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Monday, April 1, 2019

Did Novartis hand out kickbacks or host educational dinners? A jury may decide

Kickbacks, $10,000 dinners and Hooters.
Details that sound pulled from an episode of Billions are key accusations in a federal lawsuit against Swiss drugmaker Novartis that could face a jury trial after a district judge’s order Monday.
U.S. District Court Judge Paul Gardephe refused Novartis’ request for summary judgment in an 8-year-old lawsuit accusing the company of holding sham promotional events to induce physicians to prescribe its drugs to patients.

Over the course of almost 80,000 promotional events between 2002 and 2011—all of which might be scrutinized as evidence in court—federal prosecutors say Novartis wined and dined doctors as part of a “companywide scheme” to boost scripts. Among some of the over-the-top allegations was a $10,000 dinner at Nobu, a chic New York seafood restaurant, and one promotional event held on a fishing boat without educational materials on board.
“We are disappointed in today’s decision and look forward to presenting our case at trial,” Novartis spokesman Eric Althoff said via email. “We continue to believe that the government has insufficient evidence to support its claims.”

While the original complaint dates to 2011, federal prosecutors got involved in 2013 and accused Novartis of providing fancy dinners and entertainment in exchange for physicians prescribing Novartis’ drugs to patients. The government argued doctors who accepted kickbacks had billed millions of dollars to Medicare and Medicaid over the span of nearly a decade, putting Novartis afoul of the False Claims Act.
Novartis, in a request for summary judgment, said prosecutors had not presented sufficient evidence of a “nationwide kickback scheme” and that the complaint did not establish a “quid pro quo” between the company and doctors. In addition, Novartis appealed to withhold key evidence in the lawsuit tied to a 2010 settlement with the federal government on various civil and criminal charges.
Gardephe, who previously said evidence from the nearly 80,000 events would be admissible in court, said he had seen enough.
“The Court concludes that … the Government has adduced sufficient particularized evidence of a company-wide kickback scheme, and that the ‘expert-created markers’—criteria indicating that a promotional event lacks a medical educational purpose or value—are admissible evidence of such a scheme,” Gardephe wrote.
In addition, Gardephe refused to grant the company’s request to omit evidence from the previous suit in a possible trial.
Althoff said the company did not engage in kickbacks but instead used its events—what Gardephe called “purportedly educational promotional programs”—as informational sessions for doctors.
“Novartis strongly believes in the importance of peer-to-peer education,” Althoff said. “Through these speaker programs, we provide information to healthcare professionals regarding the benefits and appropriate use of our medicines to help ensure that any prescription decisions are in the best interest of patients.”

The kickback suit continues a recent run of legal trouble for Novartis. In 2015, Novartis inked a $390 million civil settlement with the Feds on claims that it worked with specialty pharmacies to push two of its drugs in exchange for paying rebates.
Novartis was also ensnared in former U.S. Special Counsel Robert Mueller’s Russian collusion investigation in November 2017 after Michael Cohen, former personal attorney for President Donald J. Trump, acknowledged receiving $1.2 million from the company. NBC News reported a senior Novartis official said the payments followed Cohen pledging access to the Trump administration after his inauguration.
The Greek government launched a criminal probe in February 2018 on allegations that 10 politicians accepted bribes from Novartis to boost its sales. In March, Novartis said an internal probe into the alleged bribery scheme showed no trace of payments between the company and Greek politicians.

