Anavex Life Sciences Announces Issuance of Blarcamesine (ANAVEX®2-73) Composition of Matter U.S. Patent Expanding its Intellectual Property Portfolio
Anavex Life Sciences (Nasdaq: AVXL) has been granted a new U.S. Patent (No. 12,180,174) for crystalline forms of ANAVEX®2-73 (blarcamesine) dihydrogen phosphate salt. The patent covers crystalline forms, freebase, transdermal patches, and enteric coated oral dosage forms for neuroprotection and treatment of neurodegenerative disorders, including Alzheimer's and Parkinson's disease.
The patent will remain in force until at least July 2039 and expands the company's existing intellectual property portfolio, which includes several U.S. Patents (Nos. 10,413,519; 10,966,952; 11,661,405; and 11,498,908). The dihydrogen phosphate crystals enable convenient once-daily oral dosing and transdermal patch delivery options, potentially improving patient compliance.
Anavex Life Sciences (Nasdaq: AVXL) ha ottenuto un nuovo brevetto statunitense (No. 12,180,174) per forme cristalline del sale di fosfato di diidrogeno di ANAVEX®2-73 (blarcamesina). Il brevetto copre forme cristalline, base libera, cerotti transdermici e forme farmaceutiche orali rivestite entericamente per la neuroprotezione e il trattamento dei disturbi neurodegenerativi, inclusi il morbo di Alzheimer e di Parkinson.
Il brevetto rimarrà in vigore fino almeno a luglio 2039 e amplia il portafoglio di proprietà intellettuale esistente dell'azienda, che include diversi brevetti statunitensi (Nos. 10,413,519; 10,966,952; 11,661,405; e 11,498,908). I cristalli di fosfato di diidrogeno consentono una somministrazione orale conveniente una volta al giorno e opzioni di somministrazione tramite cerotti transdermici, potenzialmente migliorando l'aderenza del paziente.
Anavex Life Sciences (Nasdaq: AVXL) ha recibido una nueva patente en EE. UU. (No. 12,180,174) para formas cristalinas de sal de fosfato dihidrógeno de ANAVEX®2-73 (blarcamesina). La patente cubre formas cristalinas, base libre, parches transdérmicos y formas de dosificación oral recubiertas entericamente para neuroprotección y tratamiento de trastornos neurodegenerativos, incluidos el Alzheimer y el Parkinson.
La patente permanecerá en vigor hasta al menos julio de 2039 y amplía el portafolio de propiedad intelectual existente de la empresa, que incluye varias patentes de EE. UU. (Nos. 10,413,519; 10,966,952; 11,661,405; y 11,498,908). Los cristales de fosfato dihidrógeno permiten un dosificación oral conveniente una vez al día y opciones de entrega mediante parches transdérmicos, mejorando potencialmente la adherencia del paciente.
아나벡스 생명과학 (Nasdaq: AVXL)가 ANAVEX®2-73 (블라르카메신)의 이수소 인산염 결정 형태에 대한 새로운 미국 특허(번호 12,180,174)를 부여받았습니다. 이 특허는 결정 형태, 기본 염기, 경피 패치 및 장용 코팅 경구 복용 형태를 포함하여 신경 보호 및 알츠하이머, 파킨슨병을 포함한 신경퇴행성 질환 치료를 다룹니다.
이 특허는 최소한 2039년 7월까지 유효하며, 미국 특허(번호 10,413,519; 10,966,952; 11,661,405; 및 11,498,908)를 포함한 회사의 기존 지적 재산 포트폴리오를 확장합니다. 이수소 인산염 결정은 하루에 한 번 복용하는 편리한 경구 투약 및 경피 패치 전달 옵션을 가능하게 하여 환자의 순응성을 향상시킬 수 있습니다.
Anavex Life Sciences (Nasdaq: AVXL) a obtenu un nouveau brevet américain (n° 12,180,174) pour des formes cristallines du sel de phosphate de dihydrogène d'ANAVEX®2-73 (blarcamesine). Ce brevet couvre des formes cristallines, des formes de base libre, des patchs transdermiques et des formes posologiques orales à revêtement entérique pour la neuroprotection et le traitement des troubles neurodégénératifs, y compris la maladie d'Alzheimer et la maladie de Parkinson.
