BUSINESS INSIGHTS

Humanigen and Cenexi Announce Collaboration to Manufacture Lenzilumab in France

Humanigen and Cenexi | February 09, 2022

France Humanigen, Inc. a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm,’ and Cenexi, a French CDMO specializing in the formulation, analytical development, and manufacture of complex molecule drugs, announced a collaboration aimed at making Cenexi a preferred supplier of lenzilumab in France and the European Union. The initial step of the collaboration includes the execution of a Master Supply Agreement (“MSA”) providing for Cenexi to provide aseptic fill and finish services for lenzilumab for the next five years.

Under the terms of the agreement, Humanigen will transfer the technology and knowledge to Cenexi to allow them to establish drug product processes utilizing their state-of-the-art high speed filling line at their Herouville-Saint-Clair facility in Normandy. Humanigen and Cenexi will enter into discussions to potentially expand the agreement to other services Cenexi offers. These include labeling and packaging, importation of bulk drug substance and quality release of materials in France and throughout Europe. Humanigen plans to include the Cenexi Normandy site in certain of its future regulatory filings for lenzilumab for COVID-19 and other indications. The companies will collaborate to secure potential funding and investment in capital equipment from AD Normandie, the regional authority and the Government of France, the national authority. In addition, Cenexi will assist Humanigen as it seeks an advanced purchase agreement for lenzilumab in France.

The goal of the collaboration with Cenexi is to further our efforts to establish a supply of lenzilumab made in Europe. Cenexi is an ideal partner for sterile filling and with their strong base of resources and aggressive growth plan, we may expand our collaboration beyond the typical customer/vendor relationship. We may work with Cenexi to become our preferred partner for multiple services and to establish a stable and secure supply chain for lenzilumab in France and Europe longer-term.”

Cameron Durrant, chief executive officer of Humanigen 

In 2021, French authorities modified existing regulations to provide for early access to unauthorized medicinal products. The early access authorization allows for a manufacturer to supply product to a cohort of individuals for a specific use, for example, lenzilumab for COVID-19. Humanigen plans to file a request for AAP with the Haute Authorite de Sante in February 2022.

“Cenexi desires a leadership position in France to assist in establishing a strong supply chain for COVID-19 and for future pandemics. Since 2004, Cenexi has been at the forefront of bringing critical medicines to patients and we continue to build on our strong reputation for value, high quality, flexibility and timeliness,” commented Christophe Durand, chief executive officer of Cenexi. “Our partnership with Humanigen will use our core competencies of sterile filling and to potentially expand into to an end-to-end solution for lenzilumab in France and other countries in Europe.”

Pending positive results from the NIH-sponsored ACTIV-5/BET-B study, Humanigen plans to amend the Emergency Use Authorization application in the United States. For the European Union, Humanigen anticipates submission of a Conditional Marketing Authorization with a request for Accelerated Approval in the third quarter of 2022.

Lenzilumab is an investigational product and is not approved or authorized in any country.

About Humanigen
Humanigen, Inc. is a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’. Lenzilumab is a first-in class antibody that binds to and neutralizes granulocyte-macrophage colony-stimulating factor (GM-CSF). Results from preclinical models indicate GM-CSF is an upstream regulator of many inflammatory cytokines and chemokines involved in the cytokine storm. Humanigen is developing lenzilumab as a treatment for cytokine storm associated with COVID-19 and CD19-targeted CAR-T cell therapies and is also exploring the effectiveness of lenzilumab in other inflammatory conditions such as acute Graft versus Host Disease in patients undergoing allogeneic hematopoietic stem cell transplantation, eosinophilic asthma, and rheumatoid arthritis. In addition, Humanigen is progressing a Phase 1 program focused on another proprietary monoclonal antibody, ifabotuzumab, in solid tumors.

About Cenexi
Cenexi, a major French CDMO operating in Europe with 1,500 employees and some €200 million in turnover (2021), is experiencing steady growth with four production sites  and a center of expertise dedicated to new product introduction.

Spotlight

As the cost of drug development and time to market increases to exorbitant levels.

Spotlight

As the cost of drug development and time to market increases to exorbitant levels.

Related News

RESEARCH

Pfizer and Biontech Nab Covid-19 Vaccine Authorization from U.K. For First-ever Marketed mRNA shot

Pfizer | December 03, 2020

The two organizations' BNT162b2 has become the primary COVID-19 immunization permitted in the Western world as medication controllers in the U.K. given out a crisis use approval on Wednesday, in front of choices by the U.S. also, Europe, which are normal soon. For the more extensive immunization world, the Medicines and Healthcare items Regulatory Agency's choice methods the world currently has the principal mRNA shot approved for far reaching use, opening up a fresh out of the box new part for antibody advancement. The principal portions will be conveyed to the U.K. quickly, the organizations said. A representative at the U.K's. Department of Health and Social Care said the antibody will be made accessible the nation over from one week from now. The U.K. has requested 40 million portions of the antibody—enough to immunize 20 million individuals—through an arrangement endorsed in July and extended in October. "As we envision further approvals and endorsements, we are centered around moving with a similar degree of criticalness to securely flexibly an excellent immunization around the globe. With a great many individuals turning out to be tainted, each day matters in the aggregate competition to end this staggering pandemic," Pfizer CEO Albert Bourla, Ph.D., said in an explanation, calling the U.K. gesture a "noteworthy second." Pfizer has appointed COVID-19 antibody assembling to three destinations in the U.S. also, one in Belgium. BioNTech has offices in Mainz and Idar-Oberstein in Germany, which have been delivering dosages for clinical preliminaries. The German biotech as of late purchased a Novartis plant in Marburg, Germany, to quicken business assembling of the COVID-19 immunization. In general, the two organizations have said they can create up to 50 million dosages in 2020 and up to 1.3 billion portions in 2021.

