In­tra­venous tra­madol-fo­cused Av­enue Ther­a­peu­tics may not be out of the game just yet.
Af­ter re­ceiv­ing two CRLs for their drug, Av­enue an­nounced to­day that it has re­ceived a writ­ten in­ter­im re­sponse from the FDA’s Of­fice of New Drugs that reg­u­la­tors will hold an ad­comm to reach a de­ci­sion on a for­mal dis­pute res­o­lu­tion re­quest filed by Av­enue back in Ju­ly.
This oc­curred af­ter the FDA sent Av­enue the sec­ond CRL for their drug, an in­tra­venous form of syn­thet­ic opi­oid tra­madol.
The biotech said back in June that the FDA had de­nied its ap­pli­ca­tion as the “de­layed and un­pre­dictable on­set” of pain re­duc­tion from tra­madol didn’t sug­gest a ben­e­fit as a monother­a­py. And at the time, there was not enough in­for­ma­tion to know whether it worked in com­bi­na­tion with oth­er ther­a­pies.
Av­enue dis­agreed at the time, and said they would keep push­ing for reg­u­la­to­ry ap­proval.
The FDA hasn’t yet an­nounced when the ad­comm will con­vene.  The OND will re­spond to the FDRR with­in 30 days af­ter meet­ing.
Bausch + Lomb and Clear­side Bio­med­ical an­nounced this morn­ing that the FDA ap­proved Xipere, a tri­am­ci­nolone ace­tonide in­jectable sus­pen­sion, for supra­choroidal use to treat mac­u­lar ede­ma as­so­ci­at­ed with uveitis, a form of eye in­flam­ma­tion.
Mac­u­lar ede­ma is the buildup of flu­id in the mac­u­la, lo­cat­ed in the reti­na at the back of the eye. This buildup can cause reti­nal swelling and dis­tort­ed vi­sion — and can lead to per­ma­nent vi­sion loss if left un­treat­ed, ac­cord­ing to Bausch + Lomb.
The method of choice is unique. The treat­ment us­es a mi­croin­jec­tor — de­vel­oped by Clear­side — to in­ject Xipere in­to the supra­choroidal space of the eye. That space, which is be­tween the scle­ra and choroid, may turn out to be a more ef­fec­tive method to im­prove tar­get­ed drug de­liv­ery.
Ac­cord­ing to Bausch Health chair­man and CEO Joseph Pa­pa, the com­pa­ny ex­pects to make Xipere avail­able in Q1 of next year.
“With this ap­proval, we be­gin a new era in de­liv­er­ing ther­a­pies to the back of the eye,” said Clear­side’s pres­i­dent and CEO George Lasezkay. “Xipere is the first com­mer­cial prod­uct de­vel­oped by Clear­side, the first prod­uct ap­proved for in­jec­tion in­to the supra­choroidal space and the first ther­a­py ap­proved for mac­u­lar ede­ma as­so­ci­at­ed with uveitis.”
Third-Rock backed Cedil­la Ther­a­peu­tics ex­pand­ed its Se­ries B from last year with an ad­di­tion­al $25 mil­lion, bring­ing the to­tal amount raised to $82.6 mil­lion.
The Se­ries B ex­pan­sion an­nounced to­day in­cludes new in­vestors RA Cap­i­tal Man­age­ment, Janus Hen­der­son In­vestors, Wood­line Part­ners and Lo­gos Cap­i­tal, along­side Third Rock.
The funds will sup­port Cedil­la’s con­tin­u­ing de­vel­op­ment of its two lead pro­grams: a TEAD in­hibitor for sol­id tu­mor treat­ment such as mesothe­lioma and cer­tain squa­mous cell car­ci­no­mas, along with a high­ly se­lec­tive CDK2/Cy­clin E in­hibitor for mul­ti­ple tu­mor types, in­clud­ing CDK4/6-re­sis­tant breast can­cer.
The com­pa­ny plans to ini­ti­ate IND-en­abling stud­ies for its TEAD pro­gram by next June and for the CDK2 pro­gram by the end of 2022.
“With this fi­nanc­ing, we plan to ac­cel­er­ate and ex­pand our de­vel­op­ment ef­forts by pro­gress­ing our most ad­vanced pro­grams to­ward the clin­ic while con­tin­u­ing to in­vest in on­go­ing dis­cov­ery ef­forts against ad­di­tion­al high val­ue can­cer tar­gets,” said Cedil­la pres­i­dent and CEO San­dra Glucks­mann.
Jake Sim­son, a part­ner with RA Cap­i­tal Man­age­ment, will join Cedil­la’s Board of Di­rec­tors as part of the fi­nanc­ing.
