Dan­ish drug­mak­er Gen­mab A/S is off to the races with per­haps one of the biggest biotech pub­lic list­ings in decades, hav­ing reaped over $500 mil­lion on the Nas­daq, as it po­si­tions it­self as a bonafide play­er in an­ti­body-based can­cer ther­a­pies.

The com­pa­ny, which has long served as J&J’s $JNJ key part­ner on the block­buster mul­ti­ple myelo­ma ther­a­py Darza­lex, has as­sert­ed it has been look­ing to launch its own pro­pri­etary prod­uct — one it owns at least half of — by 2025.

There are at least five such prod­ucts — which Gen­mab has fond­ly chris­tened “knock-your-socks-off an­ti­bod­ies” — in­clud­ing an an­ti­body-drug con­ju­gate (ADC) called ti­so­tum­ab ve­dotin be­ing co-de­vel­oped with Seat­tle Ge­net­ics $SGEN, and an­oth­er ADC called enapotam­ab ve­dotin that the com­pa­ny ful­ly owns. Then there’s an an­ti­body tar­get­ing sol­id tu­mors called Hexa­Body-DR5/DR5 as well as a bis­pe­cif­ic an­ti­body en­gi­neered to fight B-cell ma­lig­nan­cies called Duo­Body-CD3xCD20 — which are al­so ful­ly owned by Gen­mab. Fi­nal­ly, there’s an­oth­er bis­pe­cif­ic an­ti­body — Duo­Body-PD-L1x4-1BB — whose de­vel­op­ment is split with BioN­Tech.

Apart from these, the Copen­hagen based com­pa­ny has a string of oth­er part­ners: Gilead $GILD, No­vo Nordisk $NVO, Am­gen $AMGN, Im­mat­ics and ADC Ther­a­peu­tics.

On Thurs­day, the Copen­hagen-based com­pa­ny said it gen­er­at­ed gross pro­ceeds of $505,875,000 by sell­ing 2,850,000 or­di­nary shares of Gen­mab in the form of 28.5 mil­lion Amer­i­can De­posi­tary Shares (ADSs) at a price of $17.75 per ADS. It is set to trade un­der the sym­bol “GMAB”.

Last week, the com­pa­ny had set out the po­ten­tial terms of its IPO: with a plan to sell 27.8 mil­lion shares at $18.11 per ADS, which would have trans­lat­ed to a mar­ket cap of a whop­ping $11.8 bil­lion.

Darza­lex, which raked in $90 mil­lion in mile­stone pay­ments and $262 mil­lion in roy­al­ties and ac­count­ed for near­ly 76% of Gen­mab’s 2018 rev­enue, cur­rent­ly is be­ing test­ed in mul­ti­ple tri­als in a bid to ex­pand its use. Mean­while, com­pe­ti­tion from Sanofi $SNY is loom­ing.

Mike Grey Linkedin

Gen­mab’s oth­er mar­ket­ed treat­ment Arz­er­ra — part­nered with No­var­tis $NVS — has not fared as well. Last year, the Swiss drug­mak­er record­ed net sales of $26 mil­lion — gen­er­at­ing rough­ly $5 mil­lion in roy­al­ties for Gen­mab. The drug has been cleared for use in chron­ic lym­pho­cyt­ic leukemia and is now be­ing stud­ied for mul­ti­ple scle­ro­sis.

There were an­oth­er cou­ple of small­er IPO pric­ings on Wednes­day.

Af­ter wrest­ing con­trol of two liv­er drugs from Shire and prim­ing them for piv­otal tri­als — Mirum Phar­ma­ceu­ti­cals’ Mike Grey has steered the Cal­i­for­nia biotech to a $75 mil­lion IPO. The two drugs — mar­al­ix­i­bat and volix­i­bat — cost Mirum $7.5 mil­lion up­front. Shire — now part of Take­da — had wa­gered $260 mil­lion on Lu­me­na (where Grey was once CEO) large­ly on the promise of these two as­sets, which both tar­get the api­cal sodi­um-de­pen­dent bile acid trans­porter, a pro­tein ex­pressed in the small in­tes­tine.

