BioMarin Recieves Approval for Aldurazyme in Japan
BioMarin Pharmaceutical Inc. (BMRN) announced today that it had recieved marketing approval for Aldurazyme in Japan, the firt exclusive treatment for mucopolysaccharidosis I (MPS I) in that country.
Aldurazyme is already approved in the U.S. and Europe for treating MPS I, which is a fatal genetic disease characterized by the lack of enzyme alpha-L-iduronidase leading to a dangerous build up of complex carbohydrates in cells. The condition can cause pulmonary and cardiac failure, among other tissue and organ complications. Patients usually do no survive into adulthood
BioMarin entered into a partnership with Genzyme, whereby BioMarin is responsible for manufacturing Aldurazyme while Genzyme will commercialize the drug.
Shares of BioMarin closed Tuesday’s trading a little over $16 a share ahead of the after-hours news release.
_
Tuesday’s Top Biotech and Medical Stocks
Biotechnology
CYTRX CP [CYTR] +21.37%
ALNYLAM PHARMACEUT [ALNY] +18.80%
MEMORY PHARMACEUTICA [MEMY] +15.15%
BIOSANTE PHARMA INC [BPA] +10.78%
EXACT SCIENCES COR [EXAS] +10.61%
Diagnostic Substances
NYMOX PHARM CORP [NYMX] +10.54%
PONIARD PHARMA [PARD] +8.92%
VALERA PHARMACEUTICA [VLRX] +8.42%
GENELABS TECH INC [GNLB] +7.59%
PRESSURE BIOSCIENC [PBIO] +5.14%
Drug Delivery
NOVADEL PHARMA INC [NVD] +8.93%
MATRIXX INITIATVS [MTXX] +2.24%
COLUMBIA LABS INC [CBRX] +2.06%
FLAMEL TECH SA ADR [FLML] +1.76%
NEKTAR THERAPEUTIC [NKTR] +1.69%
Drug Manufacturers
SIRNA THERAPEUTICS [RNAI] +95.81%
SCICLONE PHARMA [SCLN] +12.72%
PROVECTUS PHARMA [PVCT.OB] +6.09%
AMERICAN ORIENTL BIO [AOB] +5.97%
OSCIENT PHARACEUT [OSCI] +5.71%
Medical Appliances & Equipment
MEDICAL SOLUTION MGT [MSMT.OB] +25.00%
UROLOGIX INC [ULGX] +5.71%
EXACTECH INC [EXAC] +5.63%
CANDELA CP [CLZR] +4.66%
BIOMET INC [BMET] +3.81%
Medical Instruments & Supplies
AMDL, INC [ADL] +23.95%
BIOJECT MEDICAL [BJCT] +21.90%
ENCISION INC [ECI] +8.83%
BIOMIMETIC THERAPEUT [BMTI] +6.72%
EP MEDSYSTEMS INC [EPMD] +6.61%
Medical Laboratories & Research
NEOGENOMICS INC [NGNM.OB] +7.58%
BIO-IMAGING TECH [BITI] +4.88%
PRIMEDEX HEALTH SYS [PMDX.OB] +3.21%
ARRAY BIOPHARMA IN [ARRY] +2.51%
PACIFIC BIOMETRICS N [PBME.OB] +1.82%
_
Merck Looking To Become RNAi Technology Leader
Pharmaceutical giant Merck (MRK) shocked the biotechnology world today as the company announced it is buying little biotech Sirna Therapeutics (RNAI) for more than $1 billion. That figure is 100% more than Sirna’s market value.
This is another move by Merck to enter the new darling of the biotechnology industry, RNAi technology. Discovered by Andrew Fire and Craig Mello in 1998, which won them the Nobel Prize last month, RNAi is a new form of RNA, an acronym for RNA interference, that can turn off other genes much like an off switch.
Scientists are excited about the potential of RNAi as a new drug discovery tool, but some also believe that RNAi can be a drug in itself.
Central to the deal is Sirna’s drug candidate for macular degeneration currently in phase 2 clinical trials.
While some may believe the $1 billion price tag placed on Sirna might be expensive, Merck’s move places the company as one of the leaders in this new technological field of biotech research. It has a partnership with Alnylam Pharmaceuticals (ALNY), a company founded in 2002, and is currently advancing its own RNAi candidate for treating lung infections caused by Respiratory Syncytial Virus. Alnylam’s drug is currently in phase 1 trials.
Shares of Alnylam were already up more than 24% in after hours trading late Monday, and will surely see more gains at the opening bell on Tuesday.
_
Watch Alert: Sonic Innovations Inc (SNCI)
Shares of Sonic Innovations (SNCI) gained more than 17% on Monday on more than 14x the daily average volume.
There was no news release or media exposure that can be detected.
Sonic Innovations develops and markets digital hearing aids and auditory testing equipment.
Shares of SNCI closed at $4.88 after reaching a day high of $5.34.
SNCI has made it on BHI’s Watch List.
