Over a year af­ter re­jec­tion, Im­munomedics emerges with po­ten­tial block­buster ap­proval

A tur­bu­lent 16 months for Im­munomedics has end­ed in a po­ten­tial block­buster ap­proval, as the FDA grant­ed an ac­cel­er­at­ed OK for their drug to treat an ag­gres­sive form of breast can­cer.

The drug, brand­ed as Trodelvy, is ap­proved for metasta­t­ic triple neg­a­tive breast can­cer — breast can­cers that lack the onco­genes that tar­get­ed ther­a­pies go af­ter and that have helped make the dis­ease treat­able for some pa­tients. The drug, which had break­through sta­tus and pri­or­i­ty re­view, showed a 33% re­sponse and me­di­an du­ra­tion of re­sponse of 7.7 months in 108 pa­tients en­rolled in their Phase II tri­al. Peak sales es­ti­mates can range as high as around $3 bil­lion.

The ap­proval comes over a month in ad­vance of the com­pa­ny’s June 2 PDU­FA date, con­tin­u­ing the agency’s trend of quick­ly ap­prov­ing can­cer drugs they deem ef­fec­tive.

Be­hzad Ag­haz­adeh

A lit­tle over a year ago, the FDA sur­prised both the com­pa­ny and in­vestors by re­ject­ing the drug. Al­though Im­munomedics $IM­MU said the con­cern had on­ly been with qual­i­ty con­trols over the fa­cil­i­ty where the drug is pro­duced, the re­jec­tion of the biotech’s main as­set shaved $1 bil­lion off the com­pa­ny’s mar­ket cap. Not long af­ter, an FDA in­spec­tion doc­u­ment raised con­cerns of a da­ta breach at one of the com­pa­ny’s fa­cil­i­ties. The CEO and CSO both lat­er ex­it­ed, and chair­man Be­hzad Ag­haz­adeh stepped in to run the com­pa­ny.

The drug, known chem­i­cal­ly as sac­i­tuzum­ab govite­can, is the com­pa­ny’s first ap­proval in their 37-year his­to­ry. An an­ti­body-drug con­ju­gate, it con­sists of a tu­mor-tar­get­ing an­ti­body at­tached to a cell-killing small mol­e­cule. The tu­mor en­gulfs the con­ju­gate and the mol­e­cule kills the can­cer cells. The idea first emerged in the ear­ly 2000s be­fore pe­ter­ing out, but has gained trac­tion again in re­cent years, most no­tably with the re­cent ap­provals of Seat­tle Ge­net­ics’ Ad­cetris and Pad­cev.

Seat­tle Ge­net­ics near­ly ac­quired the Im­munomedics drug in 2016. They agreed to an up-to $2 bil­lion deal worth $300 mil­lion be­fore ven­Bio, which owned a 9.9% stake in the com­pa­ny, led a cam­paign against the deal, with then-man­ag­ing parter Ag­haz­adeh ac­cus­ing the com­pa­ny’s lead­er­ship of try­ing to en­rich them­selves. The hus­band-and-wife team who then ran the com­pa­ny as CSO and CEO re­signed, and Ag­haz­adeh lat­er or­ga­nized a $250 mil­lion roy­al­ty deal to fund the com­pa­ny’s work.

Harout Se­mer­jian

An ac­cel­er­at­ed ap­proval is con­di­tion­al on the com­pa­ny con­duct­ing a fol­low-up study. That tri­al, though, has al­ready been stopped, with an in­de­pen­dent re­view board telling Im­munomedics ear­ly this month their drug had al­ready shown enough com­pelling ef­fi­ca­cy. On the same day of the tri­al news, the com­pa­ny al­so an­nounced that No­var­tis On­col­o­gy vet Harout Se­mer­jian had been named as the new CEO.

Com­mit­tee chair and Fred Hutch re­searcher Julie Gralow called the re­sults of the Phase III tri­al “re­mark­able.” The com­ment led Cowen’s Phil Nadeau to write, “There is lit­tle ques­tion that sac­i­tuzum­ab will soon be­come stan­dard of care in the treat­ment of re­lapsed and re­frac­to­ry mTNBC.”

Janet Woodcock (Greg Nash/Pool via AP Images)

'I re­al­ly don’t look back': Janet Wood­cock on her tran­si­tion away from drugs

Janet Woodcock may have one of the most historically long and drug-intense tenures in FDA history, but her new role is outside of all things pharma and the once-acting FDA commissioner isn’t looking back.

“No I really don’t look back,” Woodcock told Endpoints News via email on Monday morning. “Yes I will be transitioning. Longer discussion on infrastructure needed.”

Co­pay coupons gone wrong, again: Pfiz­er pays al­most $300K to set­tle com­plaints in four states

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

Delaware court rules against Gilead and Astel­las in years-long patent case

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.

Taye Diggs (courtesy Idorsia)

Idor­sia inks an­oth­er celebri­ty en­dors­er deal with ac­tor and dad Taye Dig­gs as Qu­viviq in­som­nia am­bas­sador

Idorsia’s latest Quviviq insomnia campaign details the relatable dad story of a well-known celebrity — actor and Broadway star Taye Diggs.

Diggs stopped sleeping well after the birth of his son, now more than 10 years ago. Switching mom-and-dad nightly shifts to take care of a baby interrupted his sleep patterns and led to insomnia.

“When you’re lucky enough to be living out your dream and doing what you want, but because of something as simple as a lack of sleep, you’re unable to do that, it felt absolutely — it was treacherous,” he says in an interview-style video on the Quviviq website.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,600+ biopharma pros reading Endpoints daily — and it's free.

Belén Garijo, Merck KGaA CEO (Kevin Wolf/AP Images for EMD Serono)

Mer­ck KGaA pumps €440M in­to ex­pand­ing and con­struct­ing Irish man­u­fac­tur­ing fa­cil­i­ties

The area of Ireland famous for Blarney Castle and its cliffsides along the Atlantic Ocean is seeing Merck KGaA expand its commitment there.

The German drug manufacturer is expanding its membrane and filtration manufacturing capabilities in Ireland. The company will invest approximately €440 million ($470 million) to increase membrane manufacturing capacity in Carrigtwohill, Ireland, and build a new manufacturing facility at Blarney Business Park, in County Cork, Ireland.

Rep. Katie Porter (D-CA) (Michael Brochstein/Sipa USA/Sipa via AP Images)

House Dems to Sen­ate lead­er­ship: Quick­ly move a rec­on­cil­i­a­tion bill with drug price ne­go­ti­a­tion re­forms

Twenty House Democrats, including Reps. Katie Porter of California and Susan Wild of Pennsylvania, are calling on Senate leaders to move quickly with a reconciliation bill (meaning they only need a simple majority for passage) with prescription drug pricing reforms, and to include adding new authority for Medicare to negotiate drug prices.

They also called on the Senate to specifically follow suit with the House passage of a $35 per month insulin cap (as Senate Majority Leader Chuck Schumer’s deadline for a vote on that provision has come and gone), and to cap Medicare Part D costs at $2,000 per year for seniors.

Phillip Gomez, SIGA CEO

UP­DAT­ED: On the back of SIGA Tech­nolo­gies' win with the FDA, the mon­key­pox virus sees the com­pa­ny spring­ing to fur­ther ac­tion

As the cases of monkeypox now sit at well over 100 worldwide and have spread to multiple continents, the orders for any type of vaccine against monkeypox are seeing nations and medical bodies looking to get their hands on anything and everything. And now SIGA Technologies seems to be getting in on the action.

According to Euronews, SIGA Technologies, a pharmaceutical company that is focused on providing medical countermeasures to biological and chemical attacks, is now in talks with several European authorities looking to stockpile its antiviral that can counter monkeypox. The drug known as tecovirimat or Tpoxx was approved by the FDA in 2018 as a vaccine for smallpox but was approved by the European Medicines Agency to also act against monkeypox, cowpox and complications from immunization with vaccinia.

Bris­tol My­ers dusts off an old Cel­gene chemother­a­py for use in chil­dren with a rare blood can­cer

Bristol Myers Squibb is bringing new life to a chemotherapy drug from the old Celgene pipeline as it touts another approval in a rare form of blood cancer affecting young children.

The FDA on Friday approved Vidaza (chemically known as azacitidine) for pediatric patients 1 month and older with newly diagnosed juvenile myelomonocytic leukemia (JMML). The new indication marks the first approval for Vidaza in more than a decade, though it’s commonly used to treat acute myeloid leukemia and myelodysplastic syndromes (MDS).

FDA calls for non­in­fe­ri­or­i­ty tri­als for an­tibac­te­ri­als, thanks to new drugs for re­sis­tant in­fec­tions

The FDA on Monday said it updated its recommendations for the clinical development of new antibacterial drugs, and thanks to a new clutch of drugs, sponsors will have to conduct noninferiority trials that include subjects with infections caused by certain drug-resistant organisms because an effective active control can be provided.

The guidance, which is likely to be released within the next day or so, builds on a 2017 document and specifies what noninferiority trial designs may be used “with a wider NI margin,” including cases in which the trial population is enriched for subjects with infections caused by certain drug-resistant organisms, FDA said.