Pharmacies

CDMO Celonic to beef up cell and gene therapy work at up-and-coming Novartis hub

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Like many CDMOs these days, Switzerland’s Celonic aims to make a big splash in cell and gene therapy—and it’s picked up space at an emerging Novartis life sciences hub to take that work to the next level. 

Celonic sewed up a long-term lease for production and office space in the WST-222 building of Novartis’ hub-to-be in Stein, Switzerland, dubbed Life Science Park Rheintal. The company will use the 91,500-square-foot location to set up production capacity for cell and gene therapies, next-generation vaccines and “innovative biopharmaceuticals.”

Celonic is adding up to 20 clean room suites, plus offices and laboratories for process development, method development and quality control for clients from early-stage work to market. It will also sign around 250 new employees to staff the site, which should be ready for production by the second quarter of 2022.

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RELATED: Cognate beefs up cell, gene therapy manufacturing with new plants in U.S., EU

The company hopes to offer large-scale manufacturing of so-called advanced therapies—drugs derived from genes, tissues or cells—by early next year, CEO Konstantin Matentzoglu said in a release.

Outside of Stein, Celonic is also building out a manufacturing facility for gene vectors and cell therapies at its site in Basel, Switzerland, according to the company’s website. The plant will eventually be equipped to handle process development and optimization up to early commercialization, as well as clinical production.

Celonic joins the Novartis site alongside 2,000 staffers from three pharma and biotech firms working in research, development and production.

Novartis in February unveiled plans to convert its Stein production site into a life sciences park, with an emphasis on cell and gene therapy production. Between 2020 and 2021, the company has plowed more than 200 million Swiss francs ($218 million) into its locations in Stein and Schweizerhalle. 

RELATED: Fujifilm continues CMDO expansion spree with $76M in funding for new Boston site

Drugmakers and CDMOs alike have moved on cell and gene therapy manufacturing expansions in recent months. Just this week, China-based Pharmaron agreed to pay AbbVie $118.7 million for Allergan Biologics’ manufacturing plant in Liverpool, England—fueling cell and gene therapy ambitions that kicked off with the buyout of Absorption Systems in November. 

Catalent in February said it would pick up plasmid DNA specialist Delphi Genetics, speeding plasmid production at the company’s Rockville, Maryland site. Meanwhile, Bristol Myers Squibb, fresh off its Breyanzi approval, is building a 244,000-square-foot cell therapy site at its 89-acre campus in Devens, Massachusetts—and those are just a few recent examples.

Gilead cuts jobs in California, moving some to new North Carolina business center

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Gilead Sciences’ new business service center is a win for North Carolina but comes with some losses for the company’s home state of California.

The Foster City-based pharma plans to cut 178 jobs in California effective May 30, according to a WARN notice filed with the state.

It’s “the latest example of a major Bay Area company moving workers to a cheaper location” the San Francisco Chronicle reported. Half of the jobs (89) are expected to shift to Gilead’s now-underway Research Triangle Park service center in North Carolina, according to the Chronicle, depending on how many employees choose to relocate.

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RELATED: Gilead combines shared services into one North Carolina hub, aiming for ‘cost and time zone advantages’

The new North Carolina center will employ 275 people when fully completed in two years, Gilead says. The company will spend up to $5 million on the project, the North Carolina governor’s office said in a statement.

Under a North Carolina economic development and jobs grant program, Gilead can earn up to $10 million in reimbursement payments over 12 years through the project. North Carolina estimates it will see an annual economic gain of more than $39 million.

In a statement last month, Gilead said it is committed to maintaining its headquarters—and growing its business—in Foster City. The biopharma employs more than 13,000 around the world with more than half located in California. 

RELATED: Gilead sees a blockbuster 2021 for COVID-19 drug Veklury but can grow without it: CFO

Gilead’s cost-efficiency consolidation is a familiar one in the pharma industry. Novartis stirred interest back in 2014 when it cut $3 billion in costs by creating a business services unit with hubs around the world.

Johnson & Johnson, Bristol Myers Squibb and Amgen have similar business service hubs, all in the Tampa Bay, Florida area. The most recent was Amgen’s facility which opened in 2018.

However, business services hubs can themselves end up as targets for job cuts. When Novartis rolled plans a few years ago for a 19% staff reduction, 700 jobs were cut in the business services unit, and Bristol Myers cut some jobs at its “capability center” in South Florida in 2019.

