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Investing Guides
FDA Fast Track Designation for Narmafotinib in Advanced Pancreatic Cancer
September 19, 2024
Amplia Therapeutics Limited (ASX: ATX), (“Amplia” or the “Company”), is pleased to announce that the United States Food and Drug Administration (FDA) has granted Fast Track Designation to Amplia’s Focal Adhesion Kinase inhibitor, narmafotinib, for the treatment of advanced pancreatic cancer.
HIGHLIGHTS
- The US FDA has granted Fast Track Designation to Amplia’s lead drug narmafotinib in advanced pancreatic cancer
- Fast Track Designation facilitates the development of investigational drugs and allows for expedited review
Fast Track Designation is available to drugs that may provide an advantage over current therapies in the treatment of serious conditions. It is designed to speed the development of these drugs to enable patients to receive them sooner. This Designation will grant the Company access to more frequent meetings, and written communication, with the FDA. In future, narmafotinib may be eligible for Accelerated Approval and Priority Review. The Company has previously received Orphan Drug Designation from the FDA for narmafotinib in pancreatic cancer.
The Company’s CEO and Managing Director, Dr Chris Burns, commented, “Fast Track Designation for narmafotinib is a significant milestone for the Company. 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.”
Amplia’s clinical trial in advanced pancreatic cancer, the ACCENT trial, is ongoing in Australia and South Korea. Earlier this year, the Company announced that the US FDA had cleared its IND1 application for a trial of narmafotinib in pancreatic cancer in the US. This trial is in advanced planning stages.
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.
15 October
Invion Limited Notification of Security Consolidation or Split
Invion Limited's (ASX: IVX) (“Invion” or the “Company”) notification of security consolidation or split.
ANNOUNCEMENT SUMMARY
Applicable security for the reorganisation
IVX ORDINARY FULLY PAID
IVXAX OPTION EXPIRING 22-OCT-2024 EX $0.0177
IVXAZ OPTION EXPIRING 31-OCT-2024 EX $0.0106
IVXAAK OPTION EXPIRING 01-MAY-2026 EX $0.01
IVXAAJ OPTION EXPIRING 13-JAN-2026 EX NIL
IVXAAC OPTION EXPIRING 23-SEP-2025 EX $0.017
IVXAAI OPTION EXPIRING 17-NOV-2026 EX NIL
IVXAAM OPTION EXPIRING 28-NOV-2026 EX $0.01
IVXAAL OPTION EXPIRING 01-DEC-2026 EX $0.01
Announcement Type
New Announcement
Date of this announcement
15/10/2024
Reorganisation type
Security consolidation
Trading in the post consolidation or split +securities commences on a deferred settlement basis
20/11/2024
Record Date
21/11/2024
Issue Date
28/11/2024
Click here for the full ASX Release
This article includes content from Invion Limited, 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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02 October
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.
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25 September
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.
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25 September
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
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23 September
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
The formal term ‘confirmed partial response’ means in these patients there is at least a 30% decrease in the overall size of tumour lesions, with no new tumour lesions, sustained over a two-month period.
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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18 September
Pharma Stocks: 5 Biggest Companies in 2024
The pharmaceutical industry is a major player in the overall life science sector, responsible for developing and manufacturing the majority of prescription drugs.
Companies in this space are constantly researching and creating innovative treatments for various medical conditions. In recent years, there has been a particular focus on developing new treatments for diabetes, weight loss and cancer.
With the pharmaceutical sector projected to reach a staggering US$1.6 trillion in total revenue by 2028, there is an opportunity for investors to gain exposure to the growth potential of this industry while also benefiting from the diversification and stability provided by established companies.
With that in mind, the Investing News Network has compiled a list of the five biggest drug companies by market cap. Data for this article was compiled using TradingView's stock screener on September 18, 2024.
1. Eli Lilly and Company (NYSE:LLY)
Market cap: US$860.11 billion
Founded in 1876, Eli Lilly and Company employs approximately 10,000 individuals for research and development in seven countries and has products marketed in 110 countries, including therapies for diabetes, cancer, immune system diseases and a wide range of mental health conditions. The company also has drugs in development for various medical conditions, such as skin ailments, cancers, Crohn's disease, diabetes, obesity and Alzheimer's disease.
Eli Lilly's Alzheimer's disease drug donanemab completed its Phase 3 trial in May 2023, with test results showing "significant" slowing of cognitive and functional decline for people with early symptoms of the disease. The drug, sold under the name Kisunla, was approved by the US Food and Drug Administration on July 2, 2024.
