Pure Life Healthcare Management aims to change the healthcare landscape for people suffering from post-traumatic stress disorder (PTSD) with more than 20 services to support PTSD and trauma, creating a wrap-around healthcare ecosystem that provides patients with everything they need to heal.
The company is backed by an experienced team with a deep understanding of issues surrounding mental health. It is also structured to leverage its own value chain, which includes wrap-around care clinics, occupational therapy, alternative medical treatments, pharmacies and partnerships with organizations such as Heroes Haven Society.
Key Services and PartnershipsPure Life Healthcare Management’s wraparound approach to healthcare will provide support throughout the entire healing process, from counseling and medical testing to dentistry and physiotherapy. The majority of clients are expected to require only a light to medium touch, with one to six visits per month. However, Pure Life also expects a minority of highly complex cases which will require up to $100,000 annually per client with 10 to 20 visits per month.
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Continued enrollment globally in multiple clinical studies of vepdegestrant in ER+HER2- metastatic breast cancer, including the VERITAC-2 Phase 3 trial in the second-line setting and the study lead-in for the VERITAC-3 Phase 3 trial in the first-line setting –
– Top-line data readout for VERITAC-2 remains on-track for 2H 2024 –
– Entered a transaction with Novartis providing an exclusive license for ARV-766 and sale of preclinical AR-V7 program; $150 million upfront payment and potential for up to $1.01 billion in milestones and royalties under license agreement –
– Initiated dosing in a first-in-human Phase 1 clinical trial with ARV-102, the first oral PROTAC® degrader in clinical development to treat neurodegenerative diseases –
NEW HAVEN, Conn., May 07, 2024 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today reported financial results for the first quarter ended March 31, 2024 and provided a corporate update.
"Our recently announced agreement with Novartis creates significant value for Arvinas and further validates our innovative PROTAC protein degrader platform and its potential to deliver important new treatment options for patients," said John Houston, Ph.D., Chairperson, President and Chief Executive Officer at Arvinas. "In addition to this strategic transaction, and together with Pfizer, we continued making meaningful progress advancing our Phase 3 clinical programs with vepdegestrant in ER+/HER2- metastatic breast cancer. During the quarter we also advanced ARV-102, our first PROTAC degrader with the potential to treat neurodegenerative diseases, into a Phase 1 clinical trial and we remain on track to initiate a first-in-human Phase 1 clinical trial with ARV-393, our BCL6 targeting PROTAC degrader, by the end of the second quarter. We also further strengthened our management team with key hires as we approach our first Phase 3 readout and continue progressing multiple ongoing and planned clinical-stage programs."
Recent Developments and First Quarter Business Highlights
Strategic Transaction with Novartis
Vepdegestrant
Pipeline
Corporate
Anticipated Upcoming Milestones and Expectations
Vepdegestrant
As part of Arvinas' global collaboration with Pfizer, the companies plan to:
ARV-766
Pipeline
Financial Guidance
Based on its current operating plan, Arvinas believes its cash, cash equivalents, restricted cash and marketable securities as of March 31, 2024, is sufficient to fund planned operating expenses and capital expenditure requirements into 2027.
First Quarter Financial Results
Cash, Cash Equivalents and Marketable Securities Position : As of March 31, 2024, cash, cash equivalents, restricted cash and marketable securities were $1,174.8 million as compared with $1,266.5 million as of December 31, 2023. The decrease in cash, cash equivalents, restricted cash and marketable securities of $91.7 million for the three months ended March 31, 2024, was primarily related to cash used in operations of $92.1 million, unrealized losses on marketable securities of $1.3 million and leasehold improvements of $0.1 million, partially offset by proceeds from the exercise of stock options of $1.8 million.
