On June 19, 2020 Perrigo Company plc ("Perrigo" or the "Company") (NYSE; TASE: PRGO) reported the closing of the previously announced registered public offering by Perrigo Finance Unlimited Company, an indirect wholly-owned finance subsidiary of Perrigo (the "Issuer"), of $750.0 million aggregate principal amount of the Issuer’s 3.150% Senior Notes due 2030 (the "Notes") (Press release, Perrigo Company, JUN 19, 2020, View Source [SID1234561247]). The Notes will be fully and unconditionally guaranteed on a senior unsecured basis by Perrigo.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Perrigo estimates that the total net proceeds of the offering will be approximately $737.1 million, after deducting the underwriting discount and offering expenses payable by the Issuer.

Perrigo intends to use the net proceeds of the Notes offering to fund the redemption of the Issuer’s 3.500% Senior Notes due March 15, 2021 and 3.500% Senior Notes due December 15, 2021, with the balance, if any, for general corporate purposes, which may include the repayment or redemption of additional indebtedness.

BofA Securities, J.P. Morgan and Wells Fargo Securities acted as the joint book-running managers in the offering.

The offering is being made pursuant to an effective shelf registration statement filed with the Securities and Exchange Commission. The offering will be made only by means of a prospectus supplement relating to the offering and the accompanying base prospectus, copies of which may be obtained by contacting: BofA Securities, Inc. at [email protected] or toll-free at (800) 294-1322; or by calling J.P. Morgan Securities LLC collect at (212) 834-4533; or by calling Wells Fargo Securities, LLC toll-free at (800) 645-3751 or emailing [email protected].

On June 19, 2020 GlaxoSmithKline plc (LSE/NYSE: GSK) reported the US Food and Drug Administration (FDA) will convene a meeting of the Oncologic Drugs Advisory Committee (ODAC) to review data supporting the company’s Biologics License Application (BLA) for belantamab mafodotin for the potential treatment of patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody (Press release, GlaxoSmithKline, JUN 19, 2020, View Source [SID1234561246]). The ODAC will meet virtually on 14 July 2020.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dr Axel Hoos, Senior Vice President and Head of Oncology R&D, GSK said: "We believe belantamab mafodotin and the results from the DREAMM clinical trial programme have significant potential for patients with relapsed/refractory multiple myeloma who have limited treatment options. We look forward to participating in the upcoming advisory committee meeting and working with the FDA to complete its review of the BLA."

Belantamab mafodotin received Breakthrough Therapy Designation in 2017, and the BLA was granted Priority Review status by the FDA in January 2020 based on data from the pivotal DREAMM-2 (DRiving Excellence in Approaches to Multiple Myeloma) study. Six-month primary results from the study were published in The Lancet Oncology and follow-up data were presented at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting.

Belantamab mafodotin is a potential first-in-class, humanised, anti-BCMA (antibody drug conjugate against B-cell maturation antigen) being investigated in a robust clinical trial programme for the treatment of multiple myeloma.[1] BCMA is a cell-surface protein that plays an important role in the survival of plasma cells and is universally expressed in patients with multiple myeloma.[2]

About DREAMM-2
DREAMM-2 is an open label study of belantamab mafodotin. Patients in the trial had actively progressing multiple myeloma that had worsened despite current standard of care and were randomised to two arms to receive either 2.5 mg/kg or 3.4 mg/kg belantamab mafodotin every three weeks. Overall, patients in DREAMM-2 had more advanced disease, poorer prognosis and performance status and also had a greater number of prior lines of therapy in comparison with patients in DREAMM-1, the first time in human study of belantamab mafodotin.[3]

About multiple myeloma
Multiple myeloma is the second most common blood cancer in the US and is generally considered treatable, but not curable.[4] Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.[5]

About B-cell maturation antigen (BCMA)
The normal function of BCMA is to promote plasma cell survival by transduction of signals from two known ligands, BAFF (B-cell activating factor) and APRIL (a proliferation-inducing ligand). This pathway has been shown to be important for myeloma cell growth and survival. BCMA expression is limited to B cells at later stages of development. BCMA is expressed at varying levels in myeloma patients and BCMA membrane expression is universally detected in myeloma cell lines.[2]

About belantamab mafodotin (GSK2857916)
Belantamab mafodotin is an investigational anti-body drug conjugate comprising a humanised anti-B cell maturation antigen (BCMA) monoclonal antibody conjugated to the cytotoxic agent auristatin F via non-cleavable linker. The drug linker technology is licensed from Seattle Genetics; monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa.

Belantamab mafodotin is not currently approved for use anywhere in the world.

GSK in Oncology
GSK is focused on maximising patient survival through transformational medicines. GSK’s pipeline is focused on immuno-oncology, cell therapy, cancer epigenetics, and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilising modalities such as small molecules, antibodies, antibody drug conjugates and cells, either alone or in combination.

On June 19, 2020 GlaxoSmithKline plc (LSE/NYSE: GSK) reported the US Food and Drug Administration (FDA) will convene a meeting of the Oncologic Drugs Advisory Committee (ODAC) to review data supporting the company’s Biologics License Application (BLA) for belantamab mafodotin for the potential treatment of patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody (Press release, GlaxoSmithKline, JUN 19, 2020, View Source [SID1234561245]). The ODAC will meet virtually on 14 July 2020.

Dr Axel Hoos, Senior Vice President and Head of Oncology R&D, GSK said: "We believe belantamab mafodotin and the results from the DREAMM clinical trial programme have significant potential for patients with relapsed/refractory multiple myeloma who have limited treatment options. We look forward to participating in the upcoming advisory committee meeting and working with the FDA to complete its review of the BLA."

