A Texas-based phar­ma has en­list­ed Catal­ent for oral sol­id man­u­fac­tur­ing; Cy­ti­va drops mas­sive man­u­fac­tur­ing in­vest­ment in home state

CD­MO Catal­ent has kept busy with merg­ers and ac­qui­si­tions, but Mon­day, it an­nounced a col­lab­o­ra­tion with Dis­per­Sol to ac­cel­er­ate the man­u­fac­tur­ing of the com­pa­ny’s on­col­o­gy drugs.

Catal­ent will in­stall a com­mer­cial-scale Kineti­Sol line at the oral solids de­vel­op­ment and man­u­fac­tur­ing fa­cil­i­ty in Som­er­set, NJ. The plat­form works to turn mol­e­cules with clin­i­cal promise in­to vi­able med­i­cines, and the Kineti­Sol tech­nol­o­gy will be used for all of Dis­per­Sol’s pipeline prod­ucts. That in­cludes a Phase III tri­al for iron over­load dis­or­der and a Phase II tri­al against prostate can­cer.

Dis­per­Sol will tech trans­fer its equip­ment, soft­ware and IP to New Jer­sey, and Catal­ent will pro­vide the staff need­ed, in­clud­ing qual­i­ty con­trol and as­sur­ance.

“This strate­gic col­lab­o­ra­tion with Catal­ent is in­te­gral to our com­pa­ny as we now move in­to late clin­i­cal-stage de­vel­op­ment and com­mer­cial-scale man­u­fac­tur­ing of our prod­ucts,” Dis­per­Sol CEO Ed­ward Rud­nic said in a press re­lease. “The com­mer­cial amor­phous sol­id dis­per­sion man­u­fac­tur­ing ex­per­tise of Catal­ent’s team and their glob­al­ly ac­cred­it­ed qual­i­ty sys­tems make them a per­fect part­ner for Dis­per­Sol.”

Dis­per­Sol’s ac­tive pro­grams al­so in­clude a Phase II tri­al for DST-8294, which is be­ing stud­ied to treat clot­ting dis­or­ders. The com­pa­ny al­so has DST-0058 for id­io­path­ic pul­monary fi­bro­sis and DST-5407 for non-squa­mous non-small cell lung can­cer in its pipeline.

In a lit­tle more than a month, Catal­ent has ac­quired a Ger­man cell and gene ther­a­py spe­cial­ist Rhein­Cell Ther­a­peu­tics, and inked con­tracts with Den­ver cannabid­i­ols com­pa­ny JOS Phar­ma­ceu­ti­cals, and an­oth­er Austin, TX-area pre­clin­i­cal com­pa­ny Cur­tana Phar­ma­ceu­ti­cals. With Cur­tana, the com­pa­ny will make CT-179, a drug ther­a­py for glioblas­toma, medul­loblas­toma and oth­er brain can­cers.

The com­pa­ny al­so an­nounced an up­grade to its sleek new fa­cil­i­ty in Anag­ni, Italy, the sec­ond in the last six months. Two new 2,000 liter sin­gle-use biore­ac­tors with new man­u­fac­tur­ing suites will sup­port ear­ly-phase clin­i­cal de­vel­op­ment and late-stage com­mer­cial trans­fers The project is ex­pect­ed to add 100 new em­ploy­ees, and it should be op­er­a­tional in April 2023.

Cy­ti­va drops mas­sive man­u­fac­tur­ing in­vest­ment in home state

A Mass­a­chu­setts-based life sci­ences com­pa­ny will in­vest $1.5 bil­lion over the next two years to meet a grow­ing de­mand for biotech man­u­fac­tur­ing.

Cy­ti­va, which has head­quar­ters in Marl­bor­ough, has al­ready bro­ken ground on a project that in­cludes $600 mil­lion for chro­matog­ra­phy resins, $400 mil­lion for cell cul­ture me­dia, $300 mil­lion to­ward sin­gle-use tech­nolo­gies, the Worces­ter Busi­ness Jour­nal re­ports.

In 2020, the com­pa­ny in­vest­ed $500 mil­lion in near­by Shrews­bury, MA and West­bor­ough, MA.

Bris­tol My­ers sale of Swiss site to WuXi is com­plete

Bris­tol My­ers Squibb is work­ing on re-eval­u­at­ing its man­u­fac­tur­ing port­fo­lio, and it’s just com­plet­ed one of its big-name deals of the year.

In Feb­ru­ary, WuXi AppTech’s sub­sidiary com­pa­ny WuXi STA an­nounced that it planned to ac­quire the Bris­tol My­ers site in Cou­vet, Switzer­land. That deal was fi­nal­ized on Tues­day, the drug­mak­er an­nounced in a press re­lease.