Research and Development Expenses: Research and development expenses were $84.3 million for the quarter ended March 31, 2024, as compared with $95.3 million for the quarter ended March 31, 2023. The decrease in research and development expenses of $11.0 million for the quarter was primarily due to a decrease in expenses related to our AR program (which includes ARV-766 and bavdegalutamide (ARV-110)) of $8.2 million, our ER program (which includes the cost sharing of vepdegestrant under the Vepdegestrant (ARV-471) Collaboration Agreement) of $2.3 million and our platform and exploratory programs of $0.5 million.
General and Administrative Expenses: General and administrative expenses were $24.3 million for the quarter ended March 31, 2024, as compared with $24.9 million for the quarter ended March 31, 2023. The decrease of $0.6 million was primarily due to a decrease in personnel and infrastructure related costs of $2.4 million, partially offset by an increase in professional fees of $1.3 million and increases related to establishing our commercial operations of $0.6 million.
Revenues: Revenues were $25.3 million for the quarter ended March 31, 2024 as compared with $32.5 million for the quarter ended March 31, 2023. Revenue is related to the Vepdegestrant (ARV-471) Collaboration Agreement, the collaboration and license agreement with Bayer, the collaboration and license agreement with Pfizer, the amended and restated option, license and collaboration agreement with Genentech and revenue related to our Oerth Bio joint venture. The decrease in revenue of $7.2 million was primarily due to a decrease in revenue from the Vepdegestrant (ARV-471) Collaboration Agreement of $12.5 million, a decrease of $1.8 million related to the conclusion of the performance period under the collaboration agreement with Genentech and a decrease of $1.1 million of previously constrained deferred revenue related to our Oerth Bio joint venture, offset in part by year over year increases in revenue of $5.5 million and $2.6 million from our collaboration and license agreements with Bayer and Pfizer, respectively, due to changes in estimates in 2023 of the performance period duration resulting from updated research timelines.
About Vepdegestrant (ARV-471)
Vepdegestrant is an investigational, orally bioavailable PROTAC protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of patients with ER positive (ER+)/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer. Vepdegestrant is being developed as a potential monotherapy and as part of combination therapy across multiple treatment settings for ER+/HER2- metastatic breast cancer.
In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialization of vepdegestrant; Arvinas and Pfizer will share worldwide development costs, commercialization expenses, and profits.
Vepdegestrant has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the investigation of vepdegestrant for monotherapy in the treatment of adults with ER+/HER2- locally advanced or metastatic breast cancer previously treated with endocrine-based therapy.
About ARV-766
ARV-766 is an investigational orally bioavailable PROTAC protein degrader designed to selectively target and degrade the androgen receptor (AR). Preclinically, ARV-766 has demonstrated activity in models of wild type androgen receptor tumors in addition to tumors with AR mutations or amplification, both common potential mechanisms of resistance to currently available AR-targeted therapies.
About Arvinas
Arvinas is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC targeted protein degraders, that are designed to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. In addition to its robust preclinical pipeline of PROTAC protein degraders against validated and "undruggable" targets, the company has four investigational clinical-stage programs: vepdegestrant (ARV-471) for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer; ARV-766 and bavdegalutamide for the treatment of patients with metastatic castration-resistant prostate cancer; and ARV-102 for the treatment of patients with neurodegenerative disorders. For more information, visit www.arvinas.com .
