Pfizer Announces Success of First Global Phase III Trial of Abrocitinib in Atopic Dermatitis
Novartis
Drug Development and Manufacturing
[May 16, 2019 / Pharmaceutical News Overview]Pfizer’s abrocitinib succeeds in first global Phase III trial for atopic dermatitis; Kunming Pharmaceutical Group’s novel nanotechnology-based anticancer drug receives FDA approval for clinical trials; Competition intensifies among first-line renal cell carcinoma therapies! FDA approves Bavencio plus Inlyta combination therapy; Total value of $5.7 billion! Takeda Pharmaceutical’s two drugs acquired by subsidiaries of Novartis and Johnson & Johnson... Daily Pharma News invites you to a quick read!(Click the title to access the original text)
Part 1 Policy Brief
Recently, the Shaanxi Provincial Public Resource Trading Center issued the "Notice on the Handling Results of Complaints and Appeals During the Publicity Period for the Dynamic Adjustment of Sunshine Procurement Drugs for Generic Drugs That Have Passed the Consistency Evaluation." The notice states that for generic drugs that have passed the consistency evaluation, if there were more than three provincial centralized procurement listing prices before passing the evaluation, the lowest price shall apply; if there are no new provincial listing prices after passing the evaluation, the drug shall be listed at a capped price based on the lowest listing price prior to passing the evaluation. (Saibailan)
Part 2 Listed Companies
On the 16th, Canaan Technology released an announcement regarding external investment by its wholly-owned subsidiary. The announcement stated that Canaan Bixun, a wholly-owned subsidiary of Canaan Technology, plans to invest RMB 15 million using its own funds to establish a wholly-owned sub-subsidiary—Nanjing Bixun Pharmaceutical Technology Co., Ltd. (YiOu)
| Former General Manager of Novartis Oncology China, Dai Chongde, Receives New Appointment
Novartis Oncology announced on the 15th the appointment of Chongde Dai as Head of International Markets for its Cell and Gene Therapy division, effective June 1. He will report directly to Pascal Touchon, Head of Novartis Oncology’s Cell and Gene Therapy division, and have dotted-line reporting relationships to Francis Bouchard, Head of Emerging Markets at Novartis Oncology, and Gabriel Galvan, Head of LACAN Markets. (Medical Representative)
Recently, Takeda Pharmaceutical announced that it has signed separate sale agreements with Novartis and Ethicon, a subsidiary of Johnson & Johnson. Under the agreements, Novartis will acquire Xiidra 5%, a product under Takeda’s portfolio, while Ethicon will acquire TachoSil, a fibrin sealant patch also from Takeda. Takeda will receive $3.4 billion in upfront cash payments and up to $1.9 billion in potential milestone payments from Novartis, as well as approximately $400 million in upfront cash from Ethicon. Takeda plans to use the proceeds to reduce corporate debt and accelerate deleveraging. (Arterial Network)
Part 3 Investment and Financing
| Hapvida Acquires Sao Francisco Saude for $1.26 Billion
Recently, healthcare group Hapvida announced that it will acquire Sao Francisco Saude for 5 billion reais (approximately $1.26 billion). It is understood that Hapvida will pay 4.7 billion reais in cash, with the remaining amount to be paid through the purchase of equipment and shares from Grupo São Francisco. (Arterial Network)
| TransMedics Completes $105 Million IPO Financing
Recently, TransMedics (NASDAQ: TMDX) completed a $105 million initial public offering (IPO). The company issued nearly 5.7 million shares at $16 per share, and the IPO also included an option for underwriters to purchase an additional 854,000 shares, resulting in total proceeds of $104.7 million. (Arterial Network)
CinCor Pharma recently announced the completion of a $50 million Series A financing round, led by Sofinnova Investments and 5AM Ventures. The proceeds from this round will be used to advance two indications of the company’s novel drug candidate, CIN-107, into Phase II clinical trials. (Chuangjian Hui)
Part 4 Pharmaceutical News and Medical Updates
| Pfizer’s abrocitinib achieves success in first global Phase III trial for atopic dermatitis
On the 15th, Pfizer announced that its JAK1 inhibitor abrocitinib achieved positive topline results in a Phase III study conducted in patients aged 12 years and older with moderate-to-severe atopic dermatitis. This study also marks the first clinical trial of abrocitinib’s global development program for efficacy and safety in atopic dermatitis (JADE). (PharmaCube)
