Principal Technologies Inc. (the " Company ") (TSXV: PTEC) (FSE: J07), is pleased to announce the closing of the first tranche (" Tranche 1 ") of its previously announced non-brokered private placement (the " Offering ") with one investor, MRPT Invest UG (" MRPT "), a company owned and controlled by Markus Mair . The Company issued a total of 4,000,000 units at $0.25 per unit for gross proceeds of $1,000,000 . Each unit (a " Unit ") will consist of one common share (a ' Share ") of the Company and one common share purchase warrant (a " Warrant "). Each Warrant entitles the holder to purchase one additional Share of the Company at $0.30 for a period of two (2) years from the date of closing. The Warrants are subject to a blocker term that prohibits exercise of the Warrants to the extent the holder would as a result of any exercise exceed 19.99% of then issued Shares.
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Principal Technologies Announces Extension of Private Placement Closing Date
Principal Technologies Inc. (the "Company") (TSXV: PTEC; FSE: J07), announces that it has received an extension from the TSX Venture Exchange with respect to the duration of its previously announced private placement (the "Private Placement") (see the Company's press releases dated April 3, 2024; June 7, 2024; and June 20, 2024), and intends to close a second and final tranche of the Private Placement on or before July 15, 2024.
ON BEHALF OF THE BOARD
Jerry Trent, Chief Executive Officer
Principal Technologies Inc.
For investor inquiries or further information, please contact:
Office@principal-technologies.com
Forward-looking statements:
This press release contains "forward-looking information" and "forward-looking statements" within the meaning of applicable securities laws. This information and statements address future activities, events, plans, developments and projections. All statements, other than statements of historical fact, constitute forward-looking statements or forward-looking information. Such forward-looking information and statements are frequently identified by words such as "may," "will," "should," "anticipate," "plan," "expect," "believe," "estimate," "intend" and similar terminology, and reflect assumptions, estimates, opinions and analysis made by management of the Company in light of its experience, current conditions, expectations of future developments and other factors which it believes to be reasonable and relevant.
Risks and uncertainties that may cause actual results to vary include but are not limited to the availability of financing; fluctuations in commodity prices; changes to and compliance with applicable laws and regulations, including environmental laws and obtaining requisite permits and approvals; political, economic and other risks; as well as other risks and uncertainties which are more fully described in our annual and quarterly Management's Discussion and Analysis and in other filings made by us with Canadian securities regulatory authorities and available at www.sedarplus.ca. The Company disclaims any obligation to update or revise any forward-looking information or statements except as may be required.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
PRINCIPAL TECHNOLOGIES ANNOUNCES CLOSING OF FIRST TRANCHE OF PRIVATE PLACEMENT
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PRINCIPAL TECHNOLOGIES ANNOUNCES UPSIZING OF PRIVATE PLACEMENT
/NOT FOR DISTRIBUTION TO U.S. NEWS WIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES /
Principal Technologies Inc. (the " Company ") (TSXV: PTEC) (FSE: J07), is pleased to announce an increase in the previously announced non-brokered financing of 4,000,000 units (see news release dated April 3, 2024 ), to 8,000,000 units at $0.25 (the " Offering Price ") for gross proceeds of up to $2,000,000 (the " Private Placement) . Each unit (a " Unit ") will consist of one common share (a " Share ") of the Company and one common share purchase warrant (a " Warrant "). Each Warrant entitles the holder to purchase one additional Share of the Company at $0.30 for a period of two (2) years from the date of closing. The Company has received $1,000,000 of subscriptions with funds being held in escrow. The closing of a first tranche is pending receipt of TSX Venture Exchange (" TSXV ") approval.
Proceeds of the Private Placement will be used for general working capital and corporate purposes of the Company, including those as may be required by Vivostat A/S (" Vivostat ") conditional on the closing of the acquisition of Vivostat.
The Private Placement is subject to approval of the TSXV and all securities of the Company issued pursuant to the Private Placement will be subject to a four-month hold period from the date of issuance. The Private Placement will not result in the creation of a new control person of the Company.
The securities offered have not been registered under the United States Securities Act of 1933, as amended (the " U.S. Securities Act "), or any state securities laws and may not be offered or sold absent registration or compliance with an applicable exemption from the registration requirements of the U.S. Securities Act and applicable state securities laws.
The Company also announces that principal amount of the secured loan from GreenIslands Opportunities Fund (the " Lender "), as announced in the April 3, 2024 , news release has increased from €8,000,000 to €9,000,000. The deemed price of the 2.5 million common shares (the " Consideration Shares ") issuable by the Company to the Lender as partial consideration for the acquisition of Vivostat (the " Acquisition ") shall have a deemed value of $0.25 per Consideration Share. All other terms of the loan will remain the same.
The person receiving the finder's fee in connection with the Acquisition (the " Finder's Fee "), subject to approval of the TSXV, is Reinhold Eder . The Finder's Fee will be calculated as 1% of the cash portion of the purchase price.
ON BEHALF OF THE BOARD
Jerry Trent, Chief Executive Officer
Principal Technologies Inc.
This press release contains "forward-looking information" and "forward-looking statements" within the meaning of applicable securities laws. This information and statements address future activities, events, plans, developments and projections. All statements, other than statements of historical fact, constitute forward-looking statements or forward- looking information. Such forward-looking information and statements are frequently identified by words such as "may," "will," "should," "anticipate," "plan," "expect," "believe," "estimate," "intend" and similar terminology, and reflect assumptions, estimates, opinions and analysis made by management of the Company in light of its experience, current conditions, expectations of future developments and other factors which it believes to be reasonable and relevant.
Forward-looking information and statements involve known and unknown risks and uncertainties that may cause the Company's actual results, performance, and achievements to differ materially from those expressed or implied by the forward-looking information and statements and accordingly, undue reliance should not be placed thereon. Forward-looking statements included in this press release include the closing of the Private Placement on the terms and timing set out herein; the receipt of all application Exchange and regulatory approvals and satisfaction of conditions pursuant to the Private Placement; receipt of TSXV approval for the Acquisition; realizing synergies between component companies and further acquisitions by Principal; and retention of Vivostat employees.
Risks and uncertainties that may cause actual results to vary include but are not limited to the availability of financing; fluctuations in commodity prices; changes to and compliance with applicable laws and regulations, including environmental laws and obtaining requisite permits and approvals; political, economic and other risks; as well as other risks and uncertainties which are more fully described in our annual and quarterly Management's Discussion and Analysis and in other filings made by us with Canadian securities regulatory authorities and available at www.sedarplus.ca. The Company disclaims any obligation to update or revise any forward-looking information or statements except as may be required.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
SOURCE Principal Technologies Inc.
View original content: http://www.newswire.ca/en/releases/archive/June2024/07/c4738.html
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PRINCIPAL TECHNOLOGIES ANNOUNCES LOAN FINANCING AND PRIVATE PLACEMENT AND PROVIDES UPDATE ON VIVOSTAT A/S ACQUISITION
/NOT FOR DISTRIBUTION TO U.S. NEWS WIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES /
Principal Technologies Inc. (the " Company ") (TSXV: PTEC) (FSE: J07), is pleased to announce that on March 8, 2024 it entered into a binding commitment letter with the effect that the GreenIslands Opportunities Fund (the " Lender ") will provide a secured loan in the principal amount of €8,000,000 (the " Loan ") to provide acquisition financing with respect to the cash portion of the purchase price for Vivostat AS (" Vivostat "), as further outlined in its news release dated February 6, 2024 and for general working capital purposes.
The terms of the Loan include:
- the secured loan shall be provided to the Company by the Lender on a lump sum basis;
- interest rate of 12.00% per annum on the principal amount outstanding, payable up to and including the date which is six (6) years after the initial advance under the Loan (the " Loan Maturity Date ");
- interest will be payable quarterly and principal amount payable in twenty (20) quarterly installments;
- principal amount and interest in the first year shall not be paid until the Loan Maturity Date;
- the loan will be secured by, among other things, a pledge of all the shares acquired in Vivostat; and
- payment shall be permitted in full or in part with a 6% prepayment penalty on the prepaid amount.
The Loan provides full financing for the Company to close the Vivosat acquisition, and after final adjustments any remaining funds will be utilized by the Company for working capital purposes.
