Monday’s Top Medical & Biotech Stocks
by H.S. Ayoub
BioHealth Investor
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Biotechnology
TRANSDEL PHARMACTL [TDLP.OB] +17.45%
BIOCRYST PHARM INC [BCRX] +13.55%
GENAERA CORP [GENR] +12.67%
GENETIC TECH SPON [GENE] +10.89%
ACHILLION PHARMACEUT [ACHN] +9.38%
Diagnostic Substances
INTERLEUKIN GENETICS [ILI] +7.41%
ICAGEN, INC. [ICGN] +7.28%
AVIGEN INC [AVGN] +3.33%
AMAG PHARMACEUTICALS [AMAG] +2.77%
AVALON PHARMACEUTIC [AVRX] +2.49%
Drug Delivery
BENTLEY PHARMACEUTIC [BNT] +18.27%
EMISPHERE TECH [EMIS] +8.44%
ALKERMES INC [ALKS] +7.22%
PENWEST PHARM CO [PPCO] +4.00%
ELAN CP PLC ADR [ELN] +3.47%
Drug Manufacturers
VERTEX PHARMACEUT [VRTX] +28.03%
ARYX THERAPEUTICS, I [ARYX] +24.22%
TIANYIN PHARMACEUTCL [TYNP.OB] +12.00%
AP PHARMA INC [APPA] +10.63%
TELIK INC [TELK] +8.44%
Drug Related Products
XELR8 HOLDINGS, INC [BZI] +9.26%
CURATECH INDUSTRIES [CUTC.OB] +7.14%
ARGAN INC [AGX] +5.62%
CHINA SHENGHUO PHARM [KUN] +5.34%
USANA HEALTH SCIEN [USNA] +3.23%
Generic Drugs
CATALYST PHARMACEUTI [CPRX] +6.35%
CARACO PHARMA LABS [CPD] +2.51%
BARR PHARMA INC [BRL] +1.30%
MYLAN INC [MYL] +0.96%
HI-TECH PHARMACAL [HITK] +0.89%
Medical Appliances & Equipment
ENTEROMEDICS INC. [ETRM] +20.87%
PATIENT SAFETY TECH [PSTX.OB] +19.20%
DEL GLOBAL TECH CORP [DGTC.OB] +11.37%
SRI/SURGICAL EXPRE [STRC] +9.41%
IVIVI TECHNOLOGIES, [IVVI] +6.17%
Medical Instruments & Supplies
NUCRYST PHARMACEUTIC [NCST] +53.48%
POWER MED. INT. INC. [PMII] +24.53%
BIOMERICA INC [BMRA.OB] +12.50%
ATRICURE, INC. [ATRC] +5.81%
ARISTOTLE CP [ARTL] +5.67%
Medical Laboratories & Research
NATL DENTEX CP [NADX] +4.37%
BIO-REFERENCE LAB [BRLI] +3.32%
ARRAY BIOPHARMA IN [ARRY] +3.24%
ENZO BIOCHEM INC [ENZ] +1.34%
RADNET INC [RDNT] +1.00%
- Friday’s Top Medical & Biotech Stocks
- Thursday’s Top Medical & Biotech Stocks
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Cephalon: New Player in Chronic Lymphocytic Leukemia
by Hisham S. Ayoub, DMD
BioHealth Investor
For the first time in seven years a new therapy for Chronic Lymphocytic Leukemia (CLL) has been cleared in the U.S. by the FDA. Biotech firm Cephalon’s (CEPH) TREANDA (bendamustine hydrochloride) was given final approval by the FDA on March 20, only six months after the company submitted the NDA in September of 2007.
CLL is one of the four main types of leukemia, and is characterized by a slow progression of abnormal white blood cells (lymphocytes) in the bone marrow usually spreading to other parts of the body, including lymph nodes, liver, spleen, and the central nervous system.