GenSight Biologics recently announced the initial 96-week data from the Phase III clinical trial REVERSE, evaluating its lead candidate drug GS010 for the treatment of Leber hereditary optic neuropathy (LHON). The study enrolled 37 patients with LHON who had experienced vision loss due to the 11778-ND4 mutation within 6 to 12 months prior to initiating treatment. (Sina Pharmaceutical News)
Recently, Kunming Pharmaceutical Group announced that it had received notification from its investee company, CPI, stating that the latter had received a letter from the U.S. Food and Drug Administration (FDA) approving clinical trials of CPI-200, an anticancer drug based on novel nanotechnology, for the treatment of advanced solid tumors. (Sina Medical News)
Merck and Pfizer recently announced jointly that the FDA has approved a new indication for the PD-L1 cancer immunotherapy Bavencio, namely in combination with the targeted anticancer drug Inlyta as first-line treatment for patients with advanced renal cell carcinoma (RCC). This approval makes Bavencio the first anti-PD-L1 therapy to be used as part of a combination regimen for the treatment of advanced RCC, and simultaneously triggers a €35 million milestone payment from Pfizer to Merck. (Sina Pharmaceutical News)
AbbVie Announces FDA Approval of Blockbuster Anti-Cancer Drug Venclexta, Co-Developed with Roche, in Combination with Gazyva as a First-Line Treatment for Patients with Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma. This is a Non-Chemotherapy Combination Regimen. The FDA Evaluated the Supplemental New Drug Application Through the Real-Time Oncology Review Program, Approving It Within Two Months of Acceptance. (WuXi AppTec)
| $1 Billion Development of Protein Degradation Therapies: Vertex and Kymera Reach R&D Collaboration
Vertex Pharmaceuticals and Kymera Therapeutics Announce Four-Year R&D Agreement to Co-Develop Small-Molecule Protein Degraders Targeting Multiple Proteins. This collaboration will combine Kymera’s expertise in targeted protein degradation with Vertex’s scientific, clinical, and regulatory capabilities in developing “first-in-class” therapies. (WuXi AppTec)
Emerging biotech company F-star recently announced an amendment to its development agreement with Merck for bispecific tumor immunotherapy antibodies, granting F-star full development rights to the investigational drug FS118. (WuXi AppTec)
On the 15th, the National Healthcare Security Administration announced the third batch of cases involving fraud and deception to obtain medical insurance funds, covering eight medical institutions. It is understood that this is the third batch of insurance fraud cases announced by the administration. The typical cases in this third batch not only imposed penalties on medical institutions involved in insurance fraud but also marked the first time that penalties were issued against doctors at tertiary public hospitals for insurance fraud. (Kan Yijie)
Recently, the Sichuan Provincial Drug and Medical Device Centralized Procurement Service Center issued the "Notice on Suspending Online Procurement of Certain Drugs and Recording Adverse Events." According to the notice, five drugs subject to standard online price caps had their listing qualifications voluntarily withdrawn, and two pharmaceutical companies were recorded with general adverse events. (Saibailan)
Amyloid plaques are clumps of protein fragments in the brains of Alzheimer’s patients that can disrupt neural connections. To identify these protein fragments in a manner analogous to how Facebook recognizes faces from captured images, a collaborative team of scientists from the University of California, Davis, and the University of California, San Francisco, developed machine learning tools capable of rapidly “detecting” the presence of amyloid plaques in brain tissue samples. (BioExplorer)
| Scientists Identify Potential Therapeutic Targets for Metastatic Prostate Cancer
Scientists from institutions including Weill Cornell Medicine have discovered that treating prostate cancer with drugs targeting the PHLPP2 protein may inhibit the spread of cancer cells to other organs in the body. Inhibiting PHLPP2 may reduce levels of MYC, an oncogenic protein that drives multiple types of cancer and currently cannot be targeted by conventional drug therapies. (Bioon)
| New Research Advances Genetic Studies of Cancer Cells
According to a recent study, a new method for thoroughly isolating cancer cells from blood samples enables comprehensive genetic analysis of these cells, thereby helping physicians more effectively target tumors and monitor treatment responses. (Bioon)
*Disclaimer: This article was written by an author contributing to Sina Medical News. The views expressed are solely those of the author and do not represent the position of Sina Medical News.