Novartis’ Gilenya repels generic rivals⁠—for now⁠—after federal injunction

Novartis’ multiple sclerosis med Gilenya is facing U.S. generic challengers on all sides to its blockbuster sales, and the company hoped a court order could stave them off. The Swiss drugmaker got what it asked for—and it might just keep the med at the top of Novartis’ bestseller list, at least for now.

A suite of Gilenya competitors, including Mylan, Dr. Reddy’s Laboratories and Aurobindo Pharma, have been barred from immediately launching generic versions of the drug after a U.S. district judge in Delaware issued a temporary injunction Monday at Novartis’ request. The judge, Leonard P. Stark, said allowing the generics to launch would compromise Gilenya’s ongoing patent litigation in federal court and potentially cost Novartis its $1.71 billion U.S. market share before a decision is reached.

“After what might be as long as a year of generic competition by the time we get to trial and I get a post-trial opinion done, Novartis will not be able to raise the price back to where it is now, or to where it would have been at that post-trial date in the absence of defendants’ at-risk infringement,” Stark wrote.

The temporary injunction puts a hold on the doomsday clock for Gilenya, which was first approved to treat relapsing-remitting multiple sclerosis (RRMS) in 2010. Gilenya is competing with a growing pack of branded RRMS competitors, including Roche’s hot shot Ocrevus and Merck KGaA’s Mavenclad, which analysts have pegged as a potential blockbuster, among others.

Novartis’ crusade against Gilenya generic challengers began in July 2018 after a U.S. Patent Office decision backed the drug’s patent protection until 2027. The drugmaker filed four lawsuits in federal court to put off generic launches, including the one Stark ruled on Monday, Novartis Pharmaceuticals Corporation v. Accord Healthcare, et al.

The initial patent decision was not only a win for Novartis, but also for Celgene, which was rushing its own MS candidate ozanimod to market to get ahead of the generic wave, and Biogen, which competes in the same indications as Gilenya.

In the meantime, Novartis can rest easy knowing Gilenya grew 4.4% on the year in 2018 and recently added another notch to its belt in October after besting Teva’s Copaxone in a head-to-head study in preventing patient relapses. That win was nothing to shrug at: Gilenya became the first disease-modifying MS drug to top Copaxone in preventing relapses.

That data will also help Novartis stay ahead of its competitors, including newcomer Mavenclad, a drug that’s showing promise despite a black box warning for an increased risk of cancer and birth defects. After failing to get an FDA nod all the way back in 2011, Mavenclad received its RRMS approval in April with blockbuster sales forecasts already teed up. Bernstein analyst Wimal Kapadia, for one, predicted the drug could hit $1 billion in global sales by 2025.

Novartis isn’t pinning all its MS sales hopes on Gilenya, though. It recently scored an approval for Mayzent, a drug specifically approved for the secondary progressive form of the disease and one analyst predicts will hit blockbuster heights.

https://www.fiercepharma.com/pharma/novartis-gilenya-staves-off-generic-challengers-after-federal-injunction

Bayer Hemophilia B treatment gets orphan drug designation

Bayer HealthCare (OTCPK:BAYRY) has received orphan drug designation for its use of human monoclonal IgG2 antibody against tissue factor pathway inhibitor, for the treatment of Hemophilia B.

The company had received a similar designation in March for using the approach to treat Hemophilia A.

https://seekingalpha.com/news/3473774-bayer-hemophilia-b-treatment-gets-orphan-drug-designation

Glucose meters top FDA list of secret device filings

Blood glucose meters and test strips made by the Johnson & Johnson subsidiary LifeScan accounted for the largest number of adverse-event reports that were filed without public disclosure in a U.S. Food and Drug Administration program that has since been closed down.

An initial review of data released Friday by the FDA shows LifeScan filed 2.3 million secret adverse event reports regarding its SureStep Flexx glucose meter and related diabetes products intended to be used in hospitals between 2006 and 2018.

That was more than 20 percent of the entire dataset released Friday. Spread over 21 different spreadsheets, the previously undisclosed FDA data trove included nearly 6 million reports covering more than 100 different products made by dozens of different companies.

The second-highest total was for dental implants and supplies made by Nobel Biocare, a subsidiary of Washington-based conglomerate Danaher Corp., which logged more than 700,000 adverse event reports between 1999 and 2018.

Analysis of the data is ongoing. Federal law requires the makers of medical devices to file reports with the FDA in situations where the device caused or may have caused health problems in a patient, or when a device malfunctions in a way likely to happen again. The filing of a report is not a definitive conclusion that the device caused the underlying problem.

However the FDA quietly gave out more than 100 exemptions since 1999, covering between 7 events and 2.3 million events each, in situations where the agency said the problems were already well-known. The exemptions allowed manufacturers to file spreadsheets of events through a program known as Alternative Summary Reporting (ASR).