"This loan, by our major shareholder, effectively underwrites our previously-announced acquisition of Vivostat" commented Jerry Trent , Chief Executive Officer of Principal Technologies Inc. "Vivostat is the world's leading autologous sealant solution, developed by Bristol Myers Squibb at a cost of US$100 million . We are now on track to bring this solution to the thousands of hospitals and clinics in jurisdictions in which it has never been sold, including Japan , Brazil and Australia ."
Vivostat is a profitable company generating €3.8 million in revenue in 2023.
In addition, the Company is pleased to announce a non-brokered financing of up to 4,000,000 units at $0.25 (the " Offering Price ") for gross proceeds of up to $1,000,000 (the " Private Placement) . Each unit (a " Unit ") will consist of one common share (a ' Share ") of the Company and one common share purchase warrant (a " Warrant "). Each Warrant entitles the holder to purchase one additional Share of the Company at $0.30 for a period of two (2) years from the date of closing. Proceeds of the Private Placement will be used for general working capital and corporate purposes.
In connection with the Private Placement, pursuant to the policies of the TSX Venture Exchange (the " Exchange "), the deemed price of the 2.5 million common shares issuable by the Company as partial consideration for the acquisition of Vivostat shall be revised to the Offering Price.
The Private Placement is subject to approval of the Exchange and all securities of the Company issued pursuant to the Private Placement will be subject to a four month hold period from the date of issuance. The Private Placement will not result in the creation of a new control person of the Company.
The securities offered have not been registered under the United States Securities Act of 1933, as amended (the " U.S. Securities Act "), or any state securities laws and may not be offered or sold absent registration or compliance with an applicable exemption from the registration requirements of the U.S. Securities Act and applicable state securities laws.
The Lender holds 38.03% of the Company's issued and outstanding shares and as such the Loan constitutes a related party transaction as defined under Multilateral Instrument 61-101 - Protection of Minority Security Holders in Special Transactions ("MI 61-101"). The Loan is exempt from the formal valuation requirements pursuant to Subsection 5.5(b) of MI 61-101 (Issuer Not Listed on Specified Markets) and is exempt from the minority shareholder approval requirements pursuant to Subsection 5.7(f) of MI 61-101 (Loan to Issuer, No Equity or Voting Component). The material change report in relation to the related party transactions will be filed less than 21 days before the completion of the proposed Loan as the Company wishes to complete the corresponding acquisition of Vivostat as soon as commercially feasible.
ON BEHALF OF THE BOARD
Jerry Trent , Chief Executive Officer
Principal Technologies Inc.
This press release contains "forward-looking information" and "forward-looking statements" within the meaning of applicable securities laws. This information and statements address future activities, events, plans, developments and projections. All statements, other than statements of historical fact, constitute forward-looking statements or forward-looking information. Such forward-looking information and statements are frequently identified by words such as "may," "will," "should," "anticipate," "plan," "expect," "believe," "estimate," "intend" and similar terminology, and reflect assumptions, estimates, opinions and analysis made by management of the Company in light of its experience, current conditions, expectations of future developments and other factors which it believes to be reasonable and relevant.
Risks and uncertainties that may cause actual results to vary include but are not limited to the availability of financing; fluctuations in commodity prices; changes to and compliance with applicable laws and regulations, including environmental laws and obtaining requisite permits and approvals; political, economic and other risks; as well as other risks and uncertainties which are more fully described in our annual and quarterly Management's Discussion and Analysis and in other filings made by us with Canadian securities regulatory authorities and available at www.sedarplus.ca . The Company disclaims any obligation to update or revise any forward-looking information or statements except as may be required.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
SOURCE Principal Technologies Inc.
View original content: http://www.newswire.ca/en/releases/archive/April2024/03/c3545.html
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PRINCIPAL TECHNOLOGIES ANNOUNCES FUNDAMENTAL ACQUISITION OF VIVOSTAT A/S
/Not for distribution to U.S. news wire services or for dissemination in the United States /
- Binding Share Purchase Agreement to purchase 100% of Denmark -based Vivostat A/S (" Vivostat ").
- Vivostat has a unique system for on-site preparation and application of autologous concentrated fibrin and platelet enriched fibrin sealants for use in post-surgical procedures.
- Used in over 200,000 surgical procedures, Vivostat's system has peer-reviewed evidence of zero rejection and infection rates.
- Vivostat has been profitable for the last 3 years and currently generates revenues of approximately €3,600,000 per year with a 60% gross profit margin.
- Vivostat is currently only actively marketed in six European countries representing less than 10% of its total addressable market.
- Transaction is expected to close on or before March 15, 2024 , subject to receipt of applicable approvals, including of the TSX Venture Exchange (" TSX-V ") and satisfaction of conditions.
Principal Technologies Inc. (the " Company " or " Principal ") (TSXV: PTEC) (FSE: J07), is pleased to announce that as at February 6, 2024 it entered into an arm's length binding Share Purchase Agreement (" SPA ") to acquire (the " Acquisition ") 100% of the equity interests of Vivostat, a 23-year-old Danish company which uses a unique autologous fibrin sealant solution for post-surgical use.
The Company will pay approximately €7,500,000 in cash plus 2,500,000 common shares in the capital of the Company at a price of $0.15 , based on last closing price of the common shares on the TSX-V prior to this announcement, to the owners of Vivostat, as adjusted under the SPA. The Company has received an expression of interest from a major European fund with respect to financing the Acquisition and also expects to close a concurrent non-brokered equity offering to be priced in the context of the market after the announcement of the Acquisition (the " Offering ").
Vivostat currently generates approximately €3,600,000 in revenues per year with a 60% gross profit margin. With Principal's backing and global expertise, Vivostat intends to accelerate the sales and marketing efforts in the six European Union (" EU ") countries, which currently account for the majority of sales, and to grow sales in the numerous other EU countries where it is licensed.
Jerry Trent , CEO of Principal, said, "We are delighted to announce our first major acquisition. This purchase is the culmination of an extensive due diligence process on dozens of potential healthcare targets in Europe . We were seeking a profitable target that offered truly industry-leading, licensed products with untapped global appeal. Such a target should also serve as a solid base upon which to build a profitable, scalable medtech and healthcare portfolio with strong synergies between its component companies. Vivostat checked all our boxes. We are excited to ramp up sales far beyond the current market. It is gratifying to note that all of Vivostat's key employees will remain with the Company and become critical parts of the growth we forecast for the Company."
Sven Lange , CEO of Vivostat, added, "The acquisition by Principal now sets the stage for the global sales expansion of our industry-leading and patented product, subject to securing applicable foreign licenses."
The Company expects to pay a 1% finder's fee in relation to the acquisition of Vivostat, subject to approval of the TSX-V. The transactions contemplated by the SPA and Offering are subject to receipt of all necessary regulatory approvals, and the satisfaction of various conditions to closing, including the approval of the TSX-V. The Offering remains subject to entering into definitive documentation.
The Shares issued pursuant to SPA will be subject to a hold period expiring four months and one day from the date of issuance in accordance with applicable Canadian securities laws.
Trading of the Company's common shares on the TSX-V will remain halted pending receipt and review of acceptable documentation pursuant to Section 5.6 (d) of TSXV Policy 5.3 regarding a Fundamental Acquisition.
Vivostat A/S manufactures and distributes a unique system for on-site preparation and application of autologous concentrated fibrin and platelet enriched fibrin sealants. The technology was originally developed by Bristol Myers Squibb in the 1990's at an approximate cost of over €80 million.
These fibrin sealants are beneficial in surgery to assist in the healing process and preventing infection. Vivostat's products are currently distributed primarily in the EU with over 12,500 surgical applications in the past year alone and over 200,000 since inception. The patented Vivostat system is backed by extensive positive research from peer-reviewed journals demonstrating evidence of zero rejection or infection rates.
Principal Technologies Inc. is a Canadian-based healthcare acquisition company. The Company is engaged in building a portfolio of profitable healthcare technology companies with a focus on those with global distribution potential which have intellectual property capable of enhancing medical treatment quality, cost efficiency, optimization of the patient pathway, and implementation of point of care technologies.
ON BEHALF OF THE BOARD
Jerry Trent , Chief Executive Officer
Principal Technologies Inc.
