Acacia Pharma Group plc, of Cambridge, U.K., signed a strategic in-licensing transaction with Cosmo Pharmaceuticals NV, of Dublin. The transaction grants to the group exclusive U.S. commercialization rights to the short-acting sedative Byfavo (remimazolam) and has been made alongside an equity investment and debt facility by Cosmo to finance the marketing efforts of both Barhemsys (amisulpride) and Byfavo. Cosmo will make an €10 million (US$11.1 million) equity investment in Acacia and provide a new €35 million loan facility to support commercial activities.
Aduro Biotech Inc., of Berkeley, Calif., disclosed a restructuring plan to further extend the company’s operating capital and align personnel toward executing its clinical development strategy. The company intends to reduce its current workforce by 51 employees (about 59%) across the organization, minimize its corporate facilities footprint and shut down the Aduro Biotech Europe headquarters in Oss, the Netherlands, by the end of the third quarter of 2020.
Affiris AG, of Vienna, disclosed a realignment of its development strategy on neurodegenerative diseases. The company will focus on ongoing preparations of a phase II trial to treat patients suffering from Parkinson's disease (PD). Affiris has achieved proof of concept of its Affitome technology in humans for hypercholesterolemia and Parkinson's disease with respect to safety, specific antibody production, in vivo target engagement and clinical effect, including positive long-term safety data in PD. The immunological approach mimics the epitopes of pathologic forms of proteins, Affiris said.
Almirall SA, of Barcelona, Spain, and 23andme Inc., of Sunnyvale, Calif., signed an agreement allowing Almirall to in-license 23andme's bispecific monoclonal antibody designed to block all three members of the IL-36 cytokine subfamily. Almirall will secure the rights to develop and commercialize the antibody for worldwide use. Terms were not disclosed.
ANP Technologies Inc., of Newark, Del., and Fulgent Pharma LLC, of Temple City, Calif., through their partner Moffitt Cancer Center, have licensed the rights to develop a novel targeted therapy in the area of leukemia to Celgene Corp., now part of Bristol-Myers Squibb Co., of New York. The deal leverages ANP’s nanotherapeutic platform technology. The partners will work together to develop a new cancer therapy for myelodysplastic syndrome and acute myeloid leukemia, ANP said. The Moffitt research team recently discovered that a specific pathway receptor is up-regulated in those diseases’ malignant cells, and in particular the malignant stem cells, thus offering a potentially favorable disease-specific target for therapies.
Now that Artara Therapeutics Inc., of New York, has completed its merger with Proteon Therapeutics Inc., of Waltham, Mass., the combination will operate under Artara’s name. The combined company closed an equity financing of about $42.5 million, with the net proceeds funding Artara’s lead assets, TARA-002 and intravenous choline chloride. Previous Proteon stockholders will own approximately 10% of the new company, while the previous Artara security holders and new investors will own approximately 90%.
Leverkusen, Germany-based Bayer AG and Azitra Inc., of Farmington, Conn., will collaborate to identify and characterize skin microbiome bacteria. Azitra brings Staphylococcus epidermidis strains for identifying candidates to treat adverse skin conditions and diseases. Bayer plans to develop selected S. epidermidis strains into new natural skin care products under a future license agreement. Prospective application areas include medicated skin care products for sensitive, eczema-prone skin as well as products for skin diseases such as atopic dermatitis. Financial terms were not disclosed.
Bridgebio Pharma Inc., of Palo Alto, Calif., and Catalent Inc., of Somerset, N.J. have joined to establish dedicated gene therapy development and manufacturing capacity at Catalent’s clinical and commercial manufacturing center in Harmans, Md. The deal was made to support the needs of Bridgebio’s gene therapy product candidates for congenital adrenal hyperplasia, BBP-631, and Canavan disease, BBP-812. The center is more than 400,000 square feet.
Camp4 Therapeutics Corp., of Cambridge, Mass., and Biogen Inc., also of Cambridge, agreed to a deal for addressing neurodegenerative and neurological diseases. The collaboration leverages Camp4’s platform to understanding the expression of disease-associated genes within microglial cells – the primary immune cells of the central nervous system, which are implicated in many serious neurological and neurodegenerative diseases. Camp4 receives $15 million up front, with Biogen reimbursing Camp4’s research tab. Biogen can select resulting targets for discovery, development and commercialization. Camp4 could receive development and milestone payments of up to $96 million, plus future royalties, for each of the initial selected targets and up to $173 million, plus future royalties, for each additional target.
