Global Pharma Briefs; News from Astellas, Gilead, and Alnylam
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A roundup of news from Japan (Astellas, Minovia) and the US (Gilead Sciences, Alnylam, Lumen Bioscience, and Spectrum Pharmaceuticals).

Japan

Astellas, Minovia Therapeutics in Cell-Therapy Pact
Astellas and Minovia Therapeutics, a Haifa, Israel-based clinical-stage bio/pharmaceutical company, have entered into a strategic collaboration and license agreement for the research, development, and commercialization of cell-therapy programs for diseases caused by mitochondrial dysfunction, in a deal composed of $20 million upfront and up to $420 million for each product reaching certain milestones.

Minovia uses mitochondrial transfer to deliver healthy mitochondria to diseased cells. Minovia has a technology platform called Mitochondrial Augmentation Therapy (MAT), where the patient’s own cells are isolated, loaded with healthy mitochondria obtained from a healthy donor, and then re-infused back into the patient. Minovia is currently conducting research, development, and clinical studies with MAT in mitochondrial diseases.

Through the collaboration, Astellas and Minovia aim to accelerate the creation of allogeneic mitochondrial cell-therapy programs. The two companies will jointly research cell-therapy program candidates comprised of cells derived from Astellas’ proprietary genetically engineered, induced pluripotent stem cells and augmented with Minovia’s proprietary MAT platform technology. The goal of these programs will be to treat diseases caused by mitochondrial dysfunction, through the transfer of healthy mitochondria to restore the patients’ tissues.

Astellas is engaged through its US subsidiary companies, the Astellas Institute for Regenerative Medicine and Universal Cells, to advance allogeneic cell-therapy programs derived from pluripotent stem cells.

Under the agreement, Minovia receives an upfront cash payment of $20 million. Through the joint research program with Minovia, if Astellas develops and commercializes product candidates for diseases caused by mitochondrial dysfunction, Minovia is eligible to receive up to $420 million per product in future development, regulatory and commercial milestone payments from Astellas.

Source: Astellas


US

Gilead Reports Distribution of Counterfeit HIV Medication
Gilead Sciences reports tampered and counterfeit versions of its single tablet HIV treatment regimen, Biktarvy (bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide 25 mg tablets), and its HIV treatment and prevention medication, Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets), are in circulation within US drug-distribution networks.

Distributors not authorized by Gilead to sell Gilead-branded medicine have sold these counterfeits to pharmacies where Gilead bottles have been tampered with a counterfeit foil induction seal or label and contain incorrect tablets. 

Working with the US Food and Drug Administration (FDA), Gilead says it has alerted potentially impacted pharmacies to investigate the potential for counterfeit or tampered Gilead medication sold by distributors not authorized by Gilead and to remain vigilant to the potential for this to occur in the future. 

Gilead also says it continues to work closely with the FDA, pharmacies, and legal authorities to remove counterfeit and tampered medication from circulation and to prevent future distribution of these medications.

Source: Gilead Sciences


Spectrum Pharma Issued FDA Complete Response Letter
Spectrum Pharmaceuticals, a Henderson, Nevada-based bio/pharmaceutical company focused on acquiring, developing, and commercializing targeted oncology therapies, has been issued a Complete Response Letter (CRL) by the US Food and Drug Administration (FDA) for its biologics license application for Rolontis (eflapegrastim), a drug for the treatment of neutropenia in patients receiving myelosuppressive anti-cancer drugs.

The CRL cited deficiencies related to manufacturing and indicated that a re-inspection will be necessary. The company is seeking further clarification from the FDA and says it plans to meet with the agency as soon as possible (as reported on August 6, 2021).

Source: Spectrum Pharmaceuticals


Alnylam, PeptiDream in $2.2-Bn siRNA Pact
Alnylam Pharmaceuticals, a Cambridge, Massachusetts-based bio/pharmaceutical company focused on RNA interference (RNAi) therapeutics, and PeptiDream, a peptide-based drug-discovery company, have entered into a license and collaboration agreement to discover and develop peptide-siRNA conjugates for targeted delivery of RNAi therapeutics, in a deal worth up to $2.2 billion.

Under the agreement, Alnylam will select a set of receptors for PeptiDream’s peptide-discovery platform. PeptiDream will select, optimize, and synthesize peptides for each receptor. Alnylam will then generate peptide-siRNA conjugates and perform in vitro and in vivo studies to support final peptide selection. PeptiDream will receive an upfront payment from Alnylam as well as R&D funding over the term of the research collaboration. PeptiDream may also receive payments based on the achievement of specified development, regulatory, and commercial milestones potentially totaling up to $2.2 billion. In addition, PeptiDream is eligible to receive low-to-mid single digit royalties on sales on any such Alnylam products.

Source: Alnylam Pharmaceuticals and PeptiDream


Lumen Bioscience, Google in AI Pact for Biomanufacturing
Lumen Bioscience, a clinical-stage bio/pharmaceutical company, has entered into a research collaboration with Google to apply machine learning (ML) to advance the scalability of plant-based biologic drugs using spirulina, a type of algae. 

The research details the application of ML to increase spirulina productivity using Bayesian black box optimization to explore a 17-dimensional space containing numerous environmental variables, including pH, temperature, light spectrum, and light intensity. The research was funded in part by the Bill & Melinda Gates Foundation.

Separately, Lumen Bioscience announced receipt of $2 million in additional grant funding from the Department of Energy to support further development of these research findings.

Lumen Bioscience’s platform builds on its discovery of methods for engineering spirulina and the subsequent development of a low-cost system to manufacture them at large-scale under biopharmaceutical-grade controls.

Source: Lumen Bioscience

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