Other Share-Based Awards and Cash-Based Awards, (a) Other Share-Based Awards. (o) Employee means an employee of Amcor. In summary, a strong recommendation implies that most individuals in this situation would want the recommended course of action and only a small proportion would not, while a conditional recommendation means that the majority of individuals in this situation would want the suggested course of action but many would not. Of note, the determination of immunocompromise in the phase III trials was made by study investigators based on medical history or use of immunosuppressive therapy without further clarifications. The partial exercise of an Option shall not cause the expiration, termination or cancellation of the remaining portion thereof. Absolute rate reduction for bezlotoxumab recipients was highest in patients with greater than or equal to 3 risk factors (24.8%; 95% CI: 39.1% to 9.3%), 2 risk factors (14.2%; 95% CI: 24.0% to 4.1%), or patients with 1 risk factor (14.2%; 95% CI: 21.9% to 6.4%) compared with patients with no risk factors (2.1%; 95% CI: 11.1% to 6.9%). Open Forum Infect Dis 2014; 1:ofu069. Acknowledgments. Additional, well-designed, independent, cost-effectiveness studies for patients with CDI are needed to improve the strength of this recommendation given that cost is a substantial barrier to fidaxomicin use. Prevention of recurrent Clostridioides difficile infection: a systematic review of randomized controlled trials. The updated guideline emphasized that antibiotic treatments should be administered for at least two recurrences before administering FMT. Help using this website - Accessibility statement. Amcor Cares | Amcor These pharmacologic characteristics translated into 2 phase III clinical studies (MODIFY I/II) showing reduced rates of CDI recurrence in patients with CDI given bezlotoxumab compared with placebo. McDonald LC, Gerding DN, Johnson S, et al. Investors fret Amcor CDI is first step to eventual exit (m) Effective Date means the date the Plan is adopted. Updated IDSA guideline for treatment of Clostridium difficile infection. From time to time, the Board may increase or decrease the size of the Committee, add additional members to, remove members (with or without cause) from, appoint new members in substitution therefor, and fill vacancies, however caused, in the Committee. com/. The Evidence Profile tables (presenting the balance between important desirable and undesirable outcomes and the certainty in the evidence) and the Evidence to Decision frameworks (summarizing the other key factors considered when developing the recommendations such as values and preferences, resource use, equity, acceptability, and feasibility) were developed in the GRADEpro Guideline Development Tool [13] and reviewed by the Chair and edited as appropriate. No provision of this Section8 shall be given effect to the extent such provision would result in short-swing profits liability under Section16 of the Exchange Act or violate the exemptive conditions of Rule16b-3 of the Exchange Act. Extended-pulsed fidaxomicin versus vancomycin in patients 60 years and older with Clostridium difficile infection: cost-effectiveness analysis in Spain. Clin Infect Dis 2018; 66:35562. Information and translations of Amcor in the most comprehensive dictionary definitions resource on the web. Definitions. 1. Cost-effectiveness analysis of six strategies to treat recurrent Clostridium difficile infection. "A bargain is a bargain, it is either solid or it is not, and in securities markets when you say something is a key term and you promise to do things, you should be good for your promises," he said. The overall certainty in the evidence was rated as low due to serious concerns regarding imprecision (small number of events and small sample size of these subgroups) as well as risk of bias due to the unblinded design in the EXTEND trial (for self-reported outcomes) (seeTable 3). Considering the moderate improvement in desirable effects in the absence of increased undesirable effects, the balance favors the use of fidaxomicin rather than vancomycin in patients with an initial CDI episode. The STANDS4 Network. Two nonindustry-sponsored decision analyses for recurrent CDI found that fidaxomicin was more cost-effective than vancomycin for multiple CDI recurrences if FMT was not an option [36] and vancomycin was most cost-effective for first CDI recurrence in outpatients [37]. The purpose of this guideline is to provide evidence-based guidance on the most effective management of CDI and recurrent CDI in adult patients. Searches were limited to studies published in English. IDSA handbook for clinical practiceguidelines development. Nothing in this Section10 is intended, or should be construed, to limit authority of the Committee to cause the Company to make payments based on the dividends that would be payable with respect to any Share if it were issued or outstanding, or from granting rights related to such dividends; provided that dividends that would be payable with respect to any Share subject to a performance-based. Financial support. GRADEpro guideline development tool [software]. For patients with an initial CDI episode, we suggest using fidaxomicin rather than a standard