Bristol-Myers Squibb Company
) announced that the U.S. Food and Drug Administration (FDA)
granted breakthrough therapy designation to its combination of
daclatasvir and asunaprevir, which is being developed for
treating patients suffering from genotype Ib chronic hepatitis C
virus (HCV). The U.S. regulatory body granted the designation to
the all-oral combination of daclatasvir and asunaprevir on the
basis of data from the ongoing phase III program on the regimen.
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Bristol-Myers stated in its press release that HCV affects
approximately 170 million patients worldwide with a significant
number being afflicted by the disease in the U.S. alone. The
designation should help expedite the development and review
process of the candidate.
The designation is granted to potential new treatments for
serious or life-threatening diseases or conditions where the
initial clinical data shows that the treatment has the potential
to demonstrate substantial improvement on one or more clinically
significant endpoints compared to existing treatments. We note
that this is the second breakthrough therapy designation for a
regimen including daclatasvir. In 2013, the all-oral combination
of daclatasvir, asunaprevir and BMS-791325 received a similar
designation. The regimen is being evaluated as a
fixed-dose-combination therapy for treating HCV.
Bristol-Myers is highly optimistic of the potential of the
combination therapy targeting the highly lucrative HCV market.
The Japanese approval for the all-oral combination regimen was
sought last year. Bristol-Myers is also seeking EU approval of
daclatasvir combined with other agents for treating chronic
Apart from Bristol-Myers, many established players like
) are targeting the lucrative HCV space. The HCV market saw the
arrival of a potential blockbuster treatment,
Gilead Sciences, Inc.
) Sovaldi, in December last year. The drug's initial sales have
been very encouraging.
Bristol-Myers, a biopharmaceutical company, carries a Zacks Rank
#3 (Hold). Better-ranked stocks in the biopharma space include
Alexion Pharmaceuticals, Inc.
) and Gilead Sciences. Both stocks carry a Zacks Rank #1 (Strong