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties, including statements regarding: the expected timing in connection with the completion of enrollment and readout of top-line data from the VERITAC-2 clinical trial; the expected timing of the initiation of a first-in-human Phase 1 clinical trial with ARV-393; the potential of Arvinas' PROTAC protein degrader platform and its potential to deliver new treatment options to patients; Arvinas' and Pfizer, Inc.'s ("Pfizer") plans to determine the recommended Phase 3 dose of palbociclib to be administered in combination with vepdegestrant from the study-lead in of the VERITAC-3 Phase 3 trial of vepdegestrant and palbociclib; Arvinas' and Pfizer's plans to initiate a discussion with regulatory authorities on a second-line Phase 3 trial of vepdegestrant in combination with palbociclib and potentially other CDK4/6 inhibitors, and a new first-line Phase 3 trial of vepdegestrant plus atirmociclib; the closing of the transaction with Novartis and the receipt of upfront, milestone, and royalty payments in connection with the transaction and the future development, potential marketing approval and commercialization of ARV-766; and statements regarding Arvinas' cash, cash equivalents, restricted cash and marketable securities. All statements, other than statements of historical fact, contained in this press release, including statements regarding Arvinas' strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
Arvinas may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on such forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements Arvinas makes as a result of various risks and uncertainties, including but not limited to: Arvinas' and Pfizer's performance of the respective obligations with respect to Arvinas' collaboration with Pfizer; whether Arvinas and Pfizer will be able to successfully conduct and complete clinical development for vepdegestrant; whether Arvinas will be able to successfully conduct and complete development for its other product candidates, including ARV-766, and including whether Arvinas initiates and completes clinical trials for its product candidates and receive results from its clinical trials on its expected timelines or at all; whether Arvinas and Pfizer, as appropriate, will be able to obtain marketing approval for and commercialize vepdegestrant, ARV-766 and other product candidates on current timelines or at all; the satisfaction or waiver of the closing conditions set forth in the license agreement with Novartis, each party's performance of its obligations under the license agreement; whether Novartis will be able to successfully conduct and complete clinical development, obtain marketing approval for and commercialize ARV-766; Arvinas' ability to protect its intellectual property portfolio; whether Arvinas' cash and cash equivalent resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; and other important factors discussed in the "Risk Factors" section of Arvinas' Annual Report on Form 10-K for the year ended December 31, 2023 and subsequent other reports on file with the U.S. Securities and Exchange Commission. The forward-looking statements contained in this press release reflect Arvinas' current views with respect to future events, and Arvinas assumes no obligation to update any forward-looking statements, except as required by applicable law. These forward-looking statements should not be relied upon as representing Arvinas' views as of any date subsequent to the date of this release.
Contacts
Investors:
Jeff Boyle
+1 (347) 247-5089
Jeff.Boyle@arvinas.com
Media:
Kathleen Murphy
+1 (760) 622-3771
Kathleen.Murphy@arvinas.com
| Arvinas, Inc. | |||||||
| Condensed Consolidated Balance Sheets (Unaudited) | |||||||
| (dollars and shares in millions, except per share amounts) | March 31, 2024 | December 31, 2023 | |||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 88.0 | $ | 311.7 | |||
| Restricted cash | 5.5 | 5.5 | |||||
| Marketable securities | 1,081.3 | 949.3 | |||||
| Other receivables | 7.1 | 7.2 | |||||
| Prepaid expenses and other current assets | 8.4 | 6.5 | |||||
| Total current assets | 1,190.3 | 1,280.2 | |||||
| Property, equipment and leasehold improvements, net | 10.4 | 11.5 | |||||
| Operating lease right of use assets | 2.0 | 2.5 | |||||
| Collaboration contract asset and other assets | 9.9 | 10.4 | |||||
| Total assets | $ | 1,212.6 | $ | 1,304.6 | |||
| Liabilities and stockholders' equity | |||||||
| Current liabilities: | |||||||
| Accounts payable and accrued liabilities | $ | 76.4 | $ | 92.2 | |||
| Deferred revenue | 162.9 | 163.0 | |||||
