generics.
https://thefly.com/landingPageNews.php?id=2880869
https://thefly.com/landingPageNews.php?id=2880869
Monday, March 18, 2019
S Korea radar, thermal camera system warns ‘smartphone zombies’ of traffic
A city in South Korea, which has the world’s highest smartphone penetration rate, has installed flickering lights and laser beams at a road crossing to warn “smartphone zombies” to look up and drivers to slow down, in the hope of preventing accidents.
The designers of the system were prompted by growing worry that more pedestrians glued to their phones will become casualties in a country that already has some of the highest road fatality and injury rates among developed countries.
State-run Korea Institute of Civil Engineering and Building Technology (KICT) believes its system of flickering lights at zebra crossings can warn both pedestrians and drivers.
In addition to red, yellow and blue LED lights on the pavement, “smombies” – smartphone zombies – will be warned by laser beam projected from power poles and an alert sent to the phones by an app that they are about to step into traffic.
“Increasing number of smombie accidents have occurred in pedestrian crossings, so these zombie lights are essential to prevent these pedestrian accidents,” said KICT senior researcher Kim Jong-hoon.
The multi-dimensional warning system is operated by radar sensors and thermal cameras and comes with a price tag of 15 million won ($13,250) per crossing.
Drivers are alerted by the flashing lights, which have shown to be effective 83.4 percent of the time in the institute’s tests involving about 1,000 vehicles.
In 2017, more than 1,600 pedestrians were killed in auto related accidents, which is about 40 percent of total traffic fatalities, according to data from the Traffic Accident Analysis System.
South Korea has the world’s highest smartphone penetration rate, according to Pew Research Center, with about 94 percent of adults owning the devices in 2017, compared with 77 percent in the United States and 59 percent in Japan.
For now, the smombie warning system is installed only in Ilsan, a suburban city about 30 km northwest of the capital, Seoul, but is expected to go nationwide, according to the institute.
Kim Dan-hee, a 23-year-old resident of Ilsan, welcomed the system, saying she was often too engrossed in her phone to remember to look at traffic.
“This flickering light makes me feel safe as it makes me look around again, and I hope that we can have more of these in town,” she said.
HBV-Related Liver Cancer and the Role of Aspirin
Aspirin may be chemopreventive against the development of hepatocellular carcinoma (HCC) in chronic hepatitis B (HBV), according to a large Taiwanese cohort study in JAMA Internal Medicine.
Compared with no use, daily aspirin therapy significantly lowered cumulative HCC incidence over 5 years: 5.20% (95% confidence interval 4.11-6.29) versus 7.87% (95% CI 7.15-8.60, P<0.001).
“Our findings may be of help in future efforts to further improve the chemoprevention of HBV-related HCC, and a proof-of-concept study is thus warranted,” wrote a group led by Chun-Ying Wu, MD, PhD, of Taipei Veterans General Hospital.
The study looked at 204,507 chronic hepatitis B patients in Taiwan’s National Health Insurance Research Database during the period of January 1, 1997 to December 31, 2012. Excluding those with confounding conditions, the team identified 2,123 patients who had continuously received daily aspirin for 90 or more days; they were randomly matched in a one-to-four ratio with 8,492 patients who had never received antiplatelet therapy, by propensity scores consisting of the follow-up index date, baseline characteristics, and potentially chemopreventive drug use over follow-up. Data were analyzed from August 1 to November 30, 2018.
Of the 10,615 patients included in the analysis, 7,690 (72.4%) were men, mean age was 58.8 (standard deviation, 11.8 years), and median duration of aspirin therapy was 3.1 years. More than 80% in the treated group were taking aspirin because of cardiovascular risk factors such as diabetes, hyperlipidemia, and hypertension, followed by about 40% each for coronary artery and cerebral vascular disease.
Multivariable analysis adjusted for age, male sex, liver cirrhosis, diabetes, hyperlipidemia, hypertension, statin use, metformin use, and nucleoside/nucleotide analogue (NA) use.
Independently associated with increased HCC risk were the following variables:
- Older age: HR 1.01 per year (95% CI 1.00-1.02, P=0.001)
- Male sex: HR 1.75 (95% CI 1.43-2.14, P<0.001)
- Liver cirrhosis: HR 2.89 (95% CI 2.45-3.40, P<0.001)
Correlating with reduced HCC risk were:
- NA use: HR 0.54 (95% CI 0.41-0.71, P<0.001)
- Statin use: HR 0.62 (95% CI 0.42-0.90, P=0.01)
Aspirin use also decreased HCC risk in patients not receiving NA therapy, echoing a recent study that also reported that aspirin reduced HCC risk even after effective NA therapy.
The authors noted that platelets are instrumental in the pathogenesis of HBV-related liver disease by sustaining inflammation, while aspirin blocks thromboxane A2 production and inhibits platelet activation.