Neither the TSX-V nor its Regulation Services Provider (as that term is defined in policies of the TSX-V) accepts responsibility for the adequacy or accuracy of this release.
This press release contains "forward-looking information" and "forward-looking statements" within the meaning of applicable securities laws. This information and statements address future activities, events, plans, developments and projections. All statements, other than statements of historical fact, constitute forward-looking statements or forward-looking information. Such forward-looking information and statements are frequently identified by words such as "may," "will," "should," "anticipate," "plan," "expect," "believe," "estimate," "intend" and similar terminology, and reflect assumptions, estimates, opinions and analysis made by management of the Company in light of its experience, current conditions, expectations of future developments and other factors which it believes to be reasonable and relevant.
Forward-looking information and statements involve known and unknown risks and uncertainties that may cause the Company's actual results, performance and achievements to differ materially from those expressed or implied by the forward-looking information and statements and accordingly, undue reliance should not be placed thereon. Forward-looking statements included in this press release include the closing of the transactions contemplated by the SPA and the Offering on the terms and timing set out herein; receipt of additional licences; the funding for the cash portion of the purchase price of Vivostat; the receipt of all application regulatory approvals and satisfaction of conditions pursuant to the Offering and the SPA; realizing synergies between component companies and further acquisitions by Principal; and retention of Vivostat employees.
Risks and uncertainties that may cause actual results to vary include but are not limited to the availability of financing; fluctuations in commodity prices; changes to and compliance with applicable laws and regulations, including environmental laws and obtaining requisite permits and approvals; political, economic and other risks; as well as other risks and uncertainties which are more fully described in our annual and quarterly Management's Discussion and Analysis and in other filings made by us with Canadian securities regulatory authorities and available at www.sedarplus.ca . The Company disclaims any obligation to update or revise any forward-looking information or statements except as may be required.
SOURCE Principal Technologies Inc.
View original content: http://www.newswire.ca/en/releases/archive/February2024/06/c6577.html
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PRINCIPAL TECHNOLOGIES CLOSES THIRD AND FINAL TRANCHE OF OVERSUBSCRIBED PRIVATE PLACEMENT
/Not for distribution to U.S. news wire services or for dissemination in the United States /
Principal Technologies Inc. (the " Company ") (TSXV: PTEC ), is pleased to announce the closing of the third and final tranche (" Tranche 3 ") of its previously announced non-brokered private placement (the " Offering "). The Company issued an additional 833,333 common shares (the " Shares ") at $0.15 per Share for gross proceeds of $124,999.95 bringing the total offering to 9,993,166 Shares for aggregate gross proceeds of $1,498,974.95 when combined with the two previous closings, subject to final approval from the TSX Venture Exchange (" TSXV "). For more information on the Offering, see the Company's news releases dated October 6, 2023 November 21, 2023 and December 21, 2023 .
In connection with the closing of Tranche 3, finder's fees totaling $4,000 cash were paid and non-transferable share purchase warrants issued to purchase up to 26,667 Shares of the Company for a period of twenty-four (24) months from the date of issuance, expiring on January 18, 2026 .
'We are very pleased to complete this $1.5 million private placement' said the Company's CEO, Jerry Trent. 'It provides ample funds for us to be able to seek out and validate a significant healthcare technologies opportunity for the Company, which is our main focus for 2024'.
The Company intends to use the net proceeds of the Offering for working capital in order to secure a major asset and for general corporate purposes. All currency in this news release is denominated in Canadian dollars.
All securities issued pursuant to the Offering, and any Shares that may be issuable on exercise of any such securities, will be subject to a statutory hold period expiring four months and one day from the date of issuance of such securities.
This news release does not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of any of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful, including any of the securities in the United States of America . The securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the " 1933 Act ") or any state securities laws and may not be offered or sold within the United States or to, or for account or benefit of, U.S. Persons (as defined in Regulation S under the 1933 Act) unless registered under the 1933 Act and applicable state securities laws, or an exemption from such registration requirements is available.
Jerry Trent, Chief Executive Officer
Principal Technologies Inc.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
This press release contains "forward-looking information" and "forward-looking statements" within the meaning of applicable securities laws. This information and statements address future activities, events, plans, developments and projections. All statements, other than statements of historical fact, constitute forward-looking statements or forward-looking information. Such forward-looking information and statements are frequently identified by words such as "may," "will," "should," "anticipate," "plan," "expect," "believe," "estimate," "intend" and similar terminology, and reflect assumptions, estimates, opinions and analysis made by management of the Company in light of its experience, current conditions, expectations of future developments and other factors which it believes to be reasonable and relevant. Forward-looking information and statements involve known and unknown risks and uncertainties that may cause the Company's actual results, performance and achievements to differ materially from those expressed or implied by the forward-looking information and statements and accordingly, undue reliance should not be placed thereon.
Risks and uncertainties that may cause actual results to vary include but are not limited to the availability of financing; fluctuations in commodity prices; changes to and compliance with applicable laws and regulations, including environmental laws and obtaining requisite permits; political, economic and other risks; as well as other risks and uncertainties which are more fully described in our annual and quarterly Management's Discussion and Analysis and in other filings made by us with Canadian securities regulatory authorities and available at www.sedar.com . The Company disclaims any obligation to update or revise any forward-looking information or statements except as may be required.
SOURCE Principal Technologies Inc.
View original content: http://www.newswire.ca/en/releases/archive/January2024/18/c2862.html
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Novartis receives positive CHMP opinion for Kisqali® to help reduce risk of recurrence in people with HR+/HER2- early breast cancer
- If approved, patients in Europe with stage II or III HR+/HER2- early breast cancer (EBC) at high risk of recurrence, including those with node-negative disease, will be eligible for adjuvant treatment with Kisqali ® (ribociclib) in combination with an aromatase inhibitor 1
- Recommendation is based on the Phase III NATALEE trial, where Kisqali added to endocrine therapy (ET) significantly reduced the risk of recurrence by 25% versus ET alone across a broad population of patients with HR+/HER2- early breast cancer 2
- People with stage II or III HR+/HER2- EBC face significant risk of recurrence – often as incurable metastatic disease – despite adjuvant ET and regardless of nodal involvement 3,4
- In September, Kisqali was approved by the FDA in this setting 5 ; at ESMO 2024, an updated analysis from NATALEE was presented, showing a deepening invasive disease-free survival benefit 6
Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting marketing authorization for Kisqali ® (ribociclib) for the adjuvant treatment of adults with hormone receptor-positivehuman epidermal growth factor receptor 2-negative (HR+HER2-) early breast cancer (EBC), at high risk of disease recurrence, including those with node-negative disease 1 .
"One-third of people diagnosed with stage II breast cancer and more than half of those diagnosed with stage III will unfortunately experience a return of their cancer in the long term, often as metastatic disease," said Peter A. Fasching , M.D., Professor of Translational Medicine, University Hospital Erlangen and Comprehensive Cancer Center Erlangen-EMN and NATALEE trial investigator. "If approved, Kisqali could provide an effective and tolerable adjuvant treatment option to mitigate the risk of recurrence in a broader patient population, particularly for patients who currently have limited treatment options, including those with high-risk node-negative disease."
Breast cancer is the most commonly diagnosed cancer in Europe 7 . HR+/HER2- is the most common subtype, accounting for approximately 70% of all breast cancers, and more than 40% of these are diagnosed in stage II or III 8-10 .
The positive CHMP decision is based on robust data from the Phase III NATALEE trial 2,11,12 . In the trial, Kisqali plus endocrine therapy (ET), compared to ET alone, lowered the risk of cancer recurrence by 25.1% in patients with stage II and III HR+/HER2- EBC (HR=0.749; 95% CI: 0.628, 0.892; P =0.0006) and demonstrated a consistent, clinically meaningful invasive disease-free survival (iDFS) benefit across key pre-specified subgroups 2,11 . Data from the pivotal trial also showed the safety profile of Kisqali at the 400mg dose was well-tolerated with generally low-grade symptomatic adverse events 2,11 .
An updated analysis from the NATALEE trial recently presented at the European Society for Medical Oncology (ESMO) Congress 2024 adds to the growing body of evidence supporting the potential of Kisqali to consistently reduce risk of recurrence across a broad population 6 . In the updated analysis, the iDFS benefit continued to deepen beyond the three-year Kisqali treatment period in all patient subgroups, including those with node-negative disease 2 .
