Hepatitis C, one of the major causes of liver failure, is caused by hepatitis C virus, which is spread from person to person through contact with infected blood. It is estimated that about 3.2 million Americans, and 170 million people worldwide, are chronically infected with hepatitis C virus, or HCV for short.
The standard treatment for hepatitis C is a 48-week treatment of both pegylated interferon and ribavirin. Given the fact that the current standard-of-care therapy is associated with poor response rates and significant side effects, novel medicines which could change the hepatitis C treatment landscape are being explored.
Hepatitis C is a lucrative market, and analysts estimate the total sales of hepatitis C drugs to reach $10 billion by 2017. The FDA approved two new drugs for hepatitis C this year - Merck & Co.'s (MRK) Victrelis on May 13 and Vertex Pharmaceuticals Inc.'s (VRTX) Incivek on May 23.
Building a pipeline of drug candidates for HCV, a market with high levels of unmet need, is biopharmaceutical company Idenix Pharmaceuticals Inc. (IDIX). For readers who are new to Idenix, here's what to expect in the coming months...
IDX184, a once-daily, oral HCV nucleotide polymerase inhibitor, is the company's lead product candidate. In July of this year, the company initiated enrollment of HCV-infected patients into a 12-week phase IIb trial of IDX184 in combination with pegylated interferon and ribavirin.
The trial will enroll 100 treatment-naive HCV genotype 1-infected patients and evaluate two doses of IDX184. Fifty patients will be randomized to 50 mg of IDX184 and 50 patients to 100 mg of IDX184, each for 12 weeks in combination with pegylated interferon and ribavirin. Patients will receive an additional 12 or 36 weeks of pegylated interferon and ribavirin, depending on the virologic response. Interim one month safety and antiviral activity data on the first 30 patients from the phase IIb trial of IDX184 is expected in the fourth quarter.
The full worldwide commercial rights to IDX184 are retained by Idenix. The company may seek a partner for future development of IDX184.
Last September, the FDA issued a clinical hold on IDX184 and another HCV drug candidate IDX320, following three serious adverse events that occurred during a drug-drug interaction study of the combination of IDX184 and IDX320 in healthy volunteers. The full clinical hold on IDX184 was lifted in February of this year and was replaced with a partial clinical hold. Idenix has dropped the development of IDX320 owing to the fact that the observed toxicity in the drug-drug interaction study was likely caused by IDX320.
The other compounds in the company's HCV pipeline include, non-nucleoside inhibitor IDX375, which is under phase II development, and a couple of preclinical candidates like NS5A compounds and protease inhibitor compounds. An IND ( Investigational New Drug) regulatory filing for NS5A inhibitor IDX719 is expected by this year-end.
Here's a brief overview of the company...
Idenix has major drug development and commercialization partnerships with Novartis AG (NVS), and ViiV Healthcare, an independent company jointly owned by GlaxoSmithKline plc (GSK) and Pfizer Inc. (PFE).
Under the agreement with Novartis signed in May 2003, Idenix co-developed and co-launched hepatitis B drug , telbivudine, which is sold on the market as Tyzeka/Sebivo, since 2007. Novartis has full commercialization rights to Tyzeka/Sebivo and Idenix receives royalty payments on the drug's sales. As of July 22, 2011, Novartis had about 35% stake in Idenix.
In February 2009, Idenix licensed to GlaxoSmithKline, on a worldwide basis, an HIV/AIDS drug candidate IDX899, which is now known as GSK2248761, a non-nucleoside reverse transcriptase inhibitor. GSK2248761, a phase IIb drug candidate, has been on clinical hold since February of this year, following four cases of seizures in patients treated with the compound.
Since its inception in May 1998, Idenix has incurred significant losses each year. The company generates revenue from collaborations and royalty payments associated with product sales of the hepatitis B drug made by Novartis.
For the second quarter ended June 30, 2011, Idenix incurred a net loss of $13.9 million or a loss of $0.15 per share on revenue of $1.0 million. This compares with a net loss of $16.3 million or a loss of $0.23 per share on revenue of $1.3 million in the same quarter a year ago. At the end of the second quarter of 2011, the company had cash of of $78.4 million, sufficient to sustain operations until at least the second quarter of 2012.
Idenix priced its IPO at $14 per share and went public on the NASDAQ National Market on July 22, 2004. IDIX trades in a 52-week price range of $2.57 to $7.05. At the close on Friday, (Sep.2), the stock was priced at $5.23.
Updated News
The interim one month safety and antiviral activity data for the first 30 patients from the phase IIb trial of IDX184 is expected early in the first quarter of 2012.
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