Biotech Implosion: Genitope
by Jon C. Ogg
24/7 Wall St.
Genitope Corp. (NASDAQ:GTOP) probably just made sure the workers’ kids won’t be getting much more than coal this year. Genitope announced that its pivotal Phase 3 clinical trial examining the use of MyVax® personalized immunotherapy in previously untreated follicular B-cell non-Hodgkin’s lymphoma patients did not meet its primary endpoint.
In the primary analysis, there was no statistically significant difference in the progression-free survival (PFS) of patients receiving MyVax® personalized immunotherapy compared to patients receiving the control substance. Importantly, analysis of a pre-specified endpoint in the MyVax® personalized immunotherapy arm showed a highly statistically significant difference in PFS between patients who mounted a positive immune response to the tumor-specific target and those who did not.
This fell 38% to $2.59 in regular trading as word of the trials came out at the end of the day. But now shares are down 60% to roughly $1.00 in after-hours trading. This had a prior 52-week trading range of $3.00 to $4.93.
continue reading article at 247WallSt.com
24/7 Wall St. is a regular contributor to BioHealth Investor
__________________
Friday’s Top Biotech & Medical Stocks
by H.S. Ayoub
BioHealth Investor
GENAERA CORP [GENR] +23.41%
TITAN PHARMA INC [TTP] +15.62%
AMICUS THERAPEUTICS, [FOLD] +12.26%
REXAHN PHARMACEUTICL [RXHN.OB] +11.11%
NASTECH PHARM CO [NSTK] +9.97%
Diagnostic Substances
AVALON PHARMACEUTIC [AVRX] +8.19%
AKORN INC [AKRX] +8.16%
TRINITY BIO ADR [TRIB] +8.05%
IMMUNOMEDICS INC [IMMU] +7.14%
ASPENBIO PHARMA INC [APPY] +7.08%
Drug Delivery
COLUMBIA LABS INC [CBRX] +8.26%
FLAMEL TECH SA ADR [FLML] +4.21%
ULURU INC [ULU] +3.93%
ALKERMES INC [ALKS] +3.26%
NEKTAR THERAPEUTIC [NKTR] +2.05%
Drug Manufacturers
OPKO HEALTH INC. [OPK] +15.92%
ELITE PHARMA INC [ELI] +15.76%
PRANA BIO LTD ADS S1 [PRAN] +12.68%
NEUROGEN CP [NRGN] +9.55%
NEUROCHEM INC [NRMX] +8.43%
Drug Related Products
MANNATECH INC [MTEX] +9.78%
TIENS BIOTECH GR USA [TBV] +7.57%
NUTRACEUTICAL INTL [NUTR] +3.54%
N B T Y INC [NTY] +3.22%
CURATECH INDUSTRIES [CUTC.OB] +2.44%
Generic Drugs
CARACO PHARMA LABS [CPD] +5.00%
PHARMACUTICAL CO [PRX] +3.96%
BARR PHARMA INC [BRL] +2.49%
WATSON PHARMACEUTCLS [WPI] +1.51%
ISOLAGEN INC [ILE] +1.23%
Medical Appliances & Equipment
LECTEC CORP [LECT.OB] +34.62%
RESPIRONICS INC [RESP] +22.99%
ECHO THERAPEUTICS [ECTE.OB] +21.43%
IVIVI TECHNOLOGIES, [II] +13.64%
RESMED INC [RMD] +12.98%
Medical Instruments & Supplies
STEN CORPORATION [STEN] +71.64%
CRYOCOR, INC. [CRYO] +25.67%
ANGEION CORP [ANGN] +9.83%
DEXCOM [DXCM] +9.45%
ALPHATEC HOLDINGS [ATEC] +8.25%
Medical Laboratories & Research
PREMD INC [PME] +9.91%
ARRAY BIOPHARMA IN [ARRY] +9.30%
ALLIANCE IMAGING INC [AIQ] +4.77%
ENZO BIOCHEM INC [ENZ] +3.91%
NATL DENTEX CP [NADX] +2.97%
- Thursday’s Top Biotech & Medical Stocks
- Wednesday’s Top Biotech & Medical Stocks
____________________
AngioDynamics Technology Not Responsible for Lung Tumor Treatment Deaths
by Doug Cress
Med Tech Sentinel
In February 2003, the FDA’s General and Plastic Surgery Devices Advisory Committee met and discussed thermal ablation of lung tumors. Concerns were raised about the safety and adverse event reporting associated with Radio Frequency ablation (RFA) of lung tumors.
