Friday's Top Biotech & Medical Stocks

by H.S. Ayoub
BioHealth Investor



Biotechnology

EMERGENT BIOSOLUTION [EBS] +12.25%
NASTECH PHARM CO [NSTK] +9.20%
NEUROCRINE BIOSCI [NBIX] +8.59%
ADVANCED LIFE SCIENC [ADLS] +7.77%
VIA PHARMACEUTICALS [VIAP] +7.31%



Diagnostic Substances

AVALON PHARMACEUTIC [AVRX] +9.76%
GENELABS TECH INC [GNLB] +5.30%
ASPENBIO PHARMA INC [APPY] +3.98%
LEXICON PHARMACEUTCL [LXRX] +2.36%
IMMUCELL CP [ICCC] +1.52%



Drug Delivery

ULURU INC [ULU] +15.00%
COLUMBIA LABS INC [CBRX] +7.98%
QUIGLEY CORP THE [QGLY] +6.25%
PETMED EXPRESS INC [PETS] +4.17%
BIOVAIL CORP [BVF] +3.59%



Drug Manufacturers

REGENERX BIOPHARM IN [RGN] +20.00%
MINRAD INTL INC [BUF] +12.92%
SYNVISTA THERAPEUTIC [SYI] +11.43%
OSCIENT PHARMACEUT [OSCI] +10.00%
ALEXZA PHARMACEUTICA [ALXA] +9.50%



Drug Related Products

CHINA SHENGHUO PHARM [KUN] +9.05%
TIENS BIOTECH GR USA [TBV] +3.24%
N B T Y INC [NTY] +3.04%
SCHIFF NUTRIT INTL [WNI] +2.00%
USANA HEALTH SCIEN [USNA] +1.76%



Generic Drugs

HI-TECH PHARMACAL [HITK] +5.80%
CARACO PHARMA LABS [CPD] +3.14%
CATALYST PHARMACEUTI [CPRX] +2.29%
PHARMACUTICAL CO [PRX] +1.16%
WATSON PHARMACEUTCLS [WPI] +0.69%



Medical Appliances & Equipment

REFLECT SCIENTIFIC [RSCF.OB] +22.58%
WORLD HEART CORP [WHRT] +15.32%
POSSIS MEDICAL INC [POSS] +5.85%
EDAP TMS SA ADR [EDAP] +5.68%
ZYNEX MEDICAL HLDGS [ZYNX.OB] +5.51%



Medical Instruments & Supplies

BIOMERICA INC [BMRA.OB] +18.46%
ELECTRO-OPTICAL SCIE [MELA] +9.33%
CRYOCOR, INC. [CRYO] +8.33%
AMDL, INC [ADL] +7.32%
BIOLASE TECH INCS3 [BLTI] +6.93%



Medical Laboratories & Research

AETERNA ZENTARIS [AEZS] +10.39%
INSIGHT HLTH SVC HLD [ISGT.OB] +5.26%
GENOMIC HEALTH, INC. [GHDX] +4.08%
ERESEARCHTECHNOLOG [ERES] +3.94%
PREMD INC [PME] +3.14%




- Thursday's Top Biotech & Medical Stocks
- Wednesday's Top Biotech & Medical Stocks
____________________

Biogen-Idec: Time To Buy?

by Michael Shulman
BiotechBlitz




No. It isn't time to buy BIIB.

Should I end this post right here? No. I've spent the last two weeks NOT writing and, instead, seeing what other blogs are doing to elicit feedback. The answer is pretty simple: They're writing about stocks and the news about diseases that directly point to stocks.

So, here we go with gen 2 of the BiotechBlitz.

Biogen put itself up for sale due to pressure from outside investors -- namely Carl Icahn. The stock ran up big time. I told my subscribers to get out after the run up and they cleaned up, since we had the position a long time. Now the stock has since come way back down.

So, what's going on? Was the run up pure trading frenzy or is there value in the company and the stock that makes it a buy at current prices of around $70?

Yes and no.

Yes, there is a lot of value if someone buys BIIB as it's quite a valuable asset to a dinosaur big-pharma outfit.

No, if Biogen-Idec doesn’t get bought, both from an investment and a trading perspective.

If the sale of the company is called off, the stock will temporarily go down between $5 and $10, maybe more. I believe it put itself up for sale to get Icahn off its back -- otherwise there is no logical reason to sell the company, given the current and future success of approved products in the marketplace and BIIB's pipeline.

And, if no one has made an offer, yet, I don't think one is coming (I bought some crow at the local grocery store just in case I'm wrong about this). But the company is not worth more than $70 bucks a share at current growth projections, even though I believe multiple sclerosis treatment Tysabri will become the industry standard within five years.

Speaking of Tysabri, and since you all like stocks, my next post will be about Tysabri partner Elan (ELAN). And if you want to read more about how the whole Biogen thing went down, check out Mike Huckman’s blog. He is the best pharma reporter in the business (CNBC) and his blog can be found at http://www.cnbc.com/id/15837675.




BiotechBlitz is a regular contributor to BioHealth Investor
_____________

Thursday's Top Biotech & Medical Stocks

by H.S. Ayoub
BioHealth Investor



Biotechnology

NEOSE TECH INC [NTEC] +25.20%
REGENERON PHARMACE [REGN] +23.09%
QUESTOR PHARMACEUTCL [QSC] +20.88%
3SBIO INC [SSRX] +19.27%
NUVELO INC NEW [NUVO] +17.76%



Diagnostic Substances

IMMUCELL CP [ICCC] +7.36%
LEXICON PHARMACEUTCL [LXRX] +6.60%
ORCHID CELLMARK INC [ORCH] +5.64%
[IMRX] +5.53%
HUMAN GENOME SCI [HGSI] +5.13%



Drug Delivery

ULURU INC [ULU] +10.17%
NOVEN PHARMACEUTIC [NOVN] +6.30%
ELAN CP PLC ADR [ELN] +2.95%
DELCATH SYSTEMS INC [DCTH] +2.94%
MATRIXX INITIATVS [MTXX] +1.10%



Drug Manufacturers

AXCAN PHARMA INC [AXCA] +24.73%
MGI PHARMA INC [MOGN] +18.78%
[SCMP] +15.11%
SOMAXON PHARMACEUTIC [SOMX] +12.86%
[RDEA] +10.47%



Drug Related Products

INTEGRATED BIOPHARMA [INBP] +7.46%
SALIX PHARM DEL [SLXP] +5.44%
NATURAL ALTERNATIV [NAII] +1.91%
NUTRACEUTICAL INTL [NUTR] +1.89%
ARGAN INC [AGX] +1.27%



Generic Drugs

HELICOS BIOSCIENCES [HLCS] +5.11%
HI-TECH PHARMACAL [HITK] +4.63%
LOTUS PHARMACEUTICAL [LTUS.OB] +2.86%
CATALYST PHARMACEUTI [CPRX] +2.34%
WATSON PHARMACEUTCLS [WPI] +1.32%



Medical Appliances & Equipment

PATIENT SAFETY TECH [PSTX.OB] +14.62%
ATS MEDICAL INC [ATSI] +8.79%
MEDICAL SOLUTION MGT [MSMT.OB] +8.00%
[MASI] +7.71%
[XCPL.OB] +7.14%



