Pharmaceutical Technology Editors

Pfizer announced on March 2, 2022 that it has received Breakthrough Therapy Designation from FDA for its respiratory syncytial virus (RSV) vaccine candidate (RSVpreF). The vaccine candidate is for the prevention of RSV-associated lower respiratory tract illness in infants by active immunization of pregnant women.

RSV is a common cause of respiratory illness and can be potentially life-threatening for infants. There is currently no vaccine to prevent RSV and no direct treatment other than supportive care.

FDA’s Breakthrough Therapy Designation allows for the review and development of new drugs and vaccines to be expedited in order to treat or prevent serious conditions on a faster basis. The Breakthrough Therapy Designation was granted after the results of the safety and immunogenicity of RSVpreF were assessed through a double-blinded, placebo-controlled study. The study involved healthy pregnant women ages 18 through 49 years old who were vaccinated between 28 and 36 weeks of gestation. Pfizer will publish the outcomes of the study at a future date.

“Today’s decision is a pivotal next step in our path towards potential regulatory approval for our maternal RSV vaccine candidate and is an important milestone in our efforts to help address the detrimental impact RSV disease has on infants,” said Kathrin U. Jansen, PhD, senior vice president and head of vaccine research & development at Pfizer, in a press release. “If approved by the FDA, this maternal immunization has the potential to be the first vaccine candidate to help protect infants in their vulnerable first months of life from disease caused by this highly-contagious virus. We look forward to our ongoing dialogue with the FDA to accelerate the development of our maternal RSV vaccine candidate.”
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Pfizer has received Breakthrough Therapy Designation from FDA for its RSV vaccine candidate for prevention of RSV illness in infants by active immunization of pregnant women.

Pfizer Receives FDA Breakthrough Therapy Designation for Respiratory Syncytial Virus Vaccine Candidate

FDA has granted accelerated approval for Vonjo (pacritinib) capsules to treat adults with myelofibrosis, a rare form of bone marrow disorder, along with low platelet levels.

Myelofibrosis disrupts blood cell production and causes extensive bone marrow scarring, which can lead to severe anemia and a reduced number of platelets. This can increase the risk of bleeding and cause the spleen to enlarge. Myelofibrosis can be a primary or secondary disease, occurring on its own or developing due to another bone marrow disorder, respectively.

The effectiveness of pactirinib was based on the number of patients who had a 35% or greater spleen volume reduction from the start of the study to week 24. Twenty-nine percent of patients in the pactirinib treatment group experienced a spleen volume reduction of 35% or more, compared to the 3% in the standard treatment group.

Accelerated approval was granted on the condition that pactirinib must go through another study that confirms that spleen volume reduction leads to clinical benefits for the patients, such as improvements in function or feeling.

FDA has approved Vonjo (pacritinib) capsules to treat adults with a rare form of bone marrow disorder.

FDA Approves Drug for Adults with Rare Form of Bone Marrow Disorder

Adagene, a company focused on antibody-based therapies, announced on March 2, 2022 that it is collaborating with Sanofi to generate masked monoclonal and bispecific antibodies. The companies have formed an exclusive license agreement for development and commercialization by Sanofi.

Adagene’s SAFEbody technology will be used for early research activities to develop masked versions of Sanofi candidate antibodies. All later research, product development, and commercialization will be handled by Sanofi.

SAFEbody technology utilizes precision masking technology to address safety and tolerability challenges associated with many antibody therapeutics. This technology can be applied to monoclonal and bispecific antibodies, as well as a wide variety of other therapeutics modalities.

Sanofi will make an upfront payment of $17.5 million to Adagene, as well as potential milestone payments of up to $2.5 billion.

“We are excited to work with Sanofi and unlock the potential of multiple promising yet challenging immuno-oncology targets by applying our SAFEbody precision masking technology, which is validated by extensive preclinical research as well as clinical data from our ADG126 anti-CTLA-4 program,” said Peter Luo, Ph.D., co-founder, CEO, and chairman of Adagene, in a press release. “We are at the forefront of pushing the boundaries of antibody discovery and engineering by leveraging our AI-powered technology platform. This enables dynamic and precise target engagement by our antibody-based therapeutics, which are tailor made to overcome the fundamental challenges in oncology drug development today.”

Adagene has announced SAFEbody multi-target collaboration with Sanofi for novel masked immuno-oncology antibody candidates.

Adagene Announces Collaboration with Sanofi for Novel Masked Immuno-Oncology Antibody Candidates

AbbVie announced on March 1, 2022 that it has completed the acquisition of Syndesi Therapeutics, which will help expand and strengthen AbbVie’s neuroscience portfolio. This acquisition will allow AbbVie to access Syndesi’s portfolio of novel modulators of the synaptic vesicle protein 2A (SV2A), as well as its lead molecule, SDI-118.

SDI-118 is a small molecule that is being evaluated to target nerve terminals and enhance synaptic efficiency. The cognitive impairment seen in multiple neuropsychiatric and neurodegenerative disorders is believed to be associated with synaptic dysfunction. The molecule is being evaluated as a possible treatment for these types of disorders, such as Alzheimer’s disease and major depressive disorder.

AbbVie will pay Syndesi shareholders an upfront payment of $130 million, with the potential of additional contingent payments of up to $870 million based on predetermined achievements of milestones.

