Blog

Αρχική » Blog » Επιχειρηματικά Νέα » The top 10 biopharma M&A deals of 2023

The top 10 biopharma M&A deals of 2023

While the biopharma industry’s dealmaking totals have yet to eclipse the heady highs of 2019, mergers and acquisitions were back on the menu in a big way in 2023.

Last year, the value of the top 10 M&A deals in the biopharma industry came to $115.8 billion, outranking prior sums from 2022, 2021 and 2020, which came to $65 billion, $53 billion and $97 billion, respectively.

While 2023 didn’t bring buyouts on the scale of Bristol Myers Squibb’s massive Celgene acquisition or AbbVie’s $63 billion buyout of Allergan, the industry appears to have shaken off some of the caution of the last few years.

Topping the 2023 list is Pfizer’s $43 billion merger with Seagen. That deal, announced in mid-March, came amid a flurry of interest in the booming field of antibody-drug conjugates (ADCs), which was also reflected in AbbVie’s proposed $10.1 billion takeover of ImmunoGen.

While other top deals came in at considerably less cost than Pfizer’s acquisition, the year played host to multiple sizable M&A moves, including BMS’ $14 billion bid for neuroscience specialist Karuna Therapeutics.

Speaking of neuroscience, the field—much like ADCs—caught considerable interest over the past year, as evinced not only by BMS’ Karuna buy but AbbVie’s $8.7 billion takeover of Cerevel Therapeutics, too.

Besides those agreements, Bristol made two other agreements that earned spots on this report. Roche and Biogen each made plays to bolster their presence in key disease areas.

Astellas, meanwhile, inked a buyout that’s already provided the Japanese drugmaker with an important new launch.

Five deals included in this report feature drugs that were previously approved or that gained approvals in 2023. Bristol’s Karuna buy, meanwhile, could provide the pharma giant with a launch opportunity by the end of 2024.

Editor’s note: Fierce Pharma ranked 2023’s top M&A deals based on dollar values excluding any potential milestones or contingent value rights. Those portions of the deals, if applicable, are noted in the individual profiles. 

Pfizer
Pfizer wasn’t originally expected to be the purchaser of Seagen. (Pfizer)
Pfizer and Seagen

Deal value: $43 billion
Premium: 33% above previous closing price
Date announced: March 13

Pfizer and Seagen’s $43 billion merger contributed to a torrent of interest flooding into the field of antibody-drug conjugates last year. AbbVie’s proposed $10.1 billion acquisition of ImmunoGen, featured later in this report, was another example in a busy year for ADC dealmaking.

For its part, Pfizer has made other major cancer deals in the past. Its $14 billion acquisition of Medivation brought the Astellas-partnered prostate cancer drug Xtandi. And its $11.4 billion buyout of Array BioPharma was the fifth-largest biopharma deal in 2019.

Now, Pfizer is diversifying at a critical time. Financially, the company’s performance has been sputtering lately due to low demand for COVID-19 products. In addition, its oncology portfolio had lacked exciting assets to follow up behind Xtandi and the declining blockbuster breast cancer med Ibrance.

In October, the pharma giant unveiled a $3.5 billion cost-cutting plan, only to increase the goal to $4 billion in annual savings later in the year.

Also toward the end of the year, Pfizer unveiled a new organizational structure, establishing oncology as a separate division with its own commercial and R&D operations, which are headed by cancer R&D chief Chris Boshoff, M.D., Ph.D.

Pfizer’s R&D, commercialization and manufacturing capabilities could accelerate the expansion of Seagen’s portfolio. In a 2023 interview with Fierce Pharma, then-Seagen CEO David Epstein highlighted how Pfizer could run several large phase 3 trials simultaneously, a feat that a mid-sized company like Seagen couldn’t achieve on its own.

Pfizer wasn’t initially expected to be Seagen’s purchaser, as fellow Big Pharma Merck & Co. once appeared to be the likeliest suitor to acquire the Seattle-based cancer specialist.

Merck and Seagen were already partners on several products, including a combination of Seagen and Astellas’ ADC Padcev and Merck’s PD-1 king Keytruda. But after a patent ruling favored Daiichi Sankyo in a legal battle with Seagen, Merck lowered its offer and later bowed out of the bidding process, a securities filing later showed.

