Financialnewsmedia.com News Commentary
PALM BEACH, Florida, Aug. 20, 2019 /PRNewswire/ -- Cancer drug market revenues have been steadily rising in the past few years and all indicators predict that they will continue to rise over the next several years. According to industry sources, in 20118 oncology drugs reached US$123.8 billion in sales. This figure is more than double the sales of the next market on the list, drugs treating diabetes, which reached US$48.5 Billion dollars in sales in 2018. By 2024, cancer drug sales are expected to almost double to US$236.6 Billion dollars. One of the fastest growing segments in oncology drugs will be the glioma (brain tumor) market. Another industry report projected that the Global Glioma Diagnosis and Treatment market alone is expected to grow at a CAGR of approximately 10.1% during the forecast period, 2017–2023. Active biotech and pharma companies in the markets this week include Moleculin Biotech, Inc. (NASDAQ: MBRX), Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR), AbbVie Inc. (NYSE: ABBV), Mallinckrodt plc (NYSE: MNK), Nabriva Therapeutics plc (NASDAQ: NBRV).
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.
Moleculin Biotech, Inc. (NASDAQ:MBRX) BREAKING NEWS: Moleculin Biotech, a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, today announced approval by the Emory University Clinical Trial Review Committee (CTRC) to move forward with an Investigator Initiated clinical trial of Moleculin's immune-stimulating/transcriptional-modulator, WP1066, for the treatment of pediatric brain tumors. The trial will take place at the Aflac Cancer and Blood Disorders Center at Children's Healthcare of Atlanta.
"Continued progress with the MD Anderson clinical trial of WP1066 in brain tumors has now cleared the way for a pediatric brain tumor trial with investigators from Emory University School of Medicine," commented Walter Klemp, Moleculin's Chairman and CEO. "With CTRC approval, the investigators can now submit a request for IND from the FDA for this indication referencing the MD Anderson IND already in place. Consistent with one of our stated development milestones, we continue to expect this IND to be submitted before year end."
Dr. Tobey MacDonald, Professor of the Department of Pediatrics at Emory University School of Medicine, Director of Pediatric Neuro-Oncology at Aflac Cancer and Blood Disorders Center and Principle Investigator for this clinical trial commented: "We've done a lot of preclinical research suggesting that WP1066 may be beneficial in treating pediatric brain tumors, including medulloblastoma, where there continues to be a critical unmet need for more effective therapies. We are excited to finally get this trial moving." Read this and more news for MBRX at: https://www.financialnewsmedia.com/news-mbrx/
Other recent developments in the biotech industry include:
Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) recently announced that it has dosed the first patient in SEQUOIA (AROAAT2001), a potentially pivotal Phase 2/3 clinical study of ARO-AAT, the company's second generation subcutaneously administered RNA interference (RNAi) therapeutic being developed as a treatment for a rare genetic liver disease associated with alpha-1 antitrypsin deficiency (AATD).
Bruce Given, M.D., chief operating officer and head of R&D at Arrowhead, said: "ARO-AAT is the first RNAi therapeutic derived from our proprietary Targeted RNAi Molecule, or TRiM™, platform to reach a potentially pivotal study. This is a significant milestone for Arrowhead and, more importantly, it represents potential hope for patients living with alpha-1 liver disease, who currently have no available treatment options other than liver transplant."
AbbVie Inc. (NYSE: ABBV) recently announced that the U.S. Food and Drug Administration (FDA) has approved RINVOQ™ (upadacitinib), a 15 mg, once-daily oral Janus kinase (JAK) inhibitor, for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate (MTX-IR). RINVOQ is expected to be available in the U.S. in late August 2019.
The FDA approval of RINVOQ is supported by data from the SELECT program, one of the largest registrational Phase 3 programs in RA with approximately 4,400 patients evaluated across all treatment arms in five studies.2-6 The studies include assessments of efficacy, safety and tolerability across a variety of RA patients, including those who failed or were intolerant to biologic disease-modifying anti-rheumatic drugs and who were naïve or inadequate responders to methotrexate. RINVOQ is not indicated for methotrexate-naïve patients.
Mallinckrodt plc (NYSE: MNK) recently confirmed enrollment of the first patient in the company's Phase 2a study assessing the pharmacokinetics, pharmacodynamics and safety of the oral investigational drug MNK-6106 (L-ornithine phenylacetate) versus rifaximin in patients with hepatic (liver) cirrhosis and hepatic encephalopathy (HE). Study completion is expected by first quarter 2020.
Mallinckrodt acquired MNK-6106 and the intravenous investigational drug MNK-6105 (L-ornithine phenylacetate) when it completed the acquisition of Ocera Therapeutics in December 2017. MNK-6106 is being evaluated for post-discharge continuity of care for patients with cirrhosis and, if approved, may have the potential to reduce the risk of recurrent HE episodes and possibly rehospitalization.
The company expects to begin recruiting by the end of 2019 for a Phase 3 clinical trial investigating MNK-6105 in patients being treated for acute HE in the hospital.
Nabriva Therapeutics plc (NASDAQ: NBRV) recently announced that the U.S. Food and Drug Administration (FDA) has approved Nabriva's new drug applications for the oral and intravenous (IV) formulations of Xenleta™ (lefamulin) for the treatment of community-acquired bacterial pneumonia (CABP) in adults. As the first IV and oral antibiotic with a novel mechanism of action approved by the FDA in nearly two decades, XENLETA represents an important new empiric monotherapy treatment option for adults with CABP.
"Today's approval of XENLETA is a significant breakthrough in the collective fight against the growing threat of antimicrobial resistance and provides a desperately needed IV and oral empiric monotherapy treatment option for adults with CABP," said Ted Schroeder, chief executive officer of Nabriva Therapeutics. "We are especially proud of this approval because XENLETA was discovered in our labs over a decade ago and the entire development program was designed and executed by our dedicated and passionate team. We are indebted to the patients and researchers who collaborated with us and are excited to bring to patients and healthcare providers a novel, short course, empiric monotherapy treatment option for CABP. XENLETA has a mechanism of action that is different than other approved antibiotics, resulting in a low propensity for the development of resistance, as well as a lack of cross-resistance with the beta-lactam, fluoroquinolone, glycopeptide, macrolide, and tetracycline antibiotic classes. XENLETA has a targeted in vitro spectrum of activity against the most common causative Gram-positive, Gram-negative and atypical pathogens associated with CABP, which aligns with the principles of antimicrobial stewardship."
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