Forget ImClone, Cadence Pharma Is Today’s Biotech Winner (CADX, IMCL)
You’ve already seen and read all over the web about Carl Icahn receiving a letter from Bristol-Myers that the company is offering $60.00 to acquire Imclone Systems Inc. (NASDAQ: IMCL). There is a stock moving far more than ImClone, yet it is no buyout.
Cadence Pharmaceuticals, Inc. (NASDAQ: CADX) has received written guidance from the FDA noting that one post-operative pain trial and one fever trial are sufficient to meet the pivotal clinical trial requirements for its New Drug Application for Acetavance
This pertains to the company’s intravenous formulation of acetaminophen to treat acute pain and fever in adults and children. Both studies have already been completed with positive outcomes and it is not required to initiate any additional clinical trials of Acetavance for its NDA submission.
What is crucial here is that teh company is pre-revenue stage and has only been spending cash on R&D. Cadence is up 75% in early trading at $11.28, which is actually styill not a new high.
52-Week range: $4.84 to $15.70
Avg. Volume: 115,000 shares
Market Cap: $433 million (after huge gains)
Options: N/A
Jon Ogg
July 31, 2008
Biotech Implosion: Vanda Pharmaceuticals (VNDA)
Vanda Pharmaceuticals, Inc. (NASDAQ: VNDA) is seeing a major implosion this morning. The company has disclosed that it received a dreaded FDA not-approvable letter on its iloperidone. This was its late-stage schizoprenia candidate as well. The drug candidate is apparently too close to other drugs already on the market and the FDA said more safety data would be required to consider another application.
Vanda shares are down 59% at $1.35, which has gone from the good to the bad to the ugly. Its prior 52-week trading range was $2.70 to $19.62. Its current market cap after the drop is about $36 million. While that is well under its cash levels on the books, it will burn through much cash to fulfill its FDA obligations to proceed.
This one isn’t a biotech zombie yet, but you’d never know it if you just looked at its stock chart.
Jon Ogg
July 28, 2008
Public Awareness Needed Before Vaccinating Girls with Merck’s Gardasil
by Mark S. Senak
EyeOnFDA.com
Last week, Governor Rick Perry (R-Texas) decided on a bold move when he announced an Executive Order mandating the vaccination of girls with Merck’s (MRK) new anti-HPV vaccine Gardasil. By itself, this news would be interesting. A governor so interested in public health, that he or she bypasses all other regulatory and legislative channels with an Executive Order would be newsworthy. But in this case, there is controversy.
Here is the background. Gardasil was approved last year in June, 2006 by the FDA as the first vaccine to prevent cervical cancer in women by building immunity to human papillomavirus - the most common sexually transmitted infection in the United States. The vaccine is given to young girls because it is most effective if administered prior to any HPV infection. Planned Parenthood has advocated for widespread vaccination. According to the Washington Post coverage - “The most effective vaccination programs are either given to young children or are mandated for attending school,” said Jeffrey Waldman, senior director for clinical affairs for Planned Parenthood Federation of America. Rarely does one expect to find Planned Parenthood and a conservative Republican governor of a southern state in bed together.
But some people disagree with them. Their logic (or lack thereof, depending on your point of view) echoing back to the needle exchange/condom availability controversy in HIV/AIDS prevention, is based on the belief that the vaccine will encourage or condone sexual activity. But some of the outrage directed at the Governor, by such organizations as The John Birch Society are based on the fact that some perceive the move by the Governor not to be out of public health concern, but due to lobbying by the drug’s manufacturer, Merck. In fact, apparently one of Merck’s Texas lobbyists is in fact Governor Perry’s former chief of staff.
Coverage of this issue in the media or the blogosphere generally takes note of the fact that Merck is actively lobbying in other states for mandatory coverage. Without getting into the merits of requiring the vaccination, the sudden emergence of this situation in Texas points to the need for a delicate balance between direct lobbying and public affairs efforts. In this case, it is important that parents have a full understanding of the complexities of the problem between HPV and cervical cancer, along with rates of sexual activity among teens. In that way, they understand the problem so that when the solution presents itself, by whatever mode, it has a higher level of acceptance.
I’m not saying that Merck has failed to consider the balance between lobbying and public affairs in advocating for immunization. I have no insight into their public education efforts in Texas and have no other facts at hand. But judging by some of the coverage, it is possible to consider that the governor of Texas provided a solution to a problem before many were even aware of the problem. Educating the public after the fact is much harder. While public health advocates may cheer, if people perceive big pharma is pushing solutions on them before they want them through intensive lobbying efforts and campaign contributions, the value of the geniuine public health contribution being made by a drug like Gardasil can be easily overshadowed by resentment. That does neither Merck or the pharma industry any good. It is essential that public relations communicate before lobbying activates.
By the way, anyone interested in contacting Governor Perry about this decision can do so through this link.
(This article was published by BioHealth Investor with permission of Mark S. Senak, author of EyeOnFDA.com)
RELATED READING:
- The New FDA Drug Safety Initiative
- Merck Wants Out of Pfizer’s Shadow
- Merck Putting Vioxx Behind It
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