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Monday, December 2, 2019

Morphosys CFO says tafasitamab drug sales potential above $1 billion

German biotech company Morphosys’ tafasitamab, the group’s most advanced drug which is currently being tested, has sales potential of significantly more than $1 billion a year, its finance chief said in remarks to a magazine.
“Analysts estimate sales at between half a billion to $1 billion per year. If further indications are added, for example additional forms of leukaemia, they might be significantly higher than that,” Jens Holstein told Germany’s Euro am Sonntag.
Earlier this month, a data monitoring committee recommended an increase in the number of patients to 450 from currently 330 in the ongoing “B-MIND” trial, which tests tafasitamab against relapsed or refractory diffuse large B cell lymphoma.
Holstein said he expected tafasitamab to be approved by mid-2020 in the United States, adding it could take one more year in Europe.

‘Prediabetes’ common in U.S. teens, young adults

About one in five teens and one in four young adults in the U.S. have slightly elevated blood sugar, sometimes known as “prediabetes,” that can lead to full-blown diabetes, a study suggests.
For the study, researchers examined data on blood sugar levels for 5,786 people ages 12 to 34 who hadn’t been diagnosed with diabetes. Overall, 18% of the younger people in the study, ranging in age from 12 to 18 years old, had “prediabetes,” as did 24% of the adults 19 to 34 years old.
“Prediabetes is highly prevalent in U.S. adolescents and young adults, especially in male individuals and in people with obesity,” lead study author Linda Andes of the U.S. Centers for Disease Control and Prevention in Atlanta and colleagues write in JAMA Pediatrics.
These teens and young adults with prediabetes are at increased risk not only for developing type 2 diabetes – the common form of the disease associated with obesity and aging – but also cardiovascular problems that can lead to heart attacks and strokes, the study team writes.
“These findings together with the observed increase in the prevalence of type 2 diabetes in U.S. adolescents and in diabetes-related complications in young adults highlight the need for … prevention efforts tailored to the young segment of the U.S. population,” the study team notes.
Average blood sugar levels over the course of about three months can be estimated by measuring a form of hemoglobin that binds to glucose in blood, known as A1c. Hemoglobin A1c levels of 6.5% or above signal diabetes.
Levels between 5.7% and 6.4% are considered elevated, though not yet diabetic, while 5.7% or less is considered normal.
Overall, 5.3% of teens and 8% of young adults in the study had levels in this “prediabetic” range, the study found.

To get a more complete picture of how many young people might be at risk for developing full-blown diabetes, researchers also looked at other things including so-called insulin resistance, or the body’s failure to respond normally to the hormone insulin. Diabetes can develop when the body can’t properly use insulin to convert blood sugar into energy.
They also looked at what’s known as impaired fasting glucose, when blood sugar levels are above a normal range but not quite high enough to formally diagnose diabetes.
Both teens and young adults in the study who appeared to have prediabetes had higher cholesterol and blood pressure and more fat stored around their midsections than individuals without prediabetes.
Among teens in the study, about 23% of males had prediabetes, compared with 13% of females. Differences persisted among young adults: 29% of males and 19% of females had prediabetes.
And, less than 16% of white teens had prediabetes, compared with more than 22% of black and Hispanic adolescents. This difference also carried through to early adulthood: about 21% of white people had prediabetes compared with 27% of black individuals and 29% of Hispanic young adults.
People with obesity were also most likely to have prediabetes: 26% of teens and 37% of young adults with obesity had this condition.
The study wasn’t a controlled experiment designed to prove whether or how markers of prediabetes might directly lead to diabetes in teens or young adults.

One limitation of the study is that researchers only had data to assess prediabetes at a single point in time, the study authors note.
SOURCE: bit.ly/37YCWKo JAMA Pediatrics, online December 2, 2019.

