Thursday, September 20, 2018
Avita Medical announces FDA approval of RECELL in burn treatment
AVITA Medica announced that the U.S. Food and Drug Administration approved the Company’s Premarket Approval application to market the RECELL Autologous Cell Harvesting Device to treat severe thermal burns in patients 18 years and older. The RECELL System uses a small amount of a patient’s own skin to prepare Spray-On Skin(TM) Cells at the point of care in as little as 30 minutes, providing a new way to treat thermal burns. The two randomized, controlled clinical trials supporting the FDA approval demonstrated that treatment of acute burn wounds with the RECELL System required substantially less donor skin than required with conventional split-thickness autografts to achieve closure of burn wounds. Reduction in donor skin requirements provides key clinical benefits to patients and significant reductions in the cost of treatment.
https://thefly.com/landingPageNews.php?id=2793547
Medtronic to Acquire Mazor Robotics
Acquisition to Accelerate Medtronic’s Strategy to Transform Spinal Procedures
and Improve Outcomes Through Fully-Integrated Surgical Solutions
and Improve Outcomes Through Fully-Integrated Surgical Solutions
Medtronic plc (NYSE:MDT), a
global leader in medical technology, and Mazor Robotics (NASDAQ:MZOR,
TASE:MZOR.TZ), a pioneer in the field of robotic guidance systems, today
announced the companies have entered into a definitive merger agreement under
which Medtronic will acquire all outstanding ordinary shares of Mazor for $58.50
per American Depository Share, or $29.25 (104.80 ILS) per ordinary share, in
cash, for a total of approximately $1.64 billion, or $1.34 billion net of
Medtronic’s existing stake in Mazor and cash acquired. The boards of directors
of both companies have unanimously approved the transaction.
global leader in medical technology, and Mazor Robotics (NASDAQ:MZOR,
TASE:MZOR.TZ), a pioneer in the field of robotic guidance systems, today
announced the companies have entered into a definitive merger agreement under
which Medtronic will acquire all outstanding ordinary shares of Mazor for $58.50
per American Depository Share, or $29.25 (104.80 ILS) per ordinary share, in
cash, for a total of approximately $1.64 billion, or $1.34 billion net of
Medtronic’s existing stake in Mazor and cash acquired. The boards of directors
of both companies have unanimously approved the transaction.
Medtronic’s acquisition of Mazor strengthens Medtronic’s position as a global
leader in enabling technologies for spine surgery, and drives Mazor Robotics’
vision to bring its core technology to the forefront of the global market.
Mazor’s proprietary core platform technology, including the Mazor X(TM) Robotic
Guidance System (Mazor X), and the Renaissance® Surgical-Guidance System
(Renaissance), are transforming spinal surgery from freehand procedures to
accurate, state-of-the-art, guided procedures. By combining Medtronic’s market-
leading spine implants, navigation, and intra-operative imaging technology with
Mazor’s robotic-assisted surgery (RAS) systems, Medtronic intends to offer a
fully-integrated procedural solution for surgical planning, execution and
confirmation. The companies plan to showcase this technology integration at the
upcoming NASS (North American Spine Society) 2018 Annual Meeting in Los Angeles.
leader in enabling technologies for spine surgery, and drives Mazor Robotics’
vision to bring its core technology to the forefront of the global market.
Mazor’s proprietary core platform technology, including the Mazor X(TM) Robotic
Guidance System (Mazor X), and the Renaissance® Surgical-Guidance System
(Renaissance), are transforming spinal surgery from freehand procedures to
accurate, state-of-the-art, guided procedures. By combining Medtronic’s market-
leading spine implants, navigation, and intra-operative imaging technology with
Mazor’s robotic-assisted surgery (RAS) systems, Medtronic intends to offer a
fully-integrated procedural solution for surgical planning, execution and
confirmation. The companies plan to showcase this technology integration at the
upcoming NASS (North American Spine Society) 2018 Annual Meeting in Los Angeles.
“We believe robotic-assisted procedures are the future of spine surgery,
enhancing surgeons’ abilities to perform complex procedures with greater
precision, consistency and control. Medtronic is committed to accelerating the
adoption of robotic-assisted surgery and transforming spine care through
procedural solutions that integrate implants, biologics and enabling
technologies,” said Geoff Martha, executive vice president and president of the
Restorative Therapies Group at Medtronic. “The acquisition of Mazor adds
robotic-assisted guidance systems to our expanding portfolio of enabling
technologies, and we intend to further cultivate Mazor’s legacy of innovation in
surgical robotics with the site and team in Israel as a base for future growth.”
enhancing surgeons’ abilities to perform complex procedures with greater
precision, consistency and control. Medtronic is committed to accelerating the
adoption of robotic-assisted surgery and transforming spine care through
procedural solutions that integrate implants, biologics and enabling
technologies,” said Geoff Martha, executive vice president and president of the
Restorative Therapies Group at Medtronic. “The acquisition of Mazor adds
robotic-assisted guidance systems to our expanding portfolio of enabling
technologies, and we intend to further cultivate Mazor’s legacy of innovation in
surgical robotics with the site and team in Israel as a base for future growth.”
