The Zhitong Finance App learned that Swiss pharmaceutical giant RHHBY.US (RHHBY.US) plans to name its novel oral breast cancer drug Wilserdly and has registered this name in several jurisdictions. According to information from the US Patent and Trademark Office (USPTO), Genentech, an American subsidiary of Roche, submitted a trademark application on October 27 to register this name in capital letters, and also register a floral logo. Roche has also submitted applications for the same brand name to several regulators around the world, including the European Union Intellectual Property Office.
According to people who know about this, but who asked not to be named, the brand name selected by Roche for its giredestrant therapy includes the abbreviation “SERD,” or Selective Estrogen Receptor Degraders (Selective Estrogen Receptor Degraders), a class of drugs that can damage the receptors that breast cancer cells depend on to grow.
Naming a new drug is a complicated job. Pharmaceutical companies usually hire companies that specialize in drug naming. Brand names must not be too similar to other drug names, and must be easy for consumers in different languages to pronounce. The name of the drug must not overadvertise the product or suggest that the drug has too significant curative effects, but ideally, it needs to resonate with consumers and the doctor who prescribed it. Ultimately, drug names are still subject to regulatory approval.
The name reflects Roche's ambition to brand itself in an emerging class of drugs that could reshape treatments for the most common types of breast cancer. Wilserdly's success is critical to the Swiss pharmaceutical company. Analysts believe that the drug is expected to become a major drug with annual sales of several billion dollars, and its sales peak is expected to range from 2.5 billion US dollars to 14.5 billion US dollars per year.
According to data, giredestrant is an oral serdagent developed by Roche to treat estrogen-receptor-positive (ER+) and HER2 negative (HER2-) breast cancer. The therapy completely antagonizes, strongly fixes, and deeply degrades estrogen receptors through a “molecular clamp” structure, blocks signaling pathways at the source, and inhibits cancer cell growth. Compared to traditional endocrine therapy, oral administration is more convenient and does not require injections.
The phase III study of adjuvant treatment for early breast cancer (LiDERA study) showed that compared with standard endocrine treatment, giredestrant significantly reduced the risk of recurrence or death from invasive diseases by 30% (HR = 0.70), and the 3-year survival rates for non-invasive diseases were 92.4% and 89.6%, respectively. This is the first oral SERD since 2000 that has proven superior to traditional endocrine drugs in adjuvant treatment for early-stage breast cancer.
The advanced breast cancer treatment (EVERA study) study showed that in patients with advanced ER+/HER2 treatment with CDK4/6 inhibitors, the median progression-free survival was 8.77 months and 5.49 months in the control group; the benefit was more obvious in people with ESR1 mutations (9.99 months vs. 5.45 months).
Previously, Roche was preparing for the possible approval of this drug and hoped to use this drug to dominate a new way to treat diseases. Roche is preparing to launch this drug in the US almost immediately after giredestrant is approved, and plans to launch a companion patient support program to help female patients begin treatment as soon as possible.
The US Food and Drug Administration (FDA) has granted priority review qualifications for two applications for this drug: one is for early-stage breast cancer and is expected to be reviewed on November 30; the other is for patients with advanced breast cancer, where the drug is used in combination with everolimus (everolimus), a drug that helps slow the growth of cancer cells, and the review decision is expected in December.
Currently, oral SERD drugs, including Menarini Group (Menarini Group) Orserdu and LLY.US (LLY.US) inluriyo (LLY.US), have been approved for use in some advanced breast cancer patients, but the target groups are relatively limited. Roche hopes to be the first to enter the much larger early-stage breast cancer treatment market and launch the product before AstraZeneca (AZN.US)'s Etcamah.
European patients need to wait longer before using giredestrant. Roche plans to submit an application for the drug to be marketed in Europe next year. At that time, more data, such as overall survival data, will be included in the application materials. Meanwhile, pricing negotiations may further delay the drug's launch in Europe; if the two parties fail to reach an agreement, the drug may not even be able to enter parts of the European market.