Le brevet restera en vigueur jusqu'au moins juillet 2039 et élargit le portefeuille de propriété intellectuelle existant de l'entreprise, qui comprend plusieurs brevets américains (n° 10,413,519; 10,966,952; 11,661,405; et 11,498,908). Les cristaux de phosphate de dihydrogène permettent une posologie orale pratique une fois par jour et des options de délivrance par patch transdermique, ce qui peut améliorer l'adhérence des patients.
Anavex Life Sciences (Nasdaq: AVXL) hat ein neues US-Patent (Nr. 12,180,174) für kristalline Formen des Dihydrogenphosphatsalzes von ANAVEX®2-73 (blarcamesine) erhalten. Das Patent umfasst kristalline Formen, Basispulver, transdermale Pflaster und enterisch beschichtete orale Darreichungsformen zur Neuroprotektion und Behandlung von neurodegenerativen Erkrankungen, einschließlich Alzheimer und Parkinson.
Das Patent bleibt mindestens bis Juli 2039 in Kraft und erweitert das bestehende Portfolio an geistigem Eigentum des Unternehmens, das mehrere US-Patente (Nr. 10,413,519; 10,966,952; 11,661,405; und 11,498,908) umfasst. Die Dihydrogenphosphatkristalle ermöglichen eine bequeme einmal tägliche orale Dosierung und Optionen zur transdermalen Pflasterabgabe, was möglicherweise die Patientencompliance verbessert.
- New patent protection extends until at least July 2039
- Patent covers multiple delivery methods including oral and transdermal applications
- Expands existing IP portfolio with additional formulation options
- None.
Insights
The newly issued patent (No. 12,180,174) represents a significant strategic victory for Anavex, substantially reinforcing their market position in the competitive CNS therapeutics space. The patent's scope is particularly comprehensive, covering multiple delivery mechanisms including transdermal patches and enteric coated oral dosage forms, which could translate into significant commercial advantages.
The extended protection until 2039 provides important market exclusivity for ANAVEX®2-73 (blarcamesine), effectively creating a 14+ year runway for commercialization without generic competition. The inclusion of various delivery methods is particularly valuable as it: 1) Creates multiple barriers to competition, 2) Enables market segmentation through different formulations and 3) Potentially allows for lifecycle management strategies through new delivery formats.
The crystalline polymorph patent adds another layer of protection to Anavex's existing portfolio of five U.S. patents. This type of patent is notably difficult to circumvent, as specific crystalline forms often have unique properties that are essential for drug efficacy and stability. The transdermal delivery option could be particularly lucrative for neurodegenerative conditions, where patient compliance with oral medications can be challenging.
The expansion into transdermal delivery systems represents a important strategic advancement for Anavex in the CNS therapeutics market. This development is particularly significant for several reasons:
1. Enhanced Patient Compliance: Transdermal delivery systems typically achieve higher adherence rates compared to oral medications, particularly important in neurodegenerative conditions where patients may have difficulty with pill regimens.
2. Market Differentiation: The ability to offer multiple delivery formats provides Anavex with significant competitive advantages in both pricing and market segmentation strategies.
3. Clinical Advantages: Transdermal delivery can provide more consistent drug levels in the bloodstream, potentially improving efficacy while reducing side effects - a critical factor in CNS therapeutics.
The crystalline form patent also enables improved stability and bioavailability, which could translate into more efficient manufacturing processes and potentially better profit margins. This multi-format approach positions Anavex strongly in the growing neurodegenerative disease market, particularly in Alzheimer's and Parkinson's disease segments where patient compliance is a significant challenge.
NEW YORK, Jan. 27, 2025 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) disorders, announced today it was issued a new U.S. Patent No. 12,180,174 entitled “A2-73 CRYSTALLINE POLYMORPH COMPOSITIONS OF MATTER AND METHODS OF USE THEREOF” from the United States Patent and Trademark Office (USPTO) for its U.S. Patent Application Serial Number USSN: 17/978,818. This new patent claims crystalline forms of the dihydrogen phosphate salt of ANAVEX®2-73 (blarcamesine), freebase, transdermal patches and enteric coated oral dosage forms including the same for neuroprotection and treatment of neurodegenerative disorders, including Alzheimer’s disease, Parkinson’s disease and other disorders.