Medical Instruments & Supplies

BIOTEL INC [BTEL.OB] +12.96%
[NSPH] +9.20%
VIVUS INC [VVUS] +7.34%
ELECTRO-OPTICAL SCIE [MELA] +5.14%
CRYOCOR, INC. [CRYO] +4.96%



Medical Laboratories & Research

SPHERIX INC [SPEX] +5.47%
RADNET INC [RDNT] +2.07%
BIO-IMAGING TECH [BITI] +1.38%
BIO-REFERENCE LAB [BRLI] +1.20%
PREMD INC [PME] 0.00%




- Wednesday's Top Biotech & Medical Stocks
- Tuesday's Top Biotech & Medical Stocks
____________________

Synergetics, Pointing to Pricing Pressure in the Neurosurgery Market, to Introduce New Generator

by Doug Cress
Med Tech Sentinel



Synergetics USA (SURG) has introduced a lower priced, electrosurgical generator with full feature cut and coagulation modes. The new unit is designed to fill the price gap created by its coagulation only unit, COAG, and the up-market Advantage, named DualWave.

The company’s decision was spurred by pricing pressure of competing manufacturers, who have flattened the formerly healthy margins of its premium product line. Synergetics reports that the new product should “dramatically improve sales profit margins”.

Like the DualWave bipolar generator, the new system (which will employ the Malis waveform) is capable of performing the two separate functions of cutting and coagulation. However, the system will not have the improved cutting ability of the DualWave system and will not accept hand-switched bipolar pencils.

“This unit will provide us with selling options, especially when confronted with the price compression that we’ve seen from competitors,” said Gregg D. Scheller, President and CEO of Synergetics. “[Malis] can be produced at a much lower cost and will offer an alternative to those customers who are not interested in the full featured Advantage.”

Synergetics’ products are designed and manufactured to support micro or minimally invasive surgical procedures. The company’s generators focus on eliminating heat and electrical current seepage, making them safe for use near nerves, bones, blood vessels and metal implants. In addition to its surgical devices and equipment for neurosurgery and ophthalmic applications, the company designs and manufactures reusable and disposable supplies and accessories for use with such devices and equipment.




Med Tech Sentinal is a regular contributor to BioHealth Investor
_______________

Wednesday's Top Biotech & Medical Stocks

by H.S. Ayoub
BioHealth Investor



Biotechnology

XTL BIOPHARMACEUTICA [XTLB] +28.31%
QLT INC [QLTI] +23.91%
NUVELO INC NEW [NUVO] +18.75%
GENETIC TECH SPON [GENE] +18.64%
SAVIENT PHARM INC [SVNT] +15.86%



Diagnostic Substances

IMMUNOMEDICS INC [IMMU] +18.41%
LEXICON PHARMACEUTCL [LXRX] +7.43%
AVALON PHARMACEUTIC [AVRX] +6.59%
AVIGEN INC [AVGN] +5.30%
ADVANCE MAGNETIC [AMAG] +5.30%



Drug Delivery

PENWEST PHARM CO [PPCO] +24.00%
COLUMBIA LABS INC [CBRX] +6.64%
EMISPHERE TECH [EMIS] +6.06%
MATRIXX INITIATVS [MTXX] +4.66%
NEKTAR THERAPEUTIC [NKTR] +4.61%



Drug Manufacturers

NEUROGEN CP [NRGN] +12.90%
ADOLOR CORP [ADLR] +12.87%
KERYX BIOPHARM INC [KERX] +12.16%
SIGA TECH INC [SIGA] +11.72%
DURECT CORP [DRRX] +11.39%



Drug Related Products

TIENS BIOTECH GR USA [TBV] +10.67%
CHINA SHENGHUO PHARM [KUN] +9.19%
BOND LABORATORIES [BNDB.OB] +5.56%
N B T Y INC [NTY] +5.00%
PERRIGO COMPANY [PRGO] +4.28%



Generic Drugs

CATALYST PHARMACEUTI [CPRX] +7.16%
CARACO PHARMA LABS [CPD] +5.69%
HI-TECH PHARMACAL [HITK] +4.01%
WATSON PHARMACEUTCLS [WPI] +3.42%
HELICOS BIOSCIENCES [HLCS] +3.39%



Medical Appliances & Equipment

MEDICALCV INC [MCVI.OB] +16.67%
INTUITIVE SURG INC [ISRG] +9.45%
ACCURAY INCORPORATED [ARAY] +8.43%
[MASI] +7.33%
LECTEC CORP [LECT.OB] +7.27%



Medical Instruments & Supplies

ENCISION INC [ECI] +18.42%
CRYOCOR, INC. [CRYO] +12.46%
[VLCR.OB] +9.09%
ISORAY INC [ISR] +8.16%
OCULUS INNOVATIVE SC [OCLS] +7.84%



Medical Laboratories & Research

PREMD INC [PME] +24.00% $17.6 M
ERESEARCHTECHNOLOG [ERES] +8.05% $632.6 M
GENOMIC HEALTH, INC. [GHDX] +5.83% $0
ALLIANCE IMAGING INC [AIQ] +5.36% $531.8 M
BIO-REFERENCE LAB [BRLI] +5.20%




- Tuesday's Top Biotech & Medical Stocks
- Monday's Top Biotech & Medical Stocks
____________________

John Edwards - Where the Candidates Stand on Healthcare

by Mark S. Senak
Eye On FDA




The Iowa Caucuses are fast approaching and I want to get this series done beforehand. So today, we are looking at the healthcare plan of John Edwards.

This plan is similar in nature in many ways to the Clinton plan and like that campaign, is also more comprehensive when compared to many of the other candidates. That said, the focus was even more placed on insurance - which calls for "Universal Health Care Through Shared Responsibility," with little mention of the concerns that may be specific to the pharmaceutical market place. In other words, long on insurance, short on our substance. Since the plan was issued, he has made several issue comments in press releases, but without updating the plan.

I am evaluating at the plans and candidate positioning regarding five domains:

1. Importation of Drugs - Many opponents of importation are likely to see a contradiction in his positioning on this issue. On the one hand, "Edwards will station permanent FDA inspectors to conduct spot inspections in all countries with significant imports, starting with China and India. He will also demand that China regulates is chemical exporters and require "track and trace" pedigrees on all drugs to fight counterfeits." So, while there is a dedication to safe importation, he supports importation..."Edwards has long supported the safe reimportation of prescription drugs from Canada, which could save consumers $50 billion over 10 years. [Washington Post, 5/3/07] "

2. Medicare Part D Reform - While nothing specific was found about the negotiation of drug pricing by the government in the plan, he has stated that "Edwards will repeal the law preventing Medicare from negotiating drug costs with drug makers and empower states to use Medicaid's leverage to purchase drugs at lower prices, with safeguards to preserve access. ."