Last week, the FDA released a Public Health Notification, specifically warning against lung tumor ablation using RFA.
Pointing to several studies, the statement noted,
“[The] FDA has received reports of patient deaths associated with lung tumor ablation using RF ablation devices…Patient selection, subsequent treatment, and technical use of the RF device, including placement and operation, may have contributed to the fatalities.”
“FDA has cleared many RF ablation devices as tools for general ablation of soft tissue by thermal coagulation necrosis. These devices have also been cleared for certain specific indications, including partial or complete ablation of non-resectable liver lesions and palliation of pain associated with metastatic lesions involving bone. It is important to note that they have not been cleared specifically for lung tumor ablation. Manufacturers of ablation devices cannot legally market them for use in lung tumor ablation because clinical data establishing their safety and effectiveness for this purpose have not been submitted to the agency. This includes promoting their safety and effectiveness in training programs.”
In response to the Public Health Notification, AngioDynamics (ANGO) released a statement noting that none of its RFA probes were used in reports the FDA had mentioned.
The company is developing its own RF technology to treat lung malignancies, the poorly named Rapture (in Protestant-Christian scripture, rapture is the name given to the event during which all Christians living on earth are simultaneously transported to Heaven).
AngioDynamics has conducted a 106 patient clinical trial with Rapture. The trial included patients from Europe, Australia and the U.S. There were no deaths within 30 days of treatment.
I first came across this study back in December, 2004, when RITA Medical Systems (subsequently acquired by AngioDynamics), announced the eighteen month survival statistics of the Rapture lung cancer clinical trials.
106 patients with a total of 186 tumors were treated. RFA was technically feasible in 99% of the patients. Diagnoses included non-small cell lung cancer in 33 patients, metastasis from colorectal adenocarcinoma in 52 patients, and metastasis from other primary malignancy in 15 patients. Cancer specific survival among patients with primary non-small cell lung cancer (n = 33) was 91% at both one year and eighteen months. Cancer specific survival among patients with colorectal metastases to the lung (n = 53) was 88% at one year and 82% at eighteen months.
AngioDynamics expects the Rapture clinical trial results to be published during the first half of 2008.
Med Tech Sentinel is a regular contributor to BioHealth Investor
_________________
Thursday’s Top Biotech & Medical Stocks
by H.S. Ayoub
BioHealth Investor
Biotechnology
GENAERA CORP [GENR] +25.00%
QUESTOR PHARMACEUTCL [QSC] +16.00%
ZIOPHARM ONCOLOGY IN [ZIOP] +14.50%
PLURISTEM THERAPEUTC [PSTI] +13.92%
BIOSANTE PHARMA INC [BPAX] +10.81%
Diagnostic Substances
IMARX THERAPEUTICS [IMRX] +22.01%
MONOGRAM BIOSCIENCES [MGRM] +7.14%
ROSETTA GENOMICS LTD [ROSG] +4.83%
RESPONSE GENETICS, I [RGDX] +3.86%
TRINITY BIO ADR [TRIB] +2.76%
Drug Delivery
FLAMEL TECH SA ADR [FLML] +9.30%
PENWEST PHARM CO [PPCO] +4.94%
BENTLEY PHARMACEUTIC [BNT] +4.15%
ALKERMES INC [ALKS] +3.23%
NEKTAR THERAPEUTIC [NKTR] +2.24%
Drug Manufacturers
SOMAXON PHARMACEUTIC [SOMX] +19.44%
PRANA BIO LTD ADS S1 [PRAN] +17.94%
NEURO-HITECH INC [NHPI] +16.41%
PROTALEX INC [PRTX.OB] +14.88%
NEUROGEN CP [NRGN] +11.60%
Drug Related Products
CURATECH INDUSTRIES [CUTC.OB] +17.14%
XELR8 HOLDINGS, INC [BZI] +4.17%
AUXILIUM PHARMACEUT [AUXL] +3.65%
