Court hands No­var­tis win in Gilenya patent fight; US states seek $26B+ in opi­oid cri­sis law­suit

No­var­tis has picked up a win in a long-run­ning patent fight against gener­ic ver­sions of its mul­ti­ple scle­ro­sis drug.

The com­pa­ny an­nounced Mon­day af­ter­noon that the va­lid­i­ty of its Gilenya, or fin­golimod, dos­ing reg­i­men has been up­held by the US Dis­trict Court of Delaware. As a re­sult, a com­pet­ing gener­ic fin­golimod be­ing pro­duced by HEC Pharm in­fringes on No­var­tis’ patent. The rul­ing can still be ap­pealed.

Mon­day’s de­ci­sion con­tin­ues the in­junc­tion against fin­golimod copy­cats, first grant­ed to No­var­tis in June 2019. At the time, My­lan’s plans to pro­duce a gener­ic ver­sion of GSK’s Ad­vair were al­so put on hold in or­der to al­low the No­var­tis suit to pro­ceed.

No­var­tis’ ex­clu­siv­i­ty win­dow for Gilenya in pe­di­atric treat­ments runs through De­cem­ber 25, 2027. The Swiss phar­ma first launched the MS drug back in 2010, net­ting huge prof­its over the years, in­clud­ing $738 mil­lion in the sec­ond quar­ter of 2020.

A throng of ri­val ther­a­pies have hit the mar­ket in re­cent years, how­ev­er, such as Mer­ck KG­gA’s Maven­clad and Roche’s Ocre­vus. And, back in De­cem­ber, the FDA ap­proved three Gilenya gener­ics ap­proved by the FDA back in De­cem­ber — in­clud­ing HEC Pharm’s prod­uct. When those drugs launch re­mains to be seen, giv­en the on­go­ing lit­i­ga­tion.

States seek $26B+ in opi­oid lit­i­ga­tion against dis­trib­u­tors

US states have sub­mit­ted a new re­quest in on­go­ing lit­i­ga­tion against drug dis­trib­u­tors re­lat­ed to the opi­oid epi­dem­ic.

The states are seek­ing about $26.4 bil­lion from dis­trib­u­tors McKesson, Amerisource­Ber­gen and Car­di­nal Health in an at­tempt to hold them ac­count­able for wide­spread drug ad­dic­tion, ac­cord­ing to a Wall Street Jour­nal re­port. J&J are al­so in­volved in the cur­rent talks.

Such com­pa­nies have come un­der scruti­ny for al­leged­ly fail­ing to stop or­ders from be­ing di­vert­ed for im­prop­er use. The com­pa­nies have de­nied the al­le­ga­tions, though some have reached set­tle­ments over in­ad­e­quate or­der-mon­i­tor­ing pro­grams.

More than 3,000 states, lo­cal gov­ern­ments and Na­tive Amer­i­can tribes have sued phar­ma­ceu­ti­cal play­ers over the opi­oid cri­sis. One case has gone to tri­al, pe­nal­iz­ing J&J to the tune of $465 mil­lion, while an­oth­er spurred bank­rupt­cy fil­ings from Pur­due Phar­ma.

New NASH play­er en­ters ail­ing field

A ma­jor play­er in the South Ko­re­an mar­ket is putting up big cash hop­ing to find an ef­fec­tive treat­ment in the ail­ing NASH field.

LG Chem, a di­vi­sion of the LG multi­na­tion­al con­glom­er­ate, an­nounced late Mon­day that it will com­mit $350 mil­lion to col­lab­o­rate with Chi­nese biotech Trans­Thera to de­vel­op and com­mer­cial­ize TT-01025, a pre­clin­i­cal NASH ther­a­py that in­hibits the pro­tein SSAO/VAP-1. Trans­Thera gets up­front cash and mile­stone pay­ments while LG Chem ob­tains ex­clu­sive world­wide rights with the ex­cep­tion of Chi­na and Japan.

The can­di­date is cur­rent­ly ex­pect­ed to en­ter Phase I some­time ear­ly next year.

NASH is a chron­ic and pro­gres­sive liv­er dis­ease char­ac­ter­ized by fat ac­cu­mu­la­tion and in­flam­ma­tion in the liv­er, which can lead to fi­bro­sis and im­paired liv­er func­tion. There are cur­rent­ly no ap­proved drugs in the in­di­ca­tion, but that doesn’t mean re­searchers haven’t tried over the years.

Back in June, the FDA re­ject­ed a com­pound from In­ter­cept Phar­ma­ceu­ti­cals af­ter it yield­ed the field’s first pos­i­tive Phase III da­ta in Feb­ru­ary 2019. The move was crit­i­cized by the biotech’s CEO who called the re­view “in­com­plete” at the time. A Gilead three-drug cock­tail al­so flopped a Phase II study in late 2019.

Cur­rent­ly, the new most ad­vanced NASH can­di­date comes from Akero, whose lead drug beat place­bo in Phase II tri­als mea­sur­ing liv­er re­duc­tion. An­a­lysts at the time called it the “best-in-class NASH da­ta so far.”

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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The flu virus (CDC)

Roche tacks on an­oth­er Xofluza in­di­ca­tion as flu sea­son meets pan­dem­ic

Xofluza was heralded as the first new flu drug in 20 years when it got the FDA OK back in 2018. But even so, Roche saw tough competition from cheaper Tamiflu generics that appeared to be nearly as — if not just as — effective.

Now, the pharma says the drug also can be used to prevent influenza after exposure, snagging a new approval and adding to Xofluza’s appeal as flu season meets the pandemic.

A poll sug­gests vac­cine da­ta boost­ed Pfiz­er's pub­lic im­age, but oth­er da­ta point to long road ahead

For much of the pharmaceutical industry, the pandemic presented an opportunity: to prove their value to the world and turn public opinion around on a business much of the country had come to disdain.

That theory — that helping pull the country from a pandemic could neutralize years of anger over high drug prices — was put to its biggest test this month, as three different drugmakers announced data from their Covid-19 vaccines, offering the first major evidence that industry-built inoculations could turn the tide of the outbreak in the US.

Covid-19 roundup: Rus­sia prices vac­cine 't­wo or more times cheap­er' than mR­NA shots; Sino­vac PhI­II da­ta ex­pect­ed in ear­ly De­cem­ber

The world can now purchase its first registered vaccine — at less than $10 per dose.

RDIF, the Russian sovereign wealth fund and an avid backer of Sputnik V, said the vaccine will be available internationally starting from March 2021. A two-dose regimen of the adenovirus-based vaccine, which it has said is more than 90% effective, will cost less than $20.

And they are not shy about inserting themselves right into a rivalry with Western frontrunners, namely Pfizer/BioNTech and Moderna.

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

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