One in three adults aged 60 and over suffering from a hip fracture
dies within one year. Now, a Purdue University-affiliated startup is
moving closer to the start of clinical trials for a novel injectable
drug that is targeted to heal broken bones faster and strengthen weak
bones.
The Purdue University discovered drug, NOV004, from Novosteo Inc. is
unique in that it concentrates at the fracture site while reducing
exposure to the rest of the body.
Novosteo, the startup developing the drug, was co-founded by
father-son team Philip S. Low, the Presidential Scholar for Drug
Discovery and the Ralph C. Corley Distinguished Professor of Chemistry,
and Stewart A. Low, the company’s CSO and Visiting Scholar in Purdue’s
Department of Chemistry. The treatment was developed in the Purdue
laboratory of Low in the Purdue Institute of Drug Discovery. Currently
there are 288 clinical trials performed or in process using
Purdue-developed medical treatments at 4,841 sites across the globe.
Scott Salka, who recently joined the startup as executive chair, will
use his 28 years of experience as a biotechnology entrepreneur to help
Novosteo move its innovations from the laboratory to clinical trials and
ultimately in to the hands of doctors and patients.
“We have been working on some amazing science with people truly
dedicated to making a difference in reducing the mortality and improving
the quality of life for our aging population,” said Salka. “We have
completed preclinical studies with NOV004 and are looking to take it to
clinical trials later this year.”
As CEO, Salka has successfully led efforts to advance novel drugs
through preclinical and early clinical development, most recently at
publicly traded Ampliphi, now Armata NYSE: ARMP. Prior to that he
founded and served as CEO for both Ambit Biosciences, acquired by
Daiichi Sankyo OTC: DSNKY, and Rakuten Medical.
Novosteo is already looking at the future use of the
injectable-targeted drug for other applications, including dental
implants, head and facial fractures, and hip and knee replacements. In
addition, Novosteo has a pipeline of drugs for treating an array of
musculoskeletal maladies. Salka will present some of the technology at
Biocom’s Global Life Science Partnering Conference this month in La
Jolla, California.
Novosteo’s technology is licensed through the Purdue Research
Foundation Office of Technology Commercialization. The company also
received entrepreneurial support from Purdue Foundry, an
entrepreneurship and commercialization hub in Discovery Park District’s
Convergence Center for Innovation and Collaboration where startups,
entrepreneurs, innovators and companies can collaborate with Purdue to
address global challenges in health, sustainability, IT and space.
The Purdue Institute of Drug Discovery is situated near the district,
a $1 billion-plus long-term enterprise to support a transformational
center of innovation on the western edge of the Purdue University
campus. The district already includes a public airport with a 7,000-foot
runway, and partnerships international companies including Rolls-Royce,
Schweitzer Engineering Laboratories and Saab. Visit Discovery Park
District.
Novosteo was founded to reduce the morbidity, mortality and loss of
productivity associated with bone fractures. Based on discoveries of
agents that accelerate bone regeneration and breakthroughs in methods to
target these agents selectively to fracture surfaces, Novosteo has
designed a series of fracture-targeted drugs that concentrate a drug’s
healing power specifically at the fracture site, thereby greatly
accelerating and improving the healing process. The mission of Novosteo
is to reduce the debilitating and often life-threatening effects of bone
fractures. More information is available on the Novosteo website.
https://www.eurekalert.org/pub_releases/2020-02/pu-idf021120.php
Tuesday, February 11, 2020
FDA accepts NDA for FibroGen anemia treatment
FibroGen (NASDAQ:FGEN) +4.4% after-hours following news that the Food and Drug Administration accepted its New Drug Application for roxadustat for the treatment of anemia of chronic kidney disease.
The filing of the roxadustat NDA triggers a $50M milestone payment from AstraZeneca (NYSE:AZN) to FibroGen.