Novavax was on its last leg pre-COVID. With a promising shot on deck, it’s now eying a big 2021

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Heading into last year, Novavax had just $80 million in cash and a “financial operating horizon” of six months, its CEO said this week. That’s all changed. Nowadays, the biotech has a lineup of COVID-19 vaccine orders and capacity expected to reach billions of doses.

Novavax is scaling up its COVID-19 vaccine manufacturing network and expects to reach capacity of 2 billion annual doses by midyear, CEO Stan Erck said on a Monday conference call with analysts. The biotech “started last year without any capacity to manufacture product,” he acknowledged, and in the span of a year has “built a global network of manufacturing sites and partners in 10 countries.”

Right now, the various sites in Novavax’s network are working to ramp up their production processes. The “expectation is that that all of the plants will be at full scale by April,” Erck said. 

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That way, in April, May and June, the company “should be finishing, filling and finishing product in advance of regulatory approvals,” the CEO said. Novavax is now completing production for early batches and expects to have vaccines “on the shelf when we have approval,” he added. 

RELATED: Novavax targets May approval for COVID-19 vaccine in the U.S. 

Earlier this week, Erck told CNBC that Novavax was targeting May for a potential COVID-19 vaccine authorization from the FDA. The company’s vaccine posted an 89% efficacy figure in a phase 3 trial in the U.K. The company is running another study in the U.S. and Mexico.  

In its three-decade history, Novavax has never scored a vaccine approval. Aside from its work in COVID, the company is eying an FDA nod for its flu shot NanoFlu.

On the financial side, Novavax started 2020 with $80 million in cash and a “financial operating horizon” of just six months, Erck told analysts on the call. Through the span of the COVID-19 pandemic, the company has raised $2 billion from the U.S. government and other partners, and it has purchase orders on deck “representing the potential for several billion dollars in revenue in the next 12 months,” Erck said.

RELATED: Novavax, coronavirus shot data in hand, strikes an eye-popping supply deal with global vaccine consortium 

The company has committed 110 million doses to the U.S. government, plus a total of 200 million doses to Canada, Austria, U.K. and other countries. It’s also inked a massive deal with the global vaccine consortium Covax to supply 1.1 billion doses worldwide with the help of the Serum Institute of India. 

Novavax has granted Serum Institute an exclusive license for India and Takeda an exclusive license for Japan as well.

FDA slaps FibroGen, AstraZeneca with last-minute roxadustat AdCom, cuing another delay for anemia drug

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FibroGen and AstraZeneca already endured a delay in the U.S. review of their first-in-class anemia candidate roxadustat. Just as the pair was expecting to snag its first-in-class approval, as the revised date draws near, a capricious FDA has stunned the companies with a second blow.

The FDA will convene an advisory committee to review roxadustat’s application for treating anemia caused by chronic kidney disease, both in patients who require dialysis and those who don’t, the two companies said Monday.

The new request came as a shock, given that roxadustat’s FDA decision date was already pushed back from December to March 20. But because the FDA hasn’t set a date for the meeting, industry watchers widely suspect that another delay could be imminent, with at least one analyst significantly lowering his expectations for an eventual approval.

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By FibroGen CEO Enrique Conterno’s account, the FDA had a surprising change of mind. The FDA had told FibroGen on three separate occasions that the agency didn’t plan to hold an AdComm meeting for roxa, he said during a conference call Monday.

If approved, roxa could be the first in the oral HIF-PH inhibitor class to land a U.S. green light and challenge current stand-of-care erythropoietin injectable therapies such as Amgen and Johnson & Johnson’s Epogen/Procrit. For that reason, industry watchers had pegged the drug as a potential blockbuster. SVB Leerink analyst Geoffrey Porges had estimated it could be bringing in $3 billion to $3.5 billion by the mid-2020s. But now, with the uncertainties triggered by the AdCom, he has lowered the number to $719 million in 2025 on a risk-adjusted basis.

RELATED: AstraZeneca, FibroGen’s roxadustat hits snag at FDA, but analysts figure an approval’s still on its way

Conterno acknowledged that it’s not unusual for a first-in-class med to go through an AdComm; in fact, the companies were preparing for that scenario last spring, but then stopped the work after consulting with the FDA, he said. Now, with the about-face, the two are scrambling to resume the preparation.

