Sanofi re­ports sales growth amid Dupix­en­t's Chi­na launch, but re­veals PDU­FA de­lay in Pompe dis­ease pro­gram

Sanofi re­leased its first quar­ter earn­ings re­port Wednes­day, and while the com­pa­ny saw pos­i­tive news re­gard­ing growth and sales — par­tic­u­lar­ly in Chi­na — they al­so re­vealed for the first time a de­lay in one of their lead Phase III pro­grams.

The French phar­ma’s Pompe dis­ease pro­gram aval­glu­cosi­dase al­fa saw its PDU­FA date pushed back by three months, from May 18 to Aug. 18, Sanofi not­ed in its in­vestor pre­sen­ta­tion. No rea­son was giv­en for the move, and End­points News has reached out for com­ment.

Over­all, how­ev­er, Dupix­ent con­tin­ued to prove an emerg­ing cash cow for Sanofi. The Re­gen­eron-part­nered drug pulled in more than $1 bil­lion world­wide for a year-over-year in­crease of 45.6% at the com­mon ex­change rate. Dupix­ent al­so scored a spot on Chi­na’s cov­et­ed Na­tion­al Re­im­burse­ment Drug List in March, mark­ing the of­fi­cial launch of Dupix­ent in one of the world’s largest mar­kets.

Sanofi saw to­tal net sales in­crease by 2.4%, at­trib­uted large­ly to Dupix­ent’s suc­cess.

Two of Sanofi’s oth­er fran­chis­es, Pralu­ent and Tou­jeo, al­so launched in Chi­na this past quar­ter. Though Pralu­ent sales were down 20.5% due to low­er sales in the US, the drug spiked out­side the coun­try: Sales grew 20% in Eu­rope and 45.5% out­side of the US and Eu­rope.

The Pompe dis­ease pro­gram de­lay is the lat­est in a string of re­cent set­backs for pa­tients look­ing for the first new drug in the ill­ness since 2010. That drug, Lu­mizyme, was brought un­der the Sanofi um­brel­la in the com­pa­ny’s buy­out of Gen­zyme the fol­low­ing year. It’s an en­zyme re­place­ment ther­a­py, pro­vid­ing an ar­ti­fi­cial copy of the en­zyme known as GAA, with­out which pa­tients see ir­re­versible mus­cle dam­age re­sult­ing from ex­ces­sive sug­ar buildup in cells.

Aval­glu­cosi­dase al­fa was de­signed to more eas­i­ly en­ter cells, po­ten­tial­ly al­low­ing for faster and more ef­fi­cient sug­ar pro­cess­ing. Though the pro­gram ob­tained pri­or­i­ty re­view back in No­vem­ber, an­a­lysts ex­pressed skep­ti­cism last Ju­ly af­ter it failed to prove su­pe­ri­or to Lu­mizyme in im­prov­ing res­pi­ra­to­ry func­tion in a Phase III tri­al.

On top of that, Am­i­cus saw its shares ham­mered in Feb­ru­ary af­ter its own Pompe dis­ease pro­gram flopped the pri­ma­ry in a Phase III study. Here, the Am­i­cus can­di­date did not man­age to achieve sta­tis­ti­cal­ly sig­nif­i­cant su­pe­ri­or­i­ty in a 6-minute walk test among both ERT-naive pa­tients and those who’d been switched from the ther­a­py.

Am­i­cus did re­veal, though, that the group that had switched from Lu­mizyme saw a nom­i­nal im­prove­ment at a p-val­ue of p=0.046.

Look­ing ahead to the sec­ond quar­ter, Sanofi high­light­ed its joint vac­cine ven­ture with Mer­ck, as the pair’s pe­di­atric 6-in-1 com­bi­na­tion vac­cine Vax­elis is ex­pect­ed to launch in the US be­fore the end of June. It’s the first such vac­cine to be used in the coun­try, fol­low­ing its launch in Eu­rope back in 2017 and FDA ap­proval in De­cem­ber 2018.

The shot is in­di­cat­ed for chil­dren aged be­tween 6 weeks and 4 years old, and in­oc­u­lates against diph­the­ria, tetanus, per­tus­sis, po­liomyelitis, he­pati­tis B and in­va­sive dis­ease due to Haemophilus in­fluen­zae type B.

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

UP­DAT­ED: Gink­go Bioworks re­sizes the de­f­i­n­i­tion of go­ing big in biotech, rais­ing $2.5B in a record SPAC deal that weighs in with a whop­ping $15B-plus val­u­a­tion

Ginkgo Bioworks execs always thought big. But today should redefine just how big an upstart biotech player can dream.

In the largest SPAC deal to clear the hurdles to Nasdaq, the biotech that envisioned everything from remaking synthetic meat to a whole new approach to developing drugs has joined forces with one of the biggest disruptors in biotech to slam the Richter scale on dealmaking.

