Posts for Ticker ‘FDA’

Dendreon Shares Losing House Committee Hope (DNDN)

CNBC’s Mike Huckman just announced what is going to be a disappointment for Dendreon (NASDAQ: DNDN) holders, and that may be an understatement.  The House Committee will not be forcing any action or pressing the FDA over Dendreon’s PROVENGE until FDA makes a final decision, and that could be one to three years away.  There had been hopes that the committee would uncover conflicts of interest that have been alleged by many hopeful patients and investors alike.  That doesn’t look to be in the realm of possibilities now.

As a reminder, there is still hope that the EU might actually save it when the FDA wouldn’t.

Dendreon shares are now down over 7% to $5.37, and its 52-week trading range is $3.57 to $25.25.

Jon C. Ogg
February 13, 2008

Posted on: February 13, 2008 – 3:34 pm in Biotech, FDA, , , , ,

Cephalon’s FDA Warning More of a Formality (CEPH)

Cephalon Inc. (NASDAQ:CEPH) is a biotech that has been under a bit of a low ceiling after its recent blunder regarding FENTORA.  As a reminder FENTORA is that cancer pain drug that the company issued "Dear Doctor" alerts about the potential side effects possibly leading to deaths.  The company said it believes that the deaths were the result of improper matches, improper dosing, and substitutions for other drugs. 

Cephalon gave its own warnings on this, and today the Food & Drug Administration has sent out communication of its own with warnings to pay close attention to the same issues.  Of course it included that the FDA was closely reviewing and monitoring the situation.  The long and short of it is that this is a mere formality out of the FDA and would have been expected.  There is not really any new data in the FDA letter, other than the fact the letter is out now.

Jon C. Ogg
September 26, 2007

Below is a copy of the electronic communication from the FDA:

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Posted on: September 26, 2007 – 1:12 pm in Biotech, FDA, , , ,

Looking Beyond Dendreon’s Upcoming Earnings Release (DNDN)

Dendreon Corp. (NASDAQ:DNDN) will release earnings next Tuesday, August 7, after the close.  The volatility in shares has dried up considerably as shares have only traded above $8.00 or below $7.00 for part of three trading days in July.  The company’s only expected revenues here will be from interest and the loss expected looks like it is -$0.30 on an EPS basis.  That number may change before the report.

There can always be some activist group activity here, or at least that is what incoming emails received have stated.  Some sent in to us listed "the first of many" and "Many more to come."  We’ll see if that creates some movement or not. Options are still fairly active in the open interest with over 154,000 contracts in the August $7.50 Calls and over 129,000 contracts in the $7.50 puts.  That huge open interest drops off a cliff in the near-months after this as no new FDA data is really expected.  An at-the-money straddle right now only looks like it costs $0.70, lower than in any recent month.   

All of these following issues are already known and already in the news, but on top of earnings the company is going to address the following:

  • The Company received confirmation that the U.S. Food and Drug Administration will accept either a positive interim or final analysis of survival from its ongoing IMPACT study to amend the Biologics License Application for Provenge® (sipuleucel-T), its investigational active cellular immunotherapy for metastatic, androgen-independent prostate cancer.
  • The Company continues to have strong patient enrollment in its Phase 3 IMPACT study, which is on track for completion of enrollment this year.
  • The Company completed a financing that resulted in gross proceeds of approximately $85 million from a convertible senior subordinated notes offering.
  • Presented data from an analysis of Phase 3 Studies (D9901 and D9902A) that showed a prolonged survival benefit for patients who were initially treated with PROVENGE who then went on to receive docetaxel chemotherapy after disease progression.

Obviously if there is any new development out of the FDA or if the company decides it wants a partner that will be key to watch over anything else.  We previously noted how shares may face a news vacuum through much of summer and that looks like it has been the case as trading volume has dropped and volatility in the stock has disappeared.  What we will be looking at the closest is the company’s current and projected cash burn rates since it secured the recent financing package and announced its reduced cost structure. 

This one has been eerily quiet of late as far as any real news out of the company.  We’ll follow up if there are any substantial changes ahead of the release. 

Jon C. Ogg
August 3, 2007

Jon Ogg can be reached at jonogg@247wallst.com; he does not own securities in the companies he covers.

