Don't let a slump in bio­phar­ma deals get you down — yet; The con­tro­ver­sy on drug prices is tak­ing a toll

End­points as­sess­es the big bio­phar­ma sto­ries of the week, with a lit­tle added com­men­tary on what they mean for the in­dus­try.


Hey, what about that big up­swing pre­dict­ed for bio­phar­ma M&A?

Deal­mak­ers in bio­phar­ma are end­ing April with a con­sid­er­able amount of grum­bling. This was the year that M&A was sup­posed to take off, with a new pres­i­dent bull­ish­ly as­sert­ing plans to re­form tax­es in a way that would free up bil­lions in Big Phar­ma cash held over­seas.

Didn’t hap­pen. Don­ald Trump is so far bogged down on Oba­macare re­form and not able to de­liv­er a much bal­ly­hooed tax re­form pledge — for now.

“Most peo­ple would say they are dis­ap­point­ed with the pace of M&A,” Ge­of­frey Hsu, a part­ner at the deal-ori­ent­ed Or­biMed Ad­vi­sors, told Bloomberg. “Frankly, we were ex­pect­ing more to hap­pen by this time.”

The newswire ser­vice con­clud­ed that Q1 deals were down 13% cash-wise, com­pared to the same pe­ri­od a year ago.

True, deal­mak­ers are hard to please. It’s a feast or famine world in M&A, and lean pick­ings cause a lot of dis­sat­is­fac­tion.

The year, though, is a long way from over. Don’t let a Q1 re­port make you too un­hap­py. Con­cerned, yes. Un­hap­py, no.



Drug­mak­ers face a turn­ing point on pric­ing — putting the fo­cus where it be­longs

An­oth­er big trend that is draw­ing con­sid­er­able at­ten­tion these days is the im­mense pres­sure be­ing put on drug mak­ers to rein in prices. Pay­ers in the US are get­ting bet­ter at ap­ply­ing pres­sure right on the most sen­si­tive parts of the in­dus­try, and Pres­i­dent Trump start­ed his ad­min­is­tra­tion stomp­ing on the in­dus­try’s rep for stick­er shock.

Cred­it Su­isse put its thumb right on the pulse, though, with a new re­port this week show­ing just how im­por­tant an­nu­al price hikes are to the big play­ers. Their an­a­lysts con­clude:

Ar­guably, this is the most im­por­tant is­sue for a Phar­ma in­vestor to­day. De­spite pub­lic scruti­ny, we es­ti­mate US net price ris­es con­tributed c$8.7bn in 2016 to net in­come, 100% of sec­tor EPS growth. US net price growth was >100% of Bio­gen, Lil­ly, and Ab­b­Vie’s to­tal net in­come growth. Bio­Marin, Gilead, No­vo and Re­gen­eron were the least re­liant on US net price ris­es.

In this brave new world, on­ly the in­no­v­a­tive can thrive. And that means more part­ner­ing with biotech — the true source of in­no­va­tion in the drug world. I sus­pect we’ll see a grow­ing scram­ble for the best ex­per­i­men­tal drugs lat­er in the year. And that means val­u­a­tions should con­tin­ue to point north.


A con­tro­ver­sial Marathon is mar­gin­al­ized

We just learned that Marathon has been es­sen­tial­ly forced out at PhRMA, fol­low­ing a res­ig­na­tion by Mallinck­rodt — an­oth­er de­vel­op­er that has been dogged by a drug pric­ing scan­dal.

Ku­dos to PhRMA, which has been mak­ing life more un­com­fort­able for the com­pa­nies that set the pace for Mar­tin Shkre­li. Far too many com­pa­nies have found it easy to get cheap drugs and jack up the price by as­tro­nom­i­cal amounts.

In this new bio­phar­ma world we’re liv­ing in, that kind of con­duct won’t fly. You can’t be in the club now un­less you’re dead se­ri­ous about in­vest­ing in im­por­tant new ther­a­pies. That’s not enough, but it is a healthy start. And PTC Ther­a­peu­tics may want to think over their strat­e­gy one more time.


You have a pho­to op com­ing up Sat­ur­day morn­ing. Don’t miss it.

To­mor­row Mass­Bio and some of the top lead­ers of the Boston area biotech sec­tor want to cre­ate a mo­ment for every­one to reg­is­ter their op­po­si­tion to some of the re­cent moves from Pres­i­dent Trump on im­mi­gra­tion, H1B visas and NIH fund­ing.

It has come to no sur­prise to me that the vast ma­jor­i­ty of the in­dus­try hates what it’s been see­ing over the last few months. Biotech thrives when it can re­cruit the best and the bright­est from all over the world, and the US is home to the most dy­nam­ic drug de­vel­op­ment sec­tor in the world be­cause of it.

NIH fund­ing, mean­while, cre­ates the sci­en­tif­ic foun­da­tion that bio­phar­ma rests on. Cut­ting fund­ing sig­nif­i­cant­ly now would mean lay­ing waste to a gen­er­a­tion of young sci­en­tists look­ing to make their mark.

So at 10am on Sat­ur­day every­one is be­ing asked to give up some of their free time and join the crowd on Kendall Square for an aer­i­al shot to cap­ture a pic­ture of the in­dus­try’s sol­i­dar­i­ty on this is­sue. Too bad it’s not a week­day, when most peo­ple would on­ly have to walk over from their of­fices. But that might have stopped traf­fic.

A gen­er­al view of the bronze and glass pub­lic art sculp­ture “Nerve Cen­ter” by artist Chris Williams in Kendall Square on Ju­ly 1, 2016 in Cam­bridge, Mass­a­chu­setts. Pho­to by Paul Marot­ta/Get­ty Im­ages

 

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.

Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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Re­searchers move clos­er to de­ci­pher­ing blood clots from As­traZeneca, J&J's Covid-19 vac­cines

Researchers may be nearing an answer for the mysterious and life-threatening blood clots that appeared on very rare occasions in people who received the J&J or AstraZeneca Covid-19 vaccine.

The new work builds on an early hypothesis researchers in Norway put forward last spring, when the cases first cropped up. They proposed the events were similar to blood clots that can occur in a small subset of patients who receive heparin, one of the most commonly used blood thinners.

Janet Woodcock (AP Images)

Janet Wood­cock plots her fu­ture at FDA, with se­nior ad­vi­sor role to fall back on if Califf wins con­fir­ma­tion

Acting FDA commissioner Janet Woodcock has been the face of just about every drug approval decision at the agency since the turn of the century. Since the pandemic began, she’s moved between the top of the drugs center to the head of therapeutics at Operation Warp Speed, leading the drive for work on Covid-targeted mAbs and antivirals.

Looking forward — and pending a quick Senate confirmation to cement Rob Califf’s return to the top of FDA early next year — Woodcock’s role at the agency will again be in flux.

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