Pharmaceutical Commerce Editorial Staff

Pharma Pulse rounds up insights every weekday morning from across health care. Here is the February 23, 2024 edition:

From PharmExec’s interview with Arthur Wong, managing director of S&P Global Ratings, on the state of the M&A market: “Last year, pharma companies basically stopped M&A, so the big trend right now is the return of M&A. This underscores how important it has become for the industry, especially for companies looking to hit their target growth in the future.”

Regulators say they need help monitoring AI tech in health care

“Doctors are already using unregulated artificial intelligence tools such as note-taking virtual assistants and predictive software that helps them diagnose and treat diseases. Government has slow-walked regulation of the fast-moving technology because the funding and staffing challenges facing agencies like the Food and Drug Administration in writing and enforcing rules are so vast. It’s unlikely they will catch up any time soon.”

Novo Nordisk invests in ‘quantum sensing’ for disease diagnosis, prevention

“Quantum sensing holds the potential to reform biomedical and health sciences by improving the diagnosis and prevention of diseases. The Novo Nordisk Foundation has awarded a grant of DKK 150 million to establish the Copenhagen Center for Biomedical Quantum Sensing, under which an international research collaboration aims to develop novel quantum sensing principles and techniques for early detection of diseases.”

Are digital health interventions a hypertension equalizer?

: Patients from disadvantaged populations who underwent digital health interventions for management of hypertension experienced significant reductions in blood pressure (BP), according to a new study.

From National Institutes of Health (@NIH) on X: “News: Scientists develop a simple blood test to quickly diagnose sarcoidosis.”

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The latest news for pharma industry insiders. 

Why M&A is back; AI regulations lacking; quantum sensing investment, and more: Pharma Pulse for February 23, 2024

Image credit: MichaelVi | stock.adobe.com. 

AbbVie has completed its acquisition of ImmunoGen in a deal that was announced in November 2023, which bolsters the company’s pipeline of antibody drug conjugates (ADCs).

 As part of the transaction, AbbVie acquired in cash all outstanding shares of ImmunoGen for $31.26 per share, valuing ImmunoGen at a total equity value of approximately $10.1 billion.

"Together with ImmunoGen, we have the potential to continue redefining the standard of care for those living with cancer," AbbVie President and Chief Operating Officer Robert A. Michael, said in a press release. "The addition of ImmunoGen's treatment for ovarian cancer will accelerate our ability to help patients today, expand our oncology pipeline and drive long-term revenue growth well into the next decade. I want to thank ImmunoGen for their efforts to advance science for patients and we look forward to welcoming our new colleagues to AbbVie."

As part of the transaction, AbbVie gains ImmunoGen's flagship ADC Elahere (mirvetuximab soravtansine-gynx). The FDA granted accelerated approval to Elahere in November 2022 for adults with folate receptor-alpha-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer previously administered one of three systemic treatment regimens that included bevacizumab (Avastin).

In clinical trials, Elahere demonstrated impressive anti-tumor activity, durability of response, and overall tolerability. The SORAYA trial’s primary endpoint of confirmed objective response rate was met by 31.7% of patients administered the ADC, which makes Elahere the first targeted therapy to produce a meaningful survival benefit in this patient population. Results from the Phase III MIRASOL confirmatory trial will be used to support the submission of a supplemental Biologic License Application to the FDA to gain full approval for Elahere, as well as a Marketing Authorization Application to the European Union.

Beyond Elahere, ImmunoGen's Phase I next-generation anti-FRα ADC, IMGN-151, is being evaluated for the treatment of ovarian cancer with the potential to expand into other solid tumor types. A Phase II anti-CD123 ADC, pivekimab sunirine, treats the rare blood cancer blastic plasmacytoid dendritic cell neoplasm (BPDCN). The FDA granted pivekimab sunirine with Breakthrough Therapy Designation for relapsed/refractory BPDCN.

AbbVie stated that ImmunoGen's entire oncology portfolio could drive long-term revenue growth, giving the company a potential multi-billion dollar drug that is already on the market. Additionally, the ongoing clinical development programs for Elahere may expand its use into earlier lines of therapy, with entry into large segments of patients in the ovarian cancer market over the next decade, according to AbbVie.

In the press release, AbbVie reaffirmed its previously issued 2024 full-year adjusted diluted EPS guidance range of $11.05-$11.25, including a $0.42 per share dilutive impact related to its acquisition of ImmunoGen and the pending acquisition of Cerevel Therapeutics.