A particular lymphocyte, the B cell, is affected. This pathological B cell then divides and accumulates in the bone marrow leaving little room for healthy lymphocytes. This leaves patients with a weakened immune system to fight off infections.
The condition is usually diagnosed in white males of older age, with more than 75% of those diagnosed are over 50 year old. The latest estimates peg the number of new CLL cases in the US at over 15,000 in 2007, with about 4,500 deaths.
While CLL is technically incurable, it is manageable and patients do have various options in prolonging their quality of life. Treating CLL is focused on managing symptoms rather than an outright cure.
CLL therapy has been shown to be far superior when used as a combination of agents; principally purine analogues combined with monoclonal antibodies.
Bayer Schering Pharma’s (SCH.DE) Fludara (fludarabine) and GlaxoSmithKline’s (GSK) Leukeran (chlorambucil) are purine analogues which are usually designated as primary therapy. Monoclonal antibodies used in combination with purine analogues include Roche’s (RHO.DE) MabThera (rituximab) and Bayer Schering Pharma’s MabCampath (alemtuzumab).
Enter Cephalon’s Treanda, which has been shown to be far superior to using chlorambucil in CLL patients. In an international study of over 300 patients suffering from CLL, and who have never been treated for the disease, Treanda showed a longer progression-free survival rate of 18 months versus 6 months for those taking chlorambucil, and the response to Treanda lasted on average 19 months, much longer than that seen in patients taking chlorambucil (7 months).
Treanda is expected to be available to U.S. doctors in April of 2008, and gives CLL sufferers a new treatment option for the first time since 2001. It also received Orphan Drug Designation by the FDA, which gives Cephalon market exclusivity in the U.S. until 2015.
New competition is on the horizon however as two clinical stage agents are clearing hurdles, Oral Fludarabine by Xanthus Pharmaceuticals and Acadra (acadesine) by Protherics and Advancell.
Xanthus Pharmaceuticals, a privately held company in the U.S., announced on January 3rd of 2008 that it has received FDA orphan drug designation for its fludarabine phosphate oral tablets for the treatment of CLL, and on January 22 the FDA accepted the company’s New Drug Application (NDA) for review. While IV administration of fluradabine, which is currently the favored choice for first-line treatment of CLL, has been used for some time now, the option for a patient-friendly oral version could give Xanthus substantial market share quickly. Xanthus licensed the exclusive rights to develop and market oral fludarabine in the U.S. from Schering in October of 2006.
A little further down the road is the potential approval of Acadra co-developed by Prostherics (PTIL) of the U.K. and the Spanish based nanomedical firm Advancell. Acadra has great potential as yet another new form of nucleoside analogue for the treatment of CLL. The excitement behind Acadra is that it has been shown ex-vivo to target B-cells while exhibiting only a minimal effect on T-cells in the bone marrow, much less than current chemotherapeutic agents, according to the two firms. This means patients will suffer from less complicated and severe infections associated with CLL treatment, which can be a significant cause of death. Phase I/II trials were initiated on January 11 of 2008.
Cephalon’s Treanda still has plenty of time ahead of Acadra (that is if Acadra gets approved at all), and would still be an attractive new alternative to oral fludarabine. Cephalon is also not a small development biotech firm. It was founded in 1987, is a Fortune 1000 company, and employs 3,000 people internationally.
The company has an extensive U.S. marketing and sales network already in force promoting the company’s other big drugs, including Provigil (modafinil) and Fentora (fentanyl buccal tablet), among others. Cephalon should see minimal strategic and cost barriers to ensuring the success of Treanda in the U.S. over the next few years.
With the company’s shares trading at an attractive level (near 52-week low), and strong support just under $60 (high volume surge in mid-February), it behooves investors to take a good long look at initiating a long position in Cephalon stock.
The author does not currently have any investment position in any of the companies mentioned in this article.
BioHealth Investor.com
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The FDA and Overseas Drug Approvals
by Mark Senak
Eye On FDA
Where is the Most Promising Pipeline?
