Pfiz­er los­es key Lyri­ca patent bat­tle in the UK; Kleo Phar­ma clos­es $21M Se­ries B round

→ The UK Supreme Court ruled against Pfiz­er $PFE and a patent in­volv­ing its block­buster painkiller Lyri­ca, in a ma­jor blow to the US drug­mak­er on Wednes­day. Orig­i­nal­ly de­vel­oped for epilep­sy, the drug was even­tu­al­ly cleared for use in neu­ro­path­ic pain that lat­er be­came its key mar­ket, mak­ing it one of Pfiz­er’s most suc­cess­ful drugs in the UK. Pfiz­er was hop­ing to pro­long a sec­ondary med­ical use patent for neu­ro­path­ic pain for the prod­uct, as the ba­sic patent on Lyri­ca that ex­pired five years ago al­lowed gener­ic drug­mak­ers to launch cheap­er ver­sions of the med­i­cine car­ry­ing a “skin­ny la­bel” lim­it­ing their use to epilep­sy and gen­er­al anx­i­ety dis­or­der, Reuters re­port­ed, These gener­ics would in­evitably be used as painkillers, Pfiz­er claimed in a law­suit, but af­ter the ap­peal was re­ject­ed in 2016, the case reached the SC. Pfiz­er’s sec­ondary neu­ro­path­ic pain patent ex­pired last year, the re­port added. The SC’s de­ci­sion con­sti­tutes a win for gener­ic drug­mak­ers Al­ler­gan $AGN and My­lan $MYL.

→ Im­muno-on­col­o­gy drug de­vel­op­er Kleo Phar­ma­ceu­ti­cals said it had closed an over­sub­scribed $21 mil­lion Se­ries B fi­nanc­ing round, led by its Tokyo-based part­ner Pep­tiDream and in­clud­ing par­tic­i­pa­tion of its strate­gic in­vestor and mi­graine drug de­vel­op­er Bio­haven $BHVN. Kleo is work­ing on a a new class of bi-spe­cif­ic, small mol­e­cule com­pounds de­signed to em­u­late or en­hance bi­o­log­ics against can­cer.

→ No­van $NOVN, which is de­vel­op­ing med­i­cines us­ing ni­tric ox­ide to tar­get der­ma­to­log­i­cal and on­covirus-me­di­at­ed dis­eases, said ini­tial mid-stage da­ta from its ex­per­i­men­tal drug SB206 showed promise in pa­tients with mol­lus­cum con­ta­gio­sum — a com­mon vi­ral in­fec­tion of the skin that is large­ly, if not ex­clu­sive­ly, a hu­man dis­ease.

→ Days af­ter an­nounc­ing it had se­cured the glob­al rights to der­mal pain patch Quten­za from Acor­da Ther­a­peu­tics $ACOR, Ger­many’s Grü­nen­thal said it had ac­quired the US-based Aver­i­tas Phar­ma to com­mer­cial­ize Quten­za. Fi­nan­cial de­tails of the deal were not dis­closed.

→ BioX­cel Ther­a­peu­tics $BTAI, which is fo­cused on drug de­vel­op­ment that uti­lizes ar­ti­fi­cial in­tel­li­gence, said an ear­ly-stage, 14-pa­tient study test­ing its in­tra­venous­ly ad­min­is­tered drug, dexmedeto­mi­dine, for acute treat­ment of ag­i­ta­tion in pa­tients suf­fer­ing from schiz­o­phre­nia suc­ceed­ed. Da­ta showed the drug in­duced mild seda­tive ef­fects that last­ed for 1.5 to 2 hours — a clin­i­cal­ly rel­e­vant du­ra­tion — in 9 out of the 10 pa­tients who were giv­en the drug.

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.

Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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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.

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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Bernat Olle, Vedanta Biosciences CEO

Cit­ing 'chal­leng­ing eco­nom­ic en­vi­ron­ment,' PhI­II-ready mi­cro­bio­me biotech lays off 20% of staffers

The market downturn isn’t just sweeping up public biotechs.

Vedanta Biosciences, a developer of oral drugs derived from the human microbiome, is laying off about 20% of its staff — an unfortunately common occurrence these days. But CEO Bernat Olle took the unusual step of sharing the decision on LinkedIn and offering to connect the employees being let go with any company that’s hiring in their areas.

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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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Alessandro Maselli, Catalent CEO

Catal­ent ac­quires North Car­oli­na CD­MO for $475M, boost­ing oral solids work

As Catalent has been expanding its reach in the US this year, as well as recently completing a C-suite shuffle, the company announced last night that it has acquired the CDMO Metrics Contract Services for $475 million from Mayne Pharma Group.

The acquisition will increase Catalent’s capabilities in oral solid formulation development, manufacturing and packaging as well as expand its capacity to handle more highly potent compounds.

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