Needham analyst Chad Messer kept his Strong Buy rating and $94 price target on Esperion, saying that while the top line data from the long-term safety study of bempedoic acid may have been disappointing relative to consensus, it was within his expectations. Messer notes the study’s findings of 20% LDL reduction over placebo within 12 weeks was “the lower bound” of what was observed in prior data and could be viewed as a “strong result” considering that data can “often revert to the mean”, adding that the latest study also featured a high-risk patient population.
Wednesday, May 2, 2018
Tuesday, May 1, 2018
New Digital GP Service from Aviva and Now Healthcare
Aviva is giving large corporate health insurance customers swift, convenient access to more than 1,000 GPs, through a new collaboration with digital health company, Now Healthcare Group (NHG).
NHG has become Aviva Health’s strategic provider of digital GP services, offering customers access to NHS qualified GPs via an Aviva branded mobile app, Aviva Digital GP.
The app allows customers to book video consultations with a GP, receive remote diagnoses and obtain advice on simpler medical queries directly from a GP via a live chat facility. The app will be rolled out more widely to Aviva customers over time.
Aviva is excited about appointing Now Healthcare Group as our new strategic provider of digital health services. At Aviva we’re keen to provide our customers with digital solutions to help make their lives easier and give greater control of their health. We are confident that this new relationship will provide Aviva with opportunities to enhance, evolve and change the way we look after the health of our customers.”Mark Noble, CEO, Global Health at Aviva
Further features of Aviva Digital GP include:
- A choice of whether consultations are with a male or female GP, and customers also have the option of booking consultations with the same doctor each time they use the service.
- A choice of 12 languages, so customers can select their preferred language.
- Customers have access to GPs’ credentials (such as special areas of interest) to help choose a doctor to suit their needs.
- Access to a UK-wide pharmacy network offering a next-day prescription delivery service (or 2-4 hours in central London).
- Medicines delivered directly to customers’ homes, offices or their local pharmacy.
- Repeat prescription top-ups ordered via a GP.
- A broad suite of at-home testing and monitoring kits.
Now Healthcare Group is delighted to be working with Aviva to deliver our innovative healthcare services to its vast client and customer base. This relationship, following our exemplary Care Quality Commission report, further cements our status as our industry’s leading provider, and we’re very excited to be working with one of the UK’s largest insurers to bring convenient and accessible healthcare to more and more people.”Lee Dentith, CEO & Founder of NHG
Rigel target upped by Piper
Rigel Pharmaceuticals price target raised to $8 at Piper Jaffray. Piper Jaffray analyst Christopher Raymond raised his price target on Rigel Pharmaceuticals to $8 from $7 following the company’s Q1 update and its discussions around the launch plans for Tavalisse. The analyst says the update was necessary to demonstrate the company’s ability to execute commercially. Raymond keeps his Overweight rating on Rigel Pharmaceuticals.
LabCorp to Collaborate to Aid Physicians Treating Opioid Dependent Patients
LabCorp® (NYSE: LH), a leading global life sciences company, and The Recovery Platform are announcing a new collaboration to expand access to medication-assisted opioid treatment on a national basis. The Recovery Platform is a unique monitoring tool designed to help primary care physicians address and manage opioid-use disorder patient recovery in a compliant and efficient manner. Through plug-in integration with existing electronic health records, The Recovery Platform offers a powerful set of tools to assist physicians monitoring patient compliance and progress, and to help patients stay on track with their recovery.
“We are excited to work with LabCorp as the premier diagnostic testing laboratory. LabCorp provides services to a significant number of physicians who may benefit from The Recovery Platform, which will help expand access to opioid treatment on a national basis,” said Reynold Yordy, chief technology officer and founding member of The Recovery Platform.
Laurie Peregoy, compliance director, The Recovery Platform, said “LabCorp’s extensive infrastructure, including its nearly 2,000 patient service centers providing specimen collection, commitment to high-quality, high-value lab testing and focus on compliance, made it the obvious choice for The Recovery Platform.” Peregoy further commented that “LabCorp’s recent introduction of cost-effective, dedicated test options specific to buprenorphine treatment, like Suboxone, will benefit our providers, patients, and payers.”
