|Over a week ago|
BMO Capital to hold a virtual conference » 08:4106/2306/23/20
ANTM, IMUX, SRRK, EHC, FLXN, REGN, SLGL, MORF, MNK, ETTX, AGTC, HZNP, BBIO, AQST, BTAI, CNC, LNTH, SDGR, SCPH, PHAT, HUM, HARP
Prescriptions for Success…
Prescriptions for Success Healthcare Virtual Conference will be held on June 23 at 9 am. Webcast Link
Sell Mallinckrodt, buy Endo with opioid risk coming back, says Citi » 07:0606/1706/17/20
Opioid risk is coming…
Opioid risk is coming back after the office of the New York attorney general affirmed that pre-trial proceedings are on schedule to be completed by August 4, Citi analyst Navann Ty tells investors in a research note. The New York opioid trial was set to begin on March 20, but was delayed because of COVID-19, the analyst points out. Ty remains Buy on Endo (ENDP), believing the "low opioid settlements to date and their rationale may help with future negotiations." The analyst expects penalties to not exceed low-three digit million. Ty recommends selling shares of Mallinckrodt (MNK). Absent a successful appeal, the Centers for Medicare and Medicaid Services ruling may lead to rescinding of the agreed-in-principle opioid settlement, which may threaten Mallinckrodt's continuation as a going concern, says the analyst.
Mallinckrodt to proceed with appeal despite court decision denying injunction » 10:5406/1506/15/20
Mallinckrodt announced its disappointment with the U.S. Court of Appeals for the District of Columbia decision to deny its request for a temporary injunction preventing the U.S. Centers for Medicare and Medicaid Services, or CMS, from enforcing a change in Medicaid drug rebate calculation for Acthar Gel. Mallinckrodt said in a release, "Mallinckrodt had asked for the temporary injunction as it appeals a lower court ruling that allowed CMS to reset the base date average manufacturer price, or AMP. The Appeals Court also ordered an expedited briefing and oral argument schedule that will likely lead to fall oral arguments, and potentially a ruling by end of year. As a result of today's appeals court ruling, Mallinckrodt will change the base date AMP for Acthar Gel, as directed by CMS. The effect of the change is an immediate recognition of retroactive non-recurring charges (estimated at approximately $650 million through mid-June) and the prospective loss of Acthar Medicaid net sales, which has historically contributed to Acthar Gel net sales of $90 to $100 million annually. The company will continue to appeal the March 16 ruling by the U.S. District Court for the District of Columbia that upheld CMS' position. Barring other arrangements, the cash payments for retroactive Medicaid rebate charges will be processed over time, in accordance with the normal rebate payment schedule, and the company expects the cash outlays will most likely commence in the fourth quarter of 2020. Despite the ruling, Mallinckrodt remains committed to ensuring that Medicaid patients have access to Acthar Gel." Mallinckrodt Chief Legal Officer Mark Casey said, "We are disappointed in the appeals court decision not to issue a temporary injunction to prevent CMS from enforcing this change in Medicaid rebate calculations while our case is still under appeal. We will continue our appeal, which could be decided as early as end of year, and strongly believe that the District Court misinterpreted the statute that governs the Medicaid drug rebate program and failed to hold CMS accountable to the Administrative Procedure Act. CMS twice confirmed in writing its approval of the Acthar Gel Medicaid rebate calculation in use today, before it later reversed its position without giving fair notice or any clear legal basis for doing so."
Mallinckrodt announces terlipressin medical chart study published » 06:5606/1106/11/20
Mallinckrodt announced publication of findings from a medical chart study to assess the real-world use of terlipressin and other vasopressors in hospitalized patients with hepatorenal syndrome type 1, or HRS-1, an acute and life-threatening syndrome involving acute kidney failure in people with cirrhosis. The study, funded by Mallinckrodt, found that terlipressin was associated with an improvement in kidney function among HRS-1 patients as measured by a reduction in serum creatinine, or SCr. The results of the study were published in the peer-reviewed journal Alimentary Pharmacology and Therapeutics. Mallinckrodt is investigating terlipressin for the treatment of HRS-1 in the U.S. Its safety and effectiveness have not yet been established by the FDA. Medical records of 250 adult patients with HRS-1 from 26 centers in the U.K. were reviewed, 225 of whom were treated with vasopressor therapy. The majority of patients were treated with terlipressin with a median duration of therapy of six days, in line with European Association for the Study of the Liver, or EASL, guidelines recommending terlipressin for first-line use in patients with HRS-1. A complete response was observed in 50% of patients treated with terlipressin and 23% of those treated with other vasopressors. Overall response, as measured by a complete response or partial response, was demonstrated in 73% of patients treated with terlipressin and 59% treated with other vasopressors. In addition, lower SCr at the time of treatment initiation was associated with higher complete response rates.
