Pharma & Biotech Mergers & Acquisitions News
Biotechnology
US Pharma major AbbVie has reached a definitive agreement to acquire Aliada Therapeutics, a biotech advancing therapies using a novel blood-brain barrier (BBB)-crossing technology to address challenging central nervous system (CNS) diseases. 29 October 2024
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Biotechnology
AlloVir has entered into a definitive agreement to merge with biopharma company Kalaris Therapeutics. 8 November 2024
Pharmaceutical
European regulators will decide by December 6 whether Novo Holdings, the controlling shareholder of Danish pharma giant Novo Nordisk, can finalize its $16.5 billion acquisition of contract drug manufacturer Catalent. 5 November 2024
Biotechnology
California, USA-based biotech Nektar Therapeutics’ shares closed up more than 8% at $1.33 yesterday after it announced the sale of its only manufacturing facility. 5 November 2024
Pharmaceutical
Pharmaceutical M&A came back with a bang during October, after a quiet September. 5 November 2024
Pharmaceutical
US pharma major AbbVie last week proposed $1.4 billion acquisition of US CNS drug developer Aliada Therapeutics. Last week saw a bunch of third quarter 2024 financials results, among which were Elil Lilly, AbbVie and Merck & Co. Also of note, Lexicon’s type I diabetes drug Zynquista faced a Food and Drug Administration (FDA) advisory committee review that resulted in largely negative vote against recommendation. 3 November 2024
Biotechnology
Maryland, USA–based glycobiology specialist GlycoMimetics has entered into an acquisition agreement with Crescent Biopharma, a privately held biotechnology company advancing a pipeline of oncology therapeutics designed to treat solid tumors. 30 October 2024
Biotechnology
German drugmaker Dr Falk Pharma GmbH today announced completion of the acquisition of Kynos Therapeutics, a clinical stage biopharmaceutical company focusing on the development of novel KMO inhibitors for acute and chronic inflammatory diseases. 29 October 2024
Biotechnology
US Pharma major AbbVie has reached a definitive agreement to acquire Aliada Therapeutics, a biotech advancing therapies using a novel blood-brain barrier (BBB)-crossing technology to address challenging central nervous system (CNS) diseases. 29 October 2024
Biotechnology
Ottimo Pharma, a biotech founded by Medicxi in 2020, has emerged from stealth mode with an executive team packed with prominent industry leaders. 28 October 2024
Biotechnology
Last week Vertex Pharmaceuticals released positive Phase III results for its suzetrigine for moderate-to-severed pain. Belgium’s UCB revealed that Swiss pharma giant Roche was terminating its collaboration on the Alzheimer’s candidate bepranemab. The UK’s health technology assessor the Institute for Health and Clinical Excellence (NICE) declined to recommend a second Alzheimer’s treatment, this time Eli Lilly’s Kisunla. Also of note, Lyell Immunopharma announced its planned acquisition of ImmPACT Bio and reprioritization of its own clinical pipeline. 27 October 2024
Biotechnology
California, USA-based Lyell Immunopharma (Nasdaq: LYEL) has entered into a definitive agreement to acquire privately-held US CAR-T company ImmPACT Bio. 26 October 2024
Biotechnology
Mumbai-based Mankind Pharma has completed its acquisition of Bharat Serums and Vaccines (BSV), adding to its portfolio in the women’s health and fertility market. 24 October 2024
Biotechnology
Ocuphire Pharma has announced its acquisition of Opus Genetics, a clinical-stage gene therapy company focused on treating inherited retinal diseases. 24 October 2024
Biotechnology
Connecticut, USA-based Modifi Biosciences today announced that the company has been acquired by pharma giant Merck & Co 23 October 2024
Pharmaceutical
Melbourne, Australia-based Telix Pharmaceuticals has announced the launch of Rhine Pharma, a subsidiary aimed at increasing global access to radiopharmaceuticals for cancer treatment and imaging. 22 October 2024
Pharmaceutical
French pharma major Sanofi has opened negotiations to sell a 50% controlling stake in its consumer health business Opella to US private equity firm Clayton Dubilier & Rice (CD&R). 21 October 2024
Pharmaceutical
Last week’s significant news included Denmark-based CNS drugmaker Lundbeck reaching agreement to acquire US firm Longboard Pharmaceuticals, along with its bexicaserin, for $2.6 billion. Also, US pharma giant Pfizer entered into a deal with TRIANA Biomedicines to develop molecular glue degraders. On the regulatory front, the US Food and Drug Administration (FDA) last week approved Novocure’s key product Optune Lua for lung cancer patients. Also, German biotech BioNTech and its US partner OncoC4 received a partial clinical hold from the FDA on the Phase III trial of gotistobart in lung cancer. The European Medicines Agency’s human health committee, CHMP, Reaffirmed its non-approval of PTC Therapeutic’s Translarna. 20 October 2024
