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Scrip regularly covers business development and deal-making in the biopharmaceutical industry. Deal Watch is supported by deal intelligence from Biomedtracker.

The January J.P. Morgan Healthcare Conference is known to bring a wave of biopharmaceutical deal-making, often with a major deal announcement timed for maximum attention. But this year continued a trend that started back with the 2020 meeting – research alliances and licensing deals dominate rather than large merger and acquisition activity. As of 13 January, the final day of the meeting, the year’s largest deal was a collaboration between Sanofi and Exscientia Ltd. worth up to $525m, while Pfizer Inc. made the biggest upfront cash outlay with a $300m payment to Beam Therapeutics Inc. on 10 January.

During the first two weeks of 2022, the industry has posted 21 deals with estimated value of at least $100m, of which four included upfront cash of $100m or greater. (Deal Watch Bristol Pfizer Lead Off JP Morgan Week With Two Deals Apiece) Besides, Sanofi/Exscientia and Pfizer/Beam, these included the Pfizer/BioNTech SE mRNA partnership on a shingles vaccine and a Bristol Myers Squibb Company alliance with Century Therapeutics, Inc. in cancer cell therapy development. (BioNTech Deal Shows Pfizer Is Reinvesting COVID-19 Windfall In mRNA)

No M&A deals valued at $1bn or higher were announced during this year’s conference. Even last year’s alliance and licensing-heavy J.P. Morgan week still brought Sanofi’s $1.45bn acquisition of Kymab Ltd. (Sanofi Hits MA Trail Again To Buy UKs KyMab) At the 2020 meeting, roughly two months before the COVID-19 pandemic truly took hold in the US and EU, there were no M&A deals valued at $1bn, with the biggest upfront outlay being Incyte Corporation’s $750m payment for development and commercial rights to MorphoSys AG’s anti-CD19 cell therapy tafasitamab.

By contrast, M&A deals valued at $5bn or more took center stage at J.P. Morgan in 2019 and 2018, with the 2019 event highlighted by Bristol’s $74bn buyout of Celgene Corporation. Eli Lilly and Company also acquired Loxo Oncology for $8bn that week. In 2018, Sanofi bought Bioverativ Inc. for $11.36bn and Ablynx N.V. for $5.12bn, according to Biomedtracker, while Celgene paid $9.6bn for Juno Therapeutics Inc.

Pfizer Aligns In Cancer With Dren In Third Deal Of The Week

Having already announced a base-editing partnership with Beam and lipid nanoparticle delivery agreement with Acuitas Therapeutics, Pfizer unveiled a third deal during the J.P. Morgan conference on 11 January, a research collaboration and license agreement with privately held Dren Bio, Inc. Pfizer made an upfront cash payment of $25m to Dren, which could also realize more than $1bn in development, regulatory and commercial milestones.

The collaboration will focus on the discovery and development of therapeutic bispecific antibodies for select oncology targets using Dren’s proprietary Targeted Myeloid Engager and Phagocytosis Platform. The companies will team up to advance selected oncology target programs through clinical candidate selection, at which point Pfizer will assume full responsibility for all remaining development, manufacturing, regulatory and commercialization activities.

For each product licensed by Pfizer, Dren can earn receive tiered royalties on all future net sales. The big pharma gets the right to nominate additional oncology targets under the tie-up, subject to additional cash payments and future royalties.

Based in San Carlos, CA, Dren raised a $60m series A financing in October 2020. (Finance Watch Three New Life Science VC Funds Total Nearly $1bn) The biotech has a bispecific antibody-based platform technology that engages a receptor selectively expressed on myeloid cells, including monocytes, macrophages and dendritic cells. Certain myeloid cells, such as tumor-associated macrophages (TAMs), are part of the tumor microenvironment where they can be immunosuppressive and result in poorer clinical outcomes. By repolarizing TAMs and engaging them together with dendritic cells to execute targeted phagocytosis, antigen presentation and subsequent T-cell activation, antibodies derived from the platform may expand an immunotherapy’s therapeutic and promote durable clinical responses, the companies said.

ADVANZ Obtains EU-Plus Rights To Allecra Combination Antibiotic

ADVANZ PHARMA Corp. and Allecra Therapeutics GmbH inked a license agreement on 13 January conferring rights to develop and commercialize Allecra’s antibiotic drug candidate cefepime/enmetazobactam within the EU, UK, Switzerland and Norway. The product combines enmetazobactam, an extended-spectrum β-lactamase inhibitor with cefepime, a fourth-generation cephalosporin.

In exchange, Allecra receives an upfront payment and can earn development and sales milestones for the combo product, as well as tiered royalties. The companies also signed an agreement under which Allecra will supply the finished product in the agreed upon territories. No further financial details were disclosed.

