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Key Pharma Players With HIV Focus Ahead of World Aids Day

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Acquired Immuno Deficiency Syndrome, popularly known as AIDS, is a pandemic caused due to the infection of human immunodeficiency virus (“HIV”). The virus weakens the immune system by destroying cells that fight diseases and infections, eventually leading to AIDS. Medicines for the treatment of HIV are called antiretroviral therapy (“ART”) that slow or put a check on the progression of the disease. The majority of them work either by blocking enzymes needed by HIV virus to multiply or inhibiting its entry into certain immune cells.

Like every year, World AIDS Day will be celebrated on Dec 1 in an effort to unite people in the fight against HIV, show support for HIV affected people and in memory of people who have lost their lives to AIDS-related illness.

World AIDS Day is one of the eight official global public health campaigns carried out by the World Health Organization ("WHO"). According to WHO, globally, about 36.7 million people are living with the deadly virus. Per an estimate, the disease has taken more than 35 million lives since it was first identified in 1984.

Per a UNAIDS report, more than 9.4 million people are unaware of their HIV-infected status. Thus, the theme of the 30th anniversary of this campaign is "Know Your Status."

Although there is no cure for the disease yet, there has been significant progress in the field of HIV treatment, which helps to slow disease progression and restrict secondary infections and complications. However, the huge number of HIV-affected patients shows that it is a long road ahead before the disease can be eradicated completely. The lack of knowledge of HIV status is a significant roadblock as it prevents timely and accurate treatment.

Despite improved medical understanding of HIV and significant efforts made by leading government and medical bodies to prevent and treat HIV/AIDS, this disease still has limited treatment options. Based on these statistics, it is not surprising that several healthcare companies are investing a significant amount of their R&D expenditures on developing treatments and devices for HIV and AIDS. There are more than 40 FDA-approved therapies available including 8 new regimens receiving approval this year. Several therapies are under development.

Stocks to Watch Out For

Ahead of World AIDS Day, we present some key pharma companies developing treatments for HIV.

GlaxoSmithKline (GSK - Free Report) has a long-standing commitment to HIV and AIDS. The company had developed the widely used antibiotic amoxycillin around 40 years ago, which was the first medicine approved to treat HIV. Though sales of its older HIV products — Epzicom and Selzentry — have been declining due to generic competition, its new products, Triumeq and Tivicay, are among the major drivers of the company’s top line. In 2017, it received approval for its first two-drug regimen for HIV – Juluca – which is a combination of Johnson & Johnson’s (JNJ - Free Report) Edurant and Glaxo’s Tivicay. It is also showing strong uptake. The company’s HIV portfolio generated sales of $4.6 billion in first nine-months of 2018, representing year-over-year growth of 12% at constant exchange rate.

On its third-quarter conference call, the company stated that it expects the HIV franchise to be an important growth driver for its Pharma business going forward. There were some positive developments in its HIV pipeline recently. It has made regulatory filings in the United States and Europe to get its HIV drug, Tivicay approved as a two-drug regimen (2DR) in combination with lamivudine on the back of the positive GEMINI study data. Glaxo anticipates U.S. approval in the second quarter of 2019.

Glaxo also announced positive data from both the FLAIR and ATLAS studies this year, evaluating cabotegravir plus rilpivirine in a long-acting, once-monthly HIV formulation. Glaxo believes that this long-acting injectable HIV therapy will provide a highly differentiated treatment option for patients seeking a long-lasting therapy for HIV, freeing them of the burden of daily oral therapy. It believes the positive data from these studies will allow it to file for approval in the first half of 2019.

Glaxo currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Gilead (GILD - Free Report) is another dominant player in the HIV market with an impressive portfolio. In fact, Gilead’s HIV franchise is a major contributor to sales with approved drugs like Genvoya, Truvada, Atripla, Stribild, Descovy, Odefsey and Complera. Sales at this franchise have grown 10% year over year to $10.6 billion in the first nine months of 2018. It also represents more than 65% of total product revenues for the period.

The company is the first to introduce single-tablet regimen (“STR”) for treating HIV and has several STR regimens in its portfolio. Gilead’s latest STR treatment for HIV is Biktarvy, which was approved earlier this year. The company is developing Biktarvy for treatment-naïve adults in a late-stage study. Meanwhile, Gilead is looking to transition the HIV market to drugs with improved long-term safety profiles.

However, the older drugs are facing generic competition and their sales have slumped significantly year over year.

Gilead currently sports a Zacks Rank #1.

Another company working toward developing HIV drugs is Johnson and Johnson. The company markets Juluca with Glaxo. Further, the company along with The Bill & Melinda Gates Foundation and National Institutes of Health is conducting a clinical study for an investigational mosaic HIV-1 preventive vaccine.

In July, J&J’s Symtuza, a darunavir-based once-daily single-tablet regimen for the treatment of HIV, was approved in the United States.

J&J is a Zacks Rank #2 company.

Other Drugs

Some other popular marketed HIV drugs are AbbVie’s (ABBV - Free Report) , Kaletra and Merck’s (MRK - Free Report) Isentress. In August 2018, Merck received approval for two new HIV drugs – Pifeltro and Delstrigo. These two were approved in EU this week.

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