No­var­tis sends sec­ond wag­on af­ter KRAS gold rush

Join­ing the bar­rage of com­pa­nies dig­ging head­first in­to the new­ly opened KRAS mine, No­var­tis has an­nounced a mul­ti­year agree­ment with Sixth El­e­ment Cap­i­tal and the UK Beat­son In­sti­tute for Can­cer Re­search to de­vel­op small mol­e­cules iden­ti­fied by the in­sti­tute’s drug dis­cov­ery unit.

The deal, whose specifics have not been dis­closed, is the Swiss gi­ant’s sec­ond KRAS col­lab­o­ra­tion since June, when Am­gen elec­tri­fied the field by re­veal­ing the first pa­tient ef­fi­ca­cy da­ta from a ther­a­py aimed at one of the most per­va­sive, old­est and eva­sive can­cer mu­ta­tion tar­gets. In Ju­ly, No­var­tis inked a low-mon­ey deal with Mi­rati Ther­a­peu­tics.

That deal would see No­var­tis pair­ing its SHP2 in­hibitor with Mi­rati’s years-in-the-mak­ing KRAS G12C in­hibitor, act­ing on a pop­u­lar the­o­ry that com­bin­ing a KRAS in­hibitor with an­oth­er in­hibitor – and par­tic­u­lar­ly SHP2 – will af­fect the pro­tein’s cy­cles and make it an eas­i­er tar­get.  The idea earned Rev­o­lu­tion Med­i­cines $100 mil­lion in fund­ing on the same day.

This new col­lab­o­ra­tion will see No­var­tis dig its hands di­rect­ly in­to RAS in­hibitors as it works to turn the Beat­son’s mol­e­cules in­to ac­tion­able ther­a­pies. Sixth El­e­ment Cap­i­tal’s CRT Pi­o­neer Fund will re­ceive an up­front pay­ment to fund can­cer re­search at the Beat­son In­sti­tute, along with po­ten­tial mile­stones and sin­gle-dig­it roy­al­ties.

De­spite the re­cent tor­rent of cash and col­lab­o­ra­tions that have flood­ed the KRAS field, clin­i­cal ev­i­dence is still scant. Am­gen’s sec­ond up­date from tri­als on their in­hibitor, AMG510, at the end of Sep­tem­ber was far less promis­ing than their first roll­out on lung can­cer, with a sin­gle par­tial re­sponse out of 12 col­orec­tal can­cer pa­tients. The ini­tial lung can­cer group showed 7 out of 13 pa­tients re­spond­ed.

Am­gen on­col­o­gy head Greg Friberg, though, said at the time that was to a de­gree ex­pect­ed: Colon can­cer is bi­o­log­i­cal­ly more com­plex than lung can­cer and thus a hard­er tar­get.

We’ll know more Mon­day af­ter­noon, when Mi­rati un­veils the first look at their clin­i­cal tri­al. Af­ter 40 years of mol­e­c­u­lar and pre-clin­i­cal work, the tor­rent of clin­i­cal da­ta is just be­gin­ning.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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invoX Pharma CEO Ben Toogood (L) and F-star CEO Eliot Forster

F-star bought out in $161M all-cash deal as Hong Kong's Sino Bio­pharm looks to­ward in­ter­na­tion­al ex­pan­sion

After more than a decade and a half of charting its own course, F-star Therapeutics will now settle under a new umbrella company.

The UK biotech will be acquired by invoX Pharma, a subsidiary of Hong Kong’s Sino Biopharm, in a roughly $161 million all-cash deal, the companies announced Thursday morning. F-star’s buyout will value its shares $FSTX at $7.12 apiece, nearly an 80% premium above Wednesday’s closing price.

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De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

Kelly Martin, Radius Health CEO

VC firms take os­teo­poro­sis drug­mak­er Ra­dius Health pri­vate for al­most $900M

After attacks from activist investors and disappointing returns on share prices, Radius Health has now agreed to new ownership, a direction resulting in leaving the Nasdaq.

Radius Health, a biotech out of Massachusetts with one approved product in its arsenal, announced Thursday morning that it agreed to be acquired by two VC firms: Gurnet Point Capital and Patient Square Capital. The deal, worth around $890 million, will include debt assumption and the payout of $1 CVR per share for investors. And on top of that, OrbiMed is providing debt financing.

Sen. Thom Tillis (R-NC) (J. Scott Applewhite/AP Images)

Phar­ma-friend­ly sen­a­tor calls on FDA for a third time to show patent pro­tec­tions should­n't be blamed for high drug prices

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”

EMA signs off on 3 drugs re­cent­ly re­ject­ed by FDA, in­clud­ing Bio­Mar­in's new he­mo­phil­ia gene ther­a­py

The EMA’s human medicines committee on Friday recommended three new drugs for approval or conditional approval, even as their US counterparts have rejected these three for various reasons.

In a major move, CHMP offered a thumbs-up to a conditional marketing authorization for the first gene therapy to treat severe hemophilia A, although the agency cautioned that it’s so far unknown how long the effects of infusion will last.

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