Analy­sis shows Swiss biotech in­dex out­shines Nas­daq coun­ter­part, but coro­n­avirus chal­lenges are uni­ver­sal

In 2004, the Swiss Stock Ex­change spawned its biotech in­dex — the Swiss Bio+Medtech In­dex (SXI) — as the life sci­ences sec­tor, head­lined by large suc­cess­ful bio­phar­ma com­pa­nies Roche and No­var­tis, took cen­ter stage. In the last five years through Jan­u­ary 2020, SXI has pro­duced re­turns of 59%, out­per­form­ing both the Swiss Per­for­mance In­dex (31%) and the NAS­DAQ Biotech­nol­o­gy In­dex (35%), a new analy­sis shows.

The Eu­ro­pean coun­try, fa­bled for its neu­tral­i­ty, has be­come some­thing of a hub for bi­o­log­ic and cell ther­a­py man­u­fac­tur­ing, with com­pa­nies like Bio­gen, No­var­tis and Mer­ck in­vest­ing in in­fra­struc­ture. Last year, phar­ma­ceu­ti­cal and biotech­nol­o­gy prod­ucts ac­count­ed for 40% of to­tal Swiss ex­ports.

Michael Al­tor­fer

“Some peo­ple would ar­gue Switzer­land is an ex­pen­sive place to be,” said Swiss Biotech As­so­ci­a­tion CEO Michael Al­tor­fer in an in­ter­view.

But the high rate of au­toma­tion in the coun­try re­duces the di­rect cost of la­bor, there is a sta­ble po­lit­i­cal en­vi­ron­ment, the re­cent over­haul of the tax sys­tem fa­vors R&D in­vest­ment, and Switzer­land’s free trade agree­ments with places such as Chi­na and South Ko­rea are all fac­tors that make it an at­trac­tive re­gion for the life sci­ences in­dus­try, he sug­gest­ed.

In 2019, glob­al IPOs in the bio­phar­ma sec­tor hit 57, a fall from the high of 77 a year ear­li­er. Of the class of 2019, 11 were Eu­ro­pean — but not a sin­gle Swiss biotech com­pa­ny went pub­lic.

Un­like the Unit­ed States, where ear­ly-stage and in­deed pre­clin­i­cal com­pa­nies are in­creas­ing­ly tak­ing the plunge, com­pa­nies in Switzer­land tend to take that route when they are in the lat­ter stages of de­vel­op­ment, or in­deed stick to pri­vate­ly rais­ing cap­i­tal, Al­tor­fer said.

ADC Ther­a­peu­tics, for in­stance, was con­sid­er­ing go­ing pub­lic but elect­ed in­stead to do a large pri­vate round — CHF 101 mil­lion —  in­stead.

In Switzer­land, the to­tal val­ue of fi­nanc­ings (mi­nus IPOs) in 2019 fell short of the last two years com­ing in at CHF 1.2 bil­lion, but fund­ing has hov­ered in and around the CHF 1 bil­lion mark for the last three years. In­vestors have al­so reaped gen­er­ous re­turns, for in­stance, via M&A — in 2019, for in­stance, the com­bined val­ue of deals in­volv­ing Ther­a­chon, Novim­mune and Amal Ther­a­peu­tics al­so crossed CHF 1 bil­lion.

Biotech in­vestors tend to rein­vest in Switzer­land — and about half the in­vest­ment comes from for­eign in­vestors, Al­tor­fer said.

“So these are not peo­ple that love their coun­try or peo­ple that are in­vest­ing be­cause their friends are run­ning com­pa­nies,” he quipped. “But still, it is re­mark­able that large in­sti­tu­tion­al in­vestors shy away from this sec­tor (in Switzer­land).”

With the coro­n­avirus pan­dem­ic, things are ex­pect­ed to get a bit hairy over the course of 2020 for in­dus­tries across the globe, and Switzer­land’s life sci­ences sec­tor is no ex­cep­tion. But in gen­er­al, the in­dus­try is rel­a­tive­ly im­mune to glob­al mar­ket fric­tion be­cause well, med­i­cines are not iPhones, and bio­phar­ma R&D takes years to reach fruition.

In Switzer­land, much like else­where, bio­phar­ma com­pa­nies are en­coun­ter­ing chal­lenges in start­ing and con­duct­ing clin­i­cal tri­als and pa­tient re­cruit­ment.

“It would be stu­pid if I pro­claim that we will get through this with­out de­lays,” Al­tor­fer said. “Some com­pa­nies are lucky be­cause they’re run­ning clin­i­cal tri­als in coun­tries that are not as af­fect­ed … but in gen­er­al, we have to ex­pect a sig­nif­i­cant de­lay of, I would say, at least half a year — and that’s an av­er­age fig­ure.”

“How will this re­sult in dis­tressed com­pa­nies that need to ne­go­ti­ate fi­nanc­ing rounds, based on a lack of da­ta, based on a weak po­si­tion? Of course, I can­not an­tic­i­pate the sit­u­a­tion for all these 300 com­pa­nies (in Switzer­land) what it will look like and how it will be in each and every case.”

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

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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FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

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Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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UP­DAT­ED: Es­ti­mat­ing a US price tag of $5K per course, remde­sivir is set to make bil­lions for Gilead, says key an­a­lyst

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.

Gilead bol­sters its case for block­buster hope­ful fil­go­tinib as FDA pon­ders its de­ci­sion

Before remdesivir soaked up the spotlight amid the coronavirus crisis, Gilead’s filgotinib was the star experimental drug tapped to rake in billions competing with other JAK inhibitors made by rivals including AbbVie and Eli Lilly.

Now, long term data on the drug — discovered by Gilead’s partners at Galapagos and posted as part of a virtual medical conference — have solidified the durability and safety of filgotinib in patients with rheumatoid arthritis, spanning data from three late-stage trials. An FDA decision on the drug is expected this year.

Joseph Kim, Inovio CEO (Andrew Harnik, AP Images)

Caught in a stand­off with its con­tract man­u­fac­tur­er over Covid-19 vac­cine, In­ovio files suit in an at­tempt to break free while ri­vals race ahead

Inovio was one of the first vaccine developers to snag attention for a jab that their execs said promised to end the Covid-19 pandemic. Using their own unique DNA tech, CEO Joseph Kim said it took just 3 hours to work it out.

But while rivals are racing to the finish line with ambitious plans to make vast quantities of their vaccines with billions of dollars of deals, Inovio is still stuck at the starting line on manufacturing.