Roche is bring­ing back gan­tenerum­ab from the dead, tak­ing an­oth­er stab at Alzheimer’s PhI­II

Mar­lies Spro­ll, Mor­phoSys

Alzheimer’s drugs are ex­pen­sive to test and un­like­ly to suc­ceed, but they are al­so hard to kill.

More than two years af­ter gan­tenerum­ab failed de­ci­sive­ly in treat­ing ear­ly-stage Alzheimer’s, Roche is map­ping out an at­tempt­ed come­back through a new, piv­otal Phase III pro­gram that puts them back in­to the late-stage pipeline with their sec­ond ther­a­py.

In­ves­ti­ga­tors stub­born­ly vowed back at an in­ter­na­tion­al Alzheimer’s con­fer­ence in 2015 that if you amped up the dosage of the amy­loid be­ta an­ti­body it would be pos­si­ble to track a re­al treat­ment ef­fect for Alzheimer’s, im­prov­ing cog­ni­tion and func­tion. And now Roche part­ner Mor­phoSys, which con­tributed its plat­form tech in dis­cov­er­ing the drug, says the phar­ma gi­ant is go­ing for it — again.

The Ger­man biotech says that its con­tacts at Roche are plan­ning to launch two Phase III stud­ies in mild to pro­dro­mal pa­tients some­time lat­er in the year, stick­ing to a group of pa­tients who are just be­gin­ning to demon­strate symp­toms of the mem­o­ry-wast­ing ail­ment.

Roche nev­er gave up on gan­tenerum­ab. Roche neu­ro­science de­vel­op­ment chief Paulo Fon­toura tells me they’ve been us­ing two ex­tend­ed stud­ies to see if they can safe­ly use a much, much high­er dose need­ed to have an im­pact on the dis­ease with­out stir­ring up dan­ger­ous lev­els of ARIA-E, or brain swelling.

“We want­ed to find out if 4- or 5-fold (high­er dos­es) would be suc­cess­ful,” Fon­toura tells me, while con­trol­ling any cas­es of ARIA-E. And all in­di­ca­tions,he adds, is that they are on the right track.

Noth­ing has worked in Alzheimer’s R&D over the last 14 years, and gan­tenerum­ab looked like it would join a list of the most promi­nent drugs in the field to wash out of a big Phase III. But re­searchers have al­so been em­bold­ened by bet­ter di­ag­nos­tics to se­lect pa­tients as well as by the ear­ly da­ta from Bio­gen’s ad­u­canum­ab pro­gram which has shown glim­mers of ef­fi­ca­cy. Eli Lil­ly on­ly re­cent­ly wrapped its last piv­otal shot at solanezum­ab, its third straight fail­ure.

Mer­ck has al­so con­tributed to the drum­beat of fail­ures, re­cent­ly con­ced­ing de­feat in the most ad­vanced study of a BACE drug that tried to move up­stream in the dis­ease process, pre­vent­ing the pro­duc­tion of tox­ic lev­els of amy­loid be­ta. And Lund­beck flopped with its three Phase III stud­ies of their 5-HT6 an­tag­o­nist idalopir­dine, leav­ing Ax­o­vant as the last com­pa­ny to test that symp­to­matic ap­proach in a piv­otal study.

Why the ded­i­ca­tion? There are no drugs that can mod­i­fy the pro­gres­sion of Alzheimer’s and a big de­mand for any new symp­to­matic ther­a­pies that can slow the im­pact of the dis­ease, leav­ing the field wide open for a block­buster in­tro­duc­tion. And with every set­back, re­searchers in­sist that the same drugs could work un­der dif­fer­ent cir­cum­stances.

Now Roche will soon have two piv­otal pro­grams for Alzheimer’s back in the clin­ic, with gan­tenerum­ab run­ning along­side crenezum­ab.

“This is great news for Mor­phoSys. We are de­light­ed by the strong com­mit­ment to gan­tenerum­ab as a po­ten­tial new ther­a­py for Alzheimer’s dis­ease”, com­ment­ed Mar­lies Spro­ll, the chief sci­en­tif­ic of­fi­cer of Mor­phoSys AG. “The Hu­CAL-de­rived an­ti­body gan­tenerum­ab has prop­er­ties that we be­lieve make it a promis­ing can­di­date to treat Alzheimer’s dis­ease, and we look for­ward to learn­ing more about these new Phase III tri­als.”

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

Almirall is tapping artificial intelligence on behalf of its sales force for insights and efficiencies. (via Shutterstock)

Almi­rall rolls out sales rep ar­ti­fi­cial in­tel­li­gence sys­tem, cut­ting pre-call prep and 'wind­shield time'

Dermatology specialty pharma Almirall is making its sales reps smarter. Not with extra training or educational courses, but instead with artificial intelligence tools.

It began a soft launch of a sales rep AI and machine learning platform it calls Polaris last August in one of its 7 US coverage regions. The platform from Aktana gathers information from across Almirall internal sources and external ones – such as claims and prescribing data – to generate insights for reps. Now, instead of spending hours prepping for a sales call, Polaris can generate details about a physician’s preferences, past behaviors and prescription habits for reps in minutes, said Almirall head of commercial operations Vincent Cerio.

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Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

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FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

Greg Mayes, Antios Therapeutics CEO

An­tios' HBV col­lab axed af­ter clin­i­cal hold, but biotech be­lieves safe­ty in­ci­dent is not treat­ment-re­lat­ed

The FDA has placed a clinical hold on a Phase IIa study of Antios Therapeutics’ investigational hepatitis B med, CEO Greg Mayes confirmed to Endpoints News in an emailed statement.

A safety report was delivered to the biotech on May 17 after a patient dosed in a triple combination cohort of the study had experienced bradycardia and hypotension. The triple combo included Antios’ ATI-2173, Assembly Biosciences’ vebicorvir and Viread, an approved antiviral for HIV and hepatitis B.

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Tim Schoen, BioMed Realty CEO

Life sci­ences de­vel­op­er Bio­Med Re­al­ty buys San Fran­cis­co ho­tel for $75M — re­port

In a somewhat unconventional deal, life sciences real estate developer BioMed Realty has bought a 169-room Hilton Garden Inn in South San Francisco for $75 million, the San Francisco Business Times reported.

BioMed Realty, an affiliate of Blackstone, has multiple life sciences and technology office projects in the Bay Area, including three sites within a five-minute drive of the hotel.

While the sale of the hotel property was announced earlier this month, the sellers, Summit and GIC, did not identify the buyer at the time.

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Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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