Care.com Corrects Recent Media Inaccuracies Re Services, Safety Protocols

Care.com CRCM, -6.63% the world’s largest online marketplace for finding and managing family care, issued the following statement to correct inaccuracies appearing in several recent media reports about the Company and its services.
With regard to safety vetting of caregivers:
Since launching in 2007, Care.com has been focused on helping families find in-home care solutions that best suit their needs. Recent media coverage has reported that Care.com performs no screening on the individuals listed on its site. To the contrary, we have been conducting various preliminary screenings on all individual caregivers on our site from the start of our service, and in mid-2009 began including as one such screening a search of certain available electronic criminal records. These preliminary screenings are intended to provide a baseline of safety for our online community. In addition, we offer three tiers of background checks that families can purchase and provide a comprehensive Safety Center with tools and recommendations on other steps they should take when choosing a caregiver to help ensure safe hiring decisions. Over the course of 12 years, with more than 1.5 million successful matches and strong repeat usage, we believe we have earned the trust of families.
With regard to the removal of unclaimed listings of childcare centers from the site:
We provide a directory of childcare centers for families seeking care outside of the home. These directory listings are not our primary offering to our millions of members. However, we believe they provide an important option for families given the predominance of child care deserts (today, half of Americans live in areas in which the number of children exceeds available childcare slots by a ratio of at least 3:1) and the need for more affordable care solutions. Marketing services revenue from these small and medium-sized businesses that provide childcare services represented less than 0.5% of the Company’s total revenue in 2018.
In the past, like many digital platforms, we used publicly available and third-party data sources to create free directory listings and provided the opportunity for these businesses to claim and enhance their listing. We have always noted on the site that we do not verify the information about childcare centers and again, encourage families to do their own due diligence to verify the information most important to them, such as licensing, references and the fit of the specific daycare for their child.
We recently made the decision to remove unclaimed childcare center listings, representing 45% of the total childcare centers in our database,in order to only include profiles provided or reviewed directly by the childcare center operators. The inclusion of these unclaimed listings in our database was unrelated both to our Care@Work back-up care offering and to the millions of individual caregivers who are the focus of our core consumer service.
With regard to caregiver profiles on our site:
The company’s decision to remove unclaimed childcare centers from our consumer marketplace database did not change or impact profiles of individual caregivers on Care.com.
Our site is constantly evolving and we are committed to helping families navigate the complexities of finding care for their loved ones, safely and with confidence.

Aceto Nasdaq trading to be suspended April 3

On February 19, 2019, Aceto Corporation, a New York corporation (the “Company”), and certain of its U.S. subsidiaries (collectively with the Company, the “Debtors”) each filed a voluntary petition for relief under chapter 11 of title 11 of the United States Code in the United States Bankruptcy Court for the District of New Jersey. The Debtors have proposed to jointly administer their chapter 11 cases under the caption In re Aceto Corporation, et al. (the “Chapter 11 Cases”).
As previously disclosed, on February 21, 2019, the Company received a notification from the Nasdaq Stock Market (“Nasdaq”) informing the Company that, as a result of the Chapter 11 Cases and in accordance with Nasdaq Listing Rules 5101, 5110(b) and IM-5101-1, Nasdaq had determined that the Company’s common stock would be delisted from Nasdaq. The Company timely appealed the delisting notice and appeared before the Nasdaq Hearings Panel (the “Panel”) on March 28, 2019. The Panel issued a decision on April 1, 2019 and determined to delist the Company’s common stock from Nasdaq. The suspension of trading will become effective at the open of business on April 3, 2019. The Panel also informed the Company that Nasdaq will complete the delisting by filing a Form 25 Notification of Delisting with the Securities and Exchange Commission, after the applicable appeals periods have lapsed.
The Company does not intend to appeal Nasdaq’s determination. Upon delisting, the Company expects that its common stock will commence trading on the OTC Pink Market, on April 3, 2019 under the symbol “ACETQ.” The transition does not affect the Company’s operations and does not change reporting requirements under SEC rules.

#AACR: Vaccibody, Nektar Present New Preclinical Data from Collaboration

Vaccibody AS and Nektar Therapeutics (Nasdaq: NKTR) today announced the presentation of new preclinical data for VB10.NEO, a personalized neoantigen cancer vaccine, combined with bempegaldesleukin (NKTR-214 or bempeg), a CD122-preferential IL-2 pathway agonist. These data were presented today in a poster session at the American Association for Cancer Research (AACR) Annual Meeting 2019.
‘We are excited to present these novel preclinical data that show combining bempeg with VB10.NEO synergize to increase both the breadth and the depth of the neoantigen-specific immune response. These unique and non-overlapping mechanisms produced an expansion of the VB10.NEO elicited neoantigen-specific T cells and demonstrated enhanced anti-tumor efficacy in mice. We look forward to evaluating this novel immuno-oncology combination in a clinical study in patients with advanced or metastatic squamous cell carcinoma of head and neck later this year,’ said Agnete B. Fredriksen, Ph.D., Vaccibody’s President and Chief Scientific Officer.