For a while now, I’ve been thinking about the growing number of drugs that are being approved overseas and going on the market overseas, but are not getting approved or are getting approvable letters in the U.S. It is a list that is growing.
Then today, the Wall Street Journal carried an article entitled Overseas Drugs Hit Regulatory Snags and details some of the drugs that are on the market elsewhere, but not in the U.S. The article mentions several large companies such as GlaxoSmithKline (GSK), Novartis (NVS) and Sanofi-Aventis (SNY) for Cervarix, Galvus and Rimonabant, respectively. Not mentioned are also some smaller companies, such as the Canadian firm Labopharm (DDSS) which has not gotten approval for once daily Tramadol even though it is approved in Canada. The article accounts for the post-Vioxx jitters on drug safety and a lack of FDA funding.
However, as pointed out here many times, there is more at work than a lack of funding or the current risk-averse environment. In fact, there have been budget increases and PDUFA increases - so money is flowing from both the public and private side, yet product approvals and enforcement continue a downward path. A more cautious approach might account for a slowdown in approvals and a rise in approvables, but not a lack of funding where money is up and the number of new compounds submitted is down. And neither a lack of funding or a risk-averse environment explains a lower enforcement rate.
The issues at stake are more comprehensive than money or safety issues and it is going to take a comprehensive strategy to pull the agency and the industry out of the current situation. Right now, as Congress launches multiple investigations, there is no sign of that happening and it will likely be Congress that re-writes the FDA page.
Does the approval slowdown downgrade the desirability of the American marketplace? Probably not. It may be inconvenient for patients, treaters, companies and investors, but the reality remains that the U.S. is by far the largest market for pharmaceutical products and the current situation isn’t likely to change that. According to the European Federation of Pharmaceutical Industries and Associations, North America represented 47.7% of sales of the world pharmaceutical market, while Europe represented 29.9%. EFPIA also has compiled other relevant statistics on the European market compared to the U.S. Market in The Pharmaceutical Industry in Figures. One of the facts is that between 1990 and 2006 investment in new research in the U.S. grew 5 times while in Europe it grew 2.9 times. If the U.S. regulatory market does not straighten out, that investment may find reason to ebb away.
Eye On FDA is a regular contributor to BioHealth Investor
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Friday’s Top Medical & Biotech Stocks
by H.S. Ayoub
BioHealth Investor
Subscribe now to keep up to date on the latest news, articles and daily top stocks:
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Biotechnology
PROTEO INC [PTEO.OB] +93.07%
BIOSANTE PHARMA INC [BPAX] +19.39%
TRANSDEL PHARMACTL [TDLP.OB] +19.20%
HESKA CORPORATION [HSKA] +18.52%
HEMOBIOTECH INC [HMBT.OB] +18.18%
Diagnostic Substances
REMOTEMDX INC [RMDX.OB] +13.42%
RESPONSE GENETICS, I [RGDX] +8.11%
INFINITY PHARMACEUTI [INFI] +6.82%
SYNTA PHARMACEUTICAL [SNTA] +4.49%
AVALON PHARMACEUTIC [AVRX] +4.33%
Drug Delivery
DELCATH SYSTEMS INC [DCTH] +16.00%
QUIGLEY CORP THE [QGLY] +6.25%
ACURA PHARMACEUTICAL [ACUR] +5.80%
FLAMEL TECH SA ADR [FLML] +2.05%
ARADIGM CORP [ARDM.OB] +1.79%
Drug Manufacturers
VYREX CORP DE NEW [VYXC.OB] +17.65%
GAMMA PHARMACEUTICAL [GMPM.OB] +12.50%
ACCESS PHARMACEUTICL [ACCP.OB] +10.37%
SEPRACOR INC [SEPR] +5.02%
PROVECTUS PHARMA [PVCT.OB] +5.00%
Drug Related Products
XELR8 HOLDINGS, INC [BZI] +4.85%
NUTRACEUTICAL INTL [NUTR] +3.54%
ARGAN INC [AGX] +1.96%
INTEGRATED BIOPHARMA [INBP] +1.02%
AUXILIUM PHARMACEUT [AUXL] +0.88%
