Cell­tri­on's rheuma­toid arthri­tis drug meets both end­points in PhI­II; New com­pa­ny Tri­bune emerges to take on fi­brot­ic dis­eases

Cell­tri­on Health­care an­nounced pos­i­tive re­sults from its year-long Phase III tri­al of its rheuma­toid arthri­tis drug Yu­fly­ma in pa­tients re­ceiv­ing ther­a­py on Tues­day, as the tri­al met both the pri­ma­ry and sec­ondary end­points.

The tri­al in pa­tients with mod­er­ate-to-se­vere RA test­ed 3 groups: 1 in pa­tients who re­ceived 40 mg of CT-P17 or 1 that re­ceived the ref­er­ence drug Hu­mi­ra, and a third that switched from Hu­mi­ra to CP-P17 halfway through the tri­al, for the re­main­der of the year.

The av­er­age Ctrough lev­els were main­tained af­ter week 24 in all 3 treat­ment groups, and the safe­ty pro­file was com­pa­ra­ble across all 3 groups. An­ti-drug an­ti­body and neu­tral­iz­ing an­ti­body re­sults were sim­i­lar across the 3 groups too, with 28.4%/24.8% in CT-P17 main­te­nance, 27.0%/24.3% in ref­er­ence to Hu­mi­ra main­te­nance and 28.3%/26.3% in switched to CT-P17 groups. — Josh Sul­li­van

New com­pa­ny Tri­bune emerges to take on Fi­brot­ic dis­eases

No­vo Hold­ings and Health­Cap an­nounced on Wednes­day that they have joined forces to cre­ate Tri­bune Ther­a­peu­tics, a com­pa­ny fo­cused on tar­get­ing fi­brot­ic dis­eases.

Tri­bune has emerged from stealth mode as a com­pa­ny found­ed in 2020 with a pipeline the com­pa­ny has called promis­ing, and ready to take on a range of fi­brot­ic dis­eases, in­clud­ing those that af­fect the kid­ney, lung and liv­er. The pipeline is based on re­search from Hå­vard At­tra­madal’s lab at Oslo Uni­ver­si­ty Hos­pi­tal.

Georg Vo Beiske,  the in­com­ing CEO of Tri­bune, said in a state­ment:

There is a great need for nov­el treat­ment op­tions for pa­tients suf­fer­ing from fi­brot­ic dis­eases. Tri­bune Ther­a­peu­tics is built on strong sci­ence and has the po­ten­tial to de­vel­op life-chang­ing ther­a­pies for these pa­tients. With the sup­port of No­vo Seeds and Health­Cap we are ea­ger to bring the sci­ence in­to phar­ma­ceu­ti­cal de­vel­op­ment.

— Josh Sul­li­van

Kine­ta scores fi­nanc­ing for sol­id tu­mor an­ti­body

A Seat­tle-based biotech fo­cused on on­col­o­gy closed a $10 mil­lion fi­nanc­ing round Tues­day.

Kine­ta is el­i­gi­ble to re­ceive up to $25 mil­lion in ad­di­tion­al fi­nanc­ing be­fore the end of 2021, the com­pa­ny said in a re­lease. The round was led by Cheong­bo In­dus­tri­al. The pro­ceeds will go to­ward ad­vanc­ing Kine­ta’s an­ti-VISTA an­ti­body KVA12.1 to an in­ves­ti­ga­tion­al new drug ap­pli­ca­tion with the FDA.

CEO Shawn Iado­na­to said in the press re­lease:

We are ex­cit­ed to have the con­fi­dence of this lead­ing in­vestor syn­di­cate in sup­port­ing KVA12.1 and our pipeline of nov­el im­munother­a­pies.  Clos­ing this fi­nanc­ing round fur­ther val­i­dates the in­no­v­a­tive re­search and de­vel­op­ment at Kine­ta. These new funds pro­vide the re­sources to ad­vance the pre­clin­i­cal de­vel­op­ment of our po­ten­tial best-in-class an­ti-VISTA an­ti­body to ben­e­fit pa­tients with a broad range of sol­id tu­mor can­cers.

