Astrazeneca plc, of Cambridge, U.K., completed its sale of commercial rights to Seroquel (quetiapine fumarate) and Seroquel XR (quetiapine fumarate extended release) in Europe and Russia to Cheplapharm Arzneimittel GmbH, of Mesekenhagen, Germany, and has received $178 million in return. It may also receive future sales-contingent payments of up to $61 million.
Gent, Belgium’s Augustine Therapeutics, a collaborative effort of VIB, KU Leuven, V-Bio Ventures and PMV, joined by Advent France Biotechnology and Gemma Frisius Fund, launched with $4.68 million to discover and develop treatments for patients with Charcot-Marie-Tooth disease and other neuromuscular diseases. The disease is a hereditary disorder of the peripheral nervous system, characterized by a progressive denervation of muscles.
Castle Creek Pharmaceutical Holdings Inc., of Basking Ridge, N.J., completed its acquisition of Fibrocell Science Inc., of Exton, Pa. The combined organization, which follows an initial partnership started earlier this year, has late-stage development programs in rare genetic diseases such as epidermolysis bullosa and plans to target additional rare conditions with its gene therapy platform.
Clovis Oncology Inc., of Boulder, Colo., said professor Richard Baum reported his initial clinical experience with FAP-2286, linked to Gallium-68 as a tumor-imaging compound using PET/CT and to Lutetium-177 as a therapeutic agent, in named-patient use at the International Centers for Precision Oncology Foundation symposium in Germany. He imaged 10 patients and, in each case, found that the FAP-PET/CT showed consistency with standard-of-care 18F-FDG-PET/CT scans for the same patients, including identification of both primary and metastatic lesions in liver, lung, bones, lymph nodes and other sites. Baum did not observe accumulation of FAP-2286 in healthy tissues of the 10 patients, except, as anticipated in the kidneys where FAP-2286 is excreted. In addition, Baum treated 10 patients with initial single dose administration of FAP-2286 linked with Lutetium-177. The radionuclide, approved for use with somatostatin receptor targeting agents, is in development for use with other compounds.
Deciphera Pharmaceuticals Inc., of Waltham, Mass., submitted an NDA to the FDA for ripretinib, the company’s broad-spectrum KIT and PDGFR-alpha inhibitor, for the treatment of patients with advanced gastrointestinal stromal tumors who have received prior treatment with imatinib (Gleevec, Novartis AG), sunitinib (Sutent, Pfizer Inc.) and regorafenib (Stivarga, Bayer AG). The NDA is being reviewed under the Oncology Center of Excellence Real-Time Oncology Review, or RTOR, pilot program to explore a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible, while maintaining and improving review quality, Deciphera said. In October 2019, the FDA granted breakthrough therapy designation to the product.
Eagle Pharmaceuticals Inc., of Woodcliff Lake, N.J. reached an agreement with Eli Lilly and Co., of Indianapolis, allowing Eagle to launch a three-week supply of Pemfexy (pemetrexed), a branded alternative to Lilly's Alimta (pemetrexed), on Feb. 1, 2022, with an uncapped entry on April 1, 2022.
The European Laboratory Research & Innovation Group (ELRIG) U.K. and the British Pharmacological Society, have struck a two-year agreement that they said offers an opportunity to strengthen the position and reach of each other’s scientific communities. Since the two groups work in complementary sectors of the U.K. pharmaceutical and biotech industries, academia and clinical pharmacology members of both organizations will gain access to new openings for scientific exchange and collaboration between industry, academia and the clinic to help drive the successful discovery and development of new medicines. Both groups have also committed to hosting joint and complementary meetings.
FSD Pharma Inc., of Toronto, said that Nasdaq has approved its application to have its class B subordinate voting shares listed on the market.