3. Pharmaceutical Marketing Restrictions - John Edwards believes that a large part of the rising cost of drugs is direct to consumer advertising. His plan states that "Edwards will restrict direct-to-consumer advertising for new drugs to ensure that consumers are not misled about the potential dangers of newly marketed drugs ..." The candidate has also called for a ban on DTC advertising during the first two years after a drug enters the market. In fact, in October he outlined four steps regarding DTC and marketing practices that involve restrictions and closer oversight:

Delay New Ads to Put Safety First: Edwards will institute a two-year delay on consumer advertising of all new drugs.

Get Control with Real Oversight of Advertising: Edwards will give the Food and Drug Administration real power to prevent misleading drug ads by requiring the agency's approval before drug companies can launch major ad campaigns and by increasing the penalties for drug companies that violate truth-in-advertising laws.

Require "Whole Truth" Disclosures: Edwards will improve drug makers' disclosures to the public, requiring companies to tell the public the whole truth about side effects and how effective drugs are against placebos and existing alternatives.

Help Doctors Make Decisions Based on Evidence, Not Ads: Edwards will establish a non-profit or public organization to research the best methods of providing care.

4. Follow-on-Biologic Regulation - Nothing found other than the fact that he would allow the FDA to approve "biogenerics", but see below..

5. Generic Promotion - Again with no specificity in his plan, he has made statements that favor competition. Under the sub-heading "Promoting Evidence Based Medicine" he states that "doctors sometimes prescribe name-brand drugs despite the availability of equally effective, less expensive generic drugs." However, he does nothing to say whether he supports substitution without the physician's knowledge.

Analysis: While he does not offer specifics in these five domains in the plan, looking through his press releases, one finds that he and Senator Clinton are probably on the same page when it comes to health care reform in all five domains. If elected, his presidency would seriously transform the drug market place, allowing importation (albeit safe), He does sound a note, however, of criticism of the industry and the FDA when he closes the plan by saying that he would "strengthen the Food and Drug Administration's ability to monitor new drugs after they reach the marketplace. He will also ensure that researchers evaluating medical devices and drugs are truly independent." The tone of the statement indicates a candidate who, while not speaking to the specifics outlined above, is probably like to take positions once elected that run counter to those of industry. In other words, reform is the true objective here and that reform is not likely to emulate the positions staked out by industry, and in some cases, maybe even the FDA itself.

The candidate has a blog where you might read more.



RELATED READING:
Hillary Clinton - Where the Candidates Stand on Healthcare




Eye On FDA is a regular contributor to BioHealth Investor
____________

Tuesday's Top Biotech & Medical Stocks

by H.S. Ayoub
BioHealth Investor



Biotechnology

OPEXA THERAPEUTICS [OPXA] +18.71%
OSIRIS THERAPEUTICS [OSIR] +15.63%
IMMUNOSYN CORPORATIN [IMYN.OB] +13.64%
QLT INC [QLTI] +10.83%
BARRIER THERAPEUTICS [BTRX] +10.36%



Diagnostic Substances

STARMED GROUP NEW [SMED.OB] +31.58%
ASPENBIO PHARMA INC [APPY] +18.34%
INFINITY PHARMACEUTI [INFI] +5.05%
ICAGEN, INC. [ICGN] +4.55%
ISTA PHARMACTLS [ISTA] +4.42%



Drug Delivery

ARADIGM CORP [ARDM.OB] +8.75%
GENEREX BIOTECH CORP [GNBT] +3.03%
ALKERMES INC [ALKS] +2.93%
BENTLEY PHARMACEUTIC [BNT] +2.40%
NOVEN PHARMACEUTIC [NOVN] +2.27%



Drug Manufacturers

SIMCERE PHARMA ADS [SCR] +11.67%
SANTARUS, INC. [SNTS] +7.08%
JAVELIN PHARMACEUTIC [JAV] +6.93%
ARDEA BIOSCIENCES [RDEA] +5.91%
NEUROCHEM INC [NRMX] +5.50%



Drug Related Products

MEDICAL NUTRITN USA [MDNU] +14.85%
NATURAL ALTERNATIV [NAII] +5.03%
AUXILIUM PHARMACEUT [AUXL] +4.95%
PERRIGO COMPANY [PRGO] +3.98%
SALIX PHARM DEL [SLXP] +2.58%



Generic Drugs

PHARMACUTICAL CO [PRX] +5.37%
CATALYST PHARMACEUTI [CPRX] +4.49%
MYLAN INC [MYL] +3.84%
BARR PHARMA INC [BRL] +3.12%
WATSON PHARMACEUTCLS [WPI] +2.25%



Medical Appliances & Equipment

WORLD HEART CORP [WHRT] +32.14%
SPO MEDICAL INC [SPOM.OB] +12.41%
HANSEN MEDICAL, INC. [HNSN] +11.49%
REFLECT SCIENTIFIC [RSCF.OB] +8.89%
SIGNALIFE INC. [SGN] +6.54%



Medical Instruments & Supplies

CPC OF AMERICA INC [CPCF.OB] +20.80%
ISORAY INC [ISR] +17.21%
MERIT MEDICAL SYS [MMSI] +6.57%
ANGEION CORP [ANGN] +4.56%
ORASURE TECH INC [OSUR] +3.76%



Medical Laboratories & Research

GENOMIC HEALTH, INC. [GHDX] +10.36%
PREMD INC [PME] +3.31%
ARRAY BIOPHARMA IN [ARRY] +2.83%
ENZO BIOCHEM INC [ENZ] +2.55%
ALLIANCE IMAGING INC [AIQ] +1.74%




- Monday's Top Biotech & Medical Stocks
____________________

Monday's Top Biotech & Medical Stocks

by H.S. Ayoub
BioHealth Investor



Biotechnology

INNOVIVE PHARMACEUTL [IVPH.OB] +39.84%
IOMAI CORPORATION [IOMI] +15.97%
IMMUNOSYN CORPORATIN [IMYN.OB] +12.24%
CERAGENIX PHARMACUTL [CGXP.OB] +12.24%
OSTEOLOGIX INC [OLGX.OB] +8.61%



Diagnostic Substances

LEXICON PHARMACEUTCL [LXRX] +10.21%
PRESSURE BIOSCIENC [PBIO] +5.00%
ISTA PHARMACTLS [ISTA] +3.79%
STARMED GROUP NEW [SMED.OB] +2.70%
ASPENBIO PHARMA INC [APPY] +2.33%



Drug Delivery

ARADIGM CORP [ARDM.OB] +2.56%
ULURU INC [ULU] +0.72%
QUIGLEY CORP THE [QGLY] +0.40%
MATRIXX INITIATVS [MTXX] +0.39%
ALKERMES INC [ALKS] +0.29%



Drug Manufacturers

NEUROLOGIX INC [NRGX.OB] +13.76%
MARSHALL EDWARDS [MSHL] +10.55%
CELL THERAPEUTICS [CTIC] +6.00%
MILLENNIUM PHARM [MLNM] +5.03%
ARDEA BIOSCIENCES [RDEA] +4.53%



Drug Related Products

SCHIFF NUTRIT INTL [WNI] +0.74% $167.6 M
NATROL INC [NTOL] +0.46%



Generic Drugs

HELICOS BIOSCIENCES [HLCS] +6.49%
LOTUS PHARMACEUTICAL [LTUS.OB] +4.76%
[RXEI.OB] +0.95%
ISOLAGEN INC [ILE] +0.32%
BARR PHARMA INC [BRL] +0.27%