After negotiations, Pfizer eventually bought Seagen for $229 per share, a 33% premium on the Seattle company’s previous closing price and a 40% premium on the price before reports of a potential Merck deal emerged.

With the deal, Pfizer got its hands on four commercial cancer products. Padcev, the CD30-targeted Adcetris and the tissue factor-directed Tivdak each belong to the ADC class, while HER2 agent Tukysa is a small molecule. With a coveted first-line approval and a practice-changing overall survival win in bladder cancer, Padcev is expected to reach around $7 billion in peak sales, according to analysts from Leerink Partners and Evercore ISI.

But Padcev’s huge potential in bladder cancer caused a hiccup during authorities’ antitrust review of the merger. To please the U.S. Federal Trade Commission, Pfizer proactively ended a commercialization partnership with Merck KGaA on the PD-L1 antibody Bavencio, and then it completely severed ties around the drug by agreeing to donate royalties.

Besides the in-market products, Seagen also has HER2-targeted ADC disitamab vedotin, which was developed by RemeGen in China. In another licensing deal unveiled in December, Seagen put down $53 million upfront for a mesothelin-targeted ADC made by Haror BioMed’s Nona Biosciences.

Ladiratuzumab vedotin, an LIV-1-directed ADC that’s part of a $1.6 billion partnership with Merck, has been deprioritized. Seagen’s pipeline also includes ADC prospects targeting B7-H4, STn, integrin beta-6, TIGIT, among other targets.

Bristol Myers Squibb
BMS’ Karuna Therapeutics buy offers a potential 2024 launch for a promising schizophrenia drug. (Bristol Myers Squibb)
Bristol Myers Squibb and Karuna Therapeutics

Deal value: $14 billion
Premium: 53% above previous closing price
Date announced: December 22

Bristol Myers Squibb capped off its busy year of dealmaking with a bang in the form of a $14 billion buyout of Boston-based Karuna Therapeutics. In the process, the drugmaker got its hands on a potentially groundbreaking schizophrenia asset.

If all goes well, Bristol figures the potential windfall from Karuna’s lead asset, KarTX, could more than make up for the cash the company shelled out on the biotech, which came to $330 per share. The antipsychotic could “transform the treatment of schizophrenia,” CEO Chris Boerner said in a presentation at the J.P. Morgan Healthcare Conference in early January.

KarTX is a first-in-class M1 / M4 muscarinic receptor agonist. The Karuna drug takes a different approach to treating schizophrenia than the traditional method of inhibiting D2 dopamine receptors and the 5HT-52A serotonin receptors.

In essence, Karuna’s med leverages a dual mechanism that doesn’t rely on old standards, and it could offer fewer side effects than typically seen with current treatments.

In schizophrenia, the therapy is up for an FDA decision in September. But its long-term value includes the possibility of “a number of subsequent indications,” Boerner has said.

For one, Karuna had been studying its candidate in Alzheimer’s disease psychosis. BMS has high hopes for that use and has “reason to believe”  that the novel mechanism can work, according to the CEO.

“We think that this has got a high probability of success,” Boerner emphasized at the JPM conference. The company also sees opportunities in bipolar disorder and Alzheimer’s disease agitation.

As for the initial schizophrenia nod, a launch in that population would be a “very targeted one,” the CEO said at JPM.

Still, Bristol expects “rapid switching” once the drug is on the market, BMS’ chief commercialization officer Adam Lenkowsky said on an investor call at the time of the deal.

Bristol and Karuna are operating as separate companies until the deal closes, which is expected in the first half of 2024. Both companies have turned their attention to the launch, with Karuna already having made “good progress” in hiring staffers “on the market access side,” according to Boerner.

With a patient pool of around 3.5 million people in the U.S., the schizophrenia market is on its own “not a massive opportunity,” Boerner acknowledged. Active competitors in the space, such as Lundbeck and Otsuka’s Rexulti, have been successful in adding uses such as bipolar disorder and dementia agitation to their labels.

With the deal, BMS is firmly setting up shop in the neuropsychiatry arena. KarTX could complement the company’s PRX005, an experimental Alzheimer’s drug that it gained from Prothena in exchange for $80 million. More recently, the company forked over another $55 million for exclusive worldwide rights to the asset.

