Gilead los­es key patent claims for So­val­di in Chi­na, open­ing door to ear­li­er gener­ic en­try

A par­tial patent in­val­i­da­tion by Chi­nese au­thor­i­ties has shak­en the case Gilead has been build­ing for its hep C star So­val­di by re­mov­ing a key bar­ri­er to gener­ic en­try.

The de­ci­sion means knock­offs of the high­ly ef­fec­tive hep C treat­ment can ar­rive as ear­ly as next year — rather than 2024, when the patent was orig­i­nal­ly set to ex­pire — ac­cord­ing to the Ini­tia­tive for Med­i­cines, Ac­cess, and Knowl­edge, or I-MAK. I-MAK filed one of the two re­quests for patent in­val­i­da­tion cit­ed in the rul­ing, to­geth­er with Chi­nese drug­mak­er Fu­jian Co­sunter Phar­ma.

Tahir Amin

Be­cause the patent con­cerns so­fos­bu­vir, a cru­cial base com­pound that’s al­so used to make com­bo drugs like Har­voni and Ep­clusa, this de­ci­sion could af­fect not just one prod­uct but Gilead’s whole hep C fran­chise in the coun­try.

In re­sponse to my ques­tion as to whether Gilead will ap­peal the rul­ing (they have three months to do so), a spokesper­son says the Fos­ter City, CA-based com­pa­ny has not with­drawn their claims to the so­fos­bu­vir com­pound patent ap­pli­ca­tion in Chi­na. Here’s the rest of the re­sponse:

This patent ap­pli­ca­tion is cur­rent­ly be­ing re­viewed by the Patent Re­view Board (PRB). Last week Chi­na’s PRB con­firmed the va­lid­i­ty of claims cov­er­ing the SOF metabo­lites. This de­ci­sion has no im­pact on our SOF com­pound patent ap­pli­ca­tion. Gilead is con­fi­dent in the in­tel­lec­tu­al prop­er­ty cov­er­ing the so­fos­bu­vir com­pound and all its he­pati­tis C med­i­cines, which bring the po­ten­tial of a cure to the vast ma­jor­i­ty of pa­tients suf­fer­ing from chron­ic he­pati­tis C virus (HCV) in­fec­tion. In the mean­time, we will con­tin­ue to work with the Chi­nese gov­ern­ment to fa­cil­i­tate broad ac­cess to Gilead’s he­pati­tis C med­i­cines.

While So­val­di was launched in Chi­na at one-fifth the con­tem­po­rary price in the US — al­most $9,000 for a 12-week regime — its price still fre­quent­ly comes un­der at­tack, as it has in many oth­er coun­tries around the world. In fact, Gilead has drawn crit­i­cism ever since it be­gan sell­ing the drug at $84,000 in the US. And where­as Gilead de­signed li­cens­ing deals with gener­ic com­pa­nies in coun­tries like Ukraine, Be­larus, Thai­land and Malaysia in re­sponse to com­plaints, no such agree­ment was struck in Chi­na.

Back in 2015, two years be­fore So­val­di would be ap­proved in Chi­na, the au­thor­i­ties had re­ject­ed Gilead’s ap­pli­ca­tion for an in­ac­tive pro­drug that is me­tab­o­lized once in the body.

I-MAK, which al­so played a role in that de­ci­sion, has been bring­ing le­gal chal­lenges against Gilead in a num­ber of oth­er coun­tries, in­clud­ing the US. Its co-founder Tahir Amin told STAT that even though Gilead still holds four re­main­ing patent claims on So­val­di and da­ta ex­clu­siv­i­ty in Chi­na, they shouldn’t hin­der gener­ic mak­ers as much as this patent had.

Co­sunter, which mar­ket­ed Chi­na’s first hep B gener­ic, is said to be de­vel­op­ing a copy­cat ver­sion of So­val­di.

Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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UP­DAT­ED: An em­bold­ened As­traZeneca splurges $95M on a pri­or­i­ty re­view vouch­er. Where do they need the FDA to hus­tle up?

AstraZeneca is in a hurry.

