Orbus Pharma -- Geheimtip aus Canada - 500 Beiträge pro Seite

[BrauchGeld]

Orbus Pharma lieferte in den letzten tagen super nachrichten bisher reagierte der kurs kaum ,aber wer etwas geduld mitbringt der wird belohnt.
Orbus produkt(Metoprolol Succinate XR) die generik version von Astra-Zeneca`s Beloc-ZOC 1,7 mrd US$ jahresumsatz hat vor einigen tagen gute ergebnisse erzielt.
Orbus sucht jetzt einen Partner für Metoprolol,die zulassung ist für ende 2Q 2008 geplant .
Ich denke orbus ist eine story mit happy end.
Ich hab heute weitere 10000st.(0,25€) gekauft.

Orbus Pharma

Marktkap: 15,44 mioC$ (10,5 mio€)
Kurs: 0,35 C$ (~ 0,23€)

Insider:
http://canadianinsider.ca/coReport/allTransactions.php?ticke…

ORBUS EXTENTED RELEASE PATENT APPLICATIONS FOR
FLUVASTATIN PUBLISHED (7. März 2007)
http://www.orbus.ca/reports/74660l.pdf

ORBUS PHARMA INC. ANNOUNCES SUCCESFUL
BIOEQUIVALENCE RESULTS FOR ITS
METOPROLOL SUCCINATE EXTENDED RELEASE (26. Feb 2007)
http://www.orbus.ca/reports/57588r.pdf

ORBUS RECIEVES APPROVAL AND FIRST PURCHASE ORDER FOR CEFUROXIME AXETIL IN SPAIN (15.Feb 2007)
http://www.stockhouse.ca/news/news.asp?newsid=4944575&ti…

Homepage:
http://www.orbus.ca/investors1.asp


Global Biotech Investing

Die Experten von "Global Biotech Investing" empfehlen bei der Aktie von Orbus Pharma (ISIN CA68557A1012 / WKN 813245) weiterhin dabei zu bleiben.

Trotz der Kurseinbrüche an den internationalen Börsen würden sich Anleger bei Orbus Pharma im 14-Tage-Vergleich bereits bis zu 30 Prozent in der Gewinnzone bewegen. Der Titel sei zuletzt von den Wertpapierexperten zum Kauf empfohlen worden, als das Unternehmen eine erfolgreiche Bioäquivalenz-Studie zum weltweit führenden Beta-Blocker Metoprolol Succinate publiziert habe.

Selbst wenn der kanadische Generikahersteller mit dem Generikum Metoprolol Succinate XR nur einen Bruchteil der Jahresumsätze von 1,74 Mrd. USD vom Platzhirsch BelocZOK gewinnen könne, stünde dem Unternehmen eine Umsatz- und Gewinnexplosion ins Haus. Für die beiden letzten noch ausstehenden Studien würden spätestens Ende des dritten Quartals die Ergebnisse erwartet, bevor es an die Vermarktung des Wirkstoffes gehen dürfte. Auf Grund dieser spannenden Perspektiven habe sich die Aktie in den letzten Wochen komplett immun gegen die Marktirritationen gezeigt und habe gegenüber dem Empfehlungskurs stark zugelegt.

[BrauchGeld]

Mit einer marktkap von 10,5 mio€ kann man sicherlich nicht viel falsch machen.

ORBUS PHARMA INC. ANNOUNCES SUCCESFUL
BIOEQUIVALENCE RESULTS FOR ITS
METOPROLOL SUCCINATE EXTENDED RELEASE 26. Feb 2007
TORONTO, ONTARIO - Orbus Pharma Inc., (“Orbus”) announces successful results in
all three of the bioequivalence studies (Fed, Fasted and Steady states) in its European
drug development for the 190 mg tablet of a once per day formulation for metoprolol
succinate extended release (“XR”) tablets. Metoprolol succinate is the world’s leading
cardioselective beta-blocker for hypertension, angina pectoris, heart failure, disturbances
of cardiac rhythm including, especially, supraventricular tachycardia, maintenance
treatment after myocardial infarction and functional heart disorders with palpitations and
for migraine prophylaxis.
The Orbus metoprolol succinate XR formulation is a generic version of Astra Zeneca’s
Beloc-ZOK® (metoprolol CR/XL) which had reported 2005 annual sales of US$1.7
billion. Bioequivalence studies are required for product registration to demonstrate that a
generic formulated product produces the same level of medication in the blood as the
innovator brand product. The most demanding of these studies is the “Fed” study, which
the Orbus formulation has now successfully fulfilled. Orbus will be completing
bioequivalence studies for the remaining dosage strengths to demonstrate therapeutic
equivalence for all dosage strengths of the brand product Beloc-ZOK® (metoprolol
CR/XL). These results are expected to be submitted by the end of the second quarter
of 2007 with anticipated approval of the product for sale in Europe by the end of the
second quarter 2008.
Orbus is currently conducting product out-licensing negotiations with European
companies for the marketing and manufacturing of the Orbus once-a-day metoprolol
succinate XR product. Additionally, Orbus has a U.S. patent pending covering the inhouse
developed delivery system for this product. “Our once-a-day formulation of
metoprolol, using our proprietary in-house developed controlled release technology, has
performed consistently well in development studies so we are very confident the product
will gain regulatory approval in Europe” says Jeff Renwick, President and CEO of Orbus
Pharma Inc. All batches of the Orbus metoprolol succinate XR product used for
regulatory submission were manufactured in Orbus’s Markham, Ontario plant.
Orbus Pharma Inc., headquartered in Markham, Ontario and listed on the Toronto Stock