The FDA had previously pushed back its review of roxa, asking for additional analyses of existing data sets.

There were some concerns about the drug’s heart safety profile, especially in nondialysis-dependent patients, but FibroGen and AstraZeneca largely dispelled those doubts with a pooled analysis of heart-related events in its clinical programs. Epogen and Procrit are not allowed in this patient group because of their increased cardiovascular risks. Roxa’s CV profile matched up to that of a placebo in nondialysis patients and to Epogen and Procrit in the dialysis population.

RELATED: New FibroGen CEO Conterno cut his post-Lilly ‘vacation’ short. Why? Roxadustat

But a citizen petition filed in November requested that the FDA require more cardiovascular safety data before approving roxa. The petitioners argued that the non-inferiority comparison with placebo reflected negatively on roxa, because correcting anemia should result in better heart outcomes.

In a Tuesday note, Porges suggested that the FDA might have launched the AdComm in response to the various citizens petitions, including one from Amgen. If that’s the case, then “the roxa data package stands on its own and the AdComm is not a smoking gun pointing to threatened approval,” he wrote in the note.

Porges also pointed out that such last-minute notification is “very unusual.” With no details on what exactly the FDA is concerned about, Porges has significantly lowered his confidence in the approval of roxa to 30% and 65% for nondialysis and dialysis populations, respectively, from the previous 80% to 100%. His colleague Andrew Berens lowered his estimates to 50% for both populations, saying that AstraZeneca management doesn’t expect a complete response letter, but rather a delay of the decision beyond the March 20 action date.

Mizuho analyst Difei Yang, in a Tuesday note, also predicted the drug will get its approval in both patient groups, but perhaps with a black box warning.

 Yang expects the expert panel meeting will happen around June or July, pushing back a decision to the third quarter and a commercial launch to the fourth. Porges and Berens had similar timelines.

RELATED: Akebia crashes on vadadustat flop in larger anemia indication. Will AZ, FibroGen own the market?

Roxa was first approved in China, where it generated $29.2 million sales in the fourth quarter of 2020, up from $22.7 million in the same period a year before. The drug recently earned an approval under the brand Evrenzo in Japan, where FibroGen is partnered with Astellas, and an EU decision is expected later this year.

In the HIF-PH inhibitor class, Roxa could compete with Akebia and Otsuka’s vadadustat, which is approved in Japan as Vafseo. But the Street has low expectations after that drug turned up increased heart risks compared with Amgen’s erythropoietin therapy Aranesp in nondialysis patients in the phase 3 PRO2TECT trial. GlaxoSmithKline also competes in Japan with its drug Duvroq (daprodustat).

Lilly’s Olumiant posts trial win in autoimmune hair loss, setting up potential first-in-class FDA nod

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Eli Lilly is counting on its new meds—including rheumatoid arthritis drug Olumiant—to drive growth in the years to come. With a new trial win in the autoimmune disease alopecia areata, which causes hair loss, the med might have an entirely new field to itself. 

Lilly said that baricitinib (approved in RA as Olumiant) posted positive phase 3 data in alopecia areata, where no other meds have scored FDA approvals. Lilly didn’t share detailed data, saying only that the medicine bested a placebo in meeting the primary endpoint of hair regrowth in patients with severe disease. The company plans to present detailed results at an upcoming medical conference. 

The trial included 546 patients in the U.S. and eight other countries. It was the first phase 3 trial to turn in positive results in alopecia areata, Lilly said. The company expects results from another trial of baricitinib in alopecia areata in the coming months. 

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Last year, the FDA granted breakthrough designation to baricitinib in the disease, signifying the FDA sees promise for the therapy in an area where patients are underserved. Alopecia areata can cause hair loss on the scalp, face and other areas of the body.

It’s “not a cosmetic condition,” Lotus Mallbris, Lilly VP of immunology development, said in a statement. It’s “a devastating autoimmune disease that can have significant psychological effects.” 

Lilly is “working closely with the FDA and plans to submit baricitinib for approval in the U.S.” after reviewing data from the other ongoing study, Mallbris told Fierce Pharma. In the meantime, the company is “encouraged by the results … in support of a potential path for baricitinib to become the first FDA-approved treatment for AA.”  