"There is a major unmet need for new therapies that can help improve cognitive function in patients suffering from difficult-to-treat neurologic diseases," said Tom Hudson, M.D., senior vice president, R&D, and CEO of AbbVie, in a press release. "With AbbVie's acquisition of Syndesi, we aim to advance the research of a novel, first-in-class asset for the potential treatment of cognitive impairment associated with neuropsychiatric and neurodegenerative disorders."

AbbVie has acquired Syndesi Therapeutics, expanding AbbVie’s neuroscience portfolio.

AbbVie Acquires Syndesi Therapeutics

India-based Biocon Biologics Limited (BBL), a subsidiary of Biocon, announced on Feb. 28, 2022 that it has entered into a definitive agreement to acquire the biosimilars business of its partner, Viatris, in a deal valued at approximately $3.34 billion. The board of directors of both companies have approved the transaction, which is expected to close in the second half of 2022, subject to closing conditions.

Under the agreement, Viatris will receive $2 billion on closing and up to $335 million in additional payments, which are expected to be paid in 2024. Upon closing, BBL will issue $1 billion of compulsorily convertible preference shares to Viatris, which is equivalent to an equity stake of at least 12.9% in BBL on a fully diluted basis. The companies will also enter into a transition services agreement under which Viatris will provide certain transition services, including commercialization services, for a two-year period. Viatris also will pay $50 million to BBL to fund certain capital expenditures.

Viatris’ global commercial infrastructure in developed and emerging markets

Viatris’ global biosimilars business (estimated revenue: $875 million)

Viatris’ rights in all biosimilars assets, including its in-licensed portfolio and an option to acquire Viatris’ rights in bAflibercept

Transition services for an expected two-year period

Combining Viatris’ biosimilars business with BBL will accelerate BBL’s build out of its commercial capability in developed markets, including the United States, Europe, Canada, Japan, Australia, and New Zealand.

With a current portfolio of 20 biosimilars, BBL’s acquisition of Viatris’ biosimilars assets will broaden its commercial offerings. The company will have a comprehensive biosimilar insulins portfolio, including rh-Insulin, bGlargine, and bAspart, and will gain a growing biosimilar oncology portfolio, which includes bTrastuzumab, bBevacizumab, and bPegfilgrastim. In addition, BBL will strengthen its presence in the autoimmune disease segment through in-licensed products such as bAdalimumab and bEtanercept. BBL also has access to a vaccines portfolio through a partnership with Serum Institute Life Sciences that was previously announced in September 2021 (1).

Kiran Mazumdar-Shaw will continue as the executive chairperson of BBL, and Viatris will appoint Rajiv Malik, president of Viatris, to serve on the BBL board.

“The deal will enable BBL to attain a robust commercial engine in the developed markets of US and Europe and will fast-track our journey of building a strong global brand. It will also make us future-ready for the next wave of products. This development takes our partnership with Viatris to the next level to realize our shared purpose of impacting global health by providing affordable access to high quality essential and life-saving [b]iosimilar drugs,” said Mazumdar-Shaw in a company press release.

“This deal gives BBL full ownership of Viatris’ rights in biosimilars assets, enabling us to recognize combined revenues and profits,” said Arun Chandavarkar, managing director, BBL, in the press release. “This deal [also] provides several advantages, including strategic agility and operational efficiencies, which will help us mitigate pricing pressures in a competitive global biosimilars landscape. We remain committed to sustainable growth with a strong financial profile, expanded geographical reach, and continued investments in R&D to build a world-leading biosimilars franchise. We believe that as a fully integrated global company, we will be able to enhance patient access and reduce healthcare inequities worldwide.”

1. Biocon, “Biocon Biologics and Serum Institute Life Sciences Announce Strategic Alliance,” Press Release, Sept. 16, 2021.

Biocon Biologics will acquire Viatris’ global biosimilars business, including the company’s portfolio of in-licensed biosimilar assets, in a transaction valued at over $3.3 billion.

Biocon Biologics to Acquire Biosimilars Assets from Viatris in $3.3 Billion Deal

The ROSS X-Series Inline Ultra-High Shear Mixer

The ROSS X-Series Inline Ultra-High Shear Mixer is designed for efficient high- throughput emulsification, dispersion, and homogenization. Available in both sanitary and industrial configurations, this versatile machine produces quality dispersions, suspensions, and emulsions in a variety of industries including food, cosmetic, pharmaceutical, chemical, adhesive, and composites manufacturing.

The Model HSM-409XSHD-125 (pictured right) is a clean-in-place- capable sanitary mixer featuring a type 316 stainless-steel mixing chamber, a 150-psig jacket for cooling and heating up to 250 °F, and an X-5 Series 9” diameter AL6XN stainless-steel rotor/stator that operates up to 5700 rpm (13,430 ft/min tip speed).

The X-Series mix head is a patented design made up of concentric rows of intermeshing teeth—product enters at the middle of the stator and travels outward through the radial channels. Every pass through the rotor/stator exposes the product to tremendous shear because of the combination of very tight tolerances and extremely high tip speeds. Compared to traditional colloid mills, the X-Series routinely achieves a higher reduction in droplet or agglomerate size.

The ROSS X-Series Inline Ultra-High Shear Mixer produces quality dispersions, suspensions, and emulsions in a variety of industries.