1. The Final Score: 2018 Drug & Biologic Patent Approvals

    Posted on 15.01.19 Brittany Knight, on Articles, Biologics/biosimilars, Patent Trends & Activity

    The past year was a big year for FDA approved new drugs and biologics – 59 in fact, compared to 46 in 2017 and a mere 22 in 2016. From the published list of approvals on the FDA website Novel Drug Approvals for 2018, we compiled data on the listed patents associated with these drugs. As a whole, the 59 drugs included 42 “conventional”, i.e. small molecule drugs, of which 35 were new chemical entities (NCEs approved via a New Drug Application or NDA), and 17 were biological molecules (approved via a Biological License Application or BLA). For background, “conventional” drugs are small (i.e. generally under 1000 molecular weight), synthetically manufactured chemical entities that are chemically and molecularly well-characterized. Currently, these drugs make up the majority of approved drugs. Information regarding patents and exclusivity for these “conventional” drugs is referenced in the Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the ‘Orange Book’.

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  2. Nanomedicine: A Vast Horizon on a Molecular Landscape – Part XI, Cosmeceuticals

    Posted on 14.02.18 Jing Zhou, on Articles, Biologics/biosimilars, Nanomedicine Series

    In previous installments of Nanomedicine, we have discussed the usage of nanoparticles in cancer and other diseases as both diagnostics and therapeutic agents. See, for example, magnetic nanoparticles for theranostics (Part VIII and Part X), quantum dots for bioimaging (Part VII), nanoparticles as cancer biomarkers (Part VI) and for cancer therapy (Part V), and nanoparticles as drug delivery carriers (Part IV).  These applications of nanotechnology not only have attracted increased attention from pharmaceutical companies and academic researchers, but have led to the development of innovative candidatesin clinic trials and even successful products selling in global markets. Beyond this thriving therapeutic field, another huge market for utilizing nanotechnology that might not be as widely recognized, but which already has had a great impact, is the market for cosmeceuticals.

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  3. Sandoz Wins Battle Over Biosimilars Against Amgen

    Posted on 20.07.17 David Puleo, on Articles, Biologics/biosimilars, Patent Related Court Rulings

    In April, the Supreme Court heard oral arguments from Amgen and Sandoz (the generic manufacturing arm of Novartis) regarding interpretation of the Biologics Price Competition and Innovation Act (BPCIA), which establishes an alternate pathway for FDA approval of biologics. See Sandoz Inc. v. Amgen Inc. (No. 15-1039, 15-1195). Two key issues were raised: whether a biosimilar manufacturer is (1) required to provide manufacturing information from their abbreviated biologics license application (aBLA) to the manufacturer of the original reference biologic (i.e., the reference product sponsor, or RPS) and (2) whether the biosimilar manufacturer can give the 180-day notice of intent to market the biosimilar (known as the Notice-of-Commercial Marketing) to the RPS prior to receiving FDA approval. The second question is perhaps the more interesting and financially important. If notice cannot be given prior to FDA approval, the RPS can potentially benefit from an additional period of market exclusivity because the generic would essentially not be able to market their product until 180 days after FDA approval.

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  4. Nanomedicine: A Vast Horizon on a Molecular Landscape – Part X, Magnetic Nanoparticles theranostics II

    Posted on 16.05.17 Jing Zhou, on Articles, Biologics/biosimilars, Nanomedicine Series

    Magnetic nanoparticles are superior imaging contrast agents for Magnetic Resonance Imaging (MRI) due to the intrinsic magnetic properties of nanoparticles. As of 2012, the FDA has approved several MNPs as MRI contrast agents or therapeutic agents: ferumoxides (also known as Feridex in the USA) as an MRI contrast agent for imaging liver lesions; ferucarbotran (also known as Resovist) as MRI contrast agent for imaging liver lesions; ferumoxsil (also known as GastroMARK or Lumirem) as an orally administered MRI contrast agent; and ferumoxytol (also known as Feraheme) as an intravenously administered nanoparticle to treat iron deficiency in adults with chronic kidney disease.

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  5. Nanomedicine: A Vast Horizon on a Molecular Landscape – Part IX, Organs-on-a-chip II

    Posted on 11.04.17 Jing Zhou, on Articles, Biologics/biosimilars, Nanomedicine Series

    Recently, Draper announced a three-year agreement with Pfizer. This collaboration focuses on developing effective disease models for testing potential drug candidates based on microphysiological systems, also known as “organs-on-a-chip”.

    The organs-on-a-chip technology is a three-dimensional microfluidic based multi-cell co-culture system that models the physiological, mechanical, and molecular environment of the human body and mimics the physiological functions of human organs. This technology offers unique in vitro disease models for new drug screening and toxicology testing. This technology has attracted attentions not only from academic institutes but also from the pharmaceutical industry. One of the main reasons for this interest is the potential cost and time savings for drug research and the development process. As required by the FDA drug approval process, new drug chemical entities are tested in animals before going into human Phase I testing for the drug approval process. The preclinical animal testing process is tedious and extremely expensive. Additionally, animal models are not always predictive for characterizing drug safety in humans. About 40% of drug compounds fail in Phase I clinical trials (Clinical Development Success Rates 2006-2015, BIO Industry Analysis, June 2016). To address these challenges, organs-on-a-chip has been proposed as a novel method to develop human disease models and replace preclinical animal testing.

