Maintains Buy
Monday, June 24, 2019
Alnylam’s patisiran shows durable effect in hATTR extension study
Results from a global open-label extension study evaluating the long-term effects of Alnylam Pharmaceuticals’ (ALNY -2.4%) ONPATTRO (patisiran) in polyneuropathy of hereditary ATTR (hATTR) amyloidosis showed a sustained treatment benefit. The data were presented at the Peripheral Nerve Society Annual Meeting in Genoa, Italy.
At month 6, serum transthyretin levels dropped ~80% in patients in the placebo arm who switched to patisiran and were maintained over time. Patients on treatment for 30 – 36 months experienced sustained improvements in neuropathy impairment and quality-of-life (QOL) measures versus baseline.
A new analysis of the Phase 3 APOLLO study showed that patients who were previously treated with Pfizer’s (PFE -0.2%) tafamidis (branded as Vyndaqel and Vyndamax) and received patisiran for 18 months showed significant improvements in polyneuropathy and QOL measures, on par with the overall study population.
The company also announced an indirect comparison between ONPATTRO and Ionis Pharmaceuticals (IONS -1.7%) and Akcea Therapeutics’ (AKCA-1.5%) TEGSEDI (inotersen) that it says showed “favorable treatment effects” of patisiran.
The FDA approved ONPATTRO in August 2018 for the indication.
Undaunted By FTC, UnitedHealth And Optum Ready For More Deals
News UnitedHealth Group’s Optum unit may be ready to acquire a payment processing service could be a sign the nation’s largest health insurer is ready to spend billions of dollars to further build out its network of provider and payer operations.
The Wall Street Journal late last week reported UnitedHealth is going to spend more than $3 billion on privately held Equian, which says it offers “end-to-end payment” services, managing more than $500 million in claims data.
If the story is accurate, Equian would seem to fit Optum’s services to medical care providers, employers and payers. Neither UnitedHealth nor Optum would confirm talks or a deal with Equian, saying they don’t comment on rumors.
The deal talk comes just as UnitedHealth and Optum reached a settlement with the Federal Trade Commission to buy DaVita Medical Group, whichwill bring the health insurer’s Optum health services business physician practices, urgent care centers and outpatient operations in several key markets.
But Optum and UnitedHealth seems poised to set a pace when it comes to gobbling more provider and health benefits operations as rivals are wheeling and dealing to keep up in an escalating battle in the healthcare industry to put providers of medical care under the same umbrella as health insurance companies.
Pharmacy giant CVS Health last year bought Aetna, the nation’s third-largest health insurer; Cigna last year bought the PBM Express Scripts; insurer Humana has been signing deals with multiple providers in the home care, hospice and drugstore space while big Blue Cross and Blue Shield plans including Anthem and Health Care Service Corp. are investing in primary care doctor practices and outpatient clinics.
UnitedHealth and Optum have also been mentioned in reports lately regarding a final round of bidding against rival health insurer Anthem for Magellan Health. Magellan is known for its behavioral health services though it also has a pharmacy benefit management (PBM) business and Medicaid health plans.
Analysts have been speculating Anthem and UnitedHealth are in the lead to get Magellan, but Anthem earlier this month announced plans to buy Beacon Health Options, which is also seen as a play to expand into managing mental health conditions.
Insurers increasingly are working to address social determinants of their customers outside of traditional medical care and an estimated one in five American adults suffers from mental illness, according to the National Institute of Mental Health.
Resolution Bio to develop prostate cancer blood test for Janssen, Zejula
Janssen has tapped Resolution Bioscience to help develop a companion liquid biopsy test for the PARP inhibitor Zejula (niraparib) in patients with metastatic castration-resistant prostate cancer.
Resolution’s cell-free DNA assay is currently being used in Zejula’s phase 2 and 3 development against the disease to detect homologous recombination deficiency mutations and gene deletions.
The blood test was granted a breakthrough device designation by the FDA this past May. If approved, Resolution said it could be the first in vitro diagnostic to detect gene deletions from cell-free DNA and identify both single-copy and biallelic gene deletions.
Additionally, the Kirkland, Washington-based company said it expects the test will help identify more men seeking targeted therapies such as Zejula, especially late-stage patients from which tissue for a biopsy can be difficult to collect.