| Current portion of operating lease liabilities | 1.5 | 1.9 | |||||
| Total current liabilities | 240.8 | 257.1 | |||||
| Deferred revenue | 361.0 | 386.2 | |||||
| Long term debt | 0.7 | 0.8 | |||||
| Operating lease liabilities | 0.4 | 0.5 | |||||
| Total liabilities | 602.9 | 644.6 | |||||
| Stockholders' equity: | |||||||
| Preferred stock, $0.001 par value, zero shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively | — | — | |||||
| Common stock, $0.001 par value; 68.3 and 68.0 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively | 0.1 | 0.1 | |||||
| Accumulated deficit | (1,402.1 | ) | (1,332.7 | ) | |||
| Additional paid-in capital | 2,016.1 | 1,995.7 | |||||
| Accumulated other comprehensive loss | (4.4 | ) | (3.1 | ) | |||
| Total stockholders' equity | 609.7 | 660.0 | |||||
| Total liabilities and stockholders' equity | $ | 1,212.6 | $ | 1,304.6 | |||
| Arvinas, Inc. | |||||||
| Condensed Consolidated Statements of Operations (Unaudited) | |||||||
| For the Three Months Ended March 31, | |||||||
| (dollars and shares in millions, except per share amounts) | 2024 | 2023 | |||||
| Revenue | $ | 25.3 | $ | 32.5 | |||
| Operating expenses: | |||||||
| Research and development | 84.3 | 95.3 | |||||
| General and administrative | 24.3 | 24.9 | |||||
| Total operating expenses | 108.6 | 120.2 | |||||
| Loss from operations | (83.3 | ) | (87.7 | ) | |||
| Interest and other income | 14.0 | 6.5 | |||||
| Net loss before income taxes and loss from equity method investment | (69.3 | ) | (81.2 | ) | |||
| Income tax (expense) benefit | (0.1 | ) | 0.4 | ||||
| Loss from equity method investment | — | (1.1 | ) | ||||
| Net loss | $ | (69.4 | ) | $ | (81.9 | ) | |
| Net loss per common share, basic and diluted | $ | (0.97 | ) | $ | (1.54 | ) | |
| Weighted average common shares outstanding, basic and diluted | 71.7 | 53.3 | |||||
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Jamieson Wellness Inc. ("Jamieson Wellness" or the "Company") (TSX:JWEL) announced today that the Company will release its first quarter 2024 financial results after the market close on Thursday, May 9, 2024. The Company will host a conference call for investors at 5:00 p.m. Eastern Time to discuss the first quarter 2024 results.
The call can be accessed live over the telephone by dialing 1-800-717-1738 from Canada and the U.S. or 1-646-307-1865 from international locations. A replay will be available shortly after the call and can be accessed by dialing 1-844-512-2921 from Canada and the U.S. or 1-412-317-6671 from international locations. The passcode for the replay is 1179130 and it will be available until Thursday, May 23, 2024.
Interested parties may listen to a simultaneous webcast of the conference call by logging on via the Investor Relations section of the Company's website at https://investors.jamiesonwellness.com or directly at https://viavid.webcasts.com/starthere.jsp?ei=1667077&tp_key=cc51fada0b . A replay of the webcast will be available for approximately 12 months following the call.
About Jamieson Wellness Inc.
Jamieson Wellness is dedicated to Inspiring Better Lives Every Day with its portfolio of innovative natural health brands. Established in 1922, the Jamieson brand is Canada's #1 vitamins, minerals and supplements ("VMS") brand. The Company's youtheory brand, acquired in 2022, is an established and growing lifestyle brand in the U.S. Combined, these global brands are available in more than 50 countries worldwide. The Company also offers a variety of innovative VMS products as well as sports nutrition products to consumers in Canada with its Progressive, Smart Solutions, Iron Vegan and Precision brands. The Company is a participant of the United Nations Global Compact and adheres to its principles-based approach to responsible business. For more information please visit www.jamiesonwellness.com .
Source: Jamieson Wellness Inc.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240423673211/en/
Investor and Media:
Ruth Winker
Jamieson Wellness
416-960-0052
rwinker@jamiesonlabs.com
News Provided by Business Wire via QuoteMedia
Pure Life Healthcare Management (PLHM) aims to change the healthcare landscape for people suffering from post-traumatic stress disorder (PTSD) by providing integrated, wrap-around care that responds to the unique needs of this significantly underserved population.
Over 1.3 million people in Canada live with some form of PTSD or trauma. Many are veterans, first responders, healthcare providers and social workers. In lieu of trying to heal, many simply keep pushing forward, either unable to find help or unaware help exists.