The results are “very promising and suggest that baricitinib has the potential to address the urgent needs of people living with alopecia areata,” Yale School of Medicine associate professor of dermatology Brett King added in a statement. 

RELATED: Eli Lilly, Incyte’s Olumiant notches another atopic dermatitis win. But can it fight Dupixent? 

Baricitinib is approved in the U.S. and other countries to treat rheumatoid arthritis, as well as in Europe and Japan to treat certain patients with atopic dermatitis. In the U.S., Lilly has submitted the drug to the FDA in atopic dermatitis following a phase 3 trial win.

The phase 3 trial success in alopecia areata follows another win for the drug in COVID-19. After positive trial results, the drug scored an emergency use authorization in November in combination with Gilead Sciences’ Veklury in patients who are hospitalized and require oxygen. 

The company is also testing baricitinib in systematic lupus erythematosus and juvenile idiopathic arthritis. 

RELATED: Lilly scores FDA emergency authorization for Olumiant in COVID-19, its 2nd therapeutic option 

Olumaint is among a group of new meds Lilly is counting on to propel growth in the coming years. Last year, the drug generated $639 million worldwide, a 50% leap from 2019. In total, all of Lilly’s new drugs generated about half of the company’s fourth-quarter sales.

ERS Genomics signs CRISPR license agreement with Otsuka

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Dublin-headquartered biotech company ERS Genomics has signed a license agreement with Otsuka for access to CRISPR gene editing technology.

The license grants Otsuka access to CRISPR/Cas9 technology, which the Japanese pharma company can use for its internal research and development initiatives to address areas of unmet need.

“We are extremely pleased to be able to provide Otsuka with access to the CRISPR/Cas9 license,” said Eric Rhodes, chief executive officer of ERS Genomics.

“We hope this brings significant value to Otsuka as it applies the technology to its internal programmes,” he added.

ERS Genomics was formed to provide broad access to the CRISPR/Cas9 intellectual property held by co-founder and recent Nobel prize winner Emmannuelle Charpentier.

AbbVie sells biologics plant to Pharmaron, fueling the China company’s cell and gene therapy ambitions

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Roughly half a year after closing its $63 billion megamerger with Allergan, AbbVie is letting go of the drugmaker’s Liverpool, England biologics plant. 

AbbVie agreed to sell off the biomanufacturing plant to China-based Pharmaron for $118.7 million in cash. The move comes shortly after Pharmaron bought out Absorption Systems in the U.S., paving the way for a cell and gene therapy platform that runs the gamut from early research to commercial manufacturing.

Pharmaron will fold in Allergan Biologics’ Liverpool, England site and keep the more than 150 workers now employed there, the company said in a release.

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The plant puts Pharmaron on track to add commercial manufacturing to its integrated cell and gene therapy platform, which also offers pre-clinical research and product development, Pharmaron said.

RELATED: AbbVie, Eli Lilly lead Big Pharma’s 2020 market cap growth as Merck, Gilead lag

Specifically, the Allergan Biologics plant uses a suspension cell culture system, where growth is dictated by the concentration of cells in the medium. This type of cell production is easier to scale up for commercial manufacturing than adherent cell cultures, in which growth hinges on surface area, potentially limiting product yields.

Phamaron has also set its sights on future capacity and capability upgrades at the Liverpool site, CEO Boliang Lou said in a release.

Allergan last January opened the doors to its €160m ($176 million) biologics 2 facility at its Westport Campus in County Mayo, Ireland. In addition to being the exclusive manufacturing site for Allergan’s prized Botox franchise, the company said it was eyeing other projects there, including a new microbiology and cell-based laboratory and investments in its eye products manufacturing facilities.  

RELATED: AbbVie settles trade secrets fight with Evolus, scoring $35M and royalties on Botox rival Jeuveau

The Westport plant opened just a few months before AbbVie and Allergan scored U.S. antitrust approval for their $63 billion megamerger. AbbVie is now leaning on Botox’s blockbuster sales, as well as the swift-rising antipsychotic Vraylar, as it braces for looming biosimilar competition to megablockbuster Humira.

Pharmaron, for its part, picked up non-clinical CRO Absorption Systems for $137.5 million in cash last November, snaring facilities in Philadelphia, San Diego and Boston. The deal gave a boost to Pharmaron’s established ophthalmology and medical device services and brought Absorption Systems’ cell and gene therapy R&D and testing know-how into its growing platform.

