Pharmaceutical Technology Editors

Aadi Bioscience, a US-based clinical-stage biopharmaceutical company specializing in the development of precision therapies for genetically defined cancers, announced on Aug. 26, 2021 that it has closed a previously announced merger with US-based Aerpio Pharmaceuticals. Concurrent to the merger closing, Aadi also closed a $155-million private investment in public equity (PIPE) financing of its common stock.

Under the merger, the company will focus on advancing, expanding, and commercializing Aadi’s clinical-stage pipeline, including a lead program for a nanoparticle albumin-bound mammalian target of rapamycin (mTOR) inhibitor, FYARRO (sirolimus albumin-bound nanoparticles for injectable suspension, nab-sirolimus ABI-009).

In a registration trial of FYARRO in advanced malignant perivascular epithelioid cell tumors (PEComa) (the AMPECT trial), FYARRO demonstrated meaningful clinical efficacy in malignant PEComa1, which has the highest known alteration rate of TSC1 or TSC2 genes, according to Aadi’s press release. The drug candidate has received breakthrough therapy, fast-track, and orphan designations from FDA, and a rolling new drug application (NDA) submission was completed in May 2021 for this indication, which FDA accepted in July 2021. The NDA has been granted priority review status and has a Prescription Drug User Fee Act (PDUFA) target action date of Nov. 26, 2021.

“Today’s news represents an important inflection point for Aadi and the development of FYARRO.The completion of the merger, and now becoming a public entity, allows us to take the next step toward commercialization of our pipeline. As we approach our PDUFA date for FYARRO for the treatment of patients with PEComa and prepare to initiate a registrational trial in patients with tumors harboring TSC1 and TSC2 inactivating alterations by year-end, we believe that we are optimally positioned, and look forward to advancing FYARRO to help patients with genetically driven cancers,” said Neil Desai, CEO of the new combined company, in the press release.

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Aadi Bioscience has closed its previously announced merger with Aerpio Pharmaceuticals and a concurrent $155-million PIPE investment.

Aadi Bioscience and Aerpio Pharmaceuticals Close Merger and $155 Million Private Placement

Quotient Sciences, a drug development and manufacturing services provider, announced a £6.3-million ($8.68 million)) investment in its recently acquired manufacturing facility in Alnwick, UK, on Aug. 25, 2021. This investment will expand Quotient’s drug substance manufacturing capability and create 80 jobs over the course of three years.

The Alnwick facility was acquired from Arcinova in February 2021 to expand Quotient’s service portfolio to include drug substance, drug product, and clinical testing capabilities. Their goal is to provide an “end to end” offering from candidate selection through commercial product launch, according to a company press release.

The investment will repurpose a 1500-m² footprint to include additional digital control and data capture equipment. Processing equipment with modular continuous technology designed to maximize responsiveness and agility will also be added. According to the press release, these updates, combined with a five-fold increase in scale, will increase Quotient’s complex medicine development capacity more than tenfold.

“Following our integration into Quotient Sciences earlier in the year, it is tremendously exciting to see the Alnwick facility continue to expand capabilities as we move into larger scale and commercial manufacturing,” said Roger Kilburn, senior vice-president of Candidate Development Services at Quotient Sciences, in the press release. “Science and agility are at the core of Quotient Sciences, and our team strives to innovate and develop smarter approaches to process R&D for our customers and drive the adoption of continuous processing technologies.”

Quotient Sciences is investing £6.3 million ($8.68 million) into their drug substance manufacturing capabilities.

Quotient Sciences Makes Multi-Million Dollar Investment to Expand Drug Substance Manufacturing Facility

Avantor announced a multi-year investment into its global hydration capabilities on Aug. 31, 2021 that includes a recently completed expansion to its facility in Gliwice, Poland, as well as a multi-stage expansion of its facility in Aurora, Ohio, that is expected to be completed by mid-2022.

The facility investments in Gliwice and Aurora will add to Avantor’s existing water for injection-quality (WFI) buffer manufacturing capabilities. The new equipment will provide enhanced capabilities and capacity to formulate and fill WFI-based hydration solutions, according to a company press release.

"Buffer management is a key area where biopharma manufacturers can save time while reducing risk and costs,” said Ger Brophy, executive vice-president of Biopharma Production at Avantor, in the press release. “This recent investment in our global hydration offering allows us to strengthen our [C]GMP [current good manufacturing practices] chemical manufacturing in Europe and the United States."

Avantor plans to address rising global demand for biologics with their investment in hydration capabilities.

