Pharmaceutical Technology Editors

On June 07, 2021, FDA announced the approval of Biogen’s Aduhelm (aducanumab), a new monoclonal antibody for treating Alzheimer’s disease, using the accelerated approval pathway. Aduhelm represents a first-of-its-kind treatment approved for Alzheimer’s disease and is the first new treatment approved for the disease since 2003, the agency stated in its press release.

FDA also noted in its press release that this drug is the first therapy that targets the fundamental pathophysiology of the disease. Researchers evaluated Aduhelm’s efficacy in three separate double-blind, randomized, placebo-controlled dose-ranging studies that represent 3482 patients in total. The results from the studies showed that patients receiving the treatment had significant dose-and time-dependent reduction of amyloid beta plaque, while patients in the control arm of the studies had no reduction of amyloid beta plaque, the plaques being the hallmark of Alzheimer’s disease. These results support the accelerated approval of the drug.

Under the accelerated approval provisions, FDA is requiring Biogen to conduct a new randomized, controlled clinical trial to verify the drug’s clinical benefit. If the trial fails to verify clinical benefit, FDA may initiate proceedings to withdraw approval of the drug.

Aduhelm was also granted fast track designation, which serves to expedite the development and review of drugs that are intended to treat serious conditions when initial evidence shows that the drug has potential to address an unmet medical need.

“Alzheimer’s disease is a devastating illness that can have a profound impact on the lives of people diagnosed with the disease as well as their loved ones,” said Patrizia Cavazzoni, MD, director of FDA’s Center for Drug Evaluation and Research, in the press release. “Currently available therapies only treat symptoms of the disease; this treatment option is the first therapy to target and affect the underlying disease process of Alzheimer’s. As we have learned from the fight against cancer, the accelerated approval pathway can bring therapies to patients faster while spurring more research and innovation.”

Articles

FDA has granted accelerated approval to Biogen for Aduhelm (aducanumab), a new mAb treatment for Alzheimer’ disease.

FDA Grants Accelerated Approval for Biogen’s Alzheimer’s Drug

, James Blackwell, president of The Windshire Group, LLC, discusses stumbling blocks to process development; strategies for developing, scaling up, and scaling out bioprocesses; and challenges when working across multiple sites.

Well-defined studies are crucial to effective process development

Common Challenges in Cross-Functional Process Development

Hovione announced on May 27, 2021 that it has entered into a strategic collaboration with the Institute of Experimental and Technological Biology (iBET), a research and development (R&D) institution.

Hovione was previously a founding member of the institution in 1989 and re-joined to increase its R&D programs in the areas of novel and high potential pharmaceutical technologies, while combining expertise for industrial innovation in new therapeutic fields, Hovione said in a company press release.

“We are delighted with the return of Hovione to the membership of iBET,” said Paula Alves, CEO, iBET, in the press release. “Our goal is to strengthen the R&D capabilities of our members; this important partnership with Hovione will allow [our members] to pool together complementary scientific competencies and power the development of biopharmaceuticals that are essential to patient health. To win in the area of biologics and novel therapies it is critical to have access to state-of-the art competencies and support technologies.”

“The partnership with IBET opens a new chapter in Hovione's history,” added Guy Villax, CEO of Hovione, in the press release. “We will bring together our knowledge in chemistry [and] in cutting-edge technologies [as well as our knowledge] of the market and of the FDA regulatory process with iBET’s command of cell biology, viral biology, and bioprocessing. If the twentieth century was the century of chemistry, the 21st century is the one of biology. iBET scientists have built deep knowledge in specific areas; we plan to work together to turn that knowledge into industrial innovation.”

Hovione has re-joined iBET to increase its R&D programs in novel and high potential pharmaceutical technologies and to combine expertise for industrial innovation in new therapeutic fields.

Hovione to Re-Join iBet

Aceto, a provider of specialty materials for life sciences and advanced technology markets, announced on June 2, 2021 that it has acquired Cascade Chemistry, a US-based manufacturer of active pharmaceutical ingredients (APIs), regulatory starting materials, and advanced intermediates.

Through the acquisition, Aceto can now offer its customers support throughout the drug development process and access to North American manufacturing for APIs and advanced intermediates, Aceto said in a company press release.

