19 Jan 5 Companies With Potential To Transform The HBV Therapeutics Market
Hepatitis B Virus Infection affects an estimated 257 million people worldwide and causes 780,000 deaths per year as per a report by World Health Organisation (WHO). In the U.S alone, about 2 percent of the population is living with Hepatitis B or Hepatitis C. It can lead to severe complications like Liver Cirrhosis and Hepatocellular Carcinoma if left untreated. At present, there are FDA approved vaccinations available to prevent Hepatitis B virus which are 95% effective in prevention and development of chronic diseases related to the infection.
However there is no treatment available for acute Hepatitis B. The palliative care that is offered after diagnosis of the condition aims at providing comfort, alleviating symptomatic discomfort, slowing down the progression of infection and improving the chances of long-term survival.
This paves way for increased research and development to find the cure for this chronic condition. The industry is witnessing collaborations, development of new products, acquisitions and mergers as a way to capture a majority share of the market. According to a report titled “Global Hepatitis B Virus [HBV] Treatment Market – Analysis By Type (Therapeutics, Vaccine), By End User (Male, Female) – By Region, By Country: Opportunities and Forecast (2017-2022)”, the global market is expected to achieve a CAGR of 5.30% during 2017 – 2022.
The growth in the industry is driven by improved diagnostics that help identify the disease on time, rising education and awareness about the condition and its implication, increased access to healthcare, government and regulatory support for companies engaged in finding a cure for the condition and emerging vaccines that call for lower dosages and increased effectiveness.
We take a look at some companies in the HBV market that show potential for changing the dynamics of the market in the future.
Arbutus Biopharma (NASDAQ: ABUS)
Market Cap: $ 224.68M; Current Share Price: 4.05 USD
Arbutus Biopharma is a biopharmaceutical company that is engaged in developing a portfolio of drugs with complementary mechanisms that include antiviral action, host targeting and immune based approaches. It seeks to revolutionise the HBV treatment landscape. It is currently developing therapeutics based on the Nobel-prize winning RNAi mechanism, which uses the body’s own natural processes to eliminate specific gene-products or proteins in the cell. Its proprietary delivery platform called Lipid Nanoparticle or LNP has helped establish Arbutus as leader in the field. It deters the production of disease-associated protein by encapsulating the RNAi trigger molecules in lipid particles and efficiently delivering it into the target cells.
Its novel ARB-1467 HBV RNAi product has led to many collaborations, partnerships and licensing agreements with organisations such as The Baruch S Bloomberg Institute and Drexel University for cccDNA inhibitors, capsid assembly inhibitors and hepatocellular carcinoma, or HCC, inhibitors. It has also entered into a licensing and research collaboration agreement with the Saint Louis University Liver Centre to develop Ribonuclease H (RNaseH) inhibitors. It acquired Enantigen Therapeutics, Inc. (Enantigen) in October 2014 for its HBV surface antigen secretion inhibitor program and capsid assembly inhibitor programs.
The FDA and the EMA gave an approval for its ONPATTRO™ (patisiran) resulting in a royalty stream to Arbutus. As on September 30, 2018, Arbutus had cash, cash equivalents and short-term investments totalling $142.0 million as per its Q3 financial results announced in November 2018.
ContraVir Pharmaceuticals (NASDAQ: CTRV)
Market Cap: $ 5.53M; Current Share Price: 0.34 USD
Contravir Pharmaceuticals is developing two novel anti-HBV compounds with complementary mechanisms of action namely TXL, a direct acting antiviral (DAA) nucleotide analog lipid prodrug of tenofovir (TFV) for delivering precise hepatic intracellular concentrations of tenofovir (TFV), while reducing off- target toxicities and side-effects and CRV431, an innovative and highly potent host- targeting antiviral cyclophilin inhibitor that has shown to reduce HBV DNA and surface antigen (HBsAg), while mitigating liver fibrosis and hepatocellular carcinoma.
This biopharmaceutical company is committed to offering therapeutic solutions for liver diseases arising from HBV, HCV, HDV and NASH (non-alcoholic steatohepatitis). The company expects to see potential cumulative sales exceeding $200 billion over the next 20 years in the U.S, E.U and Japan alone for a curative regimen in the HBV Segment.
It also seeks to address the unmet needs in the NASH (non-alcoholic steatohepatitis) market which is projected to have a $20 to $35 billion market by 2025. The company aims to out license and enter into strategic partnerships for TXL.
