Arrowhead Goes All in With J&J to Develop Hep B Drug for $3.7B

Courtesy josefkubes/Getty Images_John Reed_courtes

Courtesy josefkubes/Getty Images_John Reed_courtes

Arrowhead announced a deal with Johnson & Johnson that could conceivably be worth over $3.7 billion, with J&J agreeing to pick up a minor stake in the company, including the task of cultivating and promoting its ARO-HBV Hepatitis B drug.

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Arrowhead Pharmaceuticals, Inc. announced a deal with Johnson & Johnson that could conceivably be worth over $3.7 billion, with Johnson & Johnson agreeing to pick up a minor stake in the company, including the task of cultivating and promoting its ARO-HBV Hepatitis B drug.

The deal includes a worldwide license for ARO-HBV as well as an opportunity to work together on up to three gene-silencing RNA interference (RNAi) drugs. Johnson & Johnson’s Janssen Pharmaceutical unit will be carrying out this arrangement. Johnson & Johnson’s investment is at a premium of approximately 24 percent, totaling at $75 million in equity at $23 per share. Additionally, Arrowhead will be receiving $175 million in advance.

The RNA-focused Arrowhead Pharmaceuticals Inc. is striving to develop “Arrowhead Pharmaceuticals develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, characterized by the overproduction of one or more proteins. The depth and versatility of our RNAi technologies enable us to address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise druggable by small molecules and biologics.”

Their pipeline includes drugs for multiple diseases such as hypertriglyceridemia, cystic fibrosis, renal cell carcinoma, Hepatitis B, cardiovascular disease, and alpha-1 antitrypsin deficiency. Arrowhead Pharmaceuticals released preclinical data progress on ARO-ANG3, their cardiometabolic disease treatment drug, earlier this year. The current deal’s drug of focus, ARO-HBV, “is ARO-HBV is being developed to be a potentially curative therapy for patients with chronic Hepatitis B infection. ARO-HBV silences all HBV gene products and intervenes upstream of the reverse transcription process where current standard-of-care nucleotide and nucleoside analogues act. The company believes this will allow the body’s natural immune defenses to clear the virus and lead to a functional cure.”

16 million people are infected with chronic Hepatitis B in the U.S. and Western Europe alone, with the worldwide count at 400 million. Though an infected person can have an immune tolerant phase of chronic infection over the course of years with no symptoms, the levels of viral DNA and viral antigens produced can result in cirrhosis and liver cancer (HCC) over time. “The current standard of care for treatment of chronic HBV infection is a daily oral dose of nucleotide/nucleoside analogs (NUCs) or a regimen of interferon injections for approximately one year. NUCs are generally well tolerated, but patients may need lifetime treatment because viral replication often rebounds upon cessation of treatment. Interferon therapeutics can result in a functional cure in around 10% of some patient types, but treatment is often associated with significant side effects, including severe flu-like symptoms, bone marrow suppression, and autoimmune disorders.”

After Arrowhead announced details of initial trial testing with favorable data towards ARO-HBV, the drug outcomes were labeled as “revolutionary” by analysts, with the company said to be close to creating a functional cure for Hepatitis B. Janssen became an excellent candidate for a development deal, with an aspirations to “transform lives by bringing life-saving and life-changing solutions to people who need them. We’re committed to providing safe and effective medicines as well as the services and support that contribute to healthy outcomes. This calls for the best science, the most creative minds and an openness to collaborate with researchers, governments and patient organizations at every stage – from early discovery to market access and patient education.” Dr. Paul Janssen, founder of the company, stated that “there are still many diseases for which there is no cure, and effective drugs must be found. Although we have contributed to the solutions for some of these problems, we will continue our research efforts, because so much more needs to be done.”

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