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.

Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Sanofi out­lines big API plans as coro­n­avirus out­break re­port­ed­ly threat­ens short­age of 150 drugs

As the world becomes increasingly dependant on Asia for the ingredients of its medicines, Sanofi sees business to be done in Europe.

The French drugmaker said it’s creating the world’s second largest active pharmaceutical ingredients (API) manufacturer by spinning out its six current sites into a standalone company: Brindisi (Italy), Frankfurt Chemistry (Germany), Haverhill (UK), St Aubin les Elbeuf (France), Újpest (Hungary) and Vertolaye (France). They have mapped out €1 billion in expected sales by 2022 and 3,100 employees for the new operations headquartered in France.

UP­DAT­ED: NGM Bio takes leap for­ward in crowd­ed NASH field

South San Francisco-based NGM Bio may have underwhelmed with its interim analysis of a key cohort from a mid-stage NASH study last fall — but stellar topline data unveiled on Monday showed the compound induced significant signs of antifibrotic activity, NASH resolution and liver fat reduction, sending the company’s stock soaring.

There are an estimated 50+ companies focused on developing drugs for non-alcoholic steatohepatitis, or NASH, a common liver disease that has long flummoxed researchers. The first wave of NASH drug developers struggled with efficacy as well as safety — and companies big and small have crashed and burned.

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Mickey Kertesz, KidsandArtOrg via YouTube

Soft­Bank's newest, $165M biotech in­vest­ment looks for in­fec­tious traces in the blood

SoftBank has found its newest biotech investment.

The Japanese bank has invested $165 million into Karius, a company that uses blood tests to diagnose infectious diseases, as part of its new Vision Fund 2. The full scope of the new fund has yet to be announced, but the first and newly-beleaguered Vision Fund poured $100 billion into technology companies, including the biotechs Vir Biotechnology and Roivant and the sequencing company 10x Genomics.

Methicillin-resistant Staph aureus (Shutterstock)

FDA grants ‘break­through’ sta­tus to an­tibi­ot­ic al­ter­na­tive as Con­tra­Fect rush­es to join fight against su­per­bug

An experimental drug that promises to be the first anti-infective agent to prove superior to vancomycin — an antibiotic approved in 1958 — has notched the FDA’s “breakthrough” status.

ContraFect said the designation was based on Phase II data in which exebacase was tested against a superbug known as methicillin-resistant Staph aureus, or MRSA. In a subgroup analysis, the clinical responder rate at day 14 was 42.8% higher than that among those treated with standard of care, the company said (p=0.010).

Zhong Nanshan, CGTN via YouTube

Har­vard joins coro­n­avirus fight with $115 mil­lion and a high-pro­file Chi­nese part­ner

For two months, as the novel coronavirus swelled from a few early cases tied to a Wuhan market to a global epidemic, most of the world’s focus and dollars have flowed toward emergency initiatives: building vaccines at a record pace, plucking experimental antivirals out of freezers to see what sticks and immunizing mice for new antibodies.

Now a new and well-funded collaboration between Harvard and a top Chinese research institute will play the long game. In a 5-year, $115 million initiative backed by China Evergrande Group, researchers from the Harvard Medical School, Harvard T.H. Chan School of Public Health and Guangzhou Institute for Respiratory Health will study the virus in an effort to develop therapies against infections by the novel coronavirus, known as SARS–CoV-2, and to prevent new ones.

No­var­tis gets a boost in block­buster mul­ti­ple scle­ro­sis race with Roche

In the first step of what’s likely to be a long and uphill battle for the drugmaker, the FDA has accepted Novartis’s BLA submission for a new multiple sclerosis drug and given it priority review. The PDUFA date for the potential blockbuster drug is in June.

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Juergen Horn

An­i­mal health vet Juer­gen Horn makes new an­ti­body play for pets, rak­ing $15M in Se­ries A haul

Zoetis forked over $85 million in 2017 to acquire Nexvet Biopharma and its pipeline of monoclonal antibodies. Juergen Horn, Nexvet’s former chief product development officer, has now secured $15 million for his own biologic company for animals: Invetx.

Buoyed by emerging advances in gene therapies for humans, scientists have started looking at harnessing the technology for animals setting up companies such as Penn-partnered Scout Bio and George Church-founded Rejuvenate Bio. But akin to Nexvet, Invetx is working on leveraging the time-tested science of monoclonal antibodies to treat chronic diseases that afflict man’s best friend.

As coro­n­avirus out­break reach­es 'tip­ping point,' GSK lends ad­ju­vant tech to Chi­nese part­ner armed with pre­clin­i­cal vac­cine

As the coronavirus originating out of Wuhan spreads to South Korea, Italy and Iran, stoking already intense fears of a pandemic, GlaxoSmithKline has found another pair of trusted hands to place its adjuvant system. China’s Clover Biopharmaceuticals will add the adjuvant to its preclinical, protein-based vaccine candidate against SARS-CoV-2.

Clover, which is based in the inland city of Chengdu, boasts of a platform dubbed Trimer-Tag that produces covalently-trimerized fusion proteins. Its candidate, COVID-19 S-Trimer, resembles the viral spike (S)-protein found in the virus.