Avantor Makes Multi-Year Investment in Hydration Capabilities for Biologics Production

Catalent has reached an agreement to acquire Bettera Holdings for $1 billion, according to a company press release from Aug. 30, 2021. Bettera Holdings is a manufacturer specializing in the production of gummy, soft chew, and lozenge nutritional supplements.

This acquisition will complement Catalent’s existing softgel and oral dose formulation and manufacturing services. It will expand Catalent’s current consumer health technology platform with a wider range of technologies and ready-to-market product libraries, as well as a variety of packaging options to meet customers’ branding needs.

The acquisition is expected to close in 2021. As part of the deal, Catalent will acquire approximately 500 employees from Bettera, as well as their production facilities in California, Indiana, New Jersey, and Virginia.

“This acquisition allows us to significantly accelerate the growth of our consumer health business and offer customers access to the substantial potential in gummies, soft chews, and lozenges, which are experiencing double-digit growth,” said Aris Gennadios, president of Softgel and Oral Technologies at Catalent, in the press release. “This acquisition is a key strategic move for Catalent’s Consumer Health business, where our leadership in manufacturing technologies and formulation can offer customers more product development opportunities, and add manufacturing capacity in this dynamic and fast-growing segment.”

Catalent’s acquisition of Bettera paves the way for growth in the softgel and oral dose formulation and manufacturing market for nutraceuticals.

Catalent Acquires Nutraceutical for $1 Billion

USAntibiotics, the only licensed American manufacturer of penicillin-based amoxicillin and amoxil clavulanate, reopened a Bristol, Tenn. manufacturing facility on Aug. 30, 2021. The 360,000-ft

 facility had ceased operations last year until it was purchased by Jackson Healthcare, which restarted it under the new name of USAntibiotics.

When the facility is fully operational, it will be able to produce up to 300 million capsules and two billion tablets annually. The facility will be capable of manufacturing and storing a five-year supply of Amoxicillin, to supply the US strategic stockpile. According to the press release, amoxicillin accounts for 30% of all antibiotics prescribed in the US each year, for the country.

"As the first doses of USAntibiotics' life-saving drugs move down the assembly line, America will have declared its independence from Chinese antibiotics," said Rick Jackson, founder, CEO, and chairman of Jackson Healthcare, in a company press release. "Our mission is to solve our nation's reliance on foreign Amoxicillin and create a secure stockpile that will stand the test of time. Beginning today, the United States is back in the business of essential medicines."

According to Shane Jackson, president of Jackson Healthcare, there were numerous stories of dedicated people who worked without pay to keep the plant open while it was in the midst of bankruptcy.

"When we heard about the selflessness of these individuals, we knew that the company would be a perfect addition to the Jackson Healthcare family of companies," said Shane Jackson in the press release. "Their dedication to making the vital medications Americans need, even in the face of adversity, is inspiring and demonstrates their commitment to solving the supply-chain challenges long term."

USAntibiotics will serve as the sole American-based provider of amoxicillin and amoxil clavulanate.

USAntibiotics Reopens Facility, Returning Antibiotic Production to the United States

After receiving the COVID-19 vaccine from a batch of Moderna vaccines that were 

according to an Aug. 29, 2021 article in CNN

. These individuals received vaccines from lot 3004734, which was removed from circulation on August 26, 2021 along with approximately 1.63 million doses.

To date, there is no causal link between the vaccine and deaths, according to the same article in CNN. The individuals were men, ages 30 and 38, 

according to a report from Japan Times on Aug. 28, 2021

, and both had received two doses of the vaccine.

In response to these deaths and the discovery of foreign substances in additional batches of the COVID-19 vaccine, another one million doses have been temporarily suspended in Japan, 

according to an Aug. 30, 2021 article in Reuters

In the Gunma prefecture near Tokyo, a tiny black substance was found in a Moderna vaccine vial while black and pink substances were found in vials in Okinawa. Some instances of vial contaminants were suspected to be a result of needles being incorrectly inserted into vials, 

as stated in the Aug. 30, 2021 article in Reuters

, but Japan's health ministry said other vials from the lots can be used.

According to an Aug. 31, 2021 article in Reuters

, Japan's health minister said the foreign matter found in the Moderna COVID-19 vaccines in Okinawa likely happened when needles were stuck into the vials. Specifically, the health ministry believes needles may have been incorrectly inserted into vials, which broke off bits of the rubber stopper. The same article reports that Japan is currently facing its biggest wave of COVID-19 infections, largely driven by the Delta variant.

After receiving the COVID-19 vaccine from a batch of Moderna vaccines that were suspected to have contaminants, two people in Japan died. Meanwhile, another one million doses have been temporarily suspended in Japan.