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How Europe's Compassion for Hepatitis C Patients Helps Bristol-Myers

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Sometimes a drug comes along that's special enough to capture regulators attention before it's submitted for approval. That's what appears to have happened in Europe for Bristol-Myers Squibb's (NYSE: BMY  ) promising hepatitis C drug daclatasvir. The drug won regulator support as part of combination treatment with Gilead Sciences's  (NASDAQ: GILD  )  sofosbuvir for compassionate use in critical patients.

Combining for a cure
Despite Bristol having only filed the drug for approval in Japan, the European Medicines Agency, or EMA, has stepped up to recommend its use for EU patients who would otherwise succumb to liver failure without the treatment.

In a late November press release, the EMA's Committee for Medicinal Products for Human Use, or CHMP, issued a positive opinion for compassionate use of a combination therapy consisting of Bristol's daclatasvir and Gilead's sofosbuvir -- a much more widely anticipated drug.

Gilead captured widespread attention when it secured sofosbuvir in an $11.2 billion acquisition of Pharmasset in 2011. Doctors and patients have eagerly anticipated sofosbuvir's commercialization ever since, and their patience is likely to be rewarded soon given that the FDA has set a Dec. 8 decision date for sofosbuvir and that the CHMP in Europe issued a positive opinion for the drug in November.

Prompting by the Norse
The issue of compassionate use for Bristol's drug was brought to CHMP by Sweden, which requested that CHMP consider the drug combination for the hardest-to-treat patients. As a result, CHMP is backing the use of Bristol's drug in adults with the genotype 1 version of hepatitis C who would otherwise be expected to die within a year if left untreated.

CHMP's special designation was based on a combination study in which the two drugs successfully treated hepatitis C, even in cases where patients had previously failed to respond to sofosbuvir.

The results from that combination trial were as impressive as any seen so far. In phase 2, combining daclatasvir with sofosbuvir cured 100% of patients after 12 weeks. That's significant considering that the 40 patients in the trial had all failed to respond to Vertex's Incivek and Merck's Victrelis -- two drugs that hit the market to fanfare in 2010.  

This marks just the fourth time the CHMP has offered a compassionate use opinion, and it sets the stage for a new wave of combination therapies that cut across manufacturers and displace side affect laden ribavirin and interferon.

Walking away from the relationship
CHMP's decision doesn't give daclatasvir a free pass for use in Europe. It will only reach the most challenged patients and only if both doctors and their individual member states approve it. But it may indicate a willingness in Europe to embrace the drug for more widespread use, suggesting that Bristol may consider filing sooner rather than later.

It's likely disappointing to many that Gilead chose to abandon going forward with an important phase 3 trial with Bristol on the combination therapy. Instead, Gilead chose to focus on ushering its own combination remedy through clinic. It's hard to imagine that Gilead could hope to achieve 100% cure rates with its sofosbuvir and ledipasvir pair, but coming close appears good enough for Gilead. Particularly, since it can capture the entire revenue stream rather than share it with Bristol.

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