course of vancomycin (conditional recommendation, moderate certainty of evidence). PDF ATO Class Ruling Received Any Shares granted under any Incentive Awards shall be counted against the Share limit on a one-for-one basis. All recommendations were labeled as either strong or conditional according to the GRADE approach [8]. The Chair of the Guidelines panel (S. Notwithstanding anything herein to the contrary, the Company shall not (x)reprice (within the meaning of Section303A.08 of the New York Stock Exchange Listed Company Manual and any other formal or informal guidance issued by the New York Stock Exchange) any Option or share appreciation right or (y)or purchase underwater Options or share appreciation rights from a Participant for value in excess of zero, in each case without the approval of the shareholders of Amcor. This includes if you've received dividend's from this particular share portfolio. Published Bezlotoxumab for prevention of recurrent Clostridium difficile infection. Comment: Vancomycin in a tapered and pulsed regimen or vancomycin as a standard course are acceptable alternatives for a first CDI recurrence. (f) Cause means, unless otherwise determined by the Committee in the applicable Award Agreement, with respect to a Participants Termination of Service, the following: (a)in the case where there is no employment agreement, consulting agreement, change in control agreement or similar agreement in effect between the Company or an Affiliate and the Participant at the time of the grant of the Incentive Award (or where there is such an agreement but it does not define cause (or words of like import)), termination due to a Participants insubordination, dishonesty, fraud, incompetence, moral turpitude, willful misconduct, refusal to perform the Participants duties or responsibilities for any reason other than illness or incapacity, or materially unsatisfactory performance of the Participants duties for the Company or an Affiliate, as determined by the Committee in its good-faith discretion; or (b)in the case where there is an employment agreement, consulting agreement, change in control agreement or similar agreement in effect between the Company or an Affiliate and the. They are assessments of current scientific and clinical information provided as an educational service; are not continually updated and may not reflect the most recent evidence (new evidence may emerge between the time information is developed and when it is published or read); should not be considered inclusive of all proper treatments, methods of care, or as a statement of the standard of care; do not mandate any particular course of medical care; and are not intended to supplant physician judgment with respect to particular patients or special clinical situations. Both subgroups showed an increased in sustained response, despite the effect of fidaxomicin failing to achieve a statistical difference in patients with 2 or more prior recurrences. Whitehouse Station, NJ: Merck & Co, Inc, 2016. $12.25 Paid on 20 Jun 2023 (Tue) Next Payment Sign Up Required Paid on 03 Oct 2023 (Tue) Forecast Accuracy 98% Our premium tools have predicted Amcor Plc with 98% accuracy. A. J. G.-L. reports no potential conflicts. We completed an additional ad hoc subgroup analysis of the RCT data for fidaxomicin and vancomycin, separating patients with 1 prior CDI recurrence and 2 or more recurrences; the RR for sustained response to fidaxomicin at 30 days following end of therapy in patients with 1 prior recurrence was 1.23 (95% CI: 1.011.49) and 2.0 (95% CI: .884.54) for patients with 2 or more prior recurrences. Except as otherwise expressly provided in Section8 hereof or in Participants Award Agreement, no adjustment of any Incentive Award shall be made for dividends or other rights for which the record date occurs prior to the date of such issuance. Clin Infect Dis 2018; 66:e148. Panelists also were diverse in gender, geographic distribution, and years of clinical experience. The pivotal clinical trials have further been supported by 2 real-world studies that demonstrated similar reductions in CDI recurrence after initial clinical cure (ICC) among patients at high risk for recurrent CDI who received bezlotoxumab [41,42]. A medical librarian (Shandra Knight) designed the literature searches and MeSH (Medical Subject Heading) terms for Ovid Medline Ovid platform including Medline and Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Embase, and Cochrane Central Register of Controlled Trials. For patients with multiple recurrences, vancomycin in a tapered and pulsed regimen, vancomycin followed by rifaximin, and fecal microbiota transplantation are options in addition to fidaxomicin. However, there was no heterogeneity (I2: 0%) between these subgroups and the pooled effect for patients with a recurrent CDI within the last 6 months was 17.4% (95% CI: 27.5% to 7.3%) (seeFigure 5). No transfer by will or the laws of descent and distribution of any Incentive Award, or the right to exercise any Incentive Award, shall be effective to bind Amcor unless the Committee shall have been furnished with (a)written notice thereof and with a copy of the will and/or such evidence as the Committee may deem necessary to establish the validity