[BrauchGeld]

Orbus ist kein ein produkt unternehmen hier ist noch ein weiterer kassenschlager in der mache.

Orbus Pharma Inc.: Orbus Pharma Inc. announces succesful bioequivalence results in its FLUVASTATIN extended release drug development
2/7/2007

Toronto, Ontario CANADA, Feb 07, 2007 (M2 PRESSWIRE via COMTEX News Network) --
Orbus Pharma Inc. (ORB - TSX), ("Orbus") today announced the successful results of the most demanding phase of the bioequivalence studies in its European drug development of a once per day formulation for FLUVASTATIN extended release ("XR") tablets, a cholesterol reducing drug.

The Orbus XR formulation is a generic version of Novartis's Lescol XR(R) (Fluvastatin extended Release) which has reported 2005 annual worldwide sales of US$ 767 million.

Bioequivalence studies are required to demonstrate that a generic formulated product results in the same level of medication in the blood as the innovator brand product. The most demanding of these studies is the "Fed" study, which the Orbus formulation has now successfully fulfilled. Orbus will be completing the remaining two bioequivalence studies to demonstrate therapeutic equivalence to the brand product Lescol XR (R) and results are expected near the end of the second quarter of 2007 and the tentative submission date is planed in the fourth quarter 2007 with approval expected 12 to 18 months thereafter.

All batches of the XR product used for regulatory submissions are manufactured in Orbus's Markham, Ontario plant. Orbus is currently in licensing negotiations with European companies for the marketing and manufacturing of the once per day Fluvastatin product. Additionally, Orbus has a U.S. patent pending covering the in house developed delivery system for this product. "Our once-a-day formulation of Fluvastatin using our proprietary in house developed controlled release technology is a major milestone for Orbus and we are very confident that our product will gain regulatory approval in Europe" says Jeff Renwick, President and CEO of Orbus Pharma Inc.

[BrauchGeld]

Antwort auf Beitrag Nr.: 28.174.240 von BrauchGeld am 07.03.07 21:53:01

Orbus hat auch vor kurzem die erste zulassung in spanien erhalten weitere europäische länder werden in kürze folgen .
Die Aktie wird früher oder später steigen müssen .

ORBUS RECIEVES APPROVAL AND FIRST PURCHASE ORDER FOR CEFUROXIME AXETIL IN SPAIN

Toronto, Ontario CANADA, February 15, 2007 /FSC/ - Orbus Pharma Inc. (TSX: ORB), today announces it has received regulatory approval for sale in Spain of the company's generic version of Cefuroxime Axetil Tablets, in 250 mg and 500 mg dosage form. These dosage forms are equivalent to GlaxoSmithKline's Zinnat(R) (Cefuroxime Axetil) 250mg and 500mg tablets. The Cefuroxime Axetil product will be manufactured at the Orbus Pharma antibiotic plant in Cambridge, Ontario.

Subsequent to regulatory approval in Spain, the company has received the first purchase order from its Spanish marketing partner for finished packs of generic Cefuroxime Axetil Tablets. According to Jeff Renwick, President and CEO, "with this purchase order, we are looking at a significant milestone in the company's entry into the European market for a product that is strategically important to Orbus".

Cefuroxime Axetil tablets are indicated for the treatment of patients with infections caused by susceptible strains of designated organisms in the following diseases: Pharyngitis and Tonsillitis, Lower Respiratory Tract Infections, Urinary Tract Infections and Skin and Skin Structure Infections.

Pipeline:

Famciclovir is used to treat
shingles (herpes zoster) as
well as herpes simplex virus
infections. It has also been
shown to be effective for
preventing genital herpes
outbreaks.

A pivotal bioequivalence study is scheduled in the
first quarter of 2007. Validation batches are scheduled
to be completed near the end of 2006. Submission is
scheduled for mid 2007.

Produkt:
Amitryptaline
(anti-depressant)

The bioequivalence study was completed at the end of the
second quarter of 2006 with positive results for both
the Canadian as well as European reference product.
The European Union submission is expected in
February 2007 with final approval expected in mid 2008.

Produkt:
Fluvastatin
cholesterol
reducer)

A bioequivalence study was
completed in the second quarter of 2006 and results
are expected in the fourth quarter of 2006. File
registration is expected in mid 2007 and approval is
expected twelve to eighteen months later.

