Eli Lilly, Novo Nordisk weight-loss drugs could be blockbusters, Barron's says » 09:1408/1308/13/22
New weight-loss drugs,…
New weight-loss drugs, known as incretins, from Eli Lilly (LLY) and Novo Nordisk (NVO) have show striking results in studies. If insurers step up to back them, the drugs - and the stocks - could take off, Bill Alpert writes in this week's edition of Barron's. If every hefty American got treated at these drugs' current prices, the annual market for incretins would be a trillion dollars. Insurers can't afford that, of course, and access to the new drugs is highly restricted. But there's plenty of room for prices to come down and still reward Novo and Lilly shareholders, the author notes. Reference Link
What You Missed On Wall Street This Morning » 12:1108/1208/12/22
RIVN, ILMN, JNJ, TOST, LAW, LFC, PTR, SNP, ACH, SHI, LNG, AIV, HSBC, NVS, LXRX, GWH, LZ, PAYO, CERT, SMRT, MKFG, OLO, BR, SPB, HNST, VERO, ELF, SNOW, CRM, OKTA, WDAY, CIEN, IIVI, SNY, SIX
Get caught up quickly on…
Sanofi may not be liable for any Zantac litigation damages, says JPMorgan » 07:4008/1208/12/22
SNY, GSK, HLN, PFE
JPMorgan analysts Richard…
JPMorgan analysts Richard Vosser and James Gordon note that shares of GSK plc (GSK), Sanofi (SNY), Haleon (HLN) and Pfizer (PFE) have lost a combined market cap of $44B week to date, which they attribute largely to concerns around potential liabilities related to Zantac litigation. They believe the magnitude of this week's market cap hit "likely exceeds even a worst-case scenario" and also believe the market has not fairly attributed any potential Zantac liability between the various companies involved, the analysts tell investors. GSK is likely to have the clearest evidence linking Zantac use to individual named patients given that it sold the product on a prescription basis from 1983, but they still see this week's $12B hit to the company's market cap as a "potential over-reaction." Still, Vosser and Gordon state in their note that they don't see the GSK overhang shifting ahead of the first bellweather case being heard this coming February. In contrast, they believe it is possible that Sanofi may not be liable for any litigation damages given the company's indemnification agreement with Boehringer that is currently under arbitration. Even in the event Sanofi is not fully indemnified, their exposure via OTC sales would likely be lower than GSK and the company's $16.5B loss in market cap this week means an "overly bearish Zantac outlook is now likely priced in," the analysts said. The firm has an Overweight rating on Sanofi shares and a Neutral rating on GSK.
Pfizer reports 'positive' results from Phase 3 study of 20vPnC » 06:4708/1208/12/22
Pfizer announced positive…
Pfizer announced positive top-line results from its pivotal U.S. Phase 3 study in infants evaluating its 20-valent pneumococcal conjugate vaccine candidate, 20vPnC, for the prevention of invasive pneumococcal disease caused by the 20 Streptococcus pneumoniae serotypes contained in the vaccine for the pediatric population. The study had two co-primary objectives, associated with immunogenicity responses one month after the third and fourth doses of the four-dose vaccination series, respectively: non-inferiority of the percentage of participants with predefined serotype-specific immunoglobin G concentrations after Dose 3 and NI of IgG geometric mean concentrations after Dose 4. All 20 serotypes met the co-primary objective of NI of IgG GMCs after Dose 4. Fourteen of the 20 serotypes met the co-primary objective of NI of the percentage of participants with predefined IgG levels after Dose 3 (two serotypes missed by a wider margin while four narrowly missed), and all serotypes met noninferiority for the key secondary objective of IgG GMCs after Dose 3. All 20 serotypes elicited robust functional responses and increases in antibody responses after Dose 4, with the totality of data supporting the potential benefit of all serotypes in this 20-valent vaccine candidate. Overall, the safety profile of the 20vPnC candidate was consistent with Prevnar 13 given in the same schedule. A similar percentage of infants receiving either vaccine experienced local reactions (pain at the injection site, redness, and swelling), fever, and other systemic events. The study also met non-inferiority objectives for responses to co-administered routinely used pediatric vaccines. Based on the totality of positive safety and immunogenicity data, Pfizer plans to submit a supplemental Biologics License Application by the end of this year, subject to discussions with the U.S. FDA. Pfizer will seek to present and publish outcomes from this clinical trial at a future date once safety and immunogenicity data have been fully analyzed. Additional top-line results from other pediatric 20vPnC clinical trials are expected to read out in the second half of 2022, with discussions with other regulatory bodies planned once those pivotal data become available.
