CELL AND GENE THERAPY
TEMBEXA and Smallpox | September 27, 2022
Emergent BioSolutions Inc. announced that it has completed its acquisition of exclusive worldwide rights to TEMBEXA® the first oral antiviral approved by the U.S. Food and Drug Administration for all age groups for the treatment of smallpox, from Chimerix. TEMBEXA was approved in June 2021 and is indicated for the treatment of human smallpox disease in adult and pediatric patients, including neonates.
The completion of the acquisition follows the satisfaction or waiver by the parties, as applicable, of all closing conditions, including expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act), as amended, and receipt of consent from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, for a sub-contract agreement between Chimerix and Emergent.
“The addition of TEMBEXA to our smallpox medical countermeasure franchise, which consists of our smallpox vaccine and therapeutic for smallpox vaccine complications, creates a more comprehensive offering to combat this deadly public health threat. We look forward to supporting the U.S. government’s smallpox preparedness strategy on a broader scale by executing on this BARDA contract.”
Paul Williams, SVP government/MCM business at Emergent
The 10-year contract valued at up to $680 million, to supply up to 1.7 million treatment courses of tablet and suspension formulations of TEMBEXA® to the U.S. government, was awarded to Chimerix on August 29, 2022. The contract includes an initial product procurement valued at approximately $115 million, with optional future procurement, valued at up to approximately $551 million, exercisable at the sole discretion of BARDA. In addition to product procurement, the contract includes reimbursed post marketing activities of approximately $12 million.
Based on the terms of the final BARDA agreement, Emergent is expected to pay Chimerix
An upfront payment of $238 million;
Potential milestone payments of up to $124 million contingent on the potential exercise by the U.S. government of procurement options following the base period;
15% royalty on gross profit from sales of TEMBEXA outside the U.S.;
20% royalty on gross profit from sales of TEMBEXA in the U.S. that are in excess of the 1.7 million treatment courses as contemplated in the existing BARDA contract; and
Up to an additional $12.5 million upon achievement of certain development-based milestones.
TEMBEXA is an oral antiviral approved by the FDA in June 2021 for the treatment of human smallpox disease caused by variola virus in adult and pediatric patients, including neonates. TEMBEXA is formulated as 100 mg tablets and 10 mg/mL oral suspension dosed once weekly for two weeks. The oral suspension formulation is particularly important for patients who have difficulty swallowing due to age or medical status. TEMBEXA is not indicated for the treatment of diseases other than human smallpox disease.
The effectiveness of TEMBEXA for the treatment of smallpox disease has not been determined in humans because adequate and well-controlled field trials have not been feasible and inducing smallpox disease in humans to study the drug’s efficacy is not ethical. TEMBEXA efficacy may be reduced in immunocompromised patients based on studies in immune deficient animals. TEMBEXA has a BOXED WARNING for increased risk for mortality when used for longer duration.
Smallpox is a highly contagious disease caused by the variola virus. Historically, smallpox was one of the deadliest diseases in history with a case fatality rate of approximately 30%. Despite successful eradication of smallpox in the 1970s, there is considerable concern that variola virus could reappear, either through accidental release or as a weapon of bioterrorism. According to the U.S. Centers for Disease Control and Prevention variola virus is ranked in the highest risk category for bioterrorism agents due to its ease of transmission, high mortality rate, and potential to cause public panic and social disruption. Based on a recent report – The Department of Health and Human Services Fiscal Year 2023 Public Health and Social Services Emergency Fund Justification of Estimates for Appropriations Committee – smallpox remains a threat of high concern to both the domestic and international community.
About Emergent BioSolutions
At Emergent, our mission is to protect and enhance life. For over 20 years, we’ve been at work defending people from things we hope will never happen—so we are prepared just in case they ever do. We provide solutions for complex and urgent public health threats through a portfolio of vaccines and therapeutics that we develop and manufacture for governments and consumers. We also offer a range of integrated contract development and manufacturing services for pharmaceutical and biotechnology customers.
CELL AND GENE THERAPY
Adicet Bio, Inc. | September 06, 2022
Adicet Bio, Inc. a clinical-stage biotechnology company discovering and developing allogeneic gamma delta CAR T cell therapies for cancer, today announced it granted inducement awards on August 31, 2022 under Adicet’s 2022 Inducement Plan as a material inducement to employment to five individuals hired by Adicet in August 2022.