Jaguar Health Inc., of San Francisco, said a clinical research study initiated and sponsored by The University of Texas Health Science Center at Houston will be supported by its subsidiary, Napo Pharmaceuticals Inc. The study will evaluate the safety and effectiveness of Mytesi (crofelemer) for treatment of chronic idiopathic diarrhea in patients and is expected to begin enrolling patients before the end of the year. Crofelemer is the company's FDA-approved orally administered botanical drug extracted and purified from the red bark sap of the medicinal Croton lechleri tree in the Amazon rainforest. Adults with noninfectious chronic idiopathic diarrhea (defined as >20 bowel movements per week of which >50% are watery bowel movements) will be included in the study. Participants in the study will receive crofelemer 125 mg delayed-release tablets twice daily, with or without food, for four weeks. Reduction in weekly stool frequency as well as changes in stool consistency and quality of life improvements will be evaluated at the end of the study.
Neurovation Labs Inc., a New York-based company developing a diagnostic and companion treatment for post-traumatic stress disorder, said it has been awarded a U.S. Air Force SBIR phase I contract to advance the development of its technologies. Both products target the same protein increase in the fear center of the brain.
Neurovive Pharmaceutical AB, of Lund, Sweden, said it has settled its dispute with Karlsruhe, Germany-based Ciclomulsion AG. In 2004, Neurovive entered into a license agreement with Ciclomulsion granting it rights to use and develop products based on a certain pharmaceutical technology. In March 2013, Ciclomulsion initiated arbitration seeking declaratory relief aimed at establishing its rights to royalties, which it claimed Neurovive was obliged to pay it. Under terms of the settlement, Neurovive will not make any payments for the claims made in the arbitration and the ownership of the technology will remain with Neurovive. The company also will not be liable for any future royalties relating to the technology.
Omeros Corp., of Seattle, said it presented new data on its cancer immunotherapy target GPR-174 at the European Society for Medical Oncology Immuno-Oncology congress in Geneva. The presentation included new data from human ex vivo studies demonstrating that GPR-174 inhibition results in down-regulation of checkpoint and tumor-promoting factors. In addition, the data show that GPR-174 inhibitors reduce both cytotoxic T-lymphocyte-associated protein 4 and amphiregulin levels in T cells, suggesting that multiple pathways, including checkpoint and tumor-promoting factors, downstream of GPR-174 inhibition may be inactivated, further augmenting antitumor immunity and blocking tumor growth.
Oncosec Medical Inc., of Pennington, N.J., received preliminary approval for a $885,000 tax credit from the New Jersey Technology Business Tax Certificate Transfer program. The program enables companies to turn their tax losses and credits into cash proceeds to fund R&D, buy equipment and/or facilities, or cover other allowable expenditures. Oncosec develops cytokine-based intratumoral immunotherapies to stimulate the body's immune system to target and attack cancer.
Preclinical data on South San Francisco-based Oric Pharmaceuticals Inc.’s lead program, ORIC-101, show it inhibits the transcriptional induction of PD markers and reversed glucocorticoid receptor-mediated chemoresistance in vitro and in vivo in treating breast cancer. ORIC-101 is a glucocorticoid receptor antagonist that’s in a phase Ib study as a combination therapy to treat advanced solid tumors. Oric is also conducting a second phase Ib trial of ORIC-101 in combination with enzalutamide in patients with metastatic prostate cancer.
Platelet Biogenesis Inc., of Cambridge, Mass., received $2.3 million from the Medical Technology Enterprise Consortium to accelerate development of an automated, mobile bioreactor that produces PLT+ packs for field hospitals and other military medical posts. The consortium collaborates with the U.S. Army Medical Research and Development Command, which partners with private industry, academic institutions and government agencies to develop point-of-injury treatments for members of the military. Platelet’s platform generates human platelets at scale.
Scancell Ltd., of Oxford, U.K., said it signed a second collaboration and nonexclusive research agreement with an unnamed Chinese biotechnology company to assess monoclonal antibodies targeting tumor-associated glycans. The first agreement was announced in September. Scancell’s new partner will conduct preclinical studies evaluating Scancell’s monoclonal antibodies to treat cancer. Financial terms were not disclosed.
Synedgen Inc., of Claremont, Calif., received a $259,000 grant from the U.S. Army Medical Research Acquisition Activity to restore innate gastrointestinal integrity damaged by inflammatory bowel diseases. Synedgen plans to use the money to complete preclinical efficacy studies for several formulations of its oral glycopolymer pharmaceuticals to reduce GI inflammation, leaky bowl syndrome and ulcerative damage in a model of ulcerative colitis.