Haleon says it is not a party to any Zantac claims » 17:2208/1108/11/22
HLN, GSK, PFE
Haleon (HLN) released a…
Haleon (HLN) released a statement noting the recent volatility in its share price and is aware of market speculation on Haleon's potential liability in respect of Zantac product liability litigation. "Haleon is not aware of any material developments in relation to the Zantac litigation since the Haleon prospectus was issued on 1 June 2022," the company said. "Haleon is not a party to any of the Zantac claims. Haleon never marketed Zantac in any form in the U.S. Haleon is not primarily liable for any OTC or prescription claims. To the extent GSK (GSK) and/or Pfizer (PFE) are held liable in respect of OTC Zantac during the periods outlined below, Haleon may be required to indemnify GSK and/or Pfizer, only if the following conditions are met: GSK and/or Pfizer are unable to recover in respect of OTC Zantac from any third parties who are ahead of Haleon and who have given indemnities under previous transfers of rights to OTC Zantac; and Haleon is determined to be liable under the indemnification provisions among Haleon, Pfizer and GSK."
Two died from acute liver failure after use of Novartis' Zolgensma, STAT says » 16:0408/1108/11/22
Novartis this week began…
Novartis this week began notifying physicians and payers about the deaths of two children from acute liver failure over the past few months in Russia and Kazakhstan after they were administered the gene therapy Zolgensma, reported STAT News' Ed Silverman. Reference Link
Perrigo, Pfizer appear to have manageable Zantac exposure, says JPMorgan » 14:5008/1108/11/22
PRGO, PFE, SNY, GSK, HLN
JPMorgan analyst Chris…
JPMorgan analyst Chris Schott notes the refocus on Zantac liability that has emerged this week, and driven shares of GSK plc (GSK) and Sanofi (SNY) lower, and says he has been getting a number of questions on potential implications within his coverage, namely regarding Perrigo (PRGO) and Pfizer (PFE). As a store brand manufacturer, Perrigo's preemption and HatchWaxman defenses are "very strong," the company has been dismissed from one federal MDL litigation and is not named in the upcoming Madison IL trial, so he does not see Zantac litigation as a significant risk for Perrigo, Schott tells investors. Pfizer sold its rights to Zantac in 2006 and appears to be "at least partially indemnified" from any liability here by Haleon (HLN), said Schott, who contends that the company's loss of about $10B in market cap on this issue "seems overdone" relative to Pfizer's potential exposure. Schott has an Overweight rating on Perrigo shares and a Neutral rating on Pfizer.
FDA grants regular approval to Novartis' capmatinib for metastatic NSCLC » 13:5308/1108/11/22
On August 10, The FDA…
On August 10, The FDA granted regular approval to capmatinib, marketed as Tabrecta by Novartis, for adult patients with metastatic non-small cell lung cancer, or NSCLC, whose tumors have a mutation leading to mesenchymal-epithelial transition, or MET, exon 14 skipping, as detected by an FDA-approved test. Previously, on May 6, 2020, the Food and Drug Administration granted accelerated approval to capmatinib for the same indication.