It’s not a full de­par­ture of Bris­tol My­ers from Switzer­land, how­ev­er. The drug­mak­er says the coun­try re­mains an “im­por­tant strate­gic lo­ca­tion for the com­pa­ny” and says it will keep a pres­ence there, de­spite no longer hav­ing any phys­i­cal space in the coun­try.

The site, based in Neuchâ­tel, spe­cial­izes in cap­sule and tablet dosage.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

Credit: Shutterstock

How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,800+ biopharma pros reading Endpoints daily — and it's free.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Mod­er­na chips in fur­ther on African vac­cine sup­ply — but ad­vo­cates are call­ing for even more

In a sign of its growing commitment to the continent, Moderna will supply up to 110 million doses of its Covid-19 vaccine to the African Union, the company announced Tuesday. And CEO Stéphane Bancel said it’s just the first step.

“We believe our vaccine can play an important role in addressing the needs of low-income countries given its combination of high Phase 3 efficacy against COVID-19, strong durability in the real-world evidence, and superior storage and handling conditions. We recognize that access to COVID-19 vaccines continues to be a challenge in many parts of the world and we remain committed to helping to protect as many people as possible around the globe,” Bancel said in a statement.

Ugur Sahin, AP Images

As pres­sure to share tech­nol­o­gy mounts, BioN­Tech se­lects Rwan­da for lat­est vac­cine site

BioNTech’s first mRNA-based vaccine site in Africa will call Rwanda home, and construction is set to start in mid-2022, the company announced Tuesday at a public health forum.

The German company signed a memorandum of understanding, after a meeting between Rwanda’s Minister of Health, Daniel Ngamije, Senegal’s Minister of Foreign Affairs Aïssata Tall Sall, and senior BioNTech officials. Construction plans have been finalized, and assets have been ordered. The agreement will help bring end-to-end manufacturing to Africa, and as many as several hundred million doses of vaccines per year, though initial production will be more modest.

Peter Nell, Mammoth Biosciences CBO

UP­DAT­ED: Jen­nifer Doud­na spin­out inks a Mam­moth CRISPR deal with Ver­tex worth near­ly $700M

When a company gets its start in gene editing pioneer Jennifer Doudna’s lab, it’s bound to make headlines. But three years in, the fanfare still hasn’t died down for Mammoth Biosciences. Now, the Brisbane, CA-based company is cheering on its first major R&D pact.

Mammoth unveiled a nearly $700 million deal with Vertex on Tuesday morning, good for the development of in vivo gene therapies for two mystery diseases. The stars of the show are Mammoth’s ultra-small CRISPR systems, including two Cas enzymes licensed from Doudna’s lab over the past couple years, Cas14 and Casɸ.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,800+ biopharma pros reading Endpoints daily — and it's free.

An­gion's or­gan dam­age drug strikes out again, this time in high-risk kid­ney trans­plant pa­tients

After flopping a test in Covid-19 earlier this year, Angion’s lead organ damage drug has now hit the skids again in kidney transplant patients.

Angion and partner Vifor Pharma’s ANG-3777 failed to beat out placebo in terms of improving eGFR, a measure of kidney function, in patients who had received a deceased donor kidney transplant and were at high risk of developing what is known as delayed graft function, according to Phase III results released Tuesday.

(Photo courtesy Pfizer)

FDA's vac­cine ad­comm votes al­most unan­i­mous­ly in fa­vor of Pfiz­er's Covid-19 vac­cine for younger chil­dren

The FDA’s Vaccines and Related Biological Products Advisory Committee on Tuesday voted 17-0, with one panelist abstaining, that the benefits of the Pfizer-BioNTech Covid-19 vaccine outweigh the risks for children between the ages of five and 12.

The vote will likely trigger a process that could allow the shots to begin rolling out as early as next week.

The vaccine, which is one-third of the adult Pfizer dose, proved to be about 90% effective in a placebo-controlled trial in which about 1,500 kids in this age range received the vaccine, and only about 12% of those receiving the vaccine had any adverse event. All serious adverse events in the trial were unrelated to the vaccine.

An image of Alzheimer's brain tissue. The red show gingipains, a protein from P. gingivalis, intermixing with neurons (yellow) and glial cells (green)

An Alzheimer's dark­horse fails its first big tri­al, but of­fers hope for a long-over­looked hy­poth­e­sis

Three years ago, Cortexyme emerged out of obscurity with some big-name backers and an unorthodox approach to treating Alzheimer’s.

They moved their drug into a pivotal study the next year, offering one of the first major tests for a hypothesis that has fluttered on the outskirts of Alzheimer’s research for decades: that, in many cases, the disease is driven by infectious agents — the havoc they wreak in the brain and the inflammation the body uses to try to fend them off. And that quashing the infection could slow patients’ cognitive decline.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,800+ biopharma pros reading Endpoints daily — and it's free.