In February, Janssen presented data from an open-label phase 2 study of Zejula demonstrating an objective response rate of about 40% in patients with metastatic castration-resistant prostate cancer and DNA-repair pathway defects including BRCA1 and BRCA2.
“It is encouraging to see this promising response rate, since patients with this DNA-repair pathway defect typically only have an objective response rate of less than 15% and a median progression-free survival of three months with currently available therapies,” Janssen’s vice president of clinical development in prostate cancer Margaret Yu said at the time.
“Given these results, prospective biomarker testing could enable healthcare professionals to personalize therapy for patients with metastatic castration-resistant prostate cancer in the future,” Yu said. In the study, patients tested positive for a repair pathway mutation in one of eight genes.
Previously approved in ovarian cancer, Janssen picked up the worldwide rights outside of Japan for Zejula in prostate cancer from Tesaro in April 2016.
Separately, Janssen announced a data science research collaboration with the University of California, San Francisco and UC Berkeley offering a Bay Area fellowship program run by the universities and working with the product and platform teams within the Johnson & Johnson pharmaceutical arm.
Projects could include artificial intelligence-driven apps for spotting the early warning signs of disease or new methods of recruiting participants for clinical trials, according to Janssen. The agreement is part of a broader arrangement for sponsored research among the universities and Johnson & Johnson’s medical devices and consumer-focused companies, as well.
VA declines broad coverage for new J&J depression drug
A Department of Veterans Affairs committee has declined to approve widespread coverage of a new depression treatment that has generated controversy but also received an express endorsement from President Trump. Instead, the drug was approved on a more limited basis.
Many experts have embraced the medication, which is known as esketamine and is being sold by Johnson & Johnson (JNJ) under the brand name Spravato, as a critical option for patients in dire need of new treatments particularly because it might work faster than existing antidepressants.
But it has faced pushback since its approval in March, with some watchdog groups citing effectiveness and safety concerns.
It is chemically related to ketamine, which has been long used as an anesthetic during surgery and misused recreationally as a club drug. Since its approval, watchdog groups have also raised questions about deaths by suicide among three individuals who had used Spravato in a clinical trial.
In a decision Thursday, a VA committee declined to cover the drug for all beneficiaries, instead restricting the nasal spray to patients who have not responded to other treatments and requiring an authorization process before it can be prescribed.
The decision came just one week after Trump gave an unconventional endorsement of the treatment. During an Oval Office event on June 12, he predicted to Veterans AffairsSecretary Robert Wilkie that Johnson & Johnson would be very generous in pricing the treatment.
And if you like, Trump said, Ill help you negotiate.
A VA spokesperson said in a statement that drug was approved on a non-formulary basis, likening it to prior authorization that many private insurers mandate before permitting the use of potentially risky or expensive treatments.
The decision will enable VA psychiatrists to offer esketamine to patients when clinically indicated, the spokesperson said, ensuring the medication is prioritized for use in Veterans who have not previously responded to adequate trials of other available treatments for major depression.
The agency will continue to monitor the drug for safety and effectiveness compared to other depression treatments, the agency said, and could revise the drugs status if called for.
A J&J spokesman wrote that Spravato is the first new type of medicine for treatment-resistant depression in decades and offers significant and sustained improvement, bringing hope to patients who have cycled through multiple medicines without relief. We firmly believe that people suffering from treatment-resistant depression, including our nations veterans, deserve the opportunity to benefit from this breakthrough medicine.
The VA panels decision not to mandate coverage of the drug was absolutely the correct decision, said Diana Zuckerman, president of the National Center for Health Research, a nonpartisan institute that studies science and health in Washington.
The effectiveness data werent particularly good, she said. Especially for men and people over 65, and thats mostly who the VA serves.
In briefing documents submitted to a Food and Drug Administration advisory committee, the agency noted six deaths including the three suicides among patients who were taking the drug. Since the patients in question had severe illnesses and there were no distinct patterns observed among the deaths, the FDA reviewers said they did not necessarily see the deaths as drug-related.
The VAs decision to exclude Spravato from formulary coverage also came a day after the Institute for Clinical and Economic Review, a Boston nonprofit that reviews drugs and health services for cost-effectiveness, released an analysis claiming the true value of the drug was between 25% and 52% lower than Johnson & Johnsons chosen price.
Currently, its wholesale acquisition cost stands between $590 and $885 per treatment session. Costs for the first month of treatment, which includes two sessions per week, could range from $4,720 to $6,785.
