Scrip regularly covers business development and deal making in the biopharmaceutical industry. Deal Watch is supported by deal intelligence from Biomedtracker.
Lilly The Latest Pharma Company To Sign On With OpenAI
Extending biopharma’s embrace of artificial intelligence, Eli Lilly and Company unveiled a collaboration with OpenAI on 25 June focused on coming up with novel antimicrobial products to treat drug-resistant pathogens. No financial terms were disclosed.
Details on the collaboration were scant, but Lilly said using the firm’s generative artificial intelligence capabilities should create an opportunity to accelerate development of novel antimicrobials as well as the development of “custom, purpose-built” new technologies for fighting resistant pathogens.
In May, OpenAI, the corporate parent of ChatGPT, inked a partnership with Sanofi and the tech-driven pharmaceutical firm Formation Bio to "bring together data, software and tuned models to develop custom, purpose-built solutions across the drug development lifecycle." (Also see "Sanofi Cements Artificial Intelligence Ambitions With OpenAI and Formation Pact" - Scrip, 21 May, 2024.) That agreement was just Sanofi’s latest effort to harness AI technology, following pacts with Owkin, Exscientia plc and Insilico Medicine, as well as its $1bn upfront commitment in 2021 to acquire Amunix Pharmaceuticals, Inc. (Also see "$1bn Amunix Buy Brings Sanofi Next-Generation TCE Platform" - Scrip, 21 December, 2021.)
OpenAI has started other recent alliances with biopharma. On 24 April, Moderna, Inc. announced a plan to “co-innovate” embedding OpenAI’s generative AI tools into its organization. Since beginning to work together in 2023, Moderna said the collaboration had enhanced its capabilities in advanced analytics and image generation. It also led to development of a tool to help optimize dosing of vaccines, the US biotech said.
ANI To Go Public Via Merger With Alimera
ANI Pharmaceuticals, Inc. announced a definitive agreement on 24 June to acquire publicly traded, ophthalmology-focused Alimera Sciences Inc. for up to $381m in upfront consideration and sales-based milestones. Approved by each company’s board of directors, the transaction is expected to close in Q3 2024.
Under the agreement, ANI will acquire all of Alimera's outstanding shares for $5.50 per share (a 62% premium) and also repay $72.5m of the company’s debt. ANI said it will finance the transaction with a combination of cash on hand and debt financing, having obtained a $280m commitment from JP Morgan and Blackstone.
ANI said the deal will expand its existing position in ophthalmology selling Cortrophin gel for acute and chronic allergy and inflammatory conditions; grow its geographic footprint; and strengthen and complement rare disease as its largest driver of future growth, with revenues from eye care expected to increase to more than 45% of ANI’s revenues. Alimera has set 2024 revenue guidance of $105m.
Under the deal, Alimera shareholders will receive one non-tradable contingent value right (CVR) representing the right to receive up to $0.50 per share upon the achievement of certain net revenue targets in 2026 and 2027: up to $0.25 per share on net revenues exceeding $140m in 2026 and up to $0.25 per share upon net revenues in excess of $160m in 2027.
Founded in 2003, Alimera is headquartered in the US, but also has direct operations in Europe, with the company generating approximately 30% of its 2023 revenues outside the US. It sells two intravitreal implants for continuous low-dose treatment: Iluvien (fluocinolone acetonide intravitreal implant 0.19mg) is approved in the US, Europe, and the Middle East for diabetic macular edema (DME) and in Europe and the Middle East for chronic non-infectious uveitis affecting the posterior segment (NIU-PS) of the eye, and Yutiq (fluocinolone acetonide intravitreal implant 0.18mg) indicated for the treatment of chronic NIU-PS.
Alimera holds exclusive global rights to Yutiq (excluding Greater China, South Korea and Southeast Asia) through a 2023 licensing deal with EyePoint Pharmaceuticals, Inc., but currently the product is available in the US only. (Also see "Deal Watch: Novartis Acquires Gene Therapy Candidate From AvroBio" - Scrip, 24 May, 2023.) Iluvien posted 2023 sales of approximately $59m, while Yutiq brought in about $36m.
