Delcath (NASDAQ: DCTH) is a development-stage, specialty pharmaceutical and medical device company focused on oncology. Company is researching breakthroughs in regional chemotherapies with the goal of improving clinical outcomes and potentially reducing drug-related adverse events.
At glance:
- Commercial stage company focused on oncology
- Proprietary CHEMOSAT delivery systems allow unique whole organ therapy for the liver
- CHEMOSAT system has demonstrated extension of progression free survival
- Addressing large unmet market need for cancer patients who usually die of liver failure
- 2013 estimated addressable market opportunity of $2.3 billion
- Expanding clinical data expected to broaden clinical use and indication On the cusp of realizing the potential:
- EU commercial launch underway
- Reimbursement in additional key EU markets expected in Q1
- U.S. NDA under review – PDUFA date June 15, 2013
- Attractive financial model, $80 million in available resources and experienced management team to execute plan
Clinical Results
- Phase 1, 2 and 3 trials produced positive results in multiple histologies
- Melanoma Liver Mets
Positive Phase 3 results in hepatic metastatic melanoma
n=93 (90% ocular melanoma, 10% cutaneous melanoma)
- Neuroendocrine Tumor (NET) Liver Mets – mNET cohort in Phase 2 trial showed encouraging 42% objective response rate; (ORR) vs ~10% for approved targeted therapy – median overall survival of ~32 months on ITT basis Hepatocellular Carcinoma (HCC)
- Positive signal with high-dose melphalan in HCC cohort of Phase 2 trial (5/8 patients) is encouraging when approved systemic therapies have modest efficacy and challenges with tolerability
- Colorectal Cancer (CRC) Liver Mets
- Data from surgical Isolated Hepatic Perfusion (IHP) with melphalan indicates strong potential in well-defined patient population with earlier stage CRC yielding ~50-60% median response rate and median OS of 17.4-24.8 mos
- Safety profiles consistent with pivotal US Phase 3 melanoma trial
Planned 2013 studies, pending discussion with the FDA:
- Hepatocellular carcinoma (HCC) – Global Phase 3 Randomized CHEMOSAT Melphalan vs. BSC for Sorafenib Failure
- Advanced colorectal cancer (CRC) with liver dominant metastasis – Global Phase 3 Randomized CHEMOSAT Melphalan vs. Available Alternatives
- Neuroendocrine tumor (NET) with liver dominant disease – Global Phase 3 Randomized CHEMOSAT Melphalan vs. Available Alternatives
- Phase 2 studies in multiple indications: HCC, NET, CRC, melanoma
- Global Investigator-initiated trials (IITs) – opportunity-driven
U.S. Commercialization Strategy
- Launch in Q4 2013 assuming approval on PDUFA date of June 15, 2013
- Initial commercial focus on centers that are active in the EAP or participated in the Phase 3 clinical trial
- Utilize active EAP hospitals as Centers of Excellence for training and support of new centers
- Intend to seek chemosaturation specific CPT reimbursement code, based upon value proposition relative to other cancer therapies
- Educate Medical Oncologists via Medical Science Liaison (MSL)
- Direct strategy to sell to hospital based Interventional Radiologists and Surgeons
2013 Anticipated Milestones
- First patient enrolled in EAP – Q1 2013
- Secure interim reimbursement in Germany and UK – Q1 2013
- Submission for publications of Phase 3 data and mNET arm of Phase 2 data in Q1 2013
- Initiate EU Registry – Q1 2013
- First commercial sale in APLA – Q2 2013
- ODAC Panel Meeting May 2013
- Receive NDA approval of Delcath’s chemosaturation system by PDUFA date of June 15, 2013
- Commence Company’s first investigator initiated trial (IIT) – Q2 2013
- First patient enrolled in Company sponsored trial (CST) to expand indications – Q4 2013
- US commercial launch of Delcath’s chemosaturation system – Q4 2013
- First patient enrolled in Taiwan HCC pivotal trial – Q4 2013
- Execute strategic partnership for China