Teva Pharmaceutical Industries Ltd.
) recently announced that its supplemental new drug application
(sNDA) for its thrice-weekly dosing regimen of Copaxone has been
accepted for review by the US Food and Drug Administration
The 40 mg thrice-weekly (3TW - three times a week) formulation
of Copaxone represents a less frequent dosing regimen compared to
the currently available once-daily 20 mg dosing regimen.
Copaxone is approved for the reduction of the frequency of
relapses in relapsing-remitting multiple sclerosis (RRMS),
including patients who have experienced a first clinical episode
and have MRI features consistent with multiple sclerosis.
Copaxone is the key branded product at Teva. With sales of almost
$4 billion in 2012, Copaxone accounted for about 19.7% of total
Teva has been working on extending Copaxone's lifecycle. Label
expansion would help drive Copaxone sales and could reduce the
impact of generic competition once Copaxone 20 mg loses
exclusivity. A response regarding the sNDA will most likely be
out early next year.
Apart from Teva, the multiple sclerosis market has several
) among others. We expect Copaxone to face additional competitive
pressure given the entry of new players in the multiple sclerosis
market, especially Biogen's oral multiple sclerosis treatment,
Teva currently carries a Zacks Rank #3 (Hold). Teva is
currently going through a tough transition period given fewer
large generic opportunities, potential new competition for
branded products (especially Copaxone) and a higher cost
However, we are encouraged by the company's plans to improve
its position. Teva said that it intends to accelerate growth
platforms, protect and expand core franchises, expand its global
presence, pursue strategic deals and reduce the cost base. We
expect investor focus to remain on the execution of the company's
While Novartis and Pfizer are also Zacks Rank #3 stocks,
Biogen is a Zacks Rank #2 (Buy) stock.
BIOGEN IDEC INC (BIIB): Free Stock Analysis
NOVARTIS AG-ADR (NVS): Free Stock Analysis
PFIZER INC (PFE): Free Stock Analysis Report
TEVA PHARM ADR (TEVA): Free Stock Analysis
To read this article on Zacks.com click here.