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Gilead & 3 Other Drug Stocks in Focus this World AIDS Day

Zacks

World AIDS Day takes place every year on December 1 with people across the world coming together to fight against HIV, to support those living with HIV and to commemorate those who have died from an AIDS-related disease.

Everybody Counts

The slogan for this World AIDS Day is “Everybody Counts”. The goal is to ensure access to affordable and high quality care and services for people with HIV, a strong health care system, as well as the integration of HIV, tuberculosis and hepatitis services.

According to information provided by the World Health Organization (“WHO”), more than 35 million people have lost their lives due to HIV so far while one million people died last year from HIV-related causes. At the end of 2016, approximately 36.7 million people were living with HIV. Number of newly-infected HIV patients was 1.8 million in 2016.

Currently Available Treatments

While there is no cure for HIV at present, the virus can be controlled through the use of effective antiretroviral (“ARV”) drugs. According to WHO, 54% of adults and 43% of children with HIV are currently on lifelong ARV – 19.5 million people living with HIV were receiving antiretroviral therapy (“ART”) in 2016. Combination ART (combining 3 or more ATV drugs) has been found to be effective in suppressing viral replication within a person's body thereby allowing the immune system to strengthen and regain the capacity to fight off infections.

The HIV drug landscape has evolved over the years with drugs with varying mechanisms of action being approved over the years. These include multi-class combination products (Atripla, Complera, Stribild), nucleoside reverse transcriptase inhibitors (NRTIs – Combivir, Epivir, Truvada, Viread), non-nucleoside reverse transcriptase inhibitors (NNRTIs – Edurant, Sustiva), protease inhibitors (PIs – Prezista, Reyataz, Norvir), HIV integrase strand transfer inhibitors (INSTI – Isentress, Tivicay) as well as fusion inhibitors and entry inhibitors (CCR5 co-receptor antagonist).

According to WHO, new HIV infections fell by 39% between 2000 and 2016 while HIV-related deaths declined by one-third with ART saving 13.1 million lives. However, with only 70% of HIV-infected people being aware of their status, there remains significant need to spread awareness about the disease and the availability of rapid diagnostic tests (RDTs), which detect the presence or absence of HIV antibodies.

According to GlobalData, the HIV market across the United States, France, Germany, Italy, Spain, the UK, Japan, Brazil, and China, is expected to grow from $16.3 billion in 2015 to $22.5 billion by 2025.

There is significant need for new alternative ARV treatment options that come with better tolerability, higher efficacy, and lower rates of treatment discontinuation. Here is a look at a few key players in the HIV market.

4 Drug Stocks in Focus

Johnson & Johnson JNJ: J&J is a key player in the HIV market with the company introducing several transformational medicines in this therapeutic area over the last 25 years. The company and its partner GlaxoSmithKline plc GSK recently gained FDA approval for Juluca, the first, complete, single-pill, two-drug regimen for the treatment of HIV-1 infection in certain adults living with the disease who are virologically suppressed.

The once-daily, antiretroviral is a combination of Tivicay (INSTI) and Edurant (NNRTI) which maintains the safety and efficacy of a traditional three-drug regimen without an NRTI. Simpler treatment regimens will make compliance easier for HIV patients who need to stay on a consistent treatment regimen in order to keep their viral counts low.

The company is currently seeking FDA approval with partner Gilead Sciences, Inc. GILD for a darunavir-based single tablet regimen (“STR”). The once-daily regimen comprises darunavir 800mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg (D/C/F/TAF).

J&J is also working on an HIV vaccine. The company along with The Bill & Melinda Gates Foundation and National Institutes of Health is conducting an efficacy study for an investigational mosaic HIV-1 preventive vaccine. There is significant unmet need for a vaccine for HIV – although a lot of progress has been made in treating and managing the disease, almost two million people become infected every year. Developing a vaccine for HIV has proved to be challenging due to the unique properties of the virus including its ability to mutate rapidly. Moreover, genetic diversity with multiple strains and subtypes prevalent in different parts of the world are additional hurdles.

J&J is a Zacks Rank #2 (Buy) stock – you can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. The stock has gained 20.9% year to date, compared to the 16.3% rally of the industry it belongs to.

Gilead Sciences, Inc.: HIV is one of the primary areas of focus at Gilead. The company’s HIV portfolio includes drugs like Genvoya, Truvada, Atripla, Descovy, Odefsey, Complera and Stribild which contributed approximately $9.5 billion to total sales in the first nine months of 2017. Gilead’s TAF-based products like Genvoya, Descovy and Odefsey remain key growth drivers. Gilead is currently seeking FDA approval for an investigational, fixed-dose combination of BIC/FTC/TAF with the FDA expected to respond on Feb 12, 2018. Meanwhile, the company expects to complete a 6mg cohort phase I study on GS-9620 (TLR-7 agonist, HIV cure) by year end. A late-stage study evaluating Descovy for pre-exposure prophylaxis (PrEP) is scheduled to complete in the third quarter of 2018.

With the company’s hepatitis C virus (“HCV”) franchise seeing declining sales, Gilead is focusing on its HIV franchise for growth. The company’s non-HCV products are expected to generate sales of $16 – $16.5 billion in 2017. However, competition in this market is intense. Moreover, the company is facing competition from generic products as well.

Gilead is a Zacks Rank #3 (Hold) stock. The stock has gained 4.4% year to date, compared to the 2.6% rally of the industry it belongs to.

GlaxoSmithKline: Glaxo is a majority stakeholder in ViiV Healthcare, a global specialist HIV company, which was set up in partnership with Pfizer Inc. PFE in 2009 and now has Shionogi as a shareholder as well. Key products in the HIV portfolio include Triumeq and Tivicay. Glaxo is working on bringing new growth drivers into the HIV business with Juluca being a recent addition. Glaxo is exploring new treatment paradigms (two drug regimens), new modalities (long-acting injectables) and new mechanisms of actions (including maturation inhibitors and broadly neutralising antibodies). The company is working on a dolutegravir – lamivudine combination which will also be for naive patients and a long-acting cabotegravir plus rilpivirine combination.

ViiV has commenced a late-stage study on long-acting cabotegravir for the prevention of HIV infection in sexually active women. The study will compare cabotegravir injections given every two months to daily oral pre-exposure prophylaxis (PrEP) with emtricitabine/tenofovir disoproxil fumarate.

Glaxo, a Zacks Rank #3 stock, has declined 8.9% year to date, compared to the 16.3% rally of the industry it belongs to.

Merck MRK: Merck has a presence in the HIV market in the form of Isentress/Isentress HD, HIV integrase inhibitors for use in combination with other antiretroviral agents. The company’s HIV franchise brought in sales of $896 million in the first nine months of 2017, down 15% from the year-ago period mainly due to lower demand in the United States due to competitive pressures.

Merck’s HIV pipeline has a couple of late-stage candidates – MK-1439 (doravirine, NNRTI) and MK-1439A (doravirine/lamivudine/tenofovir disoproxil fumarate – DOR/3TC/TDF). The company expects to file for regulatory approval of doravirine both as a single-entity tablet and as a fixed-dose combination tablet (DOR/3TC/TDF) by year end.

Merck, a Zacks Rank #3 stock, has declined 6.1% year to date, compared to the 16.3% rally of the industry it belongs to.


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