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Imagine a line of adults lying on the ground stretching from Los Angeles to the Atlantic coast of Maine. That number of people, around 3.2 million, represents how many Americans are estimated to have chronic hepatitis-C.
Many individuals affected by chronic hep-C must take antiviral medications via injection that can cause side effects including flu-like symptoms. That could be changing in the not-too-distant future, though. Several companies are racing to develop an all-oral regimen for hepatitis-C that could transform how the disease is treated. Here are three leaders in this race.
1. Gilead Sciences (NASDAQ: GILD )
At this point, Gilead appears to be able to claim front-runner status. The biotech awaits a decision by the U.S. Food and Drug Administration on or before Dec. 8 regarding approval of sofosbuvir in combination with ribavirin as an all-oral treatment for hep-C genotypes 2 and 3. However, the big prize is getting to market with an oral regimen for genotype 1, which accounts for around 75% of all hep-C patients.
Gilead shouldn't be too far off in jumping that hurdle. The biotech has late-stage studies under way, with sofusbuvir combined with both ribavirin and its own ledipasvir. Mid-stage results for the combo were very impressive, with a 95% cure rate after eight weeks of treatment.
Unless unforeseen problems emerge, Gilead seems poised to reach the market first with its all-oral regimen for hep-C genotype 1. The company hopes to market the sofusbuvir/ledipsasvir combo next year.
2. AbbVie (NYSE: ABBV )
If AbbVie has anything to say about it, though, Gilead won't be the first to market. Scott Brun, the company's VP of pharmaceutical development, recently stated that he thinks AbbVie has "a very good shot at being first."
Brun's optimism stems from success that AbbVie has had with its own all-oral combo. Results from mid-stage studies showed that the company's antiviral combination of drugs achieved a 99% cure rate in treatment-naive patients and a 93% cure rate in all responders after 12 weeks.
Like Gilead, AbbVie currently has late-stage studies under way. Also like Gilead, the company hopes to be on the market with its drug combo in 2014. As Brun noted, "it is a very tight race."
3. Bristol-Myers Squibb (NYSE: BMY )
Regardless of which company wins that race, chances are that they won't share the market between just the two of them for long. Bristol-Myers Squibb doesn't trail too far behind with its all-oral regimen including daclatasvir, asunaprevir, and BMS-791325.
In April, Bristol announced positive phase 2 results for the combo. Up to 94% of patients were cured of hepatitis C after 24 weeks of treatment.
Bristol is now in phase 3 testing of the three-drug combo. The likelihood for now appears to be that the big drugmaker will reach the market several months after Gilead and AbbVie.
It isn't out of the question that all three of these companies could ultimately prove to be marketplace winners. The overall hepatitis-C market size is pegged to be around $20 billion. That pie will be split somehow, although how big each slice is remains to be seen.
Gilead probably stands the best shot at becoming the biggest winner. The biotech should hit the market first with its treatment (even if only barely). More importantly, there's a convenience factor that could help the sofusbuvir/ledipsasvir combo. While AbbVie's regimen requires patients to take three pills in the morning and another pill in the evening, patients taking Gilead's combo will probably only have to take one pill once per day.
This race isn't limited to Gilead, AbbVie, and Bristol. Several of other companies have other drugs a little further behind in the development cycle. Johnson & Johnson (NYSE: JNJ ) , for example, teamed up with Idenix (UNKNOWN: IDIX.DL ) to develop an all-oral regimen. The two companies, along with J&J's partner, Medivir, kicked off a mid-stage study of samatasvir combined with simeprevir in May.
The intensity of the competition ultimately means that the biggest winner of all won't be any of these companies. That honor belongs to the millions suffering from hepatitis-C -- from Los Angeles to Maine and around the world.
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