Other than PRX005 and KarTX, BMS’ neuropsychiatry pipeline will soon include Karuna’s other assets in mood and anxiety disorders. The biotech brings a clutch of assets that target the muscarinic pathway.

Merck
With its buyout of Prometheus, Merck gained a promising TL1A candidate that could treat ulcerative colitis, Crohn’s disease and other autoimmune conditions. (Photo by Thomas Frey/picture alliance via Getty Images)
Merck and Prometheus Biosciences

Deal value: $10.8 billion
Premium: 75% above previous closing price
Date announced: April 16

In February 2021, Merck made a relatively small move into immune-mediated inflammatory diseases with its $1.85 billion buyout of Pandion Therapeutics. Sixteen months later, the New Jersey drugmaker made a significantly larger play in the same disease area with its takeover of Prometheus.

The big prize in the deal is PRA-023 (now MK-7240), a novel candidate in ulcerative colitis (UC), Crohn’s disease and other autoimmune conditions. The monoclonal antibody made waves in December of 2022 with a phase 2 readout that was so impressive that it shot Prometheus’ stock price from $36.06 per share to $117.21 over a two-day span.

In a study in UC patients, the tumor necrosis factor (TNF)-like ligand 1A (TL1A) treatment provided a 26.5% remission rate at Week 12, compared with 1.5% for those on placebo. In a phase 2 trial on patients with Crohn’s disease, 49% reached remission on PRA-023, versus a historical placebo rate of 16%.

The figures set the drug up to compete with another top candidate in the TL1A space, Roivant and Pfizer’s antibody RVT-310. In October, Roche paid $7.1 billion to acquire Telavant, a company that Pfizer and Roivant established to develop the drug and commercialize it in the United States and Japan. Pfizer will commercialize it outside of the U.S. and Japan.

Sanofi also has joined the rush to get a piece of the TL1A action, paying $500 million to Teva to join the development and commercialization of TEV’574, which is in phase 2 in UC and Crohn’s.

The TL1A pathway is believed to modulate the location and severity of inflammation and fibrosis. The hope for TL1A drugs is that they will target multiple inflammatory and fibrosis pathways.

As for the Merck-Prometheus deal, the New Jersey drugmaker struck the deal as prepares to compensate for the future loss of exclusivity of cancer superstar Keytruda.

“The agreement with Prometheus will accelerate our growing presence in immunology where there remains substantial unmet patient need,” Merck CEO Robert Davis said in a statement. “This transaction adds diversity to our overall portfolio and is an important building block as we strengthen the sustainable innovation engine that will drive our growth well into the next decade.”

With the deal, Merck also gains four other candidates for bowel and immune-mediated diseases. San Diego-based Prometheus will remain a wholly owned subsidiary. The biotech has said that it expects the inflammatory bowel disease market to be worth $49 billion by 2030.

Prometheus had a market cap of $5.4 billion and its shares were trading at $114 when Merck made the buy for $200 per share, for a 75% premium. The biotech’s share price shot up 70% with the merger, while Merck’s dropped by 1%.

After the Prometheus deal was closed, Davis said that Merck was still in the market for new acquisitions.

“We continue to have a priority to do business development, so you should not necessarily expect a slowdown,” Davis said on an earnings call. “If and when assets that bring important scientific opportunities present themselves—where we see an alignment with strategy and where we can see value creation—we have the capacity and we will be willing to act on those.”

AbbVIe Cork
AbbVie was one of the first Big Pharma companies to identify ADCs as a promising way to treat cancers. (AbbVie)
AbbVie and ImmunoGen

Deal value: $10.1 billion
Premium: 95% above previous closing price
Date announced: November 30

While AbbVie doesn’t have the largest oncology division among its Big Pharma peers, the company is certainly enticed by the red-hot antibody-drug conjugate field.

Take ImmunoGen as evidence. In November, the Illinios-based pharma giant ponied up more than $10 billion to acquire the ADC-focused biotech and its approved drug Elahere, which scored an accelerated approval in 2022 as a treatment for advanced ovarian cancer that’s resistant to platinum chemotherapy.

With the deal, AbbVie moved on its “strategic priority” to enter the solid tumor space, AbbVie CEO Rick Gonzalez said on a call after striking the buyout. The CEO touted the biotech as an “extremely compelling opportunity” after offering up a hefty deal premium of about 95% over ImmunoGen’s prior-day close.

In an interesting twist, AbbVie was one of the first Big Pharma companies to identify ADCs as a promising way to treat cancers. Way back in 2011, still under the Abbott umbrella, the company paid $8 million to Seattle Genetics to leverage the ADC specialist’s tech on a single cancer target.

Seattle Genetics later became Seagen, which sold to Pfizer in 2023’s largest biopharma M&A deal.

As for AbbVie, the company is once again getting involved in cancer’s hottest treatment platform. ImmunoGen’s Elahere boasts Wall Street sales forecasts of $500 million for 2024, and analysts believe the drug could generate $2 billion in peak sales at the end of the decade. To reach that level, the drug will need to move into earlier lines of treatment.

Beyond Elahere, ImmunoGen’s pipeline includes IMGN-151, an anti-FRα follow-on that might be able to move beyond ovarian cancer, plus an anti-CD123 ADC prospect in phase 2 testing for a rare blood cancer.

In a note to clients at the time of the deal, William Blair analysts said AbbVie’s decision to tap more than four decades of ADC experience at ImmunoGen could make the combined firm a formidable competitor in the space. AbbVie’s commercial and R&D infrastructure, plus ImmunoGen’s specialized knowledge, should allow AbbVie to entrench Elahere in ovarian cancer and speed up pipeline advancements, the analysts said.

The ADC field provided a notable boost for biopharma dealmaking in 2023. Besides AbbVie’s M&A play, the year’s largest deal was centered on the technology platform. In addition, BioNTechGSK, Merck & Co. and other drugmakers have committed cash to build up their presence in the space.

Merck, for instance, made a splash in October when it paid $4 billion up front—plus $18 billion in potential milestones—to get its hands on 3 ADCs from Daiichi Sankyo.

As for AbbVie’s purchase of ImmunoGen, a securities filing at the end of the year detailed how the company didn’t actually pursue the biotech until other potential suitors were already at the negotiating table.

Two other companies, identified only as “Party A” and “Party B,” were exploring a possible purchase of ImmunoGen before the biotech’s board identified AbbVie and a group of other companies as potential bidders. After ImmunoGen solicited offers from all of the companies, AbbVie’s final proposal won out.

AbbVie
Cerevel’s clinical crown jewel is emraclidine, a phase 2 contendor for schizophrenia and Alzheimer’s disease psychosis. (AbbVie)
AbbVie and Cerevel Therapeutics

Deal value: $8.7 billion
Premium: 26% above previous closing price
Date announced: December 6

Much like Bristol Myers Squibb with Karuna, AbbVie used the waning days of 2023 to make a big bet on the industry’s neuroscience renaissance.

The company’s $8.7 billion buyout of Cerevel Therapeutics arms AbbVie with a roster of clinical assets that could eventually pull down multiple billions of dollars in sales, AbbVie CEO Richard Gonzalez said after the buyout was announced. The deal is slated to build out AbbVie’s already bustling neuro pipeline, which includes prospects for migraine, movement disorders and psychiatric disorders.

Cerevel’s clinical crown jewel is emraclidine, a phase 2 contender for schizophrenia and Alzheimer’s disease psychosis. The drug, a muscarinic M4 selective positive allosteric modulator, is in the same class as Karuna Therapeutics’ KarXT, which was the centerpiece of Bristol’s Karuna buyout later in the month of December.

AbbVie telegraphed its intention to buy out Cerevel roughly a year after emraclidine passed a key safety test that many analysts viewed as an important de-risking event for the up-and-coming drug. In December 2022, emraclidine was found not to raise patients’ blood pressure, and in fact, patients in a phase 1 trial actually had a reduction in 24-hour ambulatory systolic blood pressure at week eight.

With that, emraclidine had met the main goal of its early-stage safety study.

There’s more to Cerevel than emraclidine alone. Another major asset in the company’s pipeline is tavapadon, a dopamine D1/DF selective partial agonist for Parkinson’s disease that’s in late-stage testing. Cerevel is eyeing the med as both a monotherapy and for use in tandem with other drugs.

In its announcement around the Cerevel deal, AbbVie noted tavapadon could become a near-term “complementary asset” to AbbVie’s existing therapies for advanced Parkinson’s, specifically in earlier-stage disease.

