No­var­tis wants to be a leader in a new gen­er­a­tion of pre­scrip­tion dig­i­tal med pro­grams, pairs with Pear

The new­ly emerg­ing field of pre­scrip­tion dig­i­tal med­i­cine is tak­ing a big step for­ward to­day.

Phar­ma gi­ant No­var­tis $NVS is pair­ing up with Pear Ther­a­peu­tics, one of the lead­ing pi­o­neers in the are­na, to de­vel­op new mo­bile apps for pa­tients with schiz­o­phre­nia and mul­ti­ple scle­ro­sis.

Joris van Dam

You may re­call that Pear broke new ground a few months ago by gain­ing an FDA ap­proval for an app de­signed to help pa­tients with sub­stance abuse dis­or­der. Now the Boston/Bay Area-based biotech will work with Joris van Dam, the ex­ec­u­tive di­rec­tor for dig­i­tal ther­a­peu­tics at the No­var­tis In­sti­tutes for Bio­Med­ical Re­search, on in­ter­ac­tive dig­i­tal pro­grams for schiz­o­phre­nia and mul­ti­ple scle­ro­sis.

Get­ting a heavy­weight play­er in the bio­phar­ma in­dus­try to col­lab­o­rate with 5-year-old Pear is a big plus for dig­i­tal med­i­cine, where cog­ni­tive be­hav­ioral pro­grams are be­ing de­vel­oped to help pa­tients with chron­ic dis­or­ders. And the FDA is play­ing a key as­sist in the field, with new guide­lines in the works on how these pro­grams can prove them­selves to of­fer proof of ef­fi­ca­cy and safe­ty.

These aren’t the av­er­age kind of apps you may be fa­mil­iar with on your phone.

“These are ther­a­peu­tic treat­ments pre­scribed by doc­tors and used by pa­tients,” says van Dam. “You should treat it like a drug ther­a­py, ex­cept it’s be­ing pre­scribed and ful­filled by the cloud and not by the phar­ma­cy.”

No­var­tis and Pear are plan­ning on set­ting up clin­i­cal tri­als that can, for ex­am­ple, test how these in­ter­ac­tive pro­grams work on con­trol­ling the pos­i­tive and neg­a­tive symp­toms as­so­ci­at­ed with schiz­o­phre­nia — in­clud­ing how you re­spond to hear­ing voic­es.

And No­var­tis sees some ready ben­e­fits in keep­ing a cog­ni­tive be­hav­ioral pro­gram in your pock­et. Un­like a ther­a­pist, says v

an Dam, you can run through a 15-minute pro­gram at your con­ve­nience, with­out jour­ney­ing to a ses­sion. And they’ll have clin­i­cians gath­er the da­ta need­ed to meet the re­quired end­points, stan­dards which are cur­rent­ly un­der re­view in a pi­lot pro­gram that in­cludes Pear.

So how long will this process take?

Van Dam says that’s un­cer­tain, but he feels that there’s a lot of po­ten­tial for a full slate of these dig­i­tal meds.

There’s no word on the ex­act terms, but No­var­tis is of­fer­ing a fa­mil­iar slate of up­front, re­search sup­port, mile­stones and roy­al­ties.

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

Chris Anzalone, Arrowhead CEO

Take­da, Ar­row­head spot­light da­ta from small tri­al show­ing RNAi works in a rare liv­er con­di­tion

Almost two years after Takeda wagered $300 million cash to partner with Arrowhead on an RNAi therapy for a rare disease, the companies are spelling out Phase II data that they believe put them one step closer to their big dreams.

In a small, open label study involving only 16 patients who had liver disease associated with alpha-1 antitrypsin deficiency (AATD), Arrowhead’s candidate — fazirsiran, previously ARO-AAT — spurred substantial reductions in accumulated mutant AAT protein in the liver, a hallmark of the condition. Investigators also tracked improvements in symptoms, with seven out of 12 who received the high, 200 mg dose seeing regression of liver fibrosis.

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Am­gen takes next step with its Chi­na am­bi­tions, out-li­cens­ing drugs to Fo­s­un Phar­ma

In a bid to increase its market share in China, Amgen has agreed to a partnership with a Shanghai biotech — a collaboration and out-licensing agreement for two of its drugs.

Amgen and Fosun Pharma announced a deal Monday in a bid to increase Amgen’s presence in the country. The stated goal so far is to commercialize Amgen’s blockbuster psoriasis drug Otezla alongside Parsabiv, a drug for secondary hyperparathyroidism in adults with chronic kidney disease and on a specific type of dialysis.

As court case looms, Bris­tol My­ers touts la­bel ex­pan­sion for Breyanzi

As Bristol Myers Squibb braces for a court battle over a costly delay — at least for Celgene shareholders — for its CAR-T lymphoma treatment Breyanzi, the pharma giant is touting a label expansion in the second-line setting.

Breyanzi, also known as liso-cel, snagged a win on Friday in adults with large B-cell lymphoma (LBCL) who: don’t respond to chemotherapy, or relapse within 12 months; don’t respond or relapse after 12 months; or are not eligible for hematopoietic stem cell transplant after chemo due to their age or comorbidities.

State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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A Mer­ck part­ner is sucked in­to the fi­nan­cial quag­mire as key lender calls in a note

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.