BioWatch Stock Alert: Somanetics Jumps on Volume Spike
by H.S. Ayoub, DMD
BioHealth Investor
Shares of Somanetics Corp (SMTS) jumped 6.82% on Thursday as volume surged almost three times the three-month daily average!
There were no news or any significant events that could be detected.
Somanetics develops, manufacturs, and markets medical devices primarily in the United States. It offers the INVOS System, a non-invasive patient monitoring system that provides continuous information about changes in blood oxygen saturation levels in patients with or at risk for restricted blood flow.
The company has a small market cap of only $357 million. It has more than $50 million in cash and no debt according to the latest Yahoo! financial data.
The company has been experiencing great growth in revenue and net profit over the last few years with the sale of the INVOS System.
Shares of SMTS closed at $26.80 on Thursday, which is just shy of the 52-week high of $26.88 reached on the same day.
Somanetics is the first stock in 2008 to make BHI’s BioWatch Alert List, and will be tracked for the next two weeks.
BioHealth Investor.com
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Tested on the young, used on the old
by David E. Williams
Health business blog
Ever notice that medical devices are tested on non-Medicare populations and then paid for mostly by Medicare? Dr. Rita F. Redberg did. See (Medicare coverage decisions often based on trials in irrelevant populations)
“I was appointed to the [Medicare Evidence Development and Coverage Advisory Committee] MedCAC in 2002, and my first meeting was called because Guidant had requested expansion of defibrillator coverage in the Medicare population,” co-author Dr. Rita F. Redberg told Reuters Health. “In reviewing the technology assessment, it was obvious that the data were based on a population that was different than the population we were being asked if defibrillators would provide benefit for.”
“It was difficult to make that extrapolation, ‘how would the Medicare population do based on a study in middle-aged healthy men?’” she added. “It made me think that this was not an isolated incident.”
Sure enough, when Redberg and co-author Sanket S. Shruva looked at assessment of cardiovascular technologies between 1998 and 2006 they found that the hunch was true and their study (Variations Between Clinical Trial Participants and Medicare Beneficiaries in Evidence Used for Medicare National Coverage Decisions) was published in The Archives of Internal Medicine published on January 28, 2008.
The clinical trial participants tended to be about 10 years younger (70.8 v. 60.1) and much more likely to be male (75% v. 44%) than the Medicare population.
My understanding is that the vast majority of these devices are used in the Medicare population, so this is a legitimate point. Still, it would be a shame if the impact of this report were to require companies to do more or larger clinical trials, since it would raise development costs and keep some products off the market.
I’m sure it’s not easy, but it would be great to find a reliable way to extrapolate from typical study participants to Medicare members –or real world users of devices overall. I know that this is already done to some extent through the use of patient registries and databases such as ADHERE.
Health Business Blog is a regular contributor to BioHealth Investor
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McCain is the FrontRunner - The Tea Leaves for Pharma
by Mark S. Senak
Eye On FDA
Last night, John McCain won the Florida primary, clearly putting him in the status of front runner in the Republican Party. Hillary Clinton won Florida, even though that is an empty victory as far as delegates, she is trying to make it into something, and perhaps it does count for something.
Senator McCain’s speech sounded like one rallying all the troops around his nomination. Rudy Giuliani is going to endorse the Senator when he drops out of the race today. And Hillary Clinton is leading in most of the polls of states slated for the Super Tuesday primary.
As a matter of mathematics at this point, it would seem like the election is shaping up to eventually be a Clinton/McCain contest. If the polls for Super Tuesday are right - what would that mean?
As indicated in my earlier features on the candidates both Hillary Clinton and John McCain have indicated that they are in favor of importation and in favor of the ability of the government to negotiate Medicare Part D prices - two domains examined in my candidate series that could re-shape somewhat the pharmaceutical market. Rudy Giuliani opposed importation.
