Pharmaceutical Technology Editors

Sartorius announced that it has agreed to purchase Alubmedix through its French-listed subgroup Sartorius Stedim Biotech for £415 million (US$429 million) on Aug. 8, 2022. Albumedix is a provider of recombinant human albumin, which is used in various applications in the biopharmaceutical industry, such as an animal-free additive to cell culture media and for the stabilization of vaccines and viral therapies. The purchase is expected to close before the end of the third quarter of 2022.

According to a company press release, Albumedix will join Sartorius' Bioprocess Solutions Division. Its existing 72,000-ft2 site in Nottingham, UK, will be established as a center of excellence for innovation and good manufacturing practice-compliant production of raw materials.

“Albumedix will be an important addition to Sartorius’ advanced therapy solutions, particularly regarding our cell culture media business, as it will enable us to strengthen our position as a relevant supplier of innovative chemically defined media and critical ancillary materials,” said René Fáber, member of the executive board for the Bioprocess Solutions Division of Sartorius, in the press release. “This market offers high growth potential due to the increasing regulatory requirements as well as rising demand for the use of recombinant human albumin in near-patient applications. Albumedix will also add important formulation excipients to our vaccine production solutions, allowing us to expand our existing customer relationships and forge new ones.”

“We are delighted to be joining forces with Sartorius and look forward to accelerating our ambitious growth plans in delivering critical solutions to our global customers,” said Jonas S. Møller, CEO of Albumedix, in the release. “We have been highly impressed with Sartorius’ knowledge and capabilities in the bioprocessing markets, and we are excited to join this purposeful journey. We believe Sartorius will bring tremendous value in strengthening our market reach and broadening our innovation capacity, as well as significantly scaling up our existing platform.”

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Sartorius’ £415 million (US$429 million) acquisition of Albumedix is intended to bolster its portfolio with recombinant albumin-based solutions.

Sartorius to Acquire Albumedix for £415 Million

Catalent announced on August 9, 2022 that it has reached an agreement to acquire Metrics Contract Services, a full-service specialty contract development and manufacturing organization (CDMO), for $475 million from Mayne Pharma Group Limited.

Catalent will strengthen its capabilities in integrated oral solid formulation development, manufacturing, and packaging, as well as expand its capacity to handle highly potent compounds upon the completion of the acquisition.

The acquisition will also include Metrics’ 333,000-square-foot facility located in Greenville, NC. The facility features comprehensive capabilities to accelerate and de-risk customer programs from early development through commercial launch through a streamlines one-site solution.

“This acquisition will further expand Catalent’s ability to meet our customers’ expectations in fast-growing areas of the business and patient need. The experienced team and consistently improved, state-of-the-art facility in Greenville will provide Catalent’s customers with immediate, fit-for-scale capacity for in-demand highly potent drugs and other oral solid small-to-mid-size batch needs. This capacity is particularly important for customers with R&D pipelines featuring accelerated, orphan, and rare disease programs for oncology and other important therapeutic areas,” said Dr. Aris Gennadios, group president of Catalent’s Pharma & Consumer Health segment, in a press release.

“Over the past several years, Metrics has undergone a period of transformational change to expand its footprint and service offering, becoming a global end-to-end novel oral solid CDMO. Catalent, a global leader in advanced drug development and manufacturing, is well-positioned to continue to invest in and accelerate the growth of Metrics and we believe this transaction will be extremely positive for our Greenville team and customers,” said Scott Richards, CEO of Mayne Pharma.
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Catalent will acquire Metrics Contract Services for $475 million to expand high-potent capabilities and oral development and manufacturing capacity.

Catalent to Acquire Metrics Contract Services for $475 Million

Coherus BioSciences, a biopharmaceutical company, announced that FDA approved Cimerli (ranibizumab-eqrn) as an interchangeable biosimilar for Lucentis (ranibizumab injection) on Aug. 2, 2022. It is the first biosimilar product interchangeable with Lucentis across all five indications.

