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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

UP­DAT­ED: Boehringer nabs FDA's first in­ter­change­abil­i­ty des­ig­na­tion for its Hu­mi­ra com­peti­tor — but will it mat­ter?

The FDA late Friday awarded Boehringer Ingelheim the first interchangeability designation for its Humira biosimilar Cyltezo, meaning that when it launches in July 2023, pharmacists will be able to automatically substitute the Boehringer’s version for AbbVie’s mega-blockbuster without a doctor’s input.

The designation will likely give Boehringer, which first won approval for Cyltezo in 2017, the leg up on a crowded field of Humira competitors.

Bio­gen hit by ALS set­back with PhI­II fail­ure for tofersen — but fol­lows a fa­mil­iar strat­e­gy high­light­ing the pos­i­tive

Patients and analysts waiting to hear Sunday how Biogen’s SOD1-ALS drug tofersen fared in Phase III didn’t have to wait long for the top-line result they were all waiting for. The drug failed the primary endpoint on significantly improving the functional and neurologic decline of patients over 28 weeks as well as the extension period for continued observation.

In fact, there was very little difference in response.

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Two drug­mak­ers hit with PDU­FA date de­lays from FDA amid back­log of in­spec­tions

As the FDA is weighed down with more and more pandemic responsibilities, the agency is beginning to miss PDUFA dates with more frequency too. Two different companies on Monday said they received notices that the FDA has not completed their drug reviews on time.

The review of an NDA for Avadel Pharmaceuticals’ candidate treatment for narcolepsy is not coming this month, the company said, and the review of UCB’s BLA for bimekizumab, used to treat moderate to severe plaque psoriasis, will miss its target date as well.

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Reshma Kewalramani, Vertex CEO (YouTube)

Ver­tex gets much-need­ed win with ‘ex­tra­or­di­nary’ first pa­tient re­sults on po­ten­tial di­a­betes cure

Vertex said Monday that the first patient dosed with its cell therapy for type 1 diabetes saw their need for insulin injections vanish almost entirely, a key early step in the decades-long effort to develop a curative treatment for the chronic disease.

The patient, who had suffered five potentially life-threatening hypoglycemic — or low blood sugar — episodes in the year before the therapy, was injected with synthetic insulin-producing cells. After 90 days, the patient’s new cells produced insulin steadily and ramped up their insulin production after a meal like normal cells do, as measured by a standard biomarker for insulin production.

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Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; 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.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Scott Struthers, Crinetics CEO

Cri­net­ics spins out ra­dio­phar­ma ef­forts in­to a new com­pa­ny, high­light­ing the grow­ing field­'s al­lure

Largely known for its nonpeptide small molecule research, Crinetics has been keeping its radiopharma work comparatively under wraps. But that changed Monday afternoon as the California biotech spun out a new company focused solely on the burgeoning field.

Crinetics launched Radionetics after the closing bell Monday, the company announced, seeding the new entity with $30 million raised from 5AM Ventures and Frazier Healthcare Partners. Radionetics will start with its own radiopharma-centric platform and a pipeline of 10 programs aimed at solid tumors.

Jeffrey Nau, Oyster Point Pharma CEO

FDA OKs an in­haled ver­sion of smok­ing ces­sa­tion drug Chan­tix — for a com­mon eye dis­ease

Oyster Point Pharma now has its first FDA-approved product — Tyrvaya. And the biotech has taken a unique route to get there by using an old drug with a storied past.

The New Jersey biotech announced this morning that the FDA has approved their nasal spray product for dry eye disease on Friday — the first nasal spray to be approved for the disease. The product’s active ingredient is 0.03 mg of varenicline, also known as smoking cessation aid Chantix.