Fremanezumab is a Monoclonal Antibody owned by Teva Pharmaceutical Industries, and is involved in 33 clinical trials, of which 23 were completed, 9 are ongoing, and 1 is planned.

TEV-48125 (LBR-101, PF-04427429) is a fully humanized monoclonal antibody that selectively blocks the binding of human CGRP (calcitonin gene-related peptide) to the CGRP receptor. CGRP is released from trigeminal ganglia cells, that CGRP transcription is increased under conditions mimicking neurogenic inflammation, migraine pharmacotherapies can both reduce CGRP release and inhibit CGRP transcription, and that tumor necrosis factor-alpha (TNF-alpha), an endogenous inflammatory mediator implicated in migraine, can stimulate CGRP transcription. In migraine, activation of trigeminal nerves release CGRP and other peptides that cause the release of proinflammatory mediators.

The revenue for Fremanezumab is expected to reach a total of $1.2bn through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. View the complete picture with the Fremanezumab NPV Report.

Fremanezumab was originated by Rinat Neuroscience and is currently owned by Teva Pharmaceutical Industries. Otsuka Holdings is the other company associated in development or marketing of Fremanezumab.

Fremanezumab Overview

Fremanezumab (Ajovy / Adjovi) is a fully humanized IgG2a/kappa monoclonal antibody  acts as an anti-migraine agent. It is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cells. It is formulated as solution for the subcutaneous route of administration. Ajovy is indicated for the preventive treatment of migraine in adults who have at least 4 migraine days per month.

Fremanezumab (TEV-48125, LBR-101, PF-04427429) is under development for the treatment of migraine in children and adolescents The drug candidate is administered through intravenous and subcutaneous routes. It is an anti-CGRP humanized monoclonal antibody.

It was under development for the treatment of fibromyalgia, chronic and episodic migraine, post-traumatic headache (traumatic pain), unspecified indications, vasomotor symptoms of menopause (menopausal hot flashes), interstitial cystitis (bladder pain syndrome) and cluster headache.

Otsuka Holdings Overview

Otsuka Holdings (Otsuka) is a holding company, which operates various businesses such as pharmaceuticals, nutraceuticals, consumer products and other businesses through its subsidiaries. It focuses on the research and development, manufacture, and sale of medicines for the treatment of cancer, cardiovascular diseases, central nervous system disorders, ophthalmic diseases, gastrointestinal and respiratory diseases, infectious diseases, dermatological conditions and allergies. The company’s product portfolio includes pharmaceutical products, cosmetics, functional foods and beverages, alcoholic beverages, fine chemicals, electronic equipment, functional chemicals, medical devices and OTC products. It markets its products in North America, Europe, and Asia. Otsuka is headquartered in Chiyoda-ku, Tokyo, Japan.

The company reported revenues of (Yen) JPY1,498,276 million for the fiscal year ended December 2021 (FY2021), an increase of 5.3% over FY2020. In FY2021, the company’s operating margin was 10.3%, compared to an operating margin of 13.8% in FY2020. In FY2021, the company recorded a net margin of 8.4%, compared to a net margin of 10.4% in FY2020. The company reported revenues of JPY451,811 million for the third quarter ended September 2022, an increase of 4.1% over the previous quarter.

Quick View – Fremanezumab

Report Segments
  • Innovator (NME)
Drug Name
  • Fremanezumab
Administration Pathway
  • Intravenous
  • Subcutaneous
Therapeutic Areas
  • Central Nervous System
  • Undisclosed
  • Women’s Health
Key Companies
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.