Chinook Therapeutics Inc., of Vancouver, British Columbia, entered a license agreement with North Chicago-based Abbvie Inc. for worldwide, exclusive rights to atrasentan, an endothelin receptor antagonist. Chinook assumes global development and commercialization duties and will initiate a clinical trial of atrasentan in the second half of 2020 for biomarker-selected patients with a rare primary glomerular kidney disease at high risk for progressive kidney function loss. Chinook also receives worldwide rights to all fields of use for atrasentan and responsibility for advancing the program. Abbvie will receive an undisclosed up-front cash payment, potential future milestones and royalties and an equity stake in Chinook.
Codexis Inc., of Redwood City, Calif., and Nestlé Health Science, of Switzerland, plan to advance a lead candidate into preclinical development and early clinical studies. The newest agreement advances development of CDX-7108 for treating a gastrointestinal disorder. The companies agreed in 2017 to co-discover new enzyme therapy candidates for Nestlé’s nutritional therapies portfolio. The original agreement will be extended through 2021 to support the discovery of therapeutic candidates for additional disorders. Codexis and Nestlé retain joint ownership over the rights to CDX-7108.
Boston’s Concerto HealthAI and Pfizer Oncology, part of Pfizer Inc., of New York, expanded an existing agreement to advance Concert’s data for clinical development initiatives across breast, lung, prostate and renal cell carcinoma cancers. A Concerto-Pfizer joint steering committee will oversee the collaboration. The collaboration's first outcomes research publications are expected in the middle of this year.
Daewoong Infion, of East Java, Indonesia, said it achieved world's first halal certification for animal cells-derived biopharmaceuticals. Daewoong Infion obtained halal certification from The Assessment Institute for Foods, Drugs and Cosmetics, the Indonesian Council of Ulama for Epodion (erythropoietin), Indonesia’s first biosimilar, on Jan. 3. Epodion is an anemia treatment for dialysis patients with kidney failures and cancer patients.
The Institute for Clinical and Economic Review (ICER) released an evidence report assessing the comparative clinical effectiveness and economic value of three acute treatments for migraine: Reyvow (lasmiditan, Eli Lilly), rimegepant (Biohaven) and Ubrelvy (ubrogepant, Allergan). They are less effective overall than triptans and are expected to be much more expensive, according to ICER’s chief medical officer. But for those patients who can’t take triptans or who don't get adequate benefit from them, the evidence does demonstrate that all three therapies improve or relieve migraine symptoms in 10% to 20% more patients than respond to placebo. To reach commonly cited thresholds of cost-effectiveness, these therapies would require prices significantly below what some analysts are currently projecting. ICER's value-based price benchmark range for lasmiditan, rimegepant and ubrogepant is $2,200 to $3,200 per year. While actual prices for the treatments are not yet known, each would need to be priced well below branded Imitrex (sumatriptan, Glaxosmithkline) to reach those benchmarks.
Logicbio Therapeutics Inc., of Cambridge, Mass., inked a research collaboration with Takeda Pharmaceutical Co. Ltd., of Tokyo, to further develop LB-301, an investigational therapy using Logicbio’s promoterless, nuclease-free genome editing technology, Generide, for the treatment of Crigler-Najjar syndrome. LB-301 is a recombinant adeno-associated viral vector with a uridine disphosphate-glucuronosyltransferase-1 gene. The collaboration will bring together Logicbio’s platform for genome editing and Takeda’s expertise in researching and developing gene therapies. Takeda will provide funding for the research program and will have an option to negotiate an exclusive, worldwide license to Logicbio’s LB-301 program. Financial terms were not disclosed.