The difference may be that Hillary Clinton seems to have an ax to grind when it comes to the pharmaceutical industry. That does not appear in the McCain rhetoric, nor necessarily with the Obama rhetoric, though that is not clear. Nevertheless, the only difference between the two candidates may be about insurance and the way in which the uninsured are eventually covered.
In that case, it would seem that the candidate between McCain and Clinton who most wants to get the most people who are uninsured, to gain insurance as soon as possible, and therefore to have drug coverage, may be the most amenable candidate to pharma after all.
More on that later.
Eye On FDA is a regular contributor to BioHealth Investor
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Thursday’s Top Biotech & Medical Stocks
by H.S. Ayoub
BioHealth Investor
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Biotechnology
ATHERSYS INC [ATHX] +14.16%
SUNESIS PHARMACEUTIC [SNSS] +14.04%
NILE THERAPEUTICS [NILT.OB] +11.76%
CRITICAL THERAPEUTIC [CRTX] +11.21%
COMBINATORX [CRXX] +11.04%
Diagnostic Substances
SYNTA PHARMACEUTICAL [SNTA] +10.06%
GENELABS TECH INC [GNLB] +8.03%
IMARX THERAPEUTICS [IMRX] +7.25%
ROSETTA GENOMICS LTD [ROSG] +6.65%
CNS RESPONSE, INC. [CNSO.OB] +3.96%
Drug Delivery
PENWEST PHARM CO [PPCO] +7.16%
BIOVAIL CORP [BVF] +4.50%
ARADIGM CORP [ARDM.OB] +4.17%
ACURA PHARMACEUTICAL [ACPH.OB] +3.17%
COLUMBIA LABS INC [CBRX] +2.78%
Drug Manufacturers
GAMMA PHARMACEUTICAL [GMPM.OB] +18.42%
CELL THERAPEUTICS [CTIC] +15.28%
AMARIN CORP ADS NEW [AMRND] +9.02%
ALPHARMA INC [ALO] +7.05%
ARDEA BIOSCIENCES [RDEA] +5.36%
Drug Related Products
CURATECH INDUSTRIES [CUTC.OB] +14.29%
INTEGRATED BIOPHARMA [INBP] +11.51%
N B T Y INC [NTY] +5.07%
PRESTIGE BRAND HLGS [PBH] +3.75%
ARGAN INC [AGX] +2.63%
Generic Drugs
HI-TECH PHARMACAL [HITK] +4.44%
BARR PHARMA INC [BRL] +1.03%
WATSON PHARMACEUTCLS [WPI] +0.77%
CATALYST PHARMACEUTI [CPRX] +0.60%
Medical Appliances & Equipment
ECHO THERAPEUTICS [ECTE.OB] +20.00%
SYNERGETICS USA INC [SURG] +12.61%
INVACARE CORP [IVC] +11.19%
CYTOCORE INC [CYOE.OB] +10.64%
ENDOCARE INC [ENDO] +9.63%
Medical Instruments & Supplies
BIOMERICA INC [BMRA.OB] +33.33%
VICOR TECHNOLOGIES [VCRT.OB] +10.37%
ANGIODYNAMICS INC [ANGO] +9.21%
HAEMONETICS CP [HAE] +8.31%
ADVANCED MED OPTICS [EYE] +6.76%
Medical Laboratories & Research
ALLIANCE IMAGING INC [AIQ] +7.08%
GENOPTIX, INC. [GXDX] +6.68%
BIO-IMAGING TECH [BITI] +5.48%
ARRAY BIOPHARMA IN [ARRY] +5.00%
INSIGHT HLTH SVC HLD [ISGT.OB] +3.33%
- Wednesday’s Top Biotech & Medical Stocks
- Tuesday’s Top Biotech & Medical Stocks
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EU Hedge: Pharmion and Celgene
by Adam Rubenstein
CLSDF
A very interesting few days for Pharmion (NASDAQ: PHRM) and Celgene (NASDAQ: CELG) and how they are faring in their product approval efforts in Europe.
