Palm Beach, FL – October 21, 2019 – Acute myeloid leukemia (AML) is an orphan’s disease. The FDA defines an orphan’s disease as a condition that affects fewer than 200,000 people nationwide. Before the passage of rare disease laws in the United States, patients diagnosed with a rare disease were denied access to effective medicines because prescription drug manufacturers rarely could make a profit from marketing drugs to such small groups. Consequently, the prescription drug industry did not adequately fund research for orphan product development. Other potential sources, such as research hospitals and universities, also lacked the capital and business expertise to develop treatments for small patient groups. Despite the urgent health need for these medicines, they came to be known as orphans because companies were not interested in adopting them. The American Cancer Society’s estimates for leukemia in the United States, for 2019, indicates that approximately 61,780 new cases of leukemia and 22,840 deaths from leukemia are expected to occur in the country. Active companies in the markets this week include: Spherix Incorporated (NASDAQ: SPEX), Fluidigm Corporation (NASDAQ: FLDM), Dermira, Inc. (NASDAQ: DERM), Quotient Limited (NASDAQ: QTNT), Bristol-Myers Squibb Company (NYSE: BMY).
The global AML market, however, has found a home and several revenue projection reports, indicate that this market will not only grow, but it is growing a an ever escalating pace. Back in July of this year, a respected industry source, Mordor Intelligence, projected that The global acute myeloid leukemia market was valued at USD 701.6 million in 2018, and is estimated to be valued at approximately $1.5 billion in 2024, witnessing a CAGR of 14.0%. In just one month later another report from another respected source, iHealthcare Analyst, released a projection that was even bigger than Mordor’s previous report. iHealthcare said that the global acute myeloid leukemia market expected to reach $2.2 billion by 2025, growing at CAGR 19.6% over the forecast period.
Spherix Incorporated (NASDAQ: SPEX) BREAKING NEWS: Spherix’s President and CEO, Anthony Hayes, today released a letter to shareholders outlining the Company’s plans for its previously disclosed dividend distribution. Dear Fellow Shareholder – As we accelerate our transformation into an innovative biotech company, I believe this is the optimal time to provide our shareholders with a detailed update. I am excited at the potential for Spherix and believe we have put several important pieces in place to drive future success.
First, October 21, 2019 is the record date for our dividend distribution. If you are a shareholder of record at 5 p.m. Eastern Standard on that date, you will receive one share of Hoth Therapeutics, Inc common stock for every 29 shares of Spherix common stock you own. The distribution of the Hoth shares is currently anticipated to occur on or about October 28, 2019, subject to effectiveness of the registration statement for such shares. Spherix will not distribute fractional shares of Hoth common stock, and any fractional shares will be rounded down to the nearest whole share.
Aside from the valuable assets already owned by Spherix, it is time to look forward and build on the successful investment in Hoth. Upon the closing of the asset acquisition from CBM BioPharma, Inc. (CBM), Spherix will acquire anticancer drugs that provide shareholders access to billion-dollar oncology markets. For example, the global acute myeloid leukemia (AML) market is expected to reach $2.2 billion by 2025 growing at CAGR 19.6% over the forecast period.
Beyond the big picture, the CBM assets provide shareholders and investors with comparable drugs to help establish value in these growing markets. For example, KPC34 treats acute myeloid leukemia and has shown tremendous promise in treating relapsed/refractory AML cancer that has a certain type of mutation. TibsovoÒ, by Agios Pharmaceuticals, Inc., also treats relapsed/refractory AML that has a certain mutation of the disease. In July of 2018, the FDA approved Tibsovo (ivosidenib) for Relapsed or Refractory Acute Myeloid Leukemia with an IDH1 Mutation after a 177-person, Phase 1 study. According to results published by Agios, Tibsovo generated $13.7 million in revenue for the second quarter of 2019 and they expect that to grow. A terrific result, when you look at the approval timeline for the drug:
- Dec 26, 2017: Agios Pharmaceuticals submits new drug application to the FDA for Ivosidenib for the treatment of patients with relapsed/refractory AML and an IDH1 Mutation.
- Feb 15, 2018: FDA accepts new drug application and grants priority review for Ivosidenib in relapsed or refractory AML with an IDH1 Mutation.
- Jul 20, 2018: FDA Approves Tibsovo (ivosidenib) for relapsed or refractory Acute Myeloid Leukemia with an IDH1 Mutation.
Tibsovo is one of three similar AML drugs that have received FDA Orphan Drug status and Fast Track designation for the treatment of AML, as well as priority review. The other two drugs are IDHIFAÒ (enasidenib) by Celgene Corporation and XOSPATAÒ (gilteritinib) by Astellas Pharma US.
