BioAlliance ..Mein Bio-Topfavorit 2010 !
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| Eröffnet am: | 18.03.10 10:37 | von: Biotechmaste. | Anzahl Beiträge: | 44 |
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Wer ein Solides Investment mit richtig viel Potential sucht der ist hier sehr gut aufgehoben .Macht eure Hausaufgaben und überzeugt euch selbt .
BioAlliance ( BIO.PA)
Marktkap: 65 Mio€
Cash: 14,7 €
Kurs: 5 €
Shares Out: 12,9 M
Pipeline
http://www.bioalliancepharma.com/var/plain_site/...tenu_editorial.jpg
Präsentation März 2010
http://www.bioalliancepharma.com/eng/content/...entation%20040310.pdf
The outlook for 2010
BioAlliance Pharma's forthcoming development milestones are as follows:
* Approval of the NDA for Loramyc® in the United States: Q2 2010.
* Approval of the marketing authorization application for Setofilm® in Europe: Q2 2010.
* An alliance in Europe for Loramyc® and Setofilm®: H1 2010.
* Meetings with the European and American regulatory agencies, in order to define the registration strategy for acyclovir Lauriad®: H1 2010.
* Market launch for Loramyc® in the United States: H2 2010.
* Continuation of ongoing clinical development throughout 2010.
Investoren
http://www.bioalliancepharma.com/var/plain_site/...tenu_editorial.jpg
Bioalliance Pharma Receives European Approval for Its Second Innovative Product Setofilm®
18:35 23.03.10
PARIS--(BUSINESS WIRE)--
Regulatory News:
BioAlliance Pharma SA (Paris:BIO) (Euronext Paris BIO), a company dedicated to the treatment and supportive care of cancer and AIDS patients, today announced approval for Setofilm® in 16 European countries (by decentralized procedure).
Setofilm®,asa thin film strip, is an anti-emetic drug indicated for the prevention and treatment of -chemotherapy, radiotherapy and post operative- induced nausea and vomiting in adults and children. Thanks to its innovative pharmaceutical form, Setofilm® is thefirst product of its class to have also obtained this indication in post operative nausea and vomiting in children. Indeed, this fast dissolving film disintegrates without water in few seconds in the mouth and is a product of choice in case of risk of aspiration. It is particularly adapted for patients having difficulties to swallow, namely children or elderly.
Setofilm® is the second product BioAlliance Pharma has registered in Europe. This represents a significant step in building our portfolio and I warmly congratulate our team on this major achievement, declares Dominique Costantini, President and CEO of BioAlliance Pharma. Setofilm® represents a major advantage for patients as it meets their needs. In the supportive care area Loramyc® and Setofilm® are very complementary as they both address same frail patients, same prescribers and synergies will be reflected commercially.
In Europe, anti-emetic drugs represent a large segment of cancer supportive care market with sales of nearly 400 million in the five largest markets (IMS Health data, 2009). Ondansetron is the leading drug of its class with a 74% market share as of end 2009.
BioAlliance Pharma has acquired Setofilm® commercialization rights for Europe in 2008 from Applied Pharma Research SA (APR), Switzerland. This product is based on a proprietary oral film strip technology platform developed by APR and Labtec GmbH.
Ausblick fürs 1H 2010
Zulassung für Loramyc in USA << 20 Mio$ Milestones gibts von Par Pharma
Vermarktungspartner für SetoFilm (EU)
Vermarktungspartner für Loramyc (EU)
Da kommt noch einiges an News ..
Diesmal erhält Loramyc die Zulassungen in 13 weitere EU-Länder !!!!
http://finance.yahoo.com/news/BioAlliance-Pharma-Announces-b…
BioAlliance Pharma Announces Extension of Loramyc® Approval in 13 European Countries
It is Bringing Total European Approvals to 26 European Countries
Press Release Source: BioAlliance On Thursday March 25, 2010, 1:55 pm EDT
PARIS--(BUSINESS WIRE)--Regulatory News:
BioAlliance Pharma SA (Euronext Paris – BIO), a company dedicated to the treatment and supportive care of cancer and AIDS patients, announced today the approval of Loramyc® in 13 additional European countries* through a Mutual Recognition Procedure with France as reference member state.
