UP­DAT­ED: FDA warns small biotech Ocu­gen of po­ten­tial $10K fines for fail­ing to post tri­al re­sults

The FDA is back to warn­ing com­pa­nies of $10,000 fines for fail­ing to re­port the re­sults of clin­i­cal tri­als, this time go­ing af­ter clin­i­cal stage biotech com­pa­ny Ocu­gen, known most re­cent­ly for try­ing to bring a Covid-19 vac­cine from In­dia to the US and oth­er mar­kets.

The tri­al in ques­tion with FDA, com­plet­ed in May 2019, was a Phase III study of bri­moni­dine tar­trate na­noemul­sion eye drop to treat dry eye dis­ease. The com­pa­ny said in an SEC fil­ing in Nov. 2019 that the Phase III tri­al has com­plet­ed “and al­though the study showed that OCU310 is well tol­er­at­ed, as demon­strat­ed by no ad­verse events re­gard­ing as ‘se­vere,’ it did not meet its co-pri­ma­ry end­points for symp­toms and signs.”

The FDA is now giv­ing Ocu­gen un­til May 15 to post the re­sults from the tri­al. Al­though as not­ed by the non­prof­it Transparimed, which has ded­i­cat­ed re­sources to help this kind of re­port­ing, it’s un­clear why the FDA is tak­ing so long to tar­get com­pa­nies af­ter their tri­als fin­ish, and to fol­low up af­ter the com­pa­ny doesn’t re­spond to an ini­tial let­ter. The agency pre­vi­ous­ly sent more than 40 “Pre-No­tices of Non­com­pli­ance” to en­cour­age com­pli­ance with the Clin­i­cal­Tri­als.gov re­quire­ments.

But it’s been al­most a year since the FDA warned the first com­pa­ny for this type of in­frac­tion, as it warned Ac­celeron for its fail­ure to post re­sults from a can­cer tri­al, and sim­i­lar­ly said the com­pa­ny has 30 days to cor­rect this fail­ure or it may have to pay a $10,000 penal­ty or face crim­i­nal pros­e­cu­tion. It’s un­clear if any of the fines have ac­tu­al­ly been levied.

The agency al­so has tar­get­ed in­di­vid­u­als run­ning tri­als, in­clud­ing Los An­ge­les-based urog­y­ne­col­o­gist An­drey Petrikovets, who failed to re­lease re­sults from his tri­al, known as,”ICE-T Post­op­er­a­tive Mul­ti­modal Pain Reg­i­men Com­pared to the Stan­dard Reg­i­men in Same Day Vagi­nal Pelvic Re­con­struc­tive Surgery: A Ran­dom­ized Con­trolled Tri­al.”

Mean­while, the pres­sure is on FDA to do more in this area. A group known as the Uni­ver­si­ties Al­lied for Es­sen­tial Med­i­cines is call­ing on FDA com­mis­sion­er Rob Califf to help the agency do its job of en­forc­ing these tri­al pub­lish­ing re­quire­ments.

“Al­though vi­o­la­tions of the law have been so fre­quent and so fla­grant that they could have gen­er­at­ed over $30 bil­lion in fines to date, the FDA has his­tor­i­cal­ly ne­glect­ed its du­ty to en­force FDAAA,” the UAEM wrote in a let­ter to Califf last week. “The FDA should there­fore es­tab­lish an ac­tion­able pri­or­i­ti­za­tion frame­work for en­force­ment of FDAAA, and demon­strate an in­tent to be­gin more rig­or­ous en­force­ment.”

Ocu­gen told End­points News in an emailed state­ment:

Ocu­gen is com­mit­ted to com­pli­ance and takes trans­paren­cy re­gard­ing clin­i­cal da­ta and tri­al re­port­ing se­ri­ous­ly. We sub­mit­ted in­for­ma­tion to up­date the site af­ter tri­al was com­plet­ed. In No­vem­ber 2021, we up­dat­ed the site with ad­di­tion­al in­for­ma­tion, which is not re­flect­ed. We’ve been aware of the lat­est U.S. Food & Drug Ad­min­is­tra­tion’s re­quest to up­date clin­i­cal­tri­als.gov with re­sults of our dis­con­tin­ued, OCU310 pro­gram.  We’ve been in di­a­log with the agency ever since re­ceipt of their let­ter and we will sub­mit in­for­ma­tion as re­quest­ed ahead of their dead­line.

