E.D. Drugs Causing Amnesia?
There have always been some concerns about side-effects from drugs that treat erectile dysfunction or E.D. Some are sudden blood pressure drops, hearing loss, and some are erections lasting four hours or more. There are also other side-effects, but the newest may have a new twist: TEMPORARY AMNESIA!
A labeling approval change was approved this month from the FDA that will also list amnesia as one of the side-effects in many erectile dysfunction drugs from major pharmaceutical companies. While this is a rare condition, it is called “transient global amnesia.” Here are the companies with changes:
- Pfizer Inc. (NYSE: PFE) for Viagra
- Eli Lilly & Co. (LLY) for Cialis.
After looking around the news and doing some back-dating, it looks like the FDA already made some label changes in Bayer’s Levitra, marketed in the U.S. by GlaxoSmithKline (NYSE: GSK) and
Schering-Plough (NYSE: SGP). You can see the notes on WebMD here.
What is odd is that it is not even clear and doesn’t seem to have been proven that E.D. drugs are responsible for the temporary amnesia. As most E.D. users are older in age and/or because so much is tied to blockage, it might even be other issues entirely. Over that we can not speculate, or are last refraining from it. The drug companies haven’t said that there is a definite answer either.
Think of the good news though. This could become a great excuse builder in the world. Maybe the big head isn’t the big thinker for men after all. This might also be the best argument ever that two-fers are crucial so that you are sure to remember what you did.
“Honey, I know those pictures are proof I was caught cheating. But I can’t remember it!!!!!”
That’s about it, because any more might be inappropriate for a business site.
Have a good weekend, even you don’t remember it all.
JON C. OGG
AUGUST 22, 2008
A New Fight Against Female Sexual Dysfunction
There is new news on the fight against sexual dysfunction in women. Noven Pharmaceuticals, Inc. (NASDAQ: NOVN) has entered into global license and supply agreements with Procter & Gamble (NYSE: PG) under the consumer product giant’s Pharmaceuticals unit for the development and commercialization of prescription transdermal patches for the treatment of Hypoactive Sexual Desire Disorder in women. The condition is called HSDD. You can hear thousands of husbands cheering right now.
Noven has granted P&G an exclusive worldwide license to a testosterone patch for the treatment of HSDD in women, as well as potential next-generation patches in the same therapeutic category.
As part of this arrangement, Noven will receive royalties and manufacturing fees as well as development and sales milestones relating to the licensed products. P&G will also fund any clinical development costs and is also responsible for any regulatory filings and marketing applications associated with the licensed products.
Noven successfully formulated the licensed testosterone patch utilizing its patented DOT Matrix® transdermal delivery technology pursuant to a development agreement between Noven and P&GP established in 2003.
This is just one more product for P&G, but for Noven this might be a windfall. Its market cap is only $310 million and its total revenues for 2007 were listed as $83.161 million. This is supposed to be the crossover profitability year for Noven as well on a non-GAAP basis with analysts looking for estimates of $0.61 EPS on $102.3 million in revenues.
Jon C. Ogg
August 21, 2008
International Blood Screening Assay Recall (GPRO, NVS)
In July 2008, Gen-Probe Inc. (NASDAQ: GPRO) was notified that certain blood screening assays manufactured by the company for Novartis’ (NYSE: NVS) Vaccines & Diagnostics unit and sold outside of the United States might have been improperly stored at a Novartis warehouse in Singapore.
The company investigated the product performance and on August 12, 2008 Gen-Probe determined that it could not fully assess the potential impact of these improper storage conditions. The determination was being used to determine the ultimate performance of the product without conducting additional stability testing, which is expected to be completed over the course of the next 30 to 60 days.
Novartis and Gen-Probe agreed that products previously delivered to customers from this warehousing facility should be replaced and appropriate field actions were initiated with customers and the regulatory authorities in the affected countries.
The affected products include Novartis’ PROCLEIX and PROCLEIX ULTRIO blood screening assays. Gen-Probe believes that Novartis has sufficient inventory at other locations to prevent any significant disruption in supply to Novartis’ customers. The Company also said it does not expect to incur any charges in connection with this event and believes that Novartis may replace the majority of the affected products with replacement products that will be ordered during the remainder of 2008.
Gen-Probe is lucky that this is being considered an issue of storage by Novartis rather than another issue. Product recalls in the medical field are generally not received with much warmth.
Jon C. Ogg
August 18, 2008
Carl Icahn Still Active in BioHealth Stocks (ANX, FOLD, AMLN, BIIB, CYBX, EMIS, ENZN, REGN, TELK)
Billionaire activist investor Carl Icahn showed his biotech and medical holdings yesterday, with the ownership filing date as of June 30, 2008. Here is a snapshot of his filed holdings:
- Adventrx Pharmaceuticals Inc. (AMEX: ANX)3.459 million shares, small position for Icahn
- Amicus Therapeutics, Inc. (NASDAQ: FOLD) 201,940 shares, small stake and small interest
- Amylin Pharmaceuticals Inc. (NASDAQ: AMLN) 6.787 million shares
- Applera Corp
- Biogen-Idec (NASDAQ: BIIB) 9.948 million shares, which has actually been added to since that date
- Cyberonics (NASDAQ: CYBX) 2.008 million shares
- Emisphere Technologies, Inc. (NASDAQ: EMIS) 86,430 shares, tiny position for Icahn
- Enzon Pharma (NASDAQ: ENZN) 2.457 million shares
- Regeneron Pharma (NASDAQ: REGN) 2.508 million shares
- Telik Inc. (NASDAQ: TELK) 4.156 million shares
Jon C. Ogg
August 15, 2008
Analysts Weighing In On BioHealth Stocks (AUXL, AVRX, CPHD, MEND, AMED)
These are some of the analyst calls impacting biotech, medical, and healthcare stocks right at the open this Thursday morning:
- Auxilium Pharmaceuticals (AUXL) Cut to Neutral from BUY at B of A.
