Cardiome Pharma in der analyse
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"We are delighted to have entered into this commercialization agreement with Biospifar and continue BRINAVESS availability in the Colombian market," said Karim Lalji, Cardiome's Chief Commercial Officer. "This agreement reinforces Cardiome's commitment to have BRINAVESS available to other markets beyond Europe."
"We are pleased to have partnered with Cardiome to sell BRINAVESS in Colombia," said Fabio Ospina, Biospifar's Founder and General Director. "BRINAVESS will be a great addition to our line of hospital cardiovascular and intensive care products and provide our customers another option for the management of acute onset atrial fibrillation."
In 2011, the size of the Colombian pharmaceutical market was estimated at $3.5B, of which the hospital sector comprises $1.3B.1
References:
1.Biospifar/IMS Health, December 2011
TSX: COM
VANCOUVER, Oct. 28, 2013 /PRNewswire/ - Cardiome Pharma Corp. (NASDAQ:CRME) (TSX: COM) today announced that the abstract, Conversion of Acute Atrial Fibrillation with Propafenone or Vernakalant, is being presented as an oral presentation by Dr. Diego Conde, Chief of Cardiovascular Emergency Care Section, Instituto Cardiovascular de Buenos Aires, at the Venice Arrhythmias meeting, being held in Venice, Italy, October 27-29, 2013. This abstract is competing for the Geographical Areas Special Best Abstract Award - Latin America. Cardiome is also providing an update on journal publications by Dr. Conde of comparative studies for intravenous (IV) vernakalant in the treatment of atrial fibrillation (AF) versus other antiarrhythmic medications and electrical cardioversion.
"This series of publications led by Dr. Conde reinforces the key differentiating characteristics of vernakalant IV compared to other therapies available for conversion," stated Steen Juul-Möller, M.D., Medical Director at Cardiome Pharma Corp. "His real-life observations using vernakalant IV with respect to time required for therapeutic effect, efficacy, safety and length of stay in the emergency room are very encouraging."
"Our experience using vernakalant IV has been extremely satisfying," stated Diego Conde, M.D., Chief of Cardiovascular Emergency Care Section, Instituto Cardiovascular de Buenos Aires. "In our center, the use of oral propafenone or flecainide is fairly common. However, with the comparable efficacy and safety seen with vernakalant IV, coupled with a reduction in hospital length of stay, I believe vernakalant IV is a compelling and viable therapeutic option for the conversion of recent-onset AF in our institution."
In May 2013, the publication Propafenone Versus Vernakalant for Conversion of Recent-Onset Atrial Fibrillation authored by Dr. Conde et al., appeared in the advanced online article access of Cardiovascular Therapeutics, a peer reviewed medical journal, and represents the first study to compare these two agents.1 This study was an open label, sequential design study in patients with atrial fibrillation of less than 48 hours duration that contrasted treatment with vernakalant intravenous (N=17) to oral propafenone (N=19). Subjects received a single oral dose of 600 mg of propafenone or vernakalant IV in an initial dose of 3.0 mg/kg for 10 minutes and an additional 2 mg/kg if AF had not resolved within 15 minutes, which is in accordance with the approved dosage recommendation. Patients treated with vernakalant achieved conversion to normal sinus rhythm in a median time of 9 minutes versus 166 minutes in the propafenone group (p<0.01). Conversion rate was 78% in the propafenone group at 8 hours and 93% in the vernakalant group at 2 hours (p=NS). In addition to the more rapid time to cardioversion, patients treated with vernakalant IV experienced a significantly shorter hospital length of stay, 238 minutes versus 416 minutes (p<0.01) for patients treated with propafenone. There was one serious adverse event (transient bradycardia) in each treatment group.
Another publication titled Flecainide versus Vernakalant for Conversion of Recent-Onset Atrial Fibrillation authored by Dr. Conde et al., and published online in March 2013 in the peer-reviewed International Journal of Cardiology, showed that the time to conversion to sinus rhythm was 163 minutes in the flecainide group (300 mg single oral dose, N = 15) versus 10 minutes in the vernakalant IV group (labeled dose, N=17) (p<0.01) in patients with AF duration less than 48 hours.2 In this open-label study, patients treated with vernakalant IV experienced a significantly shorter hospital length of stay, 232 minutes versus 409 minutes (p<0.01) for the patients treated with flecainide. The conversion rate for patients treated with vernakalant at 2 hours was 86% compared to 78% for patients treated with flecainide at 8 hours (p=NS). There was one serious adverse event (transient bradycardia) in each treatment group.
