Teva Pharmaceutical Industries Limited
) announced that a new dose of its multiple sclerosis (MS) drug,
Copaxone (40mg/mL), has been approved by the U.S. Food and Drug
Administration (FDA). The drug has been approved for relapsing
forms of multiple sclerosis.
This dose of Copaxone allows three times a week subcutaneous
administration as compared to the daily administration schedule
for the currently available formulation (20 mg/mL). The lower
frequency of administration will be more convenient for patients.
The three-times-a-week Copaxone will be available within a few
New Copaxone Approval, a Major Positive
We view the approval of the new formulation of Copaxone as a
major positive for the company. We expect Teva's shares to gain
on the news.
Copaxone generated approximately $3.2 million in sales in the
first nine months of 2013, accounting for more than 20% of the
company's total revenues. However, Copaxone could start facing
generics this year.
Last month, Teva provided guidance for 2014 based on two likely
scenarios related to Copaxone - Copaxone remaining exclusive and
Copaxone going generic. The entry of Copaxone generics this year
could cut total revenues by about $500 million and earnings by 60
Teva has undertaken several initiatives (including developing new
candidates targeting MS and the new formulation of Copaxone) to
mitigate this loss. With MS candidate Nerventra receiving a
negative opinion from the Committee for Medicinal Products for
Human Use earlier this month, the FDA approval of the new
Copaxone formulation comes as a relief.
Teva is planning to switch a significant number of patients
(approximately up to 45%) from Copaxone 20 mg/mL to Copaxone 40
mg/mL in the next few months.
However, we remind investors that the competition in the MS
market is intense. Apart from injectables, several oral therapies
) Gilenya and
) Tecfidera are also available.
Teva carries a Zacks Rank #5 (Strong Sell). Some better-ranked
) carrying a Zacks Rank #1 (Strong Buy).
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