Ranibizumab-eqrn is an anti-vascular endothelial growth factor (VEGF) therapy biologic, which has been gaining traction in ophthalmology, according to a company press release. It is Coherus' second FDA approved biosimilar, following Udenyca (pegfilgrastim-cbqv), a biosimilar for Neulasta (pegfilgrastim). Coherus plans to release it in early October 2022 in both 0.3 mg and 0.5 mg dosages. Coherus also plans to release an FDA-approved Humira (adalimumab) biosimilar, Yusimry (adalimumab-aqvh), in 2023.

“[Ranibizumab-eqrn] will provide both greater treatment access and choice for patients, payors, and providers in the US retinal disease community,” said Paul Reider, chief commercial officer, Coherus BioSciences, in the press release. “Coherus is the only company in the $7 billion anti-VEGF ophthalmology market with a demonstrated track record of US commercial biosimilar success.”

“The approval of [ranibizumab-eqrn] and its upcoming launch represent a strategic inflection point for Coherus as we transition to a multi-product revenue stream,” said Denny Lanfear, CEO, Coherus BioSciences, in the press release. “[Pegfilgrastim-cbqv], our first product, established our track record of success competing in the US biosimilars market. Our upcoming launch of [ranibizumab-eqrn] and planned launch next year of our third approved product, our [adalimumab] biosimilar, [adalimumab-aqvh], will leverage this experience and knowledge.”

FDA has approved Coherus’ Cimerli (ranibizumab-eqrn) as an interchangeable biosimilar for all five indications of Lucentis.

FDA Approves Coherus’ Interchangeable Biosimilar for Lucentis

Sanofi and Innovent Biologics, a biopharmaceutical company, announced a strategic collaboration to bring oncology medicines to patients in China on Aug. 4, 2022. This agreement is designed to accelerate development and commercialization of two oncology candidates by combining them with sintilimab, a programmed cell death protein 1 immunoglobulin G4 monoclonal antibody jointly developed by Innovent and Eli Lilly and Company. According to the press release, the agreement will also see Sanofi invest €300 million (approximately $310 million USD) in Innovent.

One candidate, SAR408701 (tusamitamab ravtansine), is a potential first-in-class antibody-drug conjugate targeting carcinoembryonic antigen-related cell adhesion molecule 5, a cell-surface glycoprotein that is highly expressed in non-small cell lung cancer (NSCLC), gastric cancer, and various other cancers. Is currently in a global Phase III study for second-line NSCLC, and global Phase II studies for additional indications including first-line NSCLC, gastric cancers, and other solid tumors.

The other candidate, SAR444245 (interleukin (IL) 2), is a potential first-in-class recombinant human IL-2 variant that includes a site-directed single PEG moiety/chain that is designed to prevent it from binding to the α chain of the -2 receptor while retaining near-native affinity for the beta/gamma subunits. It is currently being investigated in global Phase II studies for the treatment of skin cancers, gastrointestinal cancer, NSCLC / mesothelioma, head and neck tumors, and lymphoma.

“This strategic collaboration with Innovent will not only accelerate the development, market access, and future commercialization of two of our key oncology medicines in selected combinations with sintilimab, but also bolster our overall presence in oncology in China,” said John Reed, global head of Research and Development, Sanofi, in the release. “We look forward to a successful partnership with Innovent, one of the most innovative companies in China, and to leveraging their development capabilities and market leadership in the country.”

“This strategic collaboration with Sanofi opens the pathway to great synergy for accelerating the pace of innovation,” said Michael Yu, chairman and CEO, Innovent, in the release. “This pioneering partnership will leverage the synergy between Sanofi and Innovent’s pipeline and R&D resources with the mutual aim to address major unmet medical needs for cancer patients.”

Sanofi and Innovent have entered into a strategic collaboration to accelerate development of oncology medicines and expand their presence in China.

Sanofi and Innovent Enter Oncology Collaboration

On Aug. 4, 2022, Amgen announced a definitive agreement to acquire ChemoCentryx, a biopharmaceutical company specializing in therapeutics to treat autoimmune diseases, inflammatory disorders, and cancer, for $52 per share in cash, which represents an enterprise value of approximately $3.7 billion. Each company’s board of directors has approved the transaction, which is expected to close in the fourth quarter of 2022.

The acquisition includes Tavneos (avacopan), an orally administered selective complement component 5a receptor inhibitor. The drug was approved by FDA in October 2021 as an adjunctive treatment in combination with standard therapy for adult patients with severe active antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis, specifically granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), the two main forms of ANCA-associated vasculitis.

