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Teva's Austedo Gets FDA Nod for Huntington Disease Treatment
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Teva Pharmaceutical Industries Ltd. (TEVA - Free Report) recently announced that the FDA has approved its investigational drug, Austedo (deutetrabenazine) tablets (previously referred to as SD-809), for the treatment of chorea associated with Huntington disease (HD).
We note that Austedo became part of Teva’s pipeline after the May 2015 acquisition of Auspex Pharmaceuticals. Austedo is the first deuterated product to be reviewed by the FDA. Considering the lack of treatments for HD, the drug’s approval will be a huge boost for the company. Austedo was previously granted Orphan Drug Designation by the FDA for the indication.
Teva’s shares have underperformed the Zacks classified Medical-Generics Drugs industry so far this year. Shares of the company lost 11.3% while the industry registered a decrease of 3.1%.
Coming back to the latest news, the approval was supported by positive data from a phase III randomized, placebo-controlled study to assess the safety and efficacy of Austedo in reducing chorea in patients with HD (First-HD).
We remind investors that Teva’s efforts to gain approval for Austedo for the treatment of HD suffered a regulatory setback in May last year with the FDA issuing a complete response letter (CRL). In October, however, the FDA accepted the resubmission of the NDA for Austedo for the given indication.
Apart from HD, Teva is evaluating Austedo for a couple of additional indications, such as treatment of patients with tardive dyskinesia (TD) and Tourette syndrome (TS). Currently, a phase III (AIM-TD) efficacy and safety study in patients with moderate-to-severe TD is in progress. In Sep 2016, the company reported encouraging top-line data from the study. Subsequently, the FDA granted priority review to the drug in Feb 2017, with prescription drug user fee act (PDUFA) goal date of Aug 30, 2017.
In a separate release, Teva announced that it has received a positive outcome to remove the pregnancy contraindication from the label of its key multiple sclerosis drug, Copaxone (40 mg/ml 3 times weekly), in the EU.
The positive outcome was received through a variation report issued by the U.K. Medicines and Healthcare Products Regulatory Agency. However, the new label does recommend avoiding the drug during pregnancy unless its treatment benefits outweigh the risks.
We note that a similar change has already been approved for Copaxone 20 mg/ml in Dec 2016.
Teva is going through a transition period as it is working on the integration of Actavis Generics – Allergan plc’s generics business that it acquired in Aug 2016. The company also purchased Allergan’s Anda Inc., the fourth-largest distributor of generic pharmaceuticals in the U.S. during the same period. The Actavis Generics acquisition will help the company strengthen its position in the key generic markets. Teva is also looking to strengthen its biosimilar pipeline.
Furthermore, Teva intends to accelerate growth platforms, protect and expand core franchises, expand its global presence, pursue strategic deals, and reduce costs. However, headwinds remain like generic competition for Copaxone as well as for branded products remain. We note that Teva is facing patent challenges for the 40 mg formulation of Copaxone from companies like Mylan and Momenta Pharmaceuticals, Inc. , which are looking to get approval for their generic versions of the drug.
Teva expects continued sales erosion for Copaxone in 2017 due to increased competition.
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Teva's Austedo Gets FDA Nod for Huntington Disease Treatment
Teva Pharmaceutical Industries Ltd. (TEVA - Free Report) recently announced that the FDA has approved its investigational drug, Austedo (deutetrabenazine) tablets (previously referred to as SD-809), for the treatment of chorea associated with Huntington disease (HD).
We note that Austedo became part of Teva’s pipeline after the May 2015 acquisition of Auspex Pharmaceuticals. Austedo is the first deuterated product to be reviewed by the FDA. Considering the lack of treatments for HD, the drug’s approval will be a huge boost for the company. Austedo was previously granted Orphan Drug Designation by the FDA for the indication.
Teva’s shares have underperformed the Zacks classified Medical-Generics Drugs industry so far this year. Shares of the company lost 11.3% while the industry registered a decrease of 3.1%.
Coming back to the latest news, the approval was supported by positive data from a phase III randomized, placebo-controlled study to assess the safety and efficacy of Austedo in reducing chorea in patients with HD (First-HD).
We remind investors that Teva’s efforts to gain approval for Austedo for the treatment of HD suffered a regulatory setback in May last year with the FDA issuing a complete response letter (CRL). In October, however, the FDA accepted the resubmission of the NDA for Austedo for the given indication.
Apart from HD, Teva is evaluating Austedo for a couple of additional indications, such as treatment of patients with tardive dyskinesia (TD) and Tourette syndrome (TS). Currently, a phase III (AIM-TD) efficacy and safety study in patients with moderate-to-severe TD is in progress. In Sep 2016, the company reported encouraging top-line data from the study. Subsequently, the FDA granted priority review to the drug in Feb 2017, with prescription drug user fee act (PDUFA) goal date of Aug 30, 2017.
In a separate release, Teva announced that it has received a positive outcome to remove the pregnancy contraindication from the label of its key multiple sclerosis drug, Copaxone (40 mg/ml 3 times weekly), in the EU.
The positive outcome was received through a variation report issued by the U.K. Medicines and Healthcare Products Regulatory Agency. However, the new label does recommend avoiding the drug during pregnancy unless its treatment benefits outweigh the risks.
We note that a similar change has already been approved for Copaxone 20 mg/ml in Dec 2016.
Teva is going through a transition period as it is working on the integration of Actavis Generics – Allergan plc’s generics business that it acquired in Aug 2016. The company also purchased Allergan’s Anda Inc., the fourth-largest distributor of generic pharmaceuticals in the U.S. during the same period. The Actavis Generics acquisition will help the company strengthen its position in the key generic markets. Teva is also looking to strengthen its biosimilar pipeline.
Furthermore, Teva intends to accelerate growth platforms, protect and expand core franchises, expand its global presence, pursue strategic deals, and reduce costs. However, headwinds remain like generic competition for Copaxone as well as for branded products remain. We note that Teva is facing patent challenges for the 40 mg formulation of Copaxone from companies like Mylan and Momenta Pharmaceuticals, Inc. , which are looking to get approval for their generic versions of the drug.
Teva expects continued sales erosion for Copaxone in 2017 due to increased competition.
Teva Pharmaceutical Industries Limited Price
Teva Pharmaceutical Industries Limited Price | Teva Pharmaceutical Industries Limited Quote
Zacks Rank
Teva currently carries a Zacks Rank #4 (Sell).
You can see the complete list of today’s Zacks #1 Rank stocks here.
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In addition to the recommendations that are available to the public on our website, how would you like to follow all Zacks' private buys and sells in real time?
Our experts cover all kinds of trades… from value to momentum . . . from stocks under $10 to ETF and option moves . . . from stocks that corporate insiders are buying up to companies that are about to report positive earnings surprises. You can even look inside exclusive portfolios that are normally closed to new investors. Starting today, for the next month, you can have unrestricted access. Click here for Zacks' private trades >>