Salarius Gets Protein Degradation Portfolio From DeuteRx

Salarius Pharmaceuticals, Inc. acquired DeuteRx, LLC’s oral, small molecule targeted protein degradation portfolio on 12 January for $1.5m in upfront cash plus $1m in stock. The deal includes the cereblon-binding molecular glue SP-3164 (formerly DRX-164), the related patent family including issued composition of matter patents, and the opportunity to develop additional undisclosed cancer-fighting assets in the targeted protein degradation space.

DeuteRx also can earn up to $53m in clinical and regulatory milestone payments and sales achievement milestone payments of up to $135m, as well as net sales royalties on net sales. Additionally, DeuteRx is could realize clinical, regulatory and sales milestone payments of up to $84m and net sales royalties for each of two future products.

Under the agreement, Salarius and DeuteRx will jointly complete SP-3164 development activities and collaborate on future product R&D. Salarius plans to develop SP-3164 as a potential treatment for hematological cancers and solid tumors with the first clinical trial slated for 2023.

Journey Medical Acquires Molecule Stabilizing Platform From VYNE

Journey Medical Corp. signed a definitive agreement on 12 January with VYNE Therapeutics Inc. to acquire the latter's Molecule Stabilizing Technology (MST) franchise for $20m up front and an additional $5m on the deal’s one-year anniversary. The agreement also provides for contingent net sales milestone payments as follows: annual net sales reaching each of $100m, $200m, $300m, $400m and $500m will trigger one-time payments of $10m, $20m, $30m, $40m and $50m, respectively, per product, up to a ceiling of $450m.

Previously known as Menlo Therapeutics, VYNE gained the MST platform through its 2019 acquisition of Foamix. ([SC126172]) The technology enables localized delivery of therapeutic agents that were not previously stable in topical formulations.

The MST franchise includes two FDA-approved minocycline products – Amzeeq topical foam, 4% for acne, and Zilxi topical foam, 1.5% for rosacea – plus a Phase II topical foam acne program, FCD105 (adapalene/minocycline). The products offer topical delivery of minocycline, an active pharmaceutical ingredient previously available only in oral form.

Sana Licenses BCMA CAR Construct From IASO And Innovent Bio

IASO Pharma Inc. and Innovent Biologics, Inc. have licensed their CAR-T therapy to Seattle-based Sana Biotechnology, Inc. The US biotech obtained non-exclusive commercial rights to a B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) construct for use in certain in vivo gene therapy and ex vivo hypoimmune cell therapy applications, the companies said on 11 January.

Nanjing, China-based IASO and Hong Kong-listed Innovent will receive an unspecified upfront payment and can realized up to roughly $204m in potential development and regulatory milestone payments across up to six products, as well as royalties.

The BCMA CAR licensed to Sana is a key part of an autologous BCMA-targeting CAR-T cell therapy candidate (CT103A/IBI326) co-developed by IASO and Innovent.

According to the latest data from the Phase I/II clinical study, CT103A/IBI326 demonstrated an overall response rate of 94.9% and a complete response/stringent complete response rate of 58.2% in 79 patients with relapsed and/or refractory multiple myeloma. (IASO-Innovent Tout Favourable Profile Of BCMA CAR-T)

In Brief:

  • Bristol Myers Squibb announced a multi-target drug discovery and licensing pact with Prellis Biologics on 13 January. No financial terms were disclosed, although Prellis gets upfront cash and research funding and can realize development and commercial milestones plus sales royalties. Under the agreement, BMS will access the San Francisco biotech’s EXIS human lymph node organoid technology platform to discover high-affinity antibody candidates that will target human proteins. Therapeutic areas of focus were not disclosed.

  • AstraZeneca PLC and BenevolentAI Limited revealed on 13 January that they are expanding their April 2019 collaboration to use artificial intelligence and machine learning in the discovery and development of novel medicines for chronic kidney disease and idiopathic pulmonary fibrosis. The partners are adding systemic lupus erythematosus (SLE) and heart failure to their efforts, after announcing in December that AstraZeneca had added a novel IPF target to the collaboration. (AstraZeneca And BenevolentAI Advance AI Partnership With Second Novel Target)

  • Lysogene SA announced on 13 January that it has terminated a 2018 partnership with Sarepta Therapeutics, Inc. focused on LYS-SAF302, an investigational gene therapy for Sanfilippo A syndrome, a lysosomal storage disorder. Following unsuccessful negotiations pertaining to manufacturing rights for the therapy, Lysogene regains all US and non-EU rights to LYS-SAF302 that were conferred to Sarepta in the original deal. (Deal Watch Licensing Alliances Amgen Places 66m Bet On Genetic Sequencing)

  • China’s Shanghai Fosun Pharmaceutical (Group) Co., Ltd. and Insilico Medicine unveiled a four-target, AI-driven discovery and development alliance on 11 January, that will entail the two firms collaborating on Insilico’s development efforts against QPTCL, a protein target in the CD47 pathway. The New York biotech gets $13m up front and an equity investment by Fosun under the deal, and can earn milestones and profit-sharing.

