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Monday, June 3, 2019

Humana swats down rumor it wants Centene

Market stakeholders have speculated that Humana could make a proposal to combine with Centene as an alternative to Centene’s planned merger with WellCare Health Plans.

KEY TAKEAWAYS

As the future of Centene’s proposed WellCare merger remain murky, some had suggested Humana might be waiting in the wings.
While share prices slumped for Centene and rose for Humana, one analyst says longer-term investors for both ‘are likely relieved.’
Humana Inc. signaled in an unusual filing Monday morning with the Securities and Exchange Commission that it has no intention of pursuing a merger with fellow health insurer Centene Corp.
The note—which sent Centene shares tumbling more than 8%shortly after markets opened—came after Centene’s proposed merger with WellCare Health Plans hit a bit of a speed bump, with antitrust regulators from the U.S. Department of Justice indicating they will scrutinize the deal that has been criticized by the American Hospital Association and others.
A report last month by Reuters’ Carl O’Donnell and Svea Herbst-Bayliss added fuel to rumors that Humana would be interested in merging with Centene if the WellCare deal falls through.
Humana said in Monday’s SEC filing that its “long-standing policy is not to comment on rumors or speculation regarding possible M&A activity.”
“However, in light of the significant investor speculation and persistent market rumors regarding the Company’s intentions with respect to pursuing a combination with Centene … the Company has chosen to make a one-time, limited exception to its no-comment policy (which continues in effect) and confirm that the Company will not make a proposal to combine with Centene as an alternative to Centene’s proposed transaction with WellCare Health Plans, Inc.,” the SEC filing states.
“The Company does not intend to make any further statement regarding the foregoing,” Humana’s filing adds.
As Centene shares sank, Humana’s rose more than 5% Monday morning.
SVB Leerink analyst Ana Gupte told the St. Louis Post-Dispatch that Humana needed to respond to claims it had been putting pressure on its stock.
“Shorter term activist shareholders of Centene may be disappointed by it, but large long-only institutional share holders of both Centene and Humana are likely relieved,” Gupte wrote in an email to the Post-Dispatch.
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Emergent Bio awarded 10-year HHS contract for VIGIV in smallpox

Emergent BioSolutions (NYSE:EBS) has received a contract award of ~$535M over 10 years for the continued supply of Vaccinia Immune Globulin Intravenous (VIGIV) into the U.S. Strategic National Stockpile (SNS) in support of smallpox preparedness.
The contract consists of a one-year base period of performance valued at $23M and nine option years.
The scope of work under the contract includes the collection of plasma, manufacturing, and delivery of finished drug product.
VIGIV is the only product licensed by the FDA for the treatment of complications due to smallpox vaccination.
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Seattle Genetics drug could provide new option for bladder cancer

  • Tumors either got smaller or stopped growing in more than two-fifths of certain advanced urothelial cancer patients put on an experimental drug from Seattle Genetics, according to clinical trial data presented Monday at the American Society of Clinical Oncology’s annual meeting.
  • The Phase 2 trial looked at patients previously treated with platinum-based chemotherapy and a PD-1 or PD-L1 checkpoint inhibitor. Among patients who had not responded to these inhibitors, 41% responded to Seattle Genetics’ drug, enfortumab vedotin. So did 38% of patients with cancer that spread to the liver.
  • The trial also enrolled patients who previously received a checkpoint inhibitor and no platinum-based chemotherapy — but data from that group, which is still enrolling, wasn’t reported at ASCO. Still, Seattle Genetics has said it is confident in the results seen thus far and plans to file its drug for approval later this year.
Seattle Genetics built its now two-decades-old business around ADCs, or antibody drug conjugates. The strategy has resulted in one product, Adcetris (brentuximab vedotin), but that number could soon rise.
Executives said in February that enfortumab vedotin, also an ADC, is “on the path to becoming” the company’s next marketed drug. A positive readout in an ongoing Phase 2 trial, they argued, would set it up for a regulatory filing in 2019 under the Food and Drug Administration’s accelerated approval program.
The company didn’t have to wait long to get that readout; topline results announced in March showed an objective response rate of 44% in the study’s first cohort — the one where patients had already been treated with platinum-based chemotherapy and a PD-1 or PD-L1 checkpoint inhibitor.
More complete data presented at ASCO found 12% of those patients had no detectable signs of cancer after receiving enfortumab vedotin. Median overall survival was a little less than a year.
On safety, a release from ASCO said the drug was well-tolerated, with 40% to 50% of patients experiencing fatigue, hair loss and decreased appetite.
ASCO noted too how patients had a median of three prior systemic treatments in the locally advanced or metastatic setting before getting Seattle Genetics’ drug.
The clinical activity seen in the Phase 2 study closely resemble what investigators saw in earlier testing. That’s reassuring, according to Arlene Siefker-Radtke, a professor at the University of Texas MD Anderson Cancer Center.
Siefker-Radtke foresees enfortumab vedotin, should it gain approval, being a welcome addition to clinicians’ list of advanced urothelial cancer treatments.
Currently, most patients are put on chemotherapy or checkpoint inhibitors, though Johnson & Johnson did in April receive FDA approval for Balversa (erdafitinib) in patients who have two types of mutation in a gene called FGFR.
“We clearly need more options,” she said in an interview with BioPharma Dive. “Having platinums, having immunotherapy and having an FGFR-targeted agent isn’t enough. And it really is thrilling seeing enfortumab vedotin come into play.”
Enfortumab vedotin is now being investigated in a Phase 3 trial as well as another study enrolling newly diagnosed patients with advanced urothelial cancer. Astellas is jointly developing the drug with Seattle Genetics.

