Novartis Shutters Sandoz Plant, Eyes Liver Cancer and Hidradenitis Suppurativa Approvals

Novartis_Harold Cunningham/Getty Images

Courtesy of Harold Cunningham/Getty Images

Novartis has had a busy few days, announcing plans to shutter a Sandoz plant, a $300 million infrastructure investment, and Cosentyx, Kisqali and Tislelizumab readouts. 

Novartis to Shutter Sandoz Plant in Wilson, NC

Weeks after Novartis officially announced plans to spin off its Sandoz generics unit, it plans to shutter the Sandoz generics factory in Wilson, North Carolina.

"To remain cost-competitive, it is important to use our sites to full production capacity," Leslie Pott, VP, Communications, Sandoz, told BioSpace. "In the case of the Wilson site, we have been trying for a while to bring in more volume, but despite all our efforts, not enough options have materialized."

Pott added that plans to close the location "will allow our manufacturing network to respond to current market pressures while focusing our investments on our strategic portfolio choices to set Sandoz up for growth and make our manufacturing network more efficient."

The site will close around the end of 2023. The original plan was to close this year to ensure products transfers were complete. It currently employs about 246 staffers and specializes in pharmaceutical oral solid dosage products for distribution in the United States and Canada.

Pott noted, "Planning for a phased closure for product transfers will allow for continued supply of our generics medicines which are currently produced at Wilson. We have put in place an effective transition plan to ensure smooth product transfers, and it will be important to keep the site running and retain our skilled teams to continue with business as usual until transfers are completed."

$300M Investment in Next-generation Biotherapeutics

Novartis will invest $300 million in next-generation biotherapeutics, it announced Monday.

This will include both drug substance and drug product development and involve sites in Switzerland, Slovenia and Austria. The company will invest $100 million in the Novartis St. Johann campus in Basel, Switzerland to establish a biologics hub to complement the existing NIBR Biologics Center.

In Menges, Slovenia, Novartis will invest $110 million in non-cGMP and cGMP clinical manufacturing capabilities. The company also plans to invest $60 million to increase development and manufacturing capacity at its Schaftenau campus in Austria.

Novartis Eyes Approval in Hidradenitis Suppurativa 

Novartis reported mixed results from the Phase III SUNSHINE and SUNRISE trials of Cosentyx in patients with hidradenitis suppurativa (HS), a skin disease marked by recurrent lumps (nodules) under the skin that break open to cause abscesses.

Novartis told BioSpace, "Once considered a rare condition, it is now thought that as many as 1 in 100 people are affected by HS. There is no cure, and current treatment regimens are limited, often inadequate, and can require a surgical approach."

The company added, "The SUNNY program, including SUNSHINE and SUNRISE, is the largest Phase III program in HS, enrolling more than 1,000 patients in 33 countries. These positive results are encouraging, and Cosentyx may potentially offer a much-needed treatment option for patients."

The data was presented at the 31st European Academy of Dermatology and Venereology (EADV) Congress.

The studies evaluated two doses of Cosentyx across 16 weeks and 52 weeks. A significantly higher proportion of patients achieved a Hidradenitis Suppurativa Clinical Response (HiSCR) when receiving Cosentyx 300mg every two weeks after a standard weekly loading dosage compared to placebo at Week 16 in both studies, Novartis reported. 

The same dosage every four weeks after standard weekly loading doses demonstrated superiority to placebo for HiSCR in the SUNRISE study but missed statistical significance in SUNSHINE.

HiSCR is defined as at least a 50% drop in abscess and inflammatory nodule count with no increase in the number of abscesses and/or draining tunnels.

The data have been submitted to European regulators with hopes of receiving approval for HS patients as soon as possible. It hopes to submit data to the FDA before the end of the year. Novartis expects to have long-term data from the studies next year.

Kisqali Adds Another Year for Advanced Breast Cancer Patients

Data from a pooled exploratory analysis of the MONALEESA Phase III trial showed Kisqali (ribociclib) plus endocrine therapy added one year of overall survival in a subroup of HR+/HER2- advanced breast cancer patients in the first-line setting. 

Patients with visceral metastases, including liver metastases and multiple metastatic sites, who received Kisqali plus endocrine therapy hit a median OS of 62.7 months. This was compared to 52.1 months for patients treated with endocrine therapy alone. Novartis is presenting the data at the European Society of Medical Oncology (ESMO) Congress.

“Patients who have visceral metastases typically have a worse prognosis and often demonstrate resistance to treatment...” stated Denise A. Yardley, M.D., senior investigator, breast cancer research program, Sarah Cannon Research Institute at Tennessee Oncology. “Ribociclib is the only CDK4/6 inhibitor to show a consistent overall survival benefit in combination with endocrine therapy, while also maintaining quality of life across the Phase III program.”

Tislelizumab Hits Mark in Liver Cancer Trial

Novartis' tislelizumab hit its mark in a trial for patients with previously untreated, unresectable hepatocellular carcinoma (HCC).

Data from the Phase III RATIONALE 301 trial comparing tislelizumab compared to sorafenib were presented at ESMO. The study was conducted in collaboration with BeiGene.

Tislelizumab showed non-inferior OS compared to sorafenib of 15.9 months versus 14.1 months, respectively. Superiority was tested but not met.

OS was consistent across subgroups and regions. Tislelizumab was linked with a higher objective response rate of 14.3% versus 5.4% and more durable responses, 36.1 months versus 11.0 months, compared to sorafenib. Median progression-free survival was 2.1 months with tislelizumab compared to 3.4 months with sorafenib.

Jeff Legos, EVP, global head of oncology and hematology development, said the company will soon discuss the results with regulatory bodies. 

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