Fierce Pharma Asia—Carvykti's growth; Sanofi, J&J sell plants; LG Chem's Aveo buy

Johnson & Johnson and Legend Biotech's multiple myeloma CAR-T ramped up sales early in its launch. Sanofi is selling a plant responsible for delivering all the company's products in Japan. J&J has offloaded a plant in India that it never opened. South Korea’s LG Chem reached a $566 million deal to acquire Aveo Oncology. And more.

1. J&J, Legend's Carvykti delivers encouraging early growth ahead of key myeloma readout

Johnson & Johnson and Legend Biotech’s CAR-T therapy Carvykti racked up $55 million in third-quarter sales. That was up from $24 million in the three months ended in June, the first full quarter it was on the market. The companies are currently working to ramp up manufacturing capacity in anticipation of a year-end phase 3 readout in multiple myeloma patients who had failed one to three prior lines of therapy.

2. Sanofi sells 50-year-old manufacturing plant in Japan to CDMO Adragos Pharma

Sanofi is selling a manufacturing site near Tokyo to German CDMO Adragos Pharma. The facility currently delivers all Sanofi products in Japan. Under a separate supply agreement, Adragos will continue to make those drugs for Sanofi for five years. The 200 employees at the site will stay on, the companies said. Adragos said it plans to further expand the site for Sanofi and other potential customers.

3. Johnson & Johnson sells baby powder plant it never opened to Hetero

In 2014, Johnson & Johnson laid out a plan to build a manufacturing facility in Hyderabad, India. Now, the company has sold the 55-acre site to Hetero without ever conducting operations there. Hetero bought the “brownfield” facility and plans to invest RS 600 crore ($73 million) for restoration and upgrades. The Indian drugmaker plans to produce biologics at the location.

4. LG Chem picks up Aveo and its kidney cancer drug Fotivda for $566M

South Korea’s LG Chem is paying $566 million to acquire Aveo Oncology. The $15-per-share price marked a 43% premium from Aveo’s closing price before the announcement. At the center of the deal is FDA-approved kidney cancer drug Fotivda and three other cancer candidates. The buyout fits LG Chem’s goal to reach 2 trillion won ($1.4 billion) of biopharma sales in 2027.

5. Takeda's Qdenga nears approval in EU, and beyond, thanks to special regulatory pathway

After an Indonesia nod, Takeda’s dengue vaccine, Qdenga, has won backing from the European Medicines Agency, teeing up a formal European Commission approval by December. The company is ready to launch the vaccine with a stocked inventory and expects to start the rollout in Indonesia early next year.

6. AstraZeneca hit with small fine in Korea over plot to stall generic of lucrative cancer med

Korea’s antitrust watchdog ruled that AstraZeneca and generics maker Alvogen stalled generics to AZ’s cancer drug Zoladex in the country, Yonhap News Agency reports. AZ is getting away with a fine of about $767,000, while Alvogen has been asked to pay about $1 million. Alvogen shelved the rollout of a generic version of Zoladex in exchange for exclusive rights to three other AZ drugs, authorities said.

7. Galderma explores a 5th manufacturing facility to meet demand

Skincare specialist Galderma is early stages of building a manufacturing facility in Singapore to support its growth in the Asia-Pacific region. The expansion comes as the company’s Cetaphil skin cleanser, along with new launches in China and other parts of Asia, contributed to its overall revenue growth in the first half of 2022.

8. Alembic hit with Form 483, citing 4 observations at Panelav plant in India

Alembic Pharmaceuticals was hit with an FDA Form 483 after a 10-day inspection at its Panelav, India, site earlier this month. None of the four observations cited is related to data integrity, Alembic said in a securities filing, adding that it believes that the problems are addressable. The facility makes oncology injectables.