Roxadustat is the first orally administered small
molecule hypoxia-inducible factor prolyl hydroxylase inhibitor accepted
by the FDA for review for the treatment of anemia of CKD.
https://seekingalpha.com/news/3540861-fda-accepts-nda-for-fibrogen-anemia-treatmentAdamas Pharma higher after positive Gocovri trial data
Adamas Pharmaceuticals (NASDAQ:ADMS) has published trial data indicating its Gocovri has maintained its treatment effect on motor complications for at least two years.
Shares are up 1.8% after hours.
The Phase 3 open-label EASE LID 2 trial enrolled
223 patients and saw the positive effect in all subgroups, including
those continuing treatment from prior double-blind trials, from placebo
or amantadine immediate release, as well as those with dyskinesia
receiving deep brain stimulation.
“These newly published results suggest that
Gocovri may reduce dyskinesia and OFF as far out as 100 weeks, providing
sustained benefits to patients with levodopa-induced dyskinesia,” says
Dr. Jean Hubble, VP of Medical Affairs for Adamas.
https://seekingalpha.com/news/3540868-adamas-pharma-higher-after-positive-gocovri-trial-dataJ&J teams up with BARDA to accelerate coronavirus vaccine development
Johnson & Johnson (NYSE:JNJ) unit Janssen Pharmaceutical Companies expands its collaboration
with the U.S. Department of Health & Human Services’ Biomedical
Advanced Research and Development Authority (BARDA) aimed at
accelerating the development of a vaccine against the coronavirus
causing the current outbreak, COVID-19 (formerly 2019-nCoV).
Janssen and BARDA will both fund R&D costs and
mobilize resources to more rapidly progress through the initial stages
of development. BARDA will provide funding to support development into
Phase 1 studies with options to provide additional funding to advance a
promising candidate.
In parallel, Janssen will work to upscale production and manufacturing capacities, leveraging its AdVac and PER.C6 technologies.
Shares up 1% after hours.
https://seekingalpha.com/news/3540807-j-and-j-teams-up-barda-to-accelerate-coronavirus-vaccine-developmentMore Patients Turning to ‘Direct Primary Care
Having quick access to a primary care doctor 24/7 is very appealing
to Mick Lowderman, 56, who is married with two children, ages 10 and 8.
He pays a monthly membership fee to AtlasMD, a direct primary care
practice in Wichita, KS.
Primary care is built on the long-term relationship between clinicians and patients. A 10- to 15-minute patient visit doesn’t support that relationship, Sullivan says.
When Kevin Boyd, 64, fell on his stairs in Wichita and broke three ribs, he didn’t go the emergency room. Instead, he called Umbehr, who told him to come to his office. He referred Boyd nearby for an X-ray and dispensed pain medications at his office. The total cost was $70.
In contrast, the first time Boyd fell and broke his ribs, he had Blue Cross Blue Shield and drove himself to the ER, where he saw the ER doctor, a radiologist for an MRI, and got shots for his pain. The total bill was $14,000, and he paid $2,600.
“I don’t put off care the way I used to because of the money I save,” says Boyd, who joined AtlasMD in 2015.
For his monthly membership fee of $75, Boyd gets several benefits, including unlimited 24/7 access to Umbehr by text, email, or phone, extended same- or next-day office visits, and free diagnostic tests and office procedures, such as EKGs, DEXA scans, and body fat analysis. If Boyd gets really sick and needs a house call, or if he needs a phone consult when traveling, those are also included in the fee.
“It’s awesome that I can call or text Dr. Josh Umbehr when my children are sick and that I have a solution before they leave for school,” he says.
For example, when one child woke up coughing recently, Mick and his wife, Jennifer, contacted ‘Dr. Josh,’ who asked them to put her on the phone to hear her cough and then take a picture of her throat and text it to him.
“He prescribed an antibiotic, which we picked up at his office the same day.”
