Palm Beach, FL –November 19, 2019 – A lot of cancer research is dealing with shrinking brain tumors and opening the door for targeted cancer therapies to work without damaging the surrounding tissue. The success rate for cancer therapies has been limited due to a combination of factors, such as the tumor’s ability to hide from and develop resistance to the treatment; excessive side effects; the treatment not being clinically effective; and the lack of penetration through the blood brain barrier. There have been a number of recent reports projecting the upcoming breakthroughs and the resultant increase in market revenues. According to various industry reports and articles, oncology drugs reached US$123.8 billion in sales in 2018 which was more than double the sales of the diabetes treatment market, which reached US$48.5 Billion dollars in sales in 2018. The articles projected that by 2024, cancer drug sales are expected to almost double to US$236.6 Billion dollars. They point to the oncology drugs in the glioma (brain tumor) market as being the fastest growing segments. Another industry report projected that the Global Glioma Diagnosis and Treatment market alone is expected to grow at a CAGR of approximately 10.1% through 2023. Active biotech and pharma companies in the markets this week include CNS Pharmaceuticals, Inc. (NASDAQ: CNSP), Amarin Corporation plc (NASDAQ: AMRN), Teva Pharmaceutical Industries Limited (NYSE: TEVA), Karuna Therapeutics, Inc. (NASDAQ: KRTX), Acasti Pharma Inc. (NASDAQ: ACST) (TSX-V: ACST).
The report continued: “Brain tumors are one of the prominent causes of cancer among children and teenagers. Glioma is the most common type of brain tumor which accounts for approximately half of all the astrocytoma. The increasing occurrence of glioblastoma over the years is responsible for the growth of the glioma diagnosis and treatment market. The upcoming drug launches and developments in research are instrumental for the growth of the market. In addition, the current unmet need is expected to drive the gliomas industry over the forecast period. Changing financial demands and access to healthcare facilities are some of the factors that are constraining the market growth. Another report from Med Gadget reported that: “A recent study from Fact.MR reported that sales of oncology small molecule drugs are forecasted to exceed $66bn in 2019, up from $63bn in 2018… The report attributes the expected growth in revenue to a rise in the prevalence of cancer, the additional oncology centers being developed, and the industry’s ability to increase the availability of oral small molecule drugs for cancer treatment.”
CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) BREAKING NEWS: CNS Pharmaceuticals Acquired Worldwide Rights for Brain Cancer Drug from Houston Pharmaceuticals – CNS Pharmaceuticals, a biotechnology company specializing in the development of novel treatments for brain tumors, completed an agreement with Houston Pharmaceuticals, Inc. (“HPI”) to obtain the rights to a worldwide, exclusive royalty-bearing, license for the chemical compound commonly known as Berubicin.
CNS’ licensing agreement with HPI grants the Company the exclusive right to develop certain patented chemical compounds for use in the treatment of cancer globally. In its agreement with HPI, the Company acquired multiple U.S. patents for Berubicin. CNS intends to apply for orphan drug status for Berubicin with the FDA for the treatment of malignant glioma.
“We believe our acquisition of the rights to Berubicin represents an important milestone in our pursuit to develop therapies for the treatment of glioblastoma, a type of brain cancer which is currently considered incurable,” stated CEO of CNS, John M. Climaco, Esq. “Our agreement with HPI expands our IP protection and provides us with developmental protection worldwide while we seek orphan drug status. We are excited to continue the clinical development of Berubicin and believe its promising tolerability and efficacy results are a testament to its therapeutic potential as a novel anthracycline agent.” Read this and more news for CNSP at: https://www.financialnewsmedia.com/news-cnsp/
Other recent developments in the biotech industry include:
Amarin Corporation plc (NASDAQ: AMRN) recently announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the U.S. Food and Drug Administration (FDA) has voted unanimously (16-0) to recommend approval of an indication and label expansion for Vascepa® (icosapent ethyl) capsules to reduce the risk of cardiovascular events in high-risk patients based on results from the landmark REDUCE-IT®1 cardiovascular outcomes trial.
The FDA is not bound by the recommendations of an advisory committee. Amarin plans to work with the agency as it completes its review of the company’s application seeking an appropriate label expansion for Vascepa to reflect REDUCE-IT results.
Teva Pharmaceutical Industries Limited (NYSE: TEVA) – Teva Pharmaceuticals USA and Celltrion Healthcare, Co. recently announced that TRUXIMA®(rituximab-abbs) injection is the first biosimilar to the reference product Rituxan®1 (rituximab) now available in the United States with a full oncology label. TRUXIMA is currently indicated for the treatment of adult patients with non-Hodgkin’s Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL):
TRUXIMA was approved by the U.S. Food and Drug Administration (FDA) as the first rituximab biosimilar. The approval was based on a review of a comprehensive data package inclusive of foundational and extensive analytical characterization, nonclinical data, clinical pharmacology, immunogenicity, clinical efficacy, and safety data. In May 2019, the FDA approved TRUXIMA to match all of the reference product’s oncology indications for NHL and CLL. In light of a patent settlement with Genentech, Celltrion and Teva have a pending FDA submission for rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA), and microscopic polyangiitis (MPA), and a license from Genentech to expand the TRUXIMA label to include these indications in Q2 2020.
Karuna Therapeutics, Inc. (NASDAQ: KRTX) a clinical-stage biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with disabling and potentially fatal neuropsychiatric disorders and pain, recently announced results from its Phase 2 clinical trial of KarXT for the treatment of acute psychosis in patients with schizophrenia. In the clinical trial, KarXT demonstrated a statistically significant and clinically meaningful 11.6 point mean reduction in total Positive and Negative Syndrome Scale (PANSS) score compared to placebo (p<0.0001) and also demonstrated good overall tolerability. A statistically significant reduction in the secondary endpoints of PANSS-Positive and PANSS-Negative scores were also observed (p<0.001).
KarXT is an oral coformulation of xanomeline (a novel muscarinic receptor agonist) and trospium (a muscarinic receptor antagonist) designed to treat psychosis and related symptoms through preferential stimulation of muscarinic receptors in the central nervous system (CNS). This combination has the potential to be a new option for treating the difficult symptoms of debilitating CNS disorders, such as schizophrenia, without subjecting patients to the problematic side effects associated with current antipsychotic standard of care therapies.
Acasti Pharma Inc. (NASDAQ: ACST) (TSX-V: ACST), a biopharmaceutical innovator focused on the research, development and commercialization of its prescription drug candidate CaPre® (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia (HTG), released some preliminary new animal data which provides additional insights into CaPre’s potential mechanism of action in diabetes. In the Company’s Phase 2 studies in humans, a statistically significant reduction of hemoglobin A1c (HbA1c) was seen in the 4 gram treatment arm of the COLT study. This is the same dose that is currently being tested in Acasti’s TRILOGY Phase 3 program in humans. This positive HbA1c result In COLT was surprising at the time, and potentially unique to CaPre, as other therapeutic OM3s had previously shown no effect on glucose metabolism in a diabetic or pre-diabetic population. The main objective for this new mechanistic diabetes mouse study was to assess if CaPre acts on glucose and/or insulin in some unique manner, and to compare results head-to-head with icosapent ethyl (VASCEPA), a marketed omega-3 therapeutic, and metformin, a widely prescribed diabetic medication.
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