For example, the FDA in 2014 allowed Medtronic to file summaries of more than 1,000 reports of patient harm following the use of its controversial Infuse bone-growth product. Although the filings were more than five years late, and included four patient deaths, the FDA decided the potential risks described the reports were already known to the medical community by the time they were submitted. The deaths were viewed as unrelated to the procedures.

The FDA also allowed the makers of surgical staplers to file more than 56,000 adverse events between 2011 and 2018, though the agency is now considering moving the devices to a higher risk category based partly on a review of the entire dataset.

And the agency has collected more than 350,000 reports of problems since 2009 following the use of breast implants, which have come under increasing scrutiny after years of complaints about health problems that critics say have been ignored by authorities.

Although they’re public information, ASR filings were previously only available through Freedom of Information Act requests, which can take a year or more to process. All 6 million or so files were released at the same time on Friday.

Taken as a whole, the data show that the ASR program grew gradually between 1999 and 2005, and then spiked in 2006 with the approval of the LifeScan exemption. The program peaked in use in 2016, with more than 528,000 adverse event reports filed that year by 68 manufacturers and their subsidiaries.

The FDA said the decision was made in 2017 to phase out the program, and it was formally ended this month with the revocation of the 13 ASRs that were still active, covering dental implants, implantable cardiac defibrillators and pacemaker electrodes.

All of the ASR data can be accessed, via CSV files, at an FDA web page.

https://www.marketscreener.com/JOHNSON-JOHNSON-4832/news/Johnson-Johnson-Glucose-meters-top-list-of-secret-device-filings-28813260/

Majority of legal claims tied to emergency department care due to delayed diagnosis

More than half the allegations filed against hospitals due to emergency department care come from cases where there is a delay or failure to make a diagnosis, according to a new report from medical professional liability insurance provider Coverys.

The Boston-based insurance provider analyzed more than 1,300 emergency department-related closed medical professional liability claims across the five-year period between 2014 and 2018. Examining the root causes of claims occurring in the ED, delay of diagnoses—including the lack of an appropriate patient/family history and physical as well as the inappropriate ordering of diagnostic tests—was among the greatest vulnerability during the emergency department episode of care.

“The ED is a really unique environment. They don’t have the luxury of having multiple visits with patients where they get to know the patient, where they can really think about the diagnosis in a non-urgent type of a situation, Ann Burke, who is the director of risk management at Coverys and a lead author on the report, told FierceHealthcare. “Basically they have one chance to get it right.”

That means, healthcare providers are going to do a focused evaluation and physical that is complaint-driven given the circumstances surrounding that patient’s presentation to get to that diagnosis as quickly as possible, either ruling out or confronting critical or life-threatening needs, she said.

According to the report, about half of the diagnosis-related allegations identified the point at which they were most vulnerable was at the initial history and physical and a quarter of those claims involved the ordering of a diagnostic test.

Cardiac and cardiovascular conditions — such as heart attacks, aortic aneurysms, aortic dissections or ruptures —triggered the most ED-related liability claims, Burke said. Infections, including sepsis, meningitis and pneumonia were also areas that trigger more ED-related claims, she said.

“Those are areas where organizations, leadership, the ED department can really start their focus on that part of the patient safety movement,” Burke said.

The report also found:

• 32% of malpractice allegations in the ED involve permanent injuries and 38% involve grave injury or death.
• 56% of ED claims involve allegations of diagnostic error, while 20% of ED claims allege an issue with the medical treatment itself.
• 44% of diagnosis-related ED claims allege failure during the initial history and physical evaluation stage, while 27% of diagnosis-related ED claims involve issues related to ordering diagnostic/lab tests.
• 49% of medication-related allegations in the ED involve three types of drugs: antibiotics, opioids and anticoagulants.
• 44% of ED-related claims cited clinical judgment as a factor.

To reduce diagnostic risks in the emergency department, the report recommends practitioners focus on three key areas including history and physical examination, the diagnostic decision-making process and ensuring the patient evaluation is ongoing throughout the ED episode of care.

“We believe our signal data provides guidance and insight into patient safety and we would urge and encourage all to look at the signals and take action within their organizations,” Burke said.

https://www.fiercehealthcare.com/hospitals-health-systems/more-than-half-malpractice-cases-due-to-failure-to-diagnose-emergency

Morgan Stanley: Medtronic’s $4B Financing Could Be 10-Cent EPS Tailwind

Medtronic PLC MDT 0.25%’s announcement that it is commencing an offer for more than $4 billion in debt securities should help the company manage its tax headwind, according to Morgan Stanley.

The Analyst

David Lewis maintained an Equal-weight rating on Medtronic with a $100 price target.