Bob Gould Ful­crum

The com­pa­ny — which has raised $120 mil­lion Se­ries A cash since launch­ing last No­vem­ber — has sold 5 mil­lion shares at $15/share — at the mid­point of its range of $14 to $16. It is set to trade on the Nas­daq on Thurs­day un­der the sym­bol “MIRM”.

While on the east coast, Ful­crum Ther­a­peu­tics has raised gross pro­ceeds of $72 mil­lion, by sell­ing 4.5 mil­lion shares at $16/share — the low­er end of its range of $16 to $18.

The Cam­bridge, Mass­a­chu­setts-based com­pa­ny — which raised $80 mil­lion in a Se­ries B round to shep­herd the first of its gene-reg­u­lat­ing small mol­e­cules in­to the clin­ic last Sep­tem­ber — is run by biotech vet­er­an Bob Gould who for­mer­ly served as Epizyme’s chief. The com­pa­ny is set to trade on Thurs­day un­der the sym­bol “FULC” on the Nas­daq.

So­cial im­age: Shut­ter­stock

Biotech is one of the smartest, best educated industries on the planet. PhDs abound. We’ve had a long enough track record to see a new generation of savvy, experienced execs coming together to run startups.

And in these times, they are being tested as never before.

Biotech is going through quite a rough patch right now. For 2 years, practically anyone with a decent resume and some half-baked ideas on biotech could start a company and get it funded. The pandemic made it easy in many ways to pull off an IPO, with traditional road shows shut down in exchange for a series of quick Zoom meetings. Generalist investors flocked as the numbers raised soared into the stratosphere.

It looks like Warren Buffett is sticking to ice cream and railroads for the moment.

The billionaire CEO of Berkshire Hathaway backed out of two major holdings in the pharma industry, Forexlive first reported, including a $410 million investment in AbbVie and a $324.4 million stake in Bristol Myers Squibb.

The move comes after Berkshire abandoned its Teva shares just last quarter, Bloomberg reported.

Nearly a year ago, more than 200 workers at Novartis’ Grimsby, UK, facility were able to hang on to their jobs after the pharma closed a Switzerland site as a part of its workforce restructuring plan. Now, it looks like those employees’ time is up, as the site has been sold, Grimsby Telegraph reported today.

The manufacturing site has been sold to Humber Industrials, a subsidiary of International Process Plants. None of the current staff members will be working with the new owners, however.

Usually reserved for making decisions on drug applications or enforcing what Congress stipulates, the FDA is now dipping its toe into the wild world of congressional politics as it attempts to fix a major court decision that could have a chilling effect on rare disease R&D.

The case in question from last October saw a US appeals court overturn a prior FDA court win, saying that the agency never should’ve approved a rare disease drug because a previously approved but more expensive drug with the same active ingredient has orphan drug exclusivity barring such an approval.

When bluebird bio’s gene therapy to treat beta thalassemia won European approval in 2019, the nearly $2 million per patient price tag for the potential cure seemed like a surmountable hurdle.

Fast forward two years later, and bluebird has withdrawn Zynteglo, the beta thal drug, along with the rest of its gene therapy portfolio from Europe, which the company said is generally unwilling to pay a fair price for the treatment.

New research published in Health Affairs today highlights the way in which the FDA’s inhaler regulations have rewarded incremental adjustments to older products, thereby enabling companies to skirt around cheaper competition.

A DC appeals court clerk and researchers from Harvard and the University of Calgary dug through all the patents and regulatory exclusivities granted to inhalers approved by the FDA between 1986 and 2020, finding that of the 62 inhalers approved, 53 (or 85%) were brand-name products, with a median of 16 years of protection from generic competition.