Umbehr is part of a growing movement of primary care doctors, including those in family, internal, and geriatric medicine, who want to practice more personalized comprehensive medicine without the burden of dealing with insurance in a traditional fee-for-service system. Most choose to not accept health insurance and charge patients a membership fee instead.
“When you look at direct primary care and other models that are cropping up, it points to our broken system that doctors don’t want to practice in and are looking for alternate solutions ― and so are patients,” says Erin Sullivan, PhD, research and curriculum director at the Center for Primary Care at Harvard Medical School.
Umbehr is in Kansas, one of 44 states that allow doctors to directly dispense medications with the exception of controlled substances. Boyd pays $2 and $3 for typically a 3-month supply of common generic medications that he can pick up at AtlasMD or have mailed to him.
Another way Umbehr saves patients money is through contracting with specialists who agree to give his patients discounted rates. For example, when Umbehr sent Boyd for an ultrasound of a possible blood clot in his leg, he was billed $120.
The popularity of these alternative models is growing. DPC Frontier, which tracks the number of direct primary care practices nationally, estimates there are 1,219 practices in 48 states and Washington, D.C. They range in size from solo practitioners to corporate, multisite direct primary care organizations with thousands of doctors, Sullivan says.
The American Academy of Family Physicians supports the direct primary care model “as a potentially powerful disruptor in the health care payment environment that has traditionally undervalued family medicine and comprehensive care,” the group says on its website.
But there are drawbacks and concerns to be aware of. For one, the
monthly fee is in addition to any insurance for major medical problems.
While many doctors and patients claim the direct care model results in
better health outcomes, there are no studies proving that, according to
an editorial in The Journal of the American Medical Association. Because
it is a retainer operation, too, the model encourages doctors to target
healthier patients, while others charge more for patients who have more
needs.
Umbehr chose to establish a direct primary care practice right out of residency. “As a premed student, I spent time in a brilliant surgeon’s practice who never figured out the business side of fee-for-service insurance with all the billing and coding. That was a peek into a bad business model.”
While the membership payment model in concierge medicine appealed to
him, “we wanted an affordable version for the masses.” Concierge primary
care practices offer similar outpatient services and amenities to
members but typically charge higher membership fees, and many also bill
insurers.
Direct primary care practices charge an average monthly fee of $78, while concierge practices charge an average monthly fee of $183.00. Umbehr also saves money on overhead with no front office or administrative staff and one registered nurse for each of AtlasMD’s five doctors. “There’s a good chance one of us will answer the phone,” he says
Umbehr limits his patient volume to 700, compared to a typical “in-network” primary care doctor who sees 2,500-3,000 patients total. This allows him to see five to six patients a day instead of 20 or more seen in a typical primary care office.
Lowderman and Boyd say that Umbehr can take care of most of their
health care needs, including minor office procedures that don’t require anesthesia
or sedation. If needed, they will pay cash for a specialist or use
their major-medical insurance plan if something more serious happens.
Major-medical plans, sometimes also called catastrophic insurance, will
cover things like trauma care, emergency surgeries, and more. They
feature low monthly premiums and high deductibles.
Lowderman, who has 12 employees in his pest control business, pays AtlasMD $50 per employee monthly to provide primary care services to them. Because he also gets customized major medical insurance through AtlasMD, he pays a total of $375.00 monthly per employee. Traditional employer insurance would have been double or triple the cost, he says.
For example, Jolene had frequent urinary tract infections. “Before Dr. Umbehr, we would call her internist and he would tell us to come down to the clinic to do the lab work. My wife had one leg and a half amputated due to infection. I was an executive with Raytheon at the time and would have to take time off from work, hire a home health nurse to collect the urine specimen and drop it off, wait 3 days to get the lab results, and then go to Walgreens to pick up Bactrim, which always worked.”
When Umbehr became their primary care doctor, Jolene would call him
up and mention a UTI, and he would start her on Bactrim, which he often
dropped off at their house on his way home. Then, a lab technician or
home health nurse the Scheidts hired would collect the urine specimen
for analysis to confirm the diagnosis.