Belantamab mafodotin received Breakthrough Therapy Designation in 2017, and the BLA was granted Priority Review status by the FDA in January 2020 based on data from the pivotal DREAMM-2 (DRiving Excellence in Approaches to Multiple Myeloma) study. Six-month primary results from the study were published in The Lancet Oncology and follow-up data were presented at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting.

Belantamab mafodotin is a potential first-in-class, humanised, anti-BCMA (antibody drug conjugate against B-cell maturation antigen) being investigated in a robust clinical trial programme for the treatment of multiple myeloma.[i] BCMA is a cell-surface protein that plays an important role in the survival of plasma cells and is universally expressed in patients with multiple myeloma.[ii]

About DREAMM-2
DREAMM-2 is an open label study of belantamab mafodotin. Patients in the trial had actively progressing multiple myeloma that had worsened despite current standard of care and were randomised to two arms to receive either 2.5 mg/kg or 3.4 mg/kg belantamab mafodotin every three weeks. Overall, patients in DREAMM-2 had more advanced disease, poorer prognosis and performance status and also had a greater number of prior lines of therapy in comparison with patients in DREAMM-1, the first time in human study of belantamab mafodotin.[iii]

About multiple myeloma
Multiple myeloma is the second most common blood cancer in the US and is generally considered treatable, but not curable.[iv] Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.[v]

About B-cell maturation antigen (BCMA)
The normal function of BCMA is to promote plasma cell survival by transduction of signals from two known ligands, BAFF (B-cell activating factor) and APRIL (a proliferation-inducing ligand). This pathway has been shown to be important for myeloma cell growth and survival. BCMA expression is limited to B cells at later stages of development. BCMA is expressed at varying levels in myeloma patients and BCMA membrane expression is universally detected in myeloma cell lines.ii

About belantamab mafodotin (GSK2857916)
Belantamab mafodotin is an investigational anti-body drug conjugate comprising a humanised anti-B cell maturation antigen (BCMA) monoclonal antibody conjugated to the cytotoxic agent auristatin F via non-cleavable linker. The drug linker technology is licensed from Seattle Genetics; monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa.

Belantamab mafodotin is not currently approved for use anywhere in the world.

GSK in Oncology
GSK is focused on maximising patient survival through transformational medicines. GSK’s pipeline is focused on immuno-oncology, cell therapy, cancer epigenetics, and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilising modalities such as small molecules, antibodies, antibody drug conjugates and cells, either alone or in combination.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On June 19, 2020 Nymox Pharmaceutical Corporation (NASDAQ: NYMX) reported that key steps in its regulatory submission preparations have been completed and the project is firmly on-track (Press release, Nymox, JUN 19, 2020, View Source [SID1234561244]). The majority of its regulatory documentation has proceeded very well, despite the inherent limitations of the business environment in 2020. Certain tasks have been hampered by the Covid pandemic restrictions, similar to other companies in the sector. These remaining tasks are expected to be completed reasonably soon as the Company regains the ability to retrieve required documentation from external sites and to complete other required tasks and on-site activities that were hindered due to the global restrictions in place.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dr. Paul Averback, CEO commented "We are extremely pleased with the progress we have been able to achieve despite these obvious limitations due to the pandemic restrictions as we reported in our 6K filing on April 24. I want to thank the whole team for putting in an extraordinary effort towards meeting our regulatory timeline goals. Extremely complex tasks have been coordinated and executed successfully. Given the ongoing reopening of the economy we now expect to attend to the remaining matters near-term. Taking into account the above factors, we are well within our projected timelines as corrected for by the addition of the previously announced Covid-related delay of several months. We are now expecting to file our applications with the authorities approximately by the end of Q3 or early Q4. We will continue to regularly update our shareholders as we complete the entire packages."

"Nymox management is very proud of the quality of our evidence and we not only look forward to the upcoming near-term submissions, but we are highly enthusiastic about the prospects for our Company and its shareholders. This is a field which has a substantial unmet medical need for safer and more effective treatments. The Company has achieved numerous major successes in the past couple years with its intellectual property applications around the world which have greatly extended the timeline value of the Company’s Fexapotide treatments for prostate enlargement and for prostate cancer", Dr. Averback said.

For further in-depth detailed information about the Nymox treatments for prostate enlargement (BPH) and early stage prostate cancer please see peer review publications at the following links: View Source and View Source and visit www.nymox.com.

For more information please contact [email protected] or 800-936-9669.

On June 19, 2020 Perrigo Company plc (NYSE; TASE: PRGO) reported that it has reached a definitive agreement to sell its U.K.-based Rosemont Pharmaceuticals business, a generic prescription pharmaceuticals manufacturer focused on liquid medicines, to a U.K.-headquartered private equity firm for £156 million or approximately $195 million in cash (Press release, Perrigo Company, JUN 19, 2020, View Source [SID1234561243]). This transaction, which was signed and closed on the same day, represents another step in Perrigo’s transformation to a consumer-focused self-care company.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Perrigo CEO and President Murray S. Kessler commented, "We are pleased to have reached an agreement to divest Perrigo’s non-core Rosemont business and look forward to ensuring a seamless transition. This divestiture, which was accomplished at an attractive ten times adjusted operating income multiple, is an example of Perrigo’s commitment to our transformation to a consumer-focused self-care company while remaining good stewards of shareholder value. We thank the Rosemont employees for their service to Perrigo and are confident the business will do well under new ownership."

In calendar year 2019, Perrigo realized $53 million in net sales and $0.12 of adjusted diluted EPS from the Rosemont business, which was previously included in the Consumer Self-Care International segment.