Amgen's Trouble in Lung Cancer Trials (AMGN)
Amgen (NASDAQ: AMGN) and Takeda Pharmaceutical Company Limited’s Millennium Pharma have issued some disappointing news on the lung cancer front. The companies have announced that enrollment in the Phase 3 MONET1 trial evaluating motesanib (AMG 706) in combination with paclitaxel and carboplatin as a first-line treatment of advanced non-small cell lung cancer has been temporarily suspended.
This follows a planned safety data review of 600 patients by the study’s independent Data Monitoring Committee. Motesanib is part of a broad co-development program between Amgen and Takeda.
The monitoring committe recommended that enrollment in the study be suspended. This is based on an observation of higher early mortality rates in the motesanib group compared to the placebo group.
The committee recommended that the squamous patients with immediately discontinue motesanib therapy based on an observation of a higher incidence of hemoptysis, but it did not recommend for the non-squamous patients to discontinue motesanib therapy.
Here are the full details from Amgen.
Jon C. Ogg
November 19, 2008
Drug Eluting Stents Vs. Bare Metals Stents Win Again
A new study funded by the Massachusetts Department of Public Health is showing further evidence to support the use of drug eluting stents over bare metal stents in heart attack patients. This study measured stent use specifically in diabetic patients. Drug-eluting stents showed improved outcomes as compared with bare metal stents in diabetics, and no excess adverse events were found with drug-eluting stents in diabetic patients. This data was reported by researchers at the American Heart Association’s Scientific Sessions 2008 in New Orleans. Some of the raw numbers appear marginal, but others are very impressive.
Drug-eluting stents reduced the risk of revascularization, heart attack and death in diabetics as compared with bare-metal stents in the largest observational comparison. The results were presented as a late-breaking clinical trial and is simultaneously published in circulation in the Journal of the American Heart Association.
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Great News For Hospital-Acquired infections (OPTR, VPHM)
If you have ever personally contracted or know anyone who has contracted hospital or long-term care born internal infection, there is a bit of good news this morning. Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) released some positive top-line results from its pivotal Phase III clinical study of Optimer’s lead anti-infective drug candidate, OPT-80, in patients with Clostridium difficile Infection (CDI).
ViroPharma (NASDAQ: VPHM) makes the competing drug called Vancocin, and its shares are down 5.7% at $11.85 in pre-market trading.
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Should Crestor & Statins Become Mass Market?
AstraZeneca plc (NYSE: AZN) is seeing a possible serious win this morning on good news from its Crestor presentation showing that it cuts heart attack and stroke risks even in healthy adults.
The company showed sata from its JUPITER study (Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvast) demonstrated that CRESTOR® 20 mg significantly reduced major cardiovascular (CV) events by a dramatic 44% compared to placebo among men and women with elevated hsCRP but low to normal cholesterol levels. CV events were defined in the study as the combined risk of myocardial infarction, stroke, arterial revascularization, hospitalization for unstable angina, or death from CV causes.
Some other results were huge as well. The combined risk of heart attack, stroke or CV death was reduced by nearly half (47%), risk of heart attack was cut by more than half (54%), risk of stroke was cut by nearly half (48%), and total mortality was significantly reduced by 20%. These results were accompanied by a median LDL-C reduction of 50% resulting in an on-treatment median LDL-C of 55 mg/dL.
This data is being presented at American Heart Association Scientific Sessions and were also published online by the New England Journal of Medicine.
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Wal-Mart Lands In Middle of Diabetic Product Recall (COV, WMT)
Covidien, Ltd. NYSE: COV) and the FDA have notified patients and healthcare professionals of a product recall which has been sold to diabetics. Wal-Mart Stores Inc. (NYSE: WMT) gets to find itself at yet another controversy, yet it isn’t really Wal-Mart’s fault on the surface.
This recall is covering the ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles used by insulin-dependent diabetes. These syringes were sold only by Wal-Mart or Sam’s Club pharmacies under the ReliOn name.
The mislabeled syringe may result in patients receiving an overdose of as much as 2.5 times the intended dose, with serious health consequences, low blood sugar, and even death. The recall applies only to lot number 813900. The product was distributed from Aug. 1, 2008 until Oct. 8, 2008, and includes 471,000 individual syringes in 4,710 boxes.
If you need to read more, here is the official notice.