_
Monday’s Top Biotech and Medical Stocks
Biotechnology
REXAHN PHARMACEUTICL [RXHN.OB] +30.56%
POINT THERAPEUTICS [POTP] +19.20%
CRITICAL THERAPEUTIC [CRTX] +11.34%
IMMTECH PHARM INC [IMM] +9.95%
POLYDEX PHARM LTD [POLXF] +9.37%
Diagnostic Substances
LEXICON GENETICS I [LEXG] +2.54%
MONOGRAM BIOSCIENCES [MGRM] +2.21%
IMMUCOR INC [BLUD] +1.64%
ISTA PHARMACTLS [ISTA] +1.49%
SONUS PHARM INC [SNUS] +1.43%
Drug Delivery
ARADIGM CORP [ARDM] +6.48%
BENTLEY PHARMACEUTIC [BNT] +1.68%
FLAMEL TECH SA ADR [FLML] +1.04%
INSITE VISION INC [ISV] +0.67%
ANDRX GROUP [ADRX] +0.16%
Drug Manufacturers
SIGA TECH INC [SIGA] +4.95%
ACUSPHERE INC [ACUS] +4.66%
DURECT CORP [DRRX] +4.05%
GERON CORP [GERN] +3.82%
AMERICAN ORIENTL BIO [AOB] +2.86%
Medical Appliances & Equipment
SONIC INNOVATIONS [SNCI] +17.59%
ARRHYTHMIA RES TECH [HRT] +5.97%
CHOLESTECH CORP [CTEC] +4.08%
VOLCANO CORPORATION [VOLC] +3.67%
KINETIC CONCEPTS INC [KCI] +3.49%
Medical Instruments & Supplies
CAS MEDICAL SYS INC [CASM] +17.65%
CARDIOTECH INTL [CTE] +14.76%
BIOMIMETIC THERAPEUT [BMTI] +13.12%
ENCISION INC [ECI] +8.70%
NUCRYST PHARMACEUTIC [NCST] +8.32%
Medical Laboratories & Research
AASTROM BIOSCIENCE [ASTM] +11.89%
BIO-IMAGING TECH [BITI] +9.28%
PSYCHEMEDICS NEW [PMD] +5.38%
ENZO BIOCHEM INC [ENZ] +4.92%
PREMD INC [PME] +4.68%
_
GSK Vaccine Could Cut Cervical Cancer by 80%
At Monday’s International Society of Pharmacoeconomics and Outcomes Research 9th Annual European Congress (ISPOR) in Copenhagen, Denmark, Glaxosmithkline PLC (GSK) announced that based on a mathematical model typically used for estimating the effect of cancer vaccines in a population its own cervical cancer candidate could reduce the rate of this cancer in women by as much as 80%.
GSK’s cancer vaccine has been developed to prevent infection with the most prevalent cancer causing sub-types of HPV, HPV16 and HPV18. This was shown in an earlier study where the company’s vaccine prevented recurrent HPV infections in women between the ages of 15-25.
The company claims that over 16,000 women have been vaccinated with its cervical cancer vaccine. The vaccine is currently undergoing phase 3 clinical trials.
Shares of GSK closed on Friday at $53.28, down by about 3%.
_
Weekly Insider Report: Biotech and Medical Stocks
The BHI Weekly Insider Report is posted on BHI once a week, usually on Sunday or Monday. BHI does not take any responsibility for any financial loss or damage caused by or related to the following reports. BHI does not guarantee the accuracy of the reports. The following information should be used for entertainment purposes only.
This week’s report:
BIOTECH
bought Trubion Pharm [TRBN]: Oct 17-23, $13 by Directors & Beneficial Owners
sold Illumina [ILMN]: Oct 20-25, $42.90-$44.80 by 2 Officers & Director
sold Gilead Sciences [GILD]: Oct 23-25, $67.20-$69.50 by 2 Officers & Director
sold Pharmaceutical Prod [PPDI]: Oct 20-24, $35-$35.49 by 2 Officers
sold Omrix BioPharm [OMRI]: Oct 23-24, $19.76-$19.95 by 2 Beneficial Owners
sold Vertex Pharm [VRTX]: Oct 23, $33.65 by Officer
sold Amylin Pharm [AMLN]: Oct 19, $46.47 by Director
sold Medicines Co [MDCO]: Oct 23, $24 by Officer
sold ISIS Pharm [ISIS]: Oct 19, $8.95-$9 by Officer
DRUGS
bought Iomai Corp [IOMI]: Oct 25, $4.38 by Director & Beneficial Owners
sold Adams Respiratory [ARXT]: Oct 20-24, $42.16-$43.47 by 2 Officers
sold Johnson & Johnson [JNJ]: Oct 24, $68.50-$68.62 by 2 Officers
sold Endo Pharm [ENDP]: Oct 23, $29.80 by Officer
sold Eli Lilly [LLY]: Oct 25-26, $56.83-$57.79 by Beneficial Owner
sold Pozen [POZN]: Oct 23, $15.00 by Officer
sold Somaxon Pharm [SOMX]: Oct 23, $15.03 by 5 Officers & Director
sold Cytokinetics [CYTK]: Oct 24, $6.99-$7.04 by Director
sold Corcept Pharm [CORT]: Oct 25, $0.84 by Officer
MEDICAL SUPPLIES
bought LeMaitre Vascular [LMAT]: Oct 19-23, $6.20-$6.43 by 2 Officers
bought Vascular Solutions [VASC]: Oct 25, $7.50 by Director
bought Aspenbio Pharma [APNB]: Oct 23, $1.80 by Officer
bought Optical Sensors [OPTL]: Oct 18, $1.30 by Beneficial Owner
sold Immucor [BLUD]: Oct 23-26, $26.00-$26.52 by Director & Officer
sold Kensey Nash [KNSY]: Oct 23-25, $31.00-$31.68 by Officer
sold Wright Medical Grp [WMGI]: Oct 24-26, $23.52-$24 by Officer
sold Arrow Int [ARRO]: Oct 20-25, $35.61-$36.12 by 2 Directors
sold AngioDynamics [ANGO]: Oct 24, $22.93 by Beneficial Owner
sold Iridex [IRIX]: Oct 19-20, $10.00 by Director
_
Watch Alert: Insite Vision (ISV)
Shares of Insite Vision (ISV) ended trading on Friday up more than 17%, on more than twice the three month average daily volume.