An in­vestor from CBI, to be named lat­er, will al­so join the Kine­ta board of di­rec­tors.

KVA12.1 is an an­ti-VISA an­ti­body in de­vel­op­ment for the treat­ment of sol­id tu­mors. VISTA block­ades can re­pro­gram sup­pres­sive myeloid cells and re­ac­ti­vate an­ti­tu­mor im­mune func­tion. — Josh Sul­li­van

As­traZeneca and Pro­teros team up in can­cer part­ner­ship

As­traZeneca is ap­point­ing a Ger­man com­pa­ny as a new col­lab­o­ra­tion part­ner, with the duo go­ing af­ter dif­fer­ent types of can­cer.

The Big Phar­ma will team up with Pro­teros Biostruc­tures on an un­spec­i­fied num­ber of new pro­grams, the pair an­nounced Wednes­day. As­traZeneca will pay out up to $75.6 mil­lion in po­ten­tial mile­stones to take Pro­teros re­search and push them for­ward in­to the clin­ic.

“Pro­teros’ pro­pri­etary dis­cov­ery plat­form en­ables us to screen epi­ge­net­ic tar­gets in a phys­i­o­log­i­cal­ly rel­e­vant set­ting, sup­port­ing ac­cel­er­at­ed dis­cov­ery and de­vel­op­ment of the next wave of an­ti-can­cer med­i­cines,” As­traZeneca se­nior VP of on­col­o­gy R&D Su­san Gal­braith said in a state­ment.

Pro­teros works with sev­er­al phar­ma com­pa­nies and biotechs to pro­vide ear­ly-stage ser­vices. The com­pa­ny says it helps “most” of the world’s 20 biggest phar­ma com­pa­nies and more than 250 bio­phar­mas. — Max Gel­man

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.

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.

Chica­go-area biotech sends 2nd drug to In­di­a's reg­u­la­tors; Pen­ny stock play­er spins out PhI­II can­cer can­di­date in­to new com­pa­ny

Pharmazz is on its way to India’s drug regulator for the second time as its investigational treatment passed muster in a Phase III study in patients with acute ischemic stroke.

The Chicago suburbs-based biotech said its drug sovateltide led to better improvement than placebo on certain measurements of neurological outcomes.

Sovateltide led an improvement of ≥2 points on mRS and an increase of ≥6 points on NIHSS at day 90 in the trial of 158 adults in India. The modified Rankin scale looks at the degree of dependence in the daily activities of people post-stroke event, and the NIH stroke scale measures the stroke-related neurologic deficit.

Pfizer CEO Albert Bourla at the World Economic Forum (Gian Ehrenzeller/Keystone via AP Images)

All about ac­cess: Pfiz­er moves to a non-prof­it mod­el for drug sales in 45 low­er-in­come coun­tries

Leading the way to increase access to cheaper drugs worldwide, Pfizer said Wednesday it will provide all current and future patent-protected medicines and vaccines available in the US or EU on a not-for-profit basis to about 1.2 billion people in 45 lower-income countries.

Rwanda, Ghana, Malawi, Senegal and Uganda are the first five countries to sign on to this accord, which will also seek to blaze new paths for quick and efficient regulatory and procurement processes to reduce the usual delays in making new medicines and vaccines available in these countries.

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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Te­va, Al­ler­gan reach yet an­oth­er opi­oid set­tle­ment — ef­fec­tive­ly end­ing WV tri­al

Teva and Allergan have reached settlements with multiple states over their involvement in the opioid crisis. Their latest is worth 9 figures.

West Virginia attorney general Patrick Morrisey announced the newest settlement, worth $161.5 million, at a press conference on Wednesday. The deal would resolve claims that the companies helped fuel the state’s opioid epidemic. If it goes through, it could become the largest state-negotiated settlement in West Virginia’s history, according to Reuters.