Mike Bloomberg (AP IMAGES)

Mike Bloomberg joins a grow­ing cho­rus of De­mo­c­ra­t­ic pres­i­den­tial can­di­dates threat­en­ing to go af­ter drug patents

As the may­or of New York City, Mike Bloomberg had a few mod­est ideas about low­er­ing pre­scrip­tion drug prices in the Big Ap­ple that gained lit­tle trac­tion. Now on the cam­paign trail on a faint hope of clinch­ing the De­mo­c­ra­t­ic pres­i­den­tial nom­i­na­tion, the bil­lion­aire has some big­ger plans — in­clud­ing one that would al­ter the patent sys­tem cen­tral to the bio­phar­ma busi­ness.

In a bare­bones drug pric­ing plan post­ed on Mon­day, Bloomberg came out blast­ing Pres­i­dent Don­ald Trump for fail­ing to de­liv­er his promise to low­er drug prices, and then mak­ing mis­lead­ing claims about them. The price of over 3,000 drugs still in­creased at a rate five times high­er than in­fla­tion in the first six months of 2019, he wrote.

So how will he fix it? Bloomberg lists a few wide­ly dis­cussed pol­i­cy pro­pos­als, in­clud­ing au­tho­riz­ing Medicare to ne­go­ti­ate drug prices (a key goal of Nan­cy Pelosi’s re­cent­ly passed House bill), al­low­ing Amer­i­cans to buy med­i­cine from oth­er coun­tries (some­thing the HHS has re­leased a plan on), and cap­ping out-of-pock­et costs for Medicare ben­e­fi­cia­ries.

He al­so pledged to elim­i­nate “pay­offs” — pre­sum­ably the arrange­ment com­mon­ly known as re­bates — from drug­mak­ers to phar­ma­cy ben­e­fit man­agers. The White House had set out to do the same but changed course to kill re­bate re­form back in Ju­ly.

But Bloomberg’s most eye-catch­ing pro­pos­al is this: “Bring gener­ic drugs to the mar­ket faster by lim­it­ing brand-name drug mak­ers to one patent that lasts 20 years.”

Ac­cel­er­at­ing the speed of gener­ics ap­proval had been a key goal for for­mer FDA Com­mis­sion­er Scott Got­tlieb, who called out brand­ed drug­mak­ers for “shenani­gans” to de­lay gener­ic drug com­pe­ti­tion. Dur­ing his tenure, Got­tlieb al­so im­ple­ment­ed new poli­cies aimed at bar­ring phar­ma from ex­ploit­ing REMS re­quire­ments for their ben­e­fit.

But chang­ing patent and IP laws could be a dras­tic ex­pan­sion of that ef­fort. Ab­b­Vie has re­port­ed­ly se­cured more than 100 patents to pro­tect Hu­mi­ra, the best-sell­ing drug on the plan­et and a multi­bil­lion-dol­lar fran­chise.

While the 20-year term is in line with cur­rent lim­its, Bloomberg al­so didn’t spec­i­fy if his so­lu­tion would al­low for patent ex­ten­sions (max­i­mum 5 years) un­der the Hatch-Wax­man Act.

The oth­er part of Bloomberg’s re­form would have drug com­pa­nies pay roy­al­ties to the NIH if they use NIH IP and turn it in­to a com­mer­cial prod­uct — which can be con­tro­ver­sial as il­lus­trat­ed in Gilead’s re­cent dis­putes with the HHS over HIV patents. Bloomberg stopped short of spelling out the con­se­quences for any phar­ma play­ers who don’t com­ply with his poli­cies. Sen­a­tors Eliz­a­beth War­ren and Bernie Sanders — who are polling ahead of Bloomberg — have both sug­gest­ed that they would seize or break drug patents over what they view as egre­gious pric­ing.

Patrick Soon-Shiong at the JP Morgan Healthcare Conference, Jan. 13, 2020 (David Paul Morris/Bloomberg via Getty Images)

Af­ter falling be­hind the lead­ers, dissed by some ex­perts, biotech show­man Patrick Soon-Sh­iong fi­nal­ly gets his Covid-19 vac­cine ready for a tri­al. But can it live up to the hype?

In January, when dozens of scientists rushed to start making a vaccine for the then-novel coronavirus, they were joined by an unlikely compatriot: Patrick Soon-Shiong, the billionaire doctor most famous for making big, controversial promises on cancer research.

Soon-Shiong had spent the last 4 years on his “Cancer Moonshot,” but part of his project meant buying a small Seattle biotech that specialized in making common-cold vectors, called adenoviruses, to train the immune system. The billionaire had been using those vectors for oncology, but the company had also developed vaccine candidates for H1N1, Lassa fever and other viruses. When the outbreak began, he pivoted.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,700+ biopharma pros reading Endpoints daily — and it's free.

Eli Lilly CEO David Ricks at the Rose Garden, May 26, 2020 (Evan Vucci/AP Images)

Eli Lil­ly lines up a block­buster deal for Covid-19 an­ti­body, right af­ter it failed a NI­AID tri­al

Two days after Eli Lilly conceded that its antibody bamlanivimab was a flop in hospitalized patients, the US government is preparing to make it a blockbuster.