"Today, many people diagnosed with HR+/HER2- early breast cancer in Europe lack options beyond endocrine therapy to help reduce their risk of cancer coming back. If approved, Kisqali could nearly double the number of patients eligible for CDK4/6 inhibitor adjuvant therapy," said Patrick Horber M.D ., President, International, Novartis. "Together with the recent FDA approval and late-breaking NATALEE data presented at ESMO, today's positive CHMP recommendation further reinforces the differentiated profile of Kisqali as a new treatment option for a broad population of patients, including those with node-negative disease."
Following the CHMP's recommendation to approve Kisqali in a broad population of patients diagnosed with HR+/HER2- EBC at high risk of recurrence, the European Commission (EC) will take a final decision within approximately two months.
About NATALEE
NATALEE is a global Phase III multi-center, randomized, open-label trial to evaluate the efficacy and safety of Kisqali ® (ribociclib) with ET as an investigational adjuvant treatment versus ET alone in patients with stage II and III HR+/HER2- EBC, being conducted in collaboration with TRIO 2,13 . The adjuvant ET in both treatment arms was a non-steroidal aromatase inhibitor (NSAI; anastrozole or letrozole) and goserelin if applicable 2,13 . The primary endpoint of NATALEE is invasive disease-free survival (iDFS) as defined by the Standardized Definitions for Efficacy End Points (STEEP) criteria 2,13 . A total of 5,101 adult patients with HR+/HER2- EBC across 20 countries were randomized in the trial 2,13 .
About Kisqali ® (ribociclib)
Kisqali ® (ribociclib) is a selective cyclin-dependent kinase inhibitor, a class of drugs that help slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6). These proteins, when over-activated, can enable cancer cells to grow and divide too quickly. Targeting CDK4/6 with enhanced precision may play a role in ensuring that cancer cells do not continue to replicate uncontrollably.
Kisqali was approved as a treatment for early breast cancer by the U.S. Food and Drug Administration (FDA) in September 2024 5 . Regulatory reviews for Kisqali as an EBC treatment are ongoing worldwide, including in the EU and China .
Kisqali has been approved as a treatment for metastatic breast cancer (MBC) patients in 99 countries worldwide, including by the U.S. FDA and the European Commission 14,15 . In the U.S., Kisqali is indicated for the treatment of adults with HR+/HER2- advanced or MBC in combination with an AI as initial ET or fulvestrant as initial ET or following disease progression on ET in post-menopausal women or in men 14 . In the EU, Kisqali is approved for the treatment of women with HR+/HER2- advanced or MBC in combination with either an AI or fulvestrant as initial ET or following disease progression 15 . In pre- or peri-menopausal women, the ET should be combined with a luteinizing hormone-releasing hormone agonist 14,15 .
In MBC, Kisqali has consistently demonstrated statistically significant overall survival benefit across three Phase III trials 16-26 . The NCCN Guidelines ® for breast cancer recommend ribociclib (Kisqali) as the only Category 1 preferred CDK4/6 inhibitor for first-line treatment of people living with HR+/HER2- when combined with an AI, making Kisqali the preferred first-line treatment of choice for US prescribers in HR+/HER2- MBC 27 . Additionally, Kisqali has the highest rating of any CDK4/6 inhibitor on the ESMO Magnitude of Clinical Benefit Scale, achieving a score of five out of five for first-line pre-menopausal patients with HR+/HER2- advanced breast cancer 28 . Further, Kisqali in combination with either letrozole or fulvestrant has uniquely, among other CDK4/6 inhibitors, received a score of four out of five for post-menopausal patients with HR+/HER2- advanced breast cancer treated in the first line 29 .
Kisqali was developed by Novartis under a research collaboration with Astex Pharmaceuticals.
Please see full Prescribing Information for Kisqali, available at www.Kisqali.com
About Novartis in Breast Cancer
For more than 30 years, Novartis has been at the forefront of driving scientific advancements for people touched by breast cancer and improving clinical practice in collaboration with the global community. With one of the most comprehensive breast cancer portfolios and pipeline, Novartis leads the industry in discovery of new therapies and combinations in HR+/HER2- breast cancer, the most common form of the disease.
Indication
What is KISQALI?
KISQALI ® (ribociclib) is a prescription medicine used to treat adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer:
- in combination with an aromatase inhibitor for stage II and III early breast cancer with a high risk of coming back
- that has gotten worse or has spread to other parts of the body (advanced or metastatic breast cancer) in combination with:
- an aromatase inhibitor as the first endocrine-based therapy; or
- fulvestrant as the first endocrine-based therapy or following disease progression on endocrine therapy
It is not known if KISQALI is safe and effective in children.
IMPORTANT SAFETY INFORMATION
KISQALI may cause serious side effects, including:
Lung problems. KISQALI may cause severe or life-threatening inflammation of the lungs during treatment that may lead to death. Tell your health care provider right away if you have any new or worsening symptoms, including:
- trouble breathing or shortness of breath
- cough with or without mucus
- chest pain
Severe skin reactions. Tell your health care provider or get medical help right away if you get severe rash or rash that keeps getting worse; reddened skin; flu-like symptoms; skin pain or burning, blistering of the lips, eyes, or mouth, blisters on the skin or skin peeling, with or without fever.
Heart rhythm problems (QT prolongation). KISQALI can cause a heart problem known as QT prolongation. This condition can cause an abnormal heartbeat and may lead to death.
- Your health care provider should check your heart and do blood tests before and during treatment with KISQALI
- Tell your health care provider right away if you have a change in your heartbeat (a fast or irregular heartbeat), or if you feel dizzy or faint
Liver problems. KISQALI can cause serious liver problems. Your health care provider should do blood tests to check your liver before and during treatment with KISQALI. Tell your health care provider right away if you get any of the following signs and symptoms of liver problems:
- yellowing of your skin or the whites of your eyes (jaundice)
- dark or brown (tea-colored) urine
- feeling very tired
- loss of appetite
- pain on the upper right side of your stomach area (abdomen)
- bleeding or bruising more easily than normal
Low white blood cell counts (neutropenia). Low white blood cell counts are very common during treatment with KISQALI and may result in infections that may be severe. Your health care provider should check your white blood cell counts before and during treatment with KISQALI. Tell your health care provider right away if you have signs and symptoms of low white blood cell counts or infections, such as fever and chills.
Your health care provider may tell you to decrease your dose, temporarily stop, or completely stop taking KISQALI if you develop certain serious side effects during treatment with KISQALI.
What should I tell my health care provider before taking KISQALI?
Before you take KISQALI, tell your health care provider if you:
- have any heart problems, including heart failure, irregular heartbeats, and QT prolongation
- have ever had a heart attack
- have a slow heartbeat (bradycardia)
- have high blood pressure that is not controlled
- have decreased thyroid gland (hypothyroidism)
- have problems with the amount of potassium, calcium, phosphorus, or magnesium in your blood
- have fever, chills, or any other signs or symptoms of infection
- have liver problems
- have kidney problems
- are pregnant, or plan to become pregnant. KISQALI can harm your unborn baby
- If you are able to become pregnant, your health care provider should do a pregnancy test before you start treatment with KISQALI
- Females who are able to become pregnant and who take KISQALI should use effective birth control during treatment and for at least 3 weeks after the last dose of KISQALI
- Talk to your health care provider about birth control methods that may be right for you during this time
- If you become pregnant or think you are pregnant, tell your health care provider right away
- are breastfeeding or plan to breastfeed. It is not known if KISQALI passes into your breast milk. Do not breastfeed during treatment with KISQALI and for at least 3 weeks after the last dose of KISQALI
Tell your health care provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. KISQALI and other medicines may affect each other, causing side effects. Know the medicines you take. Keep a list of them to show your health care provider or pharmacist when you get a new medicine.
What should I avoid while taking KISQALI?
Avoid eating grapefruit and avoid drinking grapefruit juice during treatment with KISQALI since these may increase the amount of KISQALI in your blood.
