Jazz Pharmaceuticals (EUSA Pharma USA), Inc.

Sanofi's flu vaccine manufacturing hiccup in China, DualityBio's proposed Hong Kong IPO and UCB's $680 million sale of some Chinese assets made our news this week. Sanofi has suspended distribution of its two flu vaccines in China out of concern of waning potency. BioNTech's antibody-drug conjugate partner, DualityBio, has filed for a Hong Kong IPO. UCB will offload some Chinese assets for $680 million. And more.1. Sanofi halts flu vaccine distribution in China over fear of declining potencySanofi has temporarily stopped selling its two flu vaccines, Vaxigrip and VaxigripTetra, in China after a routine quality follow-up test flagged a decline in the vaccines’ potency in doses that were not yet distributed. The company attributed the problem to “unexpected circumstances” at the company’s production line in Shenzhen, China, which supplies doses only for the Chinese market.2. Duality plans Hong Kong IPO to fund trials of BioNTech-partnered ADCs and beyondChina’s Duality Biotherapeutics has filed for a Hong Kong IPO. The antibody-drug conjugate specialist set up shop in 2019 and has attracted deals with BioNTech, BeiGene and Adcendo that could be worth more than $4 billion combined. Duality named BioNTech-partnered ADCs targeting HER2 and B7-H3 as its “core products,” with the HER2 program nearing a potential application for accelerated approval in 2025.3. UCB sells off production plant and a clutch of older meds in China for $680MAnother foreign company is trimming its business in China. UCB is selling off its mature neurology and allergy brands in mainland China, plus a manufacturing site in the Chinese city of Zhuhai, to investment shops CBC Group and Mubadala for $680 million. The Belgian company will instead explore the launch of novel medicines in immunology, neurology and rare diseases in China, UCB CEO Jean-Christophe Tellier said.4. FDA weighs limiting PD-1 drugs in stomach cancer, calls on experts to discuss Merck, BMS and BeiGene medsThe FDA will hold an advisory committee meeting to discuss whether approvals for PD-1 inhibitors in advanced gastric and gastroesophageal junction adenocarcinoma and esophageal squamous cell carcinoma should be restricted based on tumors’ PD-L1 expression. BeiGene’s two open applications for Tevimbra, plus existing approvals for Merck’s Keytruda and Bristol Myers Squibb’s Opdivo, will be examined closely.5. As sales climb, Jazz's Epidiolex falls short in Japanese study in treatment-resistant epilepsiesA phase 3 Japanese study of Jazz Pharma’s cannabinoid drug Epidiolex has failed on the primary endpoint measuring seizure frequency in certain patients with treatment-resistant epilepsies. Still, the company pointed to numeric improvements across primary and secondary endpoints, as well as the drug’s overall global data, saying it plans to speak with Japanese authorities about a potential filing.6. Ipsen sues CSPC Pharma to block rival to cancer drug Onivyde (Bloomberg Law)Ipsen has filed a patent infringement lawsuit against China’s CSPC Pharma. The lawsuit centers on Ipsen’s Onivyde, a liposome formulation of the chemotherapy irinotecan, and CSPC’s irinotecan liposome candidate, which was filed with the FDA in late 2023 for previously treated pancreatic cancer. Ipsen alleges that CSPC steps on its new patent, which was issued Aug. 13, according to the complaint (PDF).Other News of Note:7. Bora's expansion tear continues as CDMO takes up stake in Tanvex, gains manufacturing capabilities8. With new focus, Kyowa Kirin pulls decades-old breast cancer drug Fareston from US market9. Bharat Biotech to launch oral cholera vaccine developed in partnership with Hilleman Labs (release)10. Tech company Fujitsu partners with Paradigm Health to boost clinical trials in Japan11. YolTech sells China rights to cholesterol gene editing therapy to Salubris for $29M12. API maker Global Calcium stung with Form 483 filing after FDA inspection of Indian plant