Ed­i­tor’s note: Ar­ti­cle up­dat­ed with com­ment from Ocu­gen above.

Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,600+ biopharma pros reading Endpoints daily — and it's free.

Bob Nelsen (Lyell)

As bear mar­ket con­tin­ues to beat down biotech, ARCH clos­es a $3B ear­ly-stage fund

One of the biggest names in biotech investing has a whole lot of new money to spend.

ARCH Venture Partners closed its 12th venture fund early Wednesday morning, the firm said, bringing in almost $3 billion to invest in early-stage biotechs. The move comes about a year and a half after ARCH announced its previous fund, for almost $2 billion back in January 2021.

In a statement, ARCH managing director and co-founder Bob Nelsen appeared to brush off concerns about the broader market troubles, alluding to the downturn that’s seen several biotechs downsize and the XBI fall back to almost pre-pandemic levels.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,600+ biopharma pros reading Endpoints daily — and it's free.

Sanofi to cut in­sulin prices for unin­sured from $99 to $35, match­ing the in­sulin cap com­ing through Con­gress

As the House-passed bill to cap the monthly price of insulin at $35 nationwide makes its way for a Senate vote soon, Sanofi announced Wednesday morning that beginning next month it will cut the monthly price of its insulins for uninsured Americans to $35, down from $99 previously.

The announcement from Sanofi, which allows the uninsured to buy one or multiple Sanofi insulins (Lantus, Insulin Glargine U-100, Toujeo, Admelog, and Apidra) at $35 for a 30-day supply effective July 1, follows House passage (232-193) of the monthly cap in March, with just 12 Republicans voting in favor of the measure.

Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,600+ biopharma pros reading Endpoints daily — and it's free.

How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Aurobindo Pharma co-founders P. V. Ram Prasad Reddy (L) and K. Nityananda Reddy

Au­robindo Phar­ma re­ceives warn­ing let­ter from In­di­a's SEC fol­low­ing more FDA ques­tion marks

Indian-based generics manufacturer Aurobindo Pharma has been in the crosshairs of the FDA for several years now, but the company is also attracting attention from regulators within the subcontinent.

According to the Indian business news site Business Standard, a warning letter was sent to the company from the Securities Exchange Board of India, or SEBI.

The letter is related to disclosures made by the company on an ongoing FDA audit of the company’s Unit-1 API facility in Hyderabad, India as well as observations made by the US regulator between 2019 and 2022.

Ankit Mahadevia, Spero CEO

Spero’s UTI can­di­date gets the CRL ham­mer as the com­pa­ny falls in­to pen­ny stock sta­tus

Spero Therapeutics has been struggling in the past few years, dealing with FDA holds and staff reductions amidst a rough biotech market, and the latest news from the Massachusetts-based company confirms what it anticipated in May: a CRL.

The company was slapped with the no-go for its NDA, the biotech disclosed Monday. The company was seeking approval for tebipenem HBr oral tablets, intended for the treatment of adult patients with complicated urinary tract infection, or cUTI, including pyelonephritis. The FDA had set a PDUFA date of June 27.

Hank Safferstein, Generian CEO

Astel­las sub­sidiary to part­ner with Pitts­burgh up­start in search for 'un­drug­gable' pro­teins

As Astellas continues its drive to build out its gene therapy portfolio and capabilities, a subsidiary of the Japanese pharma company has entered into a collaboration with a little-known Pittsburgh biotech.

Astellas-owned Mitobridge and Generian Pharmaceuticals announced on Wednesday that they will work together in a new deal for “undruggable” protein targets. Generian will net an undisclosed upfront payment and could get up to $180 million in milestones, should anything from its platform prove successful, as well as single-digit royalties on global net sales.

Adam Simpson, Icosavax CEO

Reel­ing from Covid flop, Icosavax says its RSV can­di­date passed ear­ly test. But in­vestors need some more con­vinc­ing

Three months separated from a disappointing readout of its Covid-19 vaccine, Icosavax is back with what it calls positive topline data for a different VLP vaccine candidate — although investors aren’t impressed.

IVX-121, a vaccine candidate for respiratory syncytial virus (RSV), appeared to generate “robust” immune responses among both young and older adults, as measured by neutralizing antibodies, and appeared generally well-tolerated, Icosavax reported.