SALIX PHARM DEL [SLXP] +3.58%
CHINA SHENGHUO PHARM [KUN] +3.28%
Generic Drugs
HELICOS BIOSCIENCES [HLCS] +4.70%
HI-TECH PHARMACAL [HITK] +2.85%
CARACO PHARMA LABS [CPD] +2.25%
BARR PHARMA INC [BRL] +0.88%
Medical Appliances & Equipment
DEL GLOBAL TECH CORP [DGTC.OB] +9.26%
ECHO THERAPEUTICS [ECTE.OB] +7.69%
NATUS MEDICAL INC [BABY] +6.35%
DIGIRAD CORPORATION [DRAD] +6.11%
ESCALON MED CP [ESMC] +5.68%
Medical Instruments & Supplies
OCULUS INNOVATIVE SC [OCLS] +10.40%
CAS MEDICAL SYS INC [CASM] +8.97%
NEUROMETRIX, INC. [NURO] +8.09%
DEXCOM [DXCM] +7.10%
VASOGEN INC [VSGN] +6.70%
Medical Laboratories & Research
INSIGHT HLTH SVC HLD [ISGT.OB] +16.39%
GENOPTIX, INC. [GXDX] +4.92%
AETERNA ZENTARIS [AEZS] +3.27%
ERESEARCHTECHNOLOG [ERES] +1.61%
GENOMIC HEALTH, INC. [GHDX] +1.58%
- Wednesday’s Top Biotech & Medical Stocks
- Tuesday’s Top Biotech & Medical Stocks
____________________
Health plan association promotes “Guarantee Access”
by David E. Williams
Health business blog
A new paper from America’s Health Insurance Plans (AHIP) takes a pro-active approach to the health care coverage debate. In Guaranteeing Access to Coverage for All Americans, AHIP addresses a number of hot button issues. Notably, the proposal would guarantee access to insurance coverage for individuals –including those with pre-existing conditions and higher than average medical costs–, allow third-party review of recission decisions and pre-existing conditions, and cap premium levels for high-risk members at 150% of the base rate. The proposal, which is modeled on existing high-risk pools, relies on states and other funding sources to ensure affordability and to encourage individuals to purchase insurance.
I like the principles outlined in the proposal. In particular, “Guarantee Access” is a pragmatic alternative to guaranteed issue and community rating. The emphasis on encouraging widespread purchase of insurance is self-serving but also a legitimate public policy goal. After all, as employers reduce coverage it’s more often younger, healthier people who lose access to coverage. That raises costs for those remaining in the risk pool, who tend to be older and sicker.
Under the AHIP proposal, individuals who are denied insurance coverage –or offered substandard coverage– can apply for the Guarantee Access program. Those whose expected medical claims are <200% of the average will receive coverage from health plans at 150% or less of standard rates. Those whose claims are expected to be >200% of the average will be eligible for a Guarantee Access Plan, again at 150% or less of the standard rate. Of course, some sort of subsidy will be required to make that work. Improvements in predictive modeling enable the health plans to more accurately place people in a specific cost category.
I expect the concepts in the proposal to be viewed reasonably favorably. They are compatible with the mainstream Presidential candidates’ views and most of the state-led reform efforts (though not, of course, with single-payer). The proposal is consistent with a push toward higher levels of coverage, promoting individual responsibility, and reducing the fear of losing access to health insurance or entering medical bankruptcy. It’s also compatible with increasing the portability of health insurance, which is key to enhancing labor market flexibility.
Expect some pushback, though, on the numbers. In particular, critics will point out that 200% is a modest threshold for putting someone in the high cost category. The proposal is also silent on how the plan will be funded.
I also wonder why AHIP calls the plan “Guarantee Access” instead of “Guaranteed Access.”