Generic Drugs
WATSON PHARMACEUTCLS [WPI] +0.82%
HI-TECH PHARMACAL [HITK] +0.22%
Medical Appliances & Equipment
NEWCARDIO, INC. [NWCI.OB] +23.53%
XCORPOREAL INC [XCR] +14.00%
THERAGENICS CORP [TGX] +13.90%
MB SOFTWARE CORP [MBSB.OB] +13.33%
SONIC INNOVATIONS [SNCI] +12.86%
Medical Instruments & Supplies
BIOMIMETIC THERAPEUT [BMTI] +30.00%
MEDPRO SAFETY PD [MPSP.OB] +27.72%
CPC OF AMERICA INC [CPCF.OB] +11.72%
STEN CORPORATION [STEN] +10.91%
BIOSPHERE MEDICAL [BSMD] +7.80%
Medical Laboratories & Research
RADNET INC [RDNT] +1.75%
MEDTOX SCIENTFIC INC [MTOX] +1.63%
BIO-IMAGING TECH [BITI] +0.85%
GENOPTIX, INC. [GXDX] +0.56%
QUEST DIAGNOSTC [DGX] +0.53%
- Thursday’s Top Medical & Biotech Stocks
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Drugs: Penny Wise, But a Pound Foolish
by Michael Shulman
BiotechBlitz
I typically write about stocks of interest to investors, but today I am just hacked off. Bear with me and pardon the pun.
Not all drugs and biotech companies are created equal — and the belief that a drug may cost too much because of its price, is representative of the simplicity and shallowness of the current debate in politics and in press about healthcare costs in the United States.
We live and, for the most part, benefit from a capitalist healthcare system built into a capitalist economy — with all the commensurate risks and rewards. High-priced drugs with large profit margins are part of this system, and the numbers kicked around by politicians and the press obscure the central reality of our system: A high price for a drug is not necessarily a high cost to society when a drug saves or extends a life and when profits spur the development of treatments that (over time) reduce costs by saving or improving the lives of patients.
Two recent editorials complained about the price of cancer treatment Avastin, made by biotech giant Genentech (DNA), and Genzyme’s (GENZ) treatment, Cerezyme, for Gaucher disease.
Avastin fights various forms of cancer and costs upward of $110,000 per annum or more, while Genzeyme’s product can top more than $400,000 per annum. The Times’s editorialists believe this is way too expensive. Tell that to a patient with Gaucher’s disease or a cancer patient who lived, on average, the five and a half months predicted by the median survival of patients in the Avastin clinical trial that led to the drug’s approval. In a country that rewards creativity and success, don’t you want to reward companies for saving patients so they can reinvest the money to save more patients in the future?
I am no apologist for an industry holding many companies that currently make far too much money for what they return in improvements in public health — Amgen and its anemia drugs come to mind — but this specific complaint is misplaced and depressingly similar to the hollow campaign rhetoric dominating the air waves.
While the editorial reflected public frustration with medical costs it also is a mirror of the poverty of the healthcare debate which is increasingly dominated by the inability of patients and the general media to separate prices from costs. In reality, a seemingly high-priced drug may actually save money in the short or long run, not to mention the life of a patient.
I do not deny that patient, public and political frustration is well grounded - too many things cost too much, from allergy shots to fifteen dollar boxes of sterile tissues — but price should and cannot be confused with cost. In this instance, the clarity of the target (a $100,000 a year drug) and the vast size of the company led the debate.
If the company were a start up that had never made a penny, tried for 10 years to develop the drug and finally succeeded, would there have been criticism? Of course not, and the focus would have been on the happiness felt by surviving patients and the money saved when they left the hospital and went home to live, and not to die in a hospice.