The most common side effects of KISQALI in people with early breast cancer include:
- decreased white blood cell counts
- decreased red blood cell counts
- increased liver function tests
- infections
- increased kidney function test
- decreased platelet counts
- nausea
- headache
- tiredness
The most common side effects of KISQALI in people with advanced or metastatic breast cancer include:
- decreased white blood cell counts
- decreased red blood cell counts
- increased liver function tests
- infections
- nausea
- increased kidney function test
- tiredness
- decreased platelet counts
- diarrhea
- vomiting
- headache
- constipation
- hair loss
- cough
- rash
- back pain
- low blood sugar level
KISQALI may cause fertility problems in males, which may affect your ability to father a child. Talk to your health care provider if this is a concern for you.
Tell your health care provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of KISQALI. For more information, ask your health care provider or pharmacist. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch , or call 1-800-FDA-1088.
Please see accompanying full Prescribing Information including Patient Information .
Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "may," "could," "would," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," "to reduce," "remains," "continue," "transform," "evaluate," "likelihood," "ensuring," "updates," "should," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for Kisqali in combination with an aromatase inhibitor (AI), or regarding potential future revenues from such product. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that Kisqali in combination with an AI will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that Kisqali in combination with an AI will be commercially successful in the future. In particular, our expectations regarding Kisqali in combination with an AI could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
About Novartis
Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.
Reimagine medicine with us: Visit us at https://www.novartis.com and https://www.novartis.us , and connect with us on LinkedIn , LinkedIn US , Facebook , X/Twitter , X/Twitter US and Instagram .
References
- European Medicines Agency (EMA). Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 October 2024 . October 18, 2024 . Accessed October 18, 2024 . https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp14- 17-october-2024
- Slamon D, Lipatov O, Nowecki Z, et al. Ribociclib plus Endocrine Therapy in Early Breast Cancer. N Engl J Med . 2024;390(12):1080-1091. doi:10.1056/NEJMoa2305488
- Pan H, Gray R, Braybrooke J, et al. 20-Year Risks of Breast-Cancer Recurrence after Stopping Endocrine Therapy at 5 Years. N Engl J Med . 2017;377(19):1836-1846. doi:10.1056/NEJMoa1701830
- Gomis RR, Gawrzak S. Tumor cell dormancy. Mol Oncol . 2017;11(1):62-78. doi:10.1016/j.molonc.2016.09.009
- Novartis. Press release. FDA approves Novartis Kisqali® to reduce risk of recurrence in people with HR+/HER2- early breast cancer. September 17, 2024 . Accessed October 15 , 2024. https://www.novartis.com/news/media-releases/fda-approves-novartis-kisqali-reduce-risk-recurrence-people-hrher2-early-breast-cancer
- Fasching PA. Adjuvant Ribociclib (RIB) Plus Nonsteroidal Aromatase Inhibitor (NSAI) in Patients (Pts) With HR+/HER2− Early Breast Cancer (EBC): 4-Year Outcomes From the NATALEE Trial. LBA13. Proffered Paper presented at the European Society for Medical Oncology Congress (ESMO); September 16, 2024 ; Barcelona, Spain
- The Global Cancer Observatory. Cancer Today: GLOBOCAN 2022 Europe. 2024. Accessed October 15, 2024 . https://gco.iarc.who.int/media/globocan/factsheets/populations/908-europe-fact-sheet.pdf
- American Cancer Society. Breast Cancer Facts & Figures 2019-2020. 2019. Accessed October 15. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/breast-cancer-facts-and-figures/breast-cancer-facts-and-figures-2019-2020.pdf
- Howlader N, Altekruse SF, Li CI, et al. US incidence of breast cancer subtypes defined by joint hormone receptor and HER2 status. J Natl Cancer Inst . 2014;106(5):dju055. doi:10.1093/jnci/dju055
- Criscitiello C, Spurden D, Piercy J, et al. Health-Related Quality of Life Among Patients With HR+/HER2- Early Breast Cancer. Clin Ther . 2021;43(7):1228-1244.e4. doi:10.1016/j.clinthera.2021.04.020
- Hortobagyi G, Stroyakovskiy D, Yardley DA, et al. Ribociclib (RIB) + nonsteroidal aromatase inhibitor (NSAI) as adjuvant treatment in patients with HR+/HER2- early breast cancer: final invasive disease-free survival (iDFS) analysis from the NATALEE trial. Presented at San Antonio Breast Cancer Symposium (SABCS); December 8, 2023 ; San Antonio , USA
- Slamon D, Stroyakovskiy D, Yardley D, et al. Ribociclib and endocrine therapy as adjuvant treatment in patients with HR+/HER2− early breast cancer: primary results from the Phase III NATALEE trial. Presented at the American Society of Clinical Oncology Annual Meeting (ASCO); June 2, 2023 ; Chicago , USA .
- Clinicaltrials.gov. NCT03701334. A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/ HER2- Early Breast Cancer (NATALEE). Updated October 10, 2024 . Accessed October 14 , 2024. https://clinicaltrials.gov/study/NCT03701334 .
- Kisqali. US FDA. Prescribing Information. Novartis Pharmaceuticals Corporation; 2024. Updated September 2024 . Accessed October 15, 2024 . https://www.novartis.com/us-en/sites/novartis_us/files/kisqali.pdf
- Kisqali. EMA. Summary of product characteristics (SmPC). Novartis Europharm Limited; 2024. Updated August 21, 2024 . Accessed October 15, 2024 . https://www.ema.europa.eu/en/documents/product-information/kisqali-epar-product-information_en.pdf
- Yardley DA, et al. Pooled exploratory analysis of survival in patients (pts) with HR+/HER2- advanced breast cancer (ABC) and visceral metastases (mets) treated with ribociclib (RIB) + endocrine therapy (ET) in the MONALEESA (ML) trials. Poster presented at the European Society of Medical Oncology Congress (ESMO); September 9-13, 2022 ; Paris, France
- Neven P, et al. Updated overall survival (OS) results from the first-line (1L) population in the Phase III MONALEESA-3 trial of postmenopausal patients with HR+/HER2- advanced breast cancer (ABC) treated with ribociclib (RIB) + fulvestrant (FUL). Mini oral presented at the European Society for Medical Oncology Breast Cancer Congress; May 4, 2022 ; Paris, France
- Hortobagyi GN, Stemmer SM, Burris HA, et al. Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer. N Engl J Med . 2022;386(10):942-950. doi:10.1056/NEJMoa2114663
- Hortobagyi GN, et al. Overall survival (OS) results from the phase III MONALEESA (ML)-2 trial of postmenopausal patients with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2−) advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib. LBA 17. Proffered paper presented at the European Society of Medical Oncology Congress (ESMO); September 16-21, 2021 ; Lugano, Switzerland
- Im SA, Lu YS, Bardia A, et al. Overall survival with ribociclib plus endocrine therapy in breast cancer. N Engl J Med . 2019;381(4):307-316. doi:10.1056/NEJMoa1903765
- Slamon DJ, Neven P, Chia S, et al. Overall Survival with Ribociclib plus Fulvestrant in Advanced Breast Cancer. N Engl J Med . 2020;382(6):514-524. doi:10.1056/NEJMoa1911149
- Slamon D, et al. Overall survival (OS) results of the Phase III MONALEESA-3 trial of postmenopausal patients (pts) with hormone receptor-positive (HR+), human epidermal growth factor 2-negative (HER2-) advanced breast cancer (ABC) treated with fulvestrant (FUL) ± ribociclib (RIB). LBA7_PR. Presented at the European Society of Medical Oncology Congress (ESMO); September 29, 2019 ; Barcelona, Spain
- Slamon D, et al. Updated overall survival (OS) results from the Phase III MONALEESA-3 trial of postmenopausal patients (pts) with HR+/HER2− advanced breast cancer (ABC) treated with fulvestrant (FUL) ± ribociclib (RIB). Presented at the American Society of Clinical Oncology Annual Meeting (ASCO); June 5, 2021 ; Chicago , USA
- Tripathy D, et al. Updated overall survival (OS) results from the phase III MONALEESA-7 trial of pre- or perimenopausal patients with HR+/HER2− advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib. Presented at the San Antonio Breast Cancer Symposium (SABCS); December 9, 2020 ; Texas, USA
- Yardley DA, et al. Overall survival (OS) in patients (pts) with advanced breast cancer (ABC) with visceral metastases (mets), including those with liver mets, treated with ribociclib (RIB) plus endocrine therapy (ET) in the MONALEESA (ML) -3 and -7 trials. Presented at the American Society of Clinical Oncology Annual Meeting (ASCO); May 29-31, 2020 ; Chicago , USA
- O'Shaughnessy J, et al. Overall survival subgroup analysis by metastatic site from the Phase III MONALEESA-2 study of first-line ribociclib + letrozole in postmenopausal patients with HR+/HER2− advanced breast cancer. Presented at the San Antonio Breast Cancer Symposium (SABCS); December 7-10, 2021 ; Texas, USA
- NCCN Guidelines. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) – Breast Cancer Version 4.2024. Updated July 3, 2024 . Accessed October 15, 2024 . https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf
- European Society for Medical Oncology. Magnitude of Clinical Benefit Scale Scorecard. Updated August 14, 2023 . Accessed October 15 , 2024. https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-scorecards/scorecard-158-1
- European Society for Medical Oncology. Magnitude of Clinical Benefit Scale Scorecard. Updated April 25, 2024 . Accessed October 15, 2025 . https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-scorecards/scorecard-9-1
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Harris vs. Trump: The 2024 US Election, Drug Prices and Healthcare
The exorbitant cost of pharmaceutical drugs in the US has been a contentious issue for years, with the Republican and Democrat parties overtly at odds on the best way to lower drug prices.