of the transfer and (b)an agreement by the transferee to comply with all the terms and conditions of the Incentive Award that are or would have been applicable to the Participant and to be bound by the acknowledgements made by the Participant in connection with the grant of the Incentive Award. In addition, the treatment phase of this regimen (200 mg fidaxomicin) was only given for 5 days, which was barely sufficient to resolve CDI in the in vitro model [33] and the time to diarrhea resolution in the EXTEND trial was 34.0 hours (95% CI: 25.049.0 hours) compared with 22.0 hours (95% CI: 10.0 30.0 hours) for vancomycin [16]. Amcor policy focused on responsible sourcing of materials to ensure minimal disturbance to natural habitats and protect biodiversity. PLoS One 2016; 11:e0149521. Class Ruling CR 2019/42. The evidence also suggests that drug-related adverse events did not differ among patients receiving bezlotoxumab from those not receiving bezlotoxumab (RR: 1.27; 95% CI: .881.85; low certainty evidence). Open Forum Infect Dis 2020; 7:ofaa097. The panel labeled these as weak recommendations due to the fact that there are still limited data to guide treatment of a first recurrence," notes John K. DiBaise, M.D., from Mayo Clinic's campus in Arizona. This assessment of disclosed relationships for possible COIs was based on the relative weight of the financial relationship (ie, monetary amount) and the relevance of the relationship (ie, the degree to which an independent observer might reasonably interpret an association as related to the topic or recommendation of consideration). Whenever withholding tax obligations are incurred in connection with any Incentive Award, Amcor shall have the right to require the Participant to either: (a)remit to Amcor in cash or (b)allow Amcor to withhold Share Incentive Awards with value equal to the amount of such withholding or (c)deduct an appropriate amount from other employment income payable by Amcor either immediately or over time. Patients included in the Guery et al (2018) [16] study received an extended fidaxomicin regimen (200 mg orally twice daily for 5 days, followed by once daily on alternate days on days 725) rather than a standard regimen (200 mg orally twice daily for 10 days), although both regimens amounted to the same total dose of fidaxomicin (seeSupplementary Materials). Fidaxomicin preserves the intestinal microbiome during and after treatment of Clostridium difficile infection (CDI) and reduces both toxin reexpression and recurrence of CDI. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed. "If Iron Mountain gets away with it scot-free, and welshes on one of their key terms, it sets a precedent for others to follow and that is not in Australian investors' interests," he said. 3. Clin Infect Dis 2012; 55(Suppl 2):S1438. AMCOR PLC. Fidaxomicin versus vancomycin for infection with Clostridium difficile in Europe, Canada, and the USA: a double-blind, non-inferiority, randomised controlled trial. Subpopulations that were shown to be most cost-effective, especially if the subgroups had 1 or more episodes of CDI in the previous 6 months, were immunocompromised patients, patients aged 65 years or older, and patients with severe CDI on presentation. This recommendation remains unchanged. Viki Lascaris. The previous iteration of the guidelines also recommends vancomycin (500 mg 4 times daily orally or by nasogastric tube) rather than fidaxomicin for treatment of fulminant (previously known as severe, complicated) CDI. 6. (k) Consultant means any natural person who is an advisor, contractor or consultant to the Company. (b) Cash-Based Awards. For patients with an initial CDI episode, we suggest using fidaxomicin rather than a standard course of vancomycin (conditional recommendation, moderate certainty of evidence). For tax credits, investors must fill out Form 1116 which can get complicated. The maximum number of Shares referred to in the preceding sentences of this Section3 shall in each case be subject to adjustment as provided in Section8 and the following provisions of this Section3. The Committee may from time to time grant Cash-Based Awards to Eligible Persons in such amounts, on such terms and conditions, and for such consideration, including no consideration or such minimum consideration as may be required by applicable law, as it shall determine in its sole discretion. Shareholder Dividends | Amcor Nevertheless, a post hoc analysis showed that patients with a history of congestive heart failure (CHF) who received bezlotoxumab may be at increased risk of heart failure and mortality in the 12 weeks following the infusion (RR: 2.64 [95% CI: 1.007.03] and 1.56 [95% CI: .832.92], respectively) [40]. In the event of any change in the number of Shares of Amcor outstanding by reason of any other event or transaction, the Committee shall, to the extent deemed appropriate by the Committee, make such adjustments to the type or number of Shares with respect to which Incentive Awards may be granted and/or to the number of Shares subject to Incentive Awards. Capital gain is disregarded . BMJ 2011; 343:d5928. Both ASIC and the ASX said Iron Mountain's vow to retain an Australian CDI was not a condition set by them, suggesting regulators