Furthermore, a study in patients with AF of less than 48 hours duration who were treated with vernkalant IV had a statistically significant improvement in perception of state of health at 2 hours compared with propafenone or flecainide. Based on the EQ-5D quality of life (QoL) instrument, a mean increase of 12.1 points from baseline was seen in the vernakalant IV group while the mean increases were 5.4 points in the propafenone and 5.2 points in the flecainide group (p<0.01).3 These changes in QoL measured at 2 hours after treatment were consistent with the rapid conversion time seen in the vernakalant IV group. The full study is published online in the Cardiology Journal.
A short-communication authored by Dr. Conde et al., published online in the International Journal of Cardiology in July 2013, titled Vernakalant versus Electrical Cardioversion in Recent-Onset Atrial Fibrillation, concluded that the conversion rate of recent-onset AF and hospital length of stay was similar in patients treated with vernakalant or electrical cardioversion without statistical differences.4 The authors further stated that where electrical cardioversion protocols included the need for sedation and fasting for a minimum of 3 to 6 hours, vernakalant was found to be a safe and effective alternative to electrical cardioversion in this population. This observational study included hemodynamically stable, recent-onset AF of less than 48 hours duration without structural heart disease. Electrical cardioversion was performed in 30 patients and another 30 patients received the labeled dose of vernakalant IV. All electrical cardioversions were performed under sedation with intravenous propafol and with a minimum of 3 hours fasting. Conversion rate was 91% in the vernakalant group at 2 hours and 100% in the electrical cardioversion group (p=NS). Hospital length of stay was 246 minutes in the vernakalant group compared to 263 minutes in the electrical cardioversion group (p=NS). No adverse events were reported.
References:
Conde, D. et al. Propafenone versus vernakalant for conversion of recent-onset atrial fibrillation. Cardiovascular Therapeutics. Advance access published May 20, 2013, doi: 10.1111/1755-5922.12036
Conde, D. et al. Flecainide versus vernakalant for conversion of recent-onset atrial fibrillation. International Journal of Cardiology. Advance access published Mar 21, 2013, doi: 10.1016/j.ijcard.2013.02.006
Conde, D. et al. Vernakalant: Perception of state of health in patients with a recent-onset atrial fibrillation. Cardiology Journal. Advance access published Jul 23, 2013, doi: 10.5603/CJ.a2013.0113
Conde, D. et al. Vernakalant versus electrical cardioversion in recent-onset atrial fibrillation. International Journal of Cardiology. Advance Access published Jul 26, 2013, doi: 10.1016/j.ijcard.2013.06.055
About Cardiome Pharma Corp.
Cardiome Pharma Corp. is a biopharmaceutical company dedicated to the discovery, development and commercialization of new therapies that will improve the health of patients around the world. Cardiome has one marketed product, BRINAVESSTM (vernakalant IV), approved in Europe and other territories for the rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults.
Cardiome is traded on the NASDAQ Capital Market ( CRME ) and the Toronto Stock Exchange (COM). For more information, please visit our web site at www.cardiome.com.
Forward-Looking Statement Disclaimer
Certain statements in this news release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 or forward-looking information under applicable Canadian securities legislation that may not be based on historical fact, including without limitation statements containing the words "believe", "may", "plan", "will", "estimate", "continue", "anticipate", "intend", "expect" and similar expressions. Forward- looking statements may involve, but are not limited to, comments with respect to our objectives and priorities for the remainder of 2013 and beyond, our strategies or future actions, our targets, expectations for our financial condition and the results of, or outlook for, our operations, research and development and product and drug development. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Many such known risks, uncertainties and other factors are taken into account as part of our assumptions underlying these forward-looking statements and include, among others, the following: general economic and business conditions in the United States, Canada, Europe, and the other regions in which we operate; market demand; technological changes that could impact our existing products or our ability to develop and commercialize future products; competition; existing governmental legislation and regulations and changes in, or the failure to comply with, governmental legislation and regulations; availability of financial reimbursement coverage from governmental and third-party payers for products and related treatments; adverse results or unexpected delays in pre-clinical and clinical product development processes; adverse findings related to the safety and/or efficacy of our products or products; decisions, and the timing of decisions, made by health regulatory agencies regarding approval of our technology and products; the requirement for substantial funding to expand commercialization activities; and any other factors that may affect our performance. In addition, our business is subject to certain operating risks that may cause any results expressed or implied by the forward-looking statements in this presentation to differ materially from our actual results. These operating risks include: our ability to attract and retain qualified personnel; our ability to successfully complete pre-clinical and clinical development of our products; changes in our business strategy or development plans; intellectual property matters, including the unenforceability or loss of patent protection resulting from third-party challenges to our patents; market acceptance of our technology and products; our ability to successfully manufacture, market and sell our products; the availability of capital to finance our activities; and any other factors described in detail in our filings with the Securities and Exchange Commission available at www.sec.gov and the Canadian securities regulatory authorities at www.sedar.com. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement. All forward-looking statements and information made herein are based on our current expectations and we undertake no obligation to revise or update such forward-looking statements and information to reflect subsequent events or circumstances, except as required by law.