Medical Appliances & Equipment

DIGIRAD CORPORATION [DRAD] +16.19%
EDAP TMS SA ADR [EDAP] +11.74%
IVIVI TECHNOLOGIES, [II] +7.22%
STEREOTAXIS, INC. [STXS] +4.20%
MISONIX INC [MSON] +3.70%



Medical Instruments & Supplies

UROPLASTY INC [UPI] +7.60%
ENCISION INC [ECI] +5.13%
NMT MEDICAL INC [NMTI] +4.73%
ORTHOVITA INC [VITA] +4.14%
BIOMIMETIC THERAPEUT [BMTI] +3.50%



Medical Laboratories & Research

SPHERIX INC [SPEX] +17.60% $21.0 M
AETERNA ZENTARIS [AEZS] +8.64% $221.9 M
BIO-IMAGING TECH [BITI] +2.43% $33.5 M
PHARM PROD DEV [PPDI] +2.38% $2.7 B
LABORATORY CORP NEW [LH] +1.28%




BioHealth Investor.com
____________________

Genesis Signs Pact with Chinese Academy of Sciences

by Richard Daverman, PhD
ChinaBio Today




Genesis Pharmaceuticals Enterprises, Inc. (OTCBB: GTEC) continued its steady flow of announcements by reporting a new cooperative agreement with The Institute of Microbiology, Chinese Academy of Sciences (IMCAS). IMCAS, which performs basic and applied research in microbiology, will work with Genesis to improve the commercialization of pharmaceutical discoveries.

Genesis and IMCAS will build a "Genesis Pharmaceuticals Industrialization Model" to facilitate the commercialization of pharmaceutical discoveries. Genesis will be responsible for funding the daily operations of the collaboration, which will take place at IMCAS. When drugs have completed the first stage of experiments in the model, Genesis will conduct further testing in its own facility to determine the feasibility of commercial-scale production.

Genesis and IMCAS will work together to solve manufacturing problems, and Genesis will have the right to purchase any products that come from the model.

Genesis’ present incarnation was created less than two months ago, on October 1, 2007, when Laiyang Jiangbo Pharmaceuticals Co. completed a reverse merger with Genesis. One month later, Genesis announced that it had completed a $5 million private placement and bought a patent for the drug Ligustrazine Ferulic Acid Acetate (LFAA), a prospective anti-clotting treatment.

Recently, the company also announced pro forma results for the quarter ending September 30, the first quarter of the company’s fiscal year. Revenues dropped 8% to $16.6 million and net income was also lower by 8% at $3.2 million. Genesis attributed the slowdown to a scheduled maintenance project that took its manufacturing facility off line for five weeks. Without the stoppage, Genesis estimates that revenues would have 15% above last year’s levels.

Clarithromycin sustained-release tablets provided 65% of the company’s revenue during the first quarter, with a gross margin approaching 80.0%. Another 27% of the revenues came from Itopride Hydrochloride granules, which had an even higher gross margin percentage of close to 90%.

Genesis ended its first quarter with $4.6 million in cash, $19.6 million in working capital and a current ratio of 2.1:1. It used $3.2 million in cash flow from operations, partly to make a $3.9 million payment to raw material suppliers, hedging against anticipated rising prices for raw materials. As of September 30, 2007, Genesis had $10.8 million of bank debt and bank notes, and $30.9 million of shareholders' equity. The company has approximately 389 million shares of common stock outstanding.

Looking ahead, Genesis plans to expand its pharmaceutical offerings. The company already began sales of Baobaole chewable tablets, and it expects to be granted approval of an additional four new drugs from the China State Food and Drug Administration by the end of 2007.




ChinaBio Today is a regular contributor to BioHealth Investor
______________

India First Strategy Could Speed Up Data For FDA-EU Approvals

by Joshua Berlin
PharmAsia News




MUMBAI – Pharmaceutical companies may be able to take advantage of the relative speed to market in India to commercialize products earlier and obtain postmarketing data that could bolster drug approval applications filed later in the U.S. and Europe, according to Biocon Founder and Chairman Kiran Mazumdar-Shaw.

Speaking in Mumbai Nov. 19 during the Drug Information Association conference on Drug Discovery and Clinical Development in India, Mazumdar-Shaw noted that on average patient recruitment for clinical trials is roughly 75 percent faster in India than in the U.S. or Europe. This means that companies may advance compounds more quickly through clinical trials and reach the market first in India, she noted.

In an interview with PharmAsia News following her presentation, Mazumdar-Shaw predicted that companies like Biocon could accumulate roughly two years of postmarketing data in India prior to regulatory filing in the U.S. or Europe, where submissions would need to wait until completion of Western trials. The India postmarketing data could then be included as part of the product dossier, allowing companies to demonstrate real-world outcomes to Western regulators in an era of heightened concern about drug safety, she pointed out.

In addition, Mazumdar-Shaw told meeting attendees that the lower costs of clinical trials in India – which average roughly 30 percent to 50 percent less than in the U.S. or Europe – provide companies a strategic opportunity to study parallel indications for oncologics and other compounds in a cost-effective manner.

“What India brings to the table is the fact that failure is affordable” in drug development, she said. Drug R&D “is about making sure that you take big risks, but that they are not so expensive so you can afford to pay them and go on. This is really a true opportunity that India provides for R&D.”

Biocon has established itself as one of India's leading biopharmaceutical companies. In India, Biocon launched the first recombinant human insulin, Insugen in November 2004. The firm also markets BIOMAB-EGFR, a biologic to treat head and neck cancers, which launched in India in 2006.

In September, Biocon released positive Phase I results for its novel oral insulin product IN-105 during the European Association for Study of Diabetes meeting in Amsterdam. Biocon has completed all of the clinical development for the molecule at its headquarters in Bangalore, India. It recently received approval to begin Phase I trials in Switzerland, as well.

Biocon has several partnerships with multinational companies, including a preclinical deal signed earlier this year with Bristol-Myers Squibb focusing on medicinal chemistry, biology and drug metabolism (PharmAsia News, March 15, 2007).

Biocon also has rights to market breast cancer drug Abraxane (paclitaxel albumin-bound particles for injectable suspension) in India, Pakistan, Saudi Arabia, Kuwait and certain other South Asian and Persian Gulf countries. The oncologic is scheduled to launch next year in India after receiving regulatory approval in October.




PharmAsia News is a regular contributor to BioHealth Investor
_________________

Momentum builds for biogenerics, execs say

Nina Andrikian
Reuters Health Summit





NEW YORK (Reuters) - Despite the failure by U.S. legislators to create a path this year for generic versions of biotech drugs, companies that have invested in the products tell Reuters such legislation could pass in 2008 and yield generic biologics early in the next decade.

Momentum is clearly building, generic drugmakers and other companies that could benefit from the arrival of generic biologics said at the Reuters Health Summit in New York this week.

"The wind is at our back," Barr Pharmaceuticals (BRL) Inc Chief Executive Bruce Downey told Reuters. "We've really turned a corner in the last 15 months, and I think we're well on our way to seeing legislation."

