Achillion Pharmaceuticals Inc., of Blue Bell, Pa., shareholders approved the company’s acquisition by Alexion Pharmaceuticals Inc. and expect the deal, disclosed in October, to close in the first half of 2020. Alexion acquires Achillion for about $930 million, or $6.30 per share in cash for each share of Achillion common stock. The transaction includes nontradeable contingent value rights paid to Achillion shareholders if certain clinical and regulatory milestones are achieved within specified periods, including $1 per share for the FDA approval of danicopan and $1 per share for initiating a phase III study of ACH-5228, a second-generation oral factor D inhibitor, to treat paroxysmal nocturnal hemoglobinuria.
Indivior plc will provide Addex Therapeutics Ltd., of Geneva, Switzerland, with an additional $800,000 by year’s end to accelerate research in their development of oral gamma-aminobutyric acid subtype B (GABAB) positive allosteric modulator (PAM) compounds to treat addiction. In 2018’s original agreement, Addex received a $5 million up front and a minimum of $2 million per year of research funding for two years. Targeting GABAB with PAMs is designed to produce fewer adverse effects and lead to less tolerance compared to direct agonists. Addex recently filed an SEC registration statement for a proposed Nasdaq listing.
Astrazeneca plc, of Cambridge, U.K., is selling commercial rights to Arimidex (anastrozole) and Casodex (bicalutamide) in a number of European, African and other countries to Paris-based Juvisé Pharmaceuticals, putting the company into oncological treatments. Both are used primarily to treat breast and prostate cancers but have lost their compound patent protection in those countries. Astrazeneca divested the U.S. rights to Arimidex and Casodex in 2017. Juvisé made an up-front payment of $181 million and may make future sales-contingent payments of up to $17 million. In 2018, Arimidex had sales of $37 million in the countries covered by the agreement, while Casodex had sales of $24 million. Arimidex is an aromatase inhibitor, primarily for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer, the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer and the treatment of advanced breast cancer in postmenopausal women with disease progression, following tamoxifen therapy. Casodex is an androgen-receptor inhibitor, used as in combination therapy with a luteinising hormone-releasing hormone analogue to treat stage D2 metastatic carcinoma of the prostate.
In an update of four of its candidates, Cytomx Therapeutics Inc., of South San Francisco, Calif., noted that it advanced two lead programs, CX-072 and CX-2009, from proof of concept into phase II studies. CX-072, an anti-PD-L1 probody for patients with solid tumors, began a phase II study in combination with Yervoy (ipilimumab) in relapsed or refractory melanoma in November. The company is enrolling patients in the PROCLAIM-CX-2009 phase I/II study evaluating CX-2009 as monotherapy in patients with select advanced solid tumors, including breast cancer, castration-resistant prostate cancer, cholangiocarcinoma (bile duct cancer), endometrial cancer, head and neck cancer, non-small-cell lung cancer and ovarian cancer. In a collaboration with Abbvie Inc., Cytomx is preparing to present initial data from the phase I dose escalation portion of the PROCLAIM-CX-2029 phase I/II study. In another collaboration, Cytomx and Bristol-Myers Squibb Co. (BMS), are assembling data for presentation from the completed phase I portion of the phase I/IIa study evaluating BMS-986249 alone and in combination with Opdivo (nivolumab) in advanced solid tumors. As BMS initiates phase II, Cytomx is entitled to a $10 million milestone payment.
G3 Pharmaceuticals Inc., of Burlington, Mass., and Nestlé Health Science SA, of Lausanne, Switzerland, plan to develop, manufacture and clinically research plant-derived galectin-3 inhibitors to manage heart failure and chronic kidney disease. Nestlé has an option for exclusive global commercial rights to G3’s galectin-3 inhibitors for use in nutritional products. No financial terms were disclosed.
GB Sciences Inc., of Las Vegas, reported preclinical data that showed its cannabinoid formulations for treating Parkinson’s disease reduced behavioral changes associated with the loss of dopamine-producing neurons, which underlies the pathology of Parkinson's disease in animal models. The company said it expects to enter the clinic next year.
Lignamed LLC, of Philadelphia, published preclinical data demonstrating that lead candidate LGM-2605 iroduces a protective effect on airway hyperreactivity in a model of Th2-low asthma, a subtype of glucocorticoid resistant asthma. LGM-2605 is a small-molecule synthetic lignan with anti-inflammatory and antioxidant properties being developed as an oral treatment for Th2-low asthma. The research was published in The Journal of Allergy and Clinical Immunology. Lignamed said it expects to file an IND with the FDA in 2021.
Peptidream Inc., of Kanagawa, Japan, said it achieved its first milestone in its discovery alliance with Osaka, Japan-based Santen Pharmaceutical Co. Ltd., for the identification of candidates meeting predefined criteria, in one of the discovery programs between the companies. The achievement entitles Peptidream to receive an undisclosed payment per the research collaboration and drug discovery and development agreement announced in September 2018.
Tracon Pharmaceuticals Inc., of San Diego, 3D Medicines Co. Ltd., of Beijing, and Jiangsu Alphamab Biopharmaceuticals Ltd. of Suzhou, China, entered a deal to develop KNO-35 (envafolimab), a PD-L1 single-domain antibody administered by subcutaneous injection, for soft tissue sarcoma in North America. Tracon is responsible for the clinical development and commercialization of envafolimab in soft tissue sarcoma in North America, with the majority of development expected to occur in the U.S. Tracon will pay for the clinical trials, 3D Medicines and Jiangsu Alphamab will supply envafolimab, and Tracon is responsible for commercializing envafolimab for sarcoma in North America. At the American Society of Clinical Oncology 2019 meeting, data were presented from the SARC-028 clinical study demonstrating that the PD-1 inhibitor Keytruda (pembrolizumab) achieved a 23% response rate in 40 patients with undifferentiated pleomorphic sarcoma, irrespective of PD-L1 expression in the tumor specimen. In a separate study, the PD-L1 inhibitor Tecentriq (atezolizumab) achieved a more than 40% objective response rate in alveolar soft part sarcoma.