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Idenix News- Drug Development, Pharmaceuticals Reports Fourth Quarter and Year Ended 2012 Financial Results
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CAMBRIDGE, Mass., Feb. 25, 2013 (GLOBE NEWSWIRE) -- Idenix Pharmaceuticals, Inc. (Nasdaq:IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today reported unaudited financial results for the fourth quarter and year ended December 31, 2012. [from Jules: don't forget Vertex's nucleotide in phase 2 now ALS2000, and Gilead's GS7977, so an Idenix nucleotide would be the third. As of now it is estimated & projected that 5-8 million have HCV in the USA but 80% remain undiagnosed, so everyone is asking where are they because so far it has been hard to find them as screening projects have failed to identify increased numbers with HCV. Are the projections correct, that 5-8 mill have HCV? So right now and over the course of the next year don't expect much in the way of increasing new HCV cases because large-scale screening & awareness projects are not in the planning, at least as far as I can see. However, over the next 1-3 years there will be new oral direct-acting antivirals coming into the pharmacy & IFN-free multi-drug regimens, as many as 9 HCV drugs are in the final stages of phase 3 development/clinical trials & thereafter they are expected to become FDA approved, meaning I expect lots of publicity, lots of news, lots of mainstream press raising awareness about SVR/cure rates with these new therapies as much as 100%, about getting diagnosed, getting into care & being treated. The availability of these new therapies may be what drives awareness & screening]
Idenix Pharmaceuticals Provides Update on IDX184 and IDX19368 Development Programs, stops 2 drugs' development, starts another - (02/05/13)
Antiviral and Preclinical Profiles of HCV NS5A Inhibitors IDX380 and IDX719 - (02/01/13)
The pharmacological properties of IDX19368, a novel nucleotide prodrug, highlight its potential for use in a low-dose DAA regimen for HCV - (02/01/13)
Safety, Pharmacokinetic and Preliminary Antiviral Activity Results from a First-in-Human Study of IDX719, a Pan-Genotypic Novel HCV NS5A Inhibitor - (02/01/13)
Potent HCV Diamidate Pronucleotide Inhibitors: In Vitro Antiviral Activity Optimization (Idenix) - (02/01/13)
AASLD: IDX719, HCV NS5A Inhibitor, Demonstrates Pan-Genotypic Activity after Three Days of Monotherapy in Genotype 1, 2, 3 or 4 HCV-Infected Subjects - (01/31/13)
HCV Pipeline and Business Review
IDX719, NS5A Inhibitor Program
· In January 2013, Idenix entered into a non-exclusive collaboration with Janssen Pharmaceuticals, Inc. for the clinical development of all-oral direct-acting antiviral (DAA) HCV combination therapies. The collaboration will evaluate combinations including IDX719, Idenix's once-daily pan-genotypic NS5A inhibitor, simeprevir (TMC435), a once-daily protease inhibitor jointly developed by Janssen and Medivir AB, and TMC647055, a once-daily non-nucleoside polymerase inhibitor, boosted with low dose ritonavir, being developed by Janssen. Clinical development plans include an initial drug-drug interaction study to begin in the first quarter of 2013, followed by phase II studies as agreed between the companies and pending approval from regulatory authorities.
Nucleotide Inhibitor Program
· The Company expects to file an investigational new drug application (IND) for a lead uridine-based nucleotide analog candidate from its next-generation nucleotide prodrug discovery program in the first half of 2013. The Company also expects to conduct IND-enabling studies for additional nucleotide prodrugs in 2013.
· In February 2013, Idenix elected to discontinue the development of IDX184 and IDX19368, the Company's guanosine-based nucleotide prodrug programs, after the U.S. Food and Drug Administration (FDA) communicated that the programs would remain on a clinical hold that began in August 2012 due to cardiac adverse events seen in a competitor's phase II clinical trial of BMS-986094.
"In 2013, one of our primary goals is to generate IDX719 data in all-oral combination therapies, initially through collaborations beginning in the first half of the year, and subsequently with our own nucleotide prodrug by year end. Also, we have an intensive, rapidly accelerating nucleotide discovery effort and are on track to file one IND from this program in the first half of 2013 and at least one additional IND by the end of the year," said Ron Renaud, Idenix's President and Chief Executive Officer. "With promising candidates from two HCV classes advancing in the clinic by the end of the year, we believe we will be in a good position to evaluate multiple all-oral combination therapies for HCV."
Fourth Quarter and Year Ended 2012 Financial Results
For the fourth quarter ended December 31, 2012, Idenix reported total revenues of $0.3 million, compared to total revenues of ($0.7) million in the fourth quarter of 2011. The Company reported a net loss of $22.7 million, or $0.17 per basic and diluted share, for the fourth quarter ended December 31, 2012, compared to a net loss of $18.1 million, or $0.18 per basic and diluted share for the fourth quarter ended December 31, 2011.
For the year ended December 31, 2012, Idenix reported total revenues of $69.7 million, compared to total revenues of $7.0 million for the year ended December 31, 2011. The Company reported a net loss of $32.4 million, or $0.27 per basic and diluted share, for the year ended December 31, 2012, compared to a net loss of $52.0 million, or $0.57 per basic and diluted share for the year ended December 31, 2011. The change in net loss is mainly due to additional revenue as a result of the recognition of $36.1 million of deferred revenue in the first quarter of 2012 related to the termination of the license agreement with ViiV Healthcare Company and $27.1 million of additional revenue recognized in the third quarter of 2012 as a result of the restructuring of our collaboration with Novartis Pharma AG in July 2012. These amounts were offset by increases in research and development expenses of $28.8 million related primarily to IDX184 and IDX719, professional and legal costs of $7.1 million and an $8.0 million intangible asset impairment charge in the third quarter of 2012 related to the termination agreement with Novartis.
2013 Financial Guidance
At December 31, 2012, Idenix's cash and cash equivalents totaled $230.8 million. The Company expects that its current cash and cash equivalents will be sufficient to sustain its operations into at least the second half of 2014. This guidance assumes no milestone payments, license fees, reimbursement for development programs and no financing activities.
ABOUT IDENIX
Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a biopharmaceutical Company engaged in the discovery and development of drugs for the treatment of human viral diseases. Idenix's current focus is on the treatment of patients with hepatitis C infection. For further information about Idenix, please refer to www.idenix.com.
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