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
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
When Barron’s Runs BioHealth Stocks (CEPH, AXL, ISRG)
Today we are seeing two stocks higher after Barron’s featured these over the weekend in what traders call “The Weekly Bible” in the business.
Cephalon (NASDAQ: CEPH) is trading up slightly after Barron’s covered its promiosing pipleline. With two new products on the market and one more in 2009, Barron’s thesis was that shares are not having the same problems as other bigger drug stocks and that shareholders should be sleeping easily here. Shares are only up 0.5% at $77.37, but it is a larger company with a market cap of more than $5 Billion.
Auxilium Pharmaceuticals (NASDAQ: AUXL) is seeing a sharp 5% gain today after Barron’s talked up its Testin product, a testosterone gel used by men to live more energetic lives. Barron’s noted that the Xiaflex drug for a hand treatment in the hundreds of thousands could have blockbuster status by 2011 after launching in 2009.
Barron’s can definitely make your biotech or drug stock rise when they cover it. But remember that the axe swings both ways. Back on July 28, 2008, shares of Intuitive Surgical (NASDAQ: ISRG) took almost a $14.00 haircut after the Barron’s cover story called the company overvalued.
Jon C. Ogg
August 11, 2008
SurModics: Investors Looking Under The Hood (SRDX, MRK, JNJ)
SurModics Inc. (NASDAQ: SRDX) is seeing a sharp drop after recent news. Its partner Merck & Co. (NYSE: MRK) is still under an agreement with the SurModics in Phase IIb I-vation trials, but Merck has suspended enrollment in the study as it is studies the design. This follows a recently published study comparing laser treatment and intravitreal injections of triamcinolone acetonide in patients with diabetic macular edema. The one downgrade we have seen today is from Barrington Research.
SurModics also makes the coatings for the Johnson & Johnson (NYSE: JNJ) Cypher dreg-eluting stents. As drug-eluting stents went through a two-year controversy, that part of SurModics’ business has not grown as much as some were hoping. This company still has many applications not yet on the market, so neither situation takes the “call option” out of this company as far as evaluating its potential worth which you can see on its applicable uses on its site.
The company now has a market cap of $710 million and its most recent tangible book value after backing out goodwill and other intangibles was about $108 million. The 52-week trading range is $38.17 to $56.75, and shares this morning went as low as $38.51.
This company is actually lucky that it has only traded 360,000 shares as of 12:55 PM EST, as that is still well over double an average day but is not indicative of institutional holders throwing in the towel all over again.
Jon C. Ogg
August 11, 2008