Under the deal, AbbVie is set to acquire all outstanding shares of Cerevel for $45 apiece in cash. The transaction is slated to close in the middle of 2024.

In order to scoop up Cerevel, AbbVie had to compete against at least three different companies and contended with the risk that Pfizer might swoop in, too, according to a recent Securities and Exchange Commission document. In fact, AbbVie’s CEO personally handled much of the negotiating with Cerevel chief Ron Renaud.

As for Cerevel itself, the biotech surfaced in 2018 with assets carried over from Pfizer. At the end of 2023, Pfizer and another top investor, Bain Capital, owned 51% of Cerevel.

Even though both AbbVie and Cerevel have schizophrenia drugs, AbbVie’s Gonzalez recently said he wasn’t concerned about problems with the U.S. Federal Trade Commission over the buyout.

“Obviously, we looked very carefully at the FTC risk before we proceeded forward. I can tell you, this acquisition is not anti-competitive,” Gonzalez said in an investor call last year. He noted that psychiatry is a very “crowded and fragmented” market with “literally dozens” of available medicines.

Aside from Cerevel’s upcoming drug, AbbVie markets Vraylar for schizophrenia, though the bulk of the drug’s sales come from bipolar disorder.

Biogen
In October, just two weeks after Biogen completed its buyout of Reata, the combined companies announced they would cut 113 jobs. (Photo by John Tlumacki/The Boston Globe via Getty Images)
Biogen and Reata Pharmaceuticals

Deal value: $7.3 billion
Premium: 59% above previous closing price
Date announced: July 28

In another neuro-focused buyout from 2023, Biogen’s $7.3 million acquisition of Reata Pharmaceuticals largely centered on the latter company’s recently approved drug Skyclarys.

Skyclarys, approved by the FDA last February, represents the first and only treatment for the rare, inherited neurological disorder Friedreich’s ataxia. The medication has the potential to bring home $1.5 billion in sales in 2030, analysts have predicted.

Speaking on a conference call in late July, Biogen’s CEO Chris Viehbacher called his company “the natural owner for Skyclarys.” At the time, the CEO telegraphed plans to synergize commercialization of the Reata drug with Biogen’s own Spinraza for spinal muscular atrophy (SMA), plus its new Qalsody for amyotrophic lateral sclerosis (ALS).

Under the deal, Biogen last summer agreed to pay $172.50 per Reata share, a 59% markup on the company’s stock price at the time.

Skyclarys marked the first commercial approval in Texas-based Reata’s 21-year history. Aside from Skyclarys, Reata boasts a few investigational drugs for other neurological conditions in its pipeline, though none are in the late stages of development.

Despite Biogen’s excitement about the deal, investors were quick to criticize the deal. In a poll of investors by Mizuho, 55% said the Reata buy was a bad transaction for Biogen, while 41% favored it.

Regardless of investor sentiment, Biogen fought hard to win its prize.

Back in May, before Biogen entered the bidding process, a separate “large-cap pharmaceutical company,” dubbed “Party A,” set up a meeting with Manmeet Soni, Reata’s president, COO and CFO, to discuss collaboration opportunities in Europe, a 2023 securities filing showed.

Soon after, a senior executive from Party A contacted Warren Huff, chairman and CEO of Reata, to request an intro call to further discuss opportunities for the businesses to team up.

Ultimately, a bidding war ensued in which Biogen came out on top, anteing up about $7.3 billion in cash to acquire Reata.

Bloomberg later reported that Party A was French drug juggernaut Sanofi.

But it hasn’t all been smooth sailing for Reata staffers under the Biogen banner.

In October, just two weeks after Biogen completed its buyout of Reata, the combined companies announced they would cut 113 jobs starting in November. The layoffs were set to affect about a third of the acquired company’s staff.

The cuts were set to affect roles “where there are existing synergies at Biogen, such as general and administrative services,” plus some development workers, a Biogen spokesperson said at the time.

“That being said, we are retaining those colleagues who have been essential to the launch of Skyclarys to ensure there are no disruptions for patients,” the spokesperson added.