The European Medicines Agency issued a positive opinion to recommend approval of Pharmion’s Thalidomide® for use in combination with melphalan and prednisone as first line treatment for patients with untreated multiple myeloma, aged 65 years or older or ineligible for high dose chemotherapy. Such an opinion often yields a final marketing approval via the European Commission, typically to occur within the window of a quarter. So let’s hope for smooth sailing over the next 12-weeks or so on Thalidomide®.
On a less positive note for Celgene, a European advisory committee recommended against approving its drug Revlimid® as a treatment for anemia patients (the drug is already approved to treat multiple myeloma). The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended against expanding Revlimid’s approval to include treating transfusion-dependent anemia patients with blood disorders known as myelodysplastic syndrome.
Recall that the share price of CELG will effect the final terms in the Pharmion acquisition, you can read more about that in a previous post (here).
CLSDF is a regular contributor to BioHealth Investor
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Schering-Plough Relief on Partner Earnings
by Jon C. Ogg
24/7 Wall St.
Schering-Plough Corp. (SGP) is probably breathing a sigh of relief this morning after Merck’s earnings as it is partners with the drug giant on Vytorin and Zetia for cholesterol treatments.
The combined Vytorin & Zetia franchise was noted as having some $5.2 Billion in 2007 annual sales, with some $1.5 Billion being reported in the fourth quarter alone.
Merck (MRK) did disclose some 50 lawsuits over these sales and noted that it is complying and cooperating with investigations. But the good news is that the company’s guidance wasn’t sharply changed.
Continue reading article at 24/7 Wall Street…
24/7 Wall St. is a regular contributor to BioHealth Investor
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Wednesday’s Top Biotech & Medical Stocks
by H.S. Ayoub
BioHealth Investor
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Biotechnology
ONCOTHYREON [ONTY] +48.06%
METABASIS THERAPEUTI [MBRX] +30.86%
IMMUNOSYN CORPORATIN [IMYN.OB] +16.67%
PLURISTEM THERAPEUTC [PSTI] +14.17%
HESKA CORPORATION [HSKA] +10.53%
Diagnostic Substances
IMMUCELL CP [ICCC] +9.48%
SCOLR PHARMA INC [DDD] +7.14%
AVALON PHARMACEUTIC [AVRX] +7.05%
EPICEPT CORPORATION [EPCT] +6.77%
GENELABS TECH INC [GNLB] +4.58%
Drug Delivery
ELAN CP PLC ADR [ELN] +2.88%
BENTLEY PHARMACEUTIC [BNT] +2.17%
GENEREX BIOTECH CORP [GNBT] +0.01%
Drug Manufacturers
AVANIR PHARMACEUTICL [AVNR] +16.07%
DUSA PHARM INC [DUSA] +10.50%
NEUROCHEM INC [NRMX] +9.74%
AMARIN CORP ADS NEW [AMRND] +6.40%
NEUROGEN CP [NRGN] +5.76%
Drug Related Products
CURATECH INDUSTRIES [CUTC.OB] +6.06%
TIENS BIOTECH GR USA [TBV] +4.83%
MANNATECH INC [MTEX] +3.55%
AUXILIUM PHARMACEUT [AUXL] +2.77%
SALIX PHARM DEL [SLXP] +1.71%
Generic Drugs
CATALYST PHARMACEUTI [CPRX] +1.21%
MYLAN INC [MYL] +1.08%
CARACO PHARMA LABS [CPD] +0.78%
Medical Appliances & Equipment
IRIDEX CP [IRIX] +36.96%
SYNERGETICS USA INC [SURG] +13.86%
THERMOGENESIS CORP [KOOL] +11.24%
IVIVI TECHNOLOGIES, [IVVI] +9.62%
ZYNEX MEDICAL HLDGS [ZYNX.OB] +8.70%
