It Will Take Much More to Buy Genentech (DNA)

August 13, 2008 · Filed Under Cancer · Comments Off 

The Board of Directors of Genentech, Inc. (NYSE: DNA) had already appointed a special committee to review the $89.00 cash buyout for the rest of the company that Roche did not already own.  The committee responded today with a “NO, WE WANT MORE!” response to Roche.

In the press release, it announced that it has unanimously concluded that Roche’s proposal to acquire Genentech for $89.00 per share substantially undervalues the company and the special committee does not support the current proposal.

If you read the release, you can see they are demanding more cash to take the stock out.

  • “However, the special committee would consider a proposal that recognizes the value of the company and reflects the significant benefits that would accrue to Roche as a result of full ownership.”

If you’d like our prediction, we are happy to give it.  We think that the company is willing to be acquired, but a price of $99 to $106 is what the buyout will take to complete.  But if Genentech says that it will not play at those levels then roche may threaten to unload a larger portion of the stock.

Jon C. Ogg
August 13, 2008

Something Brewing At Dendreon? (DNDN)

July 31, 2008 · Filed Under Cancer, dendreon · Comments Off 

We just noticed a large options volume alert over at Volume Spike today, and it is one that biotech investors may care about quite a bit more because of the timing.  We have witnessed a flurry of trading in Dendreon Corp. (NASDAQ: DNDN) November stock options activity today.

We have seen what would represent more than 2 million shares in a risk reversal trade, although it could be called a myriad of terms depending upon your sophistication in trading. Frankly, most would call it a synthetic straddle.

As far as our calendar is concerned, we didn’t have any major event risk scheduled on the calendar until 2009.

After looking around there is actually some data coming out as soon as October, but the biggest data is still out into next year.  This is probably simple to explain.  Either someone put on a massive belief trade or they are hedging a large position of stock.

Jon C. Ogg
July 31, 2008

Cell Genesys Positive Prostate Cancer Study Data (CEGE, DNDN)

July 22, 2008 · Filed Under Cancer · Comments Off 

Cell Genesys, Inc. (NASDAQ: CEGE) has announced that the final data from the second of two Phase II clinical trials (G-0010) of GVAX immunotherapy for prostate cancer has been published in the online issue of Cancer.  This is the publication of the American Cancer Society.

As a reminder, this company is somewhat after the same goal as Dendreon (NASDAQ: DNDN) in the fight to treat prostate cancer.

The results from this Cell Genesys multi-center trial showed an overall median survival of 35.0 months in the subset of patients who received a dose of GVAX immunotherapy for prostate cancer comparable to that currently being evaluated in the ongoing Phase 3 program. It also noted that these results were consistent with those observed in the first multi-center Phase II trial which indicated an overall median survival of 34.9 months in those patients who received a dose comparable to that being evaluated in the Phase III program.

The survival results from both Phase II clinical trials compare favorably to the previously published median survival for metastatic hormone-refractory prostate cancer patients treated with Taxotere® chemotherapy plus prednisone, the current standard of care for this patient population.

A copy of this article titled “Phase 1/2 Dose-Escalation Study of a GM-CSF-Secreting, Allogeneic Cellular Immunotherapy for Metastatic Hormone-Refractory Prostate Cancer” can be seen at the following URL:
http://www3.interscience.wiley.com/journal/120840830/abstract

As a result, the company notes that it is on track to complete enrollment of the second of the two ongoing Phase III trials, in the first half of 2009 and its expects to reach the number of events needed to trigger final analysis of the first of the two Phase III trials in the second half of 2009.

Much of this data seems to be reaffirming what has already been observed.  But this stock has a huge short interest of more than 18.4 million shares and this has shares indicated about 5% higher in the immediate pre-market reaction.

Jon Ogg
July 22, 2008

Non-Hodgkins Lymphoma Vaccine Shows Promise (ABPI, BVTI)

July 17, 2008 · Filed Under Cancer · Comments Off 

Biovest International, Inc. (OTCBB:BVTI) is a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI). This morning the company has what appears to be some very positive cancer vaccine data. It released clinically and statistically significant unblinded data from a randomized controlled pivotal Phase 3 Fast-Tracked clinical trial of BiovaxID(R) (personalized anti-idiotype vaccine). This is for the treatment of indolent follicular non-Hodgkin’s lymphoma (NHL), which is an often fatal blood cancer.