With this approval to a total of 26 European countries for Loramyc® and the recent Setofilm® ** approval in 16 European countries, BioAlliance is building an attractive cancer supportive care portfolio including this two complementary products.
“These remarkable achievements for both Loramyc® and Setofilm® demonstrate BioAlliance Pharma’s expertise and the dedication of its teams. They will contribute to our commercial success in Europe”, said Dominique Costantini, President and CEO of BioAlliance Pharma.
06.04.2010 07:31
BioAlliance Pharma Announces Licensing of European Commercialization Rights for Loramyc® and Setofilm® to the Therabel Group in a €48.5 Million Deal
BioAlliance is now relying on partnerships to insure its growth strategy
Regulatory News:
BioAlliance Pharma SA (Euronext Paris: BIO), a company dedicated to the treatment and supportive care of cancer and AIDS patients, announces today an exclusive partnership agreement with Therabel Group for the European commercialization rights of Loramyc® and Setofilm® including France and the associated French commercial structure to a newly established entity, Therabel Hôpital Pharma.
BioAlliance will receive from Therabel up to €48.5 million of which €6.5 million as upfront payments including €4.5 million at signature and two annual payments of €1 million each end of 2011 and end of 2012. Additionally €3 million will be linked to Loramyc® reimbursement in three EU countries. The subsequent €33 million are linked to sales performance for the two licensed products. The agreement includes significant royalties on sales commensurate with the two approved products in EU.
The agreement contemplates also an equity investment from Therabel as a strategic partner in BioAlliance for €3 million. This share increase will be subject to shareholders' approval at the next general assembly meeting on April 22. The BioAlliance shares will be subscribed at €5.89 corresponding to a 15% premium over the last 20 business days. A second investment of €3 million with same 15% premium will be subscribed in 2011 subject to shareholders' meeting in 2011.
"We are delighted with this agreement with Therabel as Therabel represents an ideal strategic European partner with a hospital presence in supportive care and pain management. They offer an existing sales structure as well as all the market access support necessary these days to ensure the commercial success of our products. This agreement will bring recurrent royalty revenues to BioAlliance", declares Dominique Costantini, President and CEO of BioAlliance Pharma. "BioAlliance will transfer its commercial experience on Loramyc® to Therabel and would like to thank warmly the team for their efforts and results. BioAlliance will from now on capitalize on its development and registration expertise already validated with Loramyc®, Setofilm® and acyclovir Lauriad® (Phase 3 positive in orofacial herpes) to build shareholder's value in the years to come," concludes Dominique Costantini.
"This significant agreement strongly emphasizes our growth strategy, particularly in Europe in the supportive care area in the hospital setting. Our marketing experience as well as our promotional forces and our European coverage represent an ideal fit with BioAlliance's areas of excellence. We are delighted to add Loramyc® and Setofilm® to our portfolio. These innovative products will enable us to become very competitive in the hospital field," added Jean-Michel Robert, President of the Strategic Committee of Therabel Group.
BioAlliance Pharma announces participation in the SmallCap Event
On April 12th and 13th in Paris
Paris, March 29, 2010 - BioAlliance Pharma SA (Euronext Paris - BIO), a company dedicated to the treatment and supportive care of cancer and AIDS patients, today announced that it will participate in the SmallCap Event, a forum dedicated to meetings between institutional investors and listed companies from the Euronext Zone, on Monday 12th and Tuesday 13th of April in Paris (Salons Hoche – 9, avenue Hoche).
During these two days, the Management will meet with institutional investors to present BioAlliance Pharma and its development strategy.
http://ih.advfn.com/...hart&s=EU%5EBIO&p=0&t=19&vol=1
Marktkap : 79 M€
Cash : 21 M€ <<< 20 Mio$ kommen bald noch dazu !!!!!