The pharma giant reported early Wednesday that it struck a deal to supply the feds with 300,000 vials of the drug at a cost of $375 million — once it gets an EUA stamp from the FDA. And once that 2-month supply deal is done, the government has an option on another 650,000 doses on the same terms — which could potentially add another $800 million.

Jude Samulski, Marianne De Backer

Bay­er buys a biotech ‘race horse’ with a $4B deal — $2B in cash — aimed at go­ing big in­to gene ther­a­py

In the latest sign that Big Pharma wants a leading place in the push to develop a new generation of cell and gene therapies, Bayer is stepping up today with a $2 billion cash deal to buy out one of the fast-moving pioneers in the field, while adding up to $2 billion more in milestones if the new pharma subsidiary can deliver the goods.

As part of a continuing series of deals engineered by Bayer BD chief Marianne De Backer, the pharma player has snapped up Asklepios, more commonly referred to in more casual fashion as AskBio. And they are paying top dollar for a Research Triangle Park-based company that raised $225 million a little more than a year ago to back the brainchild of Jude Samulski, the gene therapy pioneer out of the University of North Carolina Gene Therapy Center.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,700+ biopharma pros reading Endpoints daily — and it's free.

En­her­tu picks up an­oth­er win for As­traZeneca and Dai­ichi Sankyo, join­ing the pri­or­i­ty re­view lane for gas­tric can­cer

Five months after Enhertu received twin breakthrough therapy designations, AstraZeneca and Daiichi Sankyo are one step closer to nabbing another approval for their potential blockbuster drug.

The companies announced Wednesday morning that their billion-dollar antibody-drug conjugate has received priority review for HER2 positive metastatic gastric cancer. Already approved in the US for third-line metastatic breast cancer patients that are HER2 positive, Enhertu’s gastric cancer PDUFA date is scheduled for the first quarter of 2021.

Sci­en­tists warn Amer­i­cans are ex­pect­ing too much from a coro­n­avirus vac­cine

The White House and many Americans have pinned their hopes for defeating the Covid-19 pandemic on a vaccine being developed at “warp speed.” But some scientific experts warn they’re all expecting too much, too soon.

“Everyone thinks COVID-19 will go away with a vaccine,” said William Haseltine, chair and president of Access Health International, a foundation that advocates for affordable care.

Christian Rommel (via Roche)

Bay­er fol­lows R&D deal spree by raid­ing Roche's can­cer group for its new re­search chief

The day after Bayer signed off on a $4 billion deal designed to put the company among the leaders in gene therapy development, the pharma giant has recruited a new chief for its R&D division. And they opted for an expert in the cancer field.

Christian Rommel, Roche’s head of discovery and early-stage oncology development, has been tapped to take over the job. Joerg Moeller, who got the top research post after early- and late-stage development roles were combined 2 years ago, is hitting the exit “to pursue other career opportunities.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,700+ biopharma pros reading Endpoints daily — and it's free.

No­var­tis CEO Vas Narasimhan signs off on a $231M deal to try some­thing new in the R&D fight against SARS-CoV-2

Patrick Amstutz was baptized by pandemic fire early on.

He and colleagues attended the notorious Cowen conference in early March that included some of the top Biogen execs who helped trigger a superspreader event in Boston. Heading back to his post as CEO of Molecular Partners in Switzerland, the outbreak was sweeping through Italy, triggering near panic in some quarters and creeping into the voices of people he knew, including one friend on the Italian side of the country.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,700+ biopharma pros reading Endpoints daily — and it's free.

Cedric Francois, Apellis CEO (Optum via YouTube)

UP­DAT­ED: So­bi bets $250M cash, about $1B in mile­stones for rights to a C3 ther­a­py be­ing pushed through 5 piv­otal tri­als

A couple years after licensing Novimmune’s emapalumab and turning around a quick FDA OK, Stockholm-based Sobi is betting up to $1.2 billion for rights to another rare disease drug.

The company is shelling out $250 million upfront and adding up to $915 million in milestones for rights to develop and commercialize Apellis Pharmaceuticals’ drug pegcetacoplan outside the US. Together, the companies will see the systemic C3 therapy through five registrational trials in hematology, nephrology and neurology.

Once re­ject­ed, Kala's dry eye drug now gains en­try to a field where No­var­tis is groom­ing its own block­buster

When the FDA slapped a rejection on Kala Pharma’s dry eye drug last August, the biotech’s execs promised investors that a third Phase III study — they had already started at that point — would reverse their fortune.

Today they made good on that promise, clinching an approval for Eysuvis, an ocular corticosteroid being positioned as a first-line, short term treatment of dry eye disease.

Boasting a technology invented by Bob Langer out of MIT, Eysuvis is a corticosteroid, loteprednol etabonate, delivered by mucus-penetrating particles. It promises to enhance penetration into target tissue on the ocular surface, achieving an effect quicker than systemic corticosteroids and stronger than over-the-counter eye drops.