“She didn’t need to leave the house! I finally felt like she was being treated like a head of state. My wife told me many times that dealing with such serious matters wasn’t as scary with Dr. Umbehr shepherding her through difficult medical situations,” Scheidt says. “That alone was worth a pot of gold to her, and certainly to me as well.”
Gold was feeling burned out at age 36. “I was thinking of either
quitting medicine completely or teaching at a local medical school. I
saw no sustainability in seeing people in 10-minute increments daily for
the rest of my career.”
Two years later, he left North Shore.
He read about Umbehr’s practice online and then visited him in Wichita to see it firsthand and decided to adopt a similar model. However, “there are differences between Wichita and Boston ― this area is heavy with big hospital systems that are insurance-based. Employers equate insurance with care, and trying to educate them about the value of this different primary care model is challenging.” [MORE}
https://www.medscape.com/viewarticle/925053#vp_1
Primary care is built on the long-term relationship between clinicians and patients. A 10- to 15-minute patient visit doesn’t support that relationship, Sullivan says.
When Kevin Boyd, 64, fell on his stairs in Wichita and broke three ribs, he didn’t go the emergency room. Instead, he called Umbehr, who told him to come to his office. He referred Boyd nearby for an X-ray and dispensed pain medications at his office. The total cost was $70.
In contrast, the first time Boyd fell and broke his ribs, he had Blue Cross Blue Shield and drove himself to the ER, where he saw the ER doctor, a radiologist for an MRI, and got shots for his pain. The total bill was $14,000, and he paid $2,600.
For his monthly membership fee of $75, Boyd gets several benefits, including unlimited 24/7 access to Umbehr by text, email, or phone, extended same- or next-day office visits, and free diagnostic tests and office procedures, such as EKGs, DEXA scans, and body fat analysis. If Boyd gets really sick and needs a house call, or if he needs a phone consult when traveling, those are also included in the fee.
“It’s awesome that I can call or text Dr. Josh Umbehr when my children are sick and that I have a solution before they leave for school,” he says.
For example, when one child woke up coughing recently, Mick and his wife, Jennifer, contacted ‘Dr. Josh,’ who asked them to put her on the phone to hear her cough and then take a picture of her throat and text it to him.
“He prescribed an antibiotic, which we picked up at his office the same day.”
Umbehr is part of a growing movement of primary care doctors, including those in family, internal, and geriatric medicine, who want to practice more personalized comprehensive medicine without the burden of dealing with insurance in a traditional fee-for-service system. Most choose to not accept health insurance and charge patients a membership fee instead.
“When you look at direct primary care and other models that are cropping up, it points to our broken system that doctors don’t want to practice in and are looking for alternate solutions ― and so are patients,” says Erin Sullivan, PhD, research and curriculum director at the Center for Primary Care at Harvard Medical School.
Umbehr is in Kansas, one of 44 states that allow doctors to directly dispense medications with the exception of controlled substances. Boyd pays $2 and $3 for typically a 3-month supply of common generic medications that he can pick up at AtlasMD or have mailed to him.
Another way Umbehr saves patients money is through contracting with specialists who agree to give his patients discounted rates. For example, when Umbehr sent Boyd for an ultrasound of a possible blood clot in his leg, he was billed $120.
The popularity of these alternative models is growing. DPC Frontier, which tracks the number of direct primary care practices nationally, estimates there are 1,219 practices in 48 states and Washington, D.C. They range in size from solo practitioners to corporate, multisite direct primary care organizations with thousands of doctors, Sullivan says.
The American Academy of Family Physicians supports the direct primary care model “as a potentially powerful disruptor in the health care payment environment that has traditionally undervalued family medicine and comprehensive care,” the group says on its website.
As a premed student, I spent time in a
brilliant surgeon’s practice who never figured out the business side of
fee-for-service insurance with all the billing and coding. That was a
peek into a bad business model.
