Roche lines up at the FDA's 10-yard line with $1.7B Igny­ta buy­out

Can­cer drug pow­er­house Roche $RHH­BY has swooped in to buy Igny­ta $RXDX for $1.7 bil­lion, putting the phar­ma gi­ant in di­rect com­pe­ti­tion with Loxo On­col­o­gy $LOXO and its new part­ners at Bay­er.

Igny­ta has been grab­bing the at­ten­tion of a boom­ing field with its work in ROS1 and NTRK fu­sion-pos­i­tive tu­mors, win­ning the FDA’s break­through sta­tus last May. And it’s en­gaged in a piv­otal Phase II study for its lead drug en­trec­tinib that could put Roche on the 10 yard line at the FDA.

Roche is pay­ing a 74% pre­mi­um for the stock. And the Igny­ta team will stay in its San Diego head­quar­ters for now as it looks for a near term FDA ap­proval.

Roche CEO Sev­erin Schwan has been a re­luc­tant play­er in the M&A game, but the multi­na­tion­al com­pa­ny can eas­i­ly af­ford a buy­out like this. Biotech val­u­a­tions over­all have spiked in the last few years, but on­col­o­gy — with its short path to ap­provals and po­ten­tial to nab valu­able mar­ket nich­es — has seen some of the biggest up­side.

Jonathan Lim

Igny­ta and Loxo have both dis­tin­guished them­selves by tak­ing a tu­mor-ag­nos­tic ap­proach to can­cer drug de­vel­op­ment, fo­cus­ing on a spe­cif­ic ge­net­ic mu­ta­tion that dri­ves can­cer. In the lat­est up­date, in­ves­ti­ga­tors for the com­pa­ny say that their drug en­trec­tinib — which tar­gets ROS1 fu­sion genes that dri­ve a thin slice of all NSCLC cas­es — achieved a 69% over­all re­sponse rate for lung can­cer con­firmed by in­de­pen­dent ob­servers. And the me­di­an pro­gres­sion-free sur­vival rate in the sin­gle arm study was 29.6 months.

Sig­nif­i­cant­ly, 5 of the 6 pa­tients who had mea­sur­able brain metas­tases demon­strat­ed a re­sponse to the drug — some­thing the cur­rent ROS1-pos­i­tive stan­dard of care Xalko­ri can’t do. And brain metas­tases are a ma­jor threat in lung can­cer cas­es, of­fer­ing a new av­enue to blunt dis­ease pro­gres­sion and im­prove dura­bil­i­ty in re­spons­es.

Said Igny­ta CEO Jonathan Lim:

Igny­ta has been sin­gu­lar­ly fo­cused on de­vel­op­ing pre­cise­ly tar­get­ed ther­a­peu­tics guid­ed by di­ag­nos­tics for pa­tients with rare can­cers. We are ex­cit­ed that Roche, the glob­al leader in both on­col­o­gy and per­son­alised health­care, recog­nis­es this pow­er­ful ap­proach and shares our pas­sion for ad­vanc­ing en­trec­tinib for the ben­e­fit of pa­tients.

Roche CEO Sev­erin Schwan Bloomberg via Get­ty


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 $812 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.

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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.

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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.

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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.

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.

Kevin Conroy (Exact Sciences)

UP­DAT­ED: A month af­ter Il­lu­mi­na's big Grail buy­out, Ex­act Sci­ences scoops up liq­uid biop­sy ri­val Thrive for a rel­a­tive bar­gain

Illumina is going to have a lot of work to do to prove Grail was worth those $8 billion.

Today, Exact Sciences announced that it will acquire Thrive, Grail’s chief rival among the early cancer detection startups, for a sizeable but relatively moderate $2.15 billion. The yawning gap in part reflects the vast differences in capital that have been invested to date in each company.  But both have gone toe-to-toe over the last year and a half, with Grail having published data in over 50 cancers but Thrive recently beating them to a key test for liquid biopsy companies.

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.”

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