Pharmaceutical Technology Editors

UK-headquartered pharma company, Advanz Pharma, has announced in a May 5, 2022 press release that it has signed an agreement with US biopharma company, Intercept Pharmaceuticals, to acquire most of the company’s subsidiaries and non-US operations.

According to the press release, through the agreement, Advanz Pharma will acquire Intercept’s operations in Europe, Canada, and all other non-US markets, and will include the ex-US rights for the commercialization of Ocaliva (obeticholic acid)—an orphan drug for the treatment of primary biliary cholangitis (PBC). Additionally, as per the terms of the agreement Advanz Pharma will gain the rights to commercialize obeticholic acid in non-alcoholic steatohepatitis (outside of the United States), in exchange for royalty payments on any future net sales.

“This acquisition is transformational for Advanz Pharma,” said Steffen Wagner, CEO at Advanz Pharma, in the press release. “Acquiring this high-quality rare disease business outside of the US grows our position as a partner of choice for specialty and hospital pharmaceuticals in Europe, and we are thrilled to welcome Intercept’s dedicated and experienced team, which will bring additional capabilities to us for the benefit of patients.”

“We look forward to building on this transaction as we continue to strengthen our platform for future acquisitions and in-licensing agreements to drive growth, especially in the areas of gastroenterology and hepatology as well as more broadly in rare diseases,” added Susanna El-Armale, chief corporate development officer at Advanz Pharma, in the press release.

Under the financial terms of the agreement, Advanz Pharma is expected to pay Intercept and upfront consideration of $405 million, in addition to $45 million as contingency once an extension of pediatric orphan exclusivity is received in Europe.

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Advanz Pharma has signed an agreement with Intercept Pharmaceuticals to acquire most of the its subsidiaries and non-US operations.

Advanz Pharma Signs Acquisition Agreement for Intercept Pharmaceuticals Non-US Businesses 

AstraZeneca announced on April 29, 2022 its plans to open a new strategic R&D center in Kendall Square, Cambridge, Mass. The new site will also serve as Alexion’s new corporate headquarters, a company which AstraZeneca owns.

The site will bring together approximately 1500 R&D, commercial, and corporate colleagues into a single purpose-built space. It is scheduled to be completed in 2026 and is strategically located to be near several major academic, pharma, and biotech institutions, which can be helpful for collaborations and access to future talent. The new site reinforces AstraZeneca’s Boston expansion with more than 570,000 square feet of R&D and commercial space as well as expansion for the future.

“Today’s announcement is a milestone moment following the acquisition of Alexion in July 2021,” said Pascal Soriot, CEO of AstraZeneca, in a press release. “Our combined company has already successfully leveraged internal scientific synergies, and this move will act as a catalyst for even more external collaboration and innovation. Kendall Square, Cambridge, is at the heart of the life sciences and innovation hub of the greater Boston area, and our new site will put us right at the center of this space. The move will provide access to some of the most innovative partners in academia and biotech, offering opportunities to accelerate our growth and collaborate with like-minded organizations as we continue to push the boundaries of science to deliver advances for patients.”

AstraZeneca has announced plans to open a new strategic R&D center in Cambridge, MA, which will also serve as Alexion’s headquarters.

AstraZeneca Announces Plans for New Strategic R&D Center

The Janssen Pharmaceutical Companies of Johnson & Johnson announced on April 28, 2022 the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the approval of niraparib and abiraterone acetate dual-action tablet plus prednisone for the treatment of patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).

Upon approval, niraparib and abiraterone acetate plus prednisone will be the first dual-action tablet in the European Union specifically targeting HRR gene alterations in mCRPC, according to the company. The combination is intended to be more convenient for patients and thus improve treatment compliance.

Prostate cancer is one of the most common cancers in Europe, with approximately 473,000 patients diagnosed in 2020, according to the company. Up to approximately 30% of patients with mCRPC have HRR gene alterations, which are associated with a worse prognosis compared to those without HRR gene alterations.