Health Business Blog is a regular contributor to BioHealth Investor
___________________
Wednesday’s Top Biotech & Medical Stocks
by H.S. Ayoub
BioHealth Investor
Biotechnology
CHAMPIONS BIOTECHNLG [CSBR.OB] +35.71%
GENVEC INC [GNVC] +19.01%
FAVRILLE, INC. [FVRL] +18.97%
GENAERA CORP [GENR] +17.99%
KOSAN BIOSCIENCES [KOSN] +12.29%
Diagnostic Substances
GENELABS TECH INC [GNLB] +3.88%
MYRIAD GENETICS [MYGN] +3.73%
IDEXX LABS [IDXX] +3.40%
LEXICON PHARMACEUTCL [LXRX] +2.36%
ABAXIS INC [ABAX] +2.03%
Drug Delivery
ALKERMES INC [ALKS] +4.64%
PENWEST PHARM CO [PPCO] +3.02%
MATRIXX INITIATVS [MTXX] +2.39%
FLAMEL TECH SA ADR [FLML] +2.30%
BENTLEY PHARMACEUTIC [BNT] +1.05%
Drug Manufacturers
ACCESS PHARMACEUTICL [ACCP.OB] +12.50%
PROTALEX INC [PRTX.OB] +10.00%
ALLOS THERAPEUTICS [ALTH] +9.13%
NOVABAY PHARMACEUTCL [NBY] +8.11%
SUCAMPO PHARMA. INC. [SCMP] +7.84%
Drug Related Products
CURATECH INDUSTRIES [CUTC.OB] +13.64%
MEDICAL NUTRITN USA [MDNU] +10.00%
DRAXIS HEALTH INC [DRAX] +6.38%
XELR8 HOLDINGS, INC [BZI] +4.35%
PERRIGO COMPANY [PRGO] +4.10%
Generic Drugs
HI-TECH PHARMACAL [HITK] +5.56%
CATALYST PHARMACEUTI [CPRX] +4.64%
HELICOS BIOSCIENCES [HLCS] +2.67%
PHARMACUTICAL CO [PRX] +2.34%
Medical Appliances & Equipment
EMERGENT GROUP INC [EMGP.OB] +8.33%
ENTEROMEDICS INC. [ETRM] +8.12%
RESTORE MEDICAL INC [REST] +6.30%
ALPHA PRO TECH [APT] +5.63%
ATS MEDICAL INC [ATSI] +4.79%
Medical Instruments & Supplies
CPC OF AMERICA INC [CPCF.OB] +20.69%
ANGEION CORP [ANGN] +15.44%
UROPLASTY INC [UPI] +12.64%
NMT MEDICAL INC [NMTI] +9.40%
BARD C R INC [BCR] +7.01%
Medical Laboratories & Research
AETERNA ZENTARIS [AEZS] +4.79%
ALLIANCE IMAGING INC [AIQ] +2.00%
GENOPTIX, INC. [GXDX] +1.84%
ARRAY BIOPHARMA IN [ARRY] +1.01%
MEDTOX SCIENTFIC INC [MTOX] +1.01%
- Tuesday’s Top Biotech & Medical Stocks
- Monday’s Top Biotech & Medical Stocks
____________________
Multinational Pharma Wants More from China’s Drug Rules
by Richard Daverman, PhD
ChinaBio Today
After all the hubbub of drug safety and IP protection, China took some major steps in 2007 to reform its regulatory system. In all, China has issued 53 regulations in 2007 that affect drugs, devices and food. But, according to Chen Yang, an attorney from the Beijing office of Sidley Austin, China overlooked three things on multinational pharma’s wish list:
• Defining what constitutes a new chemical entity;
• Assuring confidentiality of submissions for drug regulation;
• Linking drug approvals to patent protection.
Chen Yang made her comments in a public briefing at the New York offices of Sidley Austin.
Most important of these new regs was the drug regulation system that became effective on October 1. The new rules improve transparency by mandating the SFDA to post lists of approved drugs on its website; they require generics to be consistent with their non-generic branded versions in terms of quality, safety and efficacy; and the rules establish a “special approval” process for certain drugs.
Nevertheless, by omitting a definition of what constitutes a new chemical entity, China did not assure multinationals that the data in regulatory submissions would be kept confidential. Yang said further that even if confidentiality had been promised, cases exist in which data had been leaked. As a practical matter, therefore, she warned drug companies to include information only if they can afford for it to become public.
