Arrowhead Enters $3.7 Billion License and Collaboration Agreements with Janssen
- Upon closing, Arrowhead to receive
- Arrowhead eligible to receive additional
- Janssen to receive a worldwide exclusive license for ARO-HBV and an option to collaborate on up to three new targets
- Arrowhead will hold a conference call and webcast today,
Under the terms of the agreement, Arrowhead will receive
Arrowhead is eligible to receive up to approximately
“This agreement represents an important next step for ARO-HBV. Arrowhead
has established a leadership position in the field over the past several
years, and Janssen’s proven development capabilities, global commercial
reach, and commitment to HBV make it the ideal partner to potentially
accelerate our goal of bringing a functional cure to patients with
chronic HBV,” said
Under the agreement, Janssen receives a worldwide exclusive license to the ARO-HBV program, Arrowhead’s third-generation subcutaneously administered RNAi therapeutic candidate being developed as a potentially curative therapy for patients with chronic hepatitis B virus infection. Beyond AROHBV1001, Arrowhead’s ongoing Phase 1/2 study of ARO-HBV, Janssen will be wholly responsible for clinical development and commercialization.
Janssen can also select up to three new targets, against which Arrowhead will develop clinical candidates. These potential new candidates will leverage Arrowhead’s proprietary TRiM™ platform, and do not include Arrowhead’s current pipeline. Arrowhead will perform discovery, optimization, and preclinical development, entirely funded by Janssen, sufficient to allow the filing of a U.S. Investigational New Drug application or equivalent, at which time Janssen will have the option to take an exclusive license. If the option is exercised, Janssen will be wholly responsible for clinical development and commercialization.
The closing of the transactions is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and is expected to close during the fourth quarter of 2018.
Conference Call and Webcast Details
Investors may access a live audio webcast on the Company's website at http://ir.arrowheadpharma.com/events.cfm. For analysts that wish to participate in the conference call, please dial 855-215-6159 or 315-625-6887 and provide Conference ID 2649806.
A replay of the webcast will be available on the company’s website approximately two hours after the conclusion of the call and will remain available for 90 days. An audio replay will also be available approximately two hours after the conclusion of the call and will be available for 3 days. To access the audio replay, dial 855-859-2056 or 404-537-3406 and provide Conference ID 2649806.
is evaluating the safety, tolerability, and pharmacokinetic effects of
single-ascending doses (SAD) of ARO-HBV in healthy adult volunteers, as
well as the safety, tolerability, and pharmacodynamic effects of
multiple-ascending doses (MAD) of ARO-HBV in patients with chronic HBV.
Dosing in the SAD portion of the study is complete and included five
cohorts at dose levels of 35, 100, 200, 300, and 400 mg. Dosing in the
MAD portion of the study is ongoing and includes cohorts receiving three
doses of ARO-HBV either weekly, bi-weekly, or monthly. Arrowhead
submitted a late-breaking abstract with clinical data to the Liver
Meeting®, the Annual Meeting of the
For more information, please visit www.arrowheadpharma.com, or follow us on Twitter @ArrowheadPharma. To be added to the Company's email list and receive news directly, please visit http://ir.arrowheadpharma.com/email-alerts.
Safe Harbor Statement under the Private Securities Litigation Reform Act:
This news release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties, including the safety and efficacy of our product candidates, the duration and impact of regulatory delays in our clinical programs, our ability to finance our operations, the future success of our scientific studies, our ability to successfully develop drug candidates, the timing for starting and completing clinical trials, rapid technological change in our markets, and the enforcement of our intellectual property rights. Our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q discuss some of the important risk factors that may affect our business, results of operations and financial condition. We assume no obligation to update or revise forward-looking statements to reflect new events or circumstances.
Arrowhead Pharmaceuticals, Inc.
Vince Anzalone, CFA
Investors and Media:
LifeSci Advisors, LLC