Gilead Sciences, Inc.
), which has been in the eye of the storm with lawmakers in the
U.S. questioning the pricing of its recently approved potential
blockbuster hepatitis C virus (HCV) treatment, Sovaldi, received
encouraging news from the EU. Gilead's efforts to get its
once-daily fixed-dose HCV combination therapy - ledipasvir (NS5A
inhibitor) plus Sovaldi (nucleotide analog polymerase inhibitor)
- approved in the EU appears to be on track with the European
Medicines Agency (EMA) validating the biopharmaceutical company's
marketing application for the candidate.
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The EMA accepted the company's request for an accelerated
assessment of the application, which seeks marketing approval of
the all-oral cocktail therapy for treating adults suffering from
the genotype 1 version of chronic HCV. Acceptance of the request
has reduced the EMA's review period of the application by two
Gilead filed the marketing application on the basis of
encouraging data from three phase III studies (ION-1, ION-2 and
ION-3). The studies evaluated the combination with or without
ribavirin in almost 2000 genotype 1 chronic hepatitis C patients.
Approval of the combination would not only reduce the treatment
duration of chronic hepatitis C genotype 1 infection
significantly but also eliminate the need for interferon
injections or ribavirin, which have significant side effects.
Furthermore, the combination would become the first oral
treatment for HCV patients with genotype 1 infection to be
available in the EU following approval. Gilead stated that
majority of the HCV affected population in the EU suffers from
the genotype 1 version.
Approval for the combination has also been sought in the U.S. and
Canada. We note that
) is also aiming to bring an all-oral, interferon-free therapy
into the market for treating genotype 1 HCV.
Though pleased with the regulatory update on the combination of
ledipasvir and Sovaldi, we believe that investor focus will
remain on Gilead's response to the letter issued by the Congress'
Committee on Energy and Commerce last week expressing concerns
about the exorbitant price tag ($84,000 for a 12-week treatment
period) attached to the drug. Since HCV is more prevalent in the
low-income strata of the society, Gilead's pricing policy has
attracted severe criticism. Gilead will have to submit a response
by Apr 3.
Gilead carries a Zacks Rank #1 (Strong Buy).
Alexion Pharmaceuticals, Inc.
) are examples of biopharma stock carrying same rank as