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Monday, June 24, 2019

Bristol Opdivo Liver Cancer Study Misses Primary Endpoint

Bristol-Myers Squibb NYSE:BMY) today announced topline results from CheckMate -459, a randomized Phase 3 study evaluating Opdivo (nivolumab) versus sorafenib as a first-line treatment in patients with unresectable hepatocellular carcinoma (HCC). The trial did not achieve statistical significance for its primary endpoint of overall survival (OS) per the pre-specified analysis (HR=0.85 [95% CI: 0.72-1.02]; p=0.0752). No new safety signals were observed with Opdivo. The full study results will be presented at an upcoming medical meeting.
While CheckMate -459 did not reach its pre-specified primary endpoint, the results showed a clear trend towards improvement in OS for patients treated with Opdivocompared to sorafenib, a current standard of care.
“We are encouraged by the promising efficacy and safety trends seen with Opdivo in CheckMate -459, especially as HCC is a devastating and difficult-to-treat cancer, for which there have been no significant advances over sorafenib, a standard treatment, in more than a decade,” said Bruno Sangro, M.D., head of the Liver Unit, Clínica Universidad de Navarra, Pamplona, Spain.
Ian M. Waxman, M.D., development lead, Gastrointestinal Cancers, Bristol-Myers Squibb, commented, “We remain confident in the important role of Opdivo for the treatment of patients with HCC and look forward to evaluating insights garnered from this trial with the goal of ensuring patients with liver cancer have the opportunity to achieve the best possible outcomes.”
As part of its broad clinical program, Opdivo is being studied by the company across multiple settings and lines of therapy for HCC, including as monotherapy in the adjuvant setting (CheckMate -9DX [NCT03383458]) and in combination with Yervoy (ipilimumab) for previously treated patients (CheckMate -040 [NCT01658878]). Data from the Opdivoplus Yervoy cohort of CheckMate -040 were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2019. Bristol-Myers Squibb is grateful to the patients, caregivers and investigators involved in our clinical research program.
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Bristol Myers Squibb Provides Update on Pending Merger with Celgene

Bristol-Myers Squibb Company (NYSE: BMY) today provided an update on the approval process and timeline for the Company’s pending merger with Celgene Corporation (NASDAQ: CELG). The Company remains actively engaged in discussions with the U.S. Federal Trade Commission (“FTC”) on the FTC’s continued review of the proposed transaction. To allow the transaction to close on a timely basis in light of concerns expressed by the FTC, the Company is planning the divestiture of OTEZLA® (apremilast).
The divestiture is subject to further review by the FTC and requires that Bristol-Myers Squibb enter into a consent decree with the FTC. Once the FTC accepts the consent order and the other customary closing conditions are satisfied, Bristol-Myers Squibb intends to close the Celgene transaction at the earliest possible date, which it currently expects to be at the end of 2019 or the beginning of 2020. The proceeds of the OTEZLA sale will allow Bristol-Myers Squibb to accelerate its post-closing deleveraging plans.
Bristol-Myers Squibb and Celgene have concluded their pre-notification process with the European Commission, and are pleased to confirm that they have today submitted the formal application for clearance by the European Commission.
The Company commented:
“Bristol-Myers Squibb is committed to working with regulatory authorities around the world on the proposed combination with Celgene. The Company is focused on realizing the promise of the transaction, and is continuing to work to complete the transaction on a timely basis.
“Bristol-Myers Squibb reaffirms the significant value creation opportunity of the acquisition of Celgene. Together with $2.5 billion of cost synergies, a compelling pipeline and a strong portfolio of marketed products, the Company continues to expect growth in sales and earnings through 2025.
“The Company is continuing to develop its promising immunology pipeline asset, tyrosine kinase 2 (TYK2) inhibitor, in several autoimmune diseases, including psoriasis. Bristol-Myers Squibb looks forward to advancing its leadership in core areas of focus, including immunology, and delivering highly innovative medicines that bring meaningful benefits to patients as a combined company.”
Bristol-Myers Squibb and Celgene have received approval for Bristol-Myers Squibb’s acquisition of Celgene from their respective shareholders.
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Axsome Initiates Phase 3 Trial of AXS-05 in Major Depressive Disorder

Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, enrolled the first patient in its GEMINI (Glutamatergic and Monoaminergic Modulation in Depression) study, a Phase 3, randomized, double-blind, placebo-controlled trial of AXS-05 in the treatment of major depressive disorder (MDD). AXS-05 is a novel, oral, investigational NMDA receptor antagonist with multimodal activity. Topline results from the GEMINI trial are anticipated in the second half of 2019.
“Initiation of the placebo-controlled GEMINI Phase 3 trial continues the expedited clinical development of AXS-05 in depression. If successfully developed, AXS-05 has the potential to be the first orally administered NMDA receptor antagonist approved for the treatment of this debilitating condition,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. “Based on the results of our recent FDA Breakthrough Therapy meeting for AXS-05, we believe that either the GEMINI study in MDD or the ongoing STRIDE-1 trial in treatment resistant depression, if positive, would, in conjunction with our previously completed ASCEND trial in MDD, be sufficient to support the filing of an NDA for AXS-05 for the treatment of MDD. We continue to anticipate topline results from both the STRIDE-1 and GEMINI trials in the second half of 2019.”
In March 2019, Axsome received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for AXS-05 for the treatment of MDD.
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Medtronic Cash Tender Offers for up to $4.175B of Outstanding Debt Securities

Medtronic plc (the “Company”) (NYSE:MDT) today announced the commencement of two cash tender offers by its wholly-owned indirect subsidiaries, Medtronic, Inc. (“Medtronic, Inc.”), Medtronic Global Holdings S.C.A. (“MGH”) and Covidien International Finance S.A. (“CIFSA” and, together with Medtronic, Inc. and MGH, the “Offerors”). The first tender offer (the “Any and All Tender Offer”) is for any and all of $1.175 billion total aggregate principal amount of the outstanding senior notes listed in Table 1 below (the “Any and All Notes”), which were issued by Medtronic, Inc. The second tender offer (the “Maximum Tender Offer” and, together with the Any and All Tender Offer, the “Tender Offers”) is for up to $3.0 billion (the “Aggregate Maximum Purchase Price”) combined aggregate purchase price (excluding accrued and unpaid interest to, but not including, the applicable settlement date and excluding fees and expenses related to the Tender Offers) of the outstanding senior notes listed in Table 2 below (the “Maximum Tender Offer Notes” and, collectively with the Any and All Notes, the “Notes”).
The tables below summarize certain information regarding the Notes and the Tender Offers, including the order of priority set forth in Table 2, subject to the Series Tender Caps, if applicable, and the Aggregate Maximum Purchase Price for the Maximum Tender Offer Notes. The Any and All Notes are not subject to a cap on the aggregate purchase price.
Table 1: Any and All Notes
+——–+———+————–+————+———+———+———–+——-+ | | | | | | | | Early | | | | | | U.S. | | |Tender | | | | | Principal |Treasury |Bloomberg| |Payment| |Title of| CUSIP | | Amount |Reference|Reference| Fixed | ((2) | |Security| Numbers |Issuer/Offeror|Outstanding |Security | Page |Spread((1))| (3)) | +——–+———+————–+————+———+———+———–+——-+ |4.125% | | | | 2.375% | | | | | Senior |585055AV8| Medtronic, |$500,000,000| U.S.T. | PX4 | 15 | $30 | | Notes | | Inc. | | due | | | | |due 2021| | | |3/15/2021| | | | +——–+———+————–+————+———+———+———–+——-+ |3.125% | | | | 2.375% | | | | | Senior |585055AX4| Medtronic, |$675,000,000| U.S.T. | PX5 | 15 | $30 | | Notes | | Inc. | | due | | | | |due 2022| | | |3/15/2022| | | | +——–+———+————–+————+———+———+———–+——-+
Table 2: Maximum Tender Offer Notes