U.S. legislators have been debating bills to create a pathway to approve generic forms of many drugs that are derived from naturally occurring proteins, known as biologics.

Such medicines are more complicated to manufacture than standard chemical drugs, making it difficult to determine whether they are equivalent to the originals.

"I really believe in '08 some type of legislation will be passed," said Hospira Inc. (HSP) CEO Chris Begley at the Reuters Health Summit.

Others told Reuters it was difficult to predict the legislative process, especially in an election year, but were no less upbeat about an eventual law.

"You can't predict what's going to go on in Congress, but I do think it's starting to resonate," said Thomas Ryan, CEO of CVS Caremark Corp (CVS), the drug store chain and pharmacy benefit manager at the Reuters Health Summit.




BioHealth Investor.com
__________________

Types of Advanced Fertility Therapies

by H.S. Ayoub, DMD
BioHealth Investor



Fertility treatment still remains relatively unregulated even in the westernized nations, including the U.S. A well written article on the current contraversy over the true value of such therapies in today's edition of the Wall Street Journal summarizes the different procedures as follows:


(source: WSJ and SART.ORG)

In-Vitro Fertilization (IVF)
Egg is fertilized outside of the womb, then implanted in the uterus. Average cost is $30,000 per delivery. Live birth expectancy is 37.1% for women under the age of 35, while is is only 29.2% for those between 35 and 37.

IVF Using Donor Eggs
Healthy egg provided by another woman. Delivery rate: 52.1% for fresh embryo, 31.1% for thawed embryo.

IVF Using Thawed Embryo
Egg is fertilzed before the freezing process. Delivery rate: 31.9% for women under 35, and 27.9% for women between 35 and 37.

IVF Using Thawed Egg
Egg is not fertilized prior to freezing. Data is not sufficient, but preliminary results show that delivery rates range between 10% to 25%

Intra Cytoplasmic Sperm Injection
A single sperm is manually injected into an egg. Addressed male fertility problems, but some concerns do exist relating to increased chances of birth defects.

Pre-Implantation Genetic Diagnosis
The process of detecting single-gene mutation diseases. Clinically shown to be most useful for couples known to be disease carriers.

Pre-Implantation Genetic Screening
The process of screening for abnormal numbers of chromosomes in the genome. More useful for women who have history of multiple miscarriages, but more data needed for lower-risk women.





BioHealth Investor.com
______________________

3SBio Rises after Reporting Q3 Results

by Richard Daverman, PhD
ChinaBio Today




For a change, a China-based biopharma has released a Q3 financial report that made investors happy, sending them out to buy the stock and push its price higher. 3SBio (SSRX) reported revenues that climbed 57% (year over year) to 56.1 million RMB ($7.5 million) and profits that jumped a large 151% to 24.1 million RMB ($3.2 million).

The shares of 3SBio responded by gaining 16% in the first post-report session, moving up $2.28 to $16.68. That was a different result than experienced by most China-based biopharmas recently. In the past few days, WuXi PharmaTech (WX), Tongjitang Chinese Medicines (TCM) and Simcere Pharmaceuticals (SCR) all dropped after reporting results that were much improved over the year before, but did no more than meet the high expectations of investors.

Breaking down its numbers, 3SBio said its mainstay product, TPAIO (a version of EPO), saw its sales rise 31% to 36.3 million RMB ($4.8 million). 3SBio’s newer product, the protein-based recombinant human thrombopoietin (TPO) TPAIO, had a much larger increase of 172%, but it still produced only 14.2 million RMB ($1.9 million). Earnings per share came in at 15 cents per ADS.

Looking into the future, 3SBio says it expects to complete the Phase III trial of Nuleusin, a high-dose (36,000 IU) version of EPIAO, by the end of 2007. The Phase III trial of TPIAO for idiopathic thrombocytopenic purpura should also be finished before the end of the year.

During Q3, 3SBio reported at a scientific meeting in China on two clinical trials of its in-licensed iron-sucrose supplement. Comparing the 3SBio drug with known IV-Iron supplements, the 3SBio candidate was found to have superior safety and similar efficacy as the other products. The company also beefed up its sales force, mostly in terms of training. They have their eyes on an additional 121 hospitals for 3SBio’s line of EPAIO products. In Q3, 3SBio was successful in introducing EPIAO into the 19 major hospitals of the Beijing military hospital system. 3SBio is also building up its export business as EPAIO is currently in the process of entering the national insurance reimbursement list of Thailand.




ChinaBio Today is a regular contributor to BioHealth Investor
______________

Monday's Top Biotech & Medical Stocks

by H.S. Ayoub
BioHealth Investor



Biotechnology

QUESTOR PHARMACEUTCL [QSC] +46.56%
ACCENTIA BIOPHARMACE [ABPI] +16.36%
INNOVIVE PHARMACEUTL [IVPH.OB] +13.33%
MOLECULAR INS PHARMA [MIPI] +10.50%
HEMISPHERX BIOPHARMA [HEB] +9.77%



Diagnostic Substances

ISTA PHARMACTLS [ISTA] +14.88%
ICAGEN, INC. [ICGN] +4.03%
IMMUCELL CP [ICCC] +3.85%
REMOTEMDX INC [RMDX.OB] +3.59%
IMMUNOMEDICS INC [IMMU] +3.52%



Drug Delivery

QUIGLEY CORP THE [QGLY] +4.57%
NEKTAR THERAPEUTIC [NKTR] +4.13%
COLUMBIA LABS INC [CBRX] +2.67%
INSITE VISION INC [ISV] +0.88%
EMISPHERE TECH [EMIS] +0.52%



Drug Manufacturers

MARSHALL EDWARDS [MSHL] +10.62%
WUXI PHARMATECH ADS [WX] +8.42%
ALLOS THERAPEUTICS [ALTH] +5.57%
NEXMED INC [NEXM] +4.93%
ACETO CP [ACET] +3.60%



Drug Related Products

BOND LABORATORIES [BNDB.OB] +6.25%
ARGAN INC [AGX] +5.07%
INTEGRATED BIOPHARMA [INBP] +3.40%
IMAGENETIX INC [IAGX.OB] +3.39%
DRAXIS HEALTH INC [DRAX] +2.75%



Generic Drugs

CATALYST PHARMACEUTI [CPRX] +9.27%
ISOLAGEN INC [ILE] +3.45%
PHARMACUTICAL CO [PRX] +2.33%
CARACO PHARMA LABS [CPD] +1.42%



Medical Appliances & Equipment

BSD MEDICAL CORP [BSM] +3.70%
DEL GLOBAL TECH CORP [DGTC.OB] +3.45%
CRITICARE SYS INC [CMD] +3.38%
ROCKWELL MED TECHS [RMTI] +2.70%
LAKELAND INDS INC [LAKE] +2.36%



Medical Instruments & Supplies

VIVUS INC [VVUS] +9.03%
STRATEGIC DIAGNOST [SDIX] +7.71%
MILESTONE SCIENTIFIC [MLSS.OB] +5.00%
CAS MEDICAL SYS INC [CASM] +4.76%
APA ENTERPRISES [APAT] +4.67%