Nektar Therapeutics Inc., of San Francisco, and Bristol-Myers Squibb Co., of New York, have agreed to a new joint development plan to advance bempegaldesleukin (bempeg) plus Opdivo (nivolumab) into multiple new registrational trials. The revision to the deal originally signed in 2016 includes a new joint development plan under which Nektar and BMS will expand the active clinical development program for bempeg plus nivolumab from three ongoing registrational trials in first-line metastatic melanoma, first-line cisplatin-ineligible metastatic urothelial cancer and first-line metastatic renal cell carcinoma (RCC) to include two additional registrational trials in adjuvant melanoma and in muscle-invasive bladder cancer. In addition, a phase I/II dose-escalation and expansion study will be initiated to evaluate bempeg plus nivolumab in combination with axitinib in first-line RCC in order to support a future registrational trial. The costs for those studies will be shared based upon the cost-sharing outlined in the terms of the original collaboration agreement. BMS will independently conduct and fund a phase I/II dose-optimization and expansion study in first-line non-small-cell lung cancer with bempeg and nivolumab.
Neurocrine Biosciences Inc., of San Diego, and Idorsia Ltd., of Allschwil, Switzerland, amended their 2019 agreement granting Neurocrine an option to license ACT-709478, a selective, orally active and brain-penetrating T-type calcium channel blocker, in clinical development for the treatment of a rare pediatric epilepsy. The option also includes a research collaboration to discover, identify and develop additional T-type calcium channel blockers. Idorsia will receive $45 million up front upon exercise of the option and up to $365 million in potential development and regulatory milestone payments. In 2019, Neurocrine paid a nonrefundable $5 million up-front fee to Idorsia for the option rights to ACT-709478 and a preclinical research collaboration. Neurocrine has agreed to cover additional costs as part of the IND application. A phase I trial was completed in healthy adult subjects in 2019. A phase II study in a rare pediatric epilepsy is planned in for the second half of 2020.
Novelion Therapeutics Inc., of Vancouver, British Columbia, announced the date for commencement of implementation of the company’s voluntary liquidation: Jan. 16, 2020.
Phasebio Pharmaceuticals Inc., of Malvern, Pa., announced a financing and co-development collaboration with SFJ Pharmaceuticals, of San Diego, to support the development of PB-2452, a reversal agent for the antiplatelet therapy ticagrelor. The deal will support the global development of PB-2452, which is designed to reverse the antiplatelet activity of ticagrelor in major bleeding and urgent surgery situations. Under the terms, SFJ has agreed to fund up to $120 million to support the clinical development of PB-2452 and to assume a central role in global clinical development and regulatory activities for PB-2452 outside the U.S. SFJ will fund up to $90 million of development expenses through the end of 2021 and up to an additional $30 million based on Phasebio meeting specific, predefined clinical milestones for PB-2452. Specifically, Phasebio will pay SFJ a series of annual payments over seven to eight years following receipt of regulatory approvals in the U.S., the EU and either China or Japan, with the majority of payments to SFJ due in years three to seven following each respective regulatory approval. If PB-2452 does not receive regulatory approval in a specific territory, Phasebio will not owe any payments linked to that territory.
Prevail Therapeutics Inc., of New York, granted a compassionate-use request for the administration of PR-001 to a single patient with type 2 Gaucher disease, following approval by an international regulatory authority. Type 2 Gaucher disease is the more severe form of neuronopathic Gaucher disease (nGD), which presents in infancy and involves rapidly progressing neurodegeneration leading to death in infancy or early childhood. Separately, Prevail’s IND application for PR-001 for the treatment of nGD is now active. The company is proceeding with its phase I/II trial for type 2 Gaucher disease patients and expects to initiate patient dosing during the first half of 2020.
Revance Therapeutics Inc., of Newark, Calif., signed a U.S. distribution agreement with Teoxane SA, of Geneva, making Revance the exclusive commercialization partner of the Swiss company’s Resilient Hyaluronic Acid (RHA) technology. Revance will gain immediate and exclusive rights to commercialize Teoxane’s RHA line of fillers in the U.S.
Serimmune Inc., of Goleta, Calif., signed a deal with Atreca Inc., of Redwood City, Calif., in which Serimmune will apply its Serum Epitope Repertoire Analysis platform, which maps the antigenic targets of antibody repertoires, to identify the targets of selected therapeutic antibody candidates for oncology generated by Atreca. Terms were not disclosed.
Sorrento Therapeutics Inc., of San Diego, said that on Jan. 9, it received a nonbinding proposal from a private equity fund to acquire a majority or all the issued and outstanding shares of the company for up to $7 per share. The company’s board is reviewing the proposal. Shares of Sorrento (NASDAQ:SRNE) closed Friday at $4.76, up $1.35, or 40%.