Delaware court rules against Gilead and Astel­las in years-long patent case

A judge in Delaware has ruled against Astel­las Phar­ma and Gilead in a long-run­ning patent case over Pfiz­er-on­wed Hos­pi­ra’s gener­ic ver­sion of Lex­is­can.

The case kicked off in 2018, af­ter Hos­pi­ra sub­mit­ted an Ab­bre­vi­at­ed New Drug Ap­pli­ca­tion (AN­DA) for ap­proval to mar­ket a gener­ic ver­sion of Gilead’s Lex­is­can. The drug is used in my­ocar­dial per­fu­sion imag­ing (MPI), a type of nu­clear stress test.

Gilead and Astel­las al­leged that Hos­pi­ra’s AN­DA sub­mis­sion for re­gadeno­son in­fringed up­on sev­er­al patents, and sought a de­clara­to­ry judg­ment that Hos­pi­ra’s man­u­fac­tur­ing of the prod­uct would con­sti­tute a di­rect and in­duced in­fringe­ment. Hos­pi­ra de­nied the al­le­ga­tions, as­sert­ing in its de­fense that the patents are in­valid and fil­ing coun­ter­claims seek­ing judg­ments of non­in­fringe­ment.

Af­ter a three-day bench tri­al, Judge Colm Con­nol­ly ruled against Gilead and Astel­las. Con­nol­ly stat­ed that Gilead and Astel­las failed to prove any di­rect in­fringe­ment, and did not meet any bur­den to es­tab­lish that in­fringe­ment was breached. The par­ties are await­ing a fi­nal judge­ment.

The de­ci­sion comes as Astel­las wrote off more than half a bil­lion dol­lars in loss­es last month and gut­ted can­di­dates that were once thought to have mas­sive po­ten­tial. The com­pa­ny booked an “im­pair­ment loss” over two fis­cal quar­ters back in April, about a year af­ter writ­ing off $540 mil­lion fol­low­ing a clin­i­cal hold on its lead gene ther­a­py AT132.

For Gilead, while the com­pa­ny re­mains high on the For­tune 500 list, it suf­fered a set­back ear­li­er this year when the FDA slapped par­tial holds on stud­ies eval­u­at­ing ma­grolimab with azac­i­ti­dine. The FDA lift­ed its par­tial hold on those stud­ies last month, and Gilead said it’s on track for an in­ter­im read­out in 2023.

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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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.

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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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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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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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.

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.