A new report that came out today made this point all too well.
Genentech’s cancer drug Rituxan, in combination with chemotherapy, has helped younger patients with non-Hodgkin’s lymphoma live two-thirds of the time for five years or more, compared to 50% of the time in the early 1990s. Call it longer living through high-profit chemistry. Genzyme has a robust pipeline paid for with profits from Cerezyme.
This does not seem to faze politicians, patients and pundits who fail to discriminate among the products and the companies that supply them. Avastin is not a “me-too” product; it is not the umpteenth variation of the same pain killer; it is not a treatment for a brand new disease like restless toe syndrome. Avastin, along with many other high-priced drugs, extend and, sometimes, save lives. That is Genentech’s mission. Reducing the price of Avastin, and the flow of dollars available to develop new products at a company like Genentech will materially affect the development of new products and eventually lead to the premature death of many patients.
Do I exaggerate?
The drugs in question took more than a decade to develop and are (or were) unique when approved. Avastin is a first and best-in-class anti-angiogenesis cancer drug that reflects billions of dollars in past, current and future development costs. I follow many companies in the life sciences industry and can say without hesitation the drug’s parent and creator is considered by many (including me) to be the world’s finest cancer company. Genentech has more than 100 clinical trials underway, and is always pushing the envelope and looking for new ways to save lives. The funds for the trials and “envelope pushing” come from high-priced drugs already on the market.
Some surveys also find Genentech to be the finest place to work in the United States — and it would be difficult to find a company with a better track record for working with, and listening to, the FDA. You won’t see pictures of Genentech scientists on yachts with Congressional lobbyists and call girls — instead they spent their money on R&D last year — more than they declared as a net profit.
The laws of economics are simple — a reduction in price of current drugs will reduce Genentech’s ability to improve Avastin, develop new treatments and serve patients. Ultimately, a lower price for Avastin may actually mean a higher cost to society.
Genentech and Avastin are easy targets for politicians, the media and complaining patients. The harder (and real) targets are avoided by too many people.
What are the real drivers of runaway costs? People, not patients.
According to Dr. Mark McClellan — former FDA and Medicare chief now at the Brookings Institution — the key to cost control is keeping people healthy. The current system rewards the treatment for illness and its reimbursement and often does not pay for routine physicals and other measures to improve health, like managed exercise and diet programs.
Of course, no one ever sold a newspaper or got a vote by saying “Hey, fatso, you may need help, but the first place to start is by getting the potato chips out of your mouth.”
But sticking it to a company that has improved or saved 10s of thousands of lives (but is an easy target because of a $100,000-a-year drug) is sexy.
It would be better if the politicos, the public and the media took a look at the real cost and value of a drug, not the price — and that’s something we currently don’t do.
A good example is the recent demise of drug BiDil and NitroMed.
BiDil was the first drug ever approved by the FDA for one ethnic group: African Americans. This heart medication was so successful in trial that the patients on placebo were put on BiDil midway through the trial for ethical reasons — the patients receiving the drug saw a 43% reduction in deaths from heart attacks.
No matter — BiDil failed in the marketplace because payers (insurers and Medicare) would not pay. Medicare and private insurers asked for too high of a co-payment from patients who could not afford the drug. These payers did not, and would not, factor in a 43% reduction in deaths, and all the costs associated with a sick and dying patient, when demanding these co-payments. And this narrow view of the costs won the day! Since the drug has been approved it is probable that more patients have died unnecessarily of heart problems who could have been managed with BiDil, than the number of soldiers who have died in Iraq.
Narrow-but-headline-grabbing analyses of high-priced drugs undermine the truth: It is the value of a drug relative to its price that matters. Narrow, artificial price limits on life-saving, unique drugs can kill — and, are likely, already doing so.