Soon after becoming the darling of the VC crew and clearing the bar on a $4 billion valuation, Ginkgo — a synthetic biotech player out to reprogram cells with industrial efficiency — has now struck a deal to go public in the latest leviathan SPAC that sets its pre-money valuation at $15 billion. In one swift vault, Ginkgo will combine with Harry Sloan’s Soaring Eagle Acquisition Corp. and leap into the public markets.

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FDA un­veils six ICH guide­lines ahead of meet­ing with Health Cana­da

A sign that the FDA’s non-Covid-related processes are beginning to normalize: The release of six guidelines from the International Council of Harmonisation.

Years in development, the ICH documents offer an international perspective on drug development, with these latest guidelines covering everything from recommendations to support the classification of drug substances, featured in the M9 guidance, to standards for nonclinical safety studies for pediatric medicines in the S11 guideline.

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Sanofi, Glax­o­SmithK­line, Boehringer ac­cused of play­ing games, de­stroy­ing emails re­lat­ed to law­suit over con­t­a­m­i­nat­ed Zan­tac

A recent court filing raises new questions about how major pharma companies like Sanofi, GlaxoSmithKline, and Boehringer Ingelheim have dealt with a lawsuit related to recalls of certain over-the-counter heartburn drugs due to the presence of a potentially cancer-causing substance found in them.

More than 70,000 people who took Sanofi’s Zantac and other heartburn drugs containing ranitidine, which have been recalled over the past two years, have sued the manufacturers, including generic drugmakers, and other retailers and distributors as part of a consolidated suit before US District Court Judge Robin Rosenberg in Florida.

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Alvotech takes Ab­b­Vie to court over al­leged patent 'mine­field' sur­round­ing megablock­buster Hu­mi­ra

AbbVie has so far been successful in shooing away competition to its megablockbuster Humira, deploying a number of patents and settlements to keep biosimilars off the US market until 2023. But one Icelandic drugmaker doesn’t want to wait — and on Tuesday, it filed a lawsuit challenging what it called a patent “minefield.”

Alvotech has accused AbbVie of trying to “overwhelm” and “intimidate” it with “an outrageous number of patents of dubious validity,” according to court documents. The company is currently seeking approval for its Humira copycat AVT02, which AbbVie says would infringe upon 62 patents.

Chris Garabedian (Xontogeny)

Per­cep­tive Ad­vi­sors, Xon­toge­ny bring the band back and then some with a $515M sec­ond fund sniff­ing out lead com­pounds

When Perceptive Advisors and startup accelerator Xontogeny initially teamed up on an early-stage VC round in 2019, the partners hoped to prove their investments could be a force multiplier for early-stage companies. Now, with that proof of concept behind them, the pair have closed a second VC round worth more than double the money.

Dubbed PXV Fund II and headed by Xontogeny CEO and former Sarepta head Chris Garabedian, the $515 million fund will target 10 to 12 early-stage preclinical companies with Series A rounds in the $20 million to $40 million range with opportunities for Series B follow-ups. The oversubscribed fund is bringing the band back with initial investors from PXVI as well as new investors that include “top-tier” asset managers, endowments, foundations, family offices, and individual investors.

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A clos­er look at the FDA’s more than 700 pan­dem­ic-re­lat­ed record re­quests to re­place on­site in­spec­tions

As the pandemic constrained the FDA’s ability to travel for onsite manufacturing inspections, the agency increasingly turned to requesting records to fill the gap, even for hundreds of US-based facilities.

FDA explains in its guidance on manufacturing inspections during the pandemic that the agency can request records (not to be confused with the FDA’s remote interactive evaluations) directly from facilities “in advance of or in lieu of” certain onsite inspections. Companies are legally required to fulfill those requests because a denial may be considered limiting an inspection, which could lead to the FDA deeming a drug made at that site to be adulterated.

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Stephen Squinto, Gennao Bio CEO (Gennao)

Alex­ion co-founder Stephen Squin­to is back in the game as CEO, this time for a small gene ther­a­py play­er

With his name already behind a rare disease success story in Alexion, Stephen Squinto was looking for a great story to drive him to jump back into the biotech game. He found that in a fledging non-viral gene therapy company, and now he’s got a few backers on board as well.

On Tuesday, Gennao Bio launched with a $40 million Series A co-led by OrbiMed and Logos Capital with participation by Surveyor Capital. The biotech, which is looking to use its cell-penetrating antibody platform to deliver nucleic acid “payloads” during into the nucleus, had to rush for its initial series — and had a name change along the way.

UP­DAT­ED: Feds charge an­oth­er CRO staffer with fak­ing da­ta in a Glax­o­SmithK­line pe­di­atric asth­ma study

A Florida woman has been indicted as part of a clinical trial fraud scheme over a GlaxoSmithKline pediatric asthma study, the Justice Department announced Tuesday, the latest development in a case where three individuals have already pleaded guilty.

Jessica Palacio was charged with participating in a plot to falsify medical records, giving off the appearance that trial participants were making their scheduled visits to a Miami CRO and taking an experimental asthma medication as required. Palacio was also charged with lying to FDA investigators about her conduct.