Last year, MedPage Today reported that 325 mg of aspirin twice a week over at least 5 years reduced HCC risk by 49%. But this drug is also well known to correlate with a greater risk of gastrointestinal bleeding and hemorrhagic stroke. The Taiwanese group, however, found no significant increase in the 5-year cumulative incidence of peptic ulcer bleeding in the aspirin-treated versus the untreated group: 6.13% (95% CI 5.05-7.21) and 5.52% (95% CI 4.99-6.0, P =0.09), respectively. Nor was peptic ulcer bleeding risk in treated patients significantly higher in those with cirrhosis than without: 7.49% (95% CI 4.65-10.32) versus 5.85% (95% CI 4.68-7.01, P=0.41).
“However, patients selected in the treated group could tolerate aspirin therapy for at least 90 days; therefore, their [peptic ulcer bleeding] risk might be underestimated,” the authors acknowledged.
In a related commentary, Rena K. Fox, MD, of the University of California, San Francisco, and colleagues, called the positive findings promising, especially for HBV patients not receiving NA therapy, and called for well-designed studies to confirm the chemopreventive effect of aspirin in NA users, especially for the subgroup with cirrhosis.
“The potential role for aspirin to be used as chemoprevention for HCC would be relevant to patients worldwide and would bring a change in practice for primary care clinicians and specialists, including gastroenterology, hepatology, infectious diseases, and oncology,” Fox et al. wrote, citing aspirin’s ease of use and affordability, which could potentially benefit hundreds of millions of patients globally.
“There is optimism in the current research, but a recommendation for widespread use of aspirin across the HBV population is premature, as important questions remain, including duration of therapy, age at initiation, degree of benefit for patients taking NAs, and risk for gastroduodenal toxic effects,” the editorial cautioned.
Fox and colleagues recommended that the World Health Organization consider further investigation. “In the meantime, physicians can individually counsel patients who have an indication for aspirin about the potential for HCC risk reduction, especially if they are not candidates for NA therapy,” the editorial stated.
Study limitations, Wu and co-authors said, included its observational design, which could not determine causality and could have introduced selection and other biases, despite consideration of all potential confounders. In addition, because most patients were middle-age or older, the results may not be generalizable to younger populations. Another limitation was the unavailability of detailed laboratory data, such as HBV viral load, that indicate disease severity. Furthermore, some patients discontinued aspirin therapy during the study period, which could have impacted results. In addition, the information in the health insurance database was limited by reliance on insurance claims. Finally, although data on medications were detailed, the accuracy may have been limited by patient adherence to prescribed therapy, the researchers said.
The study was supported in part by the Ministry of Science and Technology, the National Health Research Institutes, and Taichung Veterans General Hospital, Taiwan.
One co-author reported financial relationships with Gilead and Bristol-Myers Squibb outside of the study.
Fox and associates reported having no competing interests.
Primary Source
JAMA Internal Medicine
Secondary Source
JAMA Internal Medicine
CDC: Untreated HIV Infections Barrier to Ending Epidemic
The majority of new HIV infections are transmitted through either patients who are unaware of their HIV status or from those who are aware of their infection, but are not in care, researchers found.
A mathematical model estimated that patients with undiagnosed HIV infections, and those with diagnosed HIV infections not in care, accounted for approximately 80% of new infections in 2016, reported Zihao Li, PhD, of the CDC in Atlanta, and colleagues, in Vital Signs, an early release of the Morbidity and Mortality Weekly Report.
Early HIV diagnosis and treatment are cornerstones of the recently announced plan to end the HIV epidemic in the U.S. by 2030. Indeed, a call with media on Monday used the new research as evidence that supported the implementation of this plan.
Jonathan Mermin, MD, director of the CDC National Center for HIV/AIDS, Viral Hepatitis, STD, and TB stated that Monday’s report, “highlights the gap preventing us from stopping HIV infections” and “emphasizes the impact HIV resources could have if we expanded HIV testing and treatment.”
U.S. Surgeon General VADM Jerome Adams, MD, MPH, went over the proposed funding for this initiative, stating that $291 million has been requested for Fiscal Year 2020. These funds will hope to finance “extra boots on the ground and resources to address the HIV epidemic,” he said.
But members of the media remained skeptical about the plan, with some suggesting that other HIV experts estimated an initiative of this scale would cost billions, not millions of dollars. One reporter even said that the proposed figure “doesn’t begin to tickle the toes” of combatting the HIV epidemic, especially given the cost of pre-exposure prophylaxis (PrEP), unless the administration was planning on cutting the price of drugs.
CDC Director Robert Redfield, MD, responded that this was a “multi-year initiative,” and could not release all the details of the plan at the present time. He added that the agencies who spent the last 6-7 months putting the plan together are cognizant of the issues involved.
“We’re going to get this plan done,” Redfield said.
Study Details
Li and colleagues analyzed data from the National HIV Behavioral Surveillance and the National HIV Surveillance System in a mathematical model to estimate transmission rates along the HIV continuum of care. Overall, they found the HIV transmission rate was 3.5 per 100 person years in 2016, and estimated that overall transmission had declined from 2010 (4.5 per 100 person years), mainly due to a “steady increase” in viral suppression.
But transmission rates varied significantly, depending on where patients were on the continuum of care. Overall, 33.6% of transmissions occurred by those who were “not acutely infected and unaware of their infection” and 42.6% were among those who were “aware of their HIV infection, but not in care.”
