October 20, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Johnson & Johnson will soon start a Phase II trial that will combine a mixture of Olysio, AL-335 and ACH-3102 to determine if the three-drug cocktail can effectively cut the treatment time for Hepatitis C (HCV).
If this works, JNJ might be able to come back after losing its HCV market domination to Gilead Sciences, Inc. ’s Sovaldi and Harvoni. Gilead has also been in a pricing and market battle with AbbVie ’s Viekira Pak.
JNJ’s Olysio, a NS3/4A inhibitor, received approval in November 2013. About a month later, Gilead’s Sovaldi was approved. Last year Gilead followed up with Harvoni. Generally speaking, Sovaldi and Harvoni are better drugs and have become the dominant form of HCV treatment. Patients that have non-genotype 1, a variation of HCV, are generally treated with Sovaldi.
Harvoni is a combination of Sovaldi and Gilead’s NS5A inhibitor, ledipasvir. It is used to treat patients with genotype 1 HCV. Its cure rate in clinical trials is in the 90 percent range without requiring both interferon and ribavirin, the historical HCV treatment.
Being both better and safer than traditional treatments, Harvoni and Sovaldi have become the standard of care. In the second quarter of this year, Gilead reported combined sales of the two drugs of almost $5 billion.
JNJ has struggled to compete, despite a long history in the HCV market. However, physicians realized that by combining Sovaldi with Olysio, the combination could be an effective treatment in hard-to-treat patients. This kept JNJ in the game, and brought in $2.3 billion in Olysio sales in 2014, although it got hammered after Harvoni was approved, dropping to about $79 million in the third quarter.
JNJ has fought back. In November 2014, JNJ acquired Alios BioPharma for about $1.75 billion in cash. In addition to picking up AL-8176, a drug in Phase II studies for respiratory syncytial virus (RSV) infections, it acquired two early-stage drugs for HCV. One of those was AL-335, a NS5B inhibitor similar to Sovaldi.
In May of this year, JNJ made a licensing and collaboration deal with Achillion Pharmaceuticals, Inc. to develop Achillion’s HCV assets, which include ACH-3102, ACH-3422 and sovaprevir. According to the press release, “A key objective of the collaboration will be to develop a short-duration, highly effective, pan-genotypic, oral regimen for the treatment of HCV. An initial regimen that will be explored will feature Achillion’s ACH-3012, a second-generation NS5A inhibitor currently in Phase II clinical studies that has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA), in combination with an NS3/4A HCV protease inhibitor plus an NS5B HCV polymerase inhibitor from the collaboration.”
In addition to determining the safety of the combination drug regimen, JNJ hopes the cocktail will require a short time frame than Harvoni, Sovaldi or Olysio. They are studying the drugs over various treatment cycles, four weeks, six weeks and eight weeks. Results are expected sometime in 2016.
As The Motley Fool points out, efficacy is probably not the big question, especially since Harvoni and Sarvoldi are very effective. The questions is, can the cocktail cut treatment time. If so, patients, physicians and insurance companies would likely choose it because it would be more convenient and significantly cheaper. Harvoni, Sovaldi and Viekira Pak are expensive drugs. A 12-week course of Sovaldi runs about $84,000 dollars, and Harvoni costs about $94,500. Viekira Pak is priced at about $83,320 for a 12-week regimen. Olysio runs about $66,360 for a 12-week course of treatment.
Of course, Gilead and AbbVie are undoubtedly looking at ways to cut treatment times.
AbbVie’s Viekira Pak has also faced other battles, including a Drug Safety Monitor analysis released by Advera Health in January 2015 questioning the drug’s safety profile compared to Harvoni and Sovaldi.