In the third matter, patent linkage, Yang said that companies must include an affidavit stating the new drug does not infringe on any patents. Patent disputes remain outside the jurisdiction of the SFDA, to be settled by the courts. However, if a patent is ruled to be infringed, the SFDA is not currently obligated to revoke market approval. In the previous set of rules, the revocation right was included.
Pharmas also hope the SFDA will adopt rules similar to the Orange Book system of the FDA. The FDA publishes patent information on approved drugs, but a Bolar exemption allows research on a patented product to continue without being a basis for patent infringement litigation. And once a court decides a product is infringing, multinational pharmas would like the SFDA to revoke marketing approval of the offending product.
Yang says that new rules will be promulgated in 2008 to cover good manufacturing practice, drug safety regulation, and device distribution, administration and safety reporting. One question is whether the “special approval” rules for drugs will be extended to imported drugs as well. Under the special approval rules, the process is fast-tracked and pharmas are allowed to revise clinical trial protocol while a trial is ongoing.
Yang said three provisions may be included in a new patent law, expected next year: the Bolar exemption, compulsory licensing if a public health crisis arises, and disclosure of genetic information within a patent application.
Of course, multinational pharmas would also like the patent protection extended, but Yang does not see a high probability of that particular marketing plum.
China will also review the regulation of imported devices next year. It was proposed that all imported devices be inspected, a proposal that has been indefinitely postponed. Ex-China device manufacturers claimed the new rule would cause them hardship and also harm China patients who were in need of the devices. The medical area is one in which China imports a greater dollar of product than it exports.
ChinaBio Today is a regular contributor to BioHealth Investor
______________
Tuesday’s Top Biotech & Medical Stocks
by H.S. Ayoub
BioHealth Investor
Biotechnology
EPIX PHARMACEUTICALS [EPIX] +35.35%
OBAGI MEDICAL [OMPI] +13.98%
MANNKIND CORPORATION [MNKD] +10.54%
TERCICA INC [TRCA] +9.33%
VIA PHARMACEUTICALS [VIAP] +9.24%
Diagnostic Substances
IMMUCELL CP [ICCC] +10.70%
AVALON PHARMACEUTIC [AVRX] +5.76%
IMMUCOR INC [BLUD] +4.98%
IMARX THERAPEUTICS [IMRX] +4.48%
HUMAN GENOME SCI [HGSI] +4.17%
Drug Delivery
PENWEST PHARM CO [PPCO] +11.92%
QUIGLEY CORP THE [QGLY] +4.65%
BENTLEY PHARMACEUTIC [BNT] +4.22%
NOVEN PHARMACEUTIC [NOVN] +2.49%
HOSPIRA INC [HSP] +1.10%
Drug Manufacturers
MINRAD INTL INC [BUF] +16.61%
NEUROGEN CP [NRGN] +11.51%
SUCAMPO PHARMA. INC. [SCMP] +10.81%
CELL THERAPEUTICS [CTIC] +10.10%
SANTARUS, INC. [SNTS] +9.42%
Drug Related Products
INTEGRATED BIOPHARMA [INBP] +7.14%
CHINA SHENGHUO PHARM [KUN] +6.70%
XELR8 HOLDINGS, INC [BZI] +5.50%
ZILA INC [ZILA] +5.50%
PRESTIGE BRAND HLGS [PBH] +5.15%
Generic Drugs
N/A
Medical Appliances & Equipment
ESCALON MED CP [ESMC] +32.31%
ACCURAY INCORPORATED [ARAY] +6.56%
SPECTRANETICS CP T [SPNC] +6.55%
EXACTECH INC [EXAC] +6.09%
LANGER INC [GAIT] +6.09%
Medical Instruments & Supplies
VASOGEN INC [VSGN] +22.47%
CRYOCOR, INC. [CRYO] +12.11%
ENDOLOGIX INC [ELGX] +5.36%
ATRICURE, INC. [ATRC] +5.36%
CANTEL MEDICAL CORP [CMN] +3.98%
Medical Laboratories & Research
BIO-REFERENCE LAB [BRLI] +6.06%
ALLIANCE IMAGING INC [AIQ] +6.03%
ENZO BIOCHEM INC [ENZ] +5.39%
BIO-IMAGING TECH [BITI] +3.73%
ERESEARCHTECHNOLOG [ERES] +2.78%
- Monday’s Top Biotech & Medical Stocks
____________________
Free trade in counterfeit drugs
by David E. Williams
Health business blog
The New York Times has an extensive piece today on the role of free trade zones in enabling the trade in counterfeit drugs (Counterfeit Drugs’ Path Eased by Free Trade Zones). The article describes how the seizure of drugs in a free-trade zone in Dubai led to an unraveling of fraud in Canada:
… an examination of the case reveals its link to a complex supply chain of fake drugs that ran from China through Hong Kong, the United Arab Emirates, Britain and the Bahamas, ultimately leading to an Internet pharmacy whose American customers believed they were buying medicine from Canada, according to interviews with regulators and drug company investigators in six countries.