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Merck updates on Phase 2 trial for aggressive tumor med at ASCO

  • Alterations of the MET signaling pathway are present in 3-5% of non-small cell lung cancer patients and correlate with poor prognosis
  • New interim data from Phase II VISION study (all lines of treatment) show tepotinib induced objective responses, as assessed by independent review, in 50.0% of patients identified by liquid biopsy (LBx) and 45.1% for patients identified by tissue biopsy (TBx) 
  • Median duration of response was 12.4 months for LBx-identified patients and 15.7 months for TBx-identified patients
  • Safety results for tepotinib are consistent with those reported in previous studies; most treatment-related adverse events (TRAEs) were Grade 1 and 2, and no Grade 4 or 5 TRAEs were observed
Merck KGaA, Darmstadt, Germany, a leading science and technology company, which operates its biopharmaceutical business as EMD Serono in the US and Canada, today presented updated results from the potentially registrational Phase II VISION study, showing durable anti-tumor clinical activity for the investigational targeted therapy tepotinib* across different lines of treatment in advanced non-small cell lung cancer (NSCLC) patients harboring MET exon 14 skipping mutations detected by liquid biopsy (LBx) or tissue biopsy (TBx). Data were shared in an oral presentation today at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL, US.
“Tepotinib has been designed to potentially improve outcomes in aggressive tumors that have a poor prognosis and harbor these specific alterations,” said Luciano Rossetti, Global Head of Research & Development for the Biopharma business of Merck KGaA, Darmstadt, Germany. “Tepotinib is an important part of our strategic focus on precision medicine, and both the proportion of patients responding and the duration of anti-tumor clinical activity demonstrate the potential of this investigational therapy.”
Discovered in-house at Merck KGaA, Darmstadt, Germany, tepotinib is an investigational, highly potent and selective1 oral MET kinase inhibitor that is designed to inhibit the oncogenic signaling caused by MET (gene) alterations, including both MET exon 14 skipping mutations and MET amplifications, or MET protein overexpression. Alterations of the MET signaling pathway are found in various cancer types, including 3-5% of NSCLC cases, and correlate with aggressive tumor behavior and poor clinical prognosis.2-4
“Patients with this NSCLC molecular subtype lack treatment options that have the potential to significantly improve clinical outcomes,” said Paul K. Paik, M.D., primary study investigator and Clinical Director, Thoracic Oncology Service, Memorial Sloan Kettering Cancer Center. “It is noteworthy to see data that are consistent with tepotinib’s previously reported efficacy findings in this patient population, and that also provide valuable new insight into its durable clinical activity across various treatment lines.”
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Misonix Gets FDA OK for Ultrasonic Surgical Platform

 Misonix, Inc. (Nasdaq: MSON) (“Misonix” or the “Company”), a provider of minimally invasive therapeutic ultrasonic medical devices that enhance clinical outcomes, today announced that it received 510(k) clearance by the U.S. Food and Drug Administration (FDA) for Nexus, its revolutionary ultrasonic surgical platform. Misonix will commence the commercialization of the Nexus platform in the United States in July.
Nexus is a next-generation integrated ultrasonic surgical platform that combines all the features of Misonix’s existing solutions, including BoneScalpel, SonicOne and Sonastar, into a single fully integrated platform that will also serve to power future solutions. The Nexus platform is driven by a new proprietary digital algorithm that results in more power, efficiency and control. Nexus uniquely incorporates RF capabilities, allowing for use in general surgery procedures. The device also incorporates Smart Technology that allows for easier setup and use.
Physicians will be able to utilize Nexus’ increased power to improve tissue resection rates, in concert with its proprietary digital algorithm to perform more efficient bone removal procedures. In addition, Nexus’ ease of use will enable physicians to fully leverage Nexus’ impressive capabilities via its digital touchscreen display and smart system setup.
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Avenue up on positive late-stage study of IV tramadol

Thinly traded nano cap Avenue Therapeutics (NASDAQ:ATXI) is up 16% premarket on light volume in reaction to a successful second Phase 3 clinical trial evaluating IV tramadol for the treatment of postoperative pain following abdominoplasty (tummy tuck) surgery.
The trial met the primary and all key secondary endpoints, demonstrating comparable efficacy to IV morphine.
The company plans to file its U.S. marketing application in Q4.
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Mirati up on Amgen’s KRAS inhibitor data

Mirati Therapeutics (MRTX +32.4%) is up on over 40% higher volume in apparent response to Phase 1 data on Amgen’s KRASG12C inhibitor AMG 510 presented at ASCO in Chicago.
Preliminary results showed only partial responses in five of 10 evaluable patients.
Investors appear to perceive the somewhat underwhelming data as a positive for Mirati’s KRASG12C inhibitor MRTX849, currently in IND-enabling studies.
#ASCO19
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