Philip Mor­ris nabs over 20% of Vec­tura's shares; On­copep­tides drug may be head­ed for ad­comm, CEO says

About a week af­ter Vec­tura’s board of di­rec­tors said they would unan­i­mous­ly back a Philip Mor­ris takeover, the to­bac­co gi­ant now has con­trol of more than a fifth of the res­pi­ra­to­ry drug­mak­er’s shares.

Share­hold­ers with 22.61% of Vec­tura’s shares have ten­dered their stock to Philip Mor­ris, Reuters re­port­ed on Wednes­day. The move is part of the cig­a­rette com­pa­ny’s $1.5 bil­lion bid to buy Vec­tura. Philip Mor­ris, best known for its Marl­boro prod­ucts, of­fered 165 pence per share, beat­ing out a 155 pence per share of­fer by the pri­vate eq­ui­ty firm The Car­lyle Group.

Though the deal has drawn skep­ti­cism from con­sumer ad­vo­cates, char­i­ties, an­ti-smok­ing groups and the UK’s busi­ness sec­re­tary, Vec­tura’s board is­sued a state­ment last week that it con­sid­ers Philip Mor­ris’ of­fer “fair and rea­son­able.”

“To­bac­co com­pa­nies should not prof­it from the ill­ness­es their prod­ucts cause,” a group of rep­re­sen­ta­tives from more than 20 an­ti-smok­ing and lung health or­ga­ni­za­tions wrote to Vec­tura’s board.

CEO Jacek Ol­czak says the deal is in line with his “be­yond nico­tine” strat­e­gy, which would po­si­tion the com­pa­ny to gen­er­ate more than half its rev­enue from smoke-free prod­ucts by 2025. — Nicole De­Feud­is 

On­copep­tides drug may be head­ed for ad­comm, CEO says

Fol­low­ing the FDA plac­ing a par­tial hold on its con­fir­ma­to­ry tri­al for Pepax­to, On­copep­tides said Thurs­day that the agency may call for an ad­comm to dis­cuss the study.

In its sec­ond quar­ter re­port, CEO Mar­ty Du­vall wrote in a let­ter to in­vestors that reg­u­la­tors “in­di­cat­ed that a pub­lic meet­ing may be held lat­er this year to dis­cuss the safe­ty find­ings and the con­tin­ued mar­ket­ing of the drug in the US.” The FDA placed the hold on all tri­als in­volv­ing Pepax­to on Ju­ly 8 af­ter the drug flopped the over­all sur­vival mea­sure.

Three weeks lat­er, the agency alert­ed pa­tients and health­care providers with more spe­cif­ic in­for­ma­tion, ex­plic­it­ly not­ing the drug re­sult­ed in an in­creased risk of death. Some cost-cut­ting “mea­sures” may be tak­en due to all the un­cer­tain­ty sur­round­ing the drug, Du­vall added in this let­ter.

Pepax­to won ac­cel­er­at­ed ap­proval in Feb­ru­ary, com­par­ing the drug in com­bi­na­tion with dex­am­etha­sone to a Bris­tol My­ers Squibb/steroid com­bo in pa­tients with re­lapsed or re­frac­to­ry mul­ti­ple myelo­ma. — Max Gel­man

Bris­tol My­ers nets EU ap­proval for Abec­ma

About five months af­ter get­ting FDA ap­proval for its BC­MA CAR-T ther­a­py Abec­ma, Bris­tol My­ers Squibb has now won an OK in Eu­rope.

The Eu­ro­pean Com­mis­sion ap­proved the drug for adults with re­lapsed and re­frac­to­ry mul­ti­ple myelo­ma who had pre­vi­ous­ly failed at least three ear­li­er lines of ther­a­py, Bris­tol My­ers an­nounced Thurs­day. The pri­or ther­a­py lines must have in­clud­ed an im­munomod­u­la­to­ry agent, a pro­tea­some in­hibitor and an an­ti-CD38 an­ti­body, and pa­tients had to have demon­strat­ed dis­ease pro­gres­sion on the last ther­a­py, the drug­mak­er added.

“The EC ap­proval of Abec­ma is an im­por­tant mile­stone for the treat­ment of mul­ti­ple myelo­ma, and moves us clos­er to of­fer­ing a first-in-class, per­son­al­ized ther­a­py to pa­tients in Eu­rope bat­tling this in­cur­able dis­ease af­ter ex­haust­ing pri­or treat­ment op­tions with the three stan­dards of care,” CMO Samit Hi­rawat said in a state­ment.

Bris­tol My­ers has been push­ing Abec­ma for mul­ti­ple myelo­ma along­side an­oth­er drug, Breyanzi, which was ap­proved for third-line dif­fuse large B cell lym­phoma back in Feb­ru­ary. — Max Gel­man

Third time, like the first and sec­ond, is the charm for Ada­gene, Mer­ck

Ada­gene ap­par­ent­ly loves work­ing with Mer­ck so much they’re go­ing back for thirds.

The San Fran­cis­co biotech an­nounced its third clin­i­cal tri­al col­lab­o­ra­tion on Thurs­day, aim­ing to pair its ex­per­i­men­tal an­ti-CD137 can­di­date with Mer­ck’s Keytru­da in ad­vanced or metasta­t­ic sol­id and/or hema­to­log­i­cal ma­lig­nan­cies. The new clin­i­cal study will build on monother­a­py and com­bi­na­tion ther­a­py da­ta from a Phase I tri­al of the can­di­date, called ADG106.

“While PD-1 drugs have ad­vanced the can­cer treat­ment par­a­digm, there are still a sub­stan­tial num­ber of pa­tients with ad­vanced metasta­t­ic sol­id and hema­to­log­i­cal ma­lig­nan­cies who ei­ther re­lapse or are un­re­spon­sive, high­light­ing the need for new ap­proach­es,” Ada­gene CEO Pe­ter Luo said in a state­ment.

ADG106 is an ag­o­nis­tic an­ti-CD137 IgG4 mon­o­clon­al an­ti­body be­ing eval­u­at­ed in a Phase Ib/II com­bi­na­tion study in ad­vanced sol­id tu­mors and re­lapsed/re­frac­to­ry non-Hodgkin lym­phoma. Ada­gene’s Phase I tri­als have been com­plet­ed with en­roll­ment of near­ly 100 pa­tients in both the US and Chi­na, the biotech said. — Max Gel­man

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.

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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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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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.”

Pen­ny stock biotech miss­es on its sole clin­i­cal tri­al; Cal­adrius teams up with Roche for pan­cre­at­ic can­cer col­lab­o­ra­tion

Vyne Therapeutics had put all its clinical focus on one drug: FMX114 for mild-to-moderate atopic dermatitis. However, that trial, Vyne’s only ongoing clinical trial, has now sunk.

The New Jersey biotech put out word Wednesday that the trial failed to meet its primary endpoint, listed as the change in an atopic dermatitis measure (known as ADSI) over one month. The Phase IIa trial enrolled 21 patients.