“As part of LabCorp’s mission to improve health and improve lives, our work with The Recovery Platform has the potential to positively impact millions of opioid-dependent patients and their families,” said Gary Huff, chief executive officer of LabCorp Diagnostics. “Through this collaboration, LabCorp is integrated into The Recovery Platform, demonstrating how technology can improve the delivery of care by making it easier for Suboxone providers to access lab services for their opioid-use disorder patients to remain compliant with their treatment.”
Scientific research and clinical practice have shown the value of continued care to help patients achieve and maintain recovery.1 It includes key features to help physicians adhere to Substance Abuse and Mental Health Services Administration (SAMHSA) requirements to continue prescribing Suboxone as part of medication-assisted treatment for opioid dependency.
The Recovery Platform’s lab testing feature provides digital patient notification for random testing, with a convenient dashboard to allow the care team to quickly assess the status of testing and results. LabCorp’s integration within The Recovery Platform supports patient trend analysis, and also highlights results that indicate treatment non-compliance, alerting the care team to the need for prompt intervention.
https://bit.ly/2r9TRoy
Pivotal trials at Bristol, Merck, AstraZeneca end after Incyte Phase 3 fail
The IDO R&D pipeline is in danger of being exterminated.
In the wake of a pivotal failure of Incyte’s $INCY lead IDO drug epacadostat, Bristol-Myers Squibb $BMY became the third player forced to retrench in that immuno-oncology field, dropping three late-stage studies of a rival drug it bagged in a $1.25 billion buyout. But that was just the start of a rout.
Incyte reported this morning that its wide-ranging collaborations with Big Pharma players are coming undone. In their Q1 announcement, echoing the failure of ECHO-301, the company noted:
Enrollment will be discontinued in the four additional pivotal trials of epacadostat in combination with pembrolizumab (Merck’s Keytruda), and in the two pivotal trials of epacadostat in combination with nivolumab (Bristol-Myers’ Opdivo); each of these studies will be amended to enable patients and their physicians to consider alternative therapeutic options. The pivotal trial in combination with durvalumab (AstraZeneca’s Imfinzi) in Stage 3 lung cancer will not be initiated.
A spokesperson for AstraZeneca also tells me that there is “another Phase II (combination study) in solid tumors and we’re going to stop enrollment there too.” That will be all for the ECHO-203 study — epacadostat plus durvalumab again. “Incyte did present some data from ECHO-203 at AACR: 15 patients with pancreatic cancer were enrolled across multiple dose levels, no clinical activity was observed.”
In addition, Incyte said that it is “significantly downsizing the epacadostat development program,” signaling a painful retreat for a one-time star drug that commanded projections of blockbuster peak sales.
According to clinicaltrials.gov, investigators for the big biotech today terminated a Phase III study of BMS-986205 in combination with Bristol-Myers’ Opdivo for frontline head and neck cancer. Another Phase III study for frontline Stage IV or recurrent non-small cell lung cancer using BMS-986205 and Opdivo with or without chemo versus chemo alone was withdrawn. And there’s a third study for melanoma that’s now active but not recruiting after enlisting 72 patients.
A spokesperson for Bristol-Myers told us Monday night:
Based on emerging data on the IDO pathway, we closed registrational studies of our IDO inhibitor, BMS-986205, in melanoma, SCCHN and NSCLC. We remain committed to continued research of BMS-986205-based combinations in an informed and scientifically robust manner. We will continue to evaluate BMS-986205-based combinations in our Phase 1/2 study, CA017-003.
Separately, we are working quickly with Incyte to assess our program under the collaboration.
NewLink $NLNK was the first to overhaul its approach on IDO following the Incyte disaster. The biotech scrapped a melanoma study that would have evaluated indoximod in combination with checkpoint inhibitors Keytruda or Opdivo in 600 patients. In a press release, NewLink explained the decision was made “in the context of the failure of a competitor’s trial of its enzymatic IDO inhibitor in a similar clinical setting.