Vical Incorporated (NASDAQ: VICL)
Market Cap: $ 20.79M; Current Share Price: 0.95 USD
Vical Incorporated uses its patented DNA delivery technology for developing biopharmaceutical products for the prevention and treatment of chronic infectious diseases. Its core technology is based on plasmid DNA (pDNA) that can encode any protein of interest.
This can be used for delivering a plethora of biopharmaceutical products such as antigens for vaccines used in protection from viruses, bacteria or parasites, vaccines used in treatment of cancer and immunotherapeutics. They can also stimulate angiogenesis and tissue repair in case of cardiovascular disorders.
It has nonexclusive license with Bristol-Myers Squibb Company for its Vaxfectin®, a novel proprietary cationic lipid-based formulation, that has demonstrated that it can augment both plasmid DNA-based vaccines as well as protein-based vaccines. It has a worldwide agreement wherein Bristol-Myers Squibb will use this technology to generate therapeutics for humans. It also has strategic collaborations with major players in the industry such as Astellas, AnGes and Merial.
Currently, its drug candidate, VL-2397, for invasive fungal infections is in Phase 2 clinical study stage. It was licensed from Astellas Pharma in 2015. It has received a FDA fast track approval along with a Qualified Infectious Disease Product (QIDP) and Orphan designations for the use of VL-2397 in the treatment of invasive aspergillosis.
Its other drug candidate, VR-CHB01 for chronic Hepatitis B, is in the preclinical stage.
The company reported a net loss for the third quarter of 2018 amounting to $1.5 million, or $0.07 per share, compared with a net loss of $3.1 million, or $0.27 per share, for the third quarter of 2017. As on September 30, 2018, it had cash, cash equivalents, marketable securities and long-term investments balance of $52.7 million.
Dicerna Pharmaceuticals (NASDAQ: DRNA)
Market Cap: $ 690.68M; Current Share Price: 11.01 USD
Another key player in the RNAi technology space, Dicerna’s lead product candidate DCR-PHXC, is in clinical development stage for the treatment of primary hyperoxaluria, or PH. They now have an active investigational new drug (IND) application with the FDA, along with active clinical trial applications in the United Kingdom, France and Germany. It’s proprietary, GalXCTM RNAi platform, is designed to help patients with rare inherited diseases involving the liver and other chronic infectious and cardiovascular diseases.
In preclinical studies its drug candidate DCR-HBVS has shown to target HBV messenger RNA, leading to greater than 99% reduction in circulated HBsAg in mouse models of HBV infection, providing an impetus to its efforts in finding a treatment for Chronic Hepatitis B virus infection. They have various drug candidates in the pipeline for cardio metabolic disorders, chronic liver diseases and Hypercholesterolemia (PCSK9-targeted therapy).
It has collaborations with Lilly, Alexion, and Boehringer Ingelheim for various programs. The company reported $262 million in upfront payments and equity at a premium between the three collaborations. It has allocated $200 million for its strategic programs.
As of September 30, 2018, the company had $180.4 million in cash, cash equivalents and held-to-maturity investments, as compared to $113.7 million as on December 31, 2017. The company strengthened its balance sheet with an equity financing yielding gross proceeds of $115.0 million for Q3, 2018.
Arrowhead Pharmaceuticals (NASDAQ: ARWR)
Market Cap: $ 1.35B; Current Share Price: 14.60 USD
A biopharmaceutical company that uses the RNAi technology to address unmet needs in a plethora of scenarios involving diseases with a genetic basis, Arrowhead pharmaceuticals aims to offer therapeutic solutions in various areas and target diseases that are intractable. Its drug candidates ARO-AAT for the treatment of Alpha-1 liver diseases, ARO –APCO3 for Hypertryglyceridemia are in Phase I and Phase II clinical trials stage.
In addition, it has strategic partnerships with Janssen for the development of ARO-HBV for Hepatitis B and with Amgen for AMG 890 and ARO-AMG1, its drug candidates for cardiovascular conditions. The partnership with Janssen pharmaceutical, a part of Johnson & Johnson, resulted in a deal worth approximately $3.7 billion plus royalties on commercial sales, which will allow funding for at least 6 years of the company’s operations, while the agreement with Amgen earned Arrowhead a $10 million milestone payment.
The company closed the fiscal 2018 year-end with cash and cash equivalents of $ 30.13 million as against $24.84 million for 2017.
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.