Produkt:
Metoprolol
once a day
(beta blocker)

The two most demanding phases of the
bioequivalence studies have been completed with
successful results. The remaining bioequivalence
studies are scheduled to be completed and results are
expected near the end of 2006. Regulatory submission
is expected in April 2007 with approval expected
twelve to eighteen months later.

Produkt:
Cefuroxime
axetil
(antibiotic)

Danish regulatory application was made in 2004 and
secured in 2005. Application for marketing approval
in other EU countries has been completed and
approvals are expected mid 2007. Non exclusive
licensing and supply agreements were signed with
four different companies covering the territories of
Belgium, Luxembourg, Spain, Italy and the
Philippines. The Company plans to file for Canadian
marketing approval in late 2006 or early 2007 after
completion of stability studies.

[BrauchGeld]

Vor kurzem wurde ein Top CFO eingestellt.

ORBUS PHARMA ANNOUNCES APPOINTMENT OF NEW VICE
PRESIDENT FINANCE AND CHIEF FINANCIAL OFFICER
Jeff Renwick, President and Chief Executive Officer of Orbus Pharma Inc, is
pleased to announce the appointment of Greg W. Muir as the Vice President
Finance and Chief Financial Officer effective February 12, 2007.
Mr. Muir has over 20 years of pharmaceutical industry experience and has been
the senior financial officer at two of the highest growth pharmaceutical
companies in Canada over the past 11 years. Most recently as the Vice
President Finance with Solvay Pharma and, prior, as the Director Finance with
Searle Canada. The balance of his pharmaceutical experience was in
Controllership positions with Johnson & Johnson operating divisions.
Mr. Muir has served in leadership roles for several industry associations including
Chair of the Finance Section for The Pharmaceutical Manufacturing Association
of Canada and the Finance Liaison Leader for the Ontario Pharmaceutical
Investment Climate Committee. Additionally, he was the Vice President Finance
for the Strategic Leadership Forum. Mr. Muir has an MBA from the top ranked
Schulich School of Business at York University and has a professional
accounting designation from The Certified Management Accountants of Ontario.
“We are delighted to have Mr. Muir join our team as we enter an exciting new
growth phase of the company”, said company President and CEO Jeff Renwick.
“He brings a wealth of invaluable financial and business building experience to
Orbus from a number of market leadership driven multinational pharmaceutical
companies”.
Orbus Pharma Inc., listed on The Toronto Stock Exchange under the symbol
ORB, is aggressively pursuing a global strategy of: (1) out-licensing its generic
drug developments, using proprietary delivery systems for certain products; and
(2) providing contract manufacturing and related services for finished oral dose
pharmaceutical products. For more information, please visit www.orbus.ca

[BrauchGeld]

Orbus hat seit heute eine neue homepage die schön und übersichtlich ist .

http://www.orbus.ca/

[BrauchGeld]

Antwort auf Beitrag Nr.: 28.312.439 von BrauchGeld am 15.03.07 17:02:11

Steht der ausbruch nach oben kurz bevor ?

[BrauchGeld]

[BrauchGeld]

Es scheint los zugehen ,sollte Orbus in nächster zeit einen partner melden sehen wir schnell kurse über 1 C$.

Orbus ist einfach übertrieben unterbewertet .

[BrauchGeld]

Antwort auf Beitrag Nr.: 28.332.618 von BrauchGeld am 16.03.07 18:45:30

Aktuell schon über 10% plus

http://finance.yahoo.com/q?s=orb.to

[BrauchGeld]

Excellent progress in 2006, loss narrows.
Orbus Pharma Inc. Reports 2006 Results

3/16/2007

Corporate update

To date in 2007, Orbus has received successful bioequivalence results for two of its drug development projects. The first was the third and final results for the bioequivalence studies (Fed, Fasted and Steady states) in its European drug development for the 190mg tablet of a once per day formulation for metoprolol succinate extended release ("XR") tablets. The second result was from the most demanding phase of the bioequivalence studies in its European drug development of a once per day formulation for Fluvastatin extended release ("XR") tablets. Orbus has also had its' patent applications for this once per day formulation for Fluvastatin extended release drug recently published by the United States Patent and Trade-mark Office and the Work Intellectual Property Office. The Company also received the regulatory approval for sale in Spain of its generic version of Cefuroxime Axetil tablets, in 250mg and 500mg dosage form. Subsequent to this approval, the Company has received the first purchase order for finished packs of this product.

The Company announced the appointment of Greg W. Muir as the Vice President and Chief Financial Officer effective February 12, 2007. The Company has retained First Canadian Capital Corp. as a consultant to provide investor relations services, corporate communications and financing advice.

[BrauchGeld]

Orbus könnte ein überraschungshit werden .

[BrauchGeld]

Antwort auf Beitrag Nr.: 28.369.926 von BrauchGeld am 19.03.07 13:29:30

und es geht weiter aufwärts ........

