Global Pharma Briefs: News from Asia, Europe, and the US

By Miranda Greenberg -

September 10, 2020

A roundup of news from Germany (Bayer, Recursion), India (Mylan), Spain (Grifols, Alkahest), and the US (Merck KGaA, Pfizer, NKMax America).

Germany

Bayer, Recursion in AI Drug-Discovery Pact; Bayer Takes $50-M Stake
Bayer and Recursion Pharmaceuticals, a Salt Lake City, Utah-based digital biology company for drug discovery, have entered into a strategic collaboration to use Recursion’s artificial intelligence (AI)-guided drug discovery platform and Bayer’s small-molecule compound library to discover and develop new treatments for fibrotic diseases. In addition, Bayer has invested $50 million in Recursion Pharmaceuticals through Leaps by Bayer, the investment arm of Bayer AG, in leading a Series D financing round.

Under the agreement, the parties may initiate more than 10 programs with possible development and commercial milestone payments of more than $100 million per program plus royalties on future sales. Bayer will gain the option to exclusively license novel therapeutics derived from the research activities. Bayer will contribute with its small-molecule compound library and expertise in biology and medicinal chemistry. In addition to the $50-million equity investment, Recursion will receive an upfront payment of $30 million.

Recursion’s drug-discovery platform combines automated, wet-lab biology experiments as the base for iterative learning through its computational tools. The drug-discovery platform is based on a proprietary library of over half a billion images of human cells from more than 33 million experiments conducted in-house at Recursion and coupled with advanced data analytics based on machine learning. To date, Recursion has on-boarded over 750 cellular disease models to broadly interrogate diverse therapeutic areas.

The pact will seek to discover and develop new treatments for fibrotic diseases of the lung, kidney, heart, and other areas.

Source: Bayer and Recursion Pharmaceuticals


India

Mylan Receives FDA Warning Letter for Indian API Mfg Plant
Mylan has received a Warning Letter from the US Food and Drug Administration for GMP violations for active pharmaceutical ingredients (APIs) at its plant in Pashamylaram, Patancheru, Sangareddy District, India following an inspection of the facility from February 24 to 28, 2020.

The company was cited for inadequate cleaning records for bulk storage tanks holding various materials, including mother liquids, fresh solvents, and recovered solvents. In addition, the agency said that complete impurity profiles of recovered solvents were not performed during the initial evaluation of the company’s solvent-recovery contract manufacturing organization. The agency said, that this, coupled with inadequate cleaning records, provides limited assurances that non-dedicated equipment would not contribute to cross-contamination or carry-over of residual impurities. In addition to a lack of cleaning records, the agency said that the company’s cleaning validation and verification program for non-dedicated manufacturing and storage equipment was inadequate.

The agency also said that the company failed to implement procedures to evaluate and control impurity risks associated with solvents used in its API manufacturing operations. This includes adequate testing of all incoming raw materials to confirm their suitability for manufacturing processes in which they may be used, establishing an impurity profile for solvents to ensure that they meet appropriate standards, and maintaining an ongoing program for monitoring process controls to ensure stable manufacturing and prevent unanticipated impurities.

The agency said that it had also earlier noted similar deficiencies in solvent-recovery processes at two other plants. The agency outlined a series of actions for the company to address the issues addressed in its most recent Warning Letter.

Source: US Food and Drug Administration


Spain

Grifols To Acquire Alkahest for $146 M
Grifols, a Barcelona-based healthcare company specializing in plasma medicines, has agreed to acquire the remaining equity of Alkahest, a San Carlos, California-based clinical-stage biopharmaceutical company, which it does not already own, for $146 million, to give it full ownership of the company. Alkahest is focused on developing specific plasma fractions and protein inhibitors for age-related diseases.

Alkahest currently has four candidates in six Phase II clinical trials covering therapeutic products for neurodegenerative, cognitive decline, neuromuscular and ophthalmic indications, In addition, Alkahest has developed a map of the human plasma proteome facilitating the identification of plasma proteins and their recombinant analogues as potential therapeutic medicines. This proteomic platform of targets will help Grifols and Alkahest to develop new therapeutics and diagnostics, develop new plasma proteins, new indications for currently licensed plasma proteins, biomarkers for diagnostics, recombinant proteins, and antibodies as well as small-molecule drugs.

The closing of the transaction is subject to the approval by the relevant antitrust authorities and is expected to close in early 2021.

Source: Grifols and Alkahest


US

Merck KGaA, Pfizer, NKMax America in Clinical Trial, Supply Pact, Supply
NKMax America, a Santa Ana, California-based biopharmaceutical company developing natural killer (NK) cell therapies, has entered into a clinical-trial collaboration and supply agreement with Merck KGaA and Pfizer to evaluate the safety and tolerability of SNK01, the company’s autologous NK cell therapy in combination with Bavencio (avelumab), a human anti-PD-L1 therapy co-developed and co-commercialized by Merck KGaA and Pfizer.

Under the agreement, NKMax America will be the study sponsor, and Merck KGaA and Pfizer will supply avelumab for a new study arm that will be added to an existing US Phase I clinical trial in refractory solid tumors. Under an amendment, up to 18 patients with all solid tumor types refractory to conventional treatment and independent of PD-L1 status will be enrolled to receive SNK01 plus a checkpoint inhibitor until progression or unacceptable toxicity. Enrollment of this arm is expected to begin in September 2020. Both parties will have access to the clinical data.

NKMax America has developed its own proprietary NK cell expansion and activation technology platform, which allows it to produce commercial amounts of autologous and allogenic NK cells from numerous donors.

Source: NKMax America