That's why Canada's 600,000 frontline healthcare and social work staff are experiencing record attrition rates. It's why Canada's 600,000 veterans and 700,000 first responders have significantly higher rates of PTSD and burnout compared to the general public. This is why Canada is in the process of implementing a National Strategy for PTSD focusing on prevention, early intervention and treatment.
Part of that strategy involves increasing funding for mental health services and looking for partners.
Drawing the majority of its revenue from government and insurance benefits, PLHM provides more than 20 services to support PTSD and trauma patients.
Backed by an experienced team with a deep understanding of issues surrounding mental health, PLHM is also structured to leverage its own value chain, which includes wrap-around care clinics, occupational therapy, alternative medical treatments, pharmacies and partnerships with organizations such as Heroes Haven Society.
PLHM maintains full ownership of its ecosystem, including commercial and real estate holdings.
For years, Canada has underserved the vast population suffering from PTSD. This is finally changing; and PLHM is on the front lines, guided by its corporate mantra, “connecting purpose with profit.” The company's current plan begins with a virtual care model, opening physical locations once it's onboarded enough clinics to ensure profitability on day one. With this strategy, it expects to ultimately achieve $90.85 million in revenue by 2025.
In November 2023, PLHM acquired Revolution Medical Cannabis (RMC), a virtual clinic specializing in the delivery of medical cannabis for the Canadian market. RMC has built an impressive network of doctors providing top-tier virtual care to thousands of patients across the country with its state-of-the-art platform. By integrating RMC's unique offerings, PLHM aims to enhance its current services.
Two additional clinics were acquired by PLHM in 2024, aiming to expand its physical footprint in Alberta and its virtual client base across Canada. The first acquisition is a clinic in Fort Saskatchewan, Alberta, that provides wrap-around care services for the communities it supports. The other is an education and telehealth clinic that will expand PLHM’s virtual footprint across Canada and leverage the benefits of this more extensive scale.
Targeting veterans, first responders, healthcare and social workers, PLHM’s wraparound approach to healthcare will provide support throughout the entire healing process, from counseling and medical testing to dentistry and physiotherapy. The majority of clients are expected to require only a light to medium touch, with one to six visits per month. However, PLHM also expects a minority of highly complex cases which will require up to $100,000 annually per client with 10 to 20 visits per month.
Provincial healthcare and other benefit packages will cover the majority of PLHM’s services. The company will also operate on a proven telehealth model with partnered doctors, nurses and complex care managers.
A strategic partner to PLHM, Heroes Haven Society is a not-for-profit organization primarily geared towards veterans, providing free testing and support for individuals struggling with trauma. Through this partnership agreement, clients will be referred to PLHM’s wrap-around clinic support. Heroes Haven also operates a fundraising program to help offset any costs not already covered by government and benefits packages.
With a diverse background in various industries, Shaun Good has demonstrated his leadership and entrepreneurial spirit throughout his career. After founding a successful construction company, he transitioned into a career with a major financial company. Responding to his clients' growing interest in investment opportunities, Good entered the cannabis industry in 2017.
As the founder of four companies in BC, one of which focuses on the research and development of cannabis cultivars and terpenoids for the medical industry, Good demonstrates a relentless pursuit of innovation and an endless commitment to helping others succeed.
Robert Nicholas is a seasoned entrepreneur and CEO with a proven track record of building successful companies from the ground up. As the visionary leader of Crane Power, he has expertly navigated the company to new heights, expanding its reach from a local startup to a powerhouse with a presence across Canada and the US. His keen understanding of market dynamics coupled with his ability to foster strong relationships has allowed him to assemble a team of top-tier professionals dedicated to delivering exceptional results.
Under Nichols' guidance, Crane Power has generated millions in revenue and garnered an impressive portfolio of more than 100 satisfied clients. The Crane team, known for its unwavering commitment to excellence, consistently delivers projects on time and on budget. With their impressive report card as a testament to their achievements, Nichols and his team continue to push the boundaries of innovation and excellence in their field.