“The acquisition of Cascade Chemistry supports and complements our focus on acquisitions that offer customers supply chain choice and technical expertise. With each of our acquisitions, Aceto looks to add companies that enhance our business capabilities and support our growth strategy, while aligning with our core business values,” said Gilles Cottier, CEO of Aceto, in the press release. “We aim to ensure that all our customers have access to robust solutions that are tailored to their needs and allow them to advance their compounds into clinical trials with confidence and efficiency. Cascade Chemistry is an excellent addition to the Aceto team.”

“Cascade Chemistry has a 40-year track record of applying our deep expertise to solve problems and provide our customers with the support they need to successfully complete the challenging and complex API development cycle,” added Jeremiah Marsden, president of Cascade Chemistry, in the press release. “We are proud of our reputation for quality and outstanding customer service and we welcome the opportunity to now join forces with Aceto. Access to the expanded capabilities of the Aceto family of companies will allow us to serve our clients with comprehensive, fully integrated support teams and additional service options that will further enhance and accelerate our clients’ programs.”

Through the acquisition, Aceto can now offer its customers support throughout the drug development process and access to North American manufacturing for APIs and advanced intermediates.

Aceto to Acquire Cascade Chemistry

Recro Pharma, a contract development and manufacturing organization (CDMO), announced on June 2, 2021 that it has expanded the clinical capabilities of its clinical trial services (CTS) offerings.

The added capabilities include clinical-scale sachet and blister packaging for clinical trial pharmaceuticals and a relationship with a European Union Qualified Person (QP) for its CTS offerings, the company said in a press release. Based on an audit completed by the QP, Recro meets the relevant GMP manufacturing standards and requirements for clinical trial materials to be used in the European Union.

“While our addition of CTS offerings is not yet a year old, it has already provided opportunities for our existing clients to expand their scope of work with Recro, as well as serving as a gateway for attracting new customers. This is highlighted by the fact that our recent expansion of packaging services has played an important role in increased client interest and attracting new business,” said Scott Rizzo, senior vice-president and general manager of Recro, in the press release. “In addition to the growing traction of the CTS offerings in the US, we are now positioned to carry momentum into the European market based on the successful QP audit. Taken together, these expanded capabilities will allow us to continue the positive trajectory for our CTS offerings, which typically have the benefit of a shorter sales and earnings cycle, as they become a more meaningful contributor to the overall growth of Recro.”

The added capabilities include clinical-scale sachet and blister packaging for clinical trial pharmaceuticals and a relationship with a European Union Qualified Person for its CTS offerings.

Recro to Expand its Clinical Trial Services Offerings

Aptamer Group, provider of Optimer reagents, and PinotBio, a clinical-stage oncology-focused biotechnology company, have formed a strategic collaboration aimed at the development of new drug conjugates for targeted drug delivery.

The companies will combine Aptamer’s Optimer technology with PinotBio’s technology using the chemotherapeutic FL-118 compound with specific linker. These Optimer drug conjugates will be generated and optimized against multiple undisclosed targets.

Under the terms of the agreement, PinotBio will perform pre-clinical R&D to evaluate each of the Optimer-drug conjugates. Additionally, the potential for clinical progression of each candidate as a treatment of hematological cancers will be evaluated by PinotBio. Commercial terms of the agreement were not disclosed.

“The development of drug conjugates that combine the benefits of Optimer binders to selectively and efficiently target PinotBio’s novel linker delivery system to the tumor site for activation and therapeutic delivery represents the next evolution in drug delivery technology,” said Arron Tolley, CEO of Aptamer Group, in a June 2, 2021 press release. “We are looking forward to working with the team at PinotBio and believe this collaboration has the potential to develop much-needed improved oncological treatments.”

“This field of targeted delivery of anti-cancer compounds is fast growing and at the same time fast changing. Combining three things, right target, right vehicle, and right payload is equally important,” added Doo Young Jung, CEO of PinotBio, in the press release. “I believe that through this collaboration, we can combine the right vehicle and payload to result in novel drug candidates with a potential to change the cancer treatment landscape.”

Aptamer Group and PinotBio have formed a strategic collaboration aimed at the development of new drug conjugates for targeted drug delivery.