3 days, 5 approvals-Celgene, AbbVie, Roche meds push FDA tally to 23 for the year

FiercePharma | August 19, 2019

Lawmakers may have left the nations capital for summer vacation, but regulators at the FDA are staying busy. The agency churned out five approvals just last week from companies large and small and five more decisions are due by months end. Three of last weeks green lights opened the way for launches worth half a billion or more in annual sales. But the week started with a couple of OKs smaller on the sales side, if still significant for the organizations that developed them. Pretomanid, a tuberculosis med developed by the nonprofit TB Alliance, kicked things off Wednesday with an FDA nod in drug-resistant forms of the disease. On the same day, Philly-area pharma company Harmony Biosciences picked up its first FDA nod ever, passing agency gatekeepers with narcolepsy med Wakix. GlobalData pharma analyst Sarah Elsayed said she expects Wakix to pick up a “small share” of the $1.5 billion narcolepsy market. The drug is a “welcome addition” for doctors and patients, she said, but key opinion leaders told the firm they “believe that Wakix is not as effective" as Jazz Pharma's competing Xyrem, the analyst said. After those Wednesday approvals, the agency stayed busy Thursday and Friday. Regulators signed off on Roche’s targeted cancer drug Rozlytrek, Celgene’s myelofibrosis med Inrebic and AbbVie’s rheumatoid arthritis treatment Rinvoq in quick succession.

Spotlight

Will the Pharma R&D Annual Review 2018 from Citeline’s Pharmaprojects be music to your ears, or will it sound a sour note? Find out with the Pharma R&D Annual Review 2018 infographic, now available to you as a free download.". Tune in to this visual year in review – cleverly framed in a musical motif – which features the Top Ten in therapy groups, diseases/indications, pharma companies by size of pipeline, and many more critical stats about where the pharma industry stands at the start of 2018.

Spotlight

Will the Pharma R&D Annual Review 2018 from Citeline’s Pharmaprojects be music to your ears, or will it sound a sour note? Find out with the Pharma R&D Annual Review 2018 infographic, now available to you as a free download.". Tune in to this visual year in review – cleverly framed in a musical motif – which features the Top Ten in therapy groups, diseases/indications, pharma companies by size of pipeline, and many more critical stats about where the pharma industry stands at the start of 2018.

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PHARMACY MARKET

Pfizer and BioNTech Announce a Partnership with Biovac to Develop and Distribute COVID-19 Vaccine Doses in Africa

Pfizer | July 22, 2021

Pfizer Inc. and BioNTech SE today announced the signing of a letter of intent with The Biovac Institute (Pty) Ltd, also known as "Biovac," a South African biopharmaceutical business headquartered in Cape Town, to produce the Pfizer-BioNTech COVID-19 Vaccine for sale inside the African Union. Biovac will manufacture and distribute COVID-19 vaccines as part of Pfizer and BioNTech's worldwide COVID-19 vaccine supply chain and production network, which currently spans three continents and includes more than 20 facilities. Technical transfer, on-site development, and equipment installation operations will begin immediately to enable Biovac's participation in the process. Biovac's Cape Town plant is expected to be integrated into the vaccine supply chain by the end of 2021, according to Pfizer and BioNTech. Biovac will acquire drug substances from European facilities, and final dosage manufacturing will begin in 2022. Annual production will reach 100 million finished dosages at full operating capacity. All dosages will be delivered solely inside the African Union's 55 member states. Quality, compliance, safety track record, technical capability, capacity availability, highly trained workforce, project management abilities, prior working relationship, and commitment to working with flexibility through a fast-paced program are all factors that Pfizer and BioNTech consider when selecting contract manufacturers. Since 2015, Pfizer and Biovac have collaborated on the Prevenar 13 vaccine's sterile formulation, fill, finish, and distribution. Pfizer and BioNTech have delivered more than 1 billion doses of COVID-19 vaccine to more than 100 nations and territories across the globe. The companies are firmly committed to ensuring that all people around the world have equitable and affordable access to COVID-19 vaccines, actively working with global governments and global health partners to provide 2 billion doses to low and middle-income countries in 2021 and 2022 – 1 billion each year. This comprises a non-profit arrangement to provide 500 million doses to the US government, which the government will then give to the African Union and the COVAX 92 Advanced Market Commitment (AMC) nations, as well as a 40 million dose direct supply deal with the COVAX facility. Both BioNTech and Pfizer worked together to create the Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech's unique mRNA technology. In addition to the European Union, BioNTech has emergency use authorizations or equivalent in the United States (jointly with Pfizer), Canada, and other countries in advance of a planned application for full marketing authorizations in these countries. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the US Food and Drug Administration (FDA), but it has been approved for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19), which is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in people aged 12 and up. Unless the declaration is ended or the permission withdrawn sooner, the emergency use of this product is only allowed for the duration of the declaration that conditions exist justifying the authorization of emergency use of the medical product under Section 564 (b) (1) of the FD&C Act.

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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.

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BUSINESS INSIGHTS

Aqemia Announces Pilot Study with Janssen to Utilize Aqemia’s Physics-driven Drug Discovery Technology

Aqemia | February 15, 2022

Aqemia, the next-gen pharmatech company leveraging artificial intelligence and quantum-inspired physics announces it has entered into a pilot study agreement with Janssen. Through the agreement Aqemia’s unique technology to predict the potency of small molecules for a given target based on physics-based calculations will be applied to selected Janssen datasets. The agreement aims at building a common understanding of the performance of Aqemia’s technology and how best to apply it in drug discovery projects on different types of target proteins and diseases. It includes an upfront payment from Janssen. “We are very happy to start working with Janssen’s teams to apply our unique technology to drug discovery projects”. He added, “This is a great opportunity for us to demonstrate the scalability and repeatability of Aqemia’s recent successes in drug discovery projects.” Maximilien Levesque, CEO and co-founder of Aqemia About Aqemia Aqemia is a next-gen pharmatech company generating one of the world's fastest-growing drug discovery pipeline. Our mission is to design fast innovative drug candidates for dozens of critical diseases. Our differentiation lies in our unique quantum and statistical mechanics algorithms fueling a generative artificial intelligence to design novel drug candidates. The disruptive speed and accuracy of our technological platform enables us to scale drug discovery projects just like tech projects.

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