DENDREON’S TALE STILL ALIVE
Wednesday, July 11th, 2007It seems that the Dendreon’s story has not ended yet and might not end soon. The metamorphosis of a cancer vaccine, Provenge, from an ineffective vaccine to a promising vaccine, to a vaccine that an FDA committee voted in favor of approving it (30 to 4), to an FDA reluctance to fully approve it despite the vote, crossed the barriers of logic. It is a mystery that requires explanation and for the first time, the high voice and the determination of the patients, the shareholders, analysts and physicians could not be ignored. Something is wrong and no matter what it is, or who committed it we decided that we want to know. It seems that there is a possibility for an explanation to come soon, as now, the SEC itself is also looking for the same.
Officials at Dendreon announced they they received a letter this week from the Securities and Exchange Commission, asking about the biotech’s Provenge clinical trials. The letter from the New York Regional Office of the SEC was an “informal inquiry, Dendreon officials said. It asks for information “related to the company’s clinical trials for Provenge, the company’s biologics license application for Provenge filed with the FDA, the FDA’s review of Provenge and the related correspondence to and from the company, from Jan. 1, 2007 through the present.”
“The SEC’s letter notes that the request should not be construed as any indication by the SEC or its staff that a violation of the federal securities laws has occurred nor should it be considered a reflection upon any person, entity or security,” Dendreon said, adding that officials intend to “cooperate fully with the SEC.”
Will the mystery be solved in favor of those patients? We have great hopes.
LUCRATIVE ALLIANCES
GENENTECH (DNA) and TERCICA (TRCA) signed a deal to develop a combo drug for kids suffering from growth failure. The agreement is about combining Genentech’s human growth hormone, with Tercica’s IGF-1. Genentech agreed to pay up to $53 million to Tercica to develop, manufacture and commercialize the combination treatment.
Tercica’s drug Increlex has become the only IGF-1 on the market after the firm won a patent battle against Insmed, which had to take its IGF-1 drug, Iplex, off the market. Tercica is combining its drug with Genentech’s Nutropin, a growth hormone, to form a once-daily injectable treatment for children who suffer from growth failure. In some cases, children do not respond to Nutropin alone, they need to add IGF-1 to it. The new combination drug will be administered once a day.
As part of the deal, Genentech is buying 708,591 shares of Tercica stock for $4 million. This is not the first time Genentech has bought shares in the smaller company. Tercica CEO Scarlett said that Genentech owns less than 5 percent of his company’s shares.
Tercica chief executive John “Chip” Scarlett said that his combo would treat a broader patient population. The combo would be for children with a projected adult growth of less than 5-foot-3 for men, and 5-foot-1 for women. Tercica won’t begin phase 2 testing until 2008.
It is a great idea that would increase the sales of both drugs.
SANGAMO (SGMO) and SIGMA-ALDRICH (SIAL) formed an alliance to develop laboratory research reagents based upon Sangamo’s ZFP technology. ZFPs are the dominant class of naturally occurring proteins known as transcription factors and are found in the nucleus of every cell. The companies said they will use ZFP nucleases to modify genes in cells and to develop and market products. Among the expected applications are “cell lines with enhanced protein production performance, panels of knock-out cell lines for
drug discovery, as well as novel stem cell and transgenic animal models.
SIGMA-ALDRICH will pay $13.75 million to Sangamo as a license fee and payment for 1 million shares of Sangamo’s stock, which it will buy at about $7.75 a share. Sangamo stands to get up to $22 million in further payments depending on the success of the program.
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