The Thesis

Medtronic announced Monday that it will commence an offer for up to $4.175 billion in outstanding debt securities; Lewis said the offer should be leverage neutral. (See his track record here.)

The financing could amount to as much as a 10-cent tailwind to EPS in fiscal 2020, or nearly 2% EPS growth if the company is able to complete the tender for the full amount, the analyst said.

The medical device company’s most recent guidance included $200 million to $210 million in quarterly interest expenses, Lewis said. The offer could bring interest below $175 million, boosting Medtronic’s EPS, he said.

“Management could also selectively reinvest some of these savings,” the analyst said.

https://www.benzinga.com/analyst-ratings/analyst-color/19/06/13979542/morgan-stanley-medtronics-4b-financing-could-be-10-cent-eps-tailwind

Almirall Exercises Licensing Option for Dermira’s Atopic Dermatitis Drug

Spain-based Almirall S.A. announced it will exercise its option to license the rights to Dermira, Inc.’s Phase III-ready lebrikizumab for the treatment of atopic dermatitis in Europe. The news caused shares of Dermira to jump more than 10% in premarket trading, wiping out Monday’s losses.

Almirall will develop and commercialize lebrikizumab, a novel, injectable, humanized monoclonal antibody designed to bind interleukin-13 (IL-13), in Europe for atopic dermatitis, as well as other unnamed indications, the company said this morning. IL-13 is believed to be a central pathogenic mediator that drives multiple aspects of the pathophysiology of atopic dermatitis.

Tom Wiggans, chief executive officer of Dermira, said his company was excited about the partnership and the chance to potentially bring the experimental treatment to patients in Europe through the partnership with Almirall. The two companies first entered into an agreement earlier this year. In February, Almirall paid Dermira $30 million to license the drug. Dermira licensed lebrikizumab from Roche in 2017.

Under the new agreement, Almirall will pay Dermira an additional $50 million and California-based Dermira will be eligible to receive additional payments upon the achievement of certain milestones, including $30 million in connection with the initiation of certain Phase III clinical studies. For Dermira, the deal could generate up to $85 million upon the achievement of regulatory milestones and the first commercial sale of lebrikizumab in Europe. Dermira will also be entitled to receive milestone payments upon the achievement of certain thresholds for net sales of lebrikizumab in Europe, as well as royalty payments representing percentages of net sales that range from the low double-digits to the low twenties.

Almirall’s decision to exercise its options follows positive topline results reported by Dermira in March from a Phase IIb dose-ranging study that showed all three doses of lebrikizumab met the primary endpoint. The medication demonstrated dose-dependent improvements across a range of measures characterizing the signs and symptoms of moderate-to-severe atopic dermatitis, including itch and skin inflammation, compared to placebo. The safety profile remained consistent and Dermira said the findings suggest lebrikizumab has the potential to be a best-in-disease therapy for people living with moderate-to-severe atopic dermatitis. In the U.S., Dermira plans to initiate Phase III development of lebrikizumab by the end of 2019.

“The unique characteristics of lebrikizumab and positive findings observed in our Phase IIb dose-ranging study suggest that we have the potential to offer people living with moderate-to-severe atopic dermatitis, and the healthcare practitioners who care for them, a differentiated treatment option that delivers a compelling combination of safety, efficacy, tolerability, convenience and ease of use,” Wiggans said in a statement.

Peter Guenter, Almirall’s chief executive officer, said his company is excited about its collaboration with Dermira on the lebrikizumab clinical development program. In Europe, Almirall believes lebrikizumab could achieve peak sales of around €450 million (about $512 million).

“This transaction reinforces our shared commitment to the dermatology community and supports our vision of offering truly meaningful, new treatment advances to people living with chronic, life-altering skin conditions,” Guenter said in a statement.

https://www.biospace.com/article/predicting-500-million-in-european-sales-almirall-exercises-licensing-option-for-dermira-s-atopic-dermatitis-drug/

CMS gives state Medicaid programs $50M for substance use disorder treatment

CMS will award 18-month planning grants totaling $50 million to at least 10 state Medicaid agencies for proposals that increase the capacity of substance use disorder treatment and recovery services, particularly those that address opioid use.

“CMS is pulling every lever to combat the opioid epidemic and increasing access to treatments for Americans suffering from substance use disorder is essential to addressing this issue,” Kimberly Brandt, CMS’ principal deputy administrator for policy and operations, said in a press release.

States must apply by Aug. 9. CMS plans to select proposals for an 18-month planning phase. When this 18-month period is over, the agency will choose five states to continue in a 36-month demonstration project.

https://www.beckershospitalreview.com/opioids/cms-grants-state-medicaid-programs-50m-for-substance-use-disorder-treatment.html