BiotechBlitz is a regular contributor to BioHealth Investor
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Thursday’s Top Medical & Biotech Stocks
by H.S. Ayoub
BioHealth Investor
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Biotechnology
IMMUNOSYN CORPORATIN [IMYN.OB] +19.90%
BIOSANTE PHARMA INC [BPAX] +19.88%
TITAN PHARMA INC [TTP] +14.17%
REXAHN PHARMACEUTICL [RXHN.OB] +13.64%
ANESIVA INC [ANSV] +10.00%
Diagnostic Substances
IMMUCELL CP [ICCC] +25.02%
TORREYPINES THERAPEU [TPTX] +18.32%
REMOTEMDX INC [RMDX.OB] +10.37%
AVANT IMMUNOTHERAPEU [AVAND] +9.92%
ISTA PHARMACTLS [ISTA] +8.50%
Drug Delivery
COLUMBIA LABS INC [CBRX] +3.77%
FLAMEL TECH SA ADR [FLML] +2.99%
BIOVAIL CORP [BVF] +1.49%
PENWEST PHARM CO [PPCO] +1.15%
NEKTAR THERAPEUTIC [NKTR] +1.00%
Drug Manufacturers
GEOPHARMA INC [GORX] +12.77%
NEUROGESX, INC. [NGSX] +11.21%
MAP PHARMACEUTICALS, [MAPP] +9.65%
SIGA TECH INC [SIGA] +9.50%
PROVECTUS PHARMA [PVCT.OB] +9.09%
Drug Related Products
ARGAN INC [AGX] +5.37%
DRAXIS HEALTH INC [DRAX] +3.39%
PERRIGO COMPANY [PRGO] +2.56%
AUXILIUM PHARMACEUT [AUXL] +2.40%
SCHIFF NUTRIT INTL [WNI] +2.05%
Generic Drugs
HELICOS BIOSCIENCES [HLCS] +1.00%
CATALYST PHARMACEUTI [CPRX] +0.79%
Medical Appliances & Equipment
FONAR CORP [FONR] +19.75%
SOMANETICS CORP [SMTS] +8.45%
ENDOCARE INC [ENDO] +8.33%
ESCALON MED CP [ESMC] +6.91%
LANGER INC [GAIT] +5.15%
Medical Instruments & Supplies
OCULUS INNOVATIVE SC [OCLS] +30.53%
NANOSPHERE, INC. [NSPH] +27.39%
RETRACTABLE TECH INC [RVP] +22.54%
ORTHOVITA INC [VITA] +13.30%
SAFESTITCH MEDICAL, [SFES.OB] +9.09%
Medical Laboratories & Research
SPHERIX INC [SPEX] +13.89%
PSYCHEMEDICS NEW [PMD] +2.44%
ERESEARCHTECHNOLOG [ERES] +1.97%
RADNET INC [RDNT] +1.33%
BIO-REFERENCE LAB [BRLI] +1.14%
BioHealth Investor.com
__________________
Painting the Colon: Early Stage Cancer Detection without Biopsy
by Doug Cress
Med Tech Sentinel
Most cases of colon cancer begin as small noncancerous polyps. Over time these polyps may become colon cancers. Regular screening helps identify polyps before they become cancerous, allowing for prophylactic treatment.
According to the American Cancer Society, 112,000 people are diagnosed with colon cancer annually.
The most common and effective diagnostic procedures is the oft-dreaded colonoscopy. It is recommended that individuals 50 and up get one – some 90% of colon cancers occur in this age group.
During the exam, a colonoscope, a long, slender, flexible tube attached to a video camera is used to view the colon and rectum. Polyps found during the procedure are typically biospied and analyzed.
A new technique being developed at the Stanford University School of Medicine may one day detect colon cancer without a biopsy – including early stage cancers that have not yet become polyps.
The study, led by Dr. Christopher Contag, used a unique protein that sticks to colon cells in the early stages of cancer. The protein was attached to a “fluorescent beacon”.