Biotechnology
Taiwan-based REGiMMUNE, a biopharma creating immunotherapies through the power of regulatory T cells (Tregs), and France-based Kiji Therapeutics, a specialist in induced pluripotent stem cells-mesenchymal stem cells (IPSC-MSC) engineered cell therapies for inflammatory diseases, are to merge. 18 October 2024
Biotechnology
Danish CNS specialist Lundbeck today revealed that it has reached to acquire Longboard Pharmaceuticals. 15 October 2024
Biotechnology
USA-based Kezar Life Sciences announced this week that it was pausing its Phase IIb PALIZADE trial evaluating zetomipzomib in lupus nephritis (LN) following the deaths of four patients. 10 October 2024
Pharmaceutical
Cadila Healthcare has changed its name to Zydus Lifesciences. 24 February 2022
Pharmaceutical
Switzerland-headquartered Galderma and US generics drugmaker Taro Pharmaceutical Industries have signed a definitive agreement for Taro to acquire Alchemee, formerly The Proactiv Company (TPC), from Galderma, a leading independent dermatology company. 23 February 2022
Biotechnology
Sweden-headquartered contract development and manufacturing organization Recipharm is on the M&A path again, having announced its intention earlier this month to acquire Portuguese CDMO GenIbet, today it revealed two more buys. 18 February 2022
Biotechnology
Third Harmonic Bio, a US clinical-stage company developing a first-in-class, highly selective, oral KIT inhibitor for treatment of severe allergy and inflammation, today launched from stealth, with the closing of a Series B financing that brings the total capital raised to date to $155 million. 16 February 2022
Generics
India's pharmaceutical sector is seeing a lot of M&A and fund-raising activity. 15 February 2022
Biotechnology
US private, precision oncology company Varian Biopharmaceuticals, which is developing novel therapeutics for the treatment of cancer, and SPK Acquisition Corp (SPK) (Nasdaq: SPK), a special purpose acquisition company (SPAC), today announced it has entered into a definitive merger agreement for a business combination that will result in Varian Bio becoming a publicly-traded company. 15 February 2022
Pharmaceutical
Switzerland-based Roivant Sciences has launched a new Vant subsidiary, Hemavant, which has entered into a licensing agreement with Japanese drugmaker Eisai for exclusive global rights to the investigational agent RVT-2001 (previously H3B-8800,) a potential first-in-class small molecule SF3B1 modulator. 15 February 2022
Pharmaceutical
Shares of specialty drugmaker BioDelivery Sciences International shot up 52% to $3.64 in pre-market trading today, after it agreed to be acquired by fellow USA-based Collegium Pharmaceuticals. 14 February 2022
Biotechnology
Canada-based companies Imagia Cybernetics, AI-healthcare company, and Canexia Health have announced their planned merger, which is expected to close at the end of February, subject to shareholder approval. 11 February 2022
Pharmaceutical
Russian billionaire Mikhail Fridman, together with partners, is acquiring the European assets of South African pharmaceutical manufacturer Ascendis Health. 7 February 2022
Pharmaceutical
US healthcare giant Johnson & Johnson’s unit Janssen Pharmaceuticals has acquired Anakuria Therapeutics. 7 February 2022
Pharmaceutical
India's Panacea Biotec Pharma, a subsidiary of vaccine maker Panacea Biotec, is to sell its domestic formulations business for $255 million to Mankind Pharma. 2 February 2022
Biotechnology
Having been a prolific buyer and licensor of medicines, investigational candidates and companies, including its $64 billion acquisition of Shire in 2018, Japanese drug major Takeda Pharmaceutical is also spinning out assets, some into a newly-formed companies such as Ensoma. 1 February 2022
Pharmaceutical
The first month of the year is often one of the busiest for the announcement of mergers and acquisitions (M&A) in the pharmaceutical sector. 31 January 2022
Biotechnology
By Barbara Obstoj-Cardwell. Editor
With the fourth-quarter financial results season starting, Johnson & Johnson, as ever, was the first big pharma to release figures on Tuesday, and these beat expectations. US biotech Incyte last Tuesday announced a clinical setback for its parsaclisib trial and decision to opt out of continued development of MCLA-145 with Mersus. Troubled US biotech Biogen has entered a deal to sell its nearly 50% stake in Samsung Bioepis, the biosimilars joint venture Samsung BioLogics, for $2.3 billion. TG Therapeutics suffered a setback with the US Food and Drug Administration putting a partial clinical hold on its study of leukemia candidate Ukoniq, but the news was more to do with how it slipped out.