Dr. Riyaan Hassen is a family physician trained in South Africa. His patient-focused care has led him towards changing healthcare to improve patient outcomes and the patient experience within the healthcare system. This has been achieved by founding Revolution Medical Clinic, Revolution Medical Cannabis, Wosler Diagnostics, as well as being medical director of NUMI Health, all companies with a vision of improving patient care. He is also a co-founder of NuPharma, a wellness pharmacy that brings pharmacy care mobile, virtual and in-person.
Hassen believes that hard work coupled with a caring attitude provides the best outcomes for patients but also professionally. It was during his time spent at Chris Hani Baragwanath Hospital in Soweto, South Africa that he realized the immense value of family medicine and its importance to the overall well-being of the family unit. He has a keen interest in chronic disease management and special needs families.
Ali Oonwala aims to deflate the stigma around cannabis and encourage research. A strong advocate for the potential of CBD in sports medicine and chronic pain management, Oonwala’s vision educates the public on diverse medical methods, including the positive impact of catalyzing cannabis's role in the opioid crisis.
Oonwala graduated from the University of Alberta School of Pharmacy in 2002, after practicing in Seattle for several years.
Novartis today presented results from a pre-specified interim analysis of the Phase III APPLAUSE-IgAN study of Fabhalta ® (iptacopan), an investigational Factor B inhibitor of the alternative complement pathway, in patients with IgA nephropathy (IgAN) 1 . In the analysis, patients treated with Fabhalta achieved a 38.3% (p
Proteinuria reduction is an increasingly recognized surrogate marker correlating with progression to kidney failure and has been used as an endpoint in IgAN clinical trials to support accelerated approvals 7 . The study also showed that Fabhalta was well tolerated with a favorable safety profile consistent with previously reported data 1,8 . Results were presented today during a late-breaking clinical trials session at the World Congress of Nephrology (WCN) in Buenos Aires, Argentina 1 .
"In IgAN, part of the immune system called the alternative complement pathway can become overly activated in the kidneys, which causes an inflammatory response, leading to progressive kidney damage and gradual loss of kidney function. The loss of kidney function, together with potential side effects of IgAN treatments available until recently, significantly impact patients' lives," said Professor Dana Rizk , Investigator and APPLAUSE-IgAN Steering Committee Member and professor in the UAB Division of Nephrology. "Fabhalta is the first potential treatment for IgAN that specifically targets the alternative complement pathway."
This pre-specified interim analysis included 250 patients for the efficacy analysis and 443 for the safety analysis 1 . The APPLAUSE-IgAN study continues in a double-blind fashion, and therefore only limited interim analysis results can be presented 9,10 . Submission for possible accelerated approval to the FDA was accepted and has received priority review. The primary endpoint evaluating Fabhalta's ability to slow IgAN progression by measuring the annualized total estimated glomerular filtration rate (eGFR) slope over 24 months is expected at study completion in 2025 9,10 .
"IgAN progresses over many years, and patients' needs may evolve such that different therapies may be best used at different times," said David Soergel , M.D., Global Head, Cardiovascular, Renal and Metabolism Development Unit, Novartis. "Our renal pipeline includes medicines with a variety of mechanisms which may allow them to be targeted to patients based on their clinical characteristics."
Other data presented at WCN include IgAN and C3 glomerulopathy (C3G) real-world studies. Novartis will be presenting further data from the renal portfolio at future medical meetings.
About APPLAUSE-IgAN
APPLAUSE-IgAN (NCT04578834) is a Phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of twice-daily oral Fabhalta (200 mg) in 518 adult primary IgAN patients 9,10 .
The two primary endpoints of the study for the interim and final analysis, respectively, are proteinuria reduction at 9 months as measured by UPCR, and the annualized total eGFR slope over 24 months 9,10 . At the time of final analysis, the following secondary endpoints will also be assessed: proportion of participants reaching UPCR 1.73 m 2 or maintenance dialysis or receipt of kidney transplant or death from kidney failure), change from baseline to 9 months in the fatigue scale measured by the Functional Assessment Of Chronic Illness Therapy-Fatigue questionnaire 9,10 .