When sprayed into the colon, and viewed with a Mauna Kea Technologies’ miniaturized microscope, CellVizio, researchers were able to see fluorescent patches where the protein had attached to cancerous cells.
The fine resolution afforded by the technique (researchers could spot individual cancer cells) will allow for the detection of even early stage cancers.
In the initial trial with 15 patients, the Contag detected 82% of cancerous polyps. Contag believes that by working with additional proteins, the technique will become even more accurate.
Med Tech Sentinel is a regular contributor to BioHealth Investor
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Thursday’s Top Medical & Biotech Stocks
by H.S. Ayoub
BioHealth Investor
Subscribe now to keep up to date on the latest news, articles and daily top stocks:
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Biotechnology
IOMAI CORPORATION [IOMI] +27.62%
TRUBION PHARMACEUTIC [TRBN] +22.18%
SEQUENOM INC [SQNM] +17.59%
BIOSPECIFICS TECH CP [BSTC.OB] +14.85%
3SBIO INC [SSRX] +13.82%
Diagnostic Substances
ISTA PHARMACTLS [ISTA] +12.56%
TRINITY BIO ADR [TRIB] +10.84%
IMMUNOMEDICS INC [IMMU] +9.72%
INFINITY PHARMACEUTI [INFI] +8.30%
SYNTA PHARMACEUTICAL [SNTA] +8.02%
Drug Delivery
ACURA PHARMACEUTICAL [ACUR] +15.41%
EMISPHERE TECH [EMIS] +11.66%
ELAN CP PLC ADR [ELN] +7.85%
DELCATH SYSTEMS INC [DCTH] +6.59%
NOVEN PHARMACEUTIC [NOVN] +5.14%
Drug Manufacturers
NEUROGEN CP [NRGN] +57.95%
MAP PHARMACEUTICALS, [MAPP] +15.24%
OSCIENT PHARMACEUT [OSCI] +10.00%
GAMMA PHARMACEUTICAL [GMPM.OB] +8.89%
RELIV INTL INC [RELV] +6.29%
Drug Related Products
CHINA SHENGHUO PHARM [KUN] +9.29%
MANNATECH INC [MTEX] +6.28%
PRESTIGE BRAND HLGS [PBH] +5.54%
INTEGRATED BIOPHARMA [INBP] +4.55%
SALIX PHARM DEL [SLXP] +4.26%
Generic Drugs
CARACO PHARMA LABS [CPD] +4.68%
BARR PHARMA INC [BRL] +1.20%
HELICOS BIOSCIENCES [HLCS] +0.85%
MYLAN INC [MYL] +0.73%
WATSON PHARMACEUTCLS [WPI] +0.24%
Medical Appliances & Equipment
MB SOFTWARE CORP [MBSB.OB] +21.43%
CYTOCORE INC [CYOE.OB] +12.24%
ARRHYTHMIA RES TECH [HRT] +7.97%
CYBERONICS INC [CYBX] +6.58%
VISION SCIENCES IN [VSCI] +6.25%
Medical Instruments & Supplies
MEDPRO SAFETY PD [MPSP.OB] +22.67%
ARISTOTLE CP [ARTL] +20.17%
XTENT INC [XTNT] +17.41%
UROPLASTY INC [UPI] +13.33%
SAFESTITCH MEDICAL, [SFES.OB] +13.21%
Medical Laboratories & Research
ARRAY BIOPHARMA IN [ARRY] +6.74%
ALLIANCE IMAGING INC [AIQ] +5.30%
GENOMIC HEALTH, INC. [GHDX] +4.55%
SPHERIX INC [SPEX] +3.70%
ERESEARCHTECHNOLOG [ERES] +3.02%
- Wednesday’s Top Medical & Biotech Stocks
- Tuesday’s Top Medical & Biotech Stocks
__________________
Amgen: Whither Thou Goest?
by Michael Shulman
BiotechBlitz
I have disliked Amgen (AMGN) for a very long time and have the good fortune of having two publishing platforms to discuss the company: my ChangeWave Biotech Investor service and my short service, ChangeWave Shorts.