SOURCE Cardiome Pharma Corp.
This article appears in: News Headlines
Referenced Stocks: CRME
Read more: http://www.nasdaq.com/press-release/...t-20131028-00650#ixzz2jJ7dHFyH
Warum schwächelt der Kurs in letzten Tagen vor Zahlenbekanntgabe? Die letzten News waren vielversprechend! Hat jemand mehr Wissen? Dabei bleiben oder raus? Gruss an alle Investierten.
MFG
Chali
Und in der Tat: Die Ursache des ohnehin völlig überzogenen 90% igen Kursverlust ist mittlerweile beseitigt,und Cardiome hat wieder mindestens 1000% Potential,richtig erkannt !
Aber welche ist die zweite Aktie,hm ?
Press Release: Cardiome Pharma Corp. – Mon, Oct 21, 2013 8:45 AM EDT
......
NASDAQ: CRME TSX: COM
VANCOUVER, Oct. 21, 2013 /PRNewswire/ - Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) today announced that its subsidiary, Cardiome International AG, has entered into an agreement with Algorithm S.A.L., headquartered in Beirut, Lebanon, to sell and distribute BRINAVESS™ (vernakalant intravenous) exclusively in certain Middle Eastern and North African countries. Under the terms of the agreement, Algorithm has agreed to specific annual commercial goals for BRINAVESS. Financial details of the agreement have not been disclosed.
"We are pleased to have entered into this commercialization agreement with Algorithm, a highly respected company with an impressive track record in partnering with other pharma industry leaders," said Karim Lalji, Cardiome's Chief Commercial Officer. "We look forward to continuing the commercialization of BRINAVESS in approved markets and leveraging Algorithm's expertise in gaining approvals in new ones."
"Algorithm is excited to be working with Cardiome to sell and distribute BRINAVESS," said Nabil Ghorayeb, Human Health Lead, at Algorithm. "Our company has a long and successful history in the cardiovascular market, and BRINAVESS is an excellent addition to our product portfolio that will offer our customers a treatment option for the rapid conversion of recent onset atrial fibrillation."
The initial term of this commercial agreement begins November 1, 2013 for the duration of five years and is renewable on an annual basis, or longer, thereafter. Countries covered by the agreement where Algorithm will be able to commercialize BRINAVESS include: Algeria; Bahrain; Egypt; Iran; Jordan; Kingdom of Saudi Arabia; Kuwait; Lebanon; Libya; Morocco; Oman; Qatar; Tunisia; and United Arab Emirates
Niemand. Allerdings steigt crme bei den Amis um 9%.Und das kurz vor den Zahlen am 6.11. Das ist erstmal gut. Sämtliche gute Infos zu Vertriebsvereinbarungen bzw. die Aktivitäten in Middle east, Türkei, Südafrika etc. kosten Geld. Hoffentlich bleibt noch etwas übrig? Gute Vertriebserfolge in den Regionen werden erst später ergebniswirksam. Aufgrund der moderaten MK und den Perspektiven mit BRINAVESS sollte crme durchstarten. Allen viel Erfolg!
6 November, 2013
Cardiome to conduct conference call and webcast today, November 6, at 8:00 a.m. Eastern (5:00 a.m. Pacific)
Vancouver, Canada, November 6, 2013 -- Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) today reported financial results for the third quarter and nine months ended September 30, 2013. Amounts, unless specified otherwise, are expressed in U.S. dollars and in accordance with generally accepted accounting principles used in the United States (U.S. GAAP). All share and per share amounts reflect the one-for-five share consolidation that occurred on April 12, 2013.
Summary Financial Results
Cardiome reported a net loss of $3.6 million ($0.29 per common share) for the three months ended September 30, 2013 (Q3-2013), compared to a net loss of $13.4 million ($1.10 per common share) for the three months ended September 30, 2012 (Q3-2012).
