Pharmaceutical Technology Editors

AstraZeneca has announced, in a Jan. 17, 2022 press release, that the Scottish Medicines Consortium (SMC) has accepted Osimertinib (Tagrisso) for use as a monotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations.

Lung cancer is a significant cause of cancer-related death in Scotland, with NSCLC being recorded as the most common form of the disease. It is estimated, by AstraZeneca, that through the recent acceptance of Tagrisso, approximately 192 patients in Scotland will be eligible for targeted therapy to treat locally advanced or metastatic EGFR mutated NSCLC each year.

“Osimertinib is a third-generation EGFR inhibitor that has demonstrated clear survival benefit in clinical trials when compared to the previous generation of these medicines,” said Brian Clark, consultant clinical oncologist at Beatson West of Scotland Cancer Centre, in the press release. “Getting access to this treatment is an important development for people living with advanced lung cancer in Scotland, as it provides them with a treatment option that has the potential to improve their outcomes and does not compromise quality of life.”

“This decision from the SMC is further welcome news aligned with the Scottish Government’s commitment to cancer as a national clinical priority,” added Tom Keith-Roach, president, AstraZeneca UK, in the press release. “Providing access to cutting-edge treatments like osimertinib is an important part of getting back on track post-COVID.”

“With almost half of all lung cancers in Scotland diagnosed at a late stage, there is a clear unmet need for additional effective treatment options,” said Arun Krishna, head of Oncology, AstraZeneca UK, in the press release. “Osimertinib can significantly increase survival of patients with EGFR mutation-positive NSCLC, with a comparable safety profile to first generation EGFR TKIs [tyrosine kinase inhibitors].”

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AstraZeneca's Tagrisso has been accepted for use as a monotherapy for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations in Scotland.

AstraZeneca’s Tagrisso Accepted for Use in Scotland to Treat EGFR Mutated Advanced Lung Cancer

Air France KLM Martinair Cargo (AFKLMP Cargo) and Envirotainer—provider of secure cold-chain solutions for the air transportation of pharmaceuticals—are collaborating on more sustainable air transport of pharmaceuticals, it was revealed in a Jan. 18, 2021 press release.

The companies have been partners for a long time, and each has a strong focus on sustainability. With this announcement, the companies have specified that they will intensify their partnership to strengthen their initiatives for sustainability through collaboration.

AFKLMP Cargo will be implementing in its booking system the new Envirotainer Releye container, which is reported to deliver up to 90% reduction in CO

 emissions compared with other available passive solutions when based on life-cycle analysis. Envirotainer will be investing in Sustainable Aviation Fuel (SAF), which is produced from sustainable feedstock and is claimed to reduce CO

 emissions by up to 85% when compared with conventional jet fuel.

“We are very happy that a close partner of ours since many years keeps delivering top quality service and secures that the pharmaceutical industry, together with us, provides further capacity of latest technology,” said Don Harrison, head of Global Key Accounts, Airlines at Envirotainer, in the press release.

“We really appreciate our long-term partnership with Envirotainer,” added Marcel Kuijn, global head of Pharmaceutical Logistics at AFKLMP Cargo, in the press release. “Sustainability and Pharmaceuticals are among our strategic focus areas. That is why this initiative is of such great importance to us.”

Air France KLM Martinair Cargo and Envirotainer are collaborating on more sustainable air transport of pharmaceuticals

Air France KLM Martinair Cargo and Envirotainer Collaborate on Sustainability

PharmaLex Group has announced on Jan. 18, 2022, that is has merged with MAP Group, an Italian provider of market access services. Through this merger, PharmaLex broadens its market access expertise and extends its reach into the Italian marketplace.

MAP Group was founded in 2010 and comprises three companies—MA Provider, MAPCOM Consulting, and 3P Solution. The group specializes in highly innovative products, such as advanced therapeutic medicinal products (ATMPs) under development for rare diseases and oncology, and is a leading member of the ATMP forum.

“The merger with PharmaLex perfectly complements our service offerings by leveraging our strong local market knowledge and expertise while providing our clients with broader reach across Europe,” said Elena Paola Lanati, MAP Group CEO and founder, in the company press release. “We share common principles and values with PharmaLex, in particular to help our clients navigate an increasingly complex legislative and commercial marketplace. In addition, the merger with PharmaLex provides an opportunity for our talented people to expand their careers in a broader global marketplace.”

