Valeant Pharmaceuticals International, Inc. has received positive news on the regulatory front. Its constipation drug, Relistor, received regulatory approval in the U.S., while the FDA Advisory Committee gave a recommendation favoring the approval of its psoriasis treatment, brodalumab.
Relistor’s Approval
The FDA has approved Valeant and Progenics Pharmaceuticals, Inc.’s Relistor tablets (450 mg once daily) for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain.
Valeant expects to begin sales in the third quarter of 2016.
We note that a subcutaneous injectable version of Relistor (12 mg and 8 mg) is already approved in the U.S. for the treatment of OIC in adults with chronic non-cancer pain and for the treatment of OIC in adults with advanced illness who are receiving palliative care.
We remind investors that Valeant had in-licensed development and commercialization rights for Relistor from Progenics following the acquisition of Salix Pharmaceuticals in Apr 2015.
Approval of the oral formulation for the drug should expand the eligible patient population, thereby boosting the company’s top line. We expect investor focus to remain on the commercialization of Relistor for the recently approved indication.
Drugs that are currently approved for the treatment of OIC in patients with chronic pain include Movantik and Amitiza.
FDA Drug Advisory Committee’s Opinion for Brodalumab
Valeant also announced that the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee has voted (18–0) in favor of an approval of brodalumab injection (210 mg) for the treatment of moderate-to-severe plaque psoriasis in adults. The committee’s opinion was, however, accompanied by conditions related to product labeling and post-marketing/risk management obligations.
We note that the FDA generally takes the advisory committee's recommendation into consideration when reviewing candidates but is not bound by the same. The Biologics License Application (BLA) for brodalumab was accepted by the FDA for review in Jan 2016 and a decision is expected by Nov 16, 2016.
Brodalumab is currently under review in the EU, while the Japanese Ministry of Health, Labour and Welfare gave the regulatory nod this July.
We remind investors that earlier this month, the company announced that its partner AstraZeneca plc (AZN - Free Report) has amended its license related to brodalumab. As per the amendment, AstraZeneca had terminated Valeant’s rights to develop and commercialize the product in Europe. However, Valeant still has the license to develop and commercialize brodalumab in the U.S. and other territories, except in Japan and certain other Asian countries.
We note that the psoriasis market is already crowded given the presence of products like Stelara, Enbrel and Otezla among others.
Valeant currently carries a Zacks Rank #5 (Strong Sell). Investors interested in the health sector may consider Nektar Therapeutics (NKTR - Free Report) , which currently sports a Zacks Rank #1 (Strong Buy).
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Valeant Pharmaceuticals International, Inc. has received positive news on the regulatory front. Its constipation drug, Relistor, received regulatory approval in the U.S., while the FDA Advisory Committee gave a recommendation favoring the approval of its psoriasis treatment, brodalumab.
Relistor’s Approval
The FDA has approved Valeant and Progenics Pharmaceuticals, Inc.’s Relistor tablets (450 mg once daily) for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain.
Valeant expects to begin sales in the third quarter of 2016.
We note that a subcutaneous injectable version of Relistor (12 mg and 8 mg) is already approved in the U.S. for the treatment of OIC in adults with chronic non-cancer pain and for the treatment of OIC in adults with advanced illness who are receiving palliative care.
We remind investors that Valeant had in-licensed development and commercialization rights for Relistor from Progenics following the acquisition of Salix Pharmaceuticals in Apr 2015.
Approval of the oral formulation for the drug should expand the eligible patient population, thereby boosting the company’s top line. We expect investor focus to remain on the commercialization of Relistor for the recently approved indication.
Drugs that are currently approved for the treatment of OIC in patients with chronic pain include Movantik and Amitiza.
FDA Drug Advisory Committee’s Opinion for Brodalumab
Valeant also announced that the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee has voted (18–0) in favor of an approval of brodalumab injection (210 mg) for the treatment of moderate-to-severe plaque psoriasis in adults. The committee’s opinion was, however, accompanied by conditions related to product labeling and post-marketing/risk management obligations.
We note that the FDA generally takes the advisory committee's recommendation into consideration when reviewing candidates but is not bound by the same. The Biologics License Application (BLA) for brodalumab was accepted by the FDA for review in Jan 2016 and a decision is expected by Nov 16, 2016.
Brodalumab is currently under review in the EU, while the Japanese Ministry of Health, Labour and Welfare gave the regulatory nod this July.
We remind investors that earlier this month, the company announced that its partner AstraZeneca plc (AZN - Free Report) has amended its license related to brodalumab. As per the amendment, AstraZeneca had terminated Valeant’s rights to develop and commercialize the product in Europe. However, Valeant still has the license to develop and commercialize brodalumab in the U.S. and other territories, except in Japan and certain other Asian countries.
We note that the psoriasis market is already crowded given the presence of products like Stelara, Enbrel and Otezla among others.
Valeant currently carries a Zacks Rank #5 (Strong Sell). Investors interested in the health sector may consider Nektar Therapeutics (NKTR - Free Report) , which currently sports a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, y u can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>
Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
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