This transaction builds on a relationship originated in May 2016 under a multi-
phased strategic and equity investment agreement between Medtronic and Mazor. In
August 2017, Medtronic expanded the partnership to become the exclusive
worldwide distributor of the Mazor X system, leading to the successful
installation of more than 80 Mazor X systems since launch. With today’s
announcement bringing the two companies together, Medtronic aims to accelerate
the advancement and adoption of RAS in spine to the benefit of patients,
providers, and the healthcare system more broadly.
phased strategic and equity investment agreement between Medtronic and Mazor. In
August 2017, Medtronic expanded the partnership to become the exclusive
worldwide distributor of the Mazor X system, leading to the successful
installation of more than 80 Mazor X systems since launch. With today’s
announcement bringing the two companies together, Medtronic aims to accelerate
the advancement and adoption of RAS in spine to the benefit of patients,
providers, and the healthcare system more broadly.
“Today is a historic day for spine surgery and a defining event in the market’s
evolution, and I want to acknowledge and thank all of those whose contribution
and faith have been so critical and impactful to our success,” said Ori Hadomi,
CEO of Mazor Robotics. “The Mazor team and product portfolio’s full integration
into Medtronic will maximize our impact globally through Medtronic’s channels,
advance our systems’ leadership position in the marketplace, and drive the
realization of our vision to heal through innovation.”
evolution, and I want to acknowledge and thank all of those whose contribution
and faith have been so critical and impactful to our success,” said Ori Hadomi,
CEO of Mazor Robotics. “The Mazor team and product portfolio’s full integration
into Medtronic will maximize our impact globally through Medtronic’s channels,
advance our systems’ leadership position in the marketplace, and drive the
realization of our vision to heal through innovation.”
Financial Highlights
The acquisition is expected to close during Medtronic’s third fiscal quarter
ending January 25, 2019, subject to the satisfaction of customary closing
conditions including receipt of regulatory clearances and approval by Mazor’s
shareholders. The transaction is expected to be modestly dilutive to Medtronic’s
fiscal 2019 adjusted earnings per share, but given the current strength of
Medtronic’s business, the company expects to absorb the dilution.
The acquisition is expected to close during Medtronic’s third fiscal quarter
ending January 25, 2019, subject to the satisfaction of customary closing
conditions including receipt of regulatory clearances and approval by Mazor’s
shareholders. The transaction is expected to be modestly dilutive to Medtronic’s
fiscal 2019 adjusted earnings per share, but given the current strength of
Medtronic’s business, the company expects to absorb the dilution.
Consistent with its long-term financial objectives, Medtronic projects the
acquisition to generate a double-digit return on invested capital (ROIC) by year
four, with an increasing contribution thereafter.
acquisition to generate a double-digit return on invested capital (ROIC) by year
four, with an increasing contribution thereafter.
Merck Gets Euro Panel Nod for Treatment of HIV-1 Infection
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending granting of marketing authorization for two HIV-1 medicines: DELSTRIGO™, a once-daily fixed-dose combination tablet of doravirine (100 mg), lamivudine (3TC, 300 mg) and tenofovir disoproxil fumarate (TDF, 300 mg); and PIFELTRO™ (doravirine, 100 mg), a new non-nucleoside reverse transcriptase inhibitor (NNRTI) to be administered in combination with other antiretroviral medicines. DELSTRIGO and PIFELTRO are currently under EMA review for the treatment of adults with HIV-1 infection without past or present evidence of resistance to the non-nucleoside reverse transcriptase class, lamivudine or tenofovir. These two recommendations will now be reviewed by the European Commission for marketing authorization in the European Union. Marketing authorization applications for DELSTRIGO and PIFELTRO are also under review in other countries, including Canada, Australia, and Switzerland.
“We are pleased with the CHMP’s positive opinion recommending approval of DELSTRIGO and PIFELTRO, which marks an important step forward in advancing new treatments for people living with HIV,” said Dr. George Hanna, vice president and therapeutic area head of infectious diseases, Global Clinical Development, Merck Research Laboratories. “This represents another milestone in Merck’s more than 30-year commitment to HIV research and treatment, and advances our efforts to address the unmet needs of the HIV community worldwide.”
