VistaPharm, Inc.

WuXi Biologics' stock slide, Novartis and Daiichi Sankyo's settlement, and Merck KGaA and Abbisko's licensing deal made our news this week. WuXi Biologics' gloomy business update triggered a stock market avalanche. Daiichi Sankyo and Novartis reached a $182 million settlement on their BRAF drug patent dispute. Merck KGaA linked up with China's Abbisko Therapeutics on a phase 3 joint tumor med. And more. 1. Contract manufacturing giant WuXi Bio's stock plummets as it warns of $400M revenue miss WuXi Biologics’ stock price plummeted about 24% Monday after the CDMO giant said it expects to miss this year’s revenue target by around $400 million. The company pointed to an industrywide downturn in COVID-related sales and challenges in biotech funding. The biologics manufacturer views the first half of 2024 as its darkest hours, with a positive turnaround in the second half of next year. 2. Daiichi Sankyo scores $182M from Novartis settlement in long-running patent case Novartis has agreed to pay $182 million to settle a patent dispute with Daiichi Sankyo. The case centers around Novartis’ melanoma drug Tafinlar. Daiichi’s former subsidiary Plexxikon, which developed rival BRAF drug Zelboraf, alleged that Tafinlar was made possible only because of discussions with Plexxikon about a partnership that never came to fruition. 3. Merck KGaA buys into Abbisko’s late-stage joint tumor med for $70M upfront Merck KGaA paid $70 million upfront to license greater China rights to Abbisko Therapeutics’ phase 3 candidate for tenosynovial giant cell tumor, a benign tumor of the joint. Development is underway to test the CSF-1R inhibitor, pimicotinib, in graft-versus-host disease and solid tumors. Merck has an option to expand the deal to other geographies. 4. Novartis expands radiotherapy manufacturing network with $85M plant in China Novartis has unveiled a plan to build a new radiotherapy manufacturing facility in China with an investment of about $85 million. The new plant, located in Haiyan about 60 miles from Shanghai, is expected to be operational for local production in 2026. The Chinese project adds to Novartis’ existing radiotherapy facilities in Italy, Spain and the U.S. 5. High-flying Fujifilm splashes $200M to beef up cell therapy capacity Fujifilm plans to spend $200 million between Fujifilm Cellular Dynamics and Fujifilm Diosynth Biotechnologies to expand its cell therapy capabilities. The former subsidiary, focused on human induced pluripotent stem cells, will get a new headquarters in Madison, Wisconsin; and the latter CDMO will expand an existing site in Thousand Oaks, California. 6. South Africa's Aspen expands reach with $100M buy of Sandoz's Chinese business Sandoz is selling its China business to South Africa’s Aspen Pharmacare for about $100 million, with about $20 million tied to the future performance of Sandoz’s pipeline products. Aspen expects the deal to add about $96 million in annual sales, with such products such as the synthetic hormone injectable Sandostatin. 7. Tang Capital’s Concentra back with another buyout offer, this time for LianBio LianBio has rejected an unsolicited buyout proposal by Tang Capital Partners’ Concentra Biosciences, saying the deal terms undervalue the company. LianBio, built on a business model of bringing innovative drugs to China and other Asian markets, recently launched a strategic review and sold certain Asian rights to mavacamten to Bristol Myers Squibb for $350 million. Other News of Note:  8. FDA recommends avoiding plastic syringes made in China amid safety investigation 9. With J&J settlement, Samsung Bioepis and Sandoz lock down Stelara biosimilar license 10. FDA posts a flurry of voluntary drug recalls by Teva, Glenmark, Apotex and VistaPharm 11. Coya taps familiar friend Dr. Reddy’s to commercialize ALS med