Some pills, a government official said at the time, contained cement powder.
The trail went through the Bahamas:
The site belonged to RxNorth, described by one trade association as the world’s first major online pharmacy.
A founder, Andrew Strempler, had been the subject of numerous profiles, including one in The New York Times in 2005 that described how at the age of 30 he had two Dodge Vipers, a Jaguar and a yellow Lamborghini with a license plate that reads “RX Boss.”
The article reported that Mr. Strempler’s innovation “created a whole new Canadian industry that has plugged a niche in America’s troubled health care system almost overnight, providing about $800 million worth of low-cost drugs a year to two million uninsured and underinsured Americans, many elderly.” Drugs have traditionally been cheaper in Canada…
As Mickey says, “At least with medical tourism you know what country you are in.”
I’d also be willing to bet that Pfizer’s PR people were the impetus for this story.
Health Business Blog is a regular contributor to BioHealth Investor
__________________
Monday’s Top Biotech & Medical Stocks
by H.S. Ayoub
BioHealth Investor
Biotechnology
GENITOPE CORPORATION [GTOP] +12.89%
PONIARD PHARMA [PARD] +7.65%
SAVIENT PHARM INC [SVNT] +6.88%
EXACT SCIENCES COR [EXAS] +5.00%
IDERA PHARMACEUTICAL [IDRA] +4.24%
Diagnostic Substances
ICAGEN, INC. [ICGN] +3.21%
LEXICON PHARMACEUTCL [LXRX] +2.22%
TORREYPINES THERAPEU [TPTX] +1.71%
AVALON PHARMACEUTIC [AVRX] +1.54%
RESPONSE GENETICS, I [RGDX] +1.35%
Drug Delivery
COLUMBIA LABS INC [CBRX] +4.85%
ACURA PHARMA NEW [ACPH.OB] +2.04%
MATRIXX INITIATVS [MTXX] +1.51%
BENTLEY PHARMACEUTIC [BNT] +1.25%
Drug Manufacturers
MIDDLEBROOK PHARMACL [MBRK] +6.30%
NEXMED INC [NEXM] +3.73%
NITROMED, INC. [NTMD] +3.54%
PHARMACYCLICS INC [PCYC] +3.29%
SIGA TECH INC [SIGA] +3.15%
Drug Related Products
CURATECH INDUSTRIES [CUTC.OB] +53.47%
ARGAN INC [AGX] +9.08%
N B T Y INC [NTY] +1.71%
NUTRACEUTICAL INTL [NUTR] +1.14%
SCHIFF NUTRIT INTL [WNI] +1.14%
Generic Drugs
N/A
Medical Appliances & Equipment
VISION SCIENCES IN [VSCI] +9.09%
CAMBRIDGE HEART INC [CAMH.OB] +6.67%
XCORPOREAL INC [XCR] +6.40%
EXACTECH INC [EXAC] +4.45%
CELSION CORP [CLN] +4.23%
Medical Instruments & Supplies
STEN CORPORATION [STEN] +26.15%
SENORX, INC. [SENO] +7.12%
IMPLANT SCIENCES CP [IMX] +5.94%
BIOMIMETIC THERAPEUT [BMTI] +4.85%
VASOGEN INC [VSGN] +4.71%
Medical Laboratories & Research
NATL DENTEX CP [NADX] +6.99%
PSYCHEMEDICS NEW [PMD] +0.13%
LABORATORY CORP NEW [LH] +0.05%
BioHealth Investor.com
____________________