Arrowhead Pharmaceuticals

Arrowhead Pharmaceuticals, Inc. is a publicly traded biotechnology company headquartered in Pasadena, California. Its research and development activities are centered on RNA interference, or RNAi, a biological mechanism that can reduce production of selected proteins by targeting the messenger RNA instructions used to make them. The company applies this approach to drug discovery and development across diseases in which suppression of a specific gene or protein may have therapeutic value. The company traces its origins to 1989 and operated for many years under the name Arrowhead Research Corporation. In April 2016, it adopted the name Arrowhead Pharmaceuticals, reflecting the increasing emphasis of its business on pharmaceutical development rather than a broader research-company identity. Its development portfolio has included investigational therapies directed at hepatitis B virus infection, liver disease associated with alpha-1 antitrypsin deficiency, cardiovascular disease, and other conditions involving genetically defined or otherwise difficult-to-drug targets. Arrowhead’s business model has combined internal drug discovery with partnerships and licensing transactions involving larger pharmaceutical companies. A major expansion of its RNAi capabilities occurred in 2015, when the company acquired Novartis’s complete RNAi research and development portfolio and associated assets. This transaction strengthened Arrowhead’s intellectual-property position and expanded the technical and program base from which it could advance its own candidates and form collaborations. In 2016, Arrowhead entered into two agreements with Amgen involving cardiovascular RNAi programs. One agreement granted Amgen a worldwide exclusive license to the ARO-LPA program, while a second arrangement gave Amgen an option relating to a worldwide exclusive license for ARO-AMG1. These transactions illustrated Arrowhead’s strategy of using collaborations to provide development and commercialization opportunities for selected programs. The company subsequently entered a large strategic relationship with Janssen. On October 31, 2018, Arrowhead completed a license and collaboration agreement valued at $3.7 billion for the development and commercialization of ARO-HBV, an RNAi program aimed at hepatitis B. The relationship also included a research collaboration and option arrangement under which Janssen could potentially collaborate on as many as three additional RNAi therapeutics against targets selected by Janssen. Arrowhead has described its pipeline as containing multiple investigational products at different stages of development. These programs are not equivalent to approved commercial products: the company’s principal activities are discovery, preclinical research, clinical testing, licensing, and collaboration. Accordingly, its commercial position depends on scientific results, clinical-trial outcomes, regulatory decisions, intellectual-property protection, financing, and the ability of partners to develop and commercialize licensed programs. The company’s central positioning remains that of a clinical-stage RNAi therapeutics developer with a focus on applying gene-silencing technology to diseases with substantial unmet medical need.

Arrowhead Pharmaceuticals originated in 1989 and developed into a biotechnology company focused on pharmaceutical applications of RNA interference. RNAi enables the selective reduction of gene expression by directing cellular mechanisms toward particular messenger RNA molecules. For drug developers, this creates a potential route to modulate proteins that may be difficult to address with conventional small-molecule or antibody medicines. The company’s modern identity was shaped by the expansion of its RNAi portfolio and by a shift toward partnerships with larger pharmaceutical organizations. In 2015, Arrowhead acquired Novartis’s complete RNAi research and development portfolio and associated assets. The transaction expanded the company’s technology and intellectual-property holdings and provided a broader foundation for its pipeline. In April 2016, Arrowhead Research Corporation changed its name to Arrowhead Pharmaceuticals, Inc. The renaming marked a stronger emphasis on therapeutic development. Later that year, the company announced two arrangements with Amgen relating to cardiovascular RNAi programs. Amgen received a worldwide exclusive license to ARO-LPA, and it obtained an option concerning a worldwide exclusive license for ARO-AMG1. These agreements demonstrated how Arrowhead could use external partners for the development and potential commercialization of selected programs. A further turning point came on October 31, 2018, when Arrowhead completed a license and collaboration agreement with Janssen for ARO-HBV. The agreement covered development and commercialization of the hepatitis B program and was reported as having a value of $3.7 billion. It also included a research collaboration and an option structure that could permit work on as many as three additional RNAi therapeutics directed at targets selected by Janssen. Arrowhead’s pipeline has included programs for hepatitis B, alpha-1 antitrypsin deficiency-associated liver disease, cardiovascular disease, and other serious disorders. The company’s activities encompass discovery research, preclinical development, clinical development, intellectual-property management, licensing, and strategic collaboration. Because its offerings are primarily investigational candidates rather than established consumer products, progress depends on clinical evidence, regulatory review, manufacturing, funding, partner decisions, and the protection of its underlying technology. The company remains headquartered in Pasadena, California, and trades publicly under the ticker ARWR. Its defining business proposition is the development of RNAi-based medicines, with particular attention to diseases in which reducing production of a disease-associated protein may provide a therapeutic benefit.

1. 2018Janssen agreement for ARO-HBV

   Arrowhead completed a license and collaboration agreement with Janssen for ARO-HBV and related future RNAi research opportunities.

   Source
2. 2016Corporate name changed to Arrowhead Pharmaceuticals

   Arrowhead Research Corporation adopted the name Arrowhead Pharmaceuticals, Inc.