Revenue for Q3-2013 was $0.5 million. This is an increase of $0.4 million from $0.1 million in Q3-2012 and can be primarily attributable to the recognition of the full benefit of all BRINAVESS™ sales worldwide this quarter. Prior to Q3-2013, Cardiome benefitted from the sale of BRINAVESS in the form of royalties and promotional fees in connection with the collaboration and license agreements with Merck.
Sales of BRINAVESS dropped significantly since Merck announced the termination of the collaborative agreements with Cardiome, hitting an all-time low in Q1-2013. With the signing of the transition agreement with Merck, Cardiome’s sales force began promoting BRINAVESS in Q2. Even without the ability to control discounting or the promotional message, total sales of BRINAVESS increased by 14% in Q2-2013 as compared to Q1-2013. Despite the third quarter historically being the weakest quarter for BRINAVESS sales in Europe, total sales in Q3-2013 increased by 17% compared to Q2-2013. Although Cardiome now has the ability to implement its marketing strategy with the completion of commercialization responsibility for BRINAVESS in the EU, the company does not expect to see a significant impact on sales in Q4 as it completes the transition process for regulatory product rights and product distribution responsibility for BRINAVESS. In accordance with Cardiome’s plans, it expects to be fully selling in all EU markets by the start of 2014.
Selling, general and administration (SG&A) expenditures for Q3-2013 were $4.0 million compared to $2.5 million for Q3-2012. The increase in SG&A expenditures was primarily due to an increase in costs associated with Cardiome’s sales and marketing efforts to support the commercialization of BRINAVESS. For the remainder of the year, as a result of its worldwide sales and marketing efforts, continuing transition activities with Merck, as well as, other related costs required to support the commercialization of BRINAVESS, Cardiome expects SG&A expenditures to increase as compared to 2012.
Research and development expenditures were insignificant for Q3-2013 as compared to $0.4 million for Q3-2012. The decrease in R&D expenditures compared to the same period in 2012, was primarily due to the restructuring initiatives in Q3-2012 which eliminated Cardiome’s internal research activities.
Cardiome did not incur any restructuring costs during Q3-2013 compared to $9.0 million incurred in Q3-2012 which were primarily related to employee termination benefits associated with our 2012 workforce reduction initiatives.
Other income for Q3-2013 was $0.05 million, compared to other expense of $1.0 million for Q3-2012. The decrease in other expense in 2013 was primarily due to the elimination of interest expense from the settlement of debt owed to Merck.
Liquidity and Outstanding Share Capital
At September 30, 2013, the company had cash and cash equivalents of $17.3 million. Cardiome believes its cash position and expected future cash inflows from the sale of BRINAVESS will be sufficient to finance its operational and capital needs for at least 18 months. However, future cash requirements may vary materially from those now expected due to a number of factors, including the costs associated with commercialization efforts, clinical trials, and strategic opportunities.
As of November 5, 2013, Cardiome had 12,470,335 common shares issued and outstanding and 1,102,709 common shares issuable upon the exercise of outstanding stock options at a weighted-average exercise price of CAD $7.83 per share.
Corporate Update
During Q3-2013, Cardiome partnered with AOP Orphan Pharmaceutical AG (“AOP Orphan”) to commercialize BRINAVESS in select European markets where Cardiome does not currently operate, including Austria. It is expected that AOP Orphan will support Cardiome in obtaining product registrations required for the marketing and sale of BRINAVESS in those markets where this is required and will actively call on customers to promote the product. Cardiome also entered into commercialization agreements with Tzamal Medical Ltd. and LifePharma (Z.A.M.) Ltd. to sell and distribute BRINAVESS in Israel and Cyprus, respectively. Subsequent to the end of Q3-2013, Cardiome announced that it partnered with Biospifar S.A. and Algorithm S.A.L. to sell and distribute BRINAVESS in Colombia and certain Middle Eastern and North African countries, respectively.
Cardiome also announced in Q3-2013, the approval of BRINAVESS in Turkey by the Turkish Ministry of Health and in South Africa by the Medicines Control Council.
On September 16, 2013, Cardiome announced the completion of the transfer from Merck to Cardiome of commercialization responsibility for BRINAVESS in the EU and the transfer of responsibility to complete the post-marketing study for BRINAVESS. Cardiome is now supplying BRINAVESS under its own trade dress in the EU.
