Part I:
1、PEDMARK® is the First and Only FDA-Approved Therapy Indicated to Reduce the Risk of Ototoxicity Associated with Cisplatin in Pediatric Patients with Localized, Non-Metastatic Solid Tumors 2、Orphan Drug Exclusivity Provides Seven Years of Market Exclusivity for PEDMARK® from its FDA Approval on September 20, 2022 Until September 20, 2029
The FDA’s Orphan Drug Designation program is designed to advance the development of drugs that treat a condition affecting 200,000 or fewer U.S. patients annually.
The seven-year market exclusivity for PEDMARK® began on September 20, 2022, the date of its FDA approval, and continues until September 20, 2029.
3、Additionally, the Company Has Three FDA Orange Book Listings Providing U.S. Patent Protection for PEDMARK® Until 2038/2039
In addition to Orphan Drug Exclusivity, PEDMARK® currently has three Orange Book listings for U.S. Patent No. 11,291,728 (‘728) and U.S. Patent No. 11,510,984 (‘984) that covers PEDMARK® pharmaceutical formulation and U.S. Patent No. 10,156,190 (‘190), which relates to a method of use for our PEDMARK®product. The ‘728 and ‘984 patents expire in 2039 and the ‘190 patent expires in 2038.
4、Additionally, in the approved prescribing label, the FDA has explicitly directed that PEDMARK® is not substitutable with other sodium thiosulfate products.
In the U.S. and Europe, it is estimated that, annually, more than 10,000 children may receive platinum-based chemotherapy.
The incidence of ototoxicity depends upon the dose and duration of chemotherapy, and many of these children require lifelong hearing aids. ——不清楚比例是多少呢?
source:网页链接
Part II
5、Advances in chemotherapy-based treatment approaches for pediatric patients with localized, solid tumors have improved, resulting in an 85 percent or higher five-year survival rate for these patients.
However, use of platinum-based chemotherapy, still the treatment of choice in many cases, can be toxic to the ears and cisplatin treatment frequently causes permanent and irreversible bilateral (affecting both ears) hearing loss.
6、Permanent hearing loss can be seen in approximately 60 percent of children treated with cisplatin and can be as high as 90 percent.
source: 网页链接
5 year with 60%~90% could develop hearing loss -
7、indicates $11,417.09 as the wholesale acquisition cost for a single treatment vial. How many vials per year?
Part III. Roughly Val:
10000*85%*60%=5100 yr ~ 10000*85%*90%=7650 yr
If annual cost is $10k, total: 51M~76.5M =》MktCap:255M ~380M
If annual cost is $20k, then MktCap: 500M ~ 765M