Big day loom­ing, No­var­tis' new CEO Vas Narasimhan read­ies his jump in­to a mar­ket­ing melee

Joe Jimenez
Bioreg­num
The view from John Car­roll

Next week, No­var­tis CEO Joe Jimenez will of­fi­cial­ly hand over the reins to Vas Narasimhan, a top ex­ec­u­tive at the multi­na­tion­al com­pa­ny that has scored some stand­out ap­provals dur­ing his two-year stretch run­ning the D side of R&D. And much of his near-term grades on the big test to come will sit square­ly on the fate await­ing his top picks for Phase III de­vel­op­ment projects.

To­day, No­var­tis gen­er­al­ly sat­is­fied an­a­lysts with a Q4 record that in­di­cat­ed its big woes with Gleevec copy­cats are be­ing man­aged as a set of new drugs — par­tic­u­lar­ly Cosen­tyx , Kisqali and En­tresto — gains mar­ket trac­tion as their pi­o­neer­ing CAR-T Kym­ri­ah be­gins to get es­tab­lished. That’s al­lowed the com­pa­ny to look for­ward to some mod­est growth again, trig­ger­ing a sharp 4% spike in the stock price Wednes­day morn­ing.

This year No­var­tis will jock­ey a set of drugs in a race that in­cludes the first CGRP mi­graine drug ap­proval for erenum­ab, al­lied with Am­gen and a near cer­tain win­ner at the FDA, with lots of com­pe­ti­tion bit­ing on their heels.

Kym­ri­ah will al­so al­most cer­tain­ly ex­pand its port­fo­lio of in­di­ca­tions, go­ing head-to-head with an ag­gres­sive group of play­ers at Gilead on DL­B­CL soon.

RTH258 (brolu­cizum­ab) is be­ing po­si­tioned to carve out some block­buster mar­ket ter­ri­to­ry from Re­gen­eron’s key Eylea fran­chise, some­thing that biotech is al­ready prep­ping for as Re­gen­eron hunts an OK for a quar­ter­ly in­jec­tion of Eylea, look­ing to kick back against what will be a big ad­van­tage for No­var­tis with 12-week dos­ing. Re­gen­eron, though, has al­so been ham­pered by the fail­ure of its next-gen com­bos.

Ap­provals with­out sig­nif­i­cant rev­enue in the bal­ance won’t get cel­e­brat­ed at No­var­tis un­der Narasimhan. Acute­ly aware of the chal­lenges pay­ers throw in the face of ex­pen­sive new heart meds, the com­pa­ny is po­si­tion­ing canakinum­ab — the big sur­prise in the pipeline — for a par­tic­u­lar slice of the tough car­dio mar­ket that is like­ly to ben­e­fit the most pa­tients and have the least trou­ble get­ting the drug cov­ered.

And Cosen­tyx is be­ing po­si­tioned for new in­di­ca­tions, which will al­so be chal­lenged by some heavy­weights in that mar­ket.

In every sin­gle case, the star per­form­ers in No­var­tis’ late-stage pipeline will face ei­ther di­rect, head-to-head chal­lenges or pay­er kick­backs — or both — ei­ther on the day they hit the mar­ket or what amounts to the day af­ter.

So now Narasimhan, who put the com­pa­ny in this po­si­tion as de­vel­op­ment chief, will have to prove that he can lead the mar­ket­ing team to­ward their block­buster goals in de­liv­er­ing new rev­enue from in­no­v­a­tive prod­ucts.

And then there’s 2019 and all the oth­er years that the new, young CEO plans to stay at the top.

He’s off to a sol­id start. And no one un­der­stands the pipeline strat­e­gy at No­var­tis bet­ter than Vas Narasimhan. That’s some­thing few new Big Phar­ma chiefs have been able to boast of over the past decade, a time of steadi­ly shrink­ing ROI on multi­bil­lion dol­lar R&D gam­bles. And as a re­sult, ex­pec­ta­tions are run­ning very high.


Vas Narasimhan at a Jan­u­ary 2018 news con­fer­ence in Basel. Geor­gios Ke­falas/Key­stone via AP

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

RA Cap­i­tal, Hill­house join $310M rush to back Ever­est's climb to com­mer­cial heights in Chi­na

Money has never been an issue for Everest Medicines. With an essentially open tab from their founders at C-Bridge Capital, the biotech has gone two and a half years racking up drug after drug, bringing in top exec after top exec, and issuing clinical update after update.

But now other investors want in — and they’re betting big.

Everest is closing its Series C at $310 million. The first $50 million comes from the Jiashan National Economic and Technological Development Zone; the remaining C-2 tranche was led by Janchor Partners, with RA Capital Management and Hillhouse Capital as co-leaders. Decheng Capital, GT Fund, Janus Henderson Investors, Rock Springs Capital, Octagon Investments all joined.

Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

David Meline (file photo)

Mod­er­na’s new CFO took a cut in salary to jump to the mR­NA rev­o­lu­tion­ary. But then there’s the rest of the com­pen­sa­tion pack­age

David Meline took a little off the top of his salary when he jumped from the CFO post at giant Amgen to become the numbers czar at the upstart vaccines revolutionary Moderna. But the SEC filing that goes with a major hire also illustrates how it puts him in line for a fortune — provided the biotech player makes good as a promising game changer.

To be sure, there’s nothing wrong with the base salary: $600,000. Or the up-to 50% annual cash bonus — an industry standard — that comes with it. True, the 62-year-old earned $999,000 at Amgen in 2019, but it’s the stock options that really count in the current market bliss for all things biopharma. And there Meline did well.

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Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

Por­tion of Neil Wood­ford’s re­main­ing in­vest­ments, in­clud­ing Nanopore, sold off for $284 mil­lion

It’s been precisely one year and one day since Neil Woodford froze his once-vaunted fund, and while a global pandemic has recently shielded him from the torrent of headlines, the fallout continues.

Today, the California-based patent licensing firm Acacia Research acquired the fund’s shares for 19 healthcare and biotech companies for $284 million.  Those companies include shares for public and private companies and count some of Woodford’s most prominent bio-bets, such as Theravance Biopharma, Oxford Nanopore and Mereo Biopharma, according to Sky News, which first reported the sale. It won’t include shares for BenevelontAI, the machine learning biotech once valued at $2 billion.

David Chang steps up to CEO spot at WuX­i's cell and gene ther­a­py CD­MO; David Meline is the new CFO at Mod­er­na

David Meline didn’t stay retired for long. As reported yesterday, the former Amgen exec will replace Lorence Kim as CFO of Moderna as the Big Pharma has sprinted to the front of the Covid-19 vaccine pack, getting selected as one of the finalists for Operation Warp Speed. Meline, who gets started on Monday, announced his retirement as Amgen’s CFO in October 2019, remaining in the role until the end of the year. But he’s back in the saddle at a crucial time as Moderna prepares for Phase III studies of their SARS-CoV-2 vaccine. Meline previously held leadership positions at 3M and General Motors.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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