Roche cracks Chi­na's ADC mar­ket open as Kad­cy­la scores its first breast can­cer OK in the coun­try

Roche’s Kad­cy­la has be­come the first an­ti­body-drug con­ju­gate to en­ter the Chi­nese mar­ket, mark­ing a dra­mat­ic ad­vance for both the Swiss phar­ma gi­ant and the ther­a­peu­tic class.

The lo­cal arm of Roche an­nounced the ap­proval late Tues­day, which cov­ers the ther­a­py’s use in the ad­ju­vant set­ting in pa­tients with ear­ly HER-2 pos­i­tive breast can­cer who still have resid­ual in­va­sive dis­ease af­ter re­ceiv­ing pa­cli­tax­el and Her­ceptin as neoad­ju­vant treat­ment.

That’s the same in­di­ca­tion Roche scored in Kad­cy­la’s ex­pand­ed la­bel at the FDA re­cent­ly. Since the ther­a­py was first in­tro­duced in the US, it has steadi­ly racked up block­buster sales around the world, sur­pass­ing $1 bil­lion in the first nine months of 2019.

As with the oth­er reg­u­la­tors, Chi­na’s Na­tion­al Med­ical Prod­uct Ad­min­is­tra­tion based their OK on the KATHER­INE study, Roche said, which showed that Kad­cy­la re­duced the risk of in­va­sive breast can­cer re­cur­rence or death from any cause — a met­ric known as iDFS — by 50% (p<0.0001) com­pared to Her­ceptin. At three years, 88.3% of pa­tients treat­ed with Kad­cy­la did not see their breast can­cer re­turn (by com­par­i­son, 77% of those on Her­ceptin didn’t).

“In May 2019, Kad­cy­la was ap­proved as an ad­ju­vant treat­ment for ear­ly HER-2 pos­i­tive breast can­cer, and in De­cem­ber it was ap­proved by the EU,” Hong Zhou, Roche’s head of Chi­na, not­ed in a state­ment. “Thanks to Chi­na’s ever in­creas­ing speed in new drug re­view and ap­proval, Kad­cy­la’s ap­proval time­line in Chi­na was ba­si­cal­ly aligned with the US and Eu­rope.”

In the past decade, Chi­na has risen from Roche’s 10th largest mar­ket to its sec­ond just be­hind the US, Reuters not­ed.

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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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.

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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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.

Albert Bourla, AP

UP­DAT­ED: Where's the Pfiz­er ef­fi­ca­cy read­out? CEO Bourla says 'soon,' but you're go­ing to have to wait for it

Pfizer CEO Albert Bourla had promised repeatedly that the pharma giant would know if its leading Covid-19 vaccine is effective by the end of this month — now just a few days away.

Instead, the company reported early Tuesday that it has yet to conduct any interim efficacy analyses. And it won’t now until sometime next month.

The news was included in a slide for their Q3 report.

In the morning Q3 call with analysts, Bourla says that they expect efficacy data “soon,” but noted that they wouldn’t be able to say anything until all the administrative work was done on the interim, which would take about a week. And he added that Pfizer isn’t going to say anything else about that hot topic until they have the data in hand.

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UP­DAT­ED: The dis­rup­tors at EQRx have their eyes on the PD-(L)1 mar­ket — tee­ing up $150M cash to grab 2 back­bone ther­a­pies from Chi­na

EQRx is paying top dollar to bring a pair of PD-(L)1 drugs into its portfolio of fast-follow therapies, offering $150 million upfront in what could shape up to be a $1.3 billion alliance with China’s CStone.

As early as 2017 Celgene had bet on a made-in-China PD-1 via its pact with BeiGene, quickly followed by Arcus as the second checkpoint wave was looming; more recently Eli Lilly imported longtime partner Innovent’s PD-1 in a $1 billion deal. All are diving into a space now dominated by Merck’s Keytruda franchise, where six other players are trying to catch up by carving out their own niches — and more are on their way to tap into the various I/O pairings anchored by a PD-(L)1. But none so far has quite shared EQRx’s explicit mission to disrupt the multibillion-dollar market by offering a lower cost option.

Charles Baum, Mirati CEO

UP­DAT­ED: Mi­rati plots a march to the FDA for its KRAS G12C drug, breath­ing down Am­gen’s neck with bet­ter da­ta

Mirati Therapeutics $MRTX took another closely-watched step toward a now clearly defined goal to file for an approval for its KRAS G12C cancer drug adagrasib (MRTX849), scoring a higher response rate than the last readout from the class-leading rival at Amgen but still leaving open a raft of important questions about its future.

Following a snapshot of the first handful of responses, where the drug scored a tumor response in 3 of 5 patients with non-small cell lung cancer, the response rate has now slid to 45% among a pooled group of 51 early-stage and Phase II patients, 43% — 6 of 14 — when looking solely at the Phase I/Ib. Those 14 patients had a median treatment duration of 8.2 months, with half still on therapy and 5 of 6 responders still in response.

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Yung Chyung, Scholar Rock CMO (Business Wire)

A dark horse en­trant in­to the spinal mus­cu­lar at­ro­phy field dou­bles its val­ue on some PhII da­ta

The last four years have seen a sudden explosion in treatments for spinal muscular atrophy, a neurodegenerative condition that once led patients — often young ones — with a grim prognosis and no options. The prognosis still isn’t rosy, but now there are three FDA-approved options, enough to make the choice of one difficult.

Now a fourth potential option has entered the mix. Today, Scholar Rock announced the results from a proof-of-concept testing their SMA drug by itself and in combination with Ionis’ Spinraza, showing that all patient cohorts improved on standard scales used for measuring motor function in people with SMA.