Pharmaceutical Technology Editors

The IPEC Foundation, the charitable arm of the International Pharmaceutical Excipients Council of the Americas, announced its 2021 award winners. These awards honor individuals who work to advance the healthcare community.

The Ralph Shangraw Memorial Award, which recognizes individuals who have provided outstanding research contributions in the study of excipients or excipient-related technology, was awarded to Dr. Bruno Hancock of Pfizer.

The Henk de Jong Industrial Research Award, which recognizes individuals working in an industrial setting who have made significant contributions in the field of excipient technology, was awarded to Panayiotis Constantinides, PhD

 of Biopharmaceutical & Drug Delivery Consulting.

The Patrick DeLuca Emerging Researcher Award, which recognizes a beginning career scientist (post PhD) who has demonstrated interest and dedication to the area of excipients, was awarded to Dr. Na Li of the University of Connecticut.

Five additional awards went to graduate students. The winners are:

Rishi Thakkar, University of Texas at Austin

The winners will be recognized at IPEC Foundation’s annual awards ceremony that will take place at The Notary Hotel, Philadelphia, Pennsylvania on Sunday, October 17th.

Articles

The IPEC Foundation announced its 2021 award winners, who will be honored at their annual award ceremony in Philadelphia.

The IPEC Foundation Announces 2021 Award Winners

On Aug.27, 2021, Japan suspended the use of 1.63 million doses of Moderna’s COVID-19 vaccine after a contaminant believed to be a metallic particle was found in the batch, 

according to a report from the Japanese Broadcasting Corporation

. Japanese health ministry officials found that the particle reacted to magnets, and therefore suspected it to be a metal.

The contaminants have been found at eight vaccination sites since Aug 16, 2021. The Japanese government has told 863 vaccination sites nationwide to halt the use of vaccines from the affected lots. While contaminants were only found from vials from lot 3004667, Japan also suspended vials from 3004734 and 3004956 because they were made from the same production line as the contaminated vials.

The vials were bottled by the Spanish company Rovi, which 

released a report stating that the matter could be related to an error in one of their manufacturing lines

. They also stated that they will put this lot and two adjacent ones on hold, but that no safety or efficacy issues have been identified in relation to the vaccine.

The Japanese health ministry has said they have not received reports of health issues from those who received vaccines from the affected lots. However, if these individuals notice an abnormality in their health, they encourage them to visit their doctor. They can also contact Takeda Pharmaceutical, the Japanese distributor of the Moderna vaccine.

: This is a developing story. Further updates can be found 

Japan has suspended the use of more than 1.63 million potentially contaminated doses of the Moderna vaccine.

Contaminant in Moderna Vaccines in Japan Suspected to be Metallic Particles

FSD Pharma— a life sciences holding company building a portfolio in legal psychedelics and medical cannabis—has entered a definitive agreement to acquire all of the issued and outstanding shares of Lucid Psycheceuticals for approximately US$9 million (CAD$11.3 million) in FSD Pharma stock, according to an Aug. 25, 2021 company press release. Lucid Psycheceuticals is a Canadian-based specialty psychedelic pharmaceutical company focused on the development of therapies to treat critical neurodegenerative diseases. The transaction will be effected by way of an amalgamation between Lucid, FSD Pharma, and a wholly-owned subsidiary of FSD Pharma.

Lucid was founded in 2020 and is developing novel molecules and combinations to address brain health. They are targeting neurodegenerative diseases, such as multiple sclerosis and other brain conditions. The company has exclusive worldwide licensing rights from the University Health Network to a patent-protected family of new chemical entities. Lucid-21-302, the company’s lead neurodegenerative disorders therapeutic candidate, has been derived from these chemical entities.

“The acquisition of a distinctive company like Lucid illustrates FSD Pharma’s vision to build a portfolio of biotechnology assets on a new frontier of medicine that hold the potential to treat mental health disorders and neurodegenerative diseases in a new way,” said Anthony Durkacz, interim CEO of FSD Pharma, in a press release. “Lucid has successfully developed a strong pipeline of novel therapeutic compounds—supported by IP in order to advance to future clinical trials—and we are confident that the experience the Lucid leadership team brings will allow us to immediately start the process towards clinical trials to further advance these promising therapies. This is an exciting venture for FSD Pharma that we believe represents a paradigm shift in the development and outlook of our company.”

FSD Pharma has entered a definitive agreement to acquire all of the issued and outstanding shares of Lucid Psycheceuticals for approximately US$9 million (CAD$11.3 million) in FSD Pharma stock.