Importantly, the percentage of transmissions among those taking antiretroviral therapy and virally suppressed was 0%, the authors noted.
About three-quarters of estimated transmissions were among men who have sex with men (MSM), and about 10% were among people who inject drugs. MSM also unsurprisingly had the highest transmission rate (4.4 per 100 person years).
Interestingly, while the highest transmission rate was highest among persons ages 12-34, the authors said, adults ages ≥55 had the highest portion of new infections (29.4%).
‘Diagnostic Complacency’
The authors noted that “providers play an important role” by “screening patients for HIV infection, linking patients to care and emphasizing the importance of achieving and maintaining viral suppression for personal health and prevention benefits.”
“Routine testing and targeted HIV testing are complementary approaches to addressing the 38% of transmissions that occurred from the estimated 15% of persons with undiagnosed HIV infection,” the authors wrote.
On the call, Redfield addressed what he termed “diagnostic complacency,” saying that patients were seeing the doctor, but were not being diagnosed, despite CDC recommendations for HIV testing.
He said that some of that gap could potentially be filled with “innovation in diagnostic” testing in “non-traditional, non-clinical settings,” such as testing kits ordered “over the Internet.”
Redfield also discussed how the new HIV initiative would help with identification and treatment of infections by working with communities, local health systems, and public health leaders to “[scale] up support systems for people to get the HIV care they need and stay in HIV care.” The plan would also include improved access to prevention measures, such as PrEP, condoms, and syringe disposal services.
“Science that sits on the shelf has no value. Today’s … data highlights my point,” Redfield said. “It underscores the tremendous impact we could have by focusing on diagnosis and treatment.”
Li and co-authors disclosed no relevant relationships with industry.
Primary Source
Morbidity and Mortality Weekly Report
Japan to Issue Gene-Edited Food Rules
A panel put together by Japan’s health ministry is poised to release rules governing genome-edited agricultural and marine products,according to NHK World.
This, it adds, could mean that such products could be on the market in a few months. In a separate report, NHK notes that the technology could be used to develop, for instance, more prolific rice or larger red sea bream.
According to NHK, the rules would require business to inform the government which genes they planned to alter in food to be distributed, but that they would not be required to undergo toxicity and carcinogenicity screenings. It adds that Japan’s Consumer Affairs Agency is to study how these products are to be labeled.
Last August, a Japanese government panel announced that it would not be regulating some forms of gene editing. Similarly, regulators at the Department of Agriculture in the US have said they have no plans to regulate genome-edited crops. Regulators in Europe, by contrast, have said that gene editing is a form of genetic modification that falls under the GMO Directive.
Broad Institute, Massachusetts General Hospital License CRISPR Tech to Pairwise
Agriculture and food company Pairwise announced today that it signed agreements to license CRISPR genome editing technologies from Massachusetts General Hospital and the Broad Institute.
The company said it plans to use the technologies to develop new applications in crop editing, for research to bring new foods to market, and to increase the sustainability of modern agriculture. Pairwise CEO Tom Adams noted in a statement that the company is planning to work with “a wide array of food and agriculture companies spanning row and specialty crops, fruits, and vegetables to make these critical tools accessible as we all work to tackle the challenges facing our food system.”
Specifically, Pairwise said it has obtained an exclusive license to certain unspecified MGH CRISPR technology, which it will use in agricultural applications. Access to MGH’s “optimized CRISPR enzymes” will allow the firm to overcome challenges in the food and agriculture industry, and to develop a wider array of healthy and sustainable food, Aaron Hummel, head of genome editing technologies for Pairwise, said in the statement.
“Whether through health care or healthy foods, we are all concerned with the health and well-being of the communities we serve,” Harvard Medical School pathology professor, MGH researcher, and Pairwise Cofounder Keith Joung added. “The high-fidelity and enhanced CRISPR enzymes with improved target recognition capabilities that we have developed for medical uses also have the potential to increase gene editing efficiencies and could ultimately increase the pace of innovation in agriculture.”
The company has also signed a non-exclusive license agreement with the Broad for its Cas9 and Cas12 patent portfolios for use in plants and agriculture. This license includes both Cas12a and Cas12b, Pairwise noted.
“Our goal is to maximize the scientific impact of CRISPR-Cas9 for improving agriculture, and our non-exclusive licensing agreements offer the opportunity to provide wide access to help researchers reduce food waste, limit pesticides, and improve drought resistance, while promoting safe and ethical uses of groundbreaking technologies,” Broad Chief Business Officer Issi Rozen also noted.
The Broad’s licenses prohibit the use of the institute’s CRISPR technologies for gene drives, sterile seeds, or tobacco products for human use.
Financial terms of the deals were not disclosed. Since its formation in March 2018, Pairwise has grown to more than 60 employees. The company anticipates hiring an additional 30 to 40 employees in 2019.
The Broad has made several licensing deals for its CRISPR IP over the past several months, most recently with Promega in January for knock-in of genetic reporters into the genomes of any cell or cell line.
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