I write about it whenever I hear “value” investors who know nothing about biotech or life sciences telling investors to buy the stock because it “must come back” or it’s “cheap.”
My background is the computer industry — when it had 49 personal computer companies, eight major mini-computer makes and the “bunch” of mainframe companies — the five major competitors to IBM.
All but one of those original 49 are gone, all eight minicomputer makers are gone, all of the IBM mainframe competitors are gone from that business and just three are in business, at all, doing something else.
And over and over I heard and read analysts and pundits telling people to buy these dying companies because they were “cheap” and “must come back.” Don’t you believe it!
Amgen has not created an original blockbuster drug since the breakup of the Soviet Union and has a terrible pipeline. Two-thirds of the company’s profits are from anemia drugs getting slammed by the FDA, Medicare and private insurers — with falling sales due to safety concerns revealed during the runup to a recent FDA panel meeting. The company now seems to rely more on lobbyists than scientists for its success.
I know, this sounds like a non-quantitative polemic. So let’s talk numbers.
At least $1.35-$1.55 of their anticipated $4 in 2008 profits are from anemia drugs for dialysis patients with declining sales due to declining reimbursement rates, new dosage guidelines, anticipated competition from Micera from Roche (which I believe will eventually be allowed in the U.S. by the courts and/or the ITC) and an eventual crackdown on rebates.
Some serious percentage of this is going away - and the best case for Amgen is 40 cents to 60 cents per share in profits. I see another 40 cents to 50 cents at risk in the cancer market due to an FDA panel ruling (and, eventually, an agency ruling) that will restrict the use of these drugs for an annoying reason — data shows they may accelerate death in some patients.
Oh, and cut out the rebates, someone is gong to say. Shocking! Rebates! Shocking!
So, the best case is $3 a share in profits, and at current multiples that means a $30 stock price — and this dog is being valued on profits, not growth, since there ain’t no growth.
Oh, and AMGN has announced the stock buyback.
And did I mention Moody’s may knock Amgen’s credit rating down depending on the final FDA decision on anemia drugs?
My subscribers have saved a lot of money by avoiding Amgen and some have made a lot of money buying puts on the company. Whatever you do, anytime you give consideration to this company, hear a little voice in your head saying: “value trap, value trap.”
If you don’t believe me, think Digital Equipment Corporation; or Burroughs; or how about the Osborne computer? Remember them?
BiotechBlitz is a regular contributor to BioHealth Investor
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Wednesday Recap: Biotech Restructuring Day!
by H.S. Ayoub, DMD
BioHealth Investor
Nasdaq Biotechnology Index (^NBI) -2.92%
Amex Pharmaceutical Index (^DRG) -2.69%
iShares Dow Jones Medical Devices (IHI) -1.25%
Kosan Biosciences (KOSN) up 24.34%… investors were cheering the company’s appointment of a new CEO, and its announcement that it will cut 37% of its workforce and refocus its clinical efforts to only a couple of late stage developments, as the new CEO puts it; “This represents an important step in Kosan’s evolution to a product-oriented company“. So I guess before this step the company was not interested in developing products but just to spend money on research! Joking aside, in these trying times in our economy smaller companies, especially little biotechs, need to do what Kosan just did in order to survive the next couple of years.
Alkermes (ALKS) down 0.28%… after Eli Lilly (LLY) pulled the plug on the AIR® Insulin joint program back on March 7th, Alkermes stock took a big dive, and forced its current decision to cut 18% of its workforce. I love the CEO’s comment in the press release, “The flexibility of our business model allows us to adapt our cost structure while maintaining our ability to develop innovative products of our own.” What does he mean exactly by Flexibility, firing employees?
Wednesday’s Top Medical & Biotech Stocks
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