Read More

PHARMACY MARKET

TrialCard Launches Engage HCP

TrialCard | August 31, 2021

TrialCard Incorporated today announced the launch of Engage HCP by TrialCard, a new expanded suite of services that serves as a complement to a biopharma brand's field teams, while delivering measurable results in brand reach, lead generation, and market share growth. Engage HCP by TrialCard is designed to offer a flexible array of services that can serve as standalone teams or be used to bolster the efforts of existing field teams. Engage HCP offers HCP engagement services for the following disciplines: Clinical Nurse Educators Field Reimbursement Managers Pharmaceutical Institutional, Sales, and Specialty Representatives Rare Disease Professionals Telepromotion Agents Medical Science Liaisons These augmented services strengthen TrialCard's original position in virtual detailing, which began several years ago. "TrialCard developed this suite of services to address for our clients the increasing number of "difficult to see" and "no see" HCPs," said Tom Heck, SVP of Commercial Solutions at TrialCard. "Engage HCP by TrialCard further solidifies our commitment to helping brands grow and thrive via non-traditional methods." Long before the COVID-19 global pandemic altered the traditional pharmaceutical selling cycle, pharma sales reps' access to HCPs had been decreasing for years. According to ZS's 2019 AffinityMonitor findings, only 47.3% of physicians engaged well with in-person pharma rep meetings, while just 9.6% of physicians engaged using digital tactics. TrialCard, a pioneer in digital HCP engagement, recognized this opportunity and began reaching out to physicians via digital channels years ago. "Many predict that it is unlikely society will ever return to pre-COVID-19 behavior," said Mark Bouck, President and CEO of TrialCard. "As HCPs become more accustomed and comfortable with digital communications, they will likely continue to become even less reliant on face-to-face interaction." "Our pharmaceutical sales reps enter the physician's office using technology instead of the front door," said Mike Davis, TrialCard's VP of Commercial Solutions. "While that technology is the backbone of our programs, our proven track record in supplementing a brand's field sales force is a result of the caliber of talent that we hire, the superior training and resources we provide, and the flexibility, experience, and expertise to create customized solutions for each client." About TrialCard TrialCard Incorporated is a full-service life sciences commercialization partner that provides comprehensive solutions that span the entire biopharmaceutical value chain. In addition to a foundation of fully integrated, digitally enabled patient support services, its broader offerings include everything from late-stage clinical trial management to post-marketing HCP engagement services and proprietary data-as-a-service payer intelligence and insights. Founded in 2000, TrialCard provides commercialization needs for more than 160 life science customers and has connected over 35 million patients with more than $18 billion in branded drug savings to date. The company is headquartered in Morrisville, North Carolina.

Read More

PHARMACY MARKET

Bushu Pharma's Partnership with Suzuken Group Increases Specialty Pharmaceutical Services

Bushu Pharmaceuticals Ltd. | April 28, 2021

Bushu Pharmaceuticals Ltd. has entered into a business partnership arrangement with Suzuken Co., Ltd. to provide specialty pharmaceutical producers looking to enter the Japanese market with extensive support for new product releases. In recent years, the market has seen an increase in the number of innovative specialty pharmaceuticals, such as biopharmaceuticals, regenerative medicines, and orphan drugs for rare diseases, that require strict temperature, inventory, and security control. In line with this trend, the number of pharmaceutical companies planning to bring these types of drugs to Japan has grown. These pharmaceutical manufacturers, on the other hand, often lack the necessary infrastructure, such as production facilities, delivery centers, and networks, to reach the Japanese market with minimal resources, and must therefore outsource these functions to trusted partners. Suzuken, Bushu Pharma's partner, has played an industry-leading role in Japan's pharmaceutical distribution market. Suzuken, one of the leading organizations in the industry, has a distribution network in Japan capable of supporting the international shipping of specialty pharmaceuticals. Bushu Pharma, on the other hand, has been in the contract manufacturing industry in Japan for over 20 years, holds GMP certifications from all over the world, and has a track record of exporting to over 43 countries. Bushu Pharma will establish a platform that provides one-stop holistic assistance for pharmaceutical producers seeking to penetrate the Japanese market by aligning functions and capabilities with Suzuken. About Bushu Pharmaceuticals Ltd. Bushu Pharma manufactures solid reparations, solid preparation primary packaging, injection manufacturing, and injection packaging not just for domestic pharmaceuticals but also for multinational pharmaceutical manufacturers, drawing on its expertise and understanding as a contract development and manufacturing organization (CDMO) cultivated over 20 years. Bushu Pharma has a diverse product and service offering, ranging from clinical trial supplies to commercial product development support to commercialization, as well as various production facilities and technologies. Bushu Pharma is a leading domestic contract manufacturing company in Japan that can offer optimum solutions such as technology transfer, production, packaging, and logistics from project start to project approval.

Read More