The Boston Globe - 08.08.2019

B6 The Boston Globe THURSDAY, AUGUST 8, 2019

Business

By Damian Garde
STAT
Novartis chief executive Vas
Narasimhan beganhis tenure with
an inherited scandal. Now he’s got
one all his own.
The revelationon Tuesday that
AveXis, Novartis’s gene therapy divi-
sion, submitted falsified data to the
Food and DrugAdministration is at
the very least a blemishon the brief
reign of Narasimhan, a rising figure
whotook overin early 2018 witha
promise to change the cultureat the
Swiss drug maker, which has a major
presence in Cambridge. But it also
threatens to becomea muchbigger
scandal.
At issueis what Novartis knew —
and whenit knew it — about the ma-
nipulation of data usedto win ap-
proval of its gene therapy for spinal
muscular atrophy. According to the
FDA, company officials at AveXis
were aware of the issues as early as
March but didn’t inform regulators
untillate June. The drug, the first
gene therapy for a type of SMAand
the most expensive therapy on the
market to date, was approvedin

May.

The FDA’s investigation of the is-

sue could take months.For Novartis

— and particularlyfor Narasimhan

— the stakes are high,even if FDA of-

ficials stressed that they remained

confidentthe therapy should remain

on the market.

Narasimhan, 43, took the reins at

Novartis with the stated goal of

changing the

cultureat a

drug company

that tracesits

rootsback to

1859.In more

recent years,

Novartis has

faced a string of

allegations of

bribery, charg-

es of data falsi-

fication,and

accusations of

illegalmarket-

ing. Narasimhanpromised to trans-

formthe company and make such

scandalsa thingof the past.

“Oneof the five priorities I’ve set

up for our company is buildingtrust

with society, which I see as a long

game,” Narasimhan told The New

York Times in its “Corner Office” col-

umnpublishedSunday. “This is not

going to be fast.”

NOVARTIS, PageB9

By David Gelles

NEWYORK TIMES

SHEFFIELD — A group of family members

representing more than 50 people who died in

the crash of Ethiopian Airlines Flight 302 are

calling on the Federal Aviation Administration

to conduct a full regulatory review of Boeing’s

737 Max before it is allowedto fly again.

The Max, which enteredservice in 2017, is

Boeing’s most recent update to the 737, which

was introduced in the 1960s. Because it was

not an entirely new airplane, the FAA re-

viewed only the parts of the Max that differed

significantly froma previous version of the

737.

By certifyingthe planewitha so-called

amended type

certificate, the

FAA allowed

Boeing to get the

Max flyingyears

sooner than it

would have had

the company in-

troduced a

brand-new plane

that hadto be

certifiedfor the

first time.

But with scru-

tiny of the FAA

mounting after

the crash in Ethi-

opia and an earli-

er crash in Indonesia, the families of many vic-

tims are callingon the FAA to take an entirely

new lookat the Max. The planeremains

grounded while Boeing workson a software

update and other changes intended to make

the Max safer.

MichaelStumo,whose daughter, Samya,

was killedin the Ethiopiancrash, is leading

the effort by the family members.

“The FAA was lax, compliant, and captured

at the time of the amended type certification,”

Stumosaid at his homeMonday. “There needs

to be a full recertification to catch anything

and make sure it’s safe to fly again.”

On Tuesday, the families sent a letter call-

ing for full recertification to Transportation

Secretary ElaineChao; the acting FAA admin-

istrator, Daniel Elwell; and the incoming ad-

ministrator, StephenDickson.

The letter also asked the FAA to require

that pilots be trained on simulators before

they couldfly the Max. Relativesof people

killedin othercrashes,includingthe Max

crash in Indonesia, also signed the letter.

In a statement, the FAA expressedcondo-

lencesto the victims’ families and said it wel-

comed the feedback from multiple investiga-

tions.

“The lessons learned fromthese tragedies

will be the springboardto an even greater lev-

BOEING,PageB8

By Tim Logan

GLOBESTAFF

Another drugmaker is putting

downroots in a fast-emerging busi-

nessdistrict just north of Kendall

Square.

