Thomas Appio, Bausch Health CEO

Bausch Health as­serts push to 'vig­or­ous­ly' de­fend Xi­fax­an patent lit­i­ga­tion 

Bausch Health will con­tin­ue lit­i­gat­ing over its Xi­fax­an drug, threat­en­ing to ap­peal all the way up to the US Court of Ap­peals for the Fed­er­al Cir­cuit.

The Que­bec-based com­pa­ny, through its gas­troen­terol­o­gy busi­ness Sal­ix Phar­ma­ceu­ti­cals, said it will file an ap­peal if the fi­nal or­der is con­sis­tent with an oral or­der in a Delaware dis­trict court last week cen­tered around a case against Nor­wich Phar­ma­ceu­ti­cals.

The com­pa­ny has been here be­fore, hav­ing pre­vi­ous­ly en­tered in­to set­tle­ment agree­ments with Te­va, Sun Phar­ma­ceu­ti­cals and No­var­tis’ San­doz unit con­cern­ing a gener­ic ri­fax­imin prod­uct.

In the case vs. Nor­wich, al­so known as Alvo­gen, Bausch and its Sal­ix unit are at­tempt­ing to re­tain the patent on Xi­fa­van, known gener­i­cal­ly as ri­fax­imin, for the treat­ment of ir­ri­ta­ble bow­el syn­drome with di­ar­rhea (IBS-D) and re­duc­tion in risk of overt he­pat­ic en­cephalopa­thy (HE) re­cur­rence, a neu­ro­log­i­cal dis­or­der that is caused by chron­ic, se­vere liv­er dis­ease.

Ac­cord­ing to the oral or­der, not yet fi­nal­ized, the US Dis­trict Court of Delaware is ex­pect­ed to find cer­tain US patents pro­tect­ing the drug’s 550mg tablets for re­duc­tion in risk of HE re­cur­rence valid and in­fringed, Bausch said in a state­ment on Ju­ly 28. Fur­ther, the court is ex­pect­ed to find the US patents pro­tect­ing the com­po­si­tion and use of Xi­fax­an for treat­ing IBS-D in­valid.

“While the Court has not yet en­tered any fi­nal judge­ment, ab­sent Nor­wich’s re­moval of the HE in­di­ca­tion and da­ta from their Ab­bre­vi­at­ed New Drug Ap­pli­ca­tion (AN­DA), it is ex­pect­ed that the Court will en­join Nor­wich’s pend­ing AN­DA un­til ex­pi­ra­tion of the XI­FAX­AN HE Patents in 2029,” Bausch said in a state­ment.

With that, Bausch in­tends to “vig­or­ous­ly op­pose any at­tempt by Nor­wich to re­move the HE safe­ty da­ta from its AN­DA” in an ef­fort to side­step the patents. The com­pa­ny thrice men­tions it will “vig­or­ous­ly” de­fend its IP and pur­sue any route pos­si­ble to do so.

Nor­wich can’t launch a gener­ic equiv­a­lent of Xi­fax­an un­til a re­vised AN­DA ap­proval from the FDA and an ex­pect­ed in­junc­tion mod­i­fied by the court, Bausch said.

“We are dis­ap­point­ed with to­day’s de­vel­op­ment. We strong­ly dis­agree with any con­clu­sion that our patents are not valid and in­tend to file an ap­peal to any such or­der,” Bausch CEO Thomas Ap­pio said in a state­ment.

Un­der pre­vi­ous agree­ments with Te­va, Sun and San­doz, a gener­ic ver­sion of the drug can’t be sold un­til 2028 or up­on ear­li­er ap­proval and launch of such a prod­uct.

The IBS-D in­di­ca­tion was ap­proved in May 2015 af­ter se­cur­ing the HE nod in March 2010. It had al­so been ap­proved for trav­el­er’s di­ar­rhea in 2004.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

In­cyte hit by CRL on ex­tend­ed-re­lease JAK tablets, mud­dy­ing plans for Jakafi fran­chise ex­pan­sion

The FDA has rejected Incyte’s extended-release formulation of ruxolitinib tablets, in a surprise setback for the company’s plans to build on its blockbuster Jakafi franchise.

The ruxolitinib XR tablets are designed to be taken once a day, whereas Jakafi is indicated for twice daily dosage (although some patients can take it once daily).

According to Incyte, the FDA acknowledged in its complete response letter that the study submitted in the NDA “met its objective of bioequivalence based on area under the curve (AUC) parameters but identified additional requirements for approval.”

Zhi Hong, Brii Biosciences CEO

Brii Bio­sciences stops man­u­fac­tur­ing Covid-19 an­ti­body com­bo, plans to with­draw EUA re­quest

Brii Biosciences said it will stop manufacturing its Covid-19 antibody combination, sold in China, and is working to withdraw its emergency use authorization request in the US, which it started in October 2021.

The Beijing and North Carolina biotech commercially launched the treatment in China last July but is now axing the work and reverting resources to other “high-priority programs,” per a Friday update. The focus now is namely hepatitis B viral infection, postpartum depression and major depressive disorders.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

Sergio Traversa, Relmada Therapeutics CEO

Rel­ma­da makes 'crit­i­cal changes' to PhI­II tri­al to try and save de­pres­sion drug

Relmada Therapeutics is making changes to its Phase III study of its lead drug for major depressive disorder, in an attempt to avoid problems with a prior trial that showed little difference between the drug and a placebo.

That failure in October wiped 80% from Relmada’s stock price, and was followed by another negative readout a few months later. In both cases, the company said that there had been trial sites that were associated with what it called surprising placebo effects that skewed the results compared with the drug, REL-1017.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

Paul Song, NKGen Biotech CEO

NK cell ther­a­py-fo­cused biotech eyes SPAC deal

A small, Santa Ana-based biotech created in 2017 is looking to enter a SPAC deal as it lays out plans to begin trials in its lead cell therapy candidates and bring on new executives.

Graf Acquisition Corp. IV and NKGen Biotech announced Thursday, with few other details, that the two companies signed a non-binding letter of intent to “pursue a business combination.” Graf Acquisition II and III withdrew their IPOs last year.

Peter Hecht, Cyclerion Therapeutics CEO

Hard pressed for cash, Cy­cle­ri­on looks for help fund­ing rare dis­ease drug

Cyclerion Therapeutics may have the design of a Phase IIb study ready to go, but it’s scrambling for a way to fund it.

The company said in a press release that it’s “actively evaluating the best combination of capital, capabilities, and transactions available to it to advance the development of zagociguat,” its lead candidate for a rare, genetic mitochondrial disease known as MELAS.

In a separate SEC filing, Cyclerion once again flagged “substantial doubt about (its) ability to continue as a going concern.” As of the end of 2022, it had cash and cash equivalents of only $13.4 million.

Eu­ro­pean Com­mis­sion de­lays pro­pos­al for ma­jor changes to phar­ma leg­is­la­tion

The European Commission has once again delayed the release of its proposal for an overhaul of the continent’s pharmaceutical legislation.

The release, previously anticipated on March 29, will occur “slightly later” than expected due to the “very busy College agendas of the last few weeks,” a Commission spokesperson told Endpoints News via email.

While the agency hasn’t provided an updated timeline, the spokesperson said the agenda is “always indicative and adoption dates of Commission proposals may change any time, especially when these proposals concern reforms of complex legislations of major importance.”