The transition to Cardiome of Merck’s rights and responsibilities under the collaboration and license agreements is a multi-step process and transition activities are ongoing. Cardiome expects these activities to continue throughout the remainder of 2013 and potentially into early 2014.
Conference Call
Cardiome will hold a teleconference and webcast on Wednesday, November 6, 2013 at 8:00 a.m. Eastern (5:00 a.m. Pacific). To access the conference call, please dial 416-764-8688 or 888-390-0546 and use conference ID 22279968. The webcast can be accessed through Cardiome’s website at www.cardiome.com. Webcast and telephone replays of the conference call will be available approximately two hours after the completion of the call through December 4, 2013. Please dial 416-764-8677 or 888-390-0541 and enter code 279968 to access the replay.
About Cardiome Pharma Corp.
Cardiome Pharma Corp. is a biopharmaceutical company dedicated to the discovery, development and commercialization of new therapies that will improve the health of patients around the world. Cardiome has one marketed product, BRINAVESSTM (vernakalant IV), approved in Europe and other territories for the rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults.
Cardiome is traded on the NASDAQ Capital Market (CRME) and the Toronto Stock Exchange (COM). For more information, please visit our web site at www.cardiome.com.
Für die nächste Zeit ist folgendes geplant:
- Ausbau Logistik/Legal/Regulierungs-Infrastruktur für vollen Zugriff von Cardiome auf alle Direktvermarktungsmärkte
- Ab Anfang 2014 soll in allen europ- Märkten direkt vermarktet werden
- Ausbau des Vertriebspersonals und Ausbau der Infrastruktur ist noch schneller als angenommen vonstatten gegangen
- Es soll ein Plan erstellt werden, das Brinavess der FDA präsentiert wird. Dialog wurde bereits gestartet. Jetzt stehen die Chancen laut Geschäftsleitung sehr gut mit so viel Praxiseinsatz.
- weiterer Ausbau und Beschleunigung von neuer Markterschließung, Ausbau Franchise
"everything is exatly as hoped and planned... right direction" --> Zitat Geschäftsleitung
klingt doch gut soweit...
Nur meine Meinung, keine Kaufempfehlung
crme benoetigt Zeit, um saemtliche Vertriebskanaele zu aktivieren. Brinavess kostet in D etwa 500€/20 ml/mg, brutto. In D und EU ist Potential. In USA tritt Vorhofflimmern wohl noch haeufiger auf...zu viele McDonalds.Warten auf FDA.
Also viel glück euch !
MFG
Chali
* Accelerates Cardiome's launch of BRINAVESS™ (vernakalant IV) and its transformation into a global commercial organization positioned for future growth
*Correvio is an EBITDA positive, European, specialty pharmaceutical company selling Aggrastat® (tirofiban HCL) to cardiologists in over 60 countries worldwide with annual revenues of US$30+ million
* Brings together two highly complementary, in-hospital, intravenous, cardiology products sold through a direct sales force in Europe and via specialty distributors elsewhere
* Reduces BRINAVESS build out costs and shortens the time to profitability by providing an established operational and financial infrastructure with significant operating cost synergies
*Transaction expected to be accretive immediately
"The acquisition of Correvio markedly accelerates Cardiome's recent transformation from a research and development-based company to an integrated, commercial, specialty pharmaceutical company. The Correvio acquisition fulfills many of our immediate strategic needs by providing an operational European platform, global distribution, complementary products and the financial flexibility required to accelerate the launch of BRINAVESS," stated William Hunter, M.D., Cardiome’s president and CEO. "The cash contribution from synergistic sales of AGGRASTAT will lessen our reliance on external financing by providing low cost,
ongoing funding while also shortening our road to profitability."
"We have worked hard over the years to build a scalable infrastructure to successfully promote and support AGGRASTAT sales worldwide,” stated Bert Van Den Bergh, chairman of Correvio. 'It's exciting to see a growing product like BRINAVESS able to leverage off of our existing hospital-based, cardiology platform
and capitalize on significant operational efficiencies."
Under the terms of the agreement, Cardiome has acquired 100% of Correvio through the purchase of a combination of assets and shares of its subsidiaries in exchange for 19.9% of Cardiome's outstanding shares (proforma ownership of approximately 16.6%) and a deferred cash consideration of US$12 M. The deferred
cash consideration will be repaid monthly at an amount equal to 10% of cash receipts from product sales and any applicable interest accrued at 10% compounded annually. The adjusted deferred cash consideration must be repaid in full by December 1, 2019.
http://www.streetinsider.com/Corporate+News/...+Correvio/8899804.html