This was originally developed and advanced into human clinical trials by the National Cancer Institute, and BiovaxID is designed to recruit the immune system to recognize and destroy only cancerous B-cells. Based on the highly encouraging clinical evidence reporting on vaccinated patients to date, Biovest plans to proceed with plans to seek accelerated
and/or conditional regulatory approvals in the U.S. and European Union.

The first result for vaccinated patients followed up to 80 months showed that the overall results showed that BiovaxID improved median disease-free-survival by more than one year with the control arm showing a median time to relapse from first vaccination of 21.2 months. This was compared to the BiovaxID arm which had a median time to relapse of 33.8 months. This statistically significant difference represents an increase of approximately 60% in the duration of complete remission since first vaccination. Disease-free survival was the primary endpoint of the study.

The second result for these same patients measured at 36 months from vaccination, BiovaxID improved median disease-free-survival by approximately 100% - a statistically significant improvement as compared to the control group.

So far after 90 minutes of trading (11:00 AM EST) we have seen Accentia (ABPI) trade up over 10% at $0.94 and Biovest (BVTI) is up by more than 50% at $0.51 today.

Jon Ogg

July 17, 2008

ERBITUX Approved in Japan for Colorectal Cancer

July 16, 2008 · Filed Under Cancer · Comments Off 

ImClone Systems Incorporated (NASDAQ: IMCL) is seeing a slight gain this morning after the company announced that ERBITUX(R) has received final marketing authorization in Japan to treat patients with advanced or metastatic colorectal cancer (mCRC).

ERBITUX will be used to treat Japanese patients with epidermal growth factor receptor (EGFR)-positive, curatively unresectable (inoperable), advanced or recurrent CRC, and has the use of ERBITUX plus irinotecan in second and further lines of mCRC.  ERBITUX is now the first ever EGFR-targeted monoclonal antibody to receive marketing authorization in Japan.

Bristol-Myers Squibb (NYSE: BMY) has been Imclone’s commercialization partner.  We would also note that Merck KGAA (the German Merck, not U.S.) was also in the pact that was sent in for approval back in 2007.

We have seen minimal trading so far, but as of 8:45 AM EST we have seen 1,000 shares trade and shares are indicated up over 0.5% at $41.50.  Its 52-week range is $30.34 to $49.18 and it trades an average daily volume of about 1.8 million shares.

Jon Ogg
July 16, 2008

New Patent Awarded in Bone Marrow & Stem Cell Transplants

July 2, 2008 · Filed Under Cancer, stem cells · Comments Off 

There has been an interesting award of a patent today in relation to treatment of patients in need of bone marrow or stem cell transplantation.  Chemokine Therapeutics Corp. (OTC-BB: CHKT) has announced they received this patent.  The company is a micro-cap biotechnology company developing chemokine-based therapies to treat cancer, blood disorders and vascular diseases.

While all patents do add value in theory, we do caution that patents do not always translate to instant or near-term revenues (outside of milestones from partners) for small biotech companies.

But patent #7,378,098 is an interesting one in that it pertains to in-need-of bone marrow patients and stem cells.  Both are huge growth areas for the companies that can score a win in them.  The company noted that this strengthens the foundation for its work with its drug candidate CTCE-0214, for hematogical support; mobilization of stem cells and white blood cells into circulation, which is currently in Phase I development.

This patent, “CXC Chemokine Receptor 4 Agonist Peptides,” is said to be based on evidence that treatment with SDF-1 chemokine analog prevents reduction of normal bone marrow stem cells and restores white blood cells, which reduce susceptibility to infections in cancer patients following chemotherapy treatment.

We would note that this company raised almost $1 million back in the middle of June, and calling the company a micro-cap would be an understatement.  As with all companies, we urge ANY AND ALL traders and investors to do double the amount of due diligence on companies they  are interested in the story of when it comes to micro-caps and OTC-BB stocks.

