Source: FDA
The FDA provides a detailed schedule of approved compounds in its Spotlight on Drug Innovation page, where, almost unanimously, healthcare conglomerates like Bristol-Myers Squibb (BMY), Forest Laboratories (FRX), GE Healthcare (GE), and others, govern. Leveraging their economic resources, state-of-the-art technologies, and know-how, these healthcare moguls are able to push drugs past the FDA hurdle, where small innovators often lack needed experience.
At CytRx, the team that overlooks the development of the Los Angeles-based clinical-stage oncology firm has brought a combined six compounds to market. The company’s management comprises one of the most talented pool of executives in the healthcare sector, offering investors an exotic combination of coveted know-how at unprecedented prices.
In an interview with Reuters in May, Dr. Janet Woodcock, head of the FDA's drugs center, discussed the FDA’s tightening of requirements for winning approval, which gives the experienced leadership at CytRx a significant competitive advantage over peers, having been there previously.
Personalities Who Have Gone the Distance
- CytRx chief executive Steven A. Kriegsman helped fund decitabine, a compound that found FDA approval in 2006 for the treatment of patients with myelodysplastic syndromes (MDS). SuperGen (SUPG) markets the drug under the brand name Dacogen. David Haen, VP of business development at CytRx, is said to have played an important role in the process that led to FDA approval.
- Scott Geyer, senior VP of manufacturing at CytRx, was instrumental in the development of oncology drug Nexavar, which is distributed by Onyx Pharmaceuticals (ONXX) to patients with kidney and liver cancer. In 2005 the compound received FDA approval for the treatment of patients with kidney cancer; Onyx’s Nexavar was given the go-ahead by the FDA for treating liver cancer two years later.
- Chief medical officer Dr. Daniel Levitt was integral in the development of Leucomax, interleukin-3, interleukin-6, Sandostatin and PSC-833 during his tenure at Sandoz Pharma, a division of Novartis (NVS). As director of clinical oncology and immunology at Roche (RHHBY.PK), Dr. Levitt introduced interleukin-2, one of the first FDA-approved therapies for the treatment of melanoma. Earlier this year, Bristol-Myers Squibb’s Yervoy became the first melanoma drug to receive FDA approval since interleukin-2.
Preliminary results from its ENABLE Phase 2 proof-of-concept trial demonstrated that bafetinib, the Company's Bcr-Abl, Lyn and Fyn kinase inhibitor, was clinically active in a group of patients with relapsed or refractory B-cell chronic lymphocytic leukemia (B-CLL) who have failed several other treatments for their cancer. Based on this indication of clinical activity and the low incidence of adverse events, additional patients enrolled in the ENABLE Phase 2 clinical trial will receive bafetinib as a single agent at a higher dose.
