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Mylan Receives Tentative Approval from FDA for HIV Therapy
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Mylan N.V. recently announced that it has obtained a tentative approval from the FDA under the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) for the New Drug Application for cocktail therapy Sustiva, lamivudine and Viread, 400 mg/300 mg/300 mg (TLE400).
We note that shares of Mylan have performed better than the Zacks categorized Medical-Generic Drugs industry in the past year with the stock losing 9.2% compared with the industry’s decline of 23.2%.
As a result of this approval, TLE400, an antiretroviral (ARV) fixed-dose combination will be available in developing countries as a first-line regimen for HIV/AIDS patients. We note that TLE400 was recommended by the World Health Organization in 2016 as an alternative for first-line therapy for adults diagnosed with HIV. TLE400 is formulated with a 400 mg dose of Sustiva, which is lower than the standard dose of 600 mg.
The results from Kirby Institute's ENCORE1 trial, using drugs provided by Mylan and Glead Sciences (GILD - Free Report) , also showed that a lowered dose of 400 mg Sustiva is non-inferior to a dose of 600 mg, when combined with tenofovir and emtricitabine during the 48 weeks in ART-naive adults with HIV-1 infection.
Mylan offers a wide range of ARVs which are used to treat 50% of patients diagnosed with HIV/AIDS.
Mylan has invested $250 million in expanding its ARV production capacity. This, in turn, has enabled the company to produce 4 billion ARV tablets and capsules every year.
Earlier in the month, Mylan reported fourth-quarter results which easily beat expectations both in terms of the top and bottom line driven by incremental contribution from the Meda acquisition and the non-sterile, topicals-focused business of Renaissance Acquisition Holdings which more than offset the impact of competitive pricing.
We note that Mylan has been under immense pressure since Aug 2016 when the company faced criticism for the price increase of EpiPen since its acquisition of the drug in 2007 from lawmakers, consumers and the common people alike. The pricing controversy even led to a congressional hearing and attracted immense censure.
Also, right after the pricing issue, Mylan made it to the headlines for wrongly classifying EpiPen as a generic product in the Medicaid Drug Rebate Program. The misclassification implied that Mylan has been greatly underpaying rebates to Medicaid for the drug for a long time than it would have if the drug was classified as a branded one.
Nevertheless, the company’s guidance for 2017 was encouraging.
Zacks Rank & Key Picks
Mylan currently carries a Zacks Rank #3 (Hold). Some other better-ranked stocks in the health care sector include Heska Corp. and Retrophin, Inc. . Heska and Retrophin carry a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Heska’s earnings estimates increased from $1.53 to $1.65 for 2017 and from $1.90 to $2.01 for 2018, over the last 30 days. The company posted a positive earnings surprise in all of the four trailing quarters with an average beat of 291.54%. Its share price increased 30% year to date.
Retrophin’s loss estimates narrowed from 85 cents to 72 cents for 2017 and from 67 cents to 53 cents for 2018, over the last 30 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 80.55%.
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With battery prices plummeting and charging stations set to multiply, one company stands out as the #1 stock to buy according to Zacks research.
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Mylan Receives Tentative Approval from FDA for HIV Therapy
Mylan N.V. recently announced that it has obtained a tentative approval from the FDA under the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) for the New Drug Application for cocktail therapy Sustiva, lamivudine and Viread, 400 mg/300 mg/300 mg (TLE400).
We note that shares of Mylan have performed better than the Zacks categorized Medical-Generic Drugs industry in the past year with the stock losing 9.2% compared with the industry’s decline of 23.2%.
As a result of this approval, TLE400, an antiretroviral (ARV) fixed-dose combination will be available in developing countries as a first-line regimen for HIV/AIDS patients. We note that TLE400 was recommended by the World Health Organization in 2016 as an alternative for first-line therapy for adults diagnosed with HIV. TLE400 is formulated with a 400 mg dose of Sustiva, which is lower than the standard dose of 600 mg.
The results from Kirby Institute's ENCORE1 trial, using drugs provided by Mylan and Glead Sciences (GILD - Free Report) , also showed that a lowered dose of 400 mg Sustiva is non-inferior to a dose of 600 mg, when combined with tenofovir and emtricitabine during the 48 weeks in ART-naive adults with HIV-1 infection.
Mylan offers a wide range of ARVs which are used to treat 50% of patients diagnosed with HIV/AIDS.
Mylan has invested $250 million in expanding its ARV production capacity. This, in turn, has enabled the company to produce 4 billion ARV tablets and capsules every year.
Earlier in the month, Mylan reported fourth-quarter results which easily beat expectations both in terms of the top and bottom line driven by incremental contribution from the Meda acquisition and the non-sterile, topicals-focused business of Renaissance Acquisition Holdings which more than offset the impact of competitive pricing.
We note that Mylan has been under immense pressure since Aug 2016 when the company faced criticism for the price increase of EpiPen since its acquisition of the drug in 2007 from lawmakers, consumers and the common people alike. The pricing controversy even led to a congressional hearing and attracted immense censure.
Also, right after the pricing issue, Mylan made it to the headlines for wrongly classifying EpiPen as a generic product in the Medicaid Drug Rebate Program. The misclassification implied that Mylan has been greatly underpaying rebates to Medicaid for the drug for a long time than it would have if the drug was classified as a branded one.
Nevertheless, the company’s guidance for 2017 was encouraging.
Zacks Rank & Key Picks
Mylan currently carries a Zacks Rank #3 (Hold). Some other better-ranked stocks in the health care sector include Heska Corp. and Retrophin, Inc. . Heska and Retrophin carry a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Heska’s earnings estimates increased from $1.53 to $1.65 for 2017 and from $1.90 to $2.01 for 2018, over the last 30 days. The company posted a positive earnings surprise in all of the four trailing quarters with an average beat of 291.54%. Its share price increased 30% year to date.
Retrophin’s loss estimates narrowed from 85 cents to 72 cents for 2017 and from 67 cents to 53 cents for 2018, over the last 30 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 80.55%.
Will You Make a Fortune on the Shift to Electric Cars?
Here's another stock idea to consider. Much like petroleum 150 years ago, lithium power may soon shake the world, creating millionaires and reshaping geo-politics. Soon electric vehicles (EVs) may be cheaper than gas guzzlers. Some are already reaching 265 miles on a single charge.
With battery prices plummeting and charging stations set to multiply, one company stands out as the #1 stock to buy according to Zacks research.
It's not the one you think.
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