Jon Ogg
July 2, 2008

Did Traders Get SuperGen & Celgene Wrong? (SUPG, CELG)

July 2, 2008 · Filed Under Cancer · Comments Off 

There are two interesting calls out this morning around SuperGen (NASDAQ: SUPG).  As you will recall, it was just under pressure yesterday over Dacogen missed its primary endpoints in trials.  SuperGen closed down at $1.75 yesterday on almost 2.8 million shares.  SuperGen came close to a 52-week low yesterday as its year-range had been $1.66 to $6.63.

But this morning we have already seen two analyst UPGRADES in the stock. Rodman & Renshaw has raised its old “Market Perform” rating up to a higher “Market Outperform” rating.  Susquehanna Financial, another boutique, has raised its prior “Neutral” rating to a higher “Positive” rating.

Keep in mind these are boutique calls and have yet to generate any trades this morning.  But shares are indicated higher after a near 15% drop on the bad news.  This news was what gave Celgene Corp. (NASDAQ: CELG) such a large pop yesterday.  Interestingly enough, Celgene shares are also popping by 1% higher in pre-market trading.

Jon C. Ogg
July 2, 2008

Giving Head & Neck Cancer a Cold (INGN)

July 1, 2008 · Filed Under Cancer · Comments Off 

Introgen Therapeutics Inc. (NASDAQ: INGN) has made a fairly important filing with the FDA this week, yet the importance of the filing has been overlooked.  Maybe it’s a shortened work week, maybe it is a bear market, or maybe we are just stretching for key biotech news.  It could even be a combination of all three.

All joking aside, Introgen has asked the FDA to give its Biologic License Application (”BLA”) a priority review for its gene-based therapy called Advexin for head and neck cancer.

This apparently culminates in some cases 14 years of research.  This may be a major milestone as this appears to be a filing of the first application for a gene-based therapy. The company is already seeking an approval in Europe.

Advexin is supposed to work by using inactivated cold virus cells to deliver the p53 suppressor gene into cancer cells.  The data indicates that the drug only or mainly works on people with low levels of the p53 gene.  Apparently two thirds of patients with head and neck cancer were able to take the drug in clinical trials.

Delivering gene function into the tumor could be treating a disease at its most basic and fundamental level.  Whether or not this is approved and whether or not this works as well as some hope, that is a different issue entirely.

Shares barely traded above average showing yesterday with 287,300 shares trading hands for a gain of less than 2% to $1.55.  Today isn’t much better with another 1.9% gain to $1.58 on 237,00 shares (1:30 PM EST).  Introgen’s 52-week trading range is $1.47 to $4.85, and its current market cap is $69.5 million.

Jon Ogg

July 1, 2008

SuperGen’s Pain May Be Celgene’s Gain (SUPG, CELG)

July 1, 2008 · Filed Under Cancer · Comments Off 

SuperGen (NASDAQ: SUPG) is feeling some pain today after the company reported that its Dacogen missed its primary endpoints of showing a statistically significant advantage on median survival compared to standard care.  Supergen said response rates were similar to those in other Dacogen clinical trials.  Dacogen is partnered with Eisai and treats bone-marrow disease MDS,  The results of this trial conducted by the European Organization for Research and Treatment of Cancer has SUPG down 13% to $1.78 in thin volume pre-market trading.

Interestingly enough, this is being tallied up as a win for Celgene Corporation (NASDAQ: CELG).  Its MDS treatment is Vidaza and this is now going to be counted as less competition. Celgene is up over 3% pre-market at $65.95 (9:14 AM EST) on more than 418,000 shares in pre-market trading.

As a reminder, one-time gains at large caps from smaller company woes are frequently forgotten about.  For a size comparison, the market cap for SuperGen was close to $118 million and the market cap for Celgene is over $27 Billion.

Jon Ogg
July 1, 2008

Cervical Cancer Vaccine Developments Altering Big Pharma (MRK, SNY, GSK)

June 30, 2008 · Filed Under Cancer, vaccine · Comments Off 

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

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