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MSD claims EU approval for two HIV products

Company battles back against dominant Gilead and GSK

Merck & Co/MSD’s market share in HIV has been on the slide thanks to tough competition from GlaxoSmithKline and Gilead, but it hopes to reverse that trend with two new drugs that have just been approved by the EMA.

The pair – non-nucleoside reverse transcriptase inhibitor (NNRTI) Pifeltro (doravirine) and single-tablet combination Delstrigo (doravirine, lamivudine and tenofovir disoproxil fumarate) – are a much-needed bolster for Merck’s HIV portfolio, which is currently led by blockbuster integrase inhibitor Isentress (raltegravir).

Isentress is used as an add-on therapy to other HIV drugs and brought in $1.2bn in sales last year, but has started to be squeezed by new products from GSK’s ViiV subsidiary and Gilead that offer multiple drugs in a single tablet, simplifying treatment.  Sales came in at $860m in the first nine months of this year, a fall of 11%.


The EU approval of Pifeltro and Delstrigo comes after the pair were approved in the US in August. At the time, GlobalData analyst Thomas Moore said that while the two drugs are “unlikely to match the highly successful Isentress, they are still expected to be well received by physicians, aided by the inclusion of treatment-naïve patients” in their FDA labelling. He predicted peak sales of $369m in 2023 in the top seven pharma markets for Delstrigo, and $144m for Pifeltro.

The EU label is a little different, indicating the drugs can be used for “the treatment of adults with HIV-1 infection without past or present evidence of resistance to the non-nucleoside reverse transcriptase class, lamivudine or tenofovir.”

In the US, Merck has priced Delstrigo at $70 per day, at the low end of rivals such as Gilead’s Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) and ViiV’s Triumeq (dolutegravir/abacavir/lamivudine) which have list prices closer to $80 per day, according to GlobalData. There’s no word yet on European pricing, which will be fluid as ever, depending on the reimbursement regimes in different countries.

Merck has suggested Delstrigo is slightly more effective than Gilead’s widely-prescribed Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate), which made $1.3bn in sales last year.

The two products are due to roll out onto the market in the first half of next year, according to Merck, but could face tough competition from newer combination drugs from Gilead and ViiV that aim to increase efficacy and/or reduce exposure to active ingredients in the hope of limiting side effects.

Article by
Phil Taylor

29th November 2018

From: Regulatory



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