Bristol-Myers’ decision — first reported by Xconomy — underscores a growing belief that Incyte’s failure was as much a failure of the class as an individual therapy, potentially torpedoing a wide swath of clinical trials now in the pipeline.
Incyte frankly conceded that its pivotal failure raised doubts about its entire effort, which includes a host of combination studies with checkpoint leaders like Merck and AstraZeneca. In this case, Bristol-Myers is cutting back on a drug that it acquired in a blockbuster deal to acquire Flexus 3 years ago. Investigators have repeatedly touted the drug as a potential lynchpin in immuno-oncology, focusing on an enzyme that suppresses the immune cells Opdivo and a whole new class of PD-1/L1 checkpoints are designed to unleash in an attack on cancer cells.
Ironically, Incyte has been pursuing litigation against one of its former scientists, claiming he defected to Flexus with IDO trade secrets in hand, well before the buyout. Bristol-Myers, though, has steadfastly asserted — with some support from analysts — that it had the better IDO that could leapfrog epacadostat. The leaping in IDO, though, has stopped. At least for now.
Samsung BioLogics hit by notice of accounting breach
Shares in Samsung BioLogics Co Ltd tumbled nearly 20 percent on Wednesday, losing almost $6 billion in value in their biggest daily intra-day fall, after South Korea’s financial watchdog provisionally decided it had breached an accounting rule.
The Financial Supervisory Service (FSS) said on Tuesday it had given preliminary notice to contract biotech drug manufacturer Samsung BioLogics, an affiliate of technology giant Samsung Electronics, and its auditors of measures it could take concerning the provisional breach.
Samsung BioLogics said in a regulatory filing on Wednesday that it would prove its books were sound.
But its shares fell as much as 19.8 percent to their lowest since late January, before paring losses to trade down 14.5 percent. Even then, it was Samsung BioLogics’ biggest intra-day drop since its listing in late 2016. The benchmark KOSPI <.KS11> was down 0.3 percent.
The FSS said it had begun an investigation into the company as an activist group questioned last year whether the company had breached accounting rules to inflate its net profit before its listing.
The country’s top financial regulator, the Financial Services Commission, will convene meetings to deliberate on the matter before announcing final measures.
Samsung BioLogics reported a 1.9 trillion won (1.3 billion pounds) net profit in 2015, compared to a roughly 28 billion won net loss in 2014 and a 62.4 billion won net loss in 2013.
However, the net profit was not a prerequisite for Samsung BioLogics to list in 2016, as the Korea Exchange had instituted new rules allowing companies with growth potential to list despite a net loss, said Seo Keun-hee, analyst at KB Securities.
Shares in Samsung C&T Corp, which held a 43 percent stake in Samsung BioLogics as of end-2017, also fell more than 5 percent. Shares of Samsung Elec, which owned a 31.5 percent stake in Samsung BioLogics as of end-2017, were on a trading halt on Wednesday ahead of a stock split.
Community Health posts surprise profit as costs fall
Hospital operator Community Health Systems Inc reported a surprise first-quarter profit on Tuesday, helped by lower operating costs.
The company’s shares rose about 7 pct to $4.25 in after-market trading. Total operating costs fell 21 percent to $3.48 billion.
Community Health decided to sell six of its hospitals in the quarter and said it is continuing with its divestiture plans to pay off long-term debt, which stood at $13.86 billion.
The company’s net loss attributable to shareholders narrowed to $25 million, or 22 cents per share, in the quarter ended March 31, from $199 million, or $1.79 per share, a year earlier.
Excluding items, the hospital operator earned 13 cents per share, compared with analysts’ expectations of a loss of 22 cents per share, according to Thomson Reuters I/B/E/S.
On a same-store basis, hospital admissions in the quarter decreased 2.4 percent from a year earlier.
Net operating revenue fell to $3.69 billion from $4.49 billion.
Larger rival HCA Healthcare reported a better-than-expected quarterly profit and revenue on Tuesday due to an increase in admission of patients needing advanced care to its hospital.
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