Robert Bazemore (Epizyme)

UP­DAT­ED: Robert Baze­more inks one last deal for Epizyme — adding Chi­na to Tazverik's glob­al blue­print — be­fore head­ing out from CEO of­fice

Among the ear­ly pi­o­neers of Chi­na biotech, Hutchmed (then Chi-Med) stood out for a rea­son: It large­ly stayed out of in-li­cens­ing drugs from West­ern drug­mak­ers, choos­ing in­stead to hun­ker down on de­vel­op­ing its own com­pounds — notch­ing big part­ners in As­traZeneca and Eli Lil­ly for savoli­tinib and fruquin­tinib, both on the mar­ket now, along the way.

As its peers be­gin herald­ing in-house dis­cov­ery to com­ple­ment the ex­ter­nal­ly-sourced parts of the pipeline, though, Hutchmed is once again go­ing in the op­po­site di­rec­tion.

Hutchmed is team­ing up with Epizyme — which will be un­der­go­ing some changes at the top — to de­vel­op Tazverik, the US biotech’s methyl­trans­ferase in­hibitor of EZH2, pay­ing $25 mil­lion up­front to take the lead for de­vel­op­ment and com­mer­cial­iza­tion in Chi­na.

Ap­proved in the US for cer­tain sub­types of ep­ithe­lioid sar­co­ma and fol­lic­u­lar lym­phoma, Tazverik works through an epi­ge­net­ic mech­a­nism — con­trol­ling the ex­pres­sion of cer­tain genes — and was de­signed for niche, un­reached cor­ners of the vast can­cer space. Hutchmed and Epizyme are eye­ing as many as eight po­ten­tial in­di­ca­tions in Chi­na; if they all go well, de­vel­op­ment and reg­u­la­to­ry mile­stones will add up to $110 mil­lion.

An­oth­er $175 mil­lion is re­served for sales mile­stones.

Epizyme CEO Robert Baze­more called Hutchmed an “ide­al part­ner” to de­vise and ex­e­cute new clin­i­cal tri­als in Chi­na that will then feed in­to its big­ger plans.

“Through this col­lab­o­ra­tion we an­tic­i­pate Tazverik to be­come the first EZH2 in­hibitor brought to mar­ket in Greater Chi­na,” he said in a state­ment, “and we be­lieve the in­volve­ment of Hutchmed in the glob­al de­vel­op­ment of Tazverik can al­low for a more rapid, re­source-ef­fi­cient, and ge­o­graph­i­cal­ly in­clu­sive de­vel­op­ment plan for the U.S. con­fir­ma­to­ry EZH-302 tri­al of Tazverik in sec­ond line fol­lic­u­lar lym­phoma (2L FL) in com­bi­na­tion with Revlim­id plus rit­ux­imab (‘R²’).”

He won’t be the one over­see­ing that plan, though. Hours af­ter an­nounc­ing the deal, Epizyme re­vealed that Baze­more is step­ping down. Af­ter steer­ing Tazverik to two US ap­provals, com­plet­ing the next five-year growth strat­e­gy and now en­gi­neer­ing a ma­jor deal, he be­lieves it’s time for Grant Bogle, a board di­rec­tor and for­mer ex­ec of Tesaro, to take the lead at an in­creas­ing­ly com­mer­cial­ly ori­ent­ed com­pa­ny while Baze­more can “redi­rect his time and en­er­gy to­ward oth­er ar­eas of his life that have be­come a pri­or­i­ty for him, per­son­al­ly.”

Mean­while, Chris­t­ian Hogg, Hutchmed’s chief ex­ec­u­tive, point­ed to the po­ten­tial for com­bi­na­tion ther­a­py with the can­cer drugs in its port­fo­lio.

Hutchmed’s pric­ing strat­e­gy for Tazverik will al­so serve as an in­ter­est­ing in­di­ca­tor of Chi­na’s open­ness to ex­pen­sive rare dis­ease drugs — con­sid­er­ing its price tag of $186,000. Drug­mak­ers typ­i­cal­ly have to dis­count their way in­to the Na­tion­al Re­im­burse­ment Drug List, bet­ting that they could earn more by tap­ping a much larg­er vol­ume.

Ed­i­tor’s Note: This sto­ry has been up­dat­ed to re­flect Robert Baze­more’s up­com­ing de­par­ture.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

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FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

Franz-Werner Haas, CureVac CEO (Christoph Schmidt/picture-alliance/dpa/AP Images)

Tak­ing an­oth­er shot at mR­NA glo­ry, Cure­Vac inks on­col­o­gy pact while keep­ing up with Covid work

CureVac may have lost out on the initial mRNA race to bring a Covid-19 vaccine to the market, but it’s still eager to prove that it has what it takes to be a serious player in the field.

As it updates investors on its second-generation vaccine candidates for infectious diseases in Q1 results, the German biotech says it’s beefing up its oncology pipeline.

To that end, it has struck a new collaboration with Belgium’s myNEO, which boasts of a neoantigen discovery and selection platform, to identify new targets for mRNA immunotherapies.

Robert Califf (Michael Brochstein/Sipa USA via AP Images)

House Re­pub­li­cans at­tack Chi­na-on­ly da­ta in FDA sub­mis­sions, seek new in­ves­ti­ga­tion in­to re­search in­spec­tions

Three Republican representatives are calling on the FDA to take a closer look at the applications including only clinical data from China.

The letter to FDA commissioner Rob Califf late last week comes as the agency recently rejected Eli Lilly’s anti-PD-1 antibody, which attempted to bring China-only data but ran into a bruising adcomm that may crush the hopes of any other companies looking to bring cheaper follow-ons based only on Chinese data.

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Pfizer CEO Albert Bourla at the World Economic Forum (Gian Ehrenzeller/Keystone via AP Images)

All about ac­cess: Pfiz­er moves to a non-prof­it mod­el for drug sales in 45 low­er-in­come coun­tries

Leading the way to increase access to cheaper drugs worldwide, Pfizer said Wednesday it will provide all current and future patent-protected medicines and vaccines available in the US or EU on a not-for-profit basis to about 1.2 billion people in 45 lower-income countries.

Rwanda, Ghana, Malawi, Senegal and Uganda are the first five countries to sign on to this accord, which will also seek to blaze new paths for quick and efficient regulatory and procurement processes to reduce the usual delays in making new medicines and vaccines available in these countries.

Almirall is tapping artificial intelligence on behalf of its sales force for insights and efficiencies. (via Shutterstock)

Almi­rall rolls out sales rep ar­ti­fi­cial in­tel­li­gence sys­tem, cut­ting pre-call prep and 'wind­shield time'

Dermatology specialty pharma Almirall is making its sales reps smarter. Not with extra training or educational courses, but instead with artificial intelligence tools.

It began a soft launch of a sales rep AI and machine learning platform it calls Polaris last August in one of its 7 US coverage regions. The platform from Aktana gathers information from across Almirall internal sources and external ones – such as claims and prescribing data – to generate insights for reps. Now, instead of spending hours prepping for a sales call, Polaris can generate details about a physician’s preferences, past behaviors and prescription habits for reps in minutes, said Almirall head of commercial operations Vincent Cerio.

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