Posted on: August 3, 2007 – 11:44 am in Biotech, Earnings, FDA, , , ,

Medarex Stock Options Activity Resembles Dendreon’s Trading

Stock Tickers: MEDX, DNDN

When traders made bets and saw a move of more than 200% at one point onFriday in Dendreon (DNDN), this is the sort of news that can getbiotechs with upcoming events (and even some of the old dead biotechzombies) going.  Don’t be shocked when you look back to Friday or evenover the next two weeks as traders are parsing through trades to findwhat could be the next mover like Dendreon (DNDN).  Before readingfurther, understand that trying to look for a 200% gainer is not thenorm and trying to predict a gain or loss of anything remotely close tothis in a biotech company is one that even industry and corporateinsiders have charred their fingers on many times. 

But what can be done is looking out on the horizon as far as optionstrading and open interest is telling you, and this will at least give ashot to see where some of the smart money and aggressive traders areplacing some bets and where they see a big potential move down theroad.  Medarex Inc. (MEDX-NASDAQ)is one of those names as one of the upcoming biotech review stocks towatch.  This is already a battleground stock as traders have placedbets in favor and against this name, just like they did in Dendreon,and the short interest has risen.  The company’s financials have beenleft off for a space-saving since this is already a long note, but theyhave ample operating capital and partnerships that should keep themgoing for years.  The short interest grew from 13 million shares inFebruary to 16.7 million in March, and its market cap is almost $1.6Billion.  At a $12.72 close MONDAY, shares are in the middle of a $8.51to $16.23 52-week trading range; shares have been significantly higherand lower over the last 10 years and more.

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Posted on: April 4, 2007 – 8:04 am in Biotech, , , , , ,

Barron’s Alzheimer’s Article Only Scratches the Surface

Stock Tickers: WYE, NRMX, ELN, NVS, PFE, LLY, JNJ, AZN, TRGT, SNH, SRZ, BKD, ALC, HCR, ESC, MYGN, FRX, NYMX, ICGN, MEMY, EPIX, SI, ESALY, MRK, MATK

This weekend, Barron’s has run its cover story on which companies may stand to win in the medical war against Alzheimer’s Disease.  This really only scratches the surface of this devastating problem,even though it is addressing the pipelines that may yield newtreatments.  Barron’s notes drugs that may be able to treat the disease rather than just the symptoms in the next two years.  The article still does a good job to point out the current treatments and some of the companies that have studies that have either completed or being close to completion.   

Wyeth (WYE-NYSE) was the one noted as the best investment bet in the cover story article from Barron’s, which also was noted at the biggest discount to peers. Barron’s also notes: Neurochem (NRMX-NASDAQ) out of Canada, Elan (ELN-NYSE/ADR) in Ireland (and US) (with mixed results in recent years), Novartis (NVS-NYSE/ADR) is Switzerland (And US and elsewhere), Pfizer (PFE-NYSE), Forest Labs (FRX), Eli Lilly (LLY-NYSE), Johnson & Johnson (JNJ-NYSE) were all noted with currently "on the market" drugs in the ongoing studies for possible Alzheimer’s treatments in some form or fashion.  The current drugs from J&J, Novartis, Forest and Pfizer are really meant more as slowing-agents rather than cures.  Unfortunately, there is no magic pill that just zaps this disease.

Neurochem (NRMX) mentioned in the Barron’s article is in Phase III studies in Europe and recently completed Phase III’s in North America for its Alzhemed(TM). It has already filed to raise $102 million in aggregate securities and its balance sheet indicates it may need more cash again at some point in the near future.  This one is perhaps one of the more leveraged names in the article.

Myriad Genetics (MYGN-NYSE) has just completed enrollment ofpatients in its global Phase 3 clinical trial of Flurizan(TM) inAlzheimer’s disease, the first in a new class of drugs known asSelective Amyloid Lowering Agents (SALAs).  This was also noted briefly in the Barron’s article, but these results look promising so far even though the interim results are not planned and results will be unknown until next year.

Forest Lab’s (FRX-NYSE) fiscal March 2006 saw $505 million of $2.96Billion total sales come from Namenda (R) (not Manenda), which was approved in 2003 asan Alzheimer’s treatment.

