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.

Brent Saunders [Getty Photos]

UP­DAT­ED: Ab­b­Vie seals $63B deal to buy a trou­bled Al­ler­gan — spelling out $1B in R&D cuts

Brent Saunders has found his way out of the current fix he’s in at Allergan $AGN. He’s selling the company to AbbVie for $63 billion in the latest example of the hot M&A market in biopharma.

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Turned back at the FDA, Im­muno­Gen is ax­ing 220 staffers, sell­ing pro­grams and hun­ker­ing down for a new PhI­II gam­ble

After being stymied by FDA regulators who were unconvinced by ImmunoGen’s $IMGN desperation shot at an accelerated OK based on a secondary endpoint, the struggling biotech is slashing its workforce, shuttering R&D projects and looking for buyers to pick up some of its experimental cancer assets as it goes back into a new Phase III with the lead drug.

We found out last month that the FDA had batted back their case for an accelerated approval of their antibody-drug conjugate mirvetuximab soravtansine, which had earlier failed a Phase III study for ovarian cancer. Now the other shoe is dropping.

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Bridge­Bio takes crown for biggest biotech IPO of 2019, as fel­low uni­corn Adap­tive rais­es of­fer­ing size and price

Bridge­Bio Phar­ma and Adap­tive Biotech­nolo­gies have not just up­sized IPO of­fer­ings — the pair of uni­corns have al­so raised their of­fer­ing prices above the range, haul­ing in a com­bined $648.5 mil­lion.

Neil Ku­mar’s Bridge­Bio Phar­ma, found­ed in 2015, has a sta­ble of com­pa­nies fo­cused on dis­eases that are dri­ven by de­fects in a sin­gle gene — en­com­pass­ing der­ma­tol­ogy, car­di­ol­o­gy, neu­rol­o­gy, en­docrinol­o­gy, re­nal dis­ease, and oph­thal­mol­o­gy — and can­cers with clear ge­net­ic dri­vers. The start­up mill birthed a pletho­ra of firms such as Ei­dos, Navire, QED Ther­a­peu­tics and Pelle­Pharm, which func­tion as its sub­sidiaries.

As­traZeneca chal­lenges Roche on front­line SCLC af­ter seiz­ing an in­ter­im win — and Mer­ck may not be far be­hind

The crowded playing field in the PD-1/L1 marketing game is about to get a little more complex.

This morning AstraZeneca reported that its CASPIAN study delivered a hit in an interim readout for their PD-L1 Imfinzi combined with etoposide and platinum-based chemotherapy options for frontline cases of small cell lung cancer, a tough target which has already knocked back Bristol-Myers’ shot in second-line cases. The positive data  — which we won’t see before they roll it out at an upcoming scientific conference — give AstraZeneca excellent odds of a quick vault to challenging Roche’s Tecentriq-chemo combo, approved 3 months ago for frontline SCLC in a landmark advance.

“This is the first trial offering the flexibility of combining immunotherapy with different platinum-based regimens in small cell lung cancer, expanding treatment options,” noted AstraZeneca cancer R&D chief José Baselga in a statement.

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Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

Af­ter rais­ing $158M, this up­start's founders have star back­ers and plans to break new ground in gene ther­a­py

Back in 2014, Stephanie Tagliatela opted to take an early exit out of her PhD program after working in Mark Bear’s lab at MIT, where she specialized in the synaptic connections between neuronal cells in the brain. She never finished that PhD, but she and fellow MIT student Kartik Ramamoorthi — who was on the founding team at Voyager — came away with some ideas for a gene therapy startup.

Today, fully 5 years later, she and Ramamoorthi are taking the wraps off of a $104 million mega-round designed to take the cumulative work of their preclinical formative stage for Encoded Therapeutics into human studies. They’ve now raised $158 million since starting out in Illumina’s incubator in the Bay Area, and they believe they are firmly on track to do something unique in gene therapy.

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Tasly Bio­phar­ma pitch­es long-await­ed IPO — will it trig­ger an­oth­er $1B gold rush on HKEX?

In the run up to the Hong Kong stock ex­change’s an­tic­i­pat­ed rule change — open­ing the door for Chi­nese pre-rev­enue biotechs to go pub­lic clos­er to home — more than a year ago, Tasly Bio­phar­ma was one of the big play­ers whose ru­mored in­ter­est helped stoke en­thu­si­asm for the new list­ing venue. The com­pa­ny has since kept the drum­roll rum­bling in the back­ground, rais­ing a pre-IPO round and con­vinc­ing part­ner Trans­gene to swap own­er­ship in a joint ven­ture for eq­ui­ty. Now the oth­er shoe has fi­nal­ly dropped as ex­ecs out­line plans for a pipeline dom­i­nat­ed by car­dio­vas­cu­lar drugs.

Richard Gonzalez testifying in front of Senate Finance Committee, February 2019 [AP Images]

Ab­b­Vie's $63B buy­out spot­lights the re­turn of ma­jor M&A deals — de­spite the back­lash

Big time M&A is back. But for how long?

Over the past 18 months we’ve now seen three major buyouts announced: Takeda/Shire; Bristol-Myers/Celgene and now AbbVie/Allergan. And with this latest deal it’s increasingly clear that the sharp fall from grace suffered by high-profile players which have seen their share prices blasted has created an opening for the growth players in big pharma to up their game — in sharp contrast to the popular bolt-on deals that have been driving the growth strategy at Novartis, Merck, Roche and others.

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Sanofi/Re­gen­eron mus­cle ahead of a ri­val No­var­tis/Roche team, win first ap­proval in key rhi­nos­i­nusi­tis field

Re­gen­eron and their part­ners at Sanofi have beat the No­var­tis/Roche team to the punch on an­oth­er key in­di­ca­tion for their block­buster an­ti-in­flam­ma­to­ry drug Dupix­ent. The drug team scored an ac­cel­er­at­ed FDA ap­proval for chron­ic rhi­nos­i­nusi­tis with nasal polyps, mak­ing this the first such NDA for the field.

An­a­lysts have been watch­ing this race for awhile now, as Sanofi/Re­gen­eron won a snap pri­or­i­ty re­view for what is now their third dis­ease in­di­ca­tion for this treat­ment. And they’re not near­ly done, build­ing up hopes for a ma­jor fran­chise.