+——–+———+————–+————–+———-+————–+———+———+——+——-+ | | | | | | | | | | Early | | | | | |Acceptance| | U.S. | | |Tender | | | | | Principal | Priority | |Treasury |Bloomberg| |Payment| |Title of| CUSIP | | Amount | Level( |Series Tender |Reference|Reference|Fixed | ((2) | |Security| Numbers |Issuer/Offeror| Outstanding | (4)) | Cap |Security | Page |Spread| (3)) | +——–+———+————–+————–+———-+————–+———+———+——+——-+ |6.500% | | | | | | 3.000% | | | | | Senior |585055AQ9| Medtronic, | $182,949,000 | 1 | N/A | U.S.T. | PX1 | 85 | $30 | | Notes | | Inc. | | | | due | | | | |due 2039| | | | | |2/15/2049| | | | +——–+———+————–+————–+———-+————–+———+———+——+——-+ |5.550% | | | | | | 3.000% | | | | | Senior |585055AT3| Medtronic, | $305,910,000 | 2 | N/A | U.S.T. | PX1 | 75 | $30 | | Notes | | Inc. | | | | due | | | | |due 2040| | | | | |2/15/2049| | | | +——–+———+————–+————–+———-+————–+———+———+——+——-+ |4.625% | | | | | | 3.000% | | | | | Senior |585055BU9| Medtronic, |$1,963,341,000| 3 | $100,000,000 | U.S.T. | PX1 | 70 | $30 | | Notes | | Inc. | | | | due | | | | |due 2045| | | | | |2/15/2049| | | | +——–+———+————–+————–+———-+————–+———+———+——+——-+ |4.625% | | | | | | 3.000% | | | | | Senior |585055BD7| Medtronic, | $176,594,000 | 4 | N/A | U.S.T. | PX1 | 75 | $30 | | Notes | | Inc. | | | | due | | | | |due 2044| | | | | |2/15/2049| | | | +——–+———+————–+————–+———-+————–+———+———+——+——-+ |4.500% | | | | | | 3.000% | | | | | Senior |585055AW6| Medtronic, | $128,650,000 | 5 | N/A | U.S.T. | PX1 | 75 | $30 | | Notes | | Inc. | | | | due | | | | |due 2042| | | | | |2/15/2049| | | | +——–+———+————–+————–+———-+————–+———+———+——+——-+ |4.375% | | | | | | 3.000% | | | | | Senior |585055BT2| Medtronic, |$2,381,619,000| 6 | $200,000,000 | U.S.T. | PX1 | 50 | $30 | | Notes | | Inc. | | | | due | | | | |due 2035| | | | | |2/15/2049| | | | +——–+———+————–+————–+———-+————–+———+———+——+——-+ |4.000% | | | | | | 3.000% | | | | | Senior |585055AY2| Medtronic, | $325,024,000 | 7 | N/A | U.S.T. | PX1 | 75 | $30 | | Notes | | Inc. | | | | due | | | | |due 2043| | | | | |2/15/2049| | | | +——–+———+————–+————–+———-+————–+———+———+——+——-+ |3.500% | | | | | | 2.000% | | | | | Senior |585055BS4| Medtronic, |$4,000,000,000| 8 |$1,300,000,000| U.S.T. | PX1 | 40 | $30 | | Notes | | Inc. | | | | due | | | | |due 2025| | | | | |5/31/2024| | | | +——–+———+————–+————–+———-+————–+———+———+——+——-+ |3.625% | | | | | | 2.000% | | | | | Senior |585055BC9| Medtronic, | $850,000,000 | 9 | N/A | U.S.T. | PX1 | 35 | $30 | | Notes | | Inc. | | | | due | | | | |due 2024| | | | | |5/31/2024| | | | +——–+———+————–+————–+———-+————–+———+———+——+——-+ |6.550% | | Covidien | | | | 3.000% | | | | | Senior |22303QAH3|International | $283,536,000 | 10 | N/A | U.S.T. | PX1 | 75 | $30 | | Notes | | Finance S.A. | | | | due | | | | |due 2037| | | | | |2/15/2049| | | | +——–+———+————–+————–+———-+————–+———+———+——+——-+ |3.350% | | Medtronic | | | | 2.375% | | | | | Senior |58507LAC3| Global | $850,000,000 | 11 | N/A | U.S.T. | PX1 | 30 |$30 | | Notes | | Holdings | | | | due | | | | |due 2027| | S.C.A. | | | |5/15/2029| | | | +——–+———+————–+————–+———-+————–+———+———+——+——-+ |3.150% | | | | | | 1.750% | | | | | Senior |585055BR6| Medtronic, |$2,500,000,000| 12 | N/A | U.S.T. | PX1 | 25 | $30 | | Notes | | Inc. | | | | due | | | | |due 2022| | | | | |6/15/2022| | | | +——–+———+————–+————–+———-+————–+———+———+——+——-+ |3.200% | | Covidien | | | | 1.750% | | | | | Senior |22303QAN0|International | $650,000,000 | 13 | N/A | U.S.T. | PX1 | 25 | $30 | | Notes | | Finance S.A. | | | | due | | | | |due 2022| | | | | |6/15/2022| | | | +——–+———+————–+————–+———-+————–+———+———+——+——-+ |2.950% | | Covidien | | | | 2.000% | | | | | Senior |22303QAP5|International | $309,516,000 | 14 | N/A | U.S.T. | PX1 | 25 | $30 | | Notes | | Finance S.A. | | | | due | | | | |due 2023| | | | | |5/31/2024| | | | +——–+———+————–+————–+———-+————–+———+———+——+——-+
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Glenmark: USFDA has issued CRL for Ryaltris