VistaPharm, Glemark Pharmaceuticals, Teva and Apotex all issued voluntary recalls posted on the FDA website. The FDA posted a flurry of voluntary drug recalls by drug manufacturers on its website. Below are the companies and products being recalled. VistaPharm issued its Class III recall Oct. 17 for more than 2,300 bottles of aminocaproic acid oral solution that is used to treat serious bleeding conditions, especially when the bleeding occurs after dental surgery or other kinds of surgery. The company cited failed specifications for the action, specifically, a high content of ethylene glycol. Where the product was manufactured was not provided. The bottles were distributed nationwide in the U.S. Class III recalls involve products that violate federal regulations but are unlikely to cause adverse health consequences. Aptotex issued four separate Class II recalls Nov. 1 for more than 149,000 bottles distributed nationwide in the U.S. of prescription-only paroxetine hydrochloride tablets that are used to treat a variety of conditions, including depression, obsessive-compulsive disorder and panic disorder. The company cited failed impurities and/or degradation, out-of-specification results. The products were manufactured at the company’s Toronto production site. A Class II recall is issued with a product has a lower chance of causing major injuries or death, but it is still possible for serious enough adverse events to have irreversible consequences. Glenmark Pharmaceuticals issued two separate Class II recalls for products due to a mislabeling issue involving Indomethacin and Naproxen. The recalls for both were issued Nov. 7. The company recalled 37,200 bottles of Indomethacin, which is a non-steroidal anti-inflammatory used to treat pain and arthritis symptoms. It recalled five lots (no bottle count provided) of Naproxen that is used to reduce fever or relieve mild pain due to headaches and muscle aches and other minor maladies. Both products may have been mislabeled as the other, the company said. The drugs were manufactured at both the Glenmark facility in Goa, India, and the company’s New Jersey facility. Teva issued a Class III recall for one lot of 30 unit-dose packets per carton of testosterone gel due to out-of-specification issues related to viscosity. The product, which was produced at the Teva facility in North Wales, Pennsylvania, is used to treat hypogonadism in men. The recall was issued Nov. 10 for the lot that was distributed nationwide in the U.S.

So far, Bayer has yet to receive any side effect reports tied to the recalled Vitrakvi batch. The threat of microbial contamination has triggered yet another drug recall, this time from German pharma bigwig Bayer. Bayer is recalling one lot of Vitrakvi oral solution in the U.S. after routine stability testing discovered the presence of microbial contamination identified as Penicillium brevicompactum. Specifically, Bayer is pulling one batch of Vitrakvi 20 mg/mL in 100-mL glass bottles. So far, Bayer has yet to receive any side effect reports tied to the recalled Vitrakvi batch, though the contamination scare could cause problems given that the drug—indicated for the treatment of NTRK gene fusion-positive solid tumors—is used by patients who may be immunocompromised. Data on human exposure to Penicillium brevicompactum are scarce, Bayer pointed out. Nevertheless, cases of invasive disease have been caused by similar Penicillium species, particularly in patients with underlying immunosuppression, the company said in a press release. For that reason, Bayer figures the tainted Vitrakvi batch could lead to fungal infections of the blood or potentially life-threatening pneumonia. The suspect lot was due to expire Feb. 29, 2024, Bayer said. The batch was distributed to wholesale distributors and specialty pharmacies around the world between January and February of this year. Bayer says it notified its customers of the recall Nov. 8. The company has also enlisted return management outfit Qualanex to chip in on the product pull. Patients in possession of the recalled Vitrakvi should immediately stop using the drug and get in touch with their doctor or healthcare provider, Bayer added. Bayer has had a rough stretch over the past couple days. Aside from the Vitrakvi recall, the company recently revealed its factor XIa inhibitor asundexian missed the mark in a phase 3 trial against Bristol Myers Squibb and Pfizer’s Eliquis, prompting Bayer to stop the study early. The late-stage study, OCEANIC-AF, randomized patients with atrial fibrillation at risk for stroke to receive asundexian or Eliquis. An interim look at the data showed an independent data monitoring committee that asundexian had inferior efficacy compared to the control arm, leading it to recommend stopping the trial.  Elsewhere, microbial contamination has spurred a number of other drug recalls in 2023. Back in April, Camber Pharmaceuticals pulled one lot of atovaquone oral suspension used to treat a form of pneumonia due to the presence of Bacillus cereus. Meanwhile, VistaPharm in September said it was recalling one lot of sucralfate oral suspension—a popular ulcer treatment—because the drug was also contaminated with Bacillus cereus. The bacterium behind both recalls is often associated with food poisoning. Bacillus cereus produces toxins that can cause vomiting or diarrhea, and it poses an even greater risk to immunocompromised patients.