   Source
3. 2016Amgen cardiovascular collaborations

   Arrowhead announced licensing and collaboration arrangements with Amgen for the ARO-LPA and ARO-AMG1 cardiovascular RNAi programs.

   Source
4. 2015Acquisition of Novartis RNAi portfolio

   Arrowhead acquired Novartis’s complete RNAi research and development portfolio and related assets, expanding its technology and intellectual-property holdings.

   Source
5. 1989Company founded

   Arrowhead was established, later developing into a biotechnology company focused on RNA interference therapeutics.

   Source

Clinical-stage RNAi therapeutics company

• ARO-HBVRNAi therapeutic candidate

  ARO-HBV is an investigational RNA interference program directed at hepatitis B. Arrowhead licensed development and commercialization rights under its 2018 collaboration with Janssen. The program represents the company’s application of gene-silencing technology to a chronic viral disease in which reducing production of viral and disease-associated proteins may support therapeutic intervention. It is a development-stage candidate rather than an established approved product in the supplied reference material.

• ARO-LPACardiovascular RNAi therapeutic candidate

  ARO-LPA is an RNAi program directed at a cardiovascular target. In 2016, Arrowhead granted Amgen a worldwide exclusive license connected with the program. The candidate illustrates Arrowhead’s strategy of developing gene-silencing medicines for cardiovascular disease and using pharmaceutical partnerships to support later development and commercialization.

• ARO-AMG1Cardiovascular RNAi therapeutic candidate

  ARO-AMG1 is a cardiovascular RNAi program included in Arrowhead’s 2016 arrangements with Amgen. The agreement gave Amgen an option relating to a worldwide exclusive license. The supplied reference material identifies the program and its partnering structure but does not provide sufficient information to describe a commercial launch or final clinical status.

• RNAi pipelineBiopharmaceutical development platform

  Arrowhead has developed a multi-program pipeline of investigational RNA interference medicines. The portfolio has included candidates aimed at hepatitis B, alpha-1 antitrypsin deficiency-associated liver disease, cardiovascular disease, rare diseases, and other serious conditions. Programs can occupy different stages of research and clinical development, and the portfolio is subject to changes resulting from clinical data, partnerships, licensing decisions, and regulatory review.

• 2018License ARO-HBV and establish a broader Janssen collaborationM&A

  Arrowhead sought a major pharmaceutical partner for the development and commercialization of its hepatitis B RNAi program.

  What changed. Arrowhead completed a license and collaboration agreement with Janssen for ARO-HBV, alongside research and option provisions covering up to three additional RNAi therapeutics.

  Aftermath. Janssen obtained rights to participate in development and commercialization of ARO-HBV and received potential access to additional target programs.

  Reported agreement value. $3.7 billion (2018 announced license and collaboration agreement)

  Source
• 2016Adopt the Arrowhead Pharmaceuticals nameStrategy

  The company was placing greater emphasis on pharmaceutical research and development.

  What changed. Arrowhead Research Corporation changed its corporate name to Arrowhead Pharmaceuticals, Inc.

  Aftermath. The new name more directly represented the company’s therapeutic-development focus.

  Source
• 2016Partner cardiovascular RNAi programs with AmgenM&A

  Arrowhead was seeking development and commercialization partners for cardiovascular RNAi candidates.

  What changed. The company entered two collaboration and licensing arrangements with Amgen involving ARO-LPA and ARO-AMG1.

  Aftermath. Amgen received worldwide exclusive rights for ARO-LPA and an option concerning ARO-AMG1 under the announced arrangements.

  Source
• 2015Acquire Novartis RNAi research and development assetsM&A

  Arrowhead sought to expand its RNAi technology base and intellectual-property holdings.

  What changed. The company acquired Novartis’s complete RNAi research and development portfolio and associated assets.

  Aftermath. The acquisition broadened Arrowhead’s RNAi portfolio and supported the company’s subsequent pipeline and partnering strategy.

  Source

• 2018Arrowhead completes major Janssen license and collaboration agreement for ARO-HBV

  Arrowhead closed a license and collaboration agreement with Janssen covering development and commercialization of ARO-HBV, together with a research collaboration and option arrangement for up to three additional RNAi therapeutics.

  M&A
  Source
• 2016Arrowhead changes corporate name to Arrowhead Pharmaceuticals

  The company announced a change of name from Arrowhead Research Corporation to Arrowhead Pharmaceuticals, Inc., aligning its corporate identity more closely with pharmaceutical drug development.

  Other
  Source
• 2016Arrowhead enters cardiovascular RNAi collaborations with Amgen

  Arrowhead announced two collaboration and licensing agreements with Amgen. The arrangements covered a worldwide exclusive license for ARO-LPA and an option concerning a worldwide exclusive license for ARO-AMG1.

  M&A
  Source
• 2015Arrowhead expands RNAi intellectual-property and development portfolio through Novartis transaction

  Arrowhead completed the acquisition of Novartis's complete RNAi research and development portfolio and related assets, materially expanding its RNAi technology and intellectual-property base.

  M&A
  Source

1. Arrowhead Pharmaceuticals
2. Arrowhead Pharmaceuticals official website