AbbVie also updated its previously issued 2024 first quarter adjusted diluted EPS guidance range from $2.30-$2.34 to $2.26-$2.30 to include a $0.04 per share dilutive impact from acquiring ImmunoGen.

Trading of ImmunoGen common stock on the NASDAQ stock exchange stopped before the market opened today. AbbVie said the acquisition of ImmunoGen will be accretive to the company’s diluted EPS starting in 2027 and significantly accretive over the long-term.

1. AbbVie Completes Acquisition of ImmunoGen. AbbVie. News release. February 12, 2024. Accessed February 12, 2024. 

https://news.abbvie.com/2024-02-12-AbbVie-Completes-Acquisition-of-ImmunoGen

2. AbbVie to Acquire ImmunoGen, including its Flagship Cancer Therapy ELAHERE® (mirvetuximab soravtansine-gynx), Expanding Solid Tumor Portfolio. AbbVie. News release. November 30, 2023. Accessed February 12, 2024. 

https://news.abbvie.com/2023-11-30-AbbVie-to-Acquire-ImmunoGen,-including-its-Flagship-Cancer-Therapy-ELAHERE-R-mirvetuximab-soravtansine-gynx-,-Expanding-Solid-Tumor-Portfolio

3. ImmunoGen. ImmunoGen Announces FDA Accelerated Approval of ELAHERE™ (mirvetuximab soravtansine-gynx) for the Treatment of Platinum-Resistant Ovarian. News Release. November 15, 2022. Accsessed November 30, 2023. Accessed February 12, 2024. https://www.businesswire.com/news/home/20221104005657/en

According to AbbVie, ImmunoGen's entire oncology portfolio could drive long-term revenue growth, giving the company a potential multi-billion dollar drug that is already on the market.

AbbVie Finalizes Deal to Acquire ImmunoGen With its Pipeline of Antibody Drug Conjugates 

Image Credit: Adobe Stock Images/DiegoMaravilla.com

Resource Label Group, LLC (RLG), a provider of label and packaging solutions including pressure sensitive labels, pharmaceutical packaging, and radio frequency identification/near-field communication (RFID/NFC) technology, is creating a specialty pharmaceutical and healthcare packaging division known as RLG Healthcare.

RLG Healthcare prioritization will be offering packaging solutions in the form of cartons, inserts, labels, medical guides, and physician support literature. They cater to this aforementioned industry that also includes clinical, over-the-counter (OTC), medical devices, and biotechnology.

“This is an exciting time for our people and our customers,” said Kevin Grogan, CEO of RLG Healthcare. “Our team is comprised of career pharmaceutical and packaging professionals who have a passion for quality and providing unmatched customer service. Our customers know that we understand their business and stand ready to deliver the innovative and compliant solutions they need in the ever-changing healthcare sector.”

The new BU currently has six locations in the greater Raleigh-Durham area; Winston-Salem, NC; Windsor, NJ; Simi Valley, Calif.; Buffalo, NY; and Salt Lake City, UT. RLG notes that each plant is prepared to deliver the same quality capabilities that are powered by its certified good manufacturing practice (GMP) standards, International Organization for Standardization (ISO) certifications, and G7-qualified facilities.

Mike Apperson, president and CEO of RLG, also expressed his excitement over the announcement, while noting that RLG Healthcare’s acquisitions of MedLit Solutions

 and Pharmaceutic Litho and Label Company

 provided momentum by positioning the company as a major player in both the pharma and medical packaging spaces.

“ … This consolidation into a unified team expands our reach in the healthcare and pharmaceutical industries, while still providing the nimble and responsive mindset that places our customers’ needs at the forefront of all that we do,” he commented.

1. Resource Label Group announces new specialty business unit – RLG Healthcare. 

 News release. February 8, 2024. Accessed February 9, 2024. 

https://www.businesswire.com/news/home/20240208217161/en/Resource-Label-Group-announces-new-specialty-business-unit-%E2%80%93-RLG-Healthcare

2. Resource Label Group Expands Pharmaceutical Offering With Acquisition of MedLit Solutions. 

 News release. October 18, 2022. Accessed February 9, 2024. 

https://www.businesswire.com/news/home/20221018005556/en/Resource-Label-Group-Expands-Pharmaceutical-Offering-With-Acquisition-of-MedLit-Solutions

3. Resource Label Group Expands Pharmaceutical offering with acquisition of Pharmaceutic Litho and Label Company. 

 News release. June 15, 2023. Accessed February 9, 2024. 

https://www.businesswire.com/news/home/20230615489783/en/Resource-Label-Group-Expands-Pharmaceutical-offering-with-acquisition-of-Pharmaceutic-Litho-and-Label-Company

RLG Healthcare will focus on specialty pharmaceuticals and healthcare packaging. 