Medical Laboratories & Research

NEOGENOMICS INC [NGNM.OB] +9.56%
INSIGHT HLTH SVC HLD [ISGT.OB] +5.26%
ERESEARCHTECHNOLOG [ERES] +4.88%
ARRAY BIOPHARMA IN [ARRY] +3.00%
ALLIANCE IMAGING INC [AIQ] +2.36%




____________________

Tuesday's Top Biotech & Medical Stocks

by H.S. Ayoub
BioHealth Investor



Biotechnology

GTX, INC. [GTXI] +13.16%
SEQUENOM INC [SQNM] +11.57%
CHARLES RIVER LAB [CRL] +9.80%
INNOVIVE PHARMACEUTL [IVPH.OB] +8.67%
POLYDEX PHARM LTD [POLXF] +8.04%



Diagnostic Substances

RESPONSE GENETICS, I [RGDX] +15.74%
INTERLEUKIN GENETICS [ILI] +12.07%
ABAXIS INC [ABAX] +8.26%
PRESSURE BIOSCIENC [PBIO] +6.37%
IDEXX LABS [IDXX] +4.12%



Drug Delivery

NOVEN PHARMACEUTIC [NOVN] +3.37%
EMISPHERE TECH [EMIS] +2.55%
ELAN CP PLC ADR [ELN] +2.07%
NEKTAR THERAPEUTIC [NKTR] +1.86%
HOSPIRA INC [HSP] +1.80%



Drug Manufacturers

SANTARUS, INC. [SNTS] +13.16%
PLANET TECHS INC [PLNT.OB] +12.73%
NEUROGEN CP [NRGN] +12.67%
SIMCERE PHARMA ADS [SCR] +9.99%
ALLOS THERAPEUTICS [ALTH] +8.53%



Drug Related Products

CHINA SHENGHUO PHARM [KUN] +15.62%
INTEGRATED BIOPHARMA [INBP] +9.97%
DRAXIS HEALTH INC [DRAX] +3.50%
PERRIGO COMPANY [PRGO] +2.74%
TIENS BIOTECH GR USA [TBV] +2.55%



Generic Drugs

BARR PHARMA INC [BRL] +2.37%
MYLAN INC. [MYL] +1.14%
PHARMACUTICAL CO [PRX] +1.12%
LOTUS PHARMACEUTICAL [LTUS.OB] +0.88%
CATALYST PHARMACEUTI [CPRX] +0.67%



Medical Appliances & Equipment

SHAMIR OPTICAL INDUS [SHMR] +3.85%
DIGIRAD CORPORATION [DRAD] +3.69%
WORLD HEART CORP [WHRT] +3.44%
SYNOVIS LIFE TECH [SYNO] +3.25%
MINE SAFETY APPL [MSA] +3.15%



Medical Instruments & Supplies

OSTEOTECH INC [OSTE] +16.36%
CPC OF AMERICA INC [CPCF.OB] +9.38%
PRO-DEX INC NEW [PDEX] +6.06%
BIOSPHERE MEDICAL [BSMD] +5.92%
MINDRAY MEDICAL INTL [MR] +5.11%



Medical Laboratories & Research

[GXDX] +4.91%
ALLIANCE IMAGING INC [AIQ] +3.96%
ERESEARCHTECHNOLOG [ERES] +3.85%
MEDTOX SCIENTFIC INC [MTOX] +3.33%
GENOMIC HEALTH, INC. [GHDX] +3.12%





- Monday's Top Biotech & Medical Stocks
____________________

Hillary Clinton - Where the Candidates Stand on Healthcare

by Mark Senak
Eye On FDA



By contrast to most of the other candidates, the healthcare plan laid out by Senator Hillary Clinton (D-NY) is quite comprehensive, which should be no surprise given her history with the issue. That said, the organization of the written plan is a bit of a challenge, and one is encouraged to read the entire plan rather than the three-page executive summary at the beginning, which does not exactly track with the plan.

At her campaign site, you can see a summary of Senator Clinton's healthcare plan, or you can download the entire 16-page plan. The overwhelming element to this plan is insurance reform and she aims to increase the number of insured through various mechanisms that include new insurance schemes and practices that will expand coverage, lower premiums and to increase the ability of the insured to stay that way.

It is in the last section of the plan (not the executive summary) where the five categories being addressed in this review are found under the heading "Fiscal Responsibility that Honors our Priorities" each is addressed with brevity. However, she is also laying claim with this section to $4 billion in savings as a result of their implementation:

1. Importation of Drugs - While not mentioned in the body of the plan, allowing reimportation is figured into the balance sheet at the end of the plan that computes the $4 billion savings.

2. Medicare Part D Reform - She states that she favors applying purchasing leverage to reduce prescription drug costs by allowing Medicare to negotiate lower drug prices. also part of the $4 billion savings.

3. Pharmaceutical Marketing Restrictions - There is no specific mention of what she means by this, but the plan states that she should provide "more oversight over pharmaceutical companies' financial relationships with providers." There is no mention of direct-to-consumer advertising or data marketing practices, but seems to focus solely on the relationship with prescribers. This is also part of the $4 billion savings.

4. Follow-on-Biologic Regulation - She states that part of the savings that will be realized in her plan will come from creating a pathway for "biogeneric" drug competition but fails to detail what that pathway would look like. Her choice of the term "biogenerics" regarded by many in industry as a misnomer since biologics cannot be exactly copied and therefore cannot be generics in the same sense of a chemical compound is open to interpretation, but may signal an unwillingness to embrace that position.

5. Generic Promotion - Again with no specificity, the plan states that an object of the plan is "removing barriers to generic competition" and that is the sum of dedicated effort to that subject. Whether this means an erosion of intellectual property or other means of removing barriers is simply not clear.

Analysis: If each of the elements of this plan listed above were enacted, the future growth of pharmaceutical sales would likely be impacted. As the IMS report released last week noted, one of the reasons IMS was projecting lower growth for pharmaceutical sales was the increase in generics and the attacks on intellectual property. The use of the term "biogeneric" along with the anticipation of savings to the government may mean that she is interested in a pathway that offers the least protection for intellectual property of biologics, which some may see as having a chilling effect on innovation in that industry. The plan assumes a $4 billion savings from enacting reforms 1-5 above, but without specifics addressing each of these there is no way to assess the accuracy of that claim. Despite the fact that the plan is comprehensive in scope, it is very short on details when the future of the pharmaceutical and biologic markets are concerned.

Next on deck - Senator Christopher Dodd (D-CONN). but beware, it is slim pickins.




