globenewswire | September 12, 2023
Aquestive Therapeutics, Inc. a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives, today announced acceptance by the U.S. Food and Drug Administration (FDA) of the Company’s NDA for Libervant™ (diazepam) Buccal Film in pediatric patients between two and five years of age and the assignment of a PDUFA goal date of April 28, 2024.
Aquestive’s NDA for approval of Libervant™ Buccal Film for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) in patients between two and five years of age has been accepted by the FDA. Diastat® (diazepam) Rectal Gel is the only treatment currently available to this patient population for this indication. The Company received tentative approval for Libervant for the treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) in patients 12 years of age and older in August 2022, but Libervant is currently under an orphan drug block to market access until January 2027.
“The FDA’s acceptance of our most recent filing for Libervant is another step forward in bringing this important treatment option to patients,” said Daniel Barber, Chief Executive Officer of Aquestive. “When it comes to the treatment of seizure clusters in pediatric patients with epilepsy five years of age and under, physicians and caregivers have limited options. We believe Libervant, as an oral alternative to existing device-based products, will be well-received by this patient population, if approved with market access.”
Libervant is a buccally, or inside of the cheek, administered film formulation of diazepam, a benzodiazepine intended for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern. Aquestive developed Libervant as an alternative to the device-based products currently available for patients with refractory epilepsy, including a rectal gel and nasal spray products. The FDA has granted tentative approval for Libervant for treatment of these epilepsy patients 12 years of age and older, with U.S. market access for Libervant for this age group of patients subject to the expiration of the existing orphan drug market exclusivity of a previously FDA approved drug scheduled to expire in January 2027. The NDA submitted today for Libervant for epilepsy patients between two and five years of age is subject to FDA approval, including for U.S. market access.
Aquestive is a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives. We are developing orally administered products to deliver complex molecules, providing novel alternatives to invasive and inconvenient standard of care therapies. Aquestive has five commercialized products marketed by its licensees in the U.S. and around the world, and is the exclusive manufacturer of these licensed products. The Company also collaborates with pharmaceutical companies to bring new molecules to market using proprietary, best-in-class technologies, like PharmFilm®, and has proven drug development and commercialization capabilities. Aquestive is advancing a late-stage proprietary product pipeline focused on treating diseases of the central nervous system and an earlier stage pipeline for the treatment of severe allergic reactions, including anaphylaxis.
Businesswire | July 25, 2023
ImmunoGen, Inc. a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced a multi-target license and option agreement to research novel, first-in-class ADCs with ImmunoBiochem Corporation, a privately-held biopharmaceutical company focused on the discovery of unique tumor targets and development of novel biological therapeutics. The collaboration will combine ImmunoGen's proprietary linker-payload technology with ImmunoBiochem's antibodies directed against specific targets.
"We are excited to partner with ImmunoBiochem, which brings a novel approach to tumor targeting for ADCs," said Eric Westin, ImmunoGen's Vice President of Clinical Development and Translational Sciences. "This agreement reflects our commitment to leverage our rich IP portfolio through strategic partnering in order to further reinvigorate our research and development in support of our pipeline."
Under the terms of the agreement, ImmunoBiochem will receive an upfront payment in exchange for providing ImmunoGen with an exclusive license to existing antibodies directed against a specific undisclosed target. ImmunoBiochem will be eligible to receive milestone payments and royalties based on the achievement of pre-specified development, regulatory, and commercial milestones. ImmunoGen will collaborate with ImmunoBiochem on preclinical activities and assume responsibility for the program's future clinical development and commercialization activities. ImmunoGen will also have the option to select additional targets and antibodies to license based on certain preclinical work undertaken by ImmunoBiochem. If ImmunoGen chooses to exercise this option, ImmunoBiochem will receive an option exercise payment and ImmunoGen will assume responsibility for all subsequent R&D associated with that program.
"ImmunoBiochem is extremely pleased that ImmunoGen, one of the world's leading ADC companies, will help catalyze the unique science and assets that we have been developing to engender novel strategies to tackle difficult solid tumors, particularly for patients that lack common tumor targets," said Dr. Anton Neschadim, CEO of ImmunoBiochem. "This partnership validates our differentiated thinking and will enable ImmunoBiochem to significantly expand its discovery platform and innovative pipeline."