Kurs : 6,05€
Ich sehe euch bei 10€+ bis zum Jahresende ...Viel Glück
Die 10€-Marke dürften wir wohl dieses Jahr noch sehen .
Ich freue mich schon auf die nächste Woche .
16.04.2010 19:31
BioAlliance Pharma Gains US FDA Approval for Oravig® (Loramyc® in EU)
And is eligible for a $20 million milestone payment from Strativa Pharmaceuticals, its commercial partner in the US
Regulatory News:
BioAlliance Pharma SA (Euronext Paris - BIO) (Paris:BIO), a company dedicated to the treatment and supportive care of cancer and AIDS patients, announces today the approval by the US FDA (Food and Drug Administration) of Oravig® (miconazole Lauriad®, known as Loramyc® in Europe) for the treatment of Oropharyngeal Candidiasis (OPC) in adults.
Oravig® is licensed to Strativa Pharmaceuticals, the proprietary products division of a wholly owned subsidiary of Par Pharmaceutical Companies, Inc. and will be launched in the course of this second semester. The license agreement signed in July 2007 contemplates a $20 million milestone payment upon FDA approval, additional sales milestones and royalties on sales of the product.
"This is a major achievement and the first time for a French biotech company to gain a US approval. BioAlliance expertise in development and registration at the international level is here properly recognized and rewarded. Following our commercial partnership agreement with Therabel Group for Europe (Loramyc® and Setofilm®), we are very confident in Strativa's commercialization ability to ensure Oravig® success in the US", said Dominique Costantini, President and CEO of BioAlliance Pharma.
"With Oravig®, BioAlliance has developed an innovative local treatment for oral candida infection. We are very proud to now bring Oravig® to health care providers and patients in the US", added John Mac Phee, Strativa President.
The NDA submission was based on the European file and on data from a large Phase III study (577 patients, 28 sites in the United States, Canada, and South Africa) comparing Oravig® (miconazole Lauriad®) to Mycelex® Troche (clotrimazole, the reference product in the USA) in the complete resolution of signs and symptoms of OPC.
About BioAlliance Pharma
As a preferred partner for hospital-based specialists, BioAlliance Pharma is a company which develops innovative products, especially in the fields of opportunistic infections and chemotherapy complications. In areas where medical needs are insufficiently met, its targeted approaches help overcome drug resistance and improve patient health& quality of life. BioAlliance Pharma's ambition is to become a leading player in these fields by coupling innovation to patient needs.
BioAlliance Pharma has developed an advanced product portfolio:
Loramyc® (Oropharyngeal candidiasis in immunocompromised patients): Registered in 26 European countries
Setofilm® (Prevention and treatment of -chemotherapy, radiotherapy and post operative- induced nausea and vomiting in adults and children): Registered in 16 European countries
Acyclovir Lauriad® (Labialis herpes): Positive phase III final results
Fentanyl Lauriad® (Chronic cancer pain): Positive preliminary Phase I results
AMEPTM (Invasive melanoma): Phase I
Clonidine Lauriad® (Mucositis): Phase II
Doxorubicine Transdrug® (Liver cancer): Phase II
Weitere kommende News für 2010
EU und US Zulassungsantrag für A.Lauriad
EU und US Partnerschaften für A.Lauriad
10€ dürften wir also schon bald sehen ...
http://ih.advfn.com/...hart&s=EU%5EBIO&p=0&t=19&vol=1
Da GrB
Optionen
| Boardmail an "buran" |
Wertpapier: Valerio Therapeutics SA |
http://ih.advfn.com/...hart&s=EU%5EBIO&p=0&t=19&vol=1
Marktkap : 77,7 Mio€
Cash : 29 Mio€
Kurs: 5,80€
Shares Out : 13,4 Million
Realtime Chart
http://ih.advfn.com/...hart&s=EU%5EBIO&p=0&t=19&vol=1
22 July 2010
A record turnover for Q2 2010 reflecting the successful US FDA approval
http://www.bioalliancepharma.com/eng/content/...100722EN_CAQ22010.pdf
Sieht aus als würden wir bald die 6€-Marke knacken .
http://ih.advfn.com/...hart&s=EU%5EBIO&p=0&t=19&vol=1
http://www.boursorama.com/...alliance-pharma-ca-va-monter-401132252-1
Die Aktie ist eine Perle .