The American College of Physicians, too, warned in its policy paper
on the practice that the direct care model can “potentially exacerbate
racial, ethnic and socioeconomic disparities in health care and impose
too high a cost burden on some lower-income patients.”Umbehr chose to establish a direct primary care practice right out of residency. “As a premed student, I spent time in a brilliant surgeon’s practice who never figured out the business side of fee-for-service insurance with all the billing and coding. That was a peek into a bad business model.”
Direct primary care practices charge an average monthly fee of $78, while concierge practices charge an average monthly fee of $183.00. Umbehr also saves money on overhead with no front office or administrative staff and one registered nurse for each of AtlasMD’s five doctors. “There’s a good chance one of us will answer the phone,” he says
Umbehr limits his patient volume to 700, compared to a typical “in-network” primary care doctor who sees 2,500-3,000 patients total. This allows him to see five to six patients a day instead of 20 or more seen in a typical primary care office.
Lowderman, who has 12 employees in his pest control business, pays AtlasMD $50 per employee monthly to provide primary care services to them. Because he also gets customized major medical insurance through AtlasMD, he pays a total of $375.00 monthly per employee. Traditional employer insurance would have been double or triple the cost, he says.
Managing Care
When Umbehr started his practice a decade ago, Mike Scheidt and his wife, Jolene, (now deceased) were among his first patients. “I don’t know if I would have joined if my wife had not been so sick with cancer and he could streamline perfunctory things,” Scheidt says.For example, Jolene had frequent urinary tract infections. “Before Dr. Umbehr, we would call her internist and he would tell us to come down to the clinic to do the lab work. My wife had one leg and a half amputated due to infection. I was an executive with Raytheon at the time and would have to take time off from work, hire a home health nurse to collect the urine specimen and drop it off, wait 3 days to get the lab results, and then go to Walgreens to pick up Bactrim, which always worked.”
“She didn’t need to leave the house! I finally felt like she was being treated like a head of state. My wife told me many times that dealing with such serious matters wasn’t as scary with Dr. Umbehr shepherding her through difficult medical situations,” Scheidt says. “That alone was worth a pot of gold to her, and certainly to me as well.”
Leaving Traditional Insurance
Jeffrey S. Gold, MD, opened Gold Direct Care in 2015 in Marblehead, MA, after being employed as a family medicine doctor by North Shore Medical Center in Boston for 7 years. “It was a typical insurance-based practice where I was seeing 20 to 22 patients a day. I wanted to practice medicine and not insurance paperwork, billing, and coding.”Two years later, he left North Shore.
He read about Umbehr’s practice online and then visited him in Wichita to see it firsthand and decided to adopt a similar model. However, “there are differences between Wichita and Boston ― this area is heavy with big hospital systems that are insurance-based. Employers equate insurance with care, and trying to educate them about the value of this different primary care model is challenging.” [MORE}
https://www.medscape.com/viewarticle/925053#vp_1
EXACT Sciences EPS beats by $0.87, misses on revenue
EXACT Sciences (NASDAQ:EXAS): Q4 GAAP EPS of $0.54 beats by $0.87.
Revenue of $295.6M (+106.7% Y/Y) misses by $2.04M.
Shares -2.9%.
https://seekingalpha.com/news/3540726-exact-sciences-eps-beats-0_87-misses-on-revenuePfizer axes license agreement with GlycoMimetics
In the wake of a failed late-stage study evaluating rivipansel for the treatment of vaso-occlusive crisis in sickle cell disease patients, Pfizer (PFE +0.4%) has notified licensor GlycoMimetics (GLYC +1.7%) that it will terminate their 2011 agreement.
GLYC will regain all rights to respective assets and will incur no termination penalties related to the end of the partnership.
https://seekingalpha.com/news/3540669-pfizer-axes-license-agreement-glycomimetics
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