Glaxo Submits NDA For Anti Relapse Malaria Medicine To FDA

GlaxoSmithKline plc (NYSE:GSK) in partnership with Medicines for Malaria Venture (MMV) filed a new drug application (NDA) with the FDA looking for approval of a single-dose tafenoquine to treat relapsing malaria.

Glaxo’s single-dose tafenoquine has been developed as an anti-relapse medicine for patients infected with Plasmodium vivax (P.vivax). If approved, it will be the first new anti relapse medicine for patients infected with Plasmodium vivax (P.vivax)in more than 60 years.

The NDA submission was based on the positive headline phase III data from the GATHER and DETECTIVE studies conducted by Glaxo in partnership with MMV. The studies showed that a single-dose of 300 mg tafenoquine, when given with a 3-day blood-stage chloroquine treatment, reduced the risk of relapse in patients with P.vivax malaria significantly more than placebo when given with chloroquine.

Malaria is one of the serious global healthcare challenges of today. Malaria is characterized by periodic relapses caused by the reactivation of the Plasmodium vivax parasite which can lie dormant in the liver for extended periods. Thus, providing the people with a single dose of medicine will be an important step in reducing the risk of relapse of malaria.

We note that MMV is a leading product development partnership whose mission is to reduce the burden of malaria in disease-endemic countries.

So far this year, GlaxoSmithKline’s shares have lost 6.7%, as against the industry gain of 16.2%.

Glaxo possesses one of the stronger late-stage pipelines in large-cap pharma sector. Two key pipeline products - Shingrix vaccine for the prevention of shingles and only once-daily single inhaler triple therapy for COPD -Trelegy Ellipta - were approved in the United States in October and September, respectively. While Shingrix is under review in the EU, Trelegy Ellipta was granted EU approval this month. Meanwhile, the first dual treatment for HIV, Juluca (dolutegravir + rilpivirine) received approval in the United States this month while the candidate is under review in the EU.

Back-to-back approvals of the three new products - Trelegy Ellipta, Shingrix and Juluca - have strengthened Glaxo’s competitive position.

Zacks Rank & Stocks to Consider

GlaxoSmithKline carries a Zacks Rank #3 (Hold). Some better-ranked health care stocks in the same space are Sucampo Pharmaceuticals (NASDAQ:SCMP) , Ligand Pharmaceuticals (NASDAQ:LGND) and Corcept Therapeutics Incorporated (NASDAQ:CORT) . While Sucampo sports a Zacks Rank #1 (Strong Buy), Ligand and Corcept hold a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Sucampo’s earnings per share estimates have moved up from $1.01 to $1.12 for 2017 and from $1.06 to $1.19 for 2018, over the last 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with an average beat of 15.63%.

Ligand’s earnings per share estimates have climbed $3.68 to $3.70 for 2018 over the last 60 days. The company pulled off a positive earnings surprise in two of the trailing four quarters, with an average beat of 8.22%. The share price of the company has increased 28.5% year to date.

Corcept’searnings per share estimates have moved up from 78 cents to 88 cents for 2018 over the last 30 days. The company delivered positive earnings surprises in two of the trailing four quarters, with an average beat of 14.32%. The share price of the company has increased 149.8% year to date.

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