) shares slipped 11.6% following the issuance of bioequivalence
draft guidelines by the FDA for the company's eye drug, Restasis
(cyclosporine). According to the draft guidelines, companies
wanting to make a generic version of Restasis have two options -
an in vitro study or an in vivo study.
The first option implies that no clinical trial will be needed
for a generic company to get its product approved provided
certain criteria are met. According to the agency, the generic
must be shown to be qualitatively and quantitatively similar to
The comparative physicochemical characterization of the
generic and Restasis should also be acceptable. Moreover, the
comparative study should be conducted on at least three lots of
the generic as well as Restasis. Some of the parameters that need
to be measured include globule size distribution, viscosity, pH,
zeta potential, osmolality, and surface tension.
Population bioequivalence has to be performed separately for
each peak in the globule size distribution of Restasis.
As far as the second option is concerned, only one study needs
to be conducted. In fact, the agency said that conducting a
bioequivalence study with clinical endpoint for Restasis may not
be feasible or reliable considering the product's modest
efficacy. Moreover, the study protocol will need to be approved
by the FDA.
Currently, we have low visibility on whether any company is
seeking approval for its generic version of Restasis. We expect
Allergan to issue a statement during the comment period regarding
the draft guidelines.
These draft guidelines, if finalized, could make it easier for
generic versions of Restasis to enter the market. Restasis, which
posted sales of $792 million in 2012, is slated to lose
exclusivity in the US next year. Allergan expects Restasis sales
of $850 million - $890 million in 2013. With the drug accounting
for about 13.9% of total product net sales (as of 2012), the
entry of generic versions would be a major setback for
Allergan currently carries a Zacks Rank #3 (Hold). At present,
) look well-positioned. While Santarus and Salix are Zacks Rank
#1 (Strong Buy) stocks, Novo Nordisk is a Zacks Rank #2 (Buy)
ALLERGAN INC (AGN): Free Stock Analysis
NOVO-NORDISK AS (NVO): Free Stock Analysis
SALIX PHARM-LTD (SLXP): Free Stock Analysis
SANTARUS INC (SNTS): Free Stock Analysis
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