2. Novo Nordisk (NYSE:NVO)
Market cap: US$594.89 billion
Danish company Novo Nordisk has demonstrated a commitment to addressing various health conditions, such as type I and II diabetes, obesity, hemophilia and growth disorders, and markets its therapies in 170 countries. The company's main product is the diabetes drug Ozempic, which is also marketed for obesity under the name Wegovy
It has been conducting research into a new obesity treatment called amycretin, which targets both GLP-1 and amylin receptors. Phase 2 trials are ongoing, but early-stage results show that volunteers taking amycretin have lost up to 13.1 percent of their body weight after 12 weeks, compared to 6 percent seen in patients taking Wegovy, which only targets GLP-1, according to the company.
Novo Nordisk has a working partnership with Microsoft (NYSE:MSFT) through which it uses the tech giant's artificial intelligence (AI), cloud and computational services to facilitate the discovery of new drugs and treatments. The firm announced in March it will work with AI heavyweight NVIDIA (NASDAQ:NVDA) to build the Danish Center for AI Innovation, which will host an NVIDIA supercomputer and will run on 100 percent renewable energy.
3. Johnson & Johnson (NYSE:JNJ)
Market cap: US$399.96 billion
Johnson & Johnson operates on a massive scale and encompasses various segments through its subsidiaries. Its primary pharmaceutical subsidiary is Janssen Pharmaceuticals, which focuses on cardiovascular disease and metabolism, infectious diseases and vaccines, neuroscience, oncology, immunology and pulmonary hypertension.
Johnson & Johnson acquired a clinical-stage biopharmaceutical company called Ambrx Biopharma on July 3, which will allow the company to further develop antibody-drug conjugates, expanding its offering of targeted oncology therapies.
On January 30, following positive data from a Phase III study, the company submitted its drug Darzalex Faspro to the FDA for the treatment of newly diagnosed multiple myeloma in patients who are eligible to receive a transplant. The agency approved the treatment on July 30. The same request was submitted to the European Medicines Agency on March 4, but it has not received approval there at the time of this writing.
4. Merck & Company (NYSE:MRK)
Market cap: US$300.73 billion
Merck & Company has an extensive portfolio of products, including treatments for conditions such as diabetes and cancer, as well as vaccines for a variety of diseases.
Merck has a robust research and development pipeline, with over 80 programs currently in Phase II trials, over 30 in Phase III trials and more than 10 under review. The company is actively pursuing treatments for a range of conditions, including HIV, Ebola, hepatitis C, cardio-metabolic disease and antibiotic-resistant infections.
On March 13, Merck revealed plans to develop a new version of its human papillomavirus (HPV) vaccine Gardasil; it will be a multi-valent vaccine that will protect against more strains of HPV. The company also plans to run a separate trial to evaluate the results of a single dose of Gardasil 9, its current vaccine, compared to the previous three-dose regimen. Merck intends to begin the two trials in the fourth quarter of 2024.
On September 18, the FDA approved Merck's cancer drug Keytruda for the treatment of unresectable advanced or metastatic malignant pleural mesothelioma (MPM) in adult patients, in combination with pemetrexed and platinum chemotherapy.
5. AbbVie (NYSE:ABBV)
Market cap: US$340.8 billion
AbbVie is a global biopharmaceutical company that discovers and delivers innovative medicines and solutions to address complex health issues. The company has identified five areas of focus where it believes it can make a significant impact in improving treatments for patients: immunology, oncology, neuroscience, eye care and aesthetics.
Its biggest performer was Humira, a therapy for autoimmune conditions such as rheumatoid arthritis and Crohn's disease, but its exclusivity ended in 2023 and biosimilars have now entered the market.
On February 28, AbbVie announced a strategic partnership with OSE Immunotherapeutics (LSE:0RAD,EPA:OSE), a clinical-stage immunotherapy company, to develop a monoclonal antibody to treat chronic and severe inflammation.
"This collaboration underscores our commitment to expanding our immunology portfolio with the ultimate goal of improving the standard of care for patients living with inflammatory diseases globally," said Jonathon Sedgwick, PhD, senior vice president and global head of discovery research at AbbVie.
The firm cemented that point with the March 25 news that it has entered a definitive agreement to acquire Landos Biopharma (NASDAQ:LABP), a clinical-stage biopharma company that develops oral therapeutics for autoimmune diseases.
