Watch out Am­gen and Te­va, Eli Lil­ly got its green light for a ri­val CGRP mi­graine drug — and they’re com­ing af­ter you

Eli Lil­ly has just scored the third FDA OK for a CGRP mi­graine drug, and now the phar­ma gi­ant is set­ting out to leapfrog the pi­o­neers who made it to mar­ket first.

The agency came through with the for­mal ap­proval of Em­gal­i­ty (gal­canezum­ab) on Thurs­day night, set­ting the stage for an am­bi­tious and ag­gres­sive mar­ket­ing en­gine to get revved up for a tire-burn­ing late start.

Wei-Li Shao

“We cer­tain­ly don’t think it’s a me-too sit­u­a­tion,” says Wei-Li Shao, vice pres­i­dent of the neu­ro­science busi­ness at Eli Lil­ly. 

Ob­jec­tive­ly, even some of the top play­ers in this group — such as ex-Am­gen R&D chief Sean Harp­er — rec­og­nize that the da­ta on these new CGRP drugs bear a lot of sim­i­lar­i­ties. Am­gen set the price lev­el with its $575 per month rate, which Te­va fell in line with. And now Eli Lil­ly is fol­low­ing that move down to the pen­ny.

So there’s a lot of com­pet­i­tive me-too think­ing that’s go­ing on here. But Eli Lil­ly is shoot­ing for best-in-class sta­tus by stak­ing claims to three key mes­sages:

  1. Da­ta. One in sev­en of their pa­tients achieved “mi­graine free­dom,” which is some­thing you can ex­pect to hear a lot about as the pro­mo­tion­al work be­gins. There’s no guar­an­tee, says Shao, but the pos­si­bil­i­ty of free­dom from fur­ther mi­graines could be a com­pelling lure.
    True, “most (pa­tients) get about a 50% re­duc­tion,” he says, “but this shot at mi­graine free­dom is an im­por­tant dif­fer­en­tia­tor.”
  2. Ac­cess. Lil­ly is ready to roll with a promise that con­sumers will get a chance to start tak­ing their drug with no out-of-pock­et con­tri­bu­tions to be con­cerned about.
  3. Ease of use. Lil­ly, no stranger to ad­dress­ing ma­jor mar­ket dis­eases where pa­tients have to get ac­tive­ly in­volved in dos­ing, is launch­ing with an au­to in­jec­tor that most peo­ple who use the drug should be able to swing, no prob­lem.
Er­ic Pearl­man

This is a mar­ket they as­sess as 30 mil­lion pa­tients strong, where on­ly 10% of pa­tients are be­ing treat­ed, says Er­ic Pearl­man, se­nior med­ical fel­low at Eli Lil­ly. So they know the mar­ket is big enough to carve out some big pa­tient pop­u­la­tions. An­a­lysts wouldn’t dis­agree. Some of the top ob­servers in the field be­lieve these com­pa­nies will divvy up a mar­ket with $5 bil­lion to $6 bil­lion in sales po­ten­tial by the mid-’20s as the full field of drugs are out there. Alder will like­ly be the 4th play­er, but can’t ar­rive be­fore next year.

Lil­ly has a no­table pres­ence in di­a­betes as well as on­col­o­gy, but it sees a big fu­ture for it­self in pain. 

Las­mid­i­tan has made some im­pres­sive marks in late phase de­vel­op­ment, promis­ing to add to its pres­ence in the pain field. And then there’s tanezum­ab for chron­ic pain, where there’s al­so some big ex­pec­ta­tions for fu­ture rev­enue growth.

For Lil­ly, its mi­graine drug of­fers a chance for the mar­ket­ing team to make up for time lost to an R&D group known for a steady — if not slow — ap­proach to de­vel­op­ment work.

Just be­cause they’re start­ing in third place doesn’t mean they can’t be the leader in short or­der. Now they get to prove it.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Up­dat­ed: Amid mas­sive re­struc­tur­ing, Bio­gen looks to re­duce phys­i­cal pres­ence in Boston

Biogen is putting a sizable chunk of office and research space in Kendall Square and Weston, MA up for sublease, marking another big change as the biotech grapples with the aftershock of a disastrous and controversial rollout for its Alzheimer’s drug.

The subbleases are “part of Biogen’s overall implementation of the ‘Future of Work,’ which is allowing us to optimize our footprint and reduce the amount of space we occupy, taking into consideration new elements such as the hybrid work model,” Biogen spokesperson Ashleigh Koss wrote in a statement to Endpoints News, adding that the company has had subleases across several buildings for years.