Supernus Announces Webcast of Investor Day on April 16, 2019

Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, today announced that it will host and webcast an Investor Day on Tuesday, April 16, 2019.
During the meeting, members of Supernus’ senior management team will provide a detailed discussion of the Company’s clinical programs, including SPN-810 for the treatment of Impulsive Aggression in ADHD and results of its Phase III clinical program of SPN-812 for the treatment of ADHD, and an assessment of their market opportunity. In addition, key thought leaders will share their perspectives on the current treatment paradigms, unmet medical needs, and the Company’s clinical development programs.
Presentation Date: Tuesday, April 16, 2019
Time: 8:00 a.m. ET (registration); 8:30 a.m. to 12:00 p.m. ET (presentation)
Place: Lotte New York Palace, New York City
To register to attend the event please contact Brandon.Weiner@Westwicke.com or (443) 450-4190.
A live webcast of the presentation can be accessed by visiting ‘Events & Presentations’ in the Investors section on the Company’s website at www.supernus.com. An archived replay of the webcast will be available on the Company’s website.

Esperion Publishes Bempedoic Acid Study 3 Results

– Study 3 Demonstrated Bempedoic Acid Significantly Lowered LDL-Cholesterol and Reduced hsCRP in Patients Considered Statin Intolerant –– Over 24-Weeks, Bempedoic Acid Was Observed to be Safe, Well-Tolerated, and the Muscle-Related Adverse Event Rate Did Not Differ from Placebo –– Bempedoic Acid Is an Oral, Once-daily ATP Citrate Lyase (ACL) Inhibitor that Reduces Cholesterol and Fatty Acid Synthesis in the Liver –– Research by Ulrich Laufs, MD, PhD published in the Journal of the American Heart Association –
Esperion (NASDAQ:ESPR) announced today that results from the 345 patient, 24-week, Phase 3, double-blind, placebo-controlled study of bempedoic acid (CLEAR Serenity, also known as Study 3) were published today in the Journal of the American Heart Association (JAHA). Bempedoic acid is being developed as a complementary, cost-effective, convenient, once-daily, oral therapy for the treatment of patients with elevated low-density lipoprotein cholesterol (LDL-C).  Bempedoic acid and the bempedoic acid / ezetimibe combination tablet new drug applications have been submitted to the United States Food and Drug Administration, as well as are under regulatory review for marketing authorization by the European Medicines Agency.
Study 3 evaluated the efficacy, safety, and tolerability of bempedoic acid 180 mg versus placebo in 345 patients with hypercholesterolemia and considered statin intolerant (history of intolerance to at least two statins).
The JAHA publication highlights results from the primary efficacy endpoint of LDL-C lowering at 12-weeks and key secondary endpoints of safety and tolerability over 24-weeks, including that bempedoic acid (BA):
  • significantly lowered LDL-cholesterol by 21 percent;
  • significantly reduced high-sensitivity C-reactive protein (hsCRP), an important marker of the underlying inflammation associated with cardiovascular disease, by 25 percent;
  • was observed to be safe and well-tolerated;
  • did not induce muscle symptoms in statin intolerant patients compared with placebo (BA 12.8% vs placebo 16.2%);
  • showed an adverse event rate of 64.1% compared with a placebo event rate of 56.8%, a serious adverse events rate of 6.0% compared with a placebo event rate of 3.6%, with no serious adverse events considered related to study medication;
  • showed numerically fewer new-onset or worsening of diabetes compared with the placebo group (BA 2.1% vs 4.5% placebo)

Guardant Health says draft of LCD may expand Guardant360 Medicare coverage

On March 28, Guardant Health announced that Palmetto GBA, a Medicare Administrative Contractor, has posted a draft local coverage determination, LCD, that, if implemented, would expand Medicare coverage of the company’s Guardant360 assay from advanced non-small cell lung cancer, NSCLC, to over a dozen advanced solid tumor cancer types with guideline-recommended genomic targets.The draft LCD would apply to advanced cancer patients who are covered by Medicare for next-generation sequencing of tumor tissue, but have insufficient or unavailable tissue samples and are candidates for FDA-approved treatment that is recommended by the guidelines of the National Comprehensive Cancer Network as category 1 or 2A. These cases may comprise a significant percentage of advanced cancers, especially those that have spread to the deep viscera, bone, or brain. Palmetto GBA is expected to finalize and implement the draft LCD after soliciting public comments. There can be no assurances that Palmetto GBA will finalize and implement the draft LCD.
https://thefly.com/landingPageNews.php?id=2887033