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Glaxo's (GSK) Long-Acting Drug NDA Gets Priority Tag for PrEP

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GlaxoSmithKline plc’s GSK HIV subsidiary, ViiV Healthcare announced that the FDA has granted priority review to its new drug application (NDA) for a long-acting injectable HIV regimen, cabotegravir. The NDA is seeking approval of cabotegravir for pre-exposure prophylaxis (PrEP) or HIV prevention in individuals who are at risk of HIV-1 infection and have a negative HIV-1 test prior to the initiation of treatment.

A decision from the FDA is expected by Jan 24, 2022. Cabotegravir will be the first long-acting therapy for the prevention of HIV, if approved. It will reduce the daily administration of currently available therapies for PrEP to once every eight weeks. The NDA was supported by data from two phase IIb/III studies — HPTN 083 and HPTN 084 — which demonstrated that the cabotegravir regimen is superior compared to the daily oral regimen of emtricitabine or tenofovir disoproxil fumarate in preventing HIV infection.

Please note that an oral formulation of cabotegravir, with the trade name of Vocabria, is already approved in combination with J&J’s JNJ Edurant (oral rilpivirine) for short-term treatment of HIV-1 infection. A combination of long-acting injectable cabotegravir and rilpivirine is approved as Cabenuva for treating adults with virally suppressed (HIV-1 RNA less than 50 copies per milliliter) HIV-1 infection.

In a separate press release, ViiV Healthcare announced that it has signed an exclusive collaboration and license agreement with Japan-based Shionogi to support the development of ultra long-acting HIV regimens that can be administered once every three or more months. The agreement will provide ViiV Healthcare with a license to S-365598, a third-generation investigational integrase strand transfer inhibitor that may be developed as an ultra long-acting HIV regimen. In return, ViiV Healthcare will pay £20 million in upfront payment and a £15 million payment for a clinical development milestone to Shionogi. ViiV Healthcare will also pay royalty on any potential sales, following the successful development and approval of the HIV regimen.

So far this year, Glaxo’s shares have underperformed the industry, rising 3.4% compared with the industry’s 8.2% increase.

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Zacks Investment Research

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ViiV Healthcare is an HIV company, majorly owned by Glaxo and Pfizer PFE. ViiV Healthcare focuses on advancing HIV care by exploring new treatment paradigms (two-drug regimens), modalities (long-acting injectables) and mechanisms of actions (including maturation inhibitors and broadly neutralizing antibodies). The company had signed a global collaboration and license agreement with Halozyme Therapeutics HALO for developing its ultra-long-acting medicines for treating HIV infection in June.

We remind investors that HIV is a key therapeutic area for Glaxo. However, rising competitive pressure coupled with a shift within its portfolio toward two-drug regimens is hurting sales of Glaxo’s HIV business. HIV sales totaled £1.24 billion in the first half of 2021, reflecting an increase of 4% year over year. Upon potential approval and successful development of long- and ultra long-acting HIV regimens, the company may gain a competitive advantage, which may drive its sales from the HIV segment going forward.

GlaxoSmithKline plc Price

GlaxoSmithKline plc Price
GlaxoSmithKline plc Price

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Zacks Rank

Glaxo currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.


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