The CHMP positive opinion was based on findings from two pivotal, randomized, multicenter, double-blind, active controlled Phase 3 trials, DRIVE-AHEAD and DRIVE-FORWARD, evaluating the efficacy and safety of DELSTRIGO and PIFELTRO, respectively, in participants infected with HIV-1 with no prior antiretroviral treatment history. In DRIVE-AHEAD, DELSTRIGO demonstrated sustained viral suppression through 48 weeks, meeting its primary endpoint of non-inferior efficacy compared to efavirenz (EFV)/emtricitabine (FTC)/TDF. In DRIVE-FORWARD, PIFELTRO demonstrated sustained viral suppression through 48 weeks, meeting its primary endpoint of non-inferior efficacy compared to darunavir + ritonavir, each in combination with FTC/TDF or abacavir (ABC)/3TC.
The U.S. Food and Drug Administration approved DELSTRIGO and PIFELTRO on August 30, 2018. In the United States, both DELSTRIGO and PIFELTRO are indicated for the treatment of HIV-1 infection in adult patients with no prior antiretroviral treatment experience, and are administered orally once daily with or without food. DELSTRIGO contains a boxed warning regarding post-treatment acute exacerbations of hepatitis B (HBV) infection. DELSTRIGO and PIFELTRO do not cure HIV-1 infection or AIDS.
Canada’s Canopy Rivers secures C$1.6 billion valuation in trading debut
Cannabis investor Canopy Rivers Inc, the venture arm of industry giant Canopy Growth Corp went public on Thursday in a debut that gave it a market capitalization of about C$1.6 billion ($1.24 billion), more than double its valuation prior to the listing.
Canopy Rivers listed on the Canada’s junior stock exchange through a reverse takeover of a shell company, a route preferred by the cannabis industry to tap the capital markets.
It is the latest in a string of public offerings of mostly Canadian cannabis companies seeking to profit from the imminent legalization of recreational weed in October and a raft of medical marijuana approvals around the globe.
The stock ended the day at C$8.75 on the TSX Venture exchange. The public offering was oversubscribed by more than three times, a source familiar with the situation said, declining to be identified as the information is not public.
The cannabis sector has witnessed frenzied activity that has sent valuations of the fledgling industry soaring.
Canopy Rivers has made about a dozen Canadian and international investments, which include licensed producers, pharmaceutical formulators and retail networks, according to its website.
The company allows investors to target a diversified basket of cannabis companies across a range of geographies.
The transaction was led by Canadian Imperial Bank of Commerce and GMP Securities L.P.. CIBC’s involvement marks a rare instance of a Canadian chartered bank playing a lead role in taking a cannabis company public.
Canopy Growth, which has a market value of C$15.4 billion, owns about 25 percent of Canopy Rivers. Shares of Canopy Growth closed up 6.5 percent at C$67.57 on the Toronto Stock Exchange.
“It’s Canopy Growth’s proxy for Google Ventures,” Bruce Linton, chief executive of both the companies, said in an interview with Reuters earlier this month.
Canopy Rivers is currently looking at investments in Europe and South America, Linton added.
A $4 billion investment in Canopy Growth by brewer Constellation Brands revived share prices late in the summer after a decline earlier in the year.
1st evaluation of benefits, harms of Alzheimer’s screening on patient’s family
With the support of a new $3 million, five-year National Institute on Aging grant, researchers from the Regenstrief Institute and Indiana University Center for Aging Research are conducting the first evaluation of the benefits and harms of Alzheimer’s disease screening for family members of older adults.
A majority of individuals with Alzheimer’s receive care from family members –most commonly spouses or adult children or siblings — but the effect of early identification of Alzheimer’s by screening on these caregivers has never been determined.
“Does early identification of Alzheimer’s by screening prepare family members for a future caregiving role or does it depress them?,” queries Regenstrief Institute and IU Center for Aging Research investigator Nicole Fowler, Ph.D., the principal investigator of the new study. “We know that a delayed dementia diagnosis may perpetuate family beliefs that changes in cognition are part of ‘normal aging’. These are beliefs that have been shown to aggravate caregivers’ stress, burden and sense of isolation.
“But what we don’t yet know is — if by identifying possible Alzheimer’s early — if we can better prepare family members for a caregiving role and reduce their burden.”
The new study is enrolling 1800 adults age 65 and older who have not been diagnosed with Alzheimer’s or other dementias or serious mental illness. Additionally, the family member who each older adult indicates would be most likely to be a caregiver if needed (a total of 1800 potential caregivers) will be enrolled in the study, which is known as COADS, short for Caregiver Outcomes of Alzheimer’s Disease Screening.
Each pair of older adult and family member participants will be randomized into one of three groups and tracked for 24 months.
The older adults in Group I will not receive Alzheimer’s screening. The family members will not be given any information about their older adults’ cognition.
