As can­cer de­tec­tion com­pa­nies thrive, Ex­act Sci­ences looks to con­sol­i­date by spend­ing $2.8B to ac­quire peer Ge­nom­ic Health

As pre­dict­ed by Bloomberg, can­cer di­ag­nos­tics com­pa­ny Ex­act Sci­ences is buy­ing peer Ge­nom­ic Health in a $2.8 bil­lion cash-and-stock deal. 

Ex­act Sci­ences’ flag­ship col­orec­tal can­cer test Co­lo­guard will com­ple­ment Ge­nom­ic Health’s On­co­type DX, a test de­signed to help doc­tors de­ter­mine the best course of treat­ment for women with breast can­cer. To­geth­er the tests help in­form treat­ment de­ci­sions in col­orec­tal, breast and prostate can­cer, rep­re­sent­ing rough­ly 40% of all sol­id tu­mor in­ci­dence, the com­pa­nies said.

Last year, Ex­act Sci­ences en­list­ed Pfiz­er as a US mar­ket­ing part­ner to ex­pand Co­lo­guard adop­tion. The tie-up has ramped up the use of the test — in the sec­ond quar­ter of 2019, Co­lo­guard rev­enue grew 94% year-over-year.

“We re­main Out­per­form on EXAS with our view that Co­lo­guard is still high­ly un­der-pen­e­trat­ed in a pa­tient pop­u­la­tion man­age­ment pegs at 101M where EXAS could de­liv­er 40%+ pen­e­tra­tion or $6B+ in rev­enue longer-term, from just ~5% pen­e­tra­tion to­day,” Leerink an­a­lysts wrote in a note in May.

Ge­nom­ic Health re­port­ed a 19% year-over-year jump in sec­ond-quar­ter rev­enue and es­ti­mates its On­co­type DX suite of prod­ucts in on­col­o­gy and urol­o­gy have a to­tal avail­able mar­ket of $2 bil­lion.

Com­bined un­der one roof, the com­pa­nies are look­ing to take ad­van­tage of economies of scale, as ri­vals loom large. South San Fran­cis­co biotech Freenome raised $160 mil­lion last week to con­duct a piv­otal tri­al for its blood test for col­orec­tal can­cer. Mean­while, Il­lu­mi­na spin­off Grail has raised $1.5 bil­lion to work on a mul­ti-can­cer de­tec­tion test and Third Rock-backed Thrive has scored $110 to build its liq­uid biop­sy plat­form for ear­ly can­cer de­tec­tion.

Kevin Con­roy Ex­act Sci­ences

“To­geth­er, with our col­lec­tive re­sources and broad­er plat­form, we will be able to pro­vide our ex­ist­ing tests to more peo­ple, while al­so ac­cel­er­at­ing the de­vel­op­ment and launch of fu­ture can­cer di­ag­nos­tic tests,” Ex­act Sci­ences chief Kevin Con­roy said in a state­ment on Mon­day. 

“Though we be­lieve the pipeline ben­e­fits, po­ten­tial for kit­ted prod­ucts, ex­pan­sion in­to in­ter­na­tion­al mar­kets…and ex­pe­ri­ence with FDA are win­ning as­pects of the deal; EXAS is like­ly to get more in­vestor ques­tions on the near-mid term strate­gic ra­tio­nale and $25M in 3rd year syn­er­gies,” Leerink an­a­lysts wrote in a note.

On Sat­ur­day, Bloomberg re­port­ed the deal was in­com­ing, cit­ing peo­ple fa­mil­iar with the mat­ter.

Ex­act Sci­ences shares $EXAS closed up about 1.6% on Fri­day at $117.92, while Ge­nom­ic Health’s stock $GHDX closed up 5.5% at $68.66.

Un­der the deal, which is ex­pect­ed to close at the end of the year, Ge­nom­ic Health stock­hold­ers will re­ceive $27.50 in cash and $44.50 in shares of Ex­act Sci­ences stock. If con­sum­mat­ed, Ex­act Sci­ences share­hold­ers are set to own about 91% of the com­bined com­pa­ny, while Ge­nom­ic Health stock­hold­ers will be left with the rest. Next year, the com­bined en­ti­ty ex­pects to gen­er­ate rev­enue of ap­prox­i­mate­ly $1.6 bil­lion and a gross prof­it of ap­prox­i­mate­ly $1.2 bil­lion. 

So­cial im­age: Ex­act Sci­ences

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His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

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Alessandro Maselli, Catalent CEO

Catal­ent ac­quires North Car­oli­na CD­MO for $475M, boost­ing oral solids work

As Catalent has been expanding its reach in the US this year, as well as recently completing a C-suite shuffle, the company announced last night that it has acquired the CDMO Metrics Contract Services for $475 million from Mayne Pharma Group.

The acquisition will increase Catalent’s capabilities in oral solid formulation development, manufacturing and packaging as well as expand its capacity to handle more highly potent compounds.

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House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.