Maybe its become politically untenable to cover it because of the media coverage, despite the pressure from the administration or Trump directly, Zuckerman said. We know that members of Congress were looking into this.
The offices of Sens. Johnny Isakson (R-Ga.) and Jon Tester (D-Mont.), the chairman and ranking member on the Senate Veterans Affairs Committee, respectively, did not immediately respond to requests for comment.
Abbott Laboratories: Nutrition Is the Missing Ingredient in Home Health
New research from Advocate Health Care and Abbott (NYSE: ABT) found that prioritizing nutrition care* for home health patients at risk for malnutrition had a dramatic impact on helping keep them out of the hospital – resulting in millions of dollars in healthcare cost savings. Nearly 5 million Americans annually rely on home healthcare to recover from an illness, injury or hospitalization.1,† While healthcare providers are constantly striving to improve patients’ health and minimize hospitalizations, nutrition is often not top of mind, yet it plays a critical role in helping adults bounce back and resume their normal routine.
In the first-of-its-kind study, published today in the Journal of Parenteral and Enteral Nutrition, more than 1,500 home health patients were followed for 90 days.2 The study found that when patients at risk for malnutrition received a comprehensive nutrition care program, including nutrition drinks, to aid in their recovery:
- Risk of being hospitalized was significantly reduced by 24% in the first 30 days, nearly 23% after 60 days, and 18% after 90 days.
- Healthcare costs were reduced by more than $2.3 millionor about $1,500per patient at risk for malnutrition treated over the course of 90 days.‡
”Our goal as a home healthcare provider is to help patients get back on their feet as quickly as possible and to keep them out of the hospital,” said Katie Riley, R.N., vice president, post acute chief nursing officer for Advocate Aurora Health and the lead study author. ”While the primary reason people come to home health isn’t because they’re malnourished or at risk, we have found that when we do pay attention to their nutrition care, it helps promote their strength and prevents them from going back to the hospital, which ultimately reduces healthcare costs.”
As many as 1 in 3 home health patients are at risk of malnutrition, which can impact their recovery or cause further health issues.1,3 But malnutrition often goes unrecognized as it can be invisible to the eye and can occur in both underweight and overweight individuals. Therefore, more healthcare systems are starting to focus efforts on the identification and management of malnourished or at-risk patients through regular monitoring and follow up.
Bayer, AlphaBio Control sign distribution pact for biological pest control product
The choice of pest control products with different modes of action allows farmers worldwide to apply effective resistance management strategies. Bayer and AlphaBio Control have signed a distribution agreement to market Flipper™, an innovative biological pest control product developed by AlphaBio. Under the terms of this agreement, AlphaBio grants Bayer a worldwide exclusive right (except France) to commercialize Flipper for agriculture and non-agriculture uses.
Flipper will become an essential part of Bayer’s tailored solutions, combining seeds and traits, chemical and biological crop protection products with digital services for the benefit of growers, the food chain and society. ‘Bayer is committed to reducing agriculture’s ecological footprint through innovation, also including biological and low-residue solutions such as Flipper,’ said Liam Condon, Member of the Board of Management of Bayer AG and President of the Crop Science Division.
Iain Fleming, AlphaBio’s Chief Executive, said: ‘We are immensely proud of this opportunity to be working with such a forward thinking company as Bayer. We have devoted significant resources over a number of years in bringing Flipper to the market. We have become more and more convinced of the fundamental agricultural need for this product and could not hope for a better partner to help promote and deliver Flipper to growers across each of the relevant regions. We have seen the complete determination within Bayer to deliver comprehensive integrated solutions for all crop needs and are so pleased to be a part of this.’
Flipper is a bioinsecticide-acaricide formulation based on an active substance entirely obtained from the by-product of extra-virgin olive oil production. It combats pests via contact by disrupting cell functionality and interfering with feeding activity. Flipper contains naturally occurring, long-chain carboxylic acids that are part of the normal daily diet of mammals, birds and invertebrates. It is safe for users, selective for crops, pollinators and beneficial arthropods and exempt from Maximum Residue Legislation (MRL) requirements and import tolerances, set by the European Union. It is already registered as a crop protection product in many EU countries and efforts are underway to allow it to be used across a very broad crop and efficacy spectrum in and beyond Europe.
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