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Tuesday, June 11, 2019

Nestle looks to scale up plant-based burger business

Nestle (OTCPK:NSRGY) exec Marco Settembri says the company could expand its plant-based burger sales partnership with McDonald’s (MCD+0.6%) outside of Germany or sign on new fast-food partners.
Nestle is looking to sell its Herta meat and cold cuts unit, which would free it up to scale up the meat alternatives business without competing with itself. Meanwhile, McDonald’s is widely expected to make some sort of meatless menu option announcement this year.
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Adamis amends U.S. application for higher dose naloxone, eyes fast approval

Based on FDA feedback, Adamis Pharmaceuticals (ADMP -4.5%) has removed kaléo’s EVZIO (naloxone HCl injection) 2 mg auto-injector as the Reference Listed Drug (RLD) in its marketing application seeking approval for its higher dose naloxone injection product for the emergency treatment of opioid overdose. It has also withdrawn the associated Paragraph IV certification (enables a generic drug maker to challenge an existing patent in court after notifying the patent holder).
The company hopes that the agency will now approve the application in a timely fashion since the sole remaining RLD is Narcan injectable which has no Orange Book-listed patents. The agency’s action date is October 31.
Adamis is being sued for patent infringement by kaléo but believes that its higher dose formulation does not infringe, adding that it will “continue to vigorously defend its naloxone injection product” against any infringement allegations.
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J&J’s Invokana shows CV benefit in type 2 diabetics with kidney disease

Results from a Phase 3 clinical trial, CREDENCE, evaluating Johnson & Johnson (JNJ +0.7%) unit Janssen Pharmaceuticals’ INVOKANA (canagliflozin) in patients with type 2 diabetes (T2D) and chronic kidney disease showed a positive effect cardiovascular (CV) risk. The data were presented at the American Diabetes Association Scientific Sessions in San Francisco.
A subgroup analysis showed that treatment with INVOKANA significantly reduced the risk of major CV events and kidney failure. The positive effect was observed in patients with CV risk factors but no history of CV disease as well as patients with history of CV disease. Specifically, the composite risk of CV death, heart attack or stroke was reduced by 32% in the primary prevention group and 15% in the secondary prevention group.
Treated patients also experienced 30% less risk of a composite of kidney disease measures (doubling of serum creatinine, end-stage kidney disease and renal or CV death).
In the overall population, patients receiving INVOKANA experienced 20% less risk of CV death, heart attack or stroke and 31% less risk of CV death or hospitalization for heart failure.
The FDA approved the CV benefit claim in October 2018.
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TG on go with U.S. application for umbralisib in MZL

Based on FDA feedback, TG Therapeutics (TGTX +0.3%) expects to file a U.S. marketing application seeking accelerated approval to use umbralisib to treat marginal zone lymphoma (MZL) by year-end.
The data supporting the application was generated in the Phase 2b UNITY-NHL study.
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Ziopharm up on FDA sign-off on study involving Sleeping Beauty platform

Ziopharm Oncology (ZIOP +3.3%) perks up on average volume in reaction to its announcement that the FDA has signed off on a National Cancer Institute-sponsored study evaluating T-cell receptor (TCR) T-cell therapy using the company’s Sleeping Beauty platform for the treatment of solid tumors.
Sleeping Beauty is a non-viral gene transfer technology that the NCI will use to generate neoantigen-specific T cells.
The company will host a conference call on Wednesday, June 12, at 8:30 am ET to discuss its non-viral TCR-T program.
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Humana, Epic to collaborate on real-time benefits check

Humana’s real-time benefits check tool will be integrated into Epic’s e-prescribing workflow.

Humana Inc. and Epic Systems announced plans to collaborate on a push towards value-based care Tuesday morning, with an agreement to integrate Humana’s real-time benefits check (RTBC) tool into Epic’s e-prescribing workflow.
IntelligentRx, Humana’s RTBC tool, will allow Epic to deliver “real-time pharmacy data throughout its network” and reduce administrative costs for providers, according to a Humana press release.

Alan Wheatley, president of Humana’s retail segment, said that almost half of the Louisville-based insurer’s patients currently see a doctor who utilizes Epic, which will extend the benefits from the partnership.
“The nexus of these technologies will both improve the provider experience and patient access to care by empowering them to weigh evidence-based outcomes with patients’ individual medication cost and coverage,” Wheatley said in a statement.

Alan Hutchison, vice president of population health at Epic, echoed Wheatley’s sentiments, adding that the payer-electronic health records collaboration aims to “improve quality and transparency for patients.”

Humana stated its expectations for the collaboration as increasing the timeliness of data exchanges, improving medication adherence, and reducing the cost of specialty care.
The collaboration announcement comes one week after Humana publicly rebuked rumors that the insurer was exploring a merger with Centene Corporation.
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CVS service aims to help employers manage nontraditional benefit options

  • CVS’ pharmacy benefit manager launched a vendor benefit management service allowing its employer clients to offer nontraditional tools aimed at improving employee health.
  • The program announced Tuesday will allow employers to contract and manage their relationship with third-party vendors that offer employee benefits, which could be both digital and non-digital tools.
  • The first third-party vendor in the program and available for CVS Caremark members to adopt is Sleepio, a digital program aimed at improving sleep sold by Big Health.

The move fits into the broader effort by employers, payers and others to tackle social determinants of health, paying attention to nutrition, transportation and other non-traditional health measures. Digital tools like apps and wearables are at the forefront of that trend.
This is not CVS’ only venture related to digital health tools for clients. Early this year, the company said its insurance arm, Aetna, will offer an app aimed at pairing the patient’s medical history with the Apple Watch capabilities to help members set health goals.
Although executives say the pharmacy giant’s nearly $70-billion acquisition of Aetna is complete, the companies are still facing a hurdle in implementation as a federal judge reviews their merger settlement agreement with the U.S. Department of Justice. The judge is set to hear more arguments on the matter next month.
As social factors influencing health become more of focus, payers are ramping up efforts to offer related services. And CMS is pushing these tools as well. Medicare Advantage plans, for example, now have the flexibility to cover the cost for healthy food options for some beneficiaries or carpet cleaning for those with asthma.
A report by health benefits platform Castlight underscored the trend, finding the average employer offers 14 digital health tools, either offered by a health insurance plan or a third-party vendor. Every generation is using digital health tools, though millennials are slightly more likely to use digital tools to address health problems, that report showed.
However, a recent Health Affairs study found questionable evidence on whether the efforts are working.
Despite the prevalence of digital health tools, “they have not have not yet demonstrated substantial impact on disease burden or cost in the US health care system,” according to its review of U.S.-based digital health companies.
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