Advisory firm Goetzpartners was Pharmaron’s exclusive financial adviser on the Allergan Biologics buy, while O’Melveny provided legal counsel.

Look for Eli Lilly’s Verzenio to hit $4.6B, thanks to early breast cancer win: analyst

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In the kinase inhibitor class of breast cancer drugs, Pfizer’s Ibrance has held a strong lead in market share—and sales—over Eli Lilly’s Verzenio.

But on the heels of Verzenio’s strong showing in HR+/HER2- early breast cancer—and Ibrance’s miss—one influential analyst figures the Lilly drug will quickly pick up steam. The upshot? About $4.6 billion in sales at the peak, significantly more than most pharma watchers now expect from the med.

Since its launch in 2017, Verzenio’s share of the market in metastatic breast cancer has been “steadily growing,” from 12% early last year to 20% now, Bernstein analyst Ronny Gal wrote in a Monday note to clients. And with a potential launch in HR+/HER2- early breast cancer, the drug’s sales are set to ramp up considerably, he said. 

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Lilly is “showing success with arguing for differentiation from Ibrance, and the growth will continue when the drug gains approval” in early breast cancer, the analyst wrote. The prediction comes after Verzenio posted impressive data in HR+/HER2- early breast cancer—and after Ibrance failed two studies in early breast cancer.

RELATED: Lilly’s Verzenio pressures Pfizer with practice-changing win in early breast cancer

Pfizer’s drug won an FDA approval in 2015 and generated $5.4 billion in sales last year. Verzenio, for its part, scored an FDA approval in 2017—giving Pfizer a considerable head start—and brought in $913 million last year. 

While Pfizer’s drug is already on a strong sales trajectory, Gal says Lilly can expect Verzenio to not only pass the $1 billion blockbuster threshold but gin up billions more than that each year.

Ibrance will “retain market leadership” in metastatic breast cancer, Gal wrote, but he sees Verzenio snagging 28% of that market by 2024. With those share gains plus a potential FDA nod in early breast cancer, Bernstein analysts project $4.6 billion in Verzenio sales in 2024, significantly higher than consensus Wall Street estimates of $3.2 billion. 

RELATED: Pfizer’s Ibrance kisses early breast cancer hopes goodbye with 2nd study failure

Last summer, Lilly’s drug—added to standard endocrine therapy after surgery—showed it could significantly reduce the risk of cancer recurrence by 25.3% in patients with high-risk HR-positive, HER2-negative early breast cancer.

One expert said the findings would “change practice.” The company filed the data with regulators in the fourth quarter of 2020, according to its recent annual SEC filing.

Meanwhile, Pfizer’s Ibrance has failed two studies in early breast cancer. After the second failure, SVB Leerink analyst Geoffrey Porges wrote that there’s “no saving adjuvant for Ibrance.”

Takeda keeps divestment spree rolling with $1.2B sale of diabetes meds to Japanese firm Teijin

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After inking a slate of geography-specific product selloffs last year, Takeda has turned back to Japan.

Takeda locked up a deal to sell four Type 2 diabetes meds in Japan to local drugmaker Teijin Pharma for 133 billion Japanese yen ($1.2 billion), freeing up the company to focus on its core businesses in gastroenterology, rare diseases, plasma-derived therapies, oncology and neuroscience.

The move is the latest in Takeda’s selloff spree, linked to a divesture goal it set alongside its Shire merger. The company has already exceeded its $10 billion target, but has shown no sign of slowing down, as it continued to shave off noncore products late into 2020 and early 2021.

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Under the deal, Teijin is getting its hands on four Type 2 diabetes drugs for the Japanese market—Nesina, Liovel, Inisync and Zafatek. All told, the portfolio pulled 30.8 billion yen ($288 million) in Takeda’s 2019 fiscal year, the company said.

RELATED: Takeda, debt in mind, offloads 18 drugs in Asia Pacific to Celltrion for $278M

Takeda will continue to manufacture and supply the drugs, handing off marketing rights and—eventually—marketing authorization to Teijin. The asset transfer is expected to go through on April 1, but Takeda will hold onto marketing authorization for the time being, with those rights to be awarded to Teijin later.