Ashibio Licenses Stalled FOP Candidate From Gilead
Concurrent with its exit from stealth mode and a $40m seed/series A raise, 2022 start-up ashibio disclosed a licensing agreement on 20 June for Gilead Sciences, Inc.’s andecaliximab, a discontinued asset, which it plans to develop for fibrodysplasia ossificans progressiva (FOP), a rare genetic disorder causing extra-skeletal bone formation. (Also see "Finance Watch: More Than $2.5bn In New VC Funding, Capital For Pharma Manufacturing In Africa" - Scrip, 25 June, 2024.) Terms of the agreement were not disclosed.
Andecaliximab is a humanized antibody that specifically inhibits the matrix metalloproteinase-9 (MMP-9) that Gilead was developing for solid tumors, rheumatoid arthritis, gastric cancers, cystic fibrosis and Crohn’s disease before discontinuing development.
Ashibio said it will develop andecaliximab as its lead program, based on a discovery that the MMP-9 enzyme could serve as a novel target for FOP, which is characterized by progressive heterotopic ossification, a pathological condition characterized by abnormal bone formation in muscle and soft tissues. The company plans to initiate a Phase II/III trial in patients with FOP in the second half of 2024. The US Food and Drug Administration and the European Medicines Agency designated andecaliximab an orphan drug for the treatment of FOP earlier this year.
Sanofi Taps Belharra’s Chemoproteomics Platform Capabilities
Belharra Therapeutics Inc. entered a collaboration on 18 June with Sanofi to advance the discovery of novel small-molecule therapeutics for immunological diseases. The collaboration will use Belharra’s proprietary non-covalent chemoproteomics platform to screen and validate hits against undisclosed Sanofi-designated immunology targets. Sanofi will take the lead on further preclinical and clinical development as well as commercial activities for resulting candidates.
Belharra said its chemoproteomics drug discovery engine leverages a computationally designed library of non-covalent drug-like molecules that use photoaffinity chemistry to identify which proteins bind the molecules as well as the precise binding location on the target proteins. Through this approach, the San Mateo, CA-based firm has developed an internal pipeline focused on oncology and immunology.
During the collaboration, Belharra could earn up to $700m, including $40m in upfront and near-term milestones, additional research, development and commercial milestones as well as sales royalties. In tandem with announcing a $50m series A financing in January 2023, Belharra inked a deal with Genentech across multiple therapy areas, including oncology, immuno-oncology, autoimmune and neurodegenerative diseases, that brought the biotech another $80m in upfront cash. (Also see "Finance Watch: VC Round Extensions Attractive While Stock Market Wobbles" - Scrip, 6 January, 2023.)
Tech Transfer:
- Switzerland’s Basilea Pharmaceutica Ltd. agreed on 20 June to sell lisavanbulin (BAL101553), which Basilea has investigated as a potential therapy for glioblastoma in Phase I and Phase II studies, to the Glioblastoma Foundation for an undisclosed purchase price. BAL101553 is a highly water-soluble prodrug of the synthetic small molecule BAL27862, a binder to the colchicine site of tubulin, which can promote tumor cell death. Under the deal terms, Basilea will participate in future proceeds from any commercial partnerships related to the drug. The foundation said it will continue a post-trial access program for patients from previous clinical studies to continue to receive lisavanbulin and further explore the candidate’s therapeutic value.
- Northwest Biotherapeutics, Inc. inked an exclusive license on 17 June from Roswell Park Comprehensive Cancer Center for a portfolio of dendritic cell technologies and related intellectual property. With the technologies already in Phase II clinical trials, the license is the culmination of more than two years of discussions and negotiations, Northwest noted. The license includes five new patent families that were just filed in 2023. Terms of the license agreement include standard provisions for an upfront license fee and milestones related to the first Phase II trial, first Phase III trial, first product approval and first commercial sale. If all milestones are met, the payments could total roughly $2.3m.
- Quoin Pharmaceuticals, Ltd. signed a research agreement on 12 June with the School of Pharmacy at Ireland’s University College Cork (UCC) for the development of novel topical formulations of rapamycin as potential treatments for several rare and orphan diseases. While Quoin will fund a research program at the university, the agreement does not confer any upfront payment or include rights to milestone or royalty payments by Quoin. Under the agreement, UCC will apply its proprietary dissolvable microneedle delivery technology, along with other formulation approaches, to optimize local delivery of rapamycin and potentially enhance its therapeutic effectiveness for several pre-identified clinical targets.