The main study population enrolled patients with an eGFR ≥30 mL/min/ 1.73 m 2 and UPCR ≥1 g/g at baseline 9,10 . In addition, a smaller cohort of patients with severe renal impairment (eGFR 20–30 mL/min/ 1.73 m 2 at baseline) was also enrolled to provide additional information but will not contribute to the main efficacy analyses 9,10 .
About Fabhalta ® ( iptacopan )
Fabhalta (iptacopan) is an oral, Factor B inhibitor of the alternative complement pathway 1 .
Discovered at Novartis, Fabhalta is currently in development for a range of rare diseases including IgAN, C3G, atypical hemolytic uremic syndrome ( aHUS), immune complex membranoproliferative glomerulonephritis (IC-MPGN) and lupus nephritis (LN).
Fabhalta was approved by the FDA in December 2023 for the treatment of adults with the rare blood disorder paroxysmal nocturnal hemoglobinuria (PNH) and received a positive opinion from the CHMP of the EMA in March 2024 11,12 .
About IgA nephropathy (IgAN)
IgAN is a heterogeneous, progressive, rare kidney disease 2 . Each year, approximately 25 people per million worldwide are newly diagnosed with IgAN 13 .
Up to 30% of people who have IgAN with persistent higher levels of proteinuria (≥1 g/day) may progress to kidney failure within 10 years 6 . There is a need for effective, targeted therapies for IgAN that can help slow or prevent progression to kidney failure 2,5,14 .
Novartis commitment in renal
At Novartis, our journey in nephrology began more than 40 years ago when the development and introduction of cyclosporine helped reimagine the field of transplantation and immunosuppression. We continue today with the same bold ambition to transform the lives of people living with kidney diseases.
Through our renal portfolio, we are exploring potential therapeutic options to address the current unmet needs of people living with rare kidney diseases, including IgAN, C3G, aHUS, IC-MPGN and LN. New and innovative treatment options that target the underlying causes of rare kidney diseases may slow disease progression and help people live longer without the need for infusions, dialysis or transplantation.
IgAN is a heterogeneous disease presenting with a variety of clinical manifestations, phenotypes, and variable speeds of progression 2 . In addition to Fabhalta, Novartis is advancing the development of two other therapies in IgAN with highly differentiated mechanisms of action: atrasentan, an investigational oral endothelin A (ETA) receptor antagonist, and zigakibart, an investigational subcutaneously administered anti-APRIL monoclonal antibody, which are both in Phase III development 15,16 . Through our IgAN pipeline, we are committed to creating a portfolio of innovative medicines that improve and extend the lives of people living with kidney disease.
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," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. 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 the investigational or approved products described in this press release 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 such products will be commercially successful in the future. In particular, our expectations regarding such products 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
Novartis Media Relations E-mail: media.relations@novartis.com | |||
North America | |||
Michael Meo | +1 862 274 5414 | ||
Marlena Abdinoor | +1 617 335 9525 | ||
Novartis Investor Relations E-mail: investor.relations@novartis.com | |||
North America | |||
Sloan Simpson | +1 862 345 4440 | ||
Jonathan Graham | +1 201 602 9921 | ||
Parag Mahanti | +1 973 876 4912 | ||
SOURCE Novartis Pharmaceuticals Corporation
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Arvinas to receive a $150 million upfront payment for the license of ARV-766 and the sale of Arvinas' preclinical AR-V7 program, with the potential under the License Agreement for up to $1.01 billion in development, regulatory, and commercial milestones, as well as tiered royalties –
– Novartis to be responsible for worldwide clinical development and commercialization of ARV-766 –
– Partnership expected to accelerate and broaden the development of ARV-766 as a potential first-in-class treatment option for patients with prostate cancer –
NEW HAVEN, Conn., April 11, 2024 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today announced it has entered into an exclusive strategic license agreement with Novartis (NYSE: NVS) for the worldwide development and commercialization of ARV-766, Arvinas' second generation PROTAC ® androgen receptor (AR) degrader for patients with prostate cancer. The transaction also includes an asset purchase agreement for the sale of Arvinas' preclinical AR-V7 program to Novartis.