5 Day Chart:

[BrauchGeld]

Mit etwas musik auf die explosion warten........

Ciara - Like a Boy

http://www.youtube.com/watch?v=5peZWTwPtV8

Cassie - Long way to go

http://www.youtube.com/watch?v=a-GG2al8N58&NR

Beyonce - Irreplaceable

http://www.youtube.com/watch?v=3URfWTEPmtE&mode=related&sear…

[BrauchGeld]

Hätte ich das nötige kleingeld ich würde diese firma direkt kaufen für witzige 19 mio C$ .


Ein blick auf den gestrigen Handel:

Most Recent Trades
Time Price Change #Shares Buyer Seller
11:17:23 0.43 0.025 12,500 80 National Bank 85 Scotia
10:31:53 0.43 0.025 74,000 79 CIBC 7 TD Sec
10:31:53 0.43 0.025 1,500 79 CIBC 7 TD Sec
10:15:28 0.43 0.025 8,500 2 RBC 7 TD Sec
10:01:16 0.425 0.02 2,500 33 Canaccord 2 RBC
09:58:35 0.425 0.02 5,000 33 Canaccord 19 Desjardins
09:30:26 0.425 0.02 3,000 33 Canaccord 7 TD Sec
09:30:26 0.425 0.02 6,000 33 Canaccord 2 RBC

[BrauchGeld]

Die party geht los charttechnisch ist der weg jetzt frei

[BrauchGeld]

Antwort auf Beitrag Nr.: 28.392.405 von BrauchGeld am 20.03.07 16:53:57

Orbus steigt aktuell um über 16% die marktkap liegt jetzt bei 22 mio C$ .


5 Day Chart:

[BrauchGeld]

Es sieht aus als könnte heute wieder ein schöner tag für Orbus werden

http://www.stockhouse.ca/comp_info.asp?symbol=ORB&table=LIST…

[BrauchGeld]

Antwort auf Beitrag Nr.: 28.407.699 von BrauchGeld am 21.03.07 13:40:57

Orbus steht jetzt bei 0,51 C$der nächste schub kommt sehr bald .

[BrauchGeld]

Antwort auf Beitrag Nr.: 28.451.826 von BrauchGeld am 23.03.07 14:06:56

Da ist einer auf einkaufstour:

http://canadianinsider.ca/coReport/allTransactions.php?ticke…

[BrauchGeld]

Hier eine kleine rechnung von einem Stockhouse user .
Ich wäre schon mit 8$ sehrrr zufrieden

The presentation stated ORB requires $5 million annually. If the annual revenue will be $33 million by Q3-2009, then the gross profit will be approx $25 to $28 million. Remember there are no marketing or sales expenses assiciated with the sales. That's about .40 per FD share.
With a PE of 20 it means SP of $8.00 per share.

Note, revenues are about $3 million at present.

With potential revenues of $100 million for 6 of the 8 products in the pipeline, asuming $15 million of expenses, taxes of $20 million then profit will be $1.00 per FD share, rendering a SP of $20.

Of benefit, there are $40 million of tax losses available to ORB.

However, all of these are conservative in my estimation. When dealing with an $18 billion market potential, a 3% penetration $500 million.

Again, there is limited data to go on.

[BrauchGeld]

Stockhouse rating ist heute von neutral auf optimistisch gesprungen

http://www.stockhouse.ca/comp_info.asp?symbol=ORB&table=LIST

60 - 69 - Optimistic

[butzelie]

Antwort auf Beitrag Nr.: 28.668.584 von BrauchGeld am 04.04.07 22:09:50

klar habe ich "meine" Orbus noch.
Es dürften in Zukunft eher mehr , als weniger werden .
Allerdings sollte erst mal die 0,50 nachhaltig überwunden werden.

Besonders gefällt mit das gestiegene Volumen
zumindest in Kanada ....

[BrauchGeld]

Insgesamt eine positive nachricht......

10 April
ORBUS PHARMA ESTABLISHES A STANDBY CREDIT FACILITY
WITH RELATED INVESTORS FOR CDN $1.OM
TORONTO, ONTARIO - Orbus Pharma Inc., (“Orbus”) announces it has established an
unsecured standby Credit Facility totaling CDN $1.0M through Commitment Letters with
the following related investors.
• Trimac Investment Limited Partnership: Mr. Jeff McCaig is an indirect
shareholder of Trimac Holdings Ltd which controls Trimac Investment Limited
Partnership. He is also a director of Orbus Pharma.
• Edco Capital Corporation: Mr. Murray Edwards is the principal of Edco and an
insider for Orbus Pharma.
• Balinhard Capital Corporation: Mr. Larry Moeller is the principal of Balinhard. He
is also a director of Orbus Pharma.
The above individuals have also participated in previous financing placements in 2006
and 2004. “I feel this is a strong endorsement and continued support for the good
progress we are making with our generic drug development and commercialization
agreements” said Jeff Renwick, President and CEO of Orbus.
The terms of the Credit Facility provide for an 8% annual interest charge on borrowings
and a one time standby fee of 1%. Additionally, at the time a borrowing is made; the
Lender will receive one warrant for each dollar borrowed. The warrants are exercisable
for one common share of Orbus with the exercise price for the warrants determined in
the following manner. One half of the warrants will have a value equal to the volume
weighted average trading price of the common shares on the TSX for the 20 days
ending on March 30, 2007, the effective date of the Credit Facility. The exercise price
for the remaining one half of the warrants will be equal to the volume weighted average
trading price of the common shares for the 20 days ending on the day prior to the
borrowing.
The Credit facility is required to continue our development and submission activities for
advanced stage Orbus products. According to Greg Muir; VP Finance and CFO; “the
short term Credit Facility provides cash flow stability to compensate for potential timing
fluctuations with regulatory approvals in Europe”. All borrowings against the Credit
Facility need to be repaid prior to the end of 2007.

