Reaching Undetectable HIV Viral Load Levels (MRK, BMY, GILD)
Merck & Co., Inc. (NYSE: MRK) has released some very positive data on its ongoing Phase II HIV study in data presented at the International AIDS Conference (AIDS 2008) in Mexico City, Mexico. The company’s ISENTRESS was shown to reduce HIV viral load and increased CD4 cell counts through 96 weeks in treatment. The efficacy and tolerability profile was also consistent with data seen in approved treatment-experienced indications.
ISENTRESS was put in combination with two other anti-HIV medicines, and the combined medicines was shown to have reduced HIV viral load to undetectable levels in 83% of previously untreated HIV-infected patients. This was comparable to results seen with efavirenz, which reduced HIV viral load to undetectable levels in 84% of untreated HIV-infected patients when combined with the same anti-HIV medicines in patients through 96 weeks of treatment.
Merck noted that patients taking ISENTRESS experienced a mean increase in CD4 cell counts of 221 cells/mm3 without adverse impact on total or low-density lipoprotein cholesterol, or triglycerides.
It looks like a comparable study was from Bristol-Myers Squibb (NYSE: BMY). Its CASTLE data showed that boosted REYATAZ and Lopinavir achieved similar results for undetectable viral load in previously untreated HIV-1 infected patients. A pre-specified subanalysis of the CASTLE study with once-daily boosted REYATAZ and twice-daily co-formulated lopinavir 400 mg and ritonavir 100 mg as part of H.I.V combination therapy showed similar results for undetectable viral load at 48 weeks regardless of gender in treatment-naive HIV-1 infected adults.
A Reuters report today showed scientists using monkeys to test a gel using Gilead Science’s (NASDAQ: GILD) VIREAD could also protect men from contracting HIV in anal sex tests rather than the goal of just protecting women. You can read about that study at the Reuters site.
While these are not cures, there are at least some better and better preventions and better medical treatment regimens than a decade ago.
Jon C. Ogg
August 5, 2008
Cervical Cancer Vaccine Developments Altering Big Pharma (MRK, SNY, GSK)
The new cervicval cancer vaccine market has been a boon for Big Pharma as a revenue stream that had not previously been there. Merck’s (NYSE: MRK) Gardasil, developed with Sanofi-Aventis (NYSE: SNY), is now apparently set to keep its lead position in the cervical cancer vaccine market. This lead should be maintained in principal but now its secondary competition is going to be pushed out even farther.
GlaxoSmithKline PLC (NYSE: GSK) has said today that it does not expect the FDA to approve its Cervarix, Glaxo’s cervical cancer vaccine. It believes that it will now not see FDA approval until 2009. Many analysts had modelled revenues reaching in the low-hundreds of millions as soon as 2008. This additional delay is going to assist Merck in keeping its leadership role in cervical cancer vaccines.
Gardasil is estimated at $2.5 Billion sales annually with 2007 sales being listed as $1.5 Billion for the first full year.
Jon C. Ogg
June 30, 2008
Vaccine Awards Propelling Akorn (AKRX)
Akorn, Inc. (NASDAQ: AKRX) has made a statement that has interesting financial ramifications for the company. That is even more so since the small biotech is largely under-followed by Wall Street.
Akorn has announced that its Q2-2008 net sales will exceed consensus estimates by about 15%. The company said that the revenue increases are a direct result of strength in its core business, primarily in vaccines.
It has also announced a contract award from the Centers for Disease Control and Prevention for Tetanus Diphtheria Vaccines. The contract award includes the multi dose Td Vaccine and the unit dose preservative free Td Vaccine. This award is effective July 1, 2008 for a period of twelve months.
What makes this interesting isn’t just the size of the awards nor the size of the company. Akorn has been public forever and 2008 has been an ugly chart year for the stock. The past years have shown to be very sporadic revenues with fiscal losses in each of the last 3 years. But the 2008 to 2009 period is supposed to be the transitional period for the company. It is expected to have a slight loss for 2008 but 2009 is expected to be its first real profitable year as revenues are expected to grow substantially.
Shares are only up 1% or 2% today after the news. This fits all the profiles for our weekly “10 Stocks Under $10″ newsletter over at 247WallSt.com. This looks like it is being largely overlooked, although we would look at the company’s balance sheet with at least a little more caution in case any hiccups come into play.
Jon C. Ogg
June 30, 2008
Microbix in Canada… Winning on Flu Venture in China
We don’t normally cover Canadian small cap biotechs or drug stocks up north, but sometimes money is money. Microbix Biosystems Inc. (MBX - TO) shares we up about 8% to C$0.87 on last look (2:40 PM EST). The company announced that it would be jointly developing an influenza vaccine production facility in the Hunan province in China.
The company said it is expected to be the largest production facility for flu vaccines in the country. The project is listed as a 400,000 square foot facility. The target date is quite a ways off as the company said it could be completed as early as 2012.
The factory will employ several hundred people and expected to cost C$200 million (Canadian). Half of the costs are said to be covered by the Hunan local regional government.
The facility is to utilize Microbix’s proprietary method called VIRUSMAX, which is said to double yields of the flu vaccine they manufacture. After the factory is built it is expected to make some 100 million doses a year.
This is being represented as a joint venture between the company and the regional Hunan government, and is currently a 50-50 joint venture. Microbix said it is seeking partners within the pharma sector industry to lend vaccine research, production and marketing knowledge to the operation.
Jon Ogg
June 23, 2008
AVANT’s Celldex in 3M Pact (AVAN, MMM)
There was a collaboration pact that might have been an easy one to overlook. 3M Corp. (NYSE: MMM) has signed vaccine adjuvant licenses with a company called Celldex Therapeutics. As itturns out, Celldex is a wholly owned subsidiary of AVANT Immunotherapeutics, Inc. (NASDAQ: AVAN).
Celldex signed a multi-year clinical research collaboration with 3M to access their proprietary Immune Response Modifier Resiquimod and additional toll-like receptor agonists for clinical study with Celldex’s proprietary “Antigen Presenting Cell Targeting Technology” for use as vaccine adjuvants designed to treat various cancers and infectious diseases.
3M will provide its patented toll-like receptor (TLR) agonist compounds to Celldex for an undisclosed licensing fee, milestones and royalties.
Jon Ogg
June 11, 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)
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