- Avalon Pharma (AVRX) Cut to Hold from Buy at Cantor Fitzgerald.
- Cepheid (CPHD) Cut to Neutral from Buy at UBS.
- Micrus Endovascular (MEND) Started as Hold at Needham & Co.
Amedisys (AMED) Raised to Outperform from Mkt Perform By Wachovia… more into home based healthcare and hospice, but involves caring for the aged and ill.
Jon C. Ogg
August 14, 2008
Cloning, No Longer Just For Star Wars
Cloning may invoke more controversy than any topic, short of a few that we won’t go into. But there is a new pact out there regarding animal cloning that investors may be playing ahead. Geron Corporation (NASDAQ: GERN) and Exeter Life Sciences, Inc. announced a merger of Start Licensing, Inc., a joint venture between Geron and Exeter Life Sciences, and ViaGen, Inc., a subsidiary of Exeter Life Sciences. The deal was announced Tuesday but may have ramifications for years into teh future.
This venture called Start manages and licenses a broad portfolio of intellectual property rights related to animal reproductive technologies, which of course includes animal cloning. ViaGen is a leading animal genomics and livestock cloning firm. Does the name Dolly the Sheep ring a bell?
The merger of Start and ViaGen, combines the full breadth of intellectual property rights to nuclear transfer cloning technology, including that developed at the Roslin Institute for cloning Dolly the sheep. Customers can secure a license to practice or contract cloning services.
Modified or cloned animals may answer many questions to basic needs around the world, and of course it opens up another Pandora’s Box depending on how far this is allowed to go. The companies also note that cloning has applications in the production of biopharmaceuticals, such as therapeutic proteins in milk and antibodies in blood.
Cloning anything beyond compounds and certain animals is going to open up one major controversy out there. But independent business owners would probably line up right now if this was extended to you and me. They’d likely turn in an order for 3 units if they can afford it: two for work, and one for parts.
Jon C. Ogg
August 13, 2008
It Will Take Much More to Buy Genentech (DNA)
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
Short Sellers Lightening Up Against Biotechs (AMGN, GILD, CELG, GENZ, BIIB)
Short sellers haven’t just eased up on betting against financial stocks. If you look at the major biotech stocks not involved in mergers you will see an across the board drop in the short interest in major biotechs. Below we have show the dates and the changes to represent each of the major names:
- Amgen (AMGN) 07/31/2008 short interest 31,659,693 down 22.96% from 07/15’s 41,097,709 shares.
- Gilead (GILD) 07/31/2008 short interest 33,141,320 down 0.06% from 7/15’s 12,632,227 shares.
- Celgene (CELG) 07/31/2008 short interest 12,301,038 down 20.38% from 7/15’s 5,642,397 shares.
- Genzyme (GENZ) 07/31/2008 short interest 6,839,521 down 8.21% from 7/15’s 3,888,041 shares.
- Biogen Idec (BIIB) 07/31/2008 short interest 7,467,029 down 2.67% from 7/15’s 4,819,980 shares.
With all the merger activity happening in the sector, you can imagine that short sellers probably wanted to avoid walking in one morning to find the stock up 25% on a merger announcement.
Jon C. Ogg
August 12, 2008
BIOTECH STOCK SPLITS: Alexion’s First Split (ALXN)
Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) is about to see its first corporate and investor event tomorrow of this kind. August 13 will be the EX-DATE for its 2-for-1 stock split which was announced back on July 29.
What is sort of odd is that this stock reached $100 briefly during the summer months way back in 2000 during the NASDAQ bubble days and it did not split then. It then traded as low as $10.00 by late-2002. When this came public in 1996 it was less than a $10.00 stock.
Alexion’s stock has done well as this was in the mid-$70’s in mid-July and shares put in a new 52-week and multi-year high just yesterday with shares briefly trading above $95.00. Shares are down almost 2% on light volume at 10:00 AM EST at $93.25. It isn’t happening with any conviction, but it looks like there is light profit taking with low interest from market makers this morning ahead of tomorrow’s effective split.
2007 marked the entry stage for Alexion’s revenue generation when it posted $72 million in revenues. Analysts are looking for 2008 revenues of about $247.3 million and 2009 revenues of about $382 million. 2008 is expected to be modestly profitable but analysts are looking for profits above $1.50 EPS in 2009.
The company markets Soliris (eculizumab) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), a rare and life-threatening blood disorder in the United States and Europe. The company is evaluating expanded uses and is also involved in several other various studies of unrelated treatments such as cancer vaccines, age-related macular degeneration, myasthenia gravis and multi-focal motor neuropathy, chronic lymphocytic leukemia, multiple myeloma, and asthma.
Its market cap today is $3.6 Billion and it is sometimes rather active in stock options. Alexion’s 52-week trading range is $49.26 to $95.27, which after today will read as an adjusted $24.63 to $47.635.
JON OGG
August 12, 2008
Altus Falls Sharply on Cystic Fibrosis Trial Results (ALTU)
Altus Pharmaceuticals Inc. (ALTU) is trading lower after mixed results in a cystic fibrosis Phase III trial. Unfortunately, the results weren’t quite what the investment community was hoping for.
The study met some of the endpoints, but there were hopes for better results that had been indicated and some results varied geographically between those in the U.S. and those outside the U.S. This was its Phase III efficacy trial for cystic fibrosis patients suffering from pancreatic inefficiency.
So far this morning we have also seen a downgrade as Cowen & Co. lowered its rating to NEUTRAL from Outperform.
Shares are down over 30% pre-market at $3.36 as of 8:40 AM EST.
JON OGG
August 12, 2008