The older adults and family members in Group II will be randomized to Alzheimer’s screening and will be told about the older adults’ Alzheimer’s screening results. For example, they may be advised that based on screening test performance it appears that the older adult may have memory issues and that they should follow up with their doctor. The older adult’s physician will be made aware of the screening results.
The older adults and family members in Group III will be randomized to Alzheimer’s screening and will be told about the older adults’ Alzheimer’s screening results. If the older adult has screened positive for cognitive impairment, a referral will be given to the evidence-based Aging Brain Care (ABC) Program at Eskenazi Health for diagnostic evaluation and will be offered dementia collaborative care management if Alzheimer’s is diagnosed.
“You wouldn’t screen for any other condition and do nothing with a positive result,” said Dr. Fowler, who, in addition to the Regenstrief Institute is on the faculty of IU Center for Health Innovation and Implementation Science and IU School of Medicine. “Best practice is if you are going to screen, you also need to provide state-of-the-science diagnostic care and care management. That’s what we will offer the older adults and family caregivers in Group III to see if it makes a difference for caregivers.
“We can’t stop the train from leaving the station, but we can help the journey for both the older adults and their families. This study will answer the question of how screening for Alzheimer’s affects that crucial individual — the family caregiver.”
Healthcare spending growth bounces back
Post-recession spending growth is climbing towards pre-recession levels and is largely driven by brand-name drugs, ER visits, and outpatient surgeries.
KEY TAKEAWAYS
Employer-sponsored insurance claims saw annual average growth rates of 4.1% over the past decade.
Spending growth has accelerated toward pre-recession levels over the past three years.
ER visits, outpatient services and brand-name presciption drugs account for nearly half the spending growth.
Private-sector healthcare spending grew by 44% over the past decade, rising from $3,752 per person with employer-sponsored insurance in 2007 to $5,394 in 2016, according to a study by the Health Care Cost Institute.
The recession, the Affordable Care Act, and strategic shifts in care delivery slowed spending growth but it’s since rebounded. Spending growth in 2015 and 2016 climb toward pre-recession levels seen in 2007 through 2009, according to the study, which was published online Wednesday in Health Affairs.
The study is the latest to suggest that healthcare spending is accelerating and straining budgets across the economy, from the federal government, to businesses and households.
HCCI researchers examined private employer-sponsored insurance claims for about 40 million people, and found the annual average growth rate was 4.1% over the decade, ranged from 6.3% in 2009 to 2.6% in 2014, and climbed to an average of 4.4% growth in 2015 and 2016.
“Retrospective studies like ours show that healthcare spending is cyclical,” study co-authors Amanda Frost and Kevin Kennedy said in an email to HealthLeaders.
“We observed a period of fast spending growth, followed by a period of much slower growth during the Great Recession. More recently, healthcare spending is up, and NHE predicts that we may be entering a period of faster growth.”
Adjusted for inflation, healthcare spending rose 23% from 2007 through 2016, the researchers said.
Brand-name prescriptions, ER visits, and outpatient surgery drove 48% of the per capita spending increase. Frost and Kennedy say these three high-cost growth areas “may be good targets for cost-saving measures.”
“Though, we did find that spending grew across all four main categories of health services: inpatient, outpatient, professional, and prescriptions,” they said.
The findings also provide more evidence of a fundamental shift by consumers away from inpatient settings in favor of lower-cost outpatient settings.
Per capita out-of-pocket spending on brand-name and generic prescription drugs declined, and researchers pointed to benefit design changes and patterns of service use.
“In the case of brand-name prescriptions, recent spending trends did not correlate with utilization trends,” Frost and Kennedy say. “Use of brand prescriptions has been falling each year, while spending has been increasing—suggesting price increases drove spending.”
In addition, per capita out-of-pocket spending increased by 43%, driven by outpatient and professional services. The largest increase was seen in spending for ER visits.
Frost and Kennedy conceded some limitations in their study. While the sample data represents more than 25% of the population with employer-sponsored insurance, they said it may not be representative of the larger employer-sponsored insured population.
The study also excludes spending trends for patients with public insurance, and does not track health insurance premiums paid by employers and employees or information on drug rebates and coupons.
Vanda announces HETLIOZ patent listing in FDA Orange Book
Vanda Pharmaceuticals announced that a HETLIOZ patent, number 10,071,977, is now listed in the U.S. Food and Drug Administration publication Approved Drug Products With Therapeutic Equivalence Evaluations, commonly known as the Orange Book. The ‘977 patent was issued by the United States Patent and Trademark Office on September 11, 2018 and expires in February 2035. Prior to this newly listed ‘977 patent, the HETLIOZ Orange Book listed patent with the latest expiry date was set to expire in May 2034.
https://thefly.com/landingPageNews.php?id=2793511
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