No news or media exposure can be detected.
It is an extremely large jump relative to other stocks that have made it on BHI’s watch list. However, such interest in a stock in one day, with no news, warrants attention.
Insite Vision develops and markets ophthalmic pharmaceutical products, including AzaSite, which is indicated for the treatment of bacterial conjunctivitis.
On August 28, the company announced that the FDA accepted its NDA for AzaSite for review.
Friday’s action could be a sign of an FDA decision in the near future.
Insite has made BHI’s Watch List.
_
IBD Weekly Top Ranked Medical Stocks…
The following list represents the top ten medical stocks ranked according to Earnings Per Share and Relative Strength by Investor’s Business Daily (10/28/06)
scores out of 100 (last week’s rank, change in score):
1(2) Arrhythmia Research [HRT] EPS=91 RS=98
2(3) Icon [ICLR] EPS=93 RS=96
3(4) Immucor [BLUD] EPS=95 RS=93
4(6) Wellcare [WCG] EPS=94 RS=94(+2)
5(5) Systems Xcellence [SXCL] EPS=90 RS=95(-1)
6(-) Quality Systems [QSII] EPS=98 RS=86
7(-) West Pharmaceutical [WST] EPS=90 RS=92
8(-) Bio Reference Labs [BRLI] EPS=94 RS=87
9(10) Rochester Medical [ROCM] EPS=87 RS=94
10(7) Parexel [PRXL] EPS=92 RS=89 (-4)
_
Friday’s Top Biotech and Medical Stocks
Biotechnology
INNOVIVE PHARMACEUTL [IVPH.OB] +13.33%
SENESCO TECH [SNT] +11.82%
PROGEN INDS LTD [PGLA] +8.40%
PRAECIS PHARMA [PRCS] +8.26%
BARRIER THERAPEUTICS [BTRX] +8.11%
Diagnostic Substances
DYADIC INTERNATIONAL [DIL] +9.78%
GENELABS TECH INC [GNLB] +9.03%
ORCHID CELLMARK INC [ORCH] +6.44%
SYNOVICS PHARMACEUTL [SYVC.OB] +5.26%
CYTOGEN CORP [CYTO] +2.55%
Drug Delivery
INSITE VISION INC [ISV] +17.32%
COLUMBIA LABS INC [CBRX] +6.83%
BIOPROGRESS PLC [BPRG] +5.02%
SYMBOLLON PHARM CL A [SYMBA.OB] +4.67%
ALKERMES INC [ALKS] +1.57%
Drug Manufacturers
VERTEX PHARMACEUT [VRTX] +17.62%
CARRINGTON LABS IN [CARN] +11.11%
DR. REDDY’S LAB LTD [RDY] +8.10%
DUSA PHARM INC [DUSA] +5.92%
SOMAXON PHARMACEUTIC [SOMX] +5.72%
Medical Appliances & Equipment
MEDICAL SOLUTION MGT [MSMT.OB] +14.29%
ZEVEX INTL INC [ZVXI] +7.58%
MEDIS TECH LTD [MDTL] +4.85%
CELSION CORP [CLN] +3.77%
PALOMAR MED TECH [PMTI] +3.41%
Medical Instruments & Supplies
CPC OF AMERICA INC [CPCF.OB] +11.61%
ANGEION CORP [ANGN] +11.12%
CONCEPTUS INC [CPTS] +7.83%
UROPLASTY INC [UPI] +7.03%
PERKIN ELMER INC [PKI] +5.57%
Medical Laboratories & Research
MEDASORB TECHNOLOGS [MSBT.OB] +15.20%
NEOGENOMICS INC [NGNM.OB] +12.50%
PACIFIC BIOMETRICS N [PBME.OB] +9.71%
PREMD INC [PME] +6.88%
BRITESMILE INC [BSML] +4.35%
_