We learned this morning that the pharma giant — not known as a big spender, until recently — forked over $95 million to get its hands on a priority review voucher from Sobi, otherwise known as Swedish Orphan Biovitrum.

That marks another step down on price for a PRV, which allows the holder to slash 4 months off of any FDA review time.

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Martin Shkreli [via Getty]

Pris­on­er #87850-053 does not get to add drug de­vel­op­er to his list of cred­its

Just days after Retrophin shed its last ties to founder Martin Shkreli, the biotech is reporting that the lead drug he co-invented flopped in a pivotal trial. Fosmetpantotenate flunked both the primary and key secondary endpoints in a placebo-controlled trial for a rare disease called pantothenate kinase-associated neurodegeneration, or PKAN.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology
ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development
CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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Am­gen, Al­ler­gan biosim­i­lar of Roche's block­buster Rit­ux­an clears an­oth­er US piv­otal study 

Novartis $NVS may have given up, but Amgen $AMGN and Allergan $AGN are plowing ahead with their knockoff of Roche’s blockbuster biologic Rituxan in the United States.

Their copycat, ABP 798, was found to have a clinically equivalent impact as Rituxan — meeting the main goal of the study involving CD20-positive B-cell non-Hodgkin’s lymphoma patients. This is the second trial supporting the profile of the biosimilar. In January, it came through with positive PK results in patients with rheumatoid arthritis.

BeiGene and Mus­tang nail down spe­cial FDA sta­tus for top drugs; Roche bags added cov­er­age for Hem­li­bra

→ BeiGene $BGNE is getting a boost in its drive to field a rival to Imbruvica. The FDA has offered an accelerated review to zanubrutinib, a BTK inhibitor that has posted positive results for mantle cell lymphoma. The PDUFA date lands on February 27, 2020. The drug scored breakthrough status at the beginning of the year.

→ BeiGene isn’t the only biopharma company to gain special regulatory status today. Mustang Bio $MBIO and St. Jude Children’s Research Hospital announced that MB-107, a lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency, also known as bubble boy disease, has been granted Regenerative Medicine Advanced Therapy status.

Trump ad­min­is­tra­tion re­vives bid to get drug list prices on TV ads

The Trump administration is not giving up just yet. On Wednesday, the HHS filed an appeal against a judge’s decision in July to overturn a ruling obligating drug manufacturers to disclose the list price of their therapies in television adverts — hours before it was stipulated to go into effect.

In May, the HHS published a final ruling requiring drugmakers to divulge the wholesale acquisition cost— of a 30-day supply of the drug — in tv ads in a bid to enhance price transparency in the United States. The pharmaceutical industry has vehemently opposed the rule, asserting that list prices are not what a typical patient in the United States pays for treatment — that number is typically determined by the type of (or lack thereof) insurance coverage, deductibles and out-of-pocket costs. Although there is truth to that claim, the move was considered symbolic in the Trump administration’s healthcare agenda to hold drugmakers accountable in a climate where skyrocketing drug prices have incensed Americans on both sides of the aisle.

Bob Smith, Pfizer

Pfiz­er is mak­ing a $500M state­ment to­day: Here’s how you be­come a lead play­er in the boom­ing gene ther­a­py sec­tor

Three years ago, Pfizer anted up $150 million in cash to buy Bamboo Therapeutics in Chapel Hill, NC as it cautiously stuck a toe in the small gene therapy pool of research and development.

Company execs followed up a year later with a $100 million expansion of the manufacturing operations they picked up in that deal for the UNC spinout, which came with $495 million in milestones.

And now they’re really going for it.

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Video: Putting the AI in R&D — with Badhri Srini­vasan, Tony Wood, Rosana Kapeller, Hugo Ceule­mans, Saurabh Sa­ha and Shoibal Dat­ta

During BIO this year, I had a chance to moderate a panel among some of the top tech experts in biopharma on their real-world use of artificial intelligence in R&D. There’s been a lot said about the potential of AI, but I wanted to explore more about what some of the larger players are actually doing with this technology today, and how they see it advancing in the future. It was a fascinating exchange, which you can see here. The transcript has been edited for brevity and clarity. — John Carroll