“People with prostate cancer harboring BRCA alterations face a more aggressive form of disease with worse outcomes and faster progression, sadly leading to a shorter life expectancy,” commented Professor Gerhardt Attard, primary study investigator and clinician scientist and team leader at University College London Cancer Institute, in a press release. “This submission is an important step towards improving the outcomes for people with metastatic prostate cancer harboring BRCA alterations using a targeted therapy that significantly delays the time to their cancer progressing.”

Janssen has submitted a marketing authorization application to EMA for the approval of a treatment for patients with HRR gene-mutated metastatic castration-resistant prostate cancer.

Janssen Submits Marketing Authorization Application for Treatment of Metastatic Castration-Resistant Prostate Cancer

Purolite, an Ecolab company and manufacturer of synthetic and agarose-based resins, has been awarded the Queen’s Award for Enterprise in the International Trade category.

Purolite is among the 232 organizations to be recognized nationally with a Queen’s Award for Enterprise. The company was selected for its success in innovation and international trade, as well as resilience throughout the COVID-19 pandemic.

The Queen’s Award for Enterprise, established in 1965, is the United Kingdom’s highest accolade for business success. The awards, granted annually, acknowledge firms that have excelled in exporting, social or environmental good work, or innovation.

Leighton Davies, finance director at Purolite, has received an invitation to the Buckingham Palace awards reception that is to be hosted by Prince Charles.

“It’s a tremendous honor to have won the Queen’s Award for Enterprise. I’m immensely proud of this achievement and would like to thank the fantastic teams we have in place all over the world, as well as the continued support of our valued customers,” commented Hayley Crowe, SVP and general manager of Purolite, upon the company receiving the award.

Purolite has received the Queen’s Award for Enterprise in the International Trade category.

Purolite Awarded Queen’s Award for Enterprise

Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and Cara Therapeutics announced on April 28, 2022 that the European Commission (EC) has granted marketing authorization to Kapruvia (difelikefalin) for the treatment of moderate-to-severe pruritis associated with chronic kidney disease (CKD) in adult hemodialysis patients.

The treatment was approved by FDA in the United States in August 2021 for the same indication under the name Korsuva. The EC approval allows the treatment to be used in all member states of the European Union, as well as Iceland, Liechtenstein, and Norway. According to the company, Kapruvia is the first approved therapy in Europe for the treatment of pruritis associated with CKD in hemodialysis patients. The first launches in Europe are expected in the second half of 2022.

“We are very excited about the European Commission’s approval of Kapruvia, marking an important milestone on our journey to advance and fundamentally change the treatment paradigm for people living with the severe burden of pruritus associated with chronic kidney disease,” said Dr. Klaus Henning Jensen, chief medical officer of Vifor Pharma, in a press release. “We look forward to bringing this first-in-class therapy to patients in Europe, with launch in first markets expected in the second half of 2022.”

“The European Commission’s approval of Kapruvia provides a much-needed therapy to hemodialysis patients in Europe who suffer from pruritus,” said Dr. Joana Goncalves, Chief Medical Officer of Cara Therapeutics. “We are excited to bring an innovative drug to physicians to help change the way pruritus is managed. We continue to work with our commercial partner VFMCRP, to fill a significant unmet medical need among CKD patients with pruritus in both the U.S. and Europe.”

Kapruvia has been approved by the European Commission for the treatment of moderate-to-severe pruritis in hemodialysis patients.

Kapruvia Approved by EC for Treatment of Pruritus

Validair announced on May 1, 2022 that it has formed a new company that has been appointed as a channel partner for Ireland by TSI Inc., a particle counter manufacturer and contamination control company. The agreement will allow Validair Monitoring Ireland Limited to deliver services across Ireland from its headquarters in Dublin. The new company will offer the entire TSI range of products and access to more than 20 field service and specialist technical engineers in the pharmaceutical, life sciences, biotech and research, and healthcare markets.

“Validair companies have demonstrated impressive capabilities with more than 120 TSI systems installed in the [United Kingdom] over the past 20 years, including the largest-ever global installation at Oxford Biomedica. We are very confident that the new venture will deliver the same excellent level of results that Validair customers in other territories have come to expect,” said Simon Tebb, sales manager EMEA Controlled Environments at TSI Inc., in a press release.

The new company has been appointed as a channel partner for Ireland by TSI Inc., a particle counter manufacturer.