Man­u­fac­tur­ing roundup: Al­ca­mi ac­quired by cap­i­tal groups; Wheel­er Bio starts on new man­u­fac­tur­ing site in Ok­la­homa

Two in­vest­ment groups have come to­geth­er to pur­chase the CD­MO Al­ca­mi.

Glob­al Health­care Op­por­tu­ni­ties, oth­er­wise known as GHO Cap­i­tal, and The Vis­tra Group joined to ac­quire a con­trol­ling in­ter­est in the Al­ca­mi Cor­po­ra­tion from funds as­so­ci­at­ed with two oth­er in­vest­ment groups, Am­per­sand Cap­i­tal Part­ners and Madi­son Dear­born Part­ners. The fi­nan­cial de­tails of the deal were not dis­closed to End­points News.

Mike Mor­timer, the man­ag­ing part­ner and founder of GHO Cap­i­tal, said in an email to End­points, that the com­pa­ny has ex­ten­sive ex­pe­ri­ence in the CD­MO field and has been watch­ing Al­ca­mi’s growth.

Mor­timer said in the email:

We’ve built up a very strong re­la­tion­ship with the Al­ca­mi man­age­ment team dur­ing this time and with our deep health­care mar­ket ex­per­tise and rep­u­ta­tion for sup­port­ing com­pa­nies to ex­pand their ca­pa­bil­i­ties and ge­o­graph­ic reach. Al­ca­mi rep­re­sents a unique op­por­tu­ni­ty to ac­quire a rapid­ly grow­ing CD­MO with com­ple­men­tary ca­pa­bil­i­ties in at­trac­tive mar­kets. GHO Cap­i­tal has the ex­per­tise and knowl­edge to help the Com­pa­ny fur­ther progress its com­pelling in­ter­na­tion­al growth plans.

The deal is ex­pect­ed to close at the end of the year, with GHO Cap­i­tal and The Vis­tria Group net­ting a 50/50 con­trol­ling in­ter­est in Al­ca­mi from funds af­fil­i­at­ed with MDP and Am­per­sand. Am­per­sand and Al­ca­mi plan to rein­vest eq­ui­ty as part of the ac­qui­si­tion.

Al­ca­mi has al­so pre­vi­ous­ly in­vest­ed over $140 mil­lion in “cap­i­tal ex­pen­di­ture” to add man­u­fac­tur­ing lines and lab spaces to sup­port its pro­grams in bi­o­log­ics and small mol­e­cules.


Wheel­er Bio kicks off con­struc­tion on a man­u­fac­tur­ing fa­cil­i­ty in Down­town Ok­la­homa City

The CD­MO Wheel­er Bio has em­barked on a new con­struc­tion project in Ok­la­homa.

The project will be a 35,000-square-foot drug sub­stance man­u­fac­tur­ing fa­cil­i­ty aimed at mak­ing ma­te­ri­als for clin­i­cal tri­als. The site will be in the Zig­gu­rat build­ing in down­town Ok­la­homa City and will be a part of the city’s biotech hub. The site will in­clude pro­duc­tion suites, a qual­i­ty con­trol lab, of­fices and a ware­hous­ing space.

Jesse Mc­Cool, the CEO of Wheel­er Bio, said in a state­ment about Wheel­er’s first GMP man­u­fac­tur­ing in Ok­la­homa City: “The cal­iber of col­lab­o­ra­tion so far among stake­hold­ers, in­clud­ing Wheel­er, CRB, and Lin­go has been tru­ly im­pres­sive, re­sult­ing in a de­tailed de­sign that is a per­fect re­flec­tion of our vi­sion of an ag­ile, phase ap­pro­pri­ate, ‘smart fac­to­ry’.”

Il­lu­mi­na opens new so­lu­tions cen­ter in Dubai

While Dubai may be known as more of a tourist des­ti­na­tion, one com­pa­ny is try­ing to bring a broad­er biotech pres­ence to the city.

DNA se­quenc­ing com­pa­ny Il­lu­mi­na has launched a new so­lu­tions cen­ter in Dubai in the Unit­ed Arab Emi­rates.

