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.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)

Pfiz­er makes an­oth­er bil­lion-dol­lar in­vest­ment in Eu­rope and ex­pands again in Michi­gan

Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe.

The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

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Vas Narasimhan, Novartis CEO (Thibault Camus/AP Images, Pool)

No­var­tis bol­sters Plu­vic­to's case in prostate can­cer with PhI­II re­sults

The prognosis is poor for metastatic castration-resistant prostate cancer (mCRPC) patients. Novartis wants to change that by making its recently approved Pluvicto available to patients earlier in their course of treatment.

The Swiss pharma giant unveiled Phase III results Monday suggesting that Pluvicto was able to halt disease progression in certain prostate cancer patients when administered after androgen-receptor pathway inhibitor (ARPI) therapy, but without prior taxane-based chemotherapy. The drug is currently approved for patients after they’ve received both ARPI and chemo.

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Yuling Li, Innoforce CEO

In­no­force opens new man­u­fac­tur­ing site in Chi­na

Innoforce is off to the races at its new site in the city of Hangzhou, China.

The Chinese CDMO announced last week that it has started manufacturing at the new facility, which was built to offer process development and manufacturing operations for RNA, plasmid DNA, viral vectors and other cell therapeutics. It will also serve as Innoforce’s corporate HQ.

The company said it’s investing more than $200 million in the 550,000-square-foot manufacturing base for advanced therapies. The GMP manufacturing facility features space for producing plasmids with three 30-liter bioreactors. For viral vector manufacturing, Innoforce also has 200- and 500-liter bioreactors at its disposal, along with eight suites to make cell therapies. The site also includes several labs and warehouse spaces.

FDA grants or­phan drug des­ig­na­tion to Al­ger­non's ifen­prodil, while ex­clu­siv­i­ty re­mains un­clear

As the FDA remains silent on orphan drug exclusivity in the wake of a controversial court case, the agency continues to hand out new designations. The latest: Algernon Pharmaceuticals’ experimental lung disease drug ifenprodil.

The Vancouver-based company announced on Monday that ifenprodil received orphan designation in idiopathic pulmonary fibrosis (IPF), a chronic lung condition that results in scarring of the lungs.  Most IPF patients suffer with a dry cough, and breathing can become difficult.

‘Catchy’ de­sign tops big ad buys on­line for grab­bing on­col­o­gists’ at­ten­tion — sur­vey

The cancer drug ads that get oncologists’ attention online are informative and use clear, eye-catching designs. That’s ZoomRx’s assessment in its most recent tracking survey, and while not necessarily surprising, the details in the research do break a few common misconceptions.

One of those is frequency, also known as the number of impressions an ad gets. No matter how many times oncologists saw a particular cancer drug ad, effectiveness prevailed in the survey across five drug brands. ZoomRx measured effectiveness as a combination of most attention-getting, relevant information and improved perception as reported by the doctors.

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Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Tim Walbert, Horizon Therapeutics CEO (via YouTube)

And then there were two: Janssen bows out of Hori­zon takeover ne­go­ti­a­tions

Horizon Therapeutics announced last week that it was in talks with three pharmaceutical giants that could take over the company. You can now remove one of them from the equation.

J&J’s Janssen, after Horizon reported its initial involvement in early discussions to acquire the rare disease biotech, issued a statement Saturday that said Janssen “does not intend to make an offer for Horizon,” and that Janssen is bound by restrictions set in Rule 2.8 of the Irish Takeover Rules. These rules are in place for any company interested in taking over Irish companies, with Horizon Therapeutics currently based in Dublin.

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Patrick Soon-Shiong (Evan Vucci/AP Images)

Up­dat­ed: Ar­bi­tra­tor awards $157M to Soon-Sh­iong's Im­mu­ni­ty­Bio in dis­pute with Sor­ren­to

Sorrento Therapeutics’ yearslong battle with NantCell and NANTibody has come to an arbitration award, but additional legal proceedings centered around a “catch-and-kill” scheme remain pending.

On Friday, the arbitrator in the dispute between Sorrento and NantCell and Immunotherapy NANTibody LLC issued an award that grants contractual damages and pre-award interest.

The arbitrator awarded NantCell (part of billionaire Patrick Soon-Shiong’s ImmunityBio) nearly $157 million and NANTibody close to $17 million. Post-award, prejudgment interest will accrue at 9% per annum, according to an SEC filing sent in by Sorrento.