[butzelie]

Antwort auf Beitrag Nr.: 28.745.597 von BrauchGeld am 10.04.07 19:51:46

+ 10,2 %
In Canada ist man wohl ganz deiner Meinung
Bin echt gespannt , wie es weiter geht

[butzelie]

Antwort auf Beitrag Nr.: 28.750.705 von butzelie am 11.04.07 06:08:03

un wech sinn se widder die 10 %

gestern mit 17.000 Umsatz 10% hoch
heute ( erst mal) mit 3.000 Umsatz 10% runter

[BrauchGeld]

Antwort auf Beitrag Nr.: 28.762.221 von butzelie am 11.04.07 18:12:18

Wie ich am anfang schon gesagt habe etwas geduld muss man haben .
Ich will jetzt nicht pushen aber meiner meinung nach wird sich die Aktie in naher zukunft mehr als verdoppeln ,Orbus ist einfach viel zu niedrig bewertet .

Einige news stehen fürs dieses Quartal an .

[butzelie]

Da war ja doch noch etwas Umsatz in Kanada
nur halt leider in die falsche Richtung
Ich dachte schon die wären ausgesetzt ....

warten wir noch ein Weilchen

schönes WE

[BrauchGeld]

So langsam kommt Orbus in fahrt .......

Kurs: 0,56 C$

The Orbus metoprolol succinate XR formulation is a generic version of Astra Zeneca’s
Beloc-ZOK® (metoprolol CR/XL) which had reported 2005 annual sales of US$1.7
billion. Bioequivalence studies are required for product registration to demonstrate that a
generic formulated product produces the same level of medication in the blood as the
innovator brand product. The most demanding of these studies is the “Fed” study, which
the Orbus formulation has now successfully fulfilled. Orbus will be completing
bioequivalence studies for the remaining dosage strengths to demonstrate therapeutic
equivalence for all dosage strengths of the brand product Beloc-ZOK® (metoprolol
CR/XL). These results are expected to be submitted by the end of the second quarter
of 2007 with anticipated approval of the product for sale in Europe by the end of the
second quarter 2008.
Orbus is currently conducting product out-licensing negotiations with European
companies for the marketing and manufacturing of the Orbus once-a-day metoprolol
succinate XR product. Additionally, Orbus has a U.S. patent pending covering the inhouse
developed delivery system for this product. “Our once-a-day formulation of
metoprolol, using our proprietary in-house developed controlled release technology, has
performed consistently well in development studies so we are very confident the product
will gain regulatory approval in Europe” says Jeff Renwick, President and CEO of Orbus
Pharma Inc. All batches of the Orbus metoprolol succinate XR product used for
regulatory submission were manufactured in Orbus’s Markham, Ontario plant.

[BrauchGeld]

Dieser thread ist übersichtlicher und besser als der alte .

Wird zeit das sich Orbus in neue höhen begibt...

[superzausel]

Schlußkurs heute 0,54, ist doch OK

Gruß

[BrauchGeld]

Dieser Hr. Renwick sammelt alles ein was er bekommen kann ,er hat schon einige 10.000 st.(zwischen 0,42 C$ - 58 C$ )in den letzten 2 monaten gekauft .


May 15/07 May 09/07 Renwick, Jeffrey W. 10 - Acquisition in the public market Common Shares 1,500 $0.520

May 15/07 May 14/07 Renwick, Jeffrey W. 10 - Acquisition in the public market Common Shares 1,000 $0.550

May 15/07 May 10/07 Renwick, Jeffrey W. 10 - Acquisition in the public market Common Shares 500 $0.530

May 15/07 May 10/07 Renwick, Jeffrey W. 10 - Acquisition in the public market Common Shares 2,000 $0.520

May 15/07 Apr 09/07 Renwick, Jeffrey W. 10 - Acquisition in the public market Common Shares 1,500 $0.520

May 15/07 May 09/07 Renwick, Jeffrey W. 10 - Acquisition in the public market Common Shares 1,000 $0.500

May 04/07 Apr 30/07 Edwards, Norman Murray 53 - Grant of warrants Warrants 112,500