Despite the best efforts of lawmakers on both sides of the aisle, prescription drug prices are still on the rise. Figures from the US Department of Health and Human Services show a 15.2 percent increase in the cost of prescription drugs from 2022 to 2023, with an average of US$590 per drug.
In the lead up to the 2024 US general election, the pharmaceutical industry is buttering its bread on both sides with nearly equal contributions to both parties. Citing data from OpenSecrets, KFF Health News reported in late August that drug companies had donated US$4.89 million to Democrats’ coffers and US$4.35 million to Republicans.
About one-third of the total pharma company campaign contributions are attributable to the three top donors: Pfizer (NYSE:PFE), Merck (NYSE:MRK) and Eli Lilly & Co. (NYSE:LLY).
Narrowing down on the presidential candidates, data retrieved from OpenSecrets on October 2 shows that Vice President Kamala Harris has been the bigger beneficiary of donations, receiving US$1.12 million compared to US$204,748 for former President Donald Trump. Both candidates have promised to tackle the high price of prescription drugs.
Surprisingly, the issue only came up once during the September 10 presidential debate between Harris and Trump, when Harris discussed it in response to a question from moderators about her proposed healthcare plan.
How would a potential Harris administration tackle the challenge of lowering prescription drug prices? Would pharmaceutical companies fare better under a second Trump administration?
First, let’s take a look at the healthcare policies and initiatives enacted under Trump’s prior presidency and during the current Biden-Harris administration, and then we'll examine the current platforms of the two candidates.
The Trump administration's actions on healthcare and drug prices
Trump’s stance on lowering drug prices has been mostly at odds with the core of his fellow Republicans, which hamstrung his ability to implement his proposed policies.
Did Trump lower drug prices? Trump did have some success in lowering monthly insulin prices to US$35 for Medicare Part D plans, but only under a voluntary model. However, many of his other attempts failed to get off the ground for a variety of reasons.
“His efforts were largely fragmented and faced resistance from both the industry and lawmakers,” political strategist Sergio Jose Gutierrez, told KFF Health News. “The lack of a cohesive strategy and the limited ability to implement significant changes made his approach less effective compared to what a Harris-Walz administration could offer.”
Axios reports that while Trump’s staff did try to work with House Democrats on negotiating drug prices under Medicare, he would later reject the proposal, “embracing GOP arguments it would lead to fewer cures.”
One of Trump’s attempts at lowering drug prices was the Most Favored Nation model, which would have tied the cost of certain drugs under Medicare to their costs in other, comparable countries. However, it encountered roadblocks in the courts due to challenges from pharmaceutical companies and concerns about its impact on hospitals and practices. It was ultimately never implemented, and was rescinded by the Centers for Medicare & Medicaid Services in December 2021 following multiple comment periods.
Another healthcare move under Trump that faced opposition was a plan to import drugs from abroad, which was announced during his term but required Food and Drug Administration approval. Although in 2024 Florida ultimately became the first state to win federal approval to import prescription drugs from Canada, Health Canada has put up resistance, citing the need to safeguard the country’s own limited drug supply.
In another federal court challenge to the Trump administration, several Big Pharma companies — including Merck, Eli Lily and Amgen (NASDAQ:AMGN) — took issue with a US Health and Human Services (HHS) decree that televised drug ads must include the wholesale prices of the drugs advertised. As Reuters reported, the courts sided with the pharmaceutical companies' argument that the HHS lacked the authority to force them to publicly disclose list prices and that the list prices could discourage people from seeking treatment.
With regards to the Obama-era Affordable Care Act (ACA), former President Donald Trump has been a vocal critic of it in the ongoing healthcare debate. During his time in office, his administration made several attempts to weaken the ACA. For example, according to KFF Health News, “In 2017, (Trump) unsuccessfully attempted to repeal and replace the ACA with various plans that would have increased the number of uninsured Americans to 51 million.”
The Biden-Harris administration's actions on healthcare and drug prices
Even before Kamala Harris stepped into her role as US Vice President, she has been actively taking part in improving access to affordable healthcare and lower prescription drug prices. As a Senator, she guarded against Republican efforts to dismantle the ACA and co-sponsored the Medicare For All Act, which sought to establish a true single-payer healthcare model.
The Biden-Harris administration reversed the holes Trump tried to poke in the ACA; for example, restoring outreach and enrolment assistance as well as funding. On the flip side, Harris supported and the Biden administration approved Florida’s bid to access lower cost drugs from Canada.
In 2022, VP Harris helped to pass her administration’s Inflation Reduction Act (IRA), which includes an annual US$2,000 cap on total drug spending for Medicare beneficiaries as well as extending the US$35 cap on monthly insulin supplies put forward under Trump to Medicare Part B and all Medicare Part D recipients. On top of that, she cast the tie-breaking vote in the Senate in favor of legislation allowing Medicare to negotiate drug prices on the behalf of beneficiaries.
In August 2024, the government announced it had selected the first 10 drugs set to receive lower prices in 2026 — with discounts up to 79 percent — based on those negotiations. Many are indicated for diabetes and heart conditions, and are made by pharma giants such as Bristol-Myers Squibb (NYSE:BMY), Merck, AstraZeneca (NASDAQ:AZN), Novartis (NYSE:NVS,SWX:NOVN), Amgen and Johnson & Johnson (NYSE:JNJ). More drugs, specifically biologics, will face price cuts in 2028.
In terms of price regulation for drugs in the broader market, President Joe Biden warned drug companies back in December 2023 that if prices on certain drugs developed with federal funds become too high, the government may find it necessary to seize the patents and allow competitors to make them as well. “Drugmakers are almost certain to challenge the plan in court if it is enacted,” reported the Associated Press.
Harris' 2024 healthcare and drug price platform
Now that Kamala Harris is out on the campaign trail, her healthcare and drug price platform is taking shape.
One of the policy goals of a Harris Administration is expanding the US$2,000 annual cap on prescription drug spending now enjoyed by Medicare recipients to all Americans with insurance. She said as much during her September 10 presidential debate with Trump.
“Since I’ve been vice president, we have capped the cost of prescription medications for seniors at $2,000 a year,” Harris said. “And when I am president, we will do that for all people.”
VP Harris has also vowed to protect the Affordable Care Act. “When I am president, we will do that for all people, understanding that the value I bring to this is that access to health care should be a right and not just a privilege of those who can afford it, and the plan has to be to strengthen the Affordable Care Act, not get rid of it,” she declared during the televised presidential debate.
Under Harris, the Democrats’ healthcare platform also includes ensuring prices for “brand-name and outlier generic drugs” don’t outpace the rate of inflation. The party is also keen on preventing Big Pharma from colluding on prices or manipulating the patent system.
As part of her campaign promises, Harris has also proposed to quicken the pace of lowering prescription drug prices for Medicare recipients. If elected, her administration will focus on speeding up negotiations on cutting costs on “some of the most expensive and most commonly used drugs by nearly 40 (percent) to 80 (percent),” so these discounts would come into play in 2026.