Roche
After 11 months and just $15 million spent in expenses, Roivant collected $5.3 billion for its 75% stake in Telavant. (Roche)
Roche and Telavant Holdings

Deal value: $7.1 billion
Premium: N/A
Date announced: October 23

For many industry watchers, the immediate focus on Roche’s $7.1 billion buyout of Telavant centered on how the latter company’s majority owner, Roivant, flipped a Pfizer spinoff in less than a year for a lucrative sum.

For $7.1 billion upfront and $150 million in near-term milestones, Roche bought U.S. and Japan rights to a phase 3-ready inflammatory bowel disease (IBD) candidate. Coded RVT-3101, the antibody drug targets TL1A, which was also the central theme in Merck’s $10.8 billion acquisition of Prometheus Biosciences, featured earlier in this report.

Also in October, Sanofi splurged $500 million upfront and committed up to nearly $1 billion in milestone payments to co-develop and co-commercialize Teva’s anti-TL1A candidate, called TEV’574.

TL1A  is attracting interest from drug developers because of its regulation of inflammation and fibrosis. Besides the initial focus on IBD, Roche believes TL1A holds potential in other major inflammatory indications such as atopic dermatitis, psoriasis and rheumatoid arthritis.

The Roche deal for Telavant came on the heels of phase 2b data from the TUSCANY-2 trial, which was conducted in patients with moderate to severe ulcerative colitis.

For the monthly dose that’s moving into phase 3 testing, RVT-3101 as a maintenance treatment led to an improved 36% clinical remission rate after 56 weeks compared with 29% at week 14. Endoscopic improvement also widened to 50% from the previous 36%. That study delivered the first dataset for an anti-TL1A drug in the chronic maintenance setting.

Before the TUSCANY-2 readout, Pfizer had handed off the medicine to a joint venture it formed with Roivant. Rather than maintain full ownership, Pfizer kept a 25% stake in the JV, Telavant, while Roivant got the drug for free.

Eleven months later and after roughly $15 million spent in expenses, Roivant collected $5.3 billion for its 75% stake in Telavant, according to TD Cowen analyst Yaron Werber, as cited by The Wall Street Journal.

Roche, hoping to be first in class, is pushing RVT-3101 into phase 3 at full speed after the deal closed in December. The TL1A drug joined Roche’s immunology franchise, which also features Novartis-partnered Xolair and IL-6 receptor antagonist Actemra, among other meds.

Besides RVT-3101, the Swiss pharma also obtained an option to start a collaboration with Pfizer on a p40/TL1A bispecific antibody, which is in phase 1.

Roche has suffered notable phase 3 setbacks over the years, and its five-year phase 3 success rate between 2018 and 2022 was just 58%. That figure compares with a peer average of 76%.

Those late-stage flops have created a need for Roche to pursue other candidates, Roche’s global head of pharma partnering, James Sabry, Ph.D., told Fierce Biotech on the sidelines of the 2024 annual J.P. Morgan Healthcare Conference.

In addition to Telavant, Roche in December put down $2.7 billion upfront to take over Carmot Therapeutics, a biotech with injectable dual GLP-1/GIP receptor agonists and an oral GLP-1 drug in clinical development. In July, it paid $310 million up front for a midstage hypertension candidate from Alnylam.

While Roche currently doesn’t have a commercial drug in cardiovascular or metabolic diseases, the Alnylam and Carmot deals show that the company is evolving into those areas, Sabry said.

Astellas
Astellas’ $5.9 billion buyout of Iveric Bio is the largest in the history of the Japanese company.
Astellas and Iveric Bio

Deal value: $5.9 billion
Premium: 22% over previous closing price
Date announced: April 30

Three months after Astellas made its largest-ever acquisition, the FDA approved the drug that the Japanese company had targeted in the buy. Dubbed Izervay, the medicine is a treatment for geographic atrophy (GA), which strikes those with late-stage macular degeneration.

Astellas’ acquisition looked even more inspired when Apellis’ Syfovre, the only other drug approved in the indication, was flagged in July for intraocular inflammation, a condition that can cause blindness. The side-effect concern damaged Apellis’ first-to-market advantage for the drug, which was endorsed by the FDA in February of last year.

In December, meanwhile, the U.S. regulator added a warning to the label of Syfovre. It remains to be seen if Izervay, with the same mechanism of action as a complement inhibitor, will be subject to a similar safety warning.