May 04/07 Apr 30/07 Edwards, Norman Murray 53 - Grant of warrants Warrants 112,500

May 03/07 Dec 24/04 Edwards, Norman Murray 00 - Opening Balance-Initial SEDI Report Warrants

May 03/07 Apr 30/07 Moeller, Larry G. 53 - Grant of warrants Warrants 12,500

May 01/07 Apr 17/07 Renwick, Jeffrey W. 10 - Acquisition in the public market Common Shares 1,300 $0.500

May 01/07 Apr 24/07 Renwick, Jeffrey W. 10 - Acquisition in the public market Common Shares 3,000 $0.570

May 01/07 Apr 24/07 Renwick, Jeffrey W. 10 - Acquisition in the public market Common Shares 3,000 $0.570

May 01/07 Apr 23/07 Renwick, Jeffrey W. 10 - Acquisition in the public market Common Shares 4,000 $0.540

[BrauchGeld]

Hier ein update das wichtigste hab ich rot markiert ,es sind einige news fürs 1H 2007 geplant .


http://www.sedar.com/DisplayCompanyDocuments.do?lang=EN&issu…

Pipeline Update 8. Mai 2007


Product

Oxcarbazepine
(anti-epileptic)

Description

This product used alone
or in combination with
other medications will
treat certain types of
seizures in the treatment
of epilepsy.

Status at May 8, 2007

This product is being developed with a European partner
Alfred E. Tiefenbacher GmbH and Co. (“AET”) under a
50% cost and profit sharing agreement. Submission was
made with regulatory authorities in the Netherlands and
Germany in June 2005. Marketing approval is expected
mid 2007 in Germany with sales and production at about
the same time. On November 6, 2006 the Company
announced the signing of a three way license, sale of
marketing authorisations and manufacturing agreement
with its 50% co-development partner AET and Desitin
Arzneimittel GmbH of Germany.


------------------------------------------------

Product

Cefuroxime
axetil
(antibiotic)

Description

Cefuroxime axetil is
used to treat certain
infections caused by
bacteria, such as
bronchitis; gonorrhea;
Lyme disease; and
infections of the ears,
throat, sinuses, urinary
tract, and skin.

Status at May 8, 2007
Dossier was purchased from a European company for
$247 in October 2004. The Company is currently
preparing site transfer to our Cambridge manufacturing
facility.
Danish regulatory application was made in 2004 and
secured in 2005. Application for marketing approval in
other EU countries has been completed and approvals are
expected mid 2007. In the first quarter of 2007 the
European patent office has granted a patent on the Orbus
formulation of cefuroxime axetil. Non exclusive licensing
and supply agreements were signed with four different
companies covering the territories of Belgium,
Luxembourg, Spain, Italy and the Philippines. The
Company plans to file for Canadian marketing approval in
the second quarter of 2007 after completion of stability
studies.


-------------------------------------------------

Product

Metoprolol once
a day
(beta blocker)

Description

Metoprolol is used alone
or in combination with
other medications to
treat high blood
pressure. It also is used
to prevent angina (chest
pain) and in
combination with other
medications to treat
heart failure.

Status at May 8, 2007

This product is being developed with a European partner
Alfred E. Tiefenbacher GmbH and Co. under a 50% cost
and profit sharing agreement.
A patent on the Orbus extended release formulation has
been filed. The two most demanding phases of the
bioequivalence studies have been completed with
successful results. The remaining bioequivalence studies
are scheduled to be completed and results are expected in
the second quarter of 2007. Regulatory submission is
expected in June 2007 with approval expected twelve to
eighteen months later.


-------------------------------------------------------

Product

Fluvastatin
(cholesterol
reducer)

Description

This drug works by
slowing the production
of cholesterol in the
body. The accumulation
of cholesterol and fats
along the walls of the
arteries decreases blood
flow and, therefore, the
oxygen supply to the
heart, brain, and other
parts of the body.
Lowering blood levels
of cholesterol and fats
may help to prevent
heart disease, angina,
strokes, and heart
attacks.

Status at May 8, 2007

Formulation development has been completed on an
extended release (once a day) formulation and a pilot
bioequivalence study showed equivalence to the brand
LESCOL® (trademark of Novartis AG). On March 7,
2007 the Company announced that patent applications for
its extended release formulation had been published by the
United States Patent and Trademark Office and the World
Intellectual Property Office. A bioequivalence study was
completed in the second quarter of 2006 and results are
expected in the second quarter of 2007. File registration is
expected in the first quarter 2008 and approval is expected
twelve to eighteen months later.


------------------------------------------------------

Product

Amitriptyline
(anti-depressant)

Description

Used to treat symptoms
of depression.

Status at May 8, 2007

All development work and production batches have been
completed. Stability studies are ongoing. Recent
regulatory changes in Europe now require that a
bioequivalence study be performed on this development
before submission for market approval can be made. The
bioequivalence study was completed at the end of the
second quarter of 2006 with positive results for both the
Canadian as well as European reference product. The
European Union submission is scheduled in the second
quarter of 2007 with final approval expected in mid 2008.