“We are delighted to welcome the MAP Group team to the PharmaLex Group, and we are excited about the opportunity that the merger gives us to further expand our offerings in market access, brand communications, and educational services,” added PharmaLex CEO Thomas Dobmeyer, in the press release. “The merger also enables us to extend our footprint in the important Italian marketplace, adding to our strong existing team in Milan, which provides regulatory, safety, and quality services to local clients. PharmaLex first established an office in Italy 2017 and has since built a strong local footprint. Through the merger with the MAP Group, we are further strengthening our team, allowing us to support clients throughout the product lifecycle in order to deliver exceptional, tailor-made results.”

PharmaLex Group has merged with MAP Group, broadening its market access expertise and extending its reach into the Italian marketplace.

PharmaLex Expands Integrated Market Access Expertise through Merger with MAP Group 

Developer of disease modifying therapies, Cyxone, has appointed a European contract development and manufacturing organization (CDMO) to scale-up and produce the active ingredient of its T20K drug candidate.

According to a Jan. 18, 2022 press release, the agreement will initially cover method development and then, at a later stage, will include the supply of material for use in non-clinical and clinical development activities. Additionally, production of the active ingredient will be performed in accordance with good manufacturing practice (GMP), exploring a novel manufacturing method.

T20K is a peptide that has been developed for the treatment of multiple sclerosis. The drug has demonstrated the potential capability of preventing disease progression in a model system at the preclinical stage.

“We are pleased to have established a collaboration with one of Europe’s leading manufacturers of therapeutic peptides,” said Tara Heitner, CEO, Cyxone, in the press release. “T20K GMP manufacturing is an important step before non-clinical safety studies and future clinical studies. A feasibility study will be the first step of this collaboration permitting further optimization of the scale up process. The agreement represents our commitment to the T20K program and indicates that we are on schedule with our non-clinical plans.”

Cyxone has appointed a European CDMO to scale-up and produce the active ingredient of its T20K drug candidate.

Cyxone Engages European CDMO for Scale-Up and Production of T20K

The corporate venture fund of Colorcon, Colorcon Ventures, has announced, in a Jan. 20, 2022 press release, its investment in a provider of intelligent manufacturing execution systems (MES), Apprentice.io (Apprentice).

The end-to-end platform offered by Apprentice helps streamline pharma manufacturing and remote collaboration. A suite of software solutions is offered, including intelligent batch execution, augmented procedures and workflows, predictive resource management, and immersive training. Through artificial intelligence, machine learning, and augmented reality, the platform becomes more intuitive over time.

“Our customers are striving for faster times to market, improved manufacturing consistency, as well as business continuity through times of crisis,” said Ali Rajabi-Siahboomi, vice-president and chief innovation officer at Colorcon, in the press release. “During COVID, demand for Apprentice has accelerated with several leading pharmaceutical manufacturers, as design weaknesses in legacy manufacturing systems were exposed. Based on the positive outcomes seen by industry participants, we anticipate a broader global adoption of Apprentice’s solutions.”

“We are excited to have Colorcon Ventures join us as a strategic investor on our mission to modernize pharmaceutical manufacturing and realize Pharma 4.0, with the objective of getting medicine to patients faster and safer,” added Angelo Stracquatanio, Apprentice’s founder and CEO, in the press release. “Colorcon’s global footprint and pharma relationships will be invaluable as we begin to expand our geographic reach.”

Colorcon Ventures is investing in a provider of intelligent manufacturing execution systems (MES), Apprentice.io.

Colorcon Ventures Invests in Provider of Intelligent MES

Lohxa LLC announced on Jan. 11, 2022, that it is voluntarily recalling one lot of Senna Syrup 8.8 mg/5mL, unit-dose cups due to microbial contamination. Senna Syrup is a natural vegetable laxative and is packaged in 5-mL unit-dose cups. The affected lot is AM1115S with expiration date of 01/2023 and was distributed to a wholesaler, AvKare. The product may then have been distributed by AvKare to clinics, hospitals, and healthcare providers.

According to the company, use of the contaminated product could be life threatening in patients who are elderly, have weakened immune systems, or who are at risk for heart inflammation. The company has not, as of the date of the press release, received any reports of adverse events related to the recall.

The company is voluntarily recalling one lot of Senna Syrup 8.8mg/5mL, unit-dose cups because of microbial contamination. 