Sandoz, the generic arm of
), recently announced that it is voluntarily recalling one lot of
its oral contraceptive drug, Estarylla (norgestimate and ethinyl
estradiol), in the US.
The recall was initiated after a customer reported the
presence of a placebo tablet in a row of active tablets on one
We note that Sandoz launched Estarylla and Tri-Estarylla
(norgestimate and ethinyl estradiol), generic versions of oral
contraceptives Ortho Cyclen and Ortho Tri-Cyclen, in Mar 2013,
following US Food and Drug Administration (FDA) approval.
The launch of Estarylla and Tri-Estarylla brought the total
number of oral contraceptives launched by Sandoz in the US since
Jan 2011 to 6.
Since the probability of adverse health events is minimal, we
believe Sandoz will resolve the issue soon.
Meanwhile, we are encouraged by the recent progress at Sandoz.
The company launched metronidazole 1% topical gel, a generic
version of Metrogel 1% in early July 2013 in the US.
Last month, Sandoz initiated a phase II study for its
biosimilar version of
) Enbrel (etanercept).
Enbrel is approved for several indications including the
treatment of moderate-to-severe active rheumatoid arthritis and
The main aim of the phase III study is to establish
biosimilarity on safety, efficacy and immunogenicity compared to
Enbrel for the treatment of patients with moderate-to-severe
chronic plaque-type psoriasis. Positive results from this study
will support regulatory filings in the US and EU.
Sandoz is also developing biosimilar versions of Amgen's
Neulasta (pegfilgrastim) and Neupogen (filgrastim).
Both drugs are approved for stimulating white blood cell
production in the body. Sandoz has three marketed products which
account for about 50% of all biosimilars in the combined regions
of North America, Europe, Japan and Australia.
Sandoz currently has seven phase III studies across five
biosimilar molecules in its pipeline. We are encouraged by
Sandoz' efforts to broaden its portfolio, which should boost
sales in the coming years.
Novartis currently carries a Zacks Rank #3 (Hold). Right now,
) look attractive with a Zacks Rank #2 (Buy).
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