-------------------------------------------------

Product

Famciclovir

Description

Famciclovir is used to
treat shingles (herpes
zoster) as well as herpes
simplex virus infections.
It has also been shown
to be effective for
preventing genital
herpes outbreaks.

Status at May 8, 2007

This product is being developed with a European partner
Alfred E. Tiefenbacher GmbH and Co. under a 50% cost
and profit sharing agreement. Pre-formulation work has
been completed. Pre-stability at accelerated conditions has
also been completed and product appears to be stable.
A pivotal bioequivalence study was conducted in the first
quarter of 2007. Validation batches are scheduled to be
completed in the second quarter of 2007. Submission is
scheduled for the third quarter of 2007.

---------------------------------

Product

Cholesterol
reducer

Description

Same chemical
properties as described
above in the product
fluvastatin.

Status at May 8, 2007

Orbus is developing this product under a development and
licensing agreement (covering the territories of Europe,
Middle East and North Africa) for a European customer.
Orbus will retain the rights in other countries. The
agreement provides for payments on development
milestones of EURO €100.000 plus expenses. To date
100% of this amount has been earned by Orbus. Results of
a pilot bioequivalence study undertaken in December
2005 were satisfactory for our client and they are
currently evaluating what further development work is to
be carried out by Orbus.

[BrauchGeld]

Und nachbörslich gibts wieder gute news ..................

ORBUS PHARMA INC

ORBUS PATENT APPLICATIONS FOR EXTENTED RELEASE METOPROLOL SUCCINATE PUBLISHED

5/16/2007

Toronto, ON May 16, 2007

ORBUS PATENT APPLICATIONS FOR EXTENTED RELEASE METOPROLOL SUCCINATE PUBLISHED

Toronto, Ontario CANADA, May 16, 2007 /FSC/ - Orbus Pharma Inc. (TSX: ORB), today announced that patent applications for its extended release formulation of the drug Metoprolol Succinate has been published by the United States Patent and Trade-mark Office and the World Intellectual Property Office, the latter of which represents the potential for formalized patent applications in over 125 countries worldwide.

"This in house developed drug delivery technology is proving valuable for expanding the market potential of the Orbus Metoprolol Succinate as well as demonstrating high revenue opportunities using the extended release technology in new products. Our once-a-day formulation has also performed consistently well in bioequivalence studies," says Jeff Renwick, President and CEO of Orbus Pharma Inc. All batches of the Orbus Metoprolol Succinate XR product used for regulatory submission were manufactured in Orbus's Markham, Ontario plant.

The Orbus Metoprolol Succinate XR formulation is a generic version of Astra Zeneca's Beloc-ZOK(r) (metoprolol CR/XL) which had reported 2005 annual sales of US$1.7 billion.

[superzausel]

Gut das ich nochmal nach gekauft habe, hoffentlich lohnt es sich. Der Einstigskurs dürfte aber bald zu hoch sein, oder?

[superzausel]

http://canadianinsider.ca/coReport/allTransactions.php?ticke…

Orbus Pharma Inc. (ORB) As of May 17th, 2007

May 17/07 May 08/07 Bailey, Franklin Truman 50 - Grant of options Options Employee Stock Options 100,000 $0.370

May 17/07 May 08/07 Renwick, Jeffrey W. 50 - Grant of options Options Employee Stock Options 300,000 $0.370

[BrauchGeld]

noch mehr insiderhandel ..........

http://canadianinsider.ca/coReport/allTransactions.php?ticke…

Orbus Pharma Inc. (ORB) As of May 20th, 2007
Filing Date Transaction Date Insider Name Nature of transaction Securities # or value acquired or disposed of Unit Price

May 18/07 May 08/07 Moeller, Larry G. 50 - Grant of options Options Employee Stock Options 100,000

May 18/07 Mar 19/02 McCaig, Jeffrey James 00 - Opening Balance-Initial SEDI Report Warrants

May 18/07 May 08/07 Winkler, Rodney 50 - Grant of options Options Employee Stock Options 100,000 $0.370
#
May 18/07 May 08/07 Zaleski, Andrew 50 - Grant of options Options Employee Stock Options 100,000 $0.370

May 18/07 May 09/07 McCaig, Jeffrey James 53 - Grant of warrants Warrants 125,000 $0.538

May 18/07 May 09/07 McCaig, Jeffrey James 53 - Grant of warrants Warrants 125,000 $0.439

May 18/07 Mar 19/02 McCaig, Jeffrey James 00 - Opening Balance-Initial SEDI Report Warrants

May 18/07 May 08/07 McCaig, Jeffrey James 50 - Grant of options Options Employee Stock Options 100,000 $0.370

[butzelie]

Antwort auf Beitrag Nr.: 29.403.394 von BrauchGeld am 21.05.07 14:18:20

Kann es sein das die Insider , die einzigen sind , die momentan für Umsätze sorgen ??
Ja , ich bin noch drin und bleibe es !!

butzelie

[superzausel]

In der Ruhe, liegt die Kraft. Wir werden schon unsere Gewinne abholen, besser wie ne Pusher Aktie!?!?, oder, was meint Ihr.