Medical Instruments & Supplies
BIOLASE TECH INCS3 [BLTI] +12.23%
CAS MEDICAL SYS INC [CASM] +7.87%
RETRACTABLE TECH INC [RVP] +5.71%
INFUSYSTEMS HOLDINGS [INHI.OB] +5.26%
CONCEPTUS INC [CPTS] +5.18%
Medical Laboratories & Research
SPHERIX INC [SPEX] +5.22%
GENOPTIX, INC. [GXDX] +2.26%
PSYCHEMEDICS NEW [PMD] +2.08%
BIO-REFERENCE LAB [BRLI] +1.00%
BIO-IMAGING TECH [BITI] +0.26%
- Tuesday’s Top Biotech & Medical Stocks
- Monday’s Top Biotech & Medical Stocks
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WuXi PharmaTech Puts Squeeze on Suppliers
by Richard Daverman, PhD
ChinaBio Today
WuXi PharmaTech (WX) held a conference yesterday with its suppliers. Following a classic good-news/bad-news theme, the Shanghai-based CRO told its suppliers that it expected to increase spending between 50% and 100%, but at the same time, the company asked suppliers for better terms: longer payment periods, quality guarantees and lower prices. WuXi projects its 2008 spending on equipment and materials will total between 300 million RMB ($45.5 million) and 400 million RMB ($54 million).
The theme of the half-day supplier conference, which was attended by 120 representatives of 70 companies, was “Support Partner Success.” The suppliers provide WuXi with equipment and instruments, raw materials, reagents, consumables, etc. According to Li Ge, Chairman and CEO of WuXi, the goal of the conference was to foster “a win-win cooperation for us and our suppliers.”
WuXi awarded Preferred Supplier Awards to Sigma-Aldrich and Alfa Aesar, based on their quality of management systems, the quality of products, on-time delivery, customer service and cost.
In addition, WuXi announced it has centralized supplier buying for its various facilities and for its soon-to-be acquired US division, AppTec Laboratory Services. In early January 2008, WuXi signed a letter of intent to purchase CRO AppTec for $151 million (including debt). Part of the supplier purchases will be to upgrade AppTec so that it can perform the tasks WuXi envisions for it.
In its 2007 fiscal year, AppTec produced $70 million of revenue, while WuXi is on record as expecting its 2007 revenues to be in the $130 million to $135 million range, which would mean the 2007 pro forma revenues of the combined company equal $200 million plus. So far, WuXi has not predicted its 2008 results, but Wall Street analysts have called for the existing WuXi operations by themselves to generate $205 million, an increase of 52%.
WuXi has been growing fast, doubling revenues in the first nine months of 2007 over 2006. It will have difficulty maintaining this level of growth as it gets bigger, and AppTec, though its revenues are also on the upswing, may bring the rate of growth lower as well. WuXi has promised that the acquisition will be accretive from the start, although closing the transaction will cause one-time writedowns.
WuXi has been a rollercoaster of a stock since its August IPO. The company priced slightly above the range at $14, opened at $19, and subsequently traded as high as $45 per share. The shares have backed off from those levels as the speculative fever for stocks has cooled around the globe. Today, WuXi is trading up $1.01 at $24.50.