"We are thrilled to partner with an organization that shares our dedication to delivering transformative medicines to patients with significant unmet need," said John Houston, Ph.D., Chairperson, President and Chief Executive Officer of Arvinas. "We believe the expertise and scale of Novartis will broaden the development of ARV-766 and its potential to be a first- and best-in-class treatment for patients with prostate cancer. This strategic transaction also further validates our innovative PROTAC protein degrader platform and its potential to deliver new treatments."
Under the terms of the transaction agreements, Novartis will be responsible for worldwide clinical development and commercialization of ARV-766 and will have all research, development, manufacturing, and commercialization rights with respect to the preclinical AR-V7 program. Arvinas will receive an upfront payment in the aggregate amount of $150.0 million. Under the License Agreement, Arvinas is eligible to receive additional development, regulatory, and commercial milestones of up to $1.01 billion, as well as tiered royalties for ARV-766.
Closing of the transaction is subject to the parties' receipt of any necessary consents or approvals, including the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Goldman Sachs & Co. LLC is acting as the exclusive financial advisor to Arvinas.
About ARV-766
ARV-766 is an investigational orally bioavailable PROTAC ® protein degrader designed to selectively target and degrade the androgen receptor (AR). Preclinically, ARV-766 has demonstrated activity in models of wild type androgen receptor tumors in addition to tumors with AR mutations or amplification, both common potential mechanisms of resistance to currently available AR-targeted therapies.
About Arvinas
Arvinas is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC ® Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC ® targeted protein degraders, that are designed to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. In addition to its robust preclinical pipeline of PROTAC protein degraders against validated and "undruggable" targets, the company has four investigational clinical-stage programs: vepdegestrant (ARV-471) for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer; ARV-766 and bavdegalutamide for the treatment of patients with metastatic castration-resistant prostate cancer; and ARV-102 for the treatment of patients with neurodegenerative disorders. For more information, visit www.arvinas.com .
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties, including statements regarding the potential for ARV-766 to be a first- and best-in-class treatment for patients with prostate cancer, the potential of Arvinas' PROTAC protein degrader platform and its potential to deliver new treatments, the closing of the transaction with Novartis, the receipt of upfront, milestone, and royalty payments in connection with the transaction and the future development, potential marketing approval and commercialization of ARV-766. All statements, other than statements of historical fact, contained in this press release, including statements regarding Arvinas' strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
Arvinas may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on such forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements Arvinas makes as a result of various risks and uncertainties, including but not limited to: the satisfaction or waiver of the closing conditions set forth in the license agreement with Novartis, each party's performance of its obligations under the license agreement, whether Novartis will be able to successfully conduct and complete clinical development, obtain marketing approval for and commercialize ARV-766, and other important factors discussed in the "Risk Factors" section of Arvinas' Annual Report on Form 10-K for the year ended December 31, 2023 and subsequent other reports on file with the U.S. Securities and Exchange Commission. The forward-looking statements contained in this press release reflect Arvinas' current views with respect to future events, and Arvinas assumes no obligation to update any forward-looking statements, except as required by applicable law. These forward-looking statements should not be relied upon as representing Arvinas' views as of any date subsequent to the date of this release.
Arvinas Contacts
Investor Contact:
Jeff Boyle, Arvinas Investor Relations
+1 (347) 247-5089
Jeff.Boyle@arvinas.com
Media Contact:
Kathleen Murphy, Arvinas Communications
+1 (760) 622-3771
Kathleen.Murphy@arvinas.com
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