Eye On FDA is a regular contributor to BioHealth Investor
________________

Monday's Top Biotech & Medical Stocks

by H.S. Ayoub
BioHealth Investor



Biotechnology

TERCICA INC [TRCA] +14.94%
ENTREMED INC [ENMD] +13.53%
ADVANCED LIFE SCIENC [ADLS] +9.09%
XTL BIOPHARMACEUTICA [XTLB] +8.95%
NORTHWEST BIOTH NEW [NWBO.OB] +7.41%



Diagnostic Substances

EPICEPT CORPORATION [EPCT] +12.24%
RESPONSE GENETICS, I [RGDX] +6.62%
ASPENBIO PHARMA INC [APPY] +2.86%
MERIDIAN BIOSCIENC [VIVO] +1.36%
NYMOX PHARM CORP [NYMX] +0.53%



Drug Delivery

INSITE VISION INC [ISV] +8.11%
ACURA PHARMACEUTICAL [ACUR.OB] +7.38%
QUIGLEY CORP THE [QGLY] +2.74%
BENTLEY PHARMACEUTIC [BNT] +0.98%
ALKERMES INC [ALKS] +0.78%



Drug Manufacturers

UNITED THERAPEUTIC [UTHR] +5.32%
DUSA PHARM INC [DUSA] +4.83%
UNIGENE LABS INC [UGNE.OB] +4.71%
NEUROCHEM INC [NRMX] +4.00%
PLANET TECHS INC [PLNT.OB] +3.77%



Drug Related Products

IMAGENETIX INC [IAGX.OB] +2.54%
MEDICAL NUTRITN USA [MDNU] +2.50%
SALIX PHARM DEL [SLXP] +1.33%
PERRIGO COMPANY [PRGO] +1.04%
ARGAN INC [AGX] +0.49%



Generic Drugs

HELICOS BIOSCIENCES [HLCS] +6.60%
LOTUS PHARMACEUTICAL [LTUS.OB] +3.64%
WATSON PHARMACEUTCLS [WPI] +0.67%



Medical Appliances & Equipment

SPO MEDICAL INC [SPOM.OB] +14.29%
REFLECT SCIENTIFIC [RSCF.OB] +11.36%
ZYNEX MEDICAL HLDGS [ZYNX.OB] +10.45%
EXACTECH INC [EXAC] +10.21%
SRI/SURGICAL EXPRE [STRC] +6.50%



Medical Instruments & Supplies

BIOSPHERE MEDICAL [BSMD] +20.56%
STEN CORPORATION [STEN] +11.82%
[NSPH] +9.07%
XTENT INC [XTNT] +4.66%
CARDIOTECH INTL [CTE] 0.00%



Medical Laboratories & Research

ERESEARCHTECHNOLOG [ERES] +13.32%
PREMD INC [PME] +8.43%
MEDTOX SCIENTFIC INC [MTOX] +6.62%
AETERNA ZENTARIS [AEZS] +4.28%
ENZO BIOCHEM INC [ENZ] +1.42%





- Thursday's Top Biotech & Medical Stocks
- Wednesday's Top Biotech & Medical Stocks
____________________

Follow-on Biologics Revisited: Who’s on First?

by Greg B. Scott
ChinaBio Today




On September 27, President Bush signed into law H.R. 3580, the Food and Drug Administration Amendments Act of 2007, which, according to the FDA, “represents a very significant addition to FDA authority” and provides “significant benefits for those who develop medical products, and for those who use them.” But what was most significant to the biotech industry was not the terms of the Act, but what was left out – the provision that would have given the FDA the authority to approve generic biotech drugs, or “follow-on biologics” (FOBs).

With no major health care bills expected to move through Congress for at least a year or two, FOBs may be dead until 2010. But, as Yogi Berra put it so succinctly…


“It ain’t over ‘til it’s over.”

On June 26, Senators Kennedy, Clinton, Hatch, Enzi et al introduced the bi-partisan Biologics Price Competition and Innovation Act, S1695, which provides a path for FDA approval of FOBs while (hopefully) continuing to stimulate new drug development. And on June 27, it was passed by the Senate Health, Education, Labor and Pensions Committee. So while it is still very early in the legislative process, S1695 is very much alive.

But not uncontested. U.S. sales of biotech drugs grew nearly 20 percent last year to over $40 billion. This is plenty of incentive for the players to draw battle lines and embark on an all-out war to win their fair share of the spoils.


“Déjà vu all over again.”

Advocates of S1695 believe the bill will significantly reduce the high cost of biologic drugs, thereby making them more widely available, reducing overall healthcare costs, and improving the general health of the U.S. population. It could also make generic drug manufacturers like Dr. Reddy’s, Barr, Ranbaxy, and Teva very rich, as they could now enter a very high stakes game previously unavailable to them.

Detractors believe that there are significant safety issues, due in great part to the well-known variability of biologics in manufacture. They also believe it will disincentivize the industry to invest in the most costly class of drugs to develop and manufacture. This will cause the pipeline of new biologics to dry up, and negatively impact the long term health of the U.S. population. Patient safety is obviously concern #1. But is the industry’s concern centered on safety or the lost profits that the big biotech makers like Genentech, Amgen, Biogen-Idec and others might face?


“When you come to a fork in the road, take it.”

I will leave it to the reader to determine which side of the fence they personally land on. Nevertheless, whether it’s the result of S1695 or some future bill, legal or regulatory action, the industry must eventually grapple with the complex issues of follow-on biologics: how to ensure they are safe and broadly available at a reasonable cost without negatively impacting the incentive for the industry to invest in a vital technology that is generating many of our most effective therapeutics.

If you would like to learn more about S1695 or read it in its entirety, please go www.BioBusinessNews.com/bonus.




ChinaBio Today is a regular contributor to BioHealth Investor
_________________

Networks Fuel Cancer Fright with Food Terror

by Paul Detrick
Business & Media Institute



CNN and CBS scare with 'frightening' results of study finding processed meat to cause cancer.



CBS’s “Evening News” October 31 and CNN’s “American Morning” November 1 decided to enjoy some of the Halloween spirit by scaring viewers with a “landmark” study finding consumption of processed meat could increase the risk of colon cancer.

CBS anchor Katie Couric made up her mind after the “frightening” news saying, “No more bacon for me,” and CNN’s Kiran Chetry found the news of the findings “very shocking” and noted that “I’m in real trouble here” because of her own eating habits.

Chetry went even further, “I guess what is so astounding is if they can extrapolate … that it really does cause that much of a jump in risk it should come with a warning label you know just like cigarettes or alcohol does. That’s what seems to be so surprising.”

She later warned her co-host John Roberts to ditch the bacon and to “get rid of it, just hard boiled eggs or Raisin Bran.”

Medical Correspondent for CNN Elizabeth Cohen at least allowed business its say noting, “The meat industry calls this, ‘Extreme, unfounded and irresponsible.’”

Cohen also said that it was possible to find experts not affiliated with the meat industry that would say, “not to eat processed meats at all is going a little overboard.”

“This report is suggesting moderation, not total deprivation,” added Dr. John LaPook of CBS.

The November 1 USA Today story about the report agreed. It featured Karen Collins, a cancer institute nutrition adviser who urged some caution, but not a complete ban on processed meats. “This is a wake-up call for people who eat hot dogs or pepperoni pizza regularly. They need to be looking for other alternatives. But you can still occasionally have a hot dog,” she said.

That article, written by Nanci Hellmich, also had a few more business viewpoints to share on the study.

In response to the study, Mary Young of the National Cattlemen's Beef Association said the group had “engaged scientists to review the scientific literature on the topic, and they concluded there is no evidence red meat causes cancer.”

Ceci Snyder, a registered dietitian with the National Pork Board, said, “The U.S. Dietary Guidelines include meat and processed meat, and those guidelines are based on a review of the scientific evidence.”