Jon C. Ogg
November 6, 2008
Are Contract Research Organizations The Next Bubble? (CRL, CVD, PRXL, PPDI, PDG)
Contract research organizations, or CRO’s, were one great growth story. They were in the sweet spot of the drug and biotech sectors and generated massive growth for investors. The CRO companies were also set to be serious winners as biotech and drug companies pursued cost-cutting strategies which drove business straight to the CRO’s. But there is a reason all of the prior sentences are in the past tense.
Today we saw more evidence that CRO’s are not only not immune to the current economy, they are now under fire. Charles River Laboratories International Inc. (NYSE: CRL) dropped the ball that it was cutting its guidance for 2008. The trends we saw in early August appear to coming to a crashing halt.
Last night the CRO gave earnings with a 4% rise to $0.63 EPS. Outside of charges, it earned $0.76 EPS. Its revenues also grew by 9% to $342.2 million. Thomson Reuters was expecting estimates of $0.75 EPS on $347.8 million in revenues.
But guidance is what destroyed the stock. It took a prior earnings range of $2.94 to $3.00 EPS down to a new lower range of $2.83 to $2.87 EPS. The company noted that its clients continue to invest in drug discovery and development, but noted that clients are facing a range of unprecedented challenges from drugs losing patent protection to the availability of funding for small biotech companies. It also cited drug commpanies cutting jobs, cuttiung costs, shifting to later-stage drug development programs, and either outright putting projects off or pushing out current projects to 2009.
Charles River shares and shareholders are paying a major price for this today, as this stock is down 21% at $26.60. This is also a new 52-week low as the prior range had been $30.80 to $69.19.
More and more drug companies have been farming out an increasing amount of their research to firms like Charles River Labs and Covance Inc. (NYSE: CVD). Those shares are down over 8% at $50.21 in sympathy with Charles River, and its 52-week trading range is $41.65 to $99.08.
Paraxel International Corp. (NASDAQ: PRXL) is also down over 9% at $9.22, although its 52-wee ktrading range is $6.84 to $36.16.
Pharmaceutical Product Development Inc. (NASDAQ: PPDI) is down over 6% at $26.97, and its shares have traded in a range of $24.65 to $49.39 over the last year.
PharmaNet Development Group, Inc. (NASDAQ: PDGI) is one of the few up on the day, but that is just marginally. This stock has also been torn apart and trades down more than 95% from its former highs as it has been losing money.
On election day, we noticed that there were many winners in drug and biotech stocks but the CRO stocks were performing horribly.
We would also like to note that this means also may put on additional job pressures even in the CRO sector. We noted that the drug and biotech cutbacks would allow the CRO’s to hire many more qualified workers at lower rates, but now the firms may have to focus on costs to hire rather than than quality at a cost.
This could be a very sad trend if this continues. The belief is that this is a temporary event as credit is hard to get and as venture funding may be down. But what if it isn’t? We have been wondering what laid off bank tellers, mortgage brokers, real estate employees, and stock brokers will do after the next wave of layoffs hits Wall Street and Main Street. But what exactly do laid off workers the medical and clinical research sectors go do as their next career? Whatever it is, it is likely for much lower pay.
Jon C. Ogg
November 6, 2008
Election Day's Winners & Losers in Biotech and Drug Sectors
Today’s biotech winners are as follows:
- GPC BIOTECH AG (GPCB) +80.34%
- ALSERES PHARMACEUTCL (ALSE) +32.90%
- OSIRIS THERAPEUTICS (OSIR) +18.26%
- TRANSITION THERAPEUT (TTHI) +9.68%
- REXAHN PHARMACEUTICL (RNN) +8.91%
- ANADYS PHARMACEUTICA (ANDS) +8.65%
- NEURALSTEM INC (CUR) +8.22%
- ALNYLAM PHARMACEUT (ALNY) +7.46%
- LEXICON PHARMACEUTCL (LXRX) +6.55%
Today’s Drug stock winners are:
- WYETH (WYE) +6.27%
- JAVELIN PHARMACEUTIC (JAV) +5.15%
- LILLY ELI CO (LLY) +4.41%
- SCHERING PLOUGH CP (SGP) +4.07%
- MERCK CO INC (MRK) +3.77%
- PFIZER INC (PFE) +3.03%
- BRISTOL MYERS SQIBB (BMY) +2.91%
- ASTRAZENECA PLC ADS (AZN) +2.77%
Contract research organization, or CRO,are taking it right on the chin today:
- Charles River Laboratories (CRL) -1.45%
- Covance Inc. (CVD) -6.03%
- Parexel International (PRXL) -2.65%
- Pharmaceutical Pdt. Dev. (PPDI) -4,14%
- PharmaNet Dev. Group (PDGI) -9.37%
Biotech losers are as follows:
- AMYLIN PHARMA INC (AMLN) -22.43%
- COMPUGEN LTD (CGEN) -16.15%
- QLT INC (QLTI) -10.36%
- NOVACEA, INC. (NOVC) -9.52%
- CERUS CORP (CERS) -7.01%
Jon Ogg
November 4, 2008
Osiris and Genzyme Ink Adult Stem Cell pact (OSIR, GENZ)
Osiris Therapeutics (NASDAQ: OSIR) and Genzyme (NASDAQ: GENZ) have entered into a pact to develop and commercialize what the companies are calling first-in-class adult stem cell products. Osiris was also just mentioned yesterday as one of the many stem cell beneficiaries of the 2008 presidential election.