The com­pa­ny es­tab­lished a 9,100-square-foot cen­ter with a lab­o­ra­to­ry with a wide range of se­quenc­ing and ar­ray tech­nolo­gies as well as en­gi­neers to of­fer ge­nomics ca­pa­bil­i­ties to the re­gion. The cen­ter will al­so pro­vide train­ing and ed­u­ca­tion to in­crease lo­cal ac­cess to ge­nomics tech­nol­o­gy and ap­pli­ca­tions

Su­san Tou­si, a chief com­mer­cial of­fi­cer of Il­lu­mi­na, said in a state­ment:

Il­lu­mi­na opened its UAE-based So­lu­tions Cen­ter be­cause we see tremen­dous op­por­tu­ni­ty to deep­en our al­ready strong re­la­tion­ships with the coun­try’s health and tech­nol­o­gy min­istries, as well as with sci­ence and health care pro­fes­sion­als in the re­gion. With a ded­i­cat­ed team rep­re­sent­ing the en­tire Il­lu­mi­na ecosys­tem, we are pro­vid­ing more val­ue to our chan­nel part­ners and cus­tomers in the re­gion. We are grate­ful to the UAE gov­ern­ment for sup­port­ing this and we’re hon­ored to part­ner with the coun­try on its jour­ney to­wards the era of the genome.

Cell and gene ther­a­py CD­MO cuts the rib­bon on an­oth­er New Jer­sey man­u­fac­tur­ing site

Bio­Cen­triq, a New Jer­sey-based cell and gene man­u­fac­tur­er, has opened a new man­u­fac­tur­ing fa­cil­i­ty at the Prince­ton Cor­po­rate Plaza in South Brunswick, NJ.

Ac­cord­ing to the com­pa­ny, the ad­di­tion of two clean rooms and oth­er in­fra­struc­ture will help open more pro­duc­tion ca­pac­i­ty for Bio­Cen­triq as well as pro­vide more room at its oth­er site in Newark, NJ. The new site will al­so be able to sup­port au­tol­o­gous and al­lo­gene­ic cell ther­a­py man­u­fac­tur­ing projects.

The com­pa­ny is al­so plan­ning to ex­pand the site next year with more man­u­fac­tur­ing suites, sup­port­ing labs and oth­er in­fra­struc­ture.

Haro Har­toun­ian, CEO of Bio­Cen­triq, said in a state­ment that the ad­di­tion­al GMP man­u­fac­tur­ing is key to Bio­Cen­triq’s ex­pan­sion plan, adding “with this added ca­pac­i­ty, Bio­Cen­triq can take on more projects to help biotech com­pa­nies bring their prod­ucts from bench to mar­ket.”

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Over the last four years, we’ve honored 80 women whose extraordinary accomplishments have changed the game in biopharma R&D. You can now nominate someone to be highlighted in this year’s special report. Details are here.

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Mark Womack, BioCina CEO

Q&A: BioCi­na’s new CEO Mark Wom­ack on the CD­MO he says is 'worth trav­el­ing over'

A handful of CDMOs have made changes at the top over the past few weeks, including Genezen and Curia.

That also includes Australian CDMO BioCina, which announced last week that Mark Womack would be taking the helm. Womack previously served as chief business officer at AGC Biologics, CEO of Indian manufacturer Stelis Biopharma and most recently, CEO at CDMO KBI Biopharma and Selexis SA.

BioCina completed the takeover of a Pfizer manufacturing facility in Adelaide in 2021 and is now prepping for wider growth. Endpoints News sat down with Womack to discuss his new role, plans for the future, and how to compete in the wider CDMO market. This interview has been edited for brevity and clarity.

No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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Stuart Peltz, former PTC Therapeutics CEO

Stu­art Peltz re­signs as PTC Ther­a­peu­tics CEO af­ter 25 years

Stuart Peltz, the longtime CEO of PTC Therapeutics who’s led the rare disease drug developer since its founding 25 years ago, is stepping down.

Succeeding him in the top job is Matthew Klein, who joined PTC in 2019 and was promoted to chief operating officer in 2022. In a call with analysts, he said the CEO transition has been planned for “quite some time” — in fact, as part of it, he gave the company’s presentation at the JP Morgan healthcare conference earlier this year.

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