Global Pharma Briefs: News from AstraZeneca, Takeda, Sanofi, BioNTechBy
A roundup of news from France (Sanofi), Germany (BioNTech), Japan (Takeda), the UK (AstraZeneca), and the US (Aurobindo).
Sanofi, Kiadis Pharma Update on $358-M Acquisition
Sanofi and Kiadis Pharma, an Amsterdam-based clinical-stage company developing therapeutics based on natural killer (NK) cells, have reported that the proposed EUR 308-million ($358-million) acquisition of Kiadis by Sanofi is progressing and is expected to close in the first half of 2021. Sanofi and Kiadis announced the acquisition early last month (November 2020).
Kiadis’ pipeline includes NK cell-based medicines for treating patients undergoing hematopoietic stem-cell transplant as well as for treating liquid and solid tumors and infectious diseases. NK cells seek and identify malignant cancer cells and have broad application across various tumor types. Kiadis has a proprietary platform based on allogeneic or “off-the-shelf” NK cells from healthy donors. Kiadis’ NK cell-based medicines will be developed alone and in combination with Sanofi’s existing platforms.
Source: Sanofi and Kiadis Pharma
BioNTech, InstaDeep in Pact To Form AI Lab for Immunotherapies
BioNTech, a Mainz, Germany-based immunotherapy company, and InstaDeep, a London-based company that develops artificial intelligence (AI) products, have entered into a multi-year strategic collaboration to develop immunotherapies for a range of cancers and infectious diseases through AI and machine learning.
As part of the collaboration, BioNTech and InstaDeep will form a joint AI Innovation Lab in London and Mainz, Germany, to advance a portfolio of initiatives across drug discovery and design, protein engineering, manufacturing and supply-chain optimization. The companies say one of the key research areas of the lab will be the development of vaccines and biopharmaceuticals for the treatment of cancer and prevention and therapy of infectious diseases, including COVID-19.
The long-term collaboration builds on the existing relationship between InstaDeep and BioNTech, initiated in 2019.
Source: BioNTech and InstaDeep
Takeda Completes $278-M Sale of OTC and Non-Core Assets to Celltrion
Takeda has completed its previously announced sale of select products to Celltrion, an Incheon, South Korea-based biopharmaceutical company developing innovator drugs and biosimilars, for a total value of $278 million. This deal was first announced in June 2020.
The portfolio includes 18 pharmaceutical products and over-the-counter (OTC) products sold in Asia Pacific. As part of the deal, Takeda will continue to manufacture the portfolio of divested products and supply them to Celltrion under a manufacturing and supply agreement.
The sale is part on an ongoing divestment program of non-core assets following Takeda’s $62-billion acquisition of Shire in January 2019. Its core four therapeutic areas are oncology, rare diseases, neuroscience, and gastroenterology with targeted R&D investments in plasma-derived therapies and vaccines. The company says that the proceeds from the divestments will be used to reduce debt and improve cash flow by reaching a target of 2x net debt/adjusted EBITDA (earnings before interest, taxes, depreciation, and amortization) within FY 2021 to 2023. Since January 2019, the company has announced 10 deals involving divestments of non-core assets of a total aggregate value of up to approximately $11.3 billion, including agreements to divest:
AstraZeneca To Divest European Rights of Crestor in $350-M Deal
AstraZeneca has agreed to sell its European commercial rights (except in the UK and Spain) for its anti-cholesterol drug, Crestor (rosuvastatin) and associated brands to Grünenthal, an Aachen, Germany-based pharmaceutical company, in a deal worth up to $350 million.
Under the deal, Grünenthal will make an upfront, non-contingent payment to AstraZeneca of $320 million and may also make future milestone payments of up to $30 million. The divestment is anticipated to close in the first quarter of 2021, subject to customary closing conditions and regulatory clearances. In 2019, Crestor generated sales of $136 million and profit before tax of $98 million in the countries covered by the agreement.
AstraZeneca will continue to manufacture and supply Crestor to Grünenthal during a transition period. AstraZeneca will also continue selling the medicine in other countries, including those in North America, in Japan, China and other emerging markets.
Source: AstraZeneca and Grünenthal
Aurobindo Receives FDA Warning Letter for Leaks, Impurities
Aurolife, a subsidiary of Aurobindo Pharma, a Hyderabad, India-based a manufacturer of generic pharmaceuticals and a contract manufacturer, has received a Warning Letter from the US Food and Drug Administration for GMP violations for finished pharmaceuticals at its plant in Dayton, New Jersey following an inspection of the facility from January 13 to February 12, 2020.
In the Warning Letter, the FDA cited the company for not adequately investigating the root cause of impurities in the active pharmaceutical ingredient (API), olanzapine and its finished drug product.
The agency also said that the company failed to adequately maintain its facility in a good state of repair, which included at least five instances of water leaks in its packaging area. This followed four incidences of water leakage from the ceiling of the company’s encapsulation room in 2018. Additionally, the agency cited violations of cleaning procedures with investigators observing surfaces covered in powder throughout the company’s facility, including API sampling rooms, raw material dispensing rooms, common production corridor areas, granulation rooms, and compression rooms. The agency also said that the company failed to failed to establish adequate written procedures for production and process control.
Source: US Food and Drug Administration