  • Merck & Co., Inc. and Aligos Therapeutics, Inc. said on 11 January that they had expanded a collaboration begun in December 2020 to discover and develop oligonucleotide therapies for a non-alcoholic steatohepatitis target and one additional target in the fibrosis/cardiometabolic space chosen by the US pharma. (Deal Watch Merck Co Looks To Advance NASH Ambitions With Aligos) Under the expansion, Merck in-licensed an Aligos candidate for NASH that is directed at a second target, with Aligos getting an undisclosed fee. The addition of a third target to the collaboration increases Aligos’ potential earning power under the agreement to roughly $1.374bn, from a prior $960m.

  • Fusion Pharmaceuticals Inc. unveiled a pair of research collaborations on 11 January to discover novel, peptide-based radiopharmaceuticals for the treatment of various solid tumors. The Hamilton, Ontario-based biotech, focused on next-generation radiopharmaceuticals as precision medicines, is partnering with both Pepscan Therapeutics and 48Hour Discovery, Inc. on discovery efforts with undisclosed financial terms. Each deal gives Fusion global development and commercial rights to any peptides discovered under the collaborations. Fusion raised a $105m series B financing in April 2019 to fund its work on targeted alpha-particle radiotherapeutics. (Finance Watch Q1 Biopharma Venture Capital Dips From AllTime High But Numbers Still Impress)

  • CAR-T therapy specialist Allogene Therapeutics Inc. and Antion Biosciences SA, a Swiss cell- and gene-engineering firm, unveiled a collaboration and license agreement on 11 January to use Antion’s miRNA technology (miCAR) in developing next-generation allogeneic CAR T products. Allogene gets exclusive worldwide rights to commercialize products incorporating the Antion technology developed during the collaboration. Antion an undisclosed upfront cash payment and a preferred equity investment. Allogene will pay Antion developmental and commercial milestones and a single-digit royalty on any product sales. Allogene will also take a seat on Antion’s Board of Directors.

  • Gastrointestinal medicine-focused EsoCap AG inked a worldwide antibody licensing agreement on 10 January with Upadia Holding BV to develop targeted therapeutics for Barrett’s esophagus (BE). Under the agreement, Upadia will confer licenses to multiple highly specific monoclonal antibodies, which EsoCap will attempt to develop as therapies against BE using its therapeutic film technology.

Stay tuned for the next edition of Deal Watch. You can read more about other deals that have been covered in depth by Scrip and Generics Bulletin in recent days below:

(Frances Abivax Looks A Likely MA Target)

With a candidate for ulcerative colitis set to go into Phase III soon with a safety profile that looks cleaner than anti-TNFs and the JAK class, Abivax could soon be getting some interesting offers.

(2022 Deal-Making Momentum To Be Driven By Small Companies)

The power dynamics for deal-making in 2022 may shift to smaller companies emboldened by funds from venture financing and IPOs. While the spotlight will continue to be on ADCs and cell and gene therapies, vaccines and COVID-19 treatments will predictably be hot areas for licensing, Syneos Health predicts.

(AstraZeneca Plans To Drug The Undruggable With Scorpion Partnership)

AstraZeneca will work with US biotech Scorpion to develop up to three precision medicines targeting cancer proteins previously thought undruggable via conventional methods.

(Aurobindos CuraTeQ Expands Biosimilars Deal With Orion For Baltic Countries)

Aurobindo’s CuraTeQ Biologics has expanded its biosimilar distribution agreement with Finnish Player Orion. After covering the Nordics, Austria, Hungary and Slovenia, the partnering companies have decided to expand to the Baltic countries, with launches slated for between 2023 and 2026.

(FTC Gives Green Light To ANI-Novitium Acquisition Conditions)

ANI is now firmly in the clear for its $210m acquisition of Novitium, following FTC approval of an order requiring divestiture of rights and assets to two generic products. The US-based firm is on an upward trajectory following its recent approval for Cortrophin Gel.

(Deals Or No Deals JP Morgan Sets The Tone For 2022)

No big buyouts were revealed during the annual J.P. Morgan Healthcare Conference for a third year in a row. Big pharma firms are in acquisition mode, but execs stress desire for easy integrations and scientific alliances.

(ABLs Bispecific Antibody For Parkinsons Lands In Sanofis Hands)

ABL Bio’s $1.06bn license deal with Sanofi for Parkinson's antibody is seen offering favorable terms to Korean biotech and is also poised to beef up French group’s presence in the space versus competitors.

(Beam Anticipates Pfizer Deal Will Lead To Additional Partnerships)

Pfizer’s $300m upfront payment should provide considerable runway for base-editing company Beam, which also plans multiple IND filings and enrolling the first patient in its sickle cell study this year.

(Amgen CEO Bradway On Deals Good Smaller Opportunities Are Vast)

Amgen is enthusiastic about deals of all sizes, including a new Arrakis collaboration, and is interested in large transactions like its Otezla buy – but Bradway said right-priced opportunities are fewer and farther between.

 








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