Gilead los­es key patent chal­lenge over best-sell­ing HIV drug

Gilead won’t eas­i­ly rid of it­self of this HIV patent chal­lenge.

Last year, the De­part­ment of Health and Hu­man Ser­vices said that it owned some of the patents for Gilead’s best-sell­ing HIV pre­ven­tion drug, Tru­va­da, al­so known as PrEP. Gilead re­spond­ed by ar­gu­ing in court that HHS’s patents were in­valid.

To­day, a US Patent and Trade­mark Of­fice pan­el ruled that Gilead was like­ly to lose its chal­lenge.

The rul­ing won’t de­cide the larg­er is­sue and Gilead still has two patent chal­lenges pend­ing be­fore the USP­TO. But it of­fers a sig­nif­i­cant win for both HHS and AIDS ac­tivists in their ef­forts to force Gilead to pay the fed­er­al gov­ern­ment roy­al­ties on a drug that earned the com­pa­ny $2.6 bil­lion last year.

It is high­ly un­usu­al for the fed­er­al gov­ern­ment to sue phar­ma com­pa­nies over in­tel­lec­tu­al prop­er­ty, al­though it rou­tine­ly li­cens­es out patents that came out of gov­ern­ment-backed re­search. HHS said they tried to work out such a deal with Gilead for over a year, but Gilead main­tained the gov­ern­ment didn’t have rights to the patent.

HHS has point­ed in part to the near­ly $50 mil­lion of fed­er­al grants that backed HIV pre­ven­tion work by San Fran­cis­co AIDS foun­da­tion re­searcher Robert Grant and CDC re­searcher Thomas Folks. Gilead said oth­ers had al­ready for­mu­lat­ed the idea of us­ing an HIV drug for pre-ex­po­sure pro­phy­lax­is, point­ing to guide­lines pub­lished in 2005 by the Cen­ter for HIV Iden­ti­fi­ca­tion, Pre­ven­tion, and Treat­ment Ser­vices and AIDS Part­ner­ship Cal­i­for­nia.

The fed­er­al gov­ern­ment’s un­usu­al pur­suit has been fu­eled in part by AIDS ac­tivists, who have crit­i­cized the $21,100 price tag Gilead placed on PrEP. They say gov­ern­ment roy­al­ties could be used to fund treat­ment and ed­u­ca­tion pro­grams that will ex­pand ac­cess to the drug.

The high price Gilead has charged, along with ed­u­ca­tion­al and oth­er bar­ri­ers, has helped lead to wide racial, ge­o­graph­ic and eco­nom­ic dis­par­i­ties in who has ac­cess to the drug and where the HIV epi­dem­ic still reach­es cri­sis lev­els.

Tru­va­da, a pill,  is more than 90% ef­fec­tive in pre­vent­ing HIV if tak­en prop­er­ly. Gilead has raised the price by more than $10,000 since it was in­tro­duced in 2004, when they charged $650 per month, or 7,800 per year.

The com­pa­ny has not­ed that its as­sis­tance pro­grams curb costs for many pa­tients and last year it do­nat­ed enough of PrEP to cov­er 200,000 pa­tients for 11 years.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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David Loew (Ipsen)

Ipsen snags an ap­proved can­cer drug in $247M M&A deal as an­oth­er bat­tered biotech sells cheap

You can add Paris-based Ipsen to the list of discount buyers patrolling the penny stock pack for a cheap M&A deal.

The French biotech, which has had plenty of its own problems to grapple with, has swooped in to buy Epizyme $EPZM for $247 million in cash and a CVR with milestones attached to it. Epizyme shareholders, who had to suffer through a painfully soft launch of their EZH2a inhibitor cancer drug Tazverik, will get $1.45 per share along with a $1 CVR tied to achieving $250 million in sales from the drug over four consecutive quarters as well as an OK for second-line follicular lymphoma by 1 Jan. 2028.

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AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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GSK says its drug for chron­ic hep B could ‘lead to a func­tion­al cure’ — but will it be alone or in com­bi­na­tion?

GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”

At a presentation at the EASL International Liver Congress, GSK shared that in around 450 patients who received its hep B drug bepirovirsen for 24 weeks, just under 30% had hepatitis B surface antigen and viral DNA levels that were too low to detect.

Sanofi, GSK tout 72% Omi­cron ef­fi­ca­cy in PhI­II tri­al of next-gen, bi­va­lent shot — with an eye to year-end roll­out

Sometimes, being late can give you an advantage.

That’s what Sanofi and GSK are trying to say as the Big Pharma partners report positive results from a late-stage trial of their next-gen bivalent Covid-19 vaccine, which was designed to protect against both the original strain of the SARS-CoV-2 virus and the Beta variant. Specifically, against Omicron, they note, the vaccine delivered 72% efficacy in all adults and 93.2% in those previously infected.

Matt Kapusta, uniQure CEO

In trou­bled Hunt­ing­ton’s space, uniQure’s gene ther­a­py shows ear­ly promise

In randomized clinical trial data from a small number of patients, Dutch biotech uniQure shared that its gene therapy for Huntington’s disease seems to reduce the amount of the mutant protein responsible for the disease over the course of a year.

In seven patients with early-stage Huntington’s — four who got the treatment and three who got a placebo — mutant huntingtin protein levels in the cerebrospinal fluid decreased by an average of just over 50% in patients who got the gene therapy compared to around a 17% drop in patients who got the placebo after a year.

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De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”