Today, a brief rundown of news from Jazz Pharma, Vanda Pharmaceuticals, ITM, Ashibio and Novartis that you might have missed from earlier in the week.An experimental medicine that Jazz Pharmaceuticals picked up in 2019 has failed a mid-stage study testing it against essential tremor. Researchers evaluated three doses of the medicine in 420 participants. They found the highest dose didn't meet the study's main or secondary goals, though there were “numeric improvements“ that hinted at some benefit. According to Jazz's research and development head, the company will wait for results from a separate trial focused on Parkinson's disease tremor before making a decision on next steps for the program. Those data are expected to come early next year. Jacob BellVanda Pharmaceuticals' board of directors on Thursday rejected two offers to acquire the company, determining that unsolicited bids from Cycle Group Holdings and Future Pak substantially undervalue the company. Cycle Group Holdings had proposed to acquire Vanda for $8.00 per share, while Future made a revised bid to buy the company for $8.50 to $9.00 per share in cash plus certain contingent value rights. Vanda shares have risen by 34% this year and now trade around $6 apiece. Delilah AlvaradoSteffen Schuster, CEO of radiopharmaceutical drug developer ITM, will step down from his position Sept.1 and move over to the companys supervisory board. He will be replaced by Andrew Cavey, who most recently was at Bristol Myers Squibb as an executive overseeing cancer cell therapy. Prior to Bristol Myers, Cavey was at Novartis, where he co-led the companys radiopharmaceutical strategy in prostate cancer. ITM recently raised $205 million. Ned PagliaruloAshibio emerged from stealth Thursday with $40 million in seed and Series A financing, the latter of which was led by MPM BioImpact. The funding will help the biotechnology company advance a new therapy for the rare genetic disorder fibrodysplasia ossificans progressiva, which gradually causes muscles and tendons to ossify into bone. Ashibio licensed from Gilead Sciences an antibody called andecaliximab that targets the MMP-9 gene, mutations in which appeared protective in a notable case study. The company plans to initiate a Phase 2/3 trial in the second half of 2024. Delilah AlvaradoNovartis intends to squeeze out the remaining minority shareholders of Morphosys who have not tendered their shares to the former companys acquisition of the German biotechnology firm. Novartis currently holds 91.04% of Morphosys total share capital and plans to transfer the remainder to itself for cash compensation. Novartis and Morphosys are also moving to delist the biotechs stock from the Frankfurt and Nasdaq stock exchanges. Ned Pagliarulo '

LONDON, Ontario, June 10, 2024 (GLOBE NEWSWIRE) -- London Research & Pharmaceuticals presented notable pre-clinical data about its lead compound, LRP-661, also known as Cannabidiol Sulphate (CBDS), at the Seventeenth Eilat Conference on New Antiepileptic Drugs and Devices (EILAT XVII) conference in Madrid, Spain, May 5th to May 8th, 2024. LRP-661’s data highlights its superior safety, efficacy, bioavailability, and PK in multiple species. Furthermore, LRP-661’s oral formulation ability compared to cannabidiol, marks a significant advancement in the field of epilepsy treatment. Notably, the compound demonstrates exceptional efficacy in PTZ fully kindled mice, Maximal Electroshock Seizure (MES), MES Threshold, and pentylenetetrazol (PTZ)–induced seizure data. When compared against the currently available oral solution of cannabidiol in a sesame oil suspension, LRP-661 exhibits a markedly improved safety profile, including enhanced gastrointestinal tolerability, absence of liver and renal toxicity, and a predictably low likelihood of drug-drug interactions. The presentation of this data at the prestigious EILAT XVII conference on May 7th, 2024, garnered high praise from the conference organizer and Chair, Dr. Meir Bialer, affirming the significance of LRP-661's advancements in the treatment landscape. In addition, LRP is also actively preparing orphan drug applications for both Dravet Syndrome and Lennox-Gastaut Syndrome, recognizing the urgent need for innovative therapies in these rare and debilitating conditions. This designation not only streamlines the development and approval process but also provides vital incentives for investment and innovation, ultimately accelerating the availability of life-changing therapies for those who need them most. LRP plans to release very compelling efficacy data in a Dravet syndrome model, further solidifying its commitment to addressing the unique needs of patients suffering from this challenging disorder. About LRP-661 (CBD Sulphate): LRP-661 is the lead compound in London Research & Pharmaceuticals’ portfolio. It represents an orally available, semi-synthetic cannabidiol (CBD), with predictable dosing and formulation offering promising prospects for epilepsy treatment. With the only currently available prescription formulation of cannabidiol being a sesame oil suspension marketed as Epidiolex® (a registered trademark of Jazz Pharma), which achieved sales of $845 million in 2023, LRP-661 may emerge as a potential disrupter in the field of epilepsy therapeutics. About London Research & Pharmaceuticals: London Research & Pharmaceuticals is dedicated to synthesizing highly druggable formulations of existing compounds, with a focus on addressing unmet medical needs. In addition to LRP-661, the company has generated preclinical data on various compounds targeting a spectrum of diseases, including inflammation, infectious diseases, oncology, and psychiatric disorders. London Research & Pharmaceuticals remains open to partnership discussions for its proprietary compounds as it continues to drive innovation in drug discovery and development. For inquiries, please contact: Dr. Mark Innamorato Chief Strategy Officer Email: mark.innamorato@londonresearch.ca Website: www.londonresearch.ca