During the October 1 VP debate, Harris' running mate Minnesota Governor Tim Walz reiterated her support for the ACA and held up the Medicare drug price negotiations under the Inflation Reduction Act as one of her great achievements during office.
"Kamala Harris negotiated drug prices for the first time with Medicare. We have 10 drugs that will come online, the most common ones that'll be there," he said.
Trump's running mate, Ohio Senator JD Vance, made some spurious claims about prescription drug prices only being up by 1.5 percent during the whole of Trump's first term compared to 7 percent during the Biden Administration.
CBS was quick to fact-check his statements, showing that the average annual cost of prescription drugs per person was up by 9 percent from 2017 to 2019 under Trump and up by 11 percent between 2020 and 2022 under Biden. Looking at median cost instead of average, the data shows that costs were down under both administrations.
Trump's 2024 healthcare and drug price platform
During his presidential debate with VP Kamala Harris, Trump once again voiced his strong opposition to the Affordable Care Act: “Obamacare was lousy health care — always was. It's not very good today."
While he admits his administration was unable to repeal the ACA despite dozens of attempts that were blocked by Democrats, he would rather “just let it rot.”
When asked if he had any concrete healthcare plan for the country, he replied his team only has “concepts of a plan,” are considering “different plans” and would reveal more "in the not-too-distant future."
Senator JD Vance didn't provide much detail about his potential administration's healthcare plan during his debate performance either, although he did promise "we're going to cover Americans with pre-existing conditions" when pressed by Walz about his opposition to ACA.
Some on the other side of the aisle have said all the public needs to know about Trump’s healthcare plan can be found in Project 2025, a policy initiative by the Heritage Foundation published in 2022. Since Ronald Reagan’s presidency, every four years the conservative think-tank has published a new batch of policy recommendations for the next Republican president.
Healthcare doesn’t get much space in the 900-plus page document, but what is addressed is the need to make dramatic changes to Medicaid, which serves low-income individuals and families, including repealing the law banning surprise medical billing. Also present are several directives aimed at curbing access to – and repealing FDA approval for – the abortion pill mifepristone, used in about half of US abortions, and the “week-after” contraceptive pill Ella. It also calls for the end of subsidies for stem cell or fetal cell research.
While Trump has disavowed Project 2025 and tried to distance himself from its authors, a large majority of its creators served in the first term of his administration. This includes prominent players such as Housing and Urban Development Secretary Ben Carson, acting Defense Secretary Chris Miller, deputy White House chief of staff Rick Dearborn, former Office of Management and Budget director Russ Vought and acting deputy secretary of the Department of Homeland Security Ken Cuccinelli.
Additionally, both Trump and the Heritage Foundation previously boasted that he enacted 64 percent of their recommendations within the first year of his presidency.
The 2024 GOP Platform document hosted on Trump’s campaign website states, “Healthcare and prescription drug costs are out of control. Republicans will increase Transparency, promote Choice and Competition, and expand access to new Affordable Healthcare and prescription drug options. We will protect Medicare, and ensure Seniors receive the care they need without being burdened by excessive costs.”
While VP Kamala Harris and former President Donald Trump may be on opposite sides of the debate when it comes to the Affordable Care Act, both candidates are supportive of bringing down prescription drug costs.
While KFF Health News notes that prescription drug prices have not been a topic at the forefront of Trump's campaign, they did report that those close to him say he “would likely retain Medicare price negotiations unless the pharmaceutical industry can come up with something more compelling that they’d put on the table.”
However, Axios reports that a number of high-ranking Republicans are dead set on repealing the Medicare drug price negotiations set out under the IRA.
“Trump has pledged to ‘take on Big Pharma’ through administrative actions like tying what Medicare pays to prices in other developed nations,” said the news agency. “But he could still be open to repealing the IRA drug price measures, and his campaign isn't elaborating.”
Other efforts a second-term Trump administration might take to reign in healthcare costs include placing caps on out-of-pocket insulin costs, importing US-made drugs that have been sold out of country and increasing competition among generic and biosimilar drugs.
According to KFF Health News, his administration may also seek to lower drug prices “in the Medicare 340B program, which requires drugmakers to provide outpatient drugs at reduced prices to eligible health organizations that serve lower-income and uninsured patients.”
It should be noted that in May 2024 US Court of Appeals for the District of Columbia ruled in favor of pharmaceutical companies, finding that they can limit their discounts under Medicare 340B.
As for the stalled Most Favored Nation model, one that is also supported by candidate Harris, Axios states that Trump has proposed taking executive action to make it a reality.
Investor takeaway
US federal election periods are often fraught with uncertainty for the life science sector. In the past, Republican administrations have been more favorable periods for pharmaceutical companies. However, as with most aspects of American politics and industry, Trump has changed the game. The election of either candidate poses risks for pharma stocks.
But, in terms of threats to drugmaker revenues and innovation, the Democrats’ push to more restrictive drug pricing regulations under Kamala Harris’ plans to expand the IRA present the bigger danger. The fact that nine out of the top ten pharma companies with the highest 2024 campaign contributions have donated more to the Democrats and VP Kamala Harris shows that the pharmaceutical industry is well aware of the risk and are hedging their bets. Since Harris is leading in the polls just a few weeks ahead of the election, currying favor with a future Harris-Walz administration may be in their best interest.
Don’t forget to follow @INN_LifeScience for real-time updates!
Securities Disclosure: I, Melissa Pistilli, hold no direct investment interest in any company mentioned in this article.
Amplia Therapeutics’ Narmafotinib Gets Fast-track Designation from FDA
The US Food and Drug Administration (FDA) has granted fast-track designation to narmafotinib, Amplia Therapeutics’ (ASX:ATX,OTC Pink:INNMF) lead drug for the treatment of advanced pancreatic cancer.
In a press release shared last Friday (September 20), the company explained that this designation will provide it with access to more frequent meetings and written communication with the FDA.
In the future, narmafotinib may also be able to receive accelerated approval and priority review from the FDA.
“With this designation, we can work more closely with the FDA to accelerate our clinical program and gather the most compelling evidence for regulatory approval in this devastating disease,” said Dr. Chris Burns, Amplia's CEO and managing director, also calling the news a signifiant milestone for the company.
Fast-track designation is granted to drugs that have the potential to offer an advantage over existing therapies for serious conditions. It helps speed development so patients in need can access them more quickly.
Narmafotinib is Amplia’s lead drug candidate. It is a highly selective and potent FAK inhibitor that has shown encouraging results in preclinical studies for the treatment of pancreatic and ovarian cancers.
Currently an ACCENT trial of narmafotinib is underway in Australia and South Korea. In the open-label Phase 2a trial, it is combined with chemotherapies gemcitabine and Abraxane to assess for safety, tolerability and efficacy.
Amplia was also cleared by the FDA for a trial of narmafotinib in pancreatic cancer in the US early this year, with the trial now in advanced planning stages. The FDA previously granted orphan drug designation to narmafotinib for pancreatic cancer, which Amplia said points to its promise in the treatment, prevention or diagnosis of rare diseases.
Don’t forget to follow us @INN_Australia for real-time news updates!
Securities Disclosure: I, Gabrielle de la Cruz, hold no direct investment interest in any company mentioned in this article.
Cardiol Therapeutics Achieves Target Patient Enrollment in its Phase II ARCHER Trial Investigating CardiolRx(TM) for Acute Myocarditis
Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, today announced it has achieved the target patient enrollment of 100 patients in "ARCHER", its Phase II randomized, double-blind, placebo-controlled trial evaluating the impact of CardiolRx™ on myocardial recovery in patients with acute myocarditis.
"We are pleased to have achieved our target patient enrollment in the ARCHER trial, which reflects the commitment and dedication of our clinical collaborators and participating patients. Reaching this milestone is integral to enhancing our understanding of the therapeutic impact of CardiolRx™ in acute myocarditis, a debilitating and potentially life-threatening inflammatory heart disease that significantly impairs cardiac function and patient quality of life," said Andrew Hamer, Cardiol Therapeutics' Chief Medical Officer and Head of Research & Development. "With topline results expected early next year the data from the ARCHER trial is anticipated to offer key insights concerning the effects of CardiolRx™ on myocardial recovery. Furthermore, we anticipate these findings will complement the clinical data from our MAvERIC Phase II study in recurrent pericarditis, the full results of which will be presented in November at the American Heart Association Scientific Sessions 2024."
