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TMCNet:  Enanta Pharmaceuticals Announces European Medicines Agency Validates Marketing Authorization Applications for AbbVie's Investigational, All-Oral, Interferon-Free Regimen for Genotype 1 Chronic Hepatitis C

[June 17, 2014]

Enanta Pharmaceuticals Announces European Medicines Agency Validates Marketing Authorization Applications for AbbVie's Investigational, All-Oral, Interferon-Free Regimen for Genotype 1 Chronic Hepatitis C

WATERTOWN, Mass. --(Business Wire)--

Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs in the infectious disease field, today announced that AbbVie has reported that the Marketing Authorization Applications (MAAs) for AbbVie's investigational, all-oral, interferon-free regimen primarily for the treatment of adult patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection have been fully validated and are now under accelerated assessment by the European Medicines Agency (EMA (News - Alert)).

The three direct-acting antiviral investigational regimen for GT1 consists of the fixed-dose combination of ABT-450/ritonavir (150/100mg) co-formulated with ombitasvir (ABT-267) 25mg, dosed once daily, and dasabuvir (ABT-333) 250mg with or without ribavirin (weight-based), dosed twice daily. ABT-450 is Enanta's lead protease inhibitor developed through Enanta's collaboration with AbbVie.

Accelerated assessment, which is a review process designated for new medicines of major public health interest, was granted in May 2014 by the EMA for AbbVie's investigational HCV regimen. Validation of the MAAs confirms that the submissions are complete and starts the EMA's centralized review process. If approved, AbbVie expects that its regimen could be available for marketing in the European Union in the first quarter of 2015.

The MAAs were submitted on May 8, 2014 and are supported by data from a large clinical program conducted by AbbVie, including six phase 3 studies of more than 2,300 GT1 patients in over 25 countries. Review of the MAAs will be conducted under the centralized licensing procedure, which, when finalized, provides marketing authorizations in all 28 member states of the European Union.

Protease Inhibitor Collaboration with AbbVie

In December 2006, Enanta and Abbott announced a worldwide agreement to collaborate on the discovery, development and commercialization of HCV NS3 and NS3/4A protease inhibitors and HCV- protease-inhibitor-containing drug combinations. ABT-450 is a protease inhibitor identified as a lead compound through the collaboration. Under the agreement, AbbVie is responsible for all development and commercialization activities for ABT-450. Enanta reeived $57 million in connection with signing the collaboration agreement, has received $95 million in subsequent clinical and regulatory milestone payments (including $40 million in connection with the MAA and FDA filings for the regimen described above), and is eligible to receive up to an additional $155 million in payments for regulatory and reimbursement approval milestones, as well as double-digit royalties worldwide on any revenue allocable to the collaboration's protease inhibitors. Also, for any additional collaborative HCV protease inhibitor product candidate developed under the agreement, Enanta holds an option to modify the U.S. portion of it rights to receive milestone payments and worldwide royalties. With this option, Enanta can fund 40 percent of U.S. development costs and U.S. commercialization efforts (sales and promotion costs) for the additional protease inhibitor in exchange for 40 percent of any U.S. profits ultimately achieved after regulatory approval, instead of receiving payments for U.S. commercial regulatory approval milestones and royalties on U.S. sales of that protease inhibitor.


About ABT-450

ABT-450 is an NS3 protease inhibitor discovered through Enanta's ongoing collaboration with AbbVie. AbbVie and Enanta have an agreement to collaborate on the discovery, development and commercialization of HCV NS3 and NS3/4A protease inhibitors. Protease inhibitors play an essential role in the viral life cycle of the hepatitis C virus (HCV). Inhibition of the protease prevents non-structural (NS) proteins from forming and thereby prevents replication and survival of the HCV virus. ABT-450 is part of AbbVie's investigational regimen for HCV that consists of boosted protease inhibitor ABT-450/ritonavir (referred to as ABT-450/r), NS5A inhibitor ABT-267 and non-nucleoside polymerase inhibitor ABT-333.

About Enanta

Enanta Pharmaceuticals is a research and development-focused biotechnology company that uses its robust chemistry-driven approach and drug discovery capabilities to create small molecule drugs in the infectious disease field. Enanta is discovering, and in some cases developing, novel inhibitors designed for use against the hepatitis C virus (HCV). These inhibitors include members of the direct acting antiviral (DAA) inhibitor classes - protease (partnered with AbbVie), NS5A (partnered with Novartis) and nucleotide polymerase - as well as a host-targeted antiviral (HTA) inhibitor class targeted against cyclophilin. Additionally, Enanta has created a new class of antibiotics, called Bicyclolides, for the treatment of multi-drug resistant bacteria, with a focus on developing an intravenous and oral treatment for hospital and community MRSA (methicillin-resistant Staphylococcus aureus) infections.

Forward-Looking Statement Disclaimer

This press release contains forward-looking statements, including statements with respect to the prospects for AbbVie's HCV treatment regimen containing ABT-450 for HCV and the prospects for milestone payments and royalties to Enanta resulting from any regulatory and reimbursement approvals of the regimen. Statements that are not historical facts are based on our management's current expectations, estimates, forecasts and projections about our business and the industry in which we operate and our management's beliefs and assumptions. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors that may affect actual results include the efforts of AbbVie (our collaborator on ABT-450) to obtain regulatory approvals and commercialize treatment regimens containing ABT-450, the development, regulatory and marketing efforts of others with respect to competitive HCV treatment regimens, regulatory and reimbursement actions affecting any ABT-450-containing regimen, any competitive regimen, or both, and the level of market acceptance and the pricing and rate of reimbursement for any ABT-450-containing regimen. Enanta cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Enanta undertakes no obligation to update or revise these statements, except as may be required by law.


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