Patients still depend on those drugs in Japan, but they now fall outside Takeda’s key areas of focus, the company said. With the sale, Takeda’s portfolio is set to become a bit more manageable; plus, it inches the company closer toward clearing the debt it picked up in its $59 billion Shire deal.

Specifically, Takeda says it will use the proceeds to reduce that debt and speed up deleveraging toward a target of two-times net debt to adjusted EBITDA by fiscal year 2023.

RELATED: Takeda to offload Japan consumer health unit to Blackstone for $2.3B

To help hit that target, Takeda in December agreed to offload five cardiovascular and metabolic drugs in the Chinese Mainland to local drugmaker Hasten Biopharmaceutic for $322 million. The deal followed a $278 million transaction with South Korea’s Celltrion in June and a $2.34 billion sale of Takeda’s Japanese consumer health business to a company controlled by Blackstone in August.

Meanwhile, the company sold some more noncore products—marketed mainly in Europe and Canada—in a $562 million deal with Germany’s Cheplapharm in September, and just last month unveiled plans to pawn off certain over-the-counter and prescription meds in Latin America to local firm Hypera Pharma for $825 million.

The company has breached its $10 billion divesture goal for non-core products, and counting its latest sale to Teijin, has announced 12 deals worth some $12.9 billion since January of 2019. Plus, that $10 billion is a “target,” not a “cap,” a Takeda spokeswoman said via email.

“Takeda may continue to take advantage of potential opportunities to further focus on Takeda’s five key business areas—Gastroenterology, Rare Diseases, Plasma-Derived Therapies, Oncology, and Neuroscience,” she said.

Merck, Johnson & Johnson to strike ‘wartime’ COVID-19 vaccine manufacturing deal: WaPo

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Merck & Co., a leading vaccine player worldwide, has been largely absent during the COVID-19 vaccine race. Not anymore: The drugmaker is set to partner with Johnson & Johnson to boost production of its newly authorized shot, The Washington Post reports.

President Joe Biden is set to unveil the deal Tuesday, the newspaper reports. During the first days of his administration, officials realized J&J had fallen behind on production targets, so officials jumped in to coordinate a tie-up between the companies.

Recognizing it’s a “wartime effort,” the companies agreed to join forces when they might otherwise be rivals, one unnamed official told the newspaper.

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Merck will provide access to two U.S. manufacturing sites—one where workers will make the actual vaccine substance, and another where it will be filled into vials and packaged for shipping. The partnership could potentially double J&J’s expected vaccine capacity, officials said.

A Merck spokesman said the company “remains steadfast in our commitment to contribute to the global response to the pandemic and to preparing to address future pandemics.” He didn’t confirm or deny newspaper’s reporting.

RELATED: Johnson & Johnson’s COVID-19 vaccine scores FDA authorization, adding key third shot to U.S. supply

News of the tie-up comes right after the J&J vaccine won emergency use authorization from the FDA. For Merck, it follows an embarrassing exit from the COVID-19 vaccine race after early-stage programs posted disappointing data.

After J&J’s vaccine authorization over the weekend, CEO Alex Gorsky told Bloomberg the company was “leaving no stone unturned” in its efforts to boost production. J&J has said it would have around 4 million doses to ship at launch, plus 20 million in total this month and 100 million by the end of June.

Still, the company is “doing everything we can partnering with the U.S. government and other external manufacturers to see what we can do to accelerate and increase that number as well,” Gorsky told Bloomberg.

RELATED: Merck canned its own COVID-19 vaccines. Now, it’s in talks to manufacture other companies’ shots

Merck has been teasing potential manufacturing tie-ups as well. Several weeks ago, a spokesman said the company was “actively involved” in discussions with governments, health agencies and other pharmaceutical companies to “identify the areas of pandemic response where we can play a role, including potential support for production of authorized vaccines.”

But don’t expect an immediate boost in supply from the partnership. It’ll likely take months to get the sites up and running to start churning out new doses.

The drug giants won’t be the only Big Pharma companies to team up to fight the pandemic. J&J has already enlisted Sanofi to help with vaccine production in Europe, while Pfizer and BioNTech have unveiled partnerships with Sanofi and Novartis.

On the antibody side of the fight, Roche and Regeneron have joined forces to boost capacity, as have Amgen and Eli Lilly.