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Who are the women blaz­ing trails in bio­phar­ma R&D? Nom­i­nate them for End­points' 2022 spe­cial re­port

Over the past three years, Endpoints News has spotlighted 60 women who have blazed trails and supercharged R&D across the biopharma world. And judging from the response we’ve received, to both our special reports and live events, telling their stories — including any obstacles they may have had to overcome — has inspired our readers in many different ways.

But change takes time, and the fact remains that women are still underrepresented at the upper ranks of the drug-making world.

Hervé Affagard, MaaT Pharma CEO

One year in­to clin­i­cal hold, FDA has more ques­tions about 'pooled' mi­cro­bio­me ther­a­py

The FDA is still wary about a trial testing a microbiome therapy in patients with steroid-resistant acute graft-versus-host disease (aGVHD).

A year after MaaT Pharma’s IND application in the US was first met with a clinical hold, the French biotech said the agency is maintaining the hold. The crux of the matter, MaaT suggested, has to do with the way it puts together its drug candidate, which is administered as an enema (i.e. an injection of fluid into the bowel).

Pfiz­er launch­es re­bate pro­gram for rare dis­ease pa­tients who have to stop tak­ing Panzy­ga

Pfizer is launching its second-ever rebate program, this time for Panzyga, its treatment for a rare neurological disease of the peripheral nerves.

The program began last month, according to STAT which first reported the news, and offers a refund of out-of-pocket costs for patients who must discontinue their course before the fifth treatment for “clinical reasons.”

Panzyga was approved back in 2018 to treat primary immunodeficiency (PI) in patients two years and older and chronic immune thrombocytopenia (cITP) in adults. It has since picked up an indication in chronic inflammatory demyelinating polyneuropathy (CIDP), a condition that’s characterized by weakness of the arms or legs, tingling or numbness, and a loss of deep tendon reflexes, according to the NIH.

Horizon's back-to-school campaign for children with cystinosis includes an all about me poster as part of a care package box.

Hori­zon read­ies kids and fam­i­lies for back to school with week­long ac­tiv­i­ties around rare dis­ease cysti­nosis

Going back to school is usually a bumpy readjustment from summer freedom for all kids, but especially for kids with chronic health conditions. Horizon Therapeutics is hoping to help smooth the way for some who have the rare disease cystinosis. Cystinosis is a genetic disease that causes the amino acid cystine to build up in different tissues and organs.

The “Gear Up” for school campaign is running all week with different online and at-home events and activities for families and children with cystinosis. Each family who signed up receives a care package mailed to their home including an activity coloring book “Michael’s Show-and-Tell.” The book tells Michael’s story about living with cystinosis while offering kids matching, coloring and finding object games along with information.

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Phar­mas spend mil­lions on di­a­betes ad­ver­tis­ing, but few pa­tients can re­call brand names — sur­vey

While many Big Pharma diabetes brands spend millions of dollars on TV ads every year, most people with type 2 diabetes don’t recognize specific drug brand names, according to a new study.

No brand garnered more than 30% recognition in Phreesia Life Science’s latest in-office patient survey of more than 4,000 adults with type 2 diabetes. Eli Lilly’s Trulicity topped the list as the most recognized brand with 29% of those surveyed recalling it, followed by Boehringer Ingelheim and Lilly’s Jardiance at 27% and Merck’s Januvia and Novo Nordisk tying for the third spot with 24%. Meanwhile, 76% of the patients surveyed were familiar with the generic treatment metformin.

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Faced with thou­sands of opi­oid law­suits, En­do says it will like­ly file for bank­rupt­cy 'im­mi­nent­ly'

Endo International will likely be the next pharma company to file for bankruptcy under a mountain of opioid lawsuits.

The Dublin, Ireland-based company revealed in its Q2 results on Tuesday that it’s in talks with first lien creditors, and that “these negotiations will likely result in a pre-arranged filing under Chapter 11 of the U.S. Bankruptcy Code by Endo International plc and substantially all of its subsidiaries, which could occur imminently.”

Feud be­tween two biotechs left near­ly 12M dos­es of mon­key­pox an­tivi­ral on the ta­ble

As the US embarks on a new delivery strategy to stretch out its thinning supply of monkeypox vaccines, the need for treatments could pick up as cases of the virus rise. And the amount of courses of one potential antiviral, soon to be clinically tested for efficacy in humans, was almost 12 million more than it is today, according to SEC filings.

While not greenlit for treating monkeypox, SIGA’s FDA-approved smallpox antiviral, Tpoxx, can be requested by physicians under an expanded use program. As of Monday, HHS tells Endpoints News it had tapped into more than 15,000 of the 1.7 million courses of Tpoxx that have been stockpiled, but with cases climbing over the past few weeks, demand will likely not peter out in the near future, especially if the vaccine supply runs dry.

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