AstraZeneca (AZN-NYSE) and Targacept (TRGT-NASDAQ) are in Phase II’s for AZD3480 to stimulate the brain’s memory neurotransmitters.

BUT…..there are many more companies here that need to be given some attention.  This is a huge field and there are many mid-cap and small-cap stocks that can be huge beneficiaries of this.  As we have said the Barron’s article is incomplete, and the same will obviously be true here because there are so many aspects to the story.

Our own Douglas McIntyre pointed out several nursing home and assisted care facility operators just on March 20, 2007 after the Wall Street Journal ran an article about the boomers reaching retirement age and the long-term forecasts in the dementia epidemic.  The facilities Doug noted there were Senior Housing (SNH-NYSE) (a REIT), Sunrise Senior Living (SRZ-NYSE), Brookdale Senior Living (BKD), Assisted Living (ALC-NYSE), and Manor Care (HCR).   There are many, many others worth note that have the potential to benefit from this.

Emeritus Corporations (ESC-AMEX) is a national provider of assisted living and Alzheimer’s and related dementia care services to senior citizens.  After the acquisition of Summerville Senior Living announced this last week it will operate 284 communities in 36 states comprising 24,448 units with a capacity for over 28,000 residents. Summerville is adding 81 communities comprising 7,935 units in 13 states which provide independent living, assisted living, and Alzheimer’s and dementia related services to seniors.  This one is more of a pure-play in the assisted living sector, but keep in mind that its stock ran up on this acquisition and its earnings has been spotty.

Nymox Pharmaceutical Corporation’s (NYMX-NASDAQ) in Canada holds some patent rights for statin use for the treatment and prevention of Alzheimer’s disease, so some of these larger statin makers could theoretically end up shelling out some royalties down the road.  Will they really?  Who knows, that’s a long-term issue. 

Icagen, Inc. (ICGN-NASDAQ) has potential candidates as lead compounds for dementia, including Alzheimer’s disease, for which the Company’s collaborator Astellas Pharma Inc. is conducting preclinical studies, and lead compounds for attention deficit/hyperactivity disorder, which were derived from the collaboration and for which the Company is conducting preclinical studies.

Memory Pharmaceuticals (MEMY-NASDAQ) just raised cash ($10M) to help fund its pipeline studies.  These conditions include Alzheimer’s disease, schizophrenia, bipolar disorder and depression.  This one recently saw its stock implode when its MEM1003 failed to show its effectiveness in acute mania in bipolar disorder, and this MEM1003 is actually being studied for Alzheimer’s.  We noted this at the time, so they better hope for better luck there on the new indication.

EPIX Pharmaceuticals (EPIX-NASDAQ) has a compound PRX-03140 which is in a Phase IIa clinical trial in Alzheimer’s disease.  Siemens (SI-NYSE/ADR) an agreement with Wyeth Pharmaceuticals to utilize Siemens’ new research imaging agent in Wyeth’s clinical studies of new therapies in development for Alzheimer’s disease.

 

Eisai Co. Ltd (ESALY-NASDAQ/OTC) has increased its research facilities in the US and is studying E2012 in preliminary Phase I of its gamma secretase modulator that is being evaluated as a potential new treatment for Alzheimer’s disease.  Merck (MRK-NYSE) and Martek Biosciences (MATK-NASDAQ) are each studying seperate tests (not related to each other).

Even in 2000, the Biotechnology Industry Organization estimated that in the United States alone the total cost of Alzheimer’s Disease was approximately $100 Billion per year.  Healthcare costs haven’t been static by any means, so you can take that number on up drastically from there.  After getting to witness on multiple personal occasions the devastationAlzheimer’s and Dementia causes to the patient, their finances, and theimpacts it has on immediate family, this is a topic of personalimportance and interest.  I have added on to the article because thisis a far reaching issue where it doesn’t really seem like one miraclealone is going to be a true cure that eradicates what is by no meansshort of an epidemic as we live longer and longer.  It is estimatedthat 5 million people in the United States alone are living withAlzheimer’s Disease.

Jon C. Ogg
March 31, 2007

Jon Ogg can be reached at jonogg@247wallst.com; he does not own securities in the companies he covers.

Posted on: April 1, 2007 – 12:01 pm in Biotech, Drug companies, Medical, , , , , , , , ,