J&J looks to be bolder on deals
Add Johnson & Johnson to the growing list of big pharma groups that could soon be going shopping, commented Madeleine Armstrong writing on Evaluate Vantage following release of its fourth-quarter financials. The call with analysts was dominated by questions about M&A after the company, which is in the process of spinning off its consumer business, said it would “be bolder” in strategic acquisitions in the coming years.
The preference is for small tuck-ins, but J&J’s new chief executive officer, Joaquin Duato, is not ruling out large deals, saying: “We don’t have an artificial ceiling as far as deal size.” Takeouts look likely across both pharma and medical devices, with the chief executive stating that both will be core to the new-look J&J.
Still, the bar for justifying a big deal is higher, Mr Duato said, given that these are harder to make work from an operational and financial perspective.
However, the group does not seem too hopeful of getting a bargain. When asked whether prices looked attractive given the recent pullback in biotech valuations, J&J’s chief financial officer, Joe Wolk, replied: “It’s really hard to say whether there’s been a capitulation. I think we probably need to see [it for] a little bit longer.”
Unlike Pfizer, however, J&J’s spending money has not come from its Covid vaccine. The J&J jab sold just $2.4 billion in 2021 and is forecast to net another $3.0-3.5 billion next year, mainly from use in low and middle-income countries, Ms Armstrong noted.
Endpoints News’ editor and founder John Carroll added that J&J has also made some bold promises on their top programs, outlining 14 blockbuster candidates in the pipeline with four other programs, joining the BCMA CAR-T as potential mega earners at $5 billion-plus. The other drugs in that arena include the “pipeline in a product” nipocalimab, the oral Factor XIa inhibitor milvexian (partnered with Bristol Myers), Rybrevant, a targeted NSCLC drug, and a bladder cancer platform called Taris.
J&J is using that pipeline to promise a $60 billion pharmaceutical sector by 2025, tracked by sales. The new face of the global player reflects a new day coming for J&J, which will spend much of this year setting up the spinoff of its big consumer division, after shaking up the executive committee that guides the company as it looks to prove it can be an innovative developer of new blockbusters.
Mr Carroll also noted that he Darzalex, Stelara (which loses patent protection in the USA in 2023) and Tremfya franchises continued their upward march on the sales side, delivering a 13.6% increase in worldwide sales, with a decline for Remicade.
Add it all up, and you had a beat on earnings estimates on the street, but a miss on revenue that the market largely overlooked, driving up the share price a bit over 1% this morning. Revenue jumped a little more than 10% to $24.8 billion, driven by the vaccine - which has had to endure a bright spotlight on rare cases of blood clots, which nevertheless continued to prove its efficacy outweighed any safety issues seen so far.
Incyte opts put of MCLA-145 development; parsaclisib NHL development halted
Last Tuesday, Incyte disclosed that the company has elected to opt out of continued development of Merus' PD-L1 x CD137 bispecific, MCLA-145, for the treatment of solid tumors, and also discontinued development of parsaclisib in NHL (mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), and follicular lymphoma (FL)) in the USA, commented analysts as SVB Leerink Research..
Incyte indicated the MCLA-145 decision was made as part of an ongoing review of portfolio prioritization and capital allocation. With Incyte opting out of development, Mersus regains full ex-US rights to develop and commercialize MCLA-145, although Incyte will continue to support the program for a short period while ex-US activities are transitioned. Of note, Incyte will also retain a right to residual royalty of up to 4% on sales of future commercialization of MCLA-145, if approved. Recall, Mersus recently shared an updated Phase I data set at the 2021 European Society of Molecular Oncology Imuuno-Oncology (ESMO IO) Congress that highlighted the challenging therapeutic window associated with the class, as consistent transaminase elevations and liver toxicities were observed across assets with similar targets (ie, GEN1046).
For now, the analysts have removed ex-US royalties for MCLA-145 to MRUS, pending greater visibility on Mersus' revised strategy. These changes reduce their Mersus PT to $43 from $45. In conjunction with the MCLA-145 update, Mersus announced the appointment of Shannon Campbell as chief commercial officer, effective February 2022. Incyte also announced the withdrawal of its new drug application (NDA) submission for parsaclisib in MCL, MZL, and FL. Consequent to discussions with the FDA, Incyte believed that the US confirmatory studies would not be able to be completed in a time frame that would support further investment into the program.