- Italy’s Sibylla Biotech and the University of Texas MD Anderson Cancer Center announced an agreement on 12 June to discover and develop novel small-molecule cancer therapies known as Folding Interfering Degraders (FIDs), which might disrupt the proper folding of target proteins and lead to their degradation. The parties will jointly conduct discovery and development work from target identification through drug candidate nomination on selected proteins. Once a drug candidate is nominated, Sibylla and MD Anderson said they may consider further drug development, translational and clinical activities to advance the candidate to patients in need.
In Brief:
- Norway’s Navamedic ASA and Finland’s Orion Corporation signed a license and supply agreement on 24 June for Navamedic’s Flexilev (levodopa/carbidopa) for Parkinson's disease, granting Orion exclusive rights to market, distribute and sell the product in 27 European countries, excluding Sweden, Norway, Denmark and Iceland, where Navamedic will market and sell the product. Navamedic added Flexilev to its portfolio through the acquisition of Sensidose AB in May 2023. The agreement includes an upfront payment of €2m ($2.1m) to Navamedic, in addition to potential milestones of up to €3.5m ($3.7m) upon reimbursement approval in key countries, as well as sales royalties.
- Germany’s Allecra Therapeutics GmbH and Swiss biotech Acino International AG unveiled a licensing agreement on 24 June for Acino to commercialize Allecra’s antibiotic Exblifep (cefepime/enmetazobactam) in South Africa and the member states of the Gulf Cooperation Council. In February, the US FDA approved Exblifep as a treatment for complicated urinary tract infections (cUTI), including pyelonephritis, in patients 18 years and older, followed by European Commission marketing authorization in March of Exblifep for adults with cUTI, including pyelonephritis, hospital- and ventilator-associated pneumonia, and bacteremia associated with any of the listed infections.
- Eiger BioPharmaceuticals, Inc. entered into an asset purchase agreement on 21 June with Amylyx Pharmaceuticals, Inc. for Eiger's avexitide, a GLP-1 receptor antagonist currently in Phase III for the treatment of congenital hyperinsulinism. The purchase represented a potential shift for Amylyx, which focuses primarily on neurogenerative disease. The company recently discontinued marketing its FDA-approved Relyvrio (sodium phenylbutyrate and taurursodiol) for amyotrophic lateral sclerosis following the drug’s failure to meet its primary endpoint in a Phase III trial. (Also see "Amylyx Resets As A Clinical-Stage Company, Withdrawing Relyvrio" - Scrip, 4 April, 2024.) Amylyx emerged the winning bidder for avexitide in a 17 June US bankruptcy court auction pursuant to Eiger's Chapter 11 bankruptcy proceedings. (Also see "Eiger To Close After GLP-1 Antagonist Gambit Fails" - Scrip, 2 April, 2024.) Under the agreement, Amylyx obtained all development, manufacturing and commercialization rights to avexitide for $35.1m.
- Paris-based Biophytis SA unveiled a license agreement on 20 June with Brazil’s Blanver for BIO101 in Latin America. Under the agreement, Blanver will be responsible for the registration, marketing and commercialization of BIO101 in its various indications of obesity, respiratory infections due to COVID-19, sarcopenia and Duchenne muscular dystrophy once Biophytis has completed planned clinical development programs. Biophytis will get up to €108m ($116m) including an upfront payment and potential milestone payments plus sales royalties.
- Italfarmaco S.p.A. and Iktos announced a collaboration on 18 June to develop next generation HDAC inhibitors for a variety of non-oncological diseases, including those affecting the central nervous system. Iktos said its generative modeling technology platform, Makya, will apply a ligand- and structure-based approach in designing molecules that align with Italfarmaco's candidate drug target profile.
- Biosplice Therapeutics, Inc. entered a collaboration on 13 June with Novo Nordisk A/S to develop drug candidates for diabetes. The companies will leverage Novo Nordisk’s expertise in diabetes and Biosplice’s R&D efforts focused on creating selective and potent DYRK (dual-specificity tyrosine-regulated kinase) inhibitors. Novo Nordisk will fund further preclinical development, with an exclusive option to license Biosplice’s relevant IP primarily focused on cardiometabolic disorders. Deal terms include upfront and milestone payments plus royalties for the exclusive license. Biosplice said its selective DYRK inhibitors have shown encouraging results in animal models and human islet cells that indicate the potential for potency and safety margins that may enable a first-in-class therapy for diabetes.
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:
