FDA stiff arms Evo­lus' ri­val to Al­ler­gan’s block­buster Botox, but ex­ecs promise a snap re­sponse

Evo­lus’ $EOLS at­tempt to field a ri­val to Al­ler­gan’s Botox has run in­to prob­lems at the FDA.

The biotech an­nounced Wednes­day morn­ing that the FDA has hand­ed the com­pa­ny a com­plete re­sponse let­ter for DWP-450 (prabot­u­linum­tox­i­nA). But the ex­ec­u­tive team quick­ly pinned the blame on man­u­fac­tur­ing is­sues, say­ing they can bat their re­vised ap­pli­ca­tion back to reg­u­la­tors in 90 days.

The biotech’s state­ment starts with an an­nounce­ment that the FDA has con­firmed “the fa­vor­able com­ple­tion of its pre-ap­proval in­spec­tion of Dae­woong’s man­u­fac­tur­ing fa­cil­i­ty in South Ko­rea which was pur­pose built for pro­duc­tion of DWP-450.” They go on to say that de­spite the re­jec­tion, they’re stay­ing up­beat — re­gard­less of what in­vestors might think.

And they weren’t near­ly as up­beat as man­age­ment. The biotech’s stock plunged 30% on the news.

David Moataze­di

CEO David Moataze­di — an Al­ler­gen vet who took the job just a lit­tle more than a week ago — says the re­jec­tion has noth­ing to do with da­ta, sta­tis­tics, safe­ty or phar­ma­col­o­gy of their prod­uct. “The re­main­ing ques­tions are man­age­able,” he told in­vestors on a call this morn­ing.

The biotech sig­naled at the be­gin­ning of the year that it had some se­ri­ous man­u­fac­tur­ing is­sues to deal with af­ter the FDA is­sued a heav­i­ly redact­ed re­port on their in­spec­tion of the fa­cil­i­ty.

But the com­pa­ny de­clined to get spe­cif­ic, even af­ter be­ing pressed by Wells Far­go an­a­lyst David Maris.

“Ob­vi­ous­ly it’s a con­fi­den­tial doc­u­ment so we’re not go­ing to give gran­u­lar­i­ty,” not­ed CMO Rui Ave­lar.

The com­pa­ny says that it will get a Type 2 re­view for the re­vised pitch, set­ting up time­line for a planned launch next spring. 

“We’ve large­ly de-risked the clin­i­cal de­vel­op­ment pro­gram,” says the CEO. “The path­way to com­mer­cial­iza­tion is now clear” af­ter the feed­back. And Moataze­di adds he’ll start scal­ing for a com­mer­cial launch­ing 2019.

He de­clined, though, to get in­to the specifics of the FDA’s ques­tions.

“We are pleased with the progress we con­tin­ue to make with the FDA, and this CRL con­firms our con­fi­dence in our clin­i­cal sub­mis­sion,” said Moataze­di in a state­ment. “De­fi­cien­cies cit­ed with­in the CRL are iso­lat­ed to CMC mat­ters and we ex­pect to re­spond com­pre­hen­sive­ly with­in 90 days. Over­all, we view these up­dates as pos­i­tive, which to­geth­er give us the line of sight nec­es­sary to build our com­mer­cial in­fra­struc­ture. We look for­ward to work­ing close­ly with the FDA and re­main com­mit­ted to bring­ing DWP-450 to mar­ket by spring 2019.”

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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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.

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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 Squibb sues No­var­tis for roy­al­ties sur­round­ing the use of trans­genic mice

Two Big Pharma companies are going to the mat over genetically modified mice in a licensing dispute.

Bristol Myers Squibb is suing Novartis in New York over a dispute concerning an evaluation, research and commercialization agreement stretching back to the late ’90s initially inked between Novartis and BMS’ predecessor Medarex. The deal in question allowed Novartis to use Medarex’s patented transgenic mice to develop therapeutic drugs. Novartis agreed to pay Medarex – and subsequently BMS – a royalty on sales of drugs it developed using the mice.