ChinaBio Today is a regular contributor to BioHealth Investor
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Tuesday’s Top Biotech & Medical Stocks
by H.S. Ayoub
BioHealth Investor
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Biotechnology
OPEXA THERAPEUTICS [OPXA] +27.39%
STEMCELLS INC [STEM] +19.09%
CARDIOVASCULAR BIOTH [CVBT.OB] +13.91%
COMPUGEN LTD [CGEN] +13.87%
GTC BIOTHERAP INC [GTCB] +11.65%
Diagnostic Substances
INTERLEUKIN GENETICS [ILI] +9.08%
ABAXIS INC [ABAX] +4.31%
IDEXX LABS [IDXX] +3.72%
SYNTA PHARMACEUTICAL [SNTA] +3.67%
AMAG PHARMACEUTICALS [AMAG] +2.88%
Drug Delivery
PENWEST PHARM CO [PPCO] +26.17%
ELAN CP PLC ADR [ELN] +4.88%
ACURA PHARMACEUTICAL [ACPH.OB] +4.00%
COLUMBIA LABS INC [CBRX] +3.33%
NOVEN PHARMACEUTIC [NOVN] +3.09%
Drug Manufacturers
PROTALEX INC [PRTX.OB] +14.04%
CHATTEM INC [CHTT] +12.50%
GERON CORP [GERN] +10.99%
ARDEA BIOSCIENCES [RDEA] +9.33%
SUCAMPO PHARMA. INC. [SCMP] +8.92%
Drug Related Products
LABOPHARM INC. [DDSS] +20.67%
PRESTIGE BRAND HLGS [PBH] +7.28%
SALIX PHARM DEL [SLXP] +5.71%
MANNATECH INC [MTEX] +4.78%
AUXILIUM PHARMACEUT [AUXL] +4.70%
Generic Drugs
CATALYST PHARMACEUTI [CPRX] +12.24%
HELICOS BIOSCIENCES [HLCS] +5.24%
CARACO PHARMA LABS [CPD] +1.31%
MYLAN INC [MYL] +0.82%
BARR PHARMA INC [BRL] +0.31%
Medical Appliances & Equipment
LANGER INC [GAIT] +20.40%
MEDICALCV INC [MCVI.OB] +19.51%
ZIMMER HOLDINGS INC [ZMH] +13.15%
NORTHSTAR NEUROSCI [NSTR] +11.03%
CANDELA CP [CLZR] +9.81%
Medical Instruments & Supplies
MILESTONE SCIENTIFIC [MLSS.OB] +13.04%
HOME DIAGNOSTICS, IN [HDIX] +8.66%
BIOSPHERE MEDICAL [BSMD] +8.37%
MEMRY CORPORATION [MRY] +7.83%
CRYOCOR, INC. [CRYO] +7.54%
Medical Laboratories & Research
ERESEARCHTECHNOLOG [ERES] +3.63%
PSYCHEMEDICS NEW [PMD] +2.83%
NATL DENTEX CP [NADX] +1.31%
QUEST DIAGNOSTC [DGX] +0.54%
LABORATORY CORP NEW [LH] +0.52%
- Monday’s Top Biotech & Medical Stocks
- Friday’s Top Biotech & Medical Stocks
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Breast Cancer Screening Co-Pay Could Hurt Insurers’ Bottom Line
by Doug Cress
Med Tech Sentinel
A new study in The New England Journal of Medicine found that a modest insurance co-pay was enough to deter many older women from getting potentially life-saving mammograms.
The study examined 366,475 women between the ages of 65 to 69 enrolled at 174 Medicare managed-care plans. Screening rates were 8.3% lower for women whose plans required a co-payment (versus women whose plans covered the entire cost). Co-pays averaged $20, but ranged from $12.50 to $35. During the four-year study, the number of plans requiring co-pays rose 10%, from three plans in 2001 to 21 in 2004.
Mammography has been shown to reduce the rate of mortality by as much as 20 – 40%. Because it is cheaper to treat breast cancer when caught early, it may be cost-effective for insurers to exempt elderly patients from mammogram co-pays. The American Cancer Society estimates that there were 40,060 breast cancer fatalities in 2007. Approximately 80% of breast cancers occur in women over the age of 50; in women over 65 the cancer kills one out of two.
The study supports the idea of value-based insurance, in which insurers lower co-pays and other costs to patients as a way of increasing compliance and standards of care. While such strategies may increase short term expenditures, savings can be accrued over the long term by improving the patient’s health.
With technologies on the horizon that could detect cancer in its earliest stages, insurers may begin to selectively target treatments that are best for the patient, and best for their bottom line.
[Breast Cancer Mortality Rates: Surveillance, Epidemiology, and End Results (SEER) Program, April 2004]
Med Tech Sentinel is a regular contributor to BioHealth Investor
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