The Center for Consumer Freedom said this was just part of a campaign against food. “Bottom line: Anything that tastes good must be bad,” the group said, pointing out that the researchers, “downplayed, the fact that traditional ‘health’ foods like fruits and [vegetables] don’t necessarily prevent cancer as previously believed.”

“Menu warning labels and other food cop regulations aren’t bolstered by actual empirical evidence, but by speculation and focus groups,” said the article.





Business & Media Institute is a regular contributor to BioHealth Investor
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MRI to Lead Growth in Medical-Imaging Market

by Sara Calabro
Med Tech Sentinel




The U.S. medical-imaging market — including ultrasound, magnetic resonance imaging (MRI), radiography and mammography, and computed tomography (CT) — will be worth an estimated $11.4 billion by 2012, according to a new report by BCC Research, Medical Imaging: Equipment and Related Products.

CT currently accounts for the largest share of the market — worth an estimated $2.3 billion in 2007 — and is predicted to top $3.2 billion by 2012.

But MRI scanners, now with the second-most market share, are the fastest-growing segment, with a projected CAGR of 9.8 percent. Currently valued at over $1.8 billion, the MRI scanner market is expected to exceed $2.8 billion in 2012.

The third-largest segment, ultrasound equipment, is currently valued at $1.6 billion and is expected to grow with a CAGR of 6.9 percent to $2.3 billion in 2012.

Radiography and mammography equipment also is expected to experience significant growth, from a current value of $1.3 billion in 2007 to nearly $2 billion in 2012.

And positron emission tomography (PET) scanners, including combination PET/CT machines, are expected to grow from $669.8 million this year to $991.0 million in 2012.

On Tuesday, two leading diagnostic-imaging companies — E-Z-EM (EZEM), of Lake Success, NY, and Bracco Diagnostics, the U.S. subsidiary of Milan, Italy-based Bracco Imaging — announced plans to merge. Bracco will acquire all of the outstanding shares of E-Z-EM, in a cash transaction valued at $241 million.

E-Z-EM manufacturers contrast agents for gastrointestinal radiology. Products include VoLumen, a patent-pending, low-density barium sulfate suspension for use as an oral contrast in multi-detector CT and PET/CT studies. The company also makes Empower, the first family of CT injectors on the market with patented EDA technology for detecting contrast extravasation.




Med Tech Sentinel is a regular contributor to BioHealth Investor
_________________

Malaria and HIV - Eradication and Treatment

by Mark S. Senak
Eye On FDA



During the past few weeks, I've come across an interesting juxtaposition of malaria with HIV. While there are calls to consider a bold new investment in eradication of the former, some are questioning the quest for a vaccine in the latter. When do diseases become chronic - when do we throw up our hands and accept the status quo for the sake of treating those who are infected or preventing new infections? Is there a delicate balance?

A few weeks ago at a malaria forum in Seattle sponsored by the Bill and Melinda Gates Foundation, Melinda French Gates gave a stirring speech calling for the eradication of malaria. In her talk, she recounted early failed attempts to eradicate malaria. Despite early progress, the effort ultimately did not succeed and that failure, she stated, ironically led to a resurgence of malaria as discouraged funders gave up. I was not there for her speech, nor did I watch it online, but in reading it, I was nevertheless moved as she argued that people in the least developed countries deserve two things - the infected deserve treatment while the uninfected deserve prevention - but they are also deserving of a malaria-free future through eradication. And, she emphasized, both are possible.

By contrast, in today's Washington Post called Rethinking AIDS Strategy After a String of Failures - which recounts, among other failures, the recent failure of yet another attempt at a vaccine. Not unlike those who work in the malaria community, there is some concern that spending time and resources on a vaccine may not be the best use of money when we have known interventions that prevent transmission.

For example, the article carries the following passage -

"...pressure is building from other experts -- some epidemiologists, physicians and scientists -- to shift attention away from technological fixes. They favor devoting more of the world's $10 billion annual AIDS spending to proven, lower-tech strategies against HIV, such as circumcising men, promoting sexual monogamy and making birth control more easily available to infected women."

When the world is facing a killer disease, is there room to sacrifice hope for a cure tomorrow in exchange for control of a disease today? I don't think it is an either/or prospect. As I've recounted many times on this blog, I remember when there were no HIV treatments, and frankly, very little hope for one. Those are days to which I would never hope to return.

Male circumcision. abstinence, monogamy, birth control and other methods of HIV prevention are fine. But when they don't work, people die. Just as Melinda Gates outlined in her speech on malaria - people deserve more than treatment and prevention - they deserve to hope for a world that has no HIV - or malaria.



Eye On FDA is a regular contributor to BioHealth Investor
____________

Dragon’s New Production Process to Cut Costs

by Richard Daverman, PhD
ChinaBio Today



Dragon Pharmaceutical Inc. (DRUG) has developed a new biotech production process for 7-ACA, an intermediate for Cephalosporin antibiotics. The new process replaces a chemical manufacturing technique that involved solvents, toxic waste and extreme temperatures.

Traditionally, formulating 7-ACA involved methylene chloride, N,N-dimethylaniline and trimethylchlorosilicane. These caused toxic wastes that are difficult to recycle and costly to clean up. To create the proper conditions for some of the chemical reactions, the old procedure also required temperatures between negative 40 degrees C and negative 60 degrees C, another high-cost production item.

It was, in short, an expensive procedure that escalated costs. Because so many of these expenses are no longer necessary, Dragon forecasts its product will now be more competitive than before.

The biotech method uses enzymes to catalyze reactions, eliminating expensive solvents and toxic reagents, and causing less waste. The process is also conducted at moderate temperatures.

Dragon put the first biologic line into operation last month, adding to its existing production capacity. The new line can produce 10 tons per month or 120 tons per year. This brings Dragon’s total capability to 720 tons per year. Over time, Dragon will switch all of its production to the new process.

Dragon took the opportunity afforded by the announcement to say that it is also involved in researching ways to upgrade its fermentation technology. Working with the East China University of Science and Technology, Dragon is seeking to improve its fermentation yields, particularly with Cephalosporin C. The undertaking has been named a key project under the China National High-Tech R&D Program, which is tasked with developing important technologies in the biopharma arena.

Company Snapshot

Although its corporate offices are in Vancouver, BC, Dragon’s manufacturing operations are entirely in China. The company has three separate lines of business: a Chemical Division, which manufactures APIs and pharmaceutical intermediates; a Pharma Division for producing generic drugs (especially Cephalosporin antibiotics and freeze-dry injectables); and a Biotech Division for constructing biologics, currently Erythropoietin or EPO.

In January 2005, Dragon acquired Oriental Wave Holding Ltd., which took the company from a single-product enterprise to its present state as a diversified enterprise.

Dragon is approved to produce 47 drugs by the China SFDA. It has four production facilities: one each for freeze-dry injectables, a biotech plant for EPO, a chemical plant for Clavulanic Acid (an antibiotic adjuvant), and the bulk 7-ACA plant. All of these are GMP certified, except for the bulk 7-ACA line, which as an intermediate does not require GMP approval. The company aims to sell 50% of its 7-ACA to manufacturers in India.

In the first half of 2007, revenues were up 40% at $37.9 million. Of these, 3