GlaxoSmithKline ($GSK) may be suffering from R&D setbacks, generic competition and corruption investigations in a dozen countries, but its HIV-oriented venture ViiV Healthcare is racking up new OKs. Friday, the company scored the FDA's blessing for a combo drug pegged at $5 billion in peak sales.
It's a three-way combination pill, Triumeq, which adds ViiV's newest antiviral, Tivicay (dolutegravir), to two commonly used treatments, abacavir and lamivudine. Approved last August, Tivicay was the third drug in a newer class of HIV fighters: integrase inhibitors.
|ViiV CEO Dominique Limet|
It's also the second brand-new drug for ViiV, formed four years ago as a joint venture between GSK and Pfizer ($PFE); the company now has another partner, Shionogi, the Japanese drugmaker. "We are proud to announce this important milestone, marking the second new treatment to be approved in the U.S. from our pipeline of medicines," ViiV CEO Dominique Limet said in a statement.
One of the challenges HIV patients face is remembering to take their pills--and how and when. For drugmakers, keeping patients on their meds is key to keeping sales coming. Plus, adding a brand new med to two older drugs available as generics, as abacavir and lamuvidine are, creates a new product that's not vulnerable to head-to-head generics. So, ViiV and its rivals have developed a series of combo drugs to make compliance--and competition--easier.
Gilead Sciences ($GILD), for instance, rolled out a four-in-one pill last year, Stribild, and it's well on its way to blockbuster-land. Analysts see it hitting $2.4 billion by 2016.
But persuading payers that combination pills are worth premium prices isn't always easy. With a $28,000 price tag, Stribild has come up against some resistance; some payers, including Aetna, have put the pill on its prior-authorization list to try to limit its use. A ViiV combo pill, Combivir, is excluded from some of the insurer's formularies altogether, but each of its two ingredients is available as a generic--and it faces combo copycats, too.
Of course, pricing is an issue, and we haven't yet heard from ViiV about Triumeq's cost. Tivicay got a $14,000-per-year price tag when it rolled out in the U.S. last year. Analysts see the Tivicay/Triumeq franchise bringing in $2.2 billion by 2018, with peak sales of up to $5 billion.
- read the release from ViiV
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