@Biotechmaster:
Bisher kamen doch auch etliche gute Nachrichten am Stück und die Aktie ist nicht gestiegen. Was macht dich da so sicher dass es bei den nächsten Malen klappt?
Schau dich mal um der Markt ist miserabel wie soll da eine Bioalliance steigen ? Zumindest hält sich BIOA ganz gut und es kommen noch weitere gute Nachrichten .
Oravig ist jetzt in USA erhältlich ....Die Kasse wird also bald klingeln .
24.08.2010 18:31
BioAlliance Pharma Announces the Launch of Oravig® on the US Market by Its Commercial Partner, Strativa/Par Pharmaceutical
Regulatory News:
BioAlliance Pharma SA (Paris:BIO)(Euronext Paris - BIO), a company dedicated to the supportive care and treatment of cancer patients, today announces the launch in the United States of Oravig® (known as Loramyc® in Europe) for the treatment of oropharyngeal candidiasis (OPC) in adults by its commercial partner, Strativa Pharmaceuticals, the proprietary products division of Par Pharmaceutical Companies, Inc. (NYSE:PRX).
With a US FDA approval in April 2010, BioAlliance Pharma is the first small medium-sized innovative French company to have access to the American market, the largest worldwide market.
Oravig® is already available on the US market. The national sales force meeting of Strativa is being held this week in the United States to prepare the promotion of the product to the prescribers.
«The US launch of Oravig® is the ultimate step of a process that confirms our expertise in development and registration of products at the international level. It represents a major achievement that will generate significant revenues for BioAlliance Pharma», declares Dominique Costantini, its CEO. « We are very confident in Strativa sales team's commitment and know-how to ensure Oravig® success in the US, a product presenting a strong synergy with the product portfolio already commercialized by our US partner».
http://www.bioalliancepharma.com/eng/content/...mptes%20S1%202010.pdf
25 August 2010
Consolidated accounts for the first semester of 2010: Significant revenues, Net profit for the first semester reflecting the contribution of licensing agreements, Strongly reinforced cash position
RT Chart
http://ih.advfn.com/...hart&s=EU%5EBIO&p=0&t=19&vol=1
EU und US Zulassungsantrag für Acyclovir in 2011 geplant . Die Partnerschaft(en) für das Produkt werden vorher abgeschlossen .
Acyclovir Lauriad®: US registration file submission planned end-2011
Paris, August 26th, 2010 - BioAlliance Pharma SA (Euronext Paris - BIO), a company dedicated to the supportive care and treatment of cancer patients, today announces that the US Food and Drug Administration (FDA) considers the positive results of the pivotal phase III study with acyclovir Lauriad® acceptable to submit a 505(b)(2) New Drug Application of the product in the United States.
Acyclovir Lauriad®, BioAlliance Pharma second product using the Lauriad® technology (Mucoadhesive Buccal Tablet), has been developed for the treatment of recurrent herpes labialis on the basis of one and only one tablet application as soon as the first signs of infection appear. As announced beginning of July, the European file submission is planned for mid-2011 based on the same clinical programme.
“This notification from the FDA confirms that acyclovir Lauriad® represents an innovation in the treatment of oro-facial herpes labialis and strengthens our position to find the adequate partner targeting dermatologists and general practitioners to successfully commercialize this opportunity”, declares Dominique Costantini, CEO of BioAlliance Pharma.
Neue Präsentation << Zeigt wie unterbewerte die Aktie ist
http://www.bioalliancepharma.com/eng/content/...%20260810%20Final.pdf