Astellas and Apellis are the first to reach the lucrative GA market and they’re likely to share it for a while as the most promising other candidates—a gene therapy from Roche and an oral complement inhibitor from AstraZeneca—remain in midstage testing.

Syfovre and Izervay are not cures. The drugs slow disease progression as opposed to improving or stalling central vision loss. They work by attaching to complement proteins, preventing the immune system from causing inflammation and damage to the retina.

Astellas’ acquisition of Iveric came less than a month after Naoki Okamura took over as the Japanese drugmaker’s CEO, and the success of the deal could define his tenure. The company needs to find replacements for its mega-blockbuster Xtandi, which loses patent protection in 2027.

The prostate cancer drug generated around $4.5 billion during Astellas’ last fiscal year, which ended on March 31, 2023. That total represented more than 40% of the company’s overall revenue for the year.

Okamura played a big role in Astellas’ last major acquisition, a $3 billion buyout of gene therapy specialist Audentes Therapeutics in 2019. But the deal has been a disaster, resulting in four patient deaths and more than $1 billion in accounting write-offs.

The company pulled off a savvy deal in 2009, however, when it partnered with Medivation three years before Xtandi was approved. As Astellas’ director of licensing and alliances then, Okamura was central to that deal as well.

The question now is how much Izervay can compensate for Xtandi’s inevitable decline. Jefferies analyst Stephen Barker pegs Izervay’s sales at $500 million by 2026 and $2.4 billion by 2034. By comparison, despite its safety concerns, Apellis’ Syfovre is off to a strong launch, generating sales of $138 million in the fourth quarter of 2023.

In November, Astellas presented data that showed the effectiveness of Izervay, which is dosed monthly, more than doubled from year one to year two. In the second year, Izervay produced a 19% mean reduction in GA lesion growth versus placebo. Despite the success of the primary endpoint of the trial, it did not meet the secondary objective of vision loss reduction.

Also in November, Apellis countered with three-year trial data, which showed the cumulative benefits of its own treatment. In year three, Syfovre reduced GA lesion growth by 35% when administered monthly and 24% when dosed every other month versus placebo.

BMS flag
Inked in October, Bristol’s Mirati buyout was the first of three big M&A moves for the Big Pharma company last year. ( BMS)
Bristol Myers Squibb and Mirati Therapeutics

Deal value: $4.8 billion (plus $1 billion contingent value right)
Premium: 52% above 30-day average ending October 4
Date announced: October 8

Biopharma’s dealmaking bigwig Bristol Myers Squibb made waves back in 2019 when it inked a megamerger with Celgene, a deal followed by several others in the years since.

But now that a key jewel from Celgene is bleeding share to generics, Bristol spent much of 2023 flexing its muscle at the M&A table.

In early October, Bristol Myers Squibb moved on Mirati after a yearslong courtship, inking a buyout worth up to $5.8 billion for the cancer specialist and its FDA-approved lung cancer drug Krazati.

When Bristol struck the deal, the company billed Mirati’s medicine as the best-in-class KRAS G12C inhibitor. Approved in late 2022 to treat previously treated KRAS G12C-mutated non-small cell lung cancer (NSCLC), the drug followed Amgen’s rival Lumakras onto the market.

But despite Krazati’s second-comer status, Mirati’s med could hold an advantage over its rival because of its potential to be combined with a PD-1 inhibitor thanks to a favorable liver toxicity profile.

A securities filing after the deal showed that Bristol’s possible interest in Mirati stretched way back to October 2020, when the New York-based drugmaker and two other “global pharmaceutical companies” inked confidentiality agreements to review the cancer biotech’s business.

On top of an equity deal value of $4.8 billion, Bristol agreed to pay Mirati’s shareholders $1 billion if the FDA accepts an application for the company’s pipeline drug MRTX1719 within seven years of deal closure.

For Bristol, the deal comes as the company faces growth pressures after Revlimid’s high-profile tumble over the patent cliff. Acquired in the Celgene buyout, that drug started facing generics in 2022. During the first 9 months of 2023, Revlimid sales fell 40% to $4.6 billion worldwide.

Thanks in part to the Revlimid slowdown, Bristol in July 2023 trimmed its sales forecast and warned of an overall revenue decline for the year.

After that warning, the deals started to flow. Besides Bristol’s buyout of Mirati in October, the company scooped up neurology specialist Karuna for $14 billion in December.