FDA tags psilocybin drug as clinical depression Breakthrough Therapy

The FDA has tagged psilocybin, the illegal psychoactive compound found in ‘magic mushrooms’, as a potential breakthrough treatment for major depressive disorder.
A US-based non-profit medical research organisation, the Usona Institute, is developing psilocybin to treat major depressive disorder (MDD), and has just launched a phase 2 trial.
The institute said the FDA had granted the Breakthrough Therapy status as part of an organisational commitment to promoting an efficient development programme for psilocybin in MDD.
In October last year the FDA granted COMPASS Pathways’ psilocybin-based drug the same status in treatment-resistant depression – but the indication suggested in this case is broader and would allow for earlier treatment.
The FDA gives the designation to drugs where evidence demonstrates they could be a substantial improvement over available therapies for serious or life-threatening diseases.
Drugs given the designation are hastened through the development process by the FDA, which can grant a faster six-month review if it feels the evidence is still compelling once trials are completed.
The new status follows the recent launch of Usona’s Phase 2 clinical trial, PSIL201, which will include around 80 participants at seven study sites around the US.
Two of the seven study sites are currently recruiting, with the others expected to be active by the first quarter of 2020.
Although there are several existing MDD treatments, Usona said the Breakthrough Therapy Designation recognises that psilocybin may offer a clinically significant improvement over these therapies.
According to Usona, the short-acting drug could impart profound alterations in consciousness and could enable long-term remission of depressive symptoms.
Usona is a non-profit medical research organisation that conducts and supports pre-clinical and clinical research to further the understanding of the therapeutic effects of psilocybin and other consciousness-expanding medicines.
In the UK, the Medical Research Council backed the proof-of-concept study of psilocybin for treatment-resistant depression at Imperial College London in 2015.
Notoriously used as a recreational psychoactive drug, psilocybin is deemed a highly illegal “schedule 1” drug in the US, with a potential for abuse and no currently accepted medical use.

Kamada to distribute six biosimilars in Israel

Kamada Ltd. (KMDA +0.5%) inks an agreement with Alvotech to commercialize the latter’s portfolio of six biosimilars in Israel, once approved. The first product, PF708 (branded as Bonsity), a biosimilar to Eli Lilly’s osteoporosis med Forteo (teriparatide), should be launched in 2022.
Financial terms are not disclosed.

DreamWorks co-founder ups UCLA med school scholarship fund by $46M

David Geffen, co-founder of DreamWorks Pictures, gave the David Geffen School of Medicine at UCLA an additional $46 million to extend full-ride scholarships to 120 more students, the school announced Dec. 2.
The gift ups the scholarship fund in Mr. Geffen’s name to $146 million — a sum that will enable a total of 414 students over a decade to attend UCLA’s medical school on full scholarships. Geffen Scholars receive full tuition and a living stipend through the program, which began with a $100 million gift from Mr. Geffen in 2012.
“The Geffen Scholars program is life-altering for our students and their future patients,” Kelsey Martin, MD, PhD, dean of the Geffen School of Medicine, said in a press release. “Mr. Geffen’s generosity has remarkable ripple effects.”
Since launching the scholarship fund, UCLA has tripled the percentage of students who graduate from its medical school debt-free, from 17 percent to 45 percent. Reduced debt helps students focus on patient care and pursue their specialty of choice, rather than deciding based on future income.
In addition to the $146 million scholarship fund, Mr. Geffen donated $200 million to the medical school in 2002. His gifts to UCLA total more than $450 million.

How blockchain is benefiting healthcare

Within the healthcare industry, blockchain is being used to ensure privacy while also improving data management.
Garratt Hasenstab, the president of The Mountain Life Companies, wrote for for Forbes that blockchain is being leveraged in healthcare. As a blockchain expert, Mr. Hasenstab sees the potential blockchain has to change the industry.
Blockchain has the opportunity to transform the healthcare industry by securely maintaining and distributing patient data, according to Mr. Hasenstab. If implemented, clinicians could be assured that patient data is up-to-date and stored securely.
In the pharmaceutical sector, MediLedger is testing blockchain as a secure platform to trace prescription drugs. By using blockchain, the initiative is tracking prescriptions from the manufacturers to patients’ doorsteps.
Additionally, Orderly Health and BurstIQ have teamed up to develop a provider data management platform that is run on blockchain technology.

Brainsway shares up on smoking cessation data

Shares of Brainsway BWAY, +18.96% are up 10% in premarket trading on positive trial results for its brain stimulation device as a smoking cessation tool for longtime chronic cigarette smokers. About 20% of the patients in the study who completed treatment reported a four-week continuous quit rate, compared to 8% in the placebo group. “The success demonstrated in this study in treating patients addicted to cigarettes strengthens our optimism with respect to the potential for the use of our platform technology to treat other addictions as well,” Brainsway interim CEO David Zacut said in a news release. The Israeli medical device maker went public in April. Its stock has fallen 8% over the last three months, while the S&P 500 SPX, -0.83% has gone up 7% during the same period.