Resource Label Group Introduces New Business Unit  

AstraZeneca will be financially committing $300 million toward a state-of-the-art facility in Rockville, MD, a plant that will be responsible for creating cell therapy platforms in the United States for cancer trials, along with future commercial supply.

The company is building off the momentum of previous deals made in the cell therapy space, including the purchase of Neogene Therapeutics and the agreements reached with Quell Therapeutics,

 which focused on type 1 diabetes and inflammatory bowel disease indications; the development of up to 10 novel cell and gene therapy candidate products; the targeting of solid tumors; and improving the efficacy of chimeric antigen receptor (CAR) T-cell therapies respectively.

At the Rockville plant, the production of T-cell therapies will be the main priority. The new site will help open up new positions in the field, and although the site’s initial focus is on cancer trials, AstraZeneca notes that there is always potential for expansion to other disease areas.

“We are incredibly excited that more than 150 new highly skilled jobs are being created to bring our scientific work and therapies to clinical trials which could transform the lives of patients around the world,” says Pam Cheng, EVP of global operations & IT and chief sustainability officer. “This new $300 million investment will accelerate our ambition to make next-generation cell therapy a reality, ensuring that we are ready to scale and meet the demands of patients.”

The Rockville facility will now be a part of AstraZeneca’s global manufacturing and supply network of nearly 30 manufacturing and supply sites that span 16 countries; from a convenience perspective, the new site is located less than five miles away from one of the AstraZeneca’s global R&D centers and happens to be near multiple universities, which is important to keep in mind when it comes to talent recruitment.

“AstraZeneca and the state of Maryland share a deep commitment to innovation. It makes us the perfect pairing for this next-generation cell therapy facility,” commented Maryland Gov. Wes Moore. “This significant investment in our life sciences sector will help maintain Maryland’s leadership in the industry and sharpen our competitive edge. We are deeply grateful for AstraZeneca’s partnership and continued commitment to our state.”

1. AstraZeneca expands US manufacturing footprint to accelerate ambitions in next-generation cell therapy discovery and development. 

 News release. February 6, 2024. Accessed February 7, 2024. 

https://www.businesswire.com/news/home/20240206590080/en/AstraZeneca-expands-US-manufacturing-footprint-to-accelerate-ambitions-in-next-generation-cell-therapy-discovery-and-development

2. AstraZeneca announces agreement with Quell Therapeutics to develop, manufacture and commercialize engineered T-regulatory cell therapies for autoimmune diseases. 

 News release. June 9, 2023. Accessed February 7, 2024. 

https://www.astrazeneca.com/media-centre/press-releases/2023/astrazeneca-agreement-with-quell-therapeutics.html

3. AstraZeneca announces collaboration and investment agreement with Cellectis to accelerate cell therapy and genomic medicine ambitions. 

 News release. November 1, 2023. Accessed February 7, 2024. 

https://www.astrazeneca.com/media-centre/press-releases/2023/astrazeneca-cell-and-gene-therapy-deal-w-cellectis.html

4. AbelZeta Pharma Announces Agreement with AstraZeneca to Co-Develop a novel Glypican 3 (GPC3) Armored CAR-T Therapy in China. 

 News release. December 7, 2023. Accessed February 7, 2024. 

https://www.prnewswire.com/news-releases/abelzeta-pharma-announces-agreement-with-astrazeneca-to-co-develop-a-novel-glypican-3-gpc3-armored-car-t-therapy-in-china-302008822.html

5. AstraZeneca Reaches Agreement to Acquire Cell Therapy Specialist Gracell Biotechnologies. 

 News release. January 2, 2024. Accessed February 7, 2024. 

https://www.pharmaceuticalcommerce.com/view/astrazeneca-reaches-agreement-to-acquire-cell-therapy-specialist-gracell-biotechnologies

The pharma powerhouse is investing $300 million in a plant that could be vital for the future cancer trials. 