Stem Cells Win In 2008 Presidential Election (STEM, GERN, ASTM, NBS, CHBP, KOOL, OSIR, OPXA, ACTC)
Tomorrow is the US Presidential Election, and while we do not have the known votes in, the exit polls for early voters and the polls taken from national sources are showing Obama over McCain by a small but widening margin. We are not a political sight and do not pretend to host any political opinions here. But there is one thing that looks more and more for sure: Stem Cells might as well be declared a winner regardless of who wins the election tomorrow.
In the past we have covered at 24/7 Wall St. how both Obama and Clinton attacked the Bush policies on stem cell research. After a quick review of “McCain Stem Cell” there is also a link on the McCain website showing that he has supported stem cell research.
StemCells Inc. (NASDAQ: STEM) has seen a monster rally today with shares up some 40% at $2.02 on more than 7 million shares (almost 20-times volume) after the stem cell company said that its proprietary HuCNS-SC product candidate made from purified human neural stem cells can protect the retina from progressive degeneration when transplanted into a well-established animal model. Retinal degeneration leads to loss of vision in diseases such as age-related macular degeneration and retinitis pigmentosa. We’d like to note that the company had that old shelf filing. StemCells had also received a patent for neural stem cells from all tissue sources.
What is interesting here is that there have been many bits of data today and in recent days on the topic. We can’t assure you that the administration that takes control can stop the rampage in speculative stocks in a bear market. But either candidate is going to be more “pro-stem cell research” in their policies than what we have seen over the last eaight years.
Shares of Geron Corp. (NASDAQ: GERN) are also up over 11% as the hopes that good news in one stem cell company will translate to universal benefits. Aastrom Biosciences, Inc. (NASDAQ: ASTM) is also up even much more with gains of 46% today, but its stock is well under $1.00 at $0.58.
NeoStem, Inc. (Amex: NBS) has agreed to acquire China Biopharmaceuticals Holdings, Inc. (OTCBB: CHBP). This acquisition is anticipated to expand the capabilities and reach of NeoStem, which is pioneering the pre-disease collection, processing and long-term storage of adult stem cells for future medical need. Suzhou Erye Pharmaceutical Co. Ltd., the primary subsidiary of China Biopharmaceuticals is located in Suzhou, China and is currently tracking to generate revenues of approximately US$50 million and net over US$7 million in 2008. NeoStem will hold a 51% controlling stake in Erye who currently manufactures over 100 drugs on seven GMP lines, including small molecule drugs. Erye has been in business for more than 50 years and is respected for its quality, service and reliability. Erye has begun its three year expansion and relocation program which is anticipated to enhance revenues, profits, and manufacturing capabilities in one of the fastest growing medical markets, the Peoples Republic of China.
This is an old feature, but a small company won a new patent in bone marrow & stem cell transplants.
Thermogenesis Corp. (NASDAQ: KOOL) is a small overlooked stem cell related stock engaged in the design, manufacture, and marketing of automated and semi-automated devices, and single-use processing disposables
Osiris Therapeutics, Inc. (NASDAQ: OSIR) reports earnings tomorrow, although revenues here are negligible.
Opexa Therapeutics, Inc. (NASDAQ: OPXA) is focused on autologous cellular therapy applications of its proprietary T-cell and stem cell therapies. In August it completed a $3 million private placement, to support the ongoing clinical development of Tovaxin, the company’s novel treatment for multiple sclerosis.
Advanced Cell Technology Inc. (OTC-ACTC) is involved in the development and commercialization of human embryonic and adult stem cell technology in the field of regenerative medicine. This is the most volatile of stem cell stocks and its stock has fallen from $1.00 to just over $0.04 of late. But the reason we have listed it here is because its shares are rather active and are active on most trading days.
Jon C. Ogg
November 3, 2008
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