ANCA-associated vasculitis is a group of multi-system autoimmune diseases with small vessel inflammation. With these diseases, inflamed vessels may rupture or become occluded, which gives rise to a broad array of clinical symptoms and signs related to a systemic inflammatory response. This may result in profound injury and dysfunction in the kidneys, lungs, and other organs.

Outside the United States, Tavneos is also approved in the European Union and Japan. Under the acquisition agreement, Vifor Fresenius Medical Care Renal Pharma will retain exclusive rights to commercialize the drug outside the US, except in Japan and Canada. In Japan, Kissei Pharmaceutical holds commercialization rights, and in Canada, Otsuka Canada Pharmaceutical holds commercialization rights.

ChemoCentryx also has three early-stage drug candidates that target chemoattractant receptors in other inflammatory diseases and an oral checkpoint inhibitor for cancer in its pipeline.

"We are excited to join in the T[avneos] launch and help many more patients with this serious and sometimes life-threatening disease for which there remains significant unmet medical need. We also look forward to welcoming the… team from ChemoCentryx that shares our passion for serving patients suffering from serious diseases," said Robert A. Bradway, chairman and CEO at Amgen, in a company press release.

"Last year, after 25 years of proud history, we at [ChemoCentryx ] delivered on our founding promise with the approval of T[avneos] for patients with [ANCA-associated vasculitis]. It is an honor to now join Amgen's great mission, and together begin a bright new era bringing landscape-shaping medicines [such as] T[avneos] to those who will benefit most," said Thomas J. Schall, president and CEO of ChemoCentryx, in the press release.

Amgen’s acquisition of Chemocentryx includes the autoimmune disease drug Tavneos (avacopan).

Amgen Will Acquire Chemocentryx in $4 Billion Deal

On Aug. 4, 2022, AstraZeneca and Merck, known as MSD outside the United States and Canada, announced that the European Commission (EC) approved Lynparza (olaparib) as monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline breast cancer gene (BRCA)1/2 mutations (gBRCAm), who have human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer. The approval is for patients previously treated with neoadjuvant or adjuvant chemotherapy.

With this approval for Lynparza in the European Union, AstraZeneca is set to receive a $75 million regulatory milestone payment from Merck.

The EC’s approval was based on results from a Phase III trial (OlympiA) and a recommendation from the Committee for Medicinal Products for Human Use. In the trial, Lynparza demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival, reducing the risk of invasive breast cancer recurrences, new cancers, or death by 42% compared to placebo. The drug also demonstrated a statistically significant and clinically meaningful improvement in overall survival, reducing the risk of death by 32% compared to placebo.

“[This] approval marks a new era of care in Europe for patients with an inherited form of breast cancer. For patients with high-risk early-stage breast cancer, including those with germline BRCA mutations, recurrence rates remain unacceptably high, with more than one in four of these patients seeing their cancer return following surgery and systemic treatment. Olaparib is the first PARP [Poly(ADP-Ribose)Polymerase] inhibitor to demonstrate improved overall survival for high-risk early-stage breast cancer patients with germline BRCA mutations, and I am hopeful it will become a new standard of care,” said Andrew Tutt, global chair of the OlympiA Phase III trial and professor of Oncology at The Institute of Cancer Research, London, and King’s College London, in a company press release.

“Today’s approval offers patients with germline BRCA-mutated HER2-negative early-stage breast cancer a new, much-needed treatment option. Lynparza as adjuvant treatment can significantly reduce the risk of disease recurrence and death, reinforcing the importance of conducting germline BRCA testing as soon as possible after diagnosis,” said Eliav Barr, senior vice-president, head of Global Clinical Development and chief medical officer, Merck Research Laboratories, in the press release.

Lynparza was approved in March 2022 in the United States for treating gBRCAm, HER2-negative high-risk early breast cancer. The drug is also approved in the US, European Union, Japan, and many other countries for treating patients with gBRCAm, HER2-negative, metastatic breast cancer previously treated with chemotherapy.

The European Commission has approved AstraZeneca and Merck’s Lynparza (olaparib) as an adjuvant treatment for BRCA-mutated HER2-negative high-risk early breast cancer.