Chi­nese biotech Ju­ven­tas Cell Ther­a­py com­plet­ed a Se­ries C fi­nanc­ing round, bring­ing in close to $63 mil­lion.
Ac­cord­ing to a state­ment, Ju­ven­tas will use the funds to pur­sue an NDA in Chi­na and launch im­ple­men­ta­tion of a com­mer­cial­iza­tion and in­ter­na­tion­al re­search and de­vel­op­ment plan for part­ner CASI’s CAR-T treat­ment CNCT19.
CASI shares glob­al co-com­mer­cial and prof­it-shar­ing rights with Ju­ven­tas, and in­di­rect­ly owns just over 12% of the com­pa­ny’s shares fol­low­ing com­ple­tion of the Se­ries C round.
Ju­ven­tas’ fi­nanc­ing was led by CI­CC Cap­i­tal.
“The col­lab­o­ra­tion be­tween CASI and Ju­ven­tas will speed up the adop­tion of CAR-T ther­a­py in Chi­na,” CASI CEO and chair­man Wei-Wu He said in a state­ment.
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Even though many biopharma leaders have come together in recent years to address its gender gap, the consensus is clear: We still have a long way to go.
Companies this year were 2.5 times more likely than last year to have a diversity and inclusion program in place, according to a recent BIO survey, but women are still largely absent from executive roles. Getting women to enter the industry isn’t the problem — studies show that they represent just under half of all biotech employees around the world. But climbing through the ranks can be challenging, as women still report facing stereotypes, and, unfortunately, harassment.
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Over the past couple of years, the top execs at Roche and Genentech have inked a flurry of deals aligning the global pair with several of the new players that have emerged in the booming AI and machine learning world. That strategy was supercharged in the spring of 2020 by their decision to recruit Aviv Regev out of the computational world she occupied at the Broad. And today they’re taking that computational approach in R&D to a whole new level.
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All through this year you could practically feel the frustration of the biotech investor class as M&A activity continued to drag behind expectations — or desires. Buyouts of public companies provide the essential juice for keeping stocks lively, and there’s been a notable lack of juice in 2021.
So is all that about to change, big time?
SVB Leerink’s Geoffrey Porges, a longtime student of biotech M&A, thinks so. In a lengthy analysis he put out last week, Porges totted up the cash flow of the major pharmas and determined that there was a good long list of industry buyers who would have around a half trillion dollars of cash to play with in 2022. Leverage that up with added debt and you could get that deal cache to $1.6 trillion.
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As Icelandic billionaire Róbert Wessman tries to take down AbbVie’s megablockbuster Humira in court, he’s also taking his biosimilar upstart to the big time with a $2.25 billion SPAC merger, Nasdaq launch and $450 million raise announced early Tuesday.
While Wessman’s Alvotech has not won FDA approval for any of its biosimilar candidates yet, the company was the first to file with the FDA for approval of its high-concentration Humira biosimilar and to have successfully conducted a switching study in support of a highly-coveted interchangeability designation. But other companies like Amgen, Boehringer Ingelheim and Pfizer have since caught up ahead of the launches of their own Humira biosimilar competitors in 2023.
AstraZeneca is plucking another antisense drug out of Ionis’ prolific pipeline.
Paying $200 million in cash, AstraZeneca has inked a development and commercialization deal around eplontersen — the Phase III TTR amyloidosis drug formerly known as IONIS-TTR-LRX. On top of the upfront and $485 million worth of conditional payments to follow regulatory approvals, the pharma giant is promising $2.9 billion in sales-related milestones should the drug reach megablockbuster status, plus royalties.
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Gary Glick is back at it again, founding yet another biotech company. And by the sheer size of its first raise, this may be the biggest one yet.
Glick has assembled what he calls an all-star roster and recruited one of the biggest healthcare investors in OrbiMed to put together a massive $218 million Series A for his newest venture, Odyssey Therapeutics. The launch, announced Tuesday morning and co-led by SR One Capital Management, comes not three months after Glick sold First Wave Bio to AzurRx for $229 million.
With the rush of AI permeating the biotech industry, another AI player is coming out well-organized and flush with cash. METiS Therapeutics announced this morning that it successfully put $86 million in the bank, thanks to a Series A.
Two investment firms connected to the Chinese government (People’s Insurance Company of China and China Life Insurance Company) led the financing round — and were joined by Sequoia Capital China, 5Y Capital and several other investors.
The World Health Organization said late today that it’s not recommending the use of convalescent plasma as a treatment for Covid-19 for mild or severe cases, but some U.S. experts disagree with the recommendations and say there are patients who can benefit from the plasma of those who’ve recovered from Covid-19.
The recommendation is informed by a review of 16 RCTs and a “meta-analysis on antibodies and cellular therapies for covid-19,” the WHO said, adding in a statement:
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