Glenmark Pharmaceuticals Saturday said the US Food and Drug Administration has issued a Complete Response Letter (CRL)regarding the new drug application for Ryaltris.
The CRL cites deficiencies in the Drug Master File pertaining to one of the active pharmaceutical ingredients and in manufacturing facilities, the company said in a regulatory filing.
“We would like to inform you that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application for Ryaltris (olopatadine hydrochloride [665 mcg] and mometasone furoate [25 mcg]), Nasal Spray,” Glenmark Pharmaceuticals said.
“The CRL does not specify any deficiencies with the clinical data supporting the New Drug Application for Ryaltris. We feel confident that we should be able to resolve these issues within the next 6 to 9 months,” it added.
The company said it will continue to pursue regulatory approval for Ryaltris and work closely with the FDA to determine the appropriate next steps.
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FDA orphan status to Mesoblast’s rexlemestrocel-L

The FDA has granted Orphan Drug Designation (ODD) to Mesoblast’s (NASDAQ:MESO) rexlemestrocel-L, for prevention of post-implantation mucosal bleeding in end-stage chronic heart failure (CHF) patients who require a left ventricular assist device (LVAD).
Among the benefits of Orphan Drug status is a seven-year period of market exclusivity for the indication, if approved.
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Trump Expected to Issue Executive Order in Attempt to Lower Health Care Costs

A presidential executive order compelling health care transparency across the healthcare industry is expected to be issued Monday. The order will come about a month after reports first surfaced of the plan.
Late Thursday, the Wall Street Journal reported that President Donald Trump will issue the executive order as part of an effort to drive down health care costs. According to the Journal, the executive order will direct federal agencies to put into place regulations and guidances that “could require insurers, doctors, hospitals and others in the industry to provide information about the negotiated and often discounted cost of care.” The Journal reported that the Trump administration has been planning to fight these measures through the issuance of a Department of Labor rule that would force insurers to publish the negotiated rates they pay for health care services. Additionally, the Department of Health and Human Services has been seeking public comment regarding the rights of patients to see discounted prices ahead of seeking care. Such a rule would force hospitals and other medical practices to publicly disclose the negotiated amounts they charge insurance companies.

The goal of the executive order is to arm patients with pricing data in order to provide them with a greater control over their health care costs, which has become a key political issue ahead of the 2020 presidential election, in large part due to the increasing price of prescription drugs, such as insulin, which saw prices double between 2012 and 2016. In addition to targeting the healthcare providers, the White House also issued an executive order that will force pharmaceutical companies to disclose list pricing of prescription drugs in television advertisements.
The costs of healthcare expected to play a major role in the next election cycle and the Trump administration hopes to use these executive orders as a means to support the president’s bid for re-election. Trump launched his re-election campaign earlier this week.
Citing a survey conducted by the Center for American Political Studies at Harvard and the Harris Poll, the Journal noted that 88% of voters said they “favor a government initiative mandating that insurers, hospitals, doctors and other providers disclose the cost of their services and discounted or negotiated rates.”

As could be imagined, this order is something that industry groups, including insurers and hospitals, have opposed. They claim it could cause prices to actually climb due to the fact that the disclosures could reveal some healthcare groups get larger discounts from insurers than others. Additionally, the healthcare community has argued that individuals are more concerned with their own out-of-pocket expenses, rather than the prices negotiated between insurance companies and medical providers.
As BioSpace previously reported, the White House isn’t the only political entity pushing for greater pricing disclosure. Legislation has been introduced in both chambers of Congress calling for pricing disclosure. Recently, a bipartisan bill was introduced in the U.S. Senate by Sens. Bill Cassidy, a Louisiana Republican., and Michael Bennet, a Democrat from Colorado that “would end contractual gag clauses between providers such as hospitals and insurers that can restrict the ability of patients to get cost information.” In May, Sen. Ron Wyden, an Oregon Democrat, introduced a bill that would force insurers to tell patients what their out-of-pocket expenses would be for various medications or in-network medical procedures.
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