are unlikely to penalise the American company for its backflip on maintaining an Australian security. The following list is a reflection of what has been reported to IDSA. Like vancomycin, it is orally delivered with minimal systemic absorption and it is highly active againstC. difficilein vitro. The 2017 guideline discussed 1 study [31] reporting a pooled analysis of patient subgroups with a first CDI recurrence from 2 different RCTs comparing the efficacy of fidaxomicin with vancomycin [14,15]. For recommendations requiring an update, all prior articles identified from the 2017 clinical practice guideline and meeting the predefined inclusion and exclusion criteria were also considered for final selection. AMCOR PLC CDI Accumulation Distribution . Although optimal dosing regimens are still yet to be defined, fidaxomicin has pharmacologic characteristics that may favor use of this agent in the management of patients with recurrent CDI. Amcor and Bemis combination Unanimously recommended by the Boards of Directors of both companies Amcor shareholders will receive one New Amcor CDI or share for each existing share held New Amcor to be NYSE and ASX listed Amcor and Bemis shareholders expected to own approximately 71% and 29% respectively The probability of cost-effectiveness for extended-pulsed fidaxomicin at a willingness-to-pay threshold of 30 000 (~USD 38 000) per QALY gained was 76% [26] and 99.9% at a threshold of 30 000 (~USD 35 000) per QALY gained [27]. 2. In the event of (i)a dissolution or liquidation of the Company, (ii)a sale of all or substantially all of the Companys assets (on a consolidated basis), (iii)a merger, consolidation or similar transaction involving the Company in which the holders of Shares receive consideration in respect of Shares, including cash, securities and/or other property, other than, or in addition to, shares of the surviving corporation in such transaction, the Committee shall, to the extent deemed appropriate by the Committee, have the power to: (i) cancel, effective immediately prior to the occurrence of such event, each Incentive Award (whether or not then exercisable or vested), and, in full consideration of such cancellation, pay to the Participant to whom such Incentive Award was granted an amount in cash, for each Share subject to such Incentive Award, equal to the value, as determined by the Committee, of such Incentive Award, provided that with respect to any outstanding Option or share appreciation right such value shall be equal to the excess of (A)the value, as determined by the Committee, of the property (including cash) received by the holder of a Share as a result of such event over (B)the exercise price of such Option or base price of such share appreciation right (which, for the avoidance of doubt, may be zero in the case of underwater Options and share appreciation rights); or. Cookies facilitate the functioning of this site including a member login and personalized experience. A limited number of cost-effectiveness models have compared oral fidaxomicin 200 mg 2 times daily with oral vancomycin 125 mg 4 times daily for treatment of an initial CDI episode [2428]. (x) Registration Date means the effective date of the first registration statement that is filed by Amcor and declared effective pursuant to 12(g)of the Exchange Act, with respect to any class of Amcors securities. JAMA Clinical Guidelines Synopsis: Diagnosis and treatment of Clostridium difficile infection. "RiskFactors"of Amcor'sannual report on Form 10-K for the fiscal year ended June 30, 2020. . 2020. Zacks Amcor (AMCR) Down 16% in Six Months: Is a Revival Likely? Two industry-sponsored cost-effectiveness models using the EXTEND trial data reported that, despite higher acquisition costs than vancomycin, extended-pulsed fidaxomicin was cost-effective [26,27]. Population pharmacokinetics and pharmacodynamics of bezlotoxumab in adults with primary and recurrent Clostridium difficile infection. Amcor CDI (AMC) Stock Price & News - Google Finance Aug 10, 2018 - 10.45am Sheitoyan-Pesant C, Abou Chakra CN, Ppin J, Marcil-Hguy A, Nault V, Valiquette L. Clinical and healthcare burden of multiple recurrences of Clostridium difficile infection. Our literature update identified a third RCT where information on patients experiencing recurrent CDI (1 recurrences) was available [16] (seeFigure 2). For funds and ETFs, it is derived from a multi-factor model developed by Macroaxis. The panel agrees that the cost-effectiveness analysis probably favors the use of fidaxomicin over vancomycin in patients with an initial episode of CDI due to its greater effectiveness with respect to sustained clinical response, but acknowledges that implementing this recommendation probably reduces equity due to variation in medical insurance coverage. JAMA. AMCOR PLC CDI 1:1. All studies compared fidaxomicin with a standard regimen of vancomycin (125 mg orally 4 times daily for 10 days). AMCOR PLC CDI Price Forecast 2022 - Simple Moving Average - Macroaxis All of the powers and responsibilities of the Committee under the Plan may be delegated by the Committee, in writing, to any subcommittee thereof, in which case the acts of such subcommittee shall be deemed to be acts of the Committee hereunder.