AbbVie declared a quarterly dividend of US$1.55 per share on September 6, payable on November 15, 2024.
FAQs for pharmaceutical stocks
What does the pharmaceutical industry do?
The pharmaceutical industry encompasses a variety of companies that have different — although sometimes overlapping — roles to play. The most famous players are the "Big Pharma" companies. These giants often have a variety of subsidiaries, large pipelines and many products in their portfolios.
There are also smaller pharma R&D companies, which sometimes get acquired by larger firms if their work seems promising. Companies in these categories research, develop and bring to market drugs aimed at filling unmet needs, or helping people who are resistant to pre-existing treatments.
Once patents run out on prescription drugs, generic drug manufacturers create much cheaper generic versions. Wholesale companies also play a large role in the pharma sector. According to Common Wealth Fund, wholesalers have four areas through which they affect drug buying and distribution: "setting generic drug prices, leveraging list price increases, competing in specialty drug distribution, and mitigating or exacerbating drug shortages."
What is the big pharma business model?
Big Pharma companies have a fairly consistent business model. Often, the company's R&D team will slowly develop a new drug through many stages of testing to prove the drug's efficacy, safety and necessity.
If all trials are completed successfully, the company will apply to government organizations such as the FDA, which must approve the drug before it can be mass produced, marketed and sold. Companies can skip a number of these steps by acquiring smaller companies, or through in-licensing, which results in two companies sharing the burden of a drug's development through to commercialization. However, it's worth noting that large pharma companies have many drugs in their pipelines at any given time, and many don't make it to approval.
Once a drug is approved by the relevant health organization, it can be marketed and prescribed. Because patents expire after 20 years, companies lobby and advertise to try to get as many sales as possible during that window.
Who are the "Big 3" in pharma?
The "Big 3" in pharma refers to the three largest wholesalers: AmerisourceBergen (NYSE:ABC), Cardinal Health (NYSE:CAH) and McKesson (NYSE:MCK). Collectively, those three companies account for over 92 percent of wholesale prescription drug distribution in the US.
Which country is number one in the pharma industry?
The US is the top pharmaceutical country, with five of the top 10 pharma companies by revenue headquartered in the nation. The country is also in the lead when it comes to consumer spending on pharmaceuticals — this is due to the high cost of brand-name drugs. Aside from that, the US is the top country globally for R&D spending — companies that are part of PhRMA, a trade group that represents US biopharmaceutical companies, spent US$100.84 billion on R&D in 2022 out of a total of US$244 billion spent by pharmaceutical companies globally that year.
What are the problems in the pharmaceutical industry?
One of the largest problems with the pharmaceutical industry, particularly in the US, is the high cost of treatments. According to a study looking at American prescription drug spending between 2016 and 2021, prescription drug prices were 2.5 times the cost on average of prices in similar high-income nations.
In early 2023, US President Joe Biden signed the Inflation Reduction Act (IRA) into law intending to reduce healthcare costs and improve access to medications for patients; however, it may present new challenges and opportunities for pharmaceutical companies as they adapt to the evolving regulatory and market landscape.
Critics have argued that the IRA could negatively impact drug development and innovation due to additional regulatory hurdles and increased operational costs, potentially reducing the incentive to invest in R&D. Additionally, the IRA requires drug companies to pay rebates to Medicare if they raise the price of drugs faster than inflation. If the industry can't adjust its prices in response to market conditions, it could deter investment in new drug development.
What is the future of pharmaceuticals?
Pharmaceutical companies will have to adapt to changing times. The world is shifting, with economic woes, geopolitical disruptions and supply chain concerns affecting nearly every sector. Innovation continues to accelerate as well, and the medical landscape has changed in the wake of COVID-19. Additionally, the US government is making moves to address the astronomical prices of prescription medicine as the industry comes under more scrutiny.
For a look at what is else is effecting the market, read our 2024 Pharma Market Forecast.
Are pharmaceutical stocks risky?
While established players like the Big Pharma and wholesale companies discussed above should be relatively consistent, small companies are make-or-break depending on whether their drugs are successful. This means that investors could see much higher returns compared to large companies, but run the risk of taking massive losses in the case of failure.
This is an updated version of an article originally published by the Investing News Network in 2016.
Don’t forget to follow @INN_LifeScience for real-time updates!
Securities Disclosure: I, Meagen Seatter, hold no direct investment interest in any company mentioned in this article.
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