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Dendreon, which is seeking approval for its prostate cancer drug Provenge, will likely receive an approvable letter as opposed to an outright marketing approval if the FDA reaches its expected decision by 15 May, sources said. This comes amidst considerable divergence of opinion. If the FDA does decide to approve the drug at this time, the prospects for a takeover of Dendreon, the Seattle, Washington-based biotech company, would increase substantially. One investor said that if Dendreon just so happens to obtain an FDA approval on 15 May, subject to labeling, than Provenge could be on the market in three months. This could be particularly attractive to firms that have a cancer and protein focus. He said Eli Lilly could be interested, but that the key acquirers would be those involved in biologics, such as Sanofi-Aventis, Novartis and Roche. Still, if the FDA does not approve the drug by 15 May, Dendreon’s next chance for takeout would likely be in 2010, when is announces survival results of its new 500-patient study.
On 29 March, the FDA’s Cellular, Tissue and Gene Therapies Advisory Committee reviewed the efficacy and safety data for Provenge. Based on clinical trials, the FDA panel voted 17-0 that Provenge was safe, and 13-4 that it is ”substantially effective.” The FDA is reviewing the advisory committee’s recommendation and anticipates a decision on Provenge by 15 May. Provenge is indicated for the treatment of patients with asymptomatic, metastatic, androgen-independent prostate cancer. A healthcare lobbyist noted that the FDA issues a checkpoint for all products seeking FDA approval, and that checkpoint includes two major requirements, the first being safety restrictions, which is not an problem for Dendreon. However, the lobbyist said a second requirement entails being able to check off the surrogate data clause, indicating survival and morbidity of the disease. Dendreon has not been able to comply with the latter, as it failed all primary and secondary endpoints in both its trials for D9901 and D9902A. Survival was not even an endpoint in the trials. The lobbyist said that for Dendreon to get this product approved on 15 May based only on its existing data, the FDA would have to change laws, which is highly improbable. Another scenario that could hinder approval is the relationship between the two FDA divisions, Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER).
A lobbyist and a Dendreon investor concurred that there has been a “turf war” between CBER and CDER (and the Oncologic Drugs Advisory Committee (ODAC)) on various topics. The Dendreon investor said that had CDER been reviewing Provenge, it would undoubtedly turn the vaccine down, whereas Provenge will be reviewed by CBER more favorably. However, Stephen Litwin, senior clinical consultant at the Biologics Consulting Group and an Ex-FDA inspector, argued that CBER and CDER do have a good relationship. He noted that the two organisations co-operate very carefully about oncology but commented that “one is an 800-pound gorilla [referring to CDER] and the other is a little monkey”. Both divisions will see a lot of exchange, and Litwin pointed out that the key oncology people at CDER, Dr Patricia Keegan and Dr Karen Weiss, originated from CBER. This exchange would imply CDER’s prominence in the matter, and could therefore prevent the product from gaining an FDA approval by Dendreon’s PDUFA date of 15 May, the investor stressed.
Bela Denes, senior director, clinical research at Spectrum Pharmaceuticals, a company which has four products in multiple Phase II trials, including Ozarelix, for the treatment of prostate cancer and benign prostatic hypertrophy, said ODAC has rejected the last 38 oncology drugs, only approving one. The scenario for Provenge will be to receive a letter of approval for its ongoing 500 patient phase III trial, with approval depending on its efficacy data in 2010. The investor pointed to Allos Therapeutics as a situation comparable to Provenge. In 2004 the FDA issued an approvable letter for Excelar, an Allos Therapeudics drug indicated for the treatment of patients with brain metastases originating from breast cancer. ODAC did not recommend approval of Excelar for this indication, stating the survival benefit should be considered exploratory rather than conclusive because it was seen in a subgroup of patients with brain metastases from breast cancer.
The investor said this should be a further indication of a lack of evidence for Provenge’s approval on 15 May. By not recommending approval for Excelar, ODAC had turned down a drug that was safe that appeared to be effective on a subset, which was 40% of the patients with breast cancer, and had patient advocates supporting it, the investor added. Biologics Consulting’s Litwin would not speculate on whether Provenge would be approved in May but did say that the FDA would likely comply with the 15 May PDUFA date. ”There would be no reason for holding back unless they requested more data or another analysis,” he said. Today Dendreon shares traded at USD 15.49, down from its 9 April recent high of USD 23.58.
Dendreon has a USD 1.29bn market cap.
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