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  6. The FDA Releases Guidance on Interchangeability

    Posted on 09.03.17 Nicholas Vincent, on Articles, Biologics/biosimilars, Recent News & Articles

    In January, the United States Food and Drug Administration (FDA) released a draft guidance entitled, “Considerations in Demonstrating Interchangeability” aimed at helping to implement the Biologics Price Competition and Innovation Act of 2009 (BPCIA). This guidance serves to directly address the issue of demonstrating interchangeability of biological products and the standards required to do so. Interestingly, no product has yet been shown to be interchangeable, including the four biosimiliars that have already been approved by the FDA.

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  7. Nanomedicine: A Vast Horizon on a Molecular Landscape – Part VIII, Magnetic Nanoparticles theranostics

    Posted on 07.03.17 Jing Zhou, on Articles, Biologics/biosimilars, Nanomedicine Series

    Magnetic nanoparticles, also known as superparamagnetic nanoparticles are small inorganic crystals about 5-20 nm in diameter. Two main classes of MNPs currently used for clinical imaging are ferromagnetic iron oxide nanoparticles and ultrasmall superparameganetic iron oxide nanoparticles (USPION). MNPs are usually multilayer materials, which give them their various properties and functionalities for diagnosis and disease treatment. The structure of iron oxide nanoparticles has three main components: an iron oxide core as a Magnetic Resonance Imaging (MRI) contrast agent, a biocompatible coating outside the core, and an outer therapeutic coating with specific ligands for biomarker targeting. See (US 8,945,628 by Dr. Ralph Weissleder at Massachusetts General Hospital and US 7,462,446 by Dr. Miqin Zhang at the University of Washington). This unique structure enables MNP accumulation in the sites of interest via biomarker targeting. It further allows the diagnosis of diseases, the evaluation of treatment efficacy, and the localized delivery of drugs and disease therapies. The integration of both diagnostic and therapeutic modalities into one single agent is called a theranostic agent. We will discuss the diagnostic and therapeutic properties of MNPs in cancer.

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  8. Nanomedicine: A Vast Horizon on a Molecular Landscape – Part VII, Quantum dots in medicine

    Posted on 13.12.16 Jing Zhou, on Articles, Biologics/biosimilars, Nanomedicine Series

    According to the Allied Market Research report, the global market for quantum dots will grow from about $300 million to over $5 billion dollars in the period from 2013-2020 period. So, what exactly is a quantum dot and how are they useful?

    In 1988, the term “quantum dot” (or “QD” for short) was introduced by Dr. Mark Reed at Yale University to describe nanocrystalline semiconducting fluorophores. Fluorophores are chemical materials that re-emit light when excited by a light pulse. QDs are usually core-shell systems with a semiconductor core enclosed within a shell of another semiconductor material. They usually have confined diameters in the range of 2-20 nanometers (a nanometer is 1 x 10-9 meters) in all three spatial dimensions, resulting in size quantization effects. This size quantization means the band gap (the electron and hole excitation energy levels) of the QD can be “tuned” to provide different light emission frequencies by changing the composition of the QDs and varying their diameters. For example, the larger the QD, the redder, i.e.the lower the energy, emission. Researchers have utilized QDs as efficient materials for advanced photoelectric devices and solar cells. Dr. Arthur Nozik is one of the great leaders in this field (US 4,634,641). During his tenure at the National Renewable Energy Laboratory (NREL), he led a research group to discover variant semiconductor QDs for novel optical and energy systems (US 8,685,781 and US 9,324,562 ). Additionally the surfaces of QDs can be conjugated to various molecules to vary their physical properties, for example, to increase water solubility, reduce cytotoxicity, and resist reactive oxygen formation. The QDs can also be conjugated with specific molecules to target tumor biomarkers. These unique physical properties and the surface chemical modification of QDs have attracted increasing attention to applications in bio-imaging (reviewed in Part VI), bio-analytical assays and diagnostics, as well as the development of new therapeutic agents.

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  9. The Emergent Microbiome: A Revolution for the Life Sciences – Part VII, The Microbiology of the Built Environment

    Posted on 04.10.16 Nicholas Vincent, on Biologics/biosimilars, Recent News & Articles, The Emergent Microbiome Series

    Many research efforts into the microbiome have focused primarily on the human microbiome, i.e. microorganisms within and on the body, and how changes in these microbial communities correlate with changes in health and disease. Less attention, however, has been paid to the microbial communities external to humans and how changes in these communities can affect health. These communities have a broad range, from the microbiome of indoor spaces, also called the microbiology of the built environment (MoBE), to microbial communities found outdoors. Microbial communities that give certain foods, such as San Francisco sour dough bread, various wines, beers, and even cheeses, characteristic qualities like taste and texture are also examples of external microbiomes. As with the human microbiome, scientists do not yet fully understand how changes in external or indoor microbiomes could alter human health, but we see plentiful possibilities for further research and intellectual property protection of subsequent innovation, especially with regards to the MoBE. This article concludes with a sampling of some of the patenting activity in this area.

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  10. Nanomedicine: A Vast Horizon on a Molecular Landscape – Part III, Organs-on-a-chip

    Posted on 19.05.16 Jing Zhou, on Articles, Biologics/biosimilars, Nanomedicine Series, Patent Trends & Activity

    This is the third article in a review series of “Nanomedicine: A Vast Horizon on a Molecular Landscape”. In Part I we discussed the major research and development areas in the field. Then, we briefly introduced some representative research groups and companies and their patents in nanomedicine (Part II). Here, we will start the discussion about the diagnostic applications of nanomedicine.

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