Anavex’s newest patent will be expected to remain in force at least until July 2039, not including any patent term extensions. It will expand and supplement the current ANAVEX®2-73 (blarcamesine) patent portfolio, which includes several U.S. Patents, including U.S. Patent Nos. 10,413,519; 10,966,952; 11,661,405; and 11,498,908.
“The issuance of this U.S. Patent again showcases our expertise in identifying and pursuing novel therapeutic forms and formulations that are rooted in science,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. He further added: “We believe the unique properties of the dihydrogen phosphate crystals make it possible in addition to convenient once daily oral dosing to also deliver the active (ANAVEX®2-73 freebase) in transdermal patches, which could simplify further the administration and boost patients’ compliance. As such, we believe that the addition of the dihydrogen phosphate crystals to our platform could greatly benefit the patients at large.”
About Crystal Forms
Crystal polymorphism is a unique phenomenon related to chiral compounds, wherein the compounds may crystallize into different crystal structures or crystal forms under different conditions and/or processes. Specifically for pharmaceuticals, polymorphic forms of drug substances ‘exist in different crystalline forms which differ in their physical properties’.1 These property differences may result in direct medical implications, such as ease of formulation, increased efficacy, and reduced side effects. For example, the widely used analgesic drug, acetaminophen has three polymorphic forms, I, II, and III, among which only Form I is made into commercial dosage forms as the other two forms are either meta-stable or unstable.2 Nonetheless, uncovering an optimal crystal form is NOT an easy or straightforward task, because there are so many variables and possibilities involved, and chance of success lies heavily on the researcher’s experience and insights into the compounds in question. Both ANAVEX®2-73 (blarcamesine) and ANAVEX®19-144 have the potential to form different crystal forms. Through its deep understanding and abundance experience with these two compounds, Anavex was successful in discovering crystal forms of ANAVEX®2-73 (blarcamesine) and ANAVEX®19-144 that have advantageous physiochemical and/or pharmacological properties.
This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such product will successfully complete clinical development or gain health authority approval.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel therapeutics for the treatment of neurodegenerative, neurodevelopmental, and neuropsychiatric disorders, including Alzheimer's disease, Parkinson's disease, schizophrenia, Rett syndrome, and other central nervous system (CNS) diseases, pain, and various types of cancer. Anavex's lead drug candidate, ANAVEX®2-73 (blarcamesine), has successfully completed a Phase 2a and a Phase 2b/3 clinical trial for Alzheimer's disease, a Phase 2 proof-of-concept study in Parkinson's disease dementia, and both a Phase 2 and a Phase 3 study in adult patients and one Phase 2/3 study in pediatric patients with Rett syndrome. ANAVEX®2-73 is an orally available drug candidate designed to restore cellular homeostasis by targeting SIGMAR1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer's disease. ANAVEX®2-73 also exhibited anticonvulsant, anti-amnesic, neuroprotective, and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy. The Michael J. Fox Foundation for Parkinson's Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX®2-73 for the treatment of Parkinson's disease. We believe that ANAVEX®3-71, which targets SIGMAR1 and M1 muscarinic receptors, is a promising clinical stage drug candidate demonstrating disease-modifying activity against the major hallmarks of Alzheimer's disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid, and tau pathologies. In preclinical trials, ANAVEX®3-71 has shown beneficial effects on mitochondrial dysfunction and neuroinflammation. Further information is available at www.anavex.com. You can also connect with the Company on Twitter, Facebook, Instagram, and LinkedIn.
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
For Further Information:
Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: info@anavex.com
Investors:
Andrew J. Barwicki
Investor Relations
Tel: 516-662-9461
Email: andrew@barwicki.com
1 ICH HARMONISED TRIPARTITE GUIDELINE, SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR NEW DRUG SUBSTANCES AND NEW DRUG PRODUCTS: CHEMICAL SUBSTANCES Q6A, Current Step 4 version dated 6 October 1999, page 8.
2 Lee E.H., “A practical guide to pharmaceutical polymorph screening & selection,” Asian Journal of Pharmaceutical Sciences, Vol 9, Issue 4, August 2014, Pages 163-175.
FAQ
When does Anavex's new patent (AVXL) for blarcamesine expire?
What delivery methods are covered by AVXL's new blarcamesine patent?
What conditions can be treated with AVXL's patented blarcamesine formulations?
How does AVXL's new patent strengthen their intellectual property portfolio?