The employees received, in the aggregate, non-qualified stock options to purchase 114,200 shares of Adicet’s common stock with an exercise price of $14.16 per share, the closing price of Adicet’s common stock as reported by Nasdaq on August 31, 2022. One-fourth of the shares underlying each employee’s option will vest on the one-year anniversary of each recipient’s start date and thereafter the remaining three-fourths of the shares underlying each employee’s option will vest in thirty-six substantially equal monthly installments, such that the shares underlying the option granted to each employee will be fully vested on the fourth anniversary of the recipient’s start date, in each case, subject to each such employee’s continued employment with Adicet on such vesting dates.
All of the above-described awards were granted outside of Adicet’s stockholder-approved equity incentive plans pursuant to Adicet’s 2022 Inducement Plan, which was adopted by the board of directors in January 2022. The awards were authorized by the compensation committee of the board of directors, which is comprised solely of independent directors, as a material inducement to the employees entering into employment with Adicet in accordance with Nasdaq Listing Rule 5635(c)(4).
About Adicet Bio, Inc.
Adicet Bio, Inc. is a clinical-stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer. Adicet is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors and T cell receptor-like antibodies to enhance selective tumor targeting, facilitate innate and adaptive anti-tumor immune response, and improve persistence for durable activity in patients.
CELL AND GENE THERAPY
BioFluidica, Inc. | September 28, 2022
Biofluidica, Inc., and Hamilton Company, announced a co-marketing agreement to bring advanced Liquid Biopsy capabilities to laboratories worldwide. Biofluidica has developed the next-generation liquid biopsy platform, enabling Hamilton liquid handlers to process biological samples to isolate extremely rare circulating tumor cells, circulating Leukemic cells, fetal cells, cfDNA, and exosomes. The Biofluidica platform, LiquidScan™, integrates seamlessly into the Hamilton pipetting robots. The high precision fluid control provided by the Hamilton automated pipetting channels is designed to avoid processing loss using the Biofluidica proprietary closed-loop pipetting interface with the Biofluidica microfluidic biomarker selection chips.
This announcement represents early commercialization for BioFluidica and a unique alliance for Hamilton Company. The STARlet offers a custom application-configurable liquid handling robot with sensitive programmable pneumatic features that enable walk-away automation for precision biological procedures. LiquidScan utilizes these features to isolate and enrich rare biomarker populations directly from biological samples such as a blood draw potentially replacing the need for surgical biopsies and making testing available for cancer types not previously amenable to surgical biopsy.
"LiquidScan is a novel platform that enhances the ability to perform diagnostic testing applied to many diseases, including several types of cancer, prenatal diagnostics, stroke, and infectious diseases. We have worked with Hamilton to ensure seamless automation allowing for high-throughput and lower-cost testing than current surgical biopsy procedures. There is a win-win scenario here for patients, physicians, and the healthcare system. Because LiquidScan uses a standard blood draw, and non-invasive screening, patients can receive closer monitoring of treatment regimens, and physicians can attain higher quality and earlier patient results. Expensive and time-consuming surgical procedures can be removed from the health-care system."
Rolf Muller, BioFluidica CEO
Hamilton is a leading global manufacturer, providing automated liquid handling workstations and laboratory automation technology to the scientific community. With a focus on innovative design, Hamilton products incorporate patented liquid handling technologies into a portfolio that includes liquid handling platforms, standard application-based solutions, small devices, consumables, and OEM liquid handling solutions.
Known for advancing life science, clinical diagnostics, forensics, and biotechnology industries, Hamilton products offer reliability, performance, and flexibility. Ensuring a continuous commitment to quality, Hamilton utilizes state-of-the-art manufacturing at production facilities in Reno, Nevada, and Bonaduz, Switzerland and has earned a global ISO 9001 certification. Privately held, Hamilton maintains headquarters in Reno, Nevada; Franklin, Massachusetts; and Bonaduz, Switzerland, along with subsidiary offices throughout the world.
BioFluidica Inc. is a privately held biotechnology company that has developed a revolutionary liquid biopsy platform.