Gruß an alle

[BrauchGeld]

und wieder gute news......

ORBUS SIGNS CEFUROXIME AXETIL AND AMYTRIPTYLINE LICENSING AND SUPPLY AGREEMENTS
15:25 EDT Tuesday, May 29, 2007

FSC / Press Release

ORBUS SIGNS CEFUROXIME AXETIL AND AMYTRIPTYLINE LICENSING AND SUPPLY AGREEMENTS

Toronto, Ontario CANADA, May 29, 2007 /FSC/ - Orbus Pharma Inc. (ORB - TSX), ("Orbus") today announced the signing of a 5 year non-exclusive licensing and manufacturing supply agreement with Dansk Laegemiddelforsyning DLF ApS ("DLF"), a European pharmaceutical company based in Denmark.

Under terms of the license agreement, DLF will apply to distribute the products in Denmark, Sweden and Denmark (Cefuroxime axetil only in Denmark). They will pay Orbus an undisclosed license fee according to specified milestone payments leading up to receiving regulatory approval for sale of the products in the first country. Our expectations for regulatory approval are indicated below.

* Cefuroxime axetil regulatory registration granted in Denmark, mutual recognition to remainder of Europe expected in third quarter 2007

* Amytriptyline regulatory registration expected in third quarter 2008

Orbus will manufacture the Cefuroxime axetil at its dedicated antibiotic plant in Cambridge, Ontario with the Amytriptyline manufactured at its Markham, Ontario plant. The products will be supplied to DLF in either bulk or finished packs according to their specified packaging requirements.

"This agreement provides Orbus with a terrific business opportunity. By adding DLF, a significant European pharmaceutical company, we are strengthening our distributor alliances and expanding our geographical penetration in a big way. Both factors are key to our mission of being a leading developer and manufacturer of generic pharmaceuticals," said Jeff Renwick, President & CEO of Orbus.

Cefuroxime Axetil is an antibiotic used to treat certain infections such as bronchitis, infections of the ears, throat, sinuses, urinary tract and skin. Amytriptyline is an anti-depressant used to treat symptoms of depression.

[BrauchGeld]

US-Partner für Orbus hauptprodukt metoprolol succinate ist gefunden ......

ORBUS SIGNS LETTER OF INTENT WITH BRECKENRIDGE PHARMACEUTICAL, INC.

Toronto, ON June 07, 2007

ORBUS SIGNS LETTER OF INTENT WITH BRECKENRIDGE PHARMACEUTICAL, INC.

Toronto, Ontario CANADA, June 07, 2007 /FSC/ - Orbus Pharma Inc. (TSX: ORB), ("Orbus") today announced the signing of a Letter of Intent (LOI) with Breckenridge Pharmaceutical, Inc. ("Breckenridge"), a United States based distributor of own-label pharmaceutical products. The LOI pertains to an exclusive long term profit-sharing agreement for the United States that covers the development, supply and marketing of the Orbus developed metoprolol succinate extended-release tablets. Jeff Renwick, President and CEO of Orbus Pharma, explained: "This agreement validates a tremendous market opportunity for the Orbus products in the United States and the significant financial benefits of a profit-sharing arrangement with Breckenridge, both of which are first time occurrences for us."

Under terms of the LOI, Orbus will develop and submit an Abbreviated New Drug Application ("ANDA") to the U.S. Food and Drug Administration (FDA) for metoprolol succinate extended-release tablets. Breckenridge will contribute its experience with the FDA regulatory framework, particularly with regard to ANDA procedures. Upon approval by the FDA, Orbus will manufacture and Breckenridge will market and distribute the product on an exclusive basis in the United States. On a long term basis, the two companies will be equal partners. "This profit-sharing arrangement recognizes the significance of the Orbus development efforts. It also gives us the ability to participate more broadly in the strong revenue growth Breckenridge is expecting for the product"; according to Greg Muir, VP Finance and CFO of Orbus Pharma.

The metoprolol succinate extended release tablet is a once a day beta blocker that can be used alone or in combination with other medications to treat high blood pressure. It is also used to prevent angina and, in combination with other medications, to treat heart failure. The product is a generic form of Astra Zeneca's branded product, Toprol XL, which had annual sales in the United States of approximately $1.7 billion in 2006.

Breckenridge was founded in 1983 and is headquartered in Boca Raton Florida. Its website is www.bprix.com. Breckenridge markets a broad range of ValuBrand? and generic prescription products in many therapeutic categories. Its sophisticated marketing programs and experienced sales team reaches over 100 accounts including wholesalers, distributors, chains and managed care accounts as well as retail pharmacies throughout the United States