Gilead Sciences Inc. plans to launch the triple combination antiretroviral Complera next week at a slightly higher price to Atripla, the existing standard of care triple combination for the treatment of HIV.

The company announced FDA approval of the next-generation triple combination after the close of the markets Aug. 10, regulatory action that was widely anticipated since all of the drugs used in the combination are FDA approved.

Complera will be available at a wholesale acquisition cost of $1,704 for a 30-day supply, about a 5% increase over Atripla, which costs $1,627 for a 30-day supply. The costs of both Complera and Atripla are equal to the sum of their components, Gilead said.

Complera combines three antivirals in one daily tablet: Gilead's Truvada, a fixed-dose combination of the nucleoside reverse transcriptase inhibitors emtricitabine and tenofovir, and Johnson & Johnson's Tibotec Pharmaceuticals' non-nucleoside reverse transcriptase inhibitor Edurant (rilpivirine). Atripla, in contrast combines Truvada with Bristol-Myers Squibb Co.' s older NNRTI Sustiva (efavirenz).

Atripla is Gilead's top-selling drug, with 2010 sales of $2.93 billion, but Sustiva's loss of exclusivity in 2013 could impact sales of the triple combination. With Complera, Gilead is looking to extend the life of its HIV franchise.

J&J's Edurant was approved in May as an individual antiretroviral. In clinical studies it was shown to be non-inferior to efavirenz with fewer side effects like abnormal dreams and dizziness. But it also was shown to have a higher risk of virologic failure and development of class-resistant mutations (Also see "Rilpivirine Label Highlights Risk In Patients With Higher HIV Levels, Could Limit Use" - Pink Sheet, 20 May, 2011.).

That could inhibit the uptake of Complera over Atripla, which has been on the market since 2006. Indeed, the indications section of the Complera label highlights the higher failure rate seen in patients with HIV-1 RNA greater than 100,000 copies/mL at the start of therapy compared to subjects with HIV-1 RNA less than 100,000 copies/mL, as well as the higher rate of treatment resistance compared to efavirenz. The information is consistent with the language already included in the prescribing information for Edurant.

Given the potential clinical issues and cost considerations that will come into play post-2013, Complera is expected to be a modest seller. RW Baird & Co. analyst Thomas Russo forecast sales of Complera at $6.4 million in 2011 and $210.3 million in 2012 in an Aug. 11 research note.

More important to Gilead will be the results of two Phase III studies expected to be released in the second half of the year on a quad pill that combines Truvada with two new drugs from Gilead's pipeline, the integrase inhibitor elvitegravir and the pharmacokinetic booster cobicistat.

Investors also are anxious to see Gilead successfully diversify its business beyond HIV as that market matures. The company has staked a claim for the hepatitis C space, but it is an increasingly crowded and competitive area of research and development (Also see "Gilead Recruits Hepatitis C Specialist McHutchison In Show Of Commitment" - Pink Sheet, 9 June, 2010.).

Gilead and Tibotec announced a collaboration on Complera in July 2009. Gilead is responsible for the manufacturing, registration and commercialization of the drug in the U.S., Canada, Brazil, the EU, Australia and New Zealand. At the time the collaboration was announced, Gilead said it would book all the revenues and retain all the revenues related to Truvada as well as a "significant percentage" of revenues related to Edurant.

Gilead released a second dose of good news Aug. 10, announcing that it has resolved all outstanding issues on a warning letter related to its San Dimas, Calif., manufacturing facility. Changes implemented by Gilead, primarily related to the manufacturing of AmBisome (amphotericin B) liposome and other product quality issues, were deemed sufficient, Gilead said.

The positive news led the stock to close Aug. 11 at $36.87, up 4.3% over its Aug. 10 closing price, though Gilead has come under pressure amid the broader market turmoil.

-Jessica Merrill (j.merrill@elsevier.com)

Gilead Complera Launch Imminent Following FDA Approval

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