Days later—and right in time for the deadline to be included in this report—Bristol acquired radiopharmaceutical-focused RayzeBio for $4.1 billion.

While Bristol made Fierce Pharma’s top M&A rankings three times over for 2023, the company appeared on the 2022 version of this report once for its $4.1 billion buyout of Turning Point Therapeutics.

Before that, the company didn’t appear in 2021 and earned the No. 3 spot in 2020 for its $13.1 billion buyout of MyoKardia.

BMS
With its year-end purchase of RayzeBio, BMS joins the likes of Novartis and Eli Lilly in the growing radiopharma space. (Jeremy Moeller/Getty Images)
10  Bristol Myers Squibb and RayzeBio

Deal value: $4.1 billion
Premium: 104% above previous closing price
Date announced: December 26

Just before the buzzer sounded on 2023, dealmaker extraordinaire Bristol Myers Squibb beat the clock with one final play.

The company’s RayzeBio acquisition bolsters the company’s longer-term effort to establish a presence in the buzzing radiopharma scene. By spending $62.50 per share to buy RayzeBio, BMS adds a pipeline of actinium-based radiopharmaceutical therapeutics (RPTs) to its fold.

Some highlights of the new haul, courtesy of RayzeBio, include potential treatments for gastroenteropancreatic neuroendocrine tumors (GEP-NETs), small cell lung cancer and hepatocellular carcinoma, among other cancers.

The lead asset, dubbed RYZ101, targets somatostatin receptor 2, which is over-expressed in GEP-NETs and in extensive stage small cell lung cancer. That candidate is in the enrollment stage of a phase 3 trial in certain patients with GEP-NETs.

RPTs work by binding to tumor cells and killing the cancer cells through targeted radiation. RayzeBio’s actinium-based RPTs could offer an even more targeted approach, plus stronger efficacy, than the RPTs that are currently on the market, BMS said in a statement.

“Acquiring RayzeBio’s differentiated actinium-based radiopharmaceutical platform will establish Bristol Myers Squibb’s presence in one of the most promising and fastest-growing new modalities for the treatment of patients with solid tumors—delivering radioactive payloads to cancer cells in a targeted manner,” BMS’ chief medical officer, Samit Hirawat, M.D., said in a statement.

From RayzeBio’s perspective, the biotech believes Bristol’s “well-established presence in oncology and deep expertise in developing, commercializing and manufacturing treatments on a global scale makes it the ideal partner for RayzeBio at this important moment in our evolution,” CEO Ken Song, M.D., added.

Major competitors in the radiopharma arena include Novartis and its established lutetium-based medicines Lutathera and Pluvicto, plus new entrant Eli Lilly after it forked over $1.4 billion for Point Biopharma Global.

On top of the pipeline offerings, BMS gets its hands on a state-of-the-art manufacturing facility that RayzeBio is constructing in Indiana. Drug production at the site is slated to begin in the first half of this year.

The facility represents a key facet of the deal and emphasizes the “premium value ascribed to pure-play radiopharmaceutical companies that have ownership over manufacturing,” William Blair analysts wrote in a late December note to clients.

Bristol’s pair of year-end deals are part of an effort to deliver growth through 2030 as patent cliffs and the Inflation Reduction Act (IRA) loom as threats to blockbuster meds Revlimid, Eliquis and Opdivo, which together made up 65% of the drugmaker’s total revenues in 2022.

Now, the company will turn to smaller opportunities such as “licensing opportunities, partnerships and bolt-on” purchases, as opposed to large buyouts, CEO Chris Boerner said at this year’s J.P. Morgan Healthcare Conference.

Amid a “significant period of transition” for the company, Boerner is staying focused on the pipeline, which he said could deliver more than 16 new products through 2030.

Πηγή: fiercepharma.com
Facebook
LinkedIn
X
ΣΥΝΔΕΣΗ

Δεν είστε εγγεγραμμένο μέλος της Ε.Ε.Φα.Μ;

Χρησιμοποιούμε cookies για να σας προσφέρουμε την βέλτιστη εμπειρία περιήγησης στην σελίδα μας.
Πληκτρολογήστε και πατήστε enter για να δείτε τα αποτελέσματα αναζήτησης