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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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