FSD Pharma to Acquire Lucid Psycheceuticals

QSAM Biosciences announced in an Aug. 25, 2021 press release that FDA has cleared QSAM’s Investigational New Drug (IND) application for Samarium-153 DOTMP (CycloSam), allowing the company to commence Phase I clinical trials and the dosing of patients with bone cancer. CycloSam is an investigational radiopharmaceutical for the treatment of bone cancer.

“This IND clearance is another major milestone for QSAM and the advancement of CycloSam. We expect to commence our Phase I open-label dose escalation trial in bone cancer patients by the end of this year. These trials will be intended to investigate the efficacy, safety, tolerability, and pharmacokinectics of CycloSam to establish the optimal dose for pivotal Phase II/III clinical trials,” said Douglas R. Baum, co-founder and CEO, QSAM Biosciences, in a press release. “The clearance of our IND also continues to validate our data-driven approach in oncology drug development and sets the stage for additional aggressive efforts we are undertaking in pediatric and adult cancer therapies.”

According to the press release, CycloSam is expected to be an improved formulation of a previously FDA-approved radiopharmaceutical. CycloSam uses a more efficient method of isotope manufacturing and an advanced chelation technology. This may allow for repeated dosing of patients with bone cancer in an effort to halt or reverse tumor growth.

FDA has cleared QSAM Biosciences’s IND application for Samarium-153 DOTMP (CycloSam).

Investigational Radiopharmaceutical for the Treatment of Bone Cancer Receives FDA Clearance of IND

Aerami Therapeutics—a clinical stage biopharmaceutical company developing inhaled therapies to treat severe respiratory and chronic diseases—announced in an Aug. 25, 2021 press release that FDA granted orphan drug designation for imatinib in AER-901 for the treatment of patients with pulmonary arterial hypertension (PAH). AER-901 is Aerami’s drug-device combination product candidate for inhaled imatinib for the treatment of PAH. It is currently in a Phase I trial that is estimated to be completed toward the end of 2021.

“Receiving orphan drug designation for imatinib in AER-901 is another important milestone to emerge from our PAH development program,” said Steve Thornton, CEO of Aerami, in a press release. “We are pleased with the progress we are making in our Phase I trial and believe that AER-901, which is targeted to enter Phase II/III trials in the first half of 2022, might, for the first time, provide the opportunity to modify the course of this terrible disease, and offer an important therapeutic option for patients.”

Although there aren’t many patients with PAH and the approved drugs don’t fundamentally modify or halt the progression of the disease, the global market for PAH treatments is an estimated $5.5 billion in worldwide sales in 2020, according to the company press release.

FDA granted orphan drug designation for imatinib in AER-901 for the treatment of patients with pulmonary arterial hypertension. 

FDA Grants Orphan Drug Designation to Aerami Therapeutics’s Imatinib

Global biopharmaceutical company, UCB, announced on Aug. 24, 2021, that the European Commission (EC) has approved its treatment for adults with moderate-to-severe plaque psoriasis, BIMZELX (bimekizumab). The treatment will now be available for eligible patients throughout the European Union and Iceland, Liechtenstein, and Norway.

Bimekizumab has been designed to selectively and directly inhibit two key cytokines, IL-17A and IL-17F, that drive inflammation in plaque psoriasis. The approved recommended dose of the therapy is 320 mg, which is to be administered via two subcutaneous injections every four weeks to 16 weeks, and then every eight weeks thereafter.

“The approval of BIMZELX in Europe is the first marketing authorization for this new psoriasis treatment worldwide and represents a landmark moment for the dermatology community and UCB,” said Emmanuel Caeymaex, executive vice-president, Immunology Solutions and Head of US, UCB, in the press release. “Our ambition is to transform the lives of people living with severe diseases, and we are incredibly proud to bring a new treatment option to people living with moderate to severe plaque psoriasis in Europe. We believe that bimekizumab has the potential to raise expectations of what psoriasis treatment can deliver.”

“In the pivotal Phase III studies patients treated with bimekizumab achieved superior levels of skin clearance compared to those treated with placebo, adalimumab, and ustekinumab, and in the Phase IIIb study, treatment with bimekizumab resulted in greater levels of skin clearance than secukinumab. Across studies, about 60 percent of bimekizumab-treated patients achieved complete skin clearance at week 16, and this response was maintained for up to a year,” added Richard Warren, Salford Royal NHS Foundation Trust and The University of Manchester, UK, in the press release. “The approval of bimekizumab in the EU provides a welcome new treatment option that may help more patients with moderate to severe plaque psoriasis to achieve their treatment goals.”

The European Commission has approved UCB's treatment for adults with moderate-to-severe plaque psoriasis, BIMZELX (bimekizumab). 