ARCHER Study Design
The design and rationale for ARCHER were published June 27, 2024, in the journal ESC Heart Failure. ARCHER is a Phase II multi-national, randomized, double-blind, placebo-controlled trial investigating the safety, tolerability, and impact of CardiolRx™ on myocardial recovery in patients presenting with acute myocarditis. The study has an enrollment target of 100 patients to be recruited from pre-eminent cardiovascular research centers in the United States, Canada, France, Brazil, and Israel. The primary outcome measures of the trial, which will be evaluated following 12 weeks of double-blind therapy, consist of two cardiac magnetic resonance imaging measures: left ventricular function (longitudinal strain) and myocardial edema/fibrosis (extra-cellular volume), each of which has been shown to predict long-term prognosis of patients with acute myocarditis. Additional efficacy outcome measurements include survival, freedom from major cardiovascular events, resolution of clinical symptoms, and change in biomarkers associated with cardiac function and inflammation.
Acute Myocarditis
Acute myocarditis is an inflammatory condition of the heart muscle (myocardium) characterized by chest pain, shortness of breath at rest or during activity, fatigue, rapid or irregular heartbeat (arrhythmias), and light-headedness or the feeling one might faint. The disease is an important cause of acute and fulminant heart failure and is a leading cause of sudden cardiac death in people under 35 years of age. Viral infection is the most common cause of myocarditis; however, it can also result from bacterial infection and commonly used drugs and mRNA vaccines, as well as therapies used to treat several common cancers, including chemo-therapeutic agents and immune checkpoint inhibitors. There are no FDA-approved therapies for acute myocarditis. Patients hospitalized with the condition experience an average seven-day length of stay and a 4 - 6% risk of in-hospital mortality, with average hospital charge per stay estimated at $110,000 in the United States.
Cardiol believes there is a significant opportunity to develop an important new therapy for acute myocarditis that would also be eligible for designation as an orphan drug in the United States and the European Union. Orphan drug designation programs were established to provide life sciences companies with incentives to develop new therapies for rare diseases. These incentives include periods of prolonged marketing exclusivity and exemptions from certain fees. Products with orphan drug designation also frequently qualify for accelerated regulatory review.
About Cardiol Therapeutics
Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) is a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease. The Company's lead small molecule drug candidate, CardiolRx™ (cannabidiol) oral solution, is pharmaceutically manufactured and in clinical development for use in the treatment of heart disease. It is recognized that cannabidiol inhibits activation of the inflammasome pathway, an intracellular process known to play an important role in the development and progression of inflammation and fibrosis associated with myocarditis, pericarditis, and heart failure.
Cardiol has received Investigational New Drug Application authorization from the United States Food and Drug Administration ("US FDA") to conduct clinical studies to evaluate the efficacy and safety of CardiolRx™ in two diseases affecting the heart: (i) a Phase II multi-center open-label pilot study in recurrent pericarditis (the MAvERIC-Pilot study; NCT05494788), an inflammatory disease of the pericardium which is associated with symptoms including debilitating chest pain, shortness of breath, and fatigue, and results in physical limitations, reduced quality of life, emergency department visits, and hospitalizations; and (ii) a Phase II multi-national, randomized, double-blind, placebo-controlled trial (the ARCHER trial; NCT05180240) in acute myocarditis, an important cause of acute and fulminant heart failure in young adults and a leading cause of sudden cardiac death in people less than 35 years of age. The US FDA has granted Orphan Drug Designation to CardiolRx™ for the treatment of pericarditis, which includes recurrent pericarditis.
Cardiol is also developing CRD-38, a novel subcutaneously administered drug formulation intended for use in heart failure - a leading cause of death and hospitalization in the developed world, with associated healthcare costs in the United States exceeding $30 billion annually.
For more information about Cardiol Therapeutics, please visit cardiolrx.com.
Cautionary statement regarding forward-looking information:
This news release contains "forward-looking information" within the meaning of applicable securities laws. All statements, other than statements of historical fact, that address activities, events, or developments that Cardiol believes, expects, or anticipates will, may, could, or might occur in the future are "forward-looking information". Forward looking information contained herein may include, but is not limited to, statements relating to the Company's focus on developing anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, the molecular targets and mechanism of action of the Company's product candidates, the Company's intended clinical studies and trial activities and timelines associated with such activities, including for primary efficacy endpoint and secondary endpoints, the Company's anticipation that the results of the ARCHER trial are anticipated to offer key insights concerning the effects of CardiolRx™ on myocardial recovery, the Company's expectation that the results of the ARCHER trial will complement the Company's clinical data from the MAvERIC Phase II study in recurrent pericarditis, the Company's plans to present the full results of the MAvERIC Phase II study in November 2024 at the American Heart Association Scientific Sessions 2024, the Company's expectation that there is a significant opportunity to develop an important new therapy for acute myocarditis that would also be eligible for designation as an orphan drug in the United States and the European Union, and the Company's plan to advance the development of CRD-38, a novel subcutaneous formulation of cannabidiol intended for use in heart failure. Forward-looking information contained herein reflects the current expectations or beliefs of Cardiol based on information currently available to it and is based on certain assumptions and is also subject to a variety of known and unknown risks and uncertainties and other factors that could cause the actual events or results to differ materially from any future results, performance or achievements expressed or implied by the forward-looking information, and are not (and should not be considered to be) guarantees of future performance. These risks and uncertainties and other factors include the risks and uncertainties referred to in the Company's Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission and Canadian securities regulators on April 1, 2024, as well as the risks and uncertainties associated with product commercialization and clinical studies. These assumptions, risks, uncertainties, and other factors should be considered carefully, and investors should not place undue reliance on the forward-looking information, and such information may not be appropriate for other purposes. Any forward-looking information speaks only as of the date of this press release and, except as may be required by applicable securities laws, Cardiol disclaims any intent or obligation to update or revise such forward-looking information, whether as a result of new information, future events, or results, or otherwise.
For further information, please contact:
Trevor Burns, Investor Relations +1-289-910-0855
trevor.burns@cardiolrx.com
Tumour Response in Sixth Patient Triggers Additional Recruitment in Pancreatic Cancer Trial
Amplia Therapeutics Limited (ASX: ATX), (“Amplia” or the “Company”), is pleased to announce that the Company’s Phase 2a clinical trial investigating narmafotinib in the treatment of advanced pancreatic cancer (the ACCENT trial) has achieved the required response rate to support continued enrolment in the study. Six (6) patients have now recorded confirmed partial responses (PRs) out of 16 assessed at the four-month timepoint, indicating that the combination of narmafotinib with the chemotherapies gemcitabine and Abraxane® is sufficiently active to support continuation of the trial.
HIGHLIGHTS
- Six (6) patients in the Company’s ACCENT trial in pancreatic cancer have now achieved the required reduction in tumour size with no detection of new lesions
- The ACCENT trial can now proceed to recruit the next cohort of 24 patients, giving a total of 50 patients on study
- The ACCENT trial explores the activity of narmafotinib, in combination with standard-of-care chemotherapy, in advanced pancreatic cancer patients
A total of 50 patients are planned for the Phase 2a ACCENT trial. With the six (6) confirmed PRs now obtained, recruitment of the remaining 24 patients in the trial will begin at the existing open trial sites in Australia and South Korea. Recruitment of the second cohort of patients is expected to be completed by end of Q1 2025.
A detailed interim analysis of the Phase 2a trial data obtained to date will be reported in the coming weeks; however, key points are noted below:
- Narmafotinib continues to be generally well tolerated by patients with no safety trends identified or dose reductions recorded to date
- In addition to 6 confirmed PRs, there have been 7 patients who have recorded stable disease over 2 or more months, including one patient whose stable disease has improved to achieve a partial response at their 4-month assessment
Amplia CEO and MD Dr Chris Burns commented: “Having now confirmed our sixth PR, we will move forward with recruiting the remaining 24 patients for the trial. We are actively working with our clinical sites to ensure seamless reopening of enrolment with the goal of completing recruitment by the end of March 2025. As always, we thank the patients and their loved ones for being involved with this trial"
This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics.
Click here for the full ASX Release
This article includes content from Amplia Therapeutics, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
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