Astellas had a similar approval timeline and revenue results, reporting sales of around $22 million for Xospata in the first quarter of fiscal 2019, and has said it expects that to increase to around $140 million for the full year, with an FDA approval timeline of:
- Apr 23, 2018 Astellas Submits New Drug Applications for Approval of Gilteritinib for the Treatment of FLT3mut+ Relapsed or Refractory Acute Myeloid Leukemia.
- May 29, 2018 U.S. FDA Grants Priority Review to Astellas’ New Drug Application for Gilteritinib for the Treatment of Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML).
- Nov 28, 2018 Approval FDA Approves Xospata (gilteritinib) for Acute Myeloid Leukemia (AML) with a FLT3 Mutation.
The AML cancer mutation treated by KPC34 is different than the mutations treated by the drugs referenced above, but these examples show quantitative comparable for KPC34. Spherix cannot guarantee a similar result, but we have been working closely with CBM and Wake Forest University to move KPC34 forward on a similar regulatory approval process. Read this and more news for Spherix at: https://financialnewsmedia.com/news-spex/
Recent developments in the healthcare, biotech industries:
iHealthcare added that the driving forces behind the growth include the introduction of high-priced products and strong pipeline of upcoming drugs. The Mordor report said the factors increasing the growth of this market are high Incidence and prevalence of acute myeloid leukemia, advancements in pharmacology and molecular biology to promote drug development, and increasing investments in R&D by the pharmaceutical companies. In addition, the Mordor report summed it up, saying: “The global rise in the incidence of AML, along with increased mortality due to the disease, is expected to create a huge demand for AML therapeutics, thus, augmenting the global AML market.”
Fluidigm Corporation (NASDAQ: FLDM) an innovative biotechnology tools provider with a vision to improve life through comprehensive health insight, recently announced that they will showcase innovative RNA sequencing applications using microfluidics technology at the American Society of Human Genetics (ASHG) annual meeting in Houston, Texas, from October 15 to 19.
“As the demand for RNA NGS sequencing continues to rise, many genomics laboratories have found it challenging to affordably scale NGS library preparation,” said Chris Linthwaite, President and CEO of Fluidigm. “This year at ASHG, we are excited to showcase a breakthrough automated RNA sequencing library preparation workflow that enables laboratories to efficiently produce 48 libraries at a time while substantially reducing their cost per sample. By automating the library prep workflow, shortening hands-on time and decreasing consumables waste, we can bring operational savings to mid-to-high-throughput laboratories using microfluidics technology that could amount to hundreds of thousands of dollars.”
Dermira, Inc. (NASDAQ: DERM) a biopharmaceutical company dedicated to bringing biotech ingenuity to medical dermatology by delivering differentiated, new therapies to the millions of patients living with chronic skin conditions, recently announced that detailed primary results from its Phase 2b dose-ranging study of lebrikizumab are being presented during the 39th Annual Fall Clinical Dermatology Conference in Las Vegas, NV. Lebrikizumab is currently being evaluated in a Phase 3 program in adult and adolescent patients with moderate-to-severe atopic dermatitis.
Lebrikizumab is a novel, investigational, monoclonal antibody designed to bind IL-13 with very high affinity, specifically preventing the formation of the IL-13Rα1/IL-4Rα heterodimer complex and subsequent signaling, thereby inhibiting the biological effects of IL-13 in a targeted and efficient fashion. IL-13 is believed to be a central pathogenic mediator that drives multiple aspects of the pathophysiology underlying the range of signs and symptoms of atopic dermatitis by promoting type 2 inflammation and mediating its effects on tissue, resulting in skin barrier dysfunction, itch, skin thickening and infection.
Quotient Limited (NASDAQ: QTNT) a commercial-stage diagnostics company, recently announced the positive Verification & Validation (V&V) data for the Extended Immunohematology (IH) Microarray.
“We received encouraging feedback from the ongoing Initial SDS US field trial sites, with a response from one of the sites being that the MosaiQ platform is the most user-friendly instrument used in their 27 years working in a testing lab. This in addition to the initiation of another three hypercare sites, gives me confidence in the market acceptance of MosaiQ,” said Franz Walt, Quotient’s Chief Executive Officer.
Mr. Walt added, “The Extended IH Microarray in combination with the Initial SDS Microarray, which was submitted for CE mark in June 2019, will be the first impactful and highly effective offering to hit the market. We are pleased to share these new data, which continues to demonstrate the potential of our platform.”
Bristol-Myers Squibb Company (NYSE: BMY) recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab) flat dosing schedule of 240 mg infused over 30 minutes every two weeks (Q2W) or 480 mg infused over 60 minutes every four weeks (Q4W) for the adjuvant treatment of adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. The CHMP recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU).
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