Mallinckrodt completes rolling submission of BLA of StrataGraft to FDA » 15:3906/0906/09/20
Mallinckrodt announced earlier that Stratatech, a Mallinckrodt company, has completed its rolling submission of a Biologics License Application, or BLA, to the FDA for StrataGraft, a regenerative skin tissue therapy in development for the treatment of adult patients with deep partial-thickness thermal burns. The company previously announced initiation of the rolling submission in April. StrataGraft skin tissue is an investigational product, and its safety and effectiveness have not yet been established by the FDA.
|Over a month ago|
Mallinckrodt to appeal District Court ruling » 06:5706/0106/01/20
Mallinckrodt announced that it will appeal a ruling by the U.S. District Court for the District of Columbia in a lawsuit filed by its subsidiary, Mallinckrodt ARD LLC, against the U.S. Department of Health and Human Services, or HHS, and the Centers for Medicare and Medicaid Services, or CMS, regarding the Medicaid drug rebate calculation for Acthar Gel. "The District Court denied the Company's request to reconsider its previous decision that declined to declare unlawful an action by CMS to effectuate a change in the base date average manufacturer price used to calculate those rebates. The Court also denied the company's request that it temporarily block CMS' action pending an appeal. The Company will immediately appeal to the U.S. Court of Appeals for the D.C. Circuit, where it will seek to overturn the lower court decision and temporarily block CMS action during the appellate process," the company said in a release. "We are disappointed by the Court's unwillingness to reconsider its previous decision. We believe the Court has misinterpreted the statute that governs the Medicaid drug rebate program and failed to hold the government accountable to a bedrock principle of administrative law that the government must give fair notice and a clear, legal basis for a change in policy, particularly when that policy has been relied upon by a regulated entity such as Mallinckrodt," said Mark Casey, Executive Vice President and Chief Legal Officer of Mallinckrodt. "We plan to immediately appeal to the U.S. Court of Appeals for the D.C. Circuit. Mallinckrodt remains committed to ensuring Medicaid patients have access to Acthar Gel therapy for the long term." The company added, "In asking the Court to temporarily block CMS' action, the Company described the risk that allowing CMS to move forward could inhibit the Company's ability to fund research and development activities, including COVID-19 related activities, and effectuate its opioid settlement, among other issues. As previously announced, in the absence of court intervention, the company would pay roughly $640 million in retroactive non-recurring charges from January 1, 2013 to March 27, 2020, and the annualized prospective change to the Medicaid rebate calculation would reduce Acthar Gel net sales by roughly $90 million to $100 million. Under a previous agreement with the government, CMS has agreed to not enforce a change in the Medicaid drug rebate calculation for Acthar Gel until at least June 14."
Mallinckrodt downgraded to Underweight on unclear turnaround at JPMorgan » 06:1105/1905/19/20
JPMorgan analyst Christopher Schott downgraded Mallinckrodt to Underweight from Neutral without a price target. With the fundamental story "looking increasingly challenged" amid Acthar, Inomax and Ofirmev erosion, and multiple legal challenges facing the business, Mallinckrodt does not have a clear path to a turnaround, Schott tells investors in a research note.
Mallinckrodt downgraded to Underweight from Neutral at JPMorgan » 05:3205/1905/19/20
JPMorgan analyst Christopher Schott downgraded Mallinckrodt to Underweight from Neutral.
Fly Intel: Pre-market Movers » 09:0805/0505/05/20
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Check out this morning's…
Mallinckrodt down 7.6% after reporting Q1 results 08:0905/0505/05/20