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Eyes On Pharma Blog 

Eyes on Current Events - Deals, Approvals & Operations






Lonza, AstraZeneca, and Bristol Myers Squibb accelerate with mergers and acquisitions.

 

  • Expected to close in second half of 2024 at deal value of $1.2 billion, CDMO manufacturer Lonza is to acquire Genentech’s biologics manufacturing plant in Vacaville, California. Designed to produce large-scale biologics, the site’s bioreactor capacity measures 330,000 litres.

  • AstraZeneca anticipates closing a deal in Q2  valued at approximately $2.4 billion as it moves to acquire radiopharmaceutical company Fusion Pharmaceuticals. Together the companies plan to work on the development of the next-generation radio-conjugate therapies. FPI-2265, Fusion’s lead candidate, targets prostate specific membrane antigen in metastatic castration-resistant prostate cancer.

  • Bristol Myers Squibb acquired Karuna Therapeutics for $14 billion, this year’s largest biopharma M&A, expanding its neuroscience portfolio. Karuna’s new drug Application for KarXT (xanomeline-trospium) in schizophrenia and psychosis in Alzheimer’s disease, was accepted by the FDA with its verdict due in September 2024.

 

 


Long-Awaited NASH Approval


Madrigal Pharma gets their drug, Rezdiffra, for liver scarring treatment approved by the FDA. Along with diet and exercise, the drug can be administered to patients who are suffering from noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver scarring. The first-ever approved drug to treat scarring caused by fatty liver disease is expected to be available to patients in the US in April. Madrigal Pharma shares advanced by nearly 30% so far this year, 14% higher at around $277 last Friday.




Tryvio Adds New Option to Hypertension Patients


Idorsia’s Tryvio gains FDA approval. J&J licensed back the drug to Idorsia in September last year to see it approved for the treatment of hypertension in combination with other anti-hypertensive drugs. Tryvio (aprocitentan) is an endothelin receptor antagonist that is designed to inhibit the binding of endothelin (ET) -1 to ETA and ETB receptors and is the first drug approved to target this pathway.


Tryvio brings an additional treatment option to hypertension, aiding patients who failed to achieve complete control with typical methods utilized by other anti-hypertensive drugs. Idorsia intends to take the drug to the market during the second half of the year. J&J is due 30% of any money that stems from out-licensing or divesting the medicine, plus 10% of the proceeds from deals for any Idorsia products following Tryvio’s approval. Analysts at one point projected sales to peak at $2.5 billion for Tryvio. Idorsia’s first nine months of 2023 revenues amounted to $ 147 million.




Bayer Organizing for Customer Value

A reshuffle of Bayer’s leadership team is on the horizon with hopes to become more mission-centric and value focused. On April 1st 2024, Sebastian Guth will become the new Chief Operating Officer responsible for Bayer’s global commercial operations. Guth will drive Bayer’s commercial strategy in an attempt to enhance customer value, maximize market opportunities to generate greater profitability and revenue growth. The new COO will continue to report to Stefan Oelrich, Member of the Board of Management, Bayer AG and President of Bayer’s Pharmaceutical Division.

 

A recently formed ‘Global Commercialization’ organisation will include major parts of Bayer’s former strategic business unit Oncology, Global Marketing and Digital & Commercial Innovation together with parts of Medical Affairs & Pharmacovigilance. This newly formed organization will be led by Christine Roth, (currently leading Bayer’s Oncology unit), starting on June 1st 2024. Roth will continue to report to Stefan Oelrich. Both the head of ‘Research & Development’ Christian Rommel and the head of ‘Product Supply’ Holger Weintritt will continue to report to Stefan Oelrich.

“We have decided to dismantle our traditional model with functional silos and many layers of hierarchy. We are replacing it with our new operating model, which has Product and Customer Teams at its center”, said Stefan Oelrich.


Chinese biotechs’ operations blocked by US government.

WuXi App Tec, genomics group BGI, and other Chinese biotech companies with US operations are subjects to legislation intended to limit their activity as entities linked to ‘foreign adversaries’ of the USA.


On 6th March the Senate Homeland Security Committee approved the legislation, introduced in Congress by both Democrats and Republicans, dubbed the BIOSECURE Act in January, and prohibits federal funding going to companies such as these. Aimed to prevent the theft of sensitive American genetic data and personal health information, the measure follows significant congressional pressure on BIO with requests from lawmakers for reviews of its lobbying activities on behalf of WuXi.


The US legislature’s move does not concern the biotech sphere only, as the House of Representatives announces its approval of a bill that could ban the Chinese social media platform TikTok unless it cuts ties with its Chinese parent company.





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