ImmunoGen is developing the next generation of antibody-drug conjugates (ADCs) to improve outcomes for cancer patients. By generating targeted therapies with enhanced anti-tumor activity and favorable tolerability profiles, we aim to disrupt the progression of cancer and offer our patients more good days. We call this our commitment to TARGET A BETTER NOW™.
ABOUT IMMUNOBIOCHEM CORPORATION
ImmunoBiochem is an innovative biopharmaceutical company on a mission to develop novel biological therapeutics to address significant unmet need in oncology and immuno-oncology. ImmunoBiochem uses a combination of high-throughput functional screens, bioinformatics and AI/ML to unravel unique biology in the tumor microenvironment, particularly in the cancer cell secretome, and to discover novel tumor targets that could be exploited with various targeted therapeutic modalities. ImmunoBiochem, a Johnson & Johnson Innovation JLABS alumnus, is headquartered in Toronto, at the heart of Canada's largest biomedical research hub, and has worked closely on some of its novel programs with the University of Toronto, Canada's top university and amongst the world's leading institutions in research and innovation.
Business Insights, PHARMACY MARKET
Businesswire | August 03, 2023
MedinCell During today’s Q2 earnings call, Richard Francis, President and CEO of Teva, and Eric Hughes, Executive Vice President, Global R&D & Chief Medical Officer, commented the US launch of UZEDY since May 2023 and the olanzapine Long-Acting Injectable (LAI).
Richard Francis said1
“We are actually right on plan or slightly ahead of our market access strategy targets and we are very happy with the launch.”
“The newest member of our innovative family is said risperidone, our long-acting treatment for schizophrenia. Now, to remind everybody, this is a $4 billion market and we've only just launched UZEDY, but we're very pleased with the feedback we're getting from healthcare professionals. And they're confirming that the product profile that we have is unique and advantageous. Now we're seeing this in the fact that our NBRX2 is 40%, so already we're getting 40% of the risperidone long-acting market. We're also seeing hospitals look to use our free samples and free trial requests, and we're having good discussions with our payers. So once again, I think excitement around UZEDY early days, but initial feedback is very positive.”
UZEDY, a long-acting injectable (LAI) risperidone for the treatment of schizophrenia in adults, is the first FDA-approved product based on MedinCell’s BEPO technology. MedinCell is eligible for up to $105m commercial milestones and for royalties on net sales.
About LAI olanzapine (mdc-TJK), initiated in January 2023
Eric Hughes said1
“Our Olanzapine Phase 3 study is actually enrolling very quickly.”
“Olanzapine as an oral agent account for 20% of the patients being treated today, but only less than 1% of patients on the long-acting form are being using that product. And that's primarily because of the safety profile3.”
Richard Francis, said1
“With olanzapine, I've already highlighted the fact that it's a $4 billion market. But if we do manage to bring this to the market with a favorable safety profile, I think we have a real opportunity to have a significant product on our hands here.”
mdc-TJK is an investigational long-acting injectable olanzapine also based on BEPO technology. If approved, it could be the first olanzapine LAI with a favorable safety profile offering a valued treatment option as a complement to UZEDY for severe schizophrenia patients. MedinCell is eligible for $12m left out of $17m of development milestones, for up to $105m commercial milestones and for royalties on net sales.
MedinCell is a commercial-stage technology pharmaceutical company developing long-acting injectable drugs in many therapeutic areas. Our innovative treatments aim to guarantee compliance with medical prescriptions, to improve the effectiveness and accessibility of medicines, and to reduce their environmental footprint. They combine already known and used active ingredients with our proprietary BEPO® technology which controls the delivery of a drug at a therapeutic level for several days, weeks or months from the subcutaneous or local injection of a simple deposit of a few millimeters, entirely bioresorbable. The first treatment based on BEPO technology, intended for the treatment of schizophrenia, was approved by the FDA in April 2023, and is now distributed in the United States by Teva under the name UZEDY™.