The company stated that the withdrawal was not related to any changes observed to the drug's existing efficacy or safety profile. According to management, the company will cease further development for parsaclisib in these lymphomas in the USA, though the asset will continue to be studied as part of a combination with Jakafi (myelofibrosis) and for autoimmune hemolytic anemia (AIHA).
With the update, the analysts are removing US credit for parsaclisib in their estimates, reducing their Incyte PT to $61 from $66. They previously had estimated sales of parsaclisib in NHL of $731 million at peak in 2030, which helped offset the revenue decrease modeled for Jakafi in 2027 following the drug's patent expiry. Parsaclisib combination trials as part of the company's Jakafi life cycle program, LIMBER, if successful, could potentially be co-formulated and thus, help offset this patent expiry.
Biogen sells its Bioepis stake bit by bit
Biogen’s sale of its 49.9% stake in Samsung Bioepis to the other party in the joint venture, Samsung Biologics, could be a move towards shoring Biogen up in the wake of the Aduhelm mess, commented Elizabeth Cairns writing on Evaluate Vantage.
The $2.3 billion price – $1 billion cash up front followed by $812.5 million a year later and $437.5 million a year after that – has disappointed Wells Fargo analysts, however. They note that the price is only just higher than the $2.24 billion valuation Samsung gave the stake in 2018, and suggest that the lack of other interested parties and private nature of the stake might explain the low price. Mizuho analysts go further, citing a South Korea news article that valued Bioepis at around $10 billion and suggesting that Biogen held on to its stake so long because it was waiting for half that sum.
Also commenting, EndPoints News senior editor Amber Tong noted it turns out the Korea Economic Daily was onto something when, over the Christmas break, it reported that Samsung was in the process of making a buyout bid for Biogen. Samsung quickly denied the rumor, and then we heard nothing more on the matter for another month.
For Biogen, the exit from biosimilars elevates the stakes of an already fraught focus in neurosciences, anchored by the controversial Alzheimer’s drug, Aduhelm. At the same time, the deal gives the biotech some cash to burn as it grapples with disappointing Aduhelm sales and a negative Medicare coverage decision that poses serious implications for reimbursement.
TG slips out a nasty surprise for investors
TG Therapeutics has worked hard, sometimes against the odds, to convince investors and the FDA of the benefits of U2, its chronic lymphocytic leukemia project. Last Thursday the story took another twist as it emerged that the combo, under review by the agency for close to a year, was on partial clinical hold, commented Jacob Plieth on Evaluate Vantage.
TG fell 41%, a harsh reaction even considering the abysmal performance of biotech markets so far this year. One reason why investors and analysts have come down hard on the company is that the hold bombshell did not fall in a formal announcement but was slipped out at an investor meeting and subsequently confirmed in a low-key regulatory filing.
If the company was hoping to create minimum fuss the strategy clearly failed. For whatever reason US clinical holds now appear to be a near-daily occurrence, with companies hit including Denali, Dyne, Yumanity, Viking, Cortexyme, Mustang Bio and Gilead. TG has not escaped the FDA’s attention.
U2 comprises Ukoniq, a PI3K delta inhibitor approved as monotherapy for indolent lymphomas, and the anti-CD20 MAb ublituximab, separately under US review for multiple sclerosis, an indication the sell-side now sees as generating the vast majority of its blockbuster 2026 sales forecasts, according to Evaluate Pharma. 30 January 2022
Biotechnology
UK gene and cell therapy group Oxford Biomedica and US genetic medicines company Homology Medicines have agreed to establish a high-performing, full scope adeno-associated virus (AAV) manufacturing and innovation business in the USA. 28 January 2022
Biosimilars
South Korea-based Samsung BioLogics has reached an agreement for the buyout of Biogen's (Nasdaq: BIIB) stake in their biosimilars joint venture, Samsung Bioepis, for $2.3 billion. 28 January 2022
Generics
Texas, USA-based Mark Cuban Cost Plus Drug Company (MCCPDC) officially launched its online pharmacy yesterday. The launch comes just weeks after its pharmacy benefit manager (PBM) operation was established - both critical efforts in the company's pursuit to help shield consumers from inflated drug prices. 28 January 2022
Biotechnology
Germany-headquartered biotech atai Life Sciences saw its shares rise 3.9% to $5.77 this morning, after announcing the launch of Invyxis, a new, wholly-owned platform company committed to developing new chemical entities (NCEs) and to further pioneering next-generation mental health treatments. 27 January 2022
Biotechnology
A new California, USA-based biotechnology company, named Septerna, has launched today with the aim of discovering and advancing novel small molecule medicines targeting G protein-coupled receptors (GPCRs). 27 January 2022
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