Cerevel Therapeutics said Wednes-

day it will leaseabout60,000square

feet in a new buildingat Cambridge

Crossing, a massive43-acre develop-

mentstraddlingthe Cambridge-

Somerville-Boston lines. The com-

plex, which is under construction, al-

readyis sprouting several life science

office and lab buildings.

A spinoff of pharmaceutical giant

Pfizer, Cerevel was formed last year —

witha $350millioninvestmentby

Bain Capital— to developtherapies

for central nervoussystem disorders

suchas Parkinson’s and Alzheimer’s

diseases. The company will movenext

year into a buildingon Jacobs Street

that’s nearly complete and will also

house the North American headquar-

ters of Philips Healthcare.

“With its proximity to leading life

sciencecompanies,academicmedical

centers, and financial institutions,

Cambridge Crossing will be a terrific

location for Cerevel Therapeutics dur-

ing this critical phase of growth and

expansion,” said Tony Coles, executive

chairperson of the company. “The

state-of-the-art office and laboratory

spacecoupledwith convenient access

to public transportation and unique

amenities will be key factors that help

us continueto attract and retain top

talent.”

It’s the latest in a string of winsfor

developerDivcoWest, which has

leased1.3 million squarefeet of office

and lab space at Cambridge Crossing

since relaunching the project two

yearsago. Along withPhilips, drug-

maker Sanofihas leased two full

buildings — now underway — for

about 900,000 square feet in all.

DivcoWest is also in talks with po-

tentialtenants for spacein a fourth

building — at 504,000 squarefeet —

that’s being built.

TimLogan canbe reached at

[email protected]

Twitter at @bytimlogan.

Developersare lining up to place their

bets at the old Wonderland dog track.

Yes, the greyhounds stopped racing there

a decade ago. This is a new kind of gam-

ble: figuring out the right mix of uses for

the 33.6-acre property, and calculating

how much to risk on it.

Pretty much everyone in Revere

wants to know how this will play out,

and the high-profile property’s fate could

come up during the mayoral race this fall

as the incumbent, Brian Arrigo, gears up

for a rematch against former mayor Dan

Rizzo.

Brokers at Newmark Knight Frank

say there has beenintense interest since

they begandistributing an offering

memorandum a few weeks ago on behalf

of the property owner, CBW Lending, a

group that includes local businessman

Joe O’Donnell and Vornado Realty Trust

of New York City. There had been rumors

of a possible buyer in the past, but this

represents the first formal marketing

effort for the site.

It’s easy to see why developers would

find it enticing. We’re talking about a

blank-slate property just six miles from

downtown Boston with enough room for

up to 3.6 million square feet of develop-

CHESTO, PageB9

Novartis CEO in hot seat

in falsified data allegation

FDA says officials

knewof issueswith

drug for months

Families

demand full

review of

Boeing jet

Survivors of two crashes’

victims questionFAA’s

commitment to safety

Cerevel moving into Cambridge Crossing

Pfizerspinoff will

lease 60 ,000 square

feet in new building

Old greyhound racetrack

spurs new bets: on real estate

Blank-slate site just 6 miles from downtownBoston hits themarket

JASON JOHNS FORTHEBOSTON GLOBE/FILE

WonderlandGreyhoundPark, a short walkfromthe BlueLine,was runninglive dog races five nightsper weekin 2007.

NATEATWATER/COURTESY OF DIVCOWEST

A buildingcurrentlyunderconstruction at CambridgeCrossingwill

housedrugstartup Cerevel Therapeutics.

JonChesto

CHESTOMEANS BUSINESS

BLOOMBERG NEWS

Novartis CEOVas

Narasimhan.

JONATHAN WIGGS/GLOBESTAFF/FILE

Demolitionbeganat the formerGreyhoundparkin Octoberof 2017.

‘Thereneedsto

bea fullrecert-

ificationto

catchanything

andmake sure

it’ssafeto fly

again.’

MICHAEL STUMO,

father of a victim