Renewed Zantac litigation concerns sinking these big-cap drugmakers » 13:3508/1108/11/22
GSK, SNY, HLN, PFE
Shares of GSK plc (GSK),…
Sanofi says 'confident in its legal defenses' related to U.S. Zantac litigation » 12:3008/1108/11/22
SNY, GSK, PFE
Sanofi issued the…
Sanofi issued the following media update: "In response to the recent highly speculative news flow regarding the U.S. Zantac litigation at a time when there have not been any material developments, Sanofi remains confident in its legal defenses and wishes to make the following statement, consistent with what has been disclosed previously: On September 13, 2019, FDA issued a statement alerting the public that some ranitidine medicines, including over-the-counter Zantac, contained a nitrosamine impurity called N-nitrosodimethylamine, or NDMA, at low levels. NDMA is a known environmental contaminant found in drinking water, soil, and common foods, including meats, dairy products, and vegetables. People are routinely exposed to small amounts of NDMA every day. FDA subsequently announced that its preliminary testing showed NDMA levels exceeded FDA's allowable limit in some of the samples it tested. Upon receipt of this information, however, Sanofi quickly mobilized, ran additional confirmatory testing, and out of an abundance of caution issued a voluntary recall of all ranitidine Zantac OTC products in the U.S. and Canada. Since 2019, the medical, scientific, and regulatory communities have extensively evaluated the safety of Zantac's active ingredient ranitidine, and the data shows there is no evidence of consumer harm from real-world use of Zantac. Over time, both FDA and the European Medicines Agency have evaluated the available data and found no evidence that ranitidine causes cancer. Regardless of the scientific evidence, within days of FDA's 2019 announcement, purported class actions and personal injury lawsuits were filed in US courts, seeking economic damages or alleging that Zantac caused various cancers. However, given that Sanofi acted responsibly at all times and the lack of scientific support for plaintiffs' claims, Sanofi is fully confident in its defenses to the litigation. Sanofi stands by the safety of the medicine today. Importantly, Sanofi acquired the OTC rights to Zantac less than three years before these lawsuits commenced, and after the medicine had been on the market for more than 35 years. In addition to Sanofi, three other companies that marketed Rx and/or branded OTC Zantac over time -- GSK, Pfizer, and Boehringer Ingelheim -- are also named as defendants in these actions. Other additionally named defendants have included dozens of generic manufacturers, retailers, and pharmaceutical distributors. The first trial that may involve Sanofi as a defendant is currently scheduled for February 2023 as a part of the California state court proceedings. Sanofi is not a defendant in many of the other cases currently set for trial. Sanofi's sales of Zantac account for only a very small percentage of the product's total sales over the 35+ years that Rx and OTC Zantac was available. Potential historical brand liability was not all passed to Sanofi upon its acquisition of Zantac. Sanofi acquired the marketing rights to Zantac from Boehringer Ingelheim in 2017. Boehringer Ingelheim continued to manufacture Zantac during the period Sanofi marketed the product. As to the respective indemnification rights and obligations of Sanofi in the context of its acquisition of the product from Boehringer Ingelheim, those obligations are being disputed between the parties in the arbitration. The arbitration award is expected to be rendered around year-end 2022. Regardless of the arbitration outcome, the legal defenses in the US litigation are strong. As of August 1, 2022, Sanofi was aware of approximately 2,850 personal injury plaintiffs across both state and federal jurisdictions with filed cases naming Sanofi in addition to other defendants. When factoring in additional Zantac cases that do not involve Sanofi, Sanofi is aware of approximately 3,450 total personal injury plaintiffs across all jurisdictions. There are other potential personal injury claimants who, in lieu of filing a court case, have instead joined a registry of "unfiled" claims established by the federal MDL court. The data on these potential cases remain preliminary and unverified and subject to change. It remains unknown how many unfiled claimants who have participated in the Registry may file suit, or whether any of those claimants will name Sanofi as a defendant in any such suits. Over time, the number of unfiled claims alleging either Rx and/or OTC use and implicating a variety of defendants in these actions has exceeded 150,000 - a significant number of these claims, however, do not implicate Sanofi. The science does not support the plaintiffs' claims in this litigation. There is no reliable evidence that Zantac causes any of the alleged injuries under real-world conditions, and Sanofi remains fully confident in its defenses. Given the strength of our case and the uncertainty of future proceedings no contingencies have been established." Reference Link