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ARDM (Mkap $47 M) Peak Sales $1.2 -1.5 Milliarden (=P3 Daten im 2H 2016)

eröffnet am 14.03.16 16:45:29 von
Biohero

neuester Beitrag 07.06.16 23:05:49 von
bluebirdnr1


Avatar
Biohero
14.03.16 16:45:29
Beitrag Nr. 1
Eigentlich wollte ich erst das Nicox pferd reiten dann anschließend auf diese Aktie umsatteln leider ist mir Nicox davongelaufen und wenn ich etwas nicht zu meinem Kurs bekomme lasse ich die finger davon .

Die folgende Aktie die ich vorstellen will trifft alle meine kriterien um zu investieren und das habe ich auch getan auch wenn es nicht ganz einfach war ein paar Aktien einzusammeln .

Es geht um Aradigm (Nasdaq: ARDM) die ein Inhaliermittel (Pulmaquin) für die behandlung der Lungenkrankheit Non-CF-Bronchiektasen entwickelt haben . Pulmaquin befindet sich in 2 Phase 3 Studien und in beiden ist die Rekrutierung bereits abgeschlossen und erste Ergebnisse werden im 2H 2016 erwartet . Es gibt bisher kein Zugelassenes Produkt speziell für diese Lungenkrankkeit . Aradigm hat für das Produkt einen super deal mit dem spanischen Riesen Grifols ausgehandelt (mehr details unten) .

Nun zu den Gründen warum mir die Aktie sehr gut gefällt :

1) Aktie wird fast auf Cash-Niveau gehandelt ( Marktkap $47 M / Cash $39.9 M)
2) Low float Aktie und kaum bekannt obwohl an der Nasdaq gelistet
3) Pulmaquin hat Blockbuster Plus Potential
4) Pulmaquin ist mit QIDP ,Orphan Drug und Fast Track Status ausgestattet
5) Management ist gut und hat viel Erfahrung
6) Super Deal mit Grifols für Pulmaquin


ARDM ist der inbegriff einer Unterbewertung die Aktie müsste schon jetzt bei mindestens $15 pro Aktie notieren mit dem was die Firma bis dato schon geleistet hat . Das Produkt stellt was Markt Potential angeht z.b. das DMD Produkt von Santhera in den Schatten . Der Ausverkauf an den Aktienmärkten in den letzten Wochen hat diese Aktie die ohnehin schon billig war mit in die Tiefe gerissen aber andererseits ist das für Schnäppchenjäger wie mich eine hervorragende gelegenheit .Ich denke ARDM könnte ein äußert lukratives Investment werden mit dem bevorstehenden Runup und Phase 3 Ergebnisse . Wer also Biotechs mag und das Risiko nicht scheut sollte hier zuschlagen .


Aradigm (ARDM)

Marktkap: $47 Million
Cash $39.9 Million
Kurs $3.20

Aktienanzahl: 14.73 Million


Pipeline
http://www.aradigm.com/products_pipeline.html


Aradigm Corporation Completes Enrollment in the Second Phase III Study of Pulmaquin in Non-Cystic Fibrosis Bronchiectasis (ORBIT-3)
http://investor.aradigm.com/releasedetail.cfm?ReleaseID=9362…


Aradigm Corporation Completes Enrollment in Phase III Study of Pulmaquin in Non-Cystic Fibrosis Bronchiectasis (ORBIT-4)
http://investor.aradigm.com/releasedetail.cfm?ReleaseID=9325…


Grifols and Aradigm Corporation Complete the Closing of Worldwide Licensing Agreement to Develop and Commercialize Pulmaquin®
http://investor.aradigm.com/releasedetail.cfm?ReleaseID=7875…



Eine ausführliche Analyse über Aradigm
https://www.baystreet.ca/articles/research_reports/lifesci/2…

Licensing Agreement with Grifols Validates Aradigm’s Inhaled Antibiotic Approach. In May 2013, Aradigm announced an exclusive worldwide licensing agreement with Grifols (NasdaqGS:GRFS) covering both of Aradigm’s proprietary, liposomal formulations of ciprofloxacin, Lipoquin and Pulmaquin.The deal provides up to $65 million for developmental and clinical expenses related to the BE indication. Aradigm can receive an additional $25 million in development milestones. Grifols is responsible for commercialization upon FDA and EU approvals. Aradigm will receive tiered royalties on worldwide sales of 12.5% on the first $300 million annually, and increasing to 20% above that. Aradigm will also receive a transfer price mark-up on the supplied product. Grifols also received an option to license Aradigm’s AERx® pulmonary drug delivery platform for another drug, and made a $26 million investment in Aradigm. Grifols is a Spanish multinational pharmaceutical company with over $5 billion in sales for 2012, and almost 75 years of experience selling, promoting, and distributing healthcare products. Grifols is an ideal partner with experience in respiratory indications in the US, and has a successful 25 year track record selling Prolastin-C for patients with emphysema due to deficiency of alpha1-proteinase inhibitor. Grifols, along with existing and new investors, also led a $41.4 million round of financing that greatly extends Aradigm’s cash runway, and will allow the Company to focus on the execution of its clinical trials for BE and other indications.



Pulmaquin's Potential
Bronchiectasis is observed in patients with cystic fibrosis on a frequent basis. However, it is less common in patients without cystic fibrosis. According to Aradigm, non-cystic fibrosis bronchiectasis affects more than 110,000 people in the U.S. As a result, Pulmaquin was granted orphan drug designation by the FDA in June 2011. The orphan drug status means that if approved, Pulmaquin can command a higher price. Also, in the U.S., there are no drugs approved right now for the treatment of bronchiectasis. The incidence of bronchiectasis is growing at 9% a year in the U.S. In Europe, the disease affects 210,000 patients. According to Igor Gonda, president and CEO of Aradigm, Pulmaquin for bronchiectasis is a billion-dollar plus opportunity globally.
Avatar
Biohero
14.03.16 20:18:45
Beitrag Nr. 2
Antwort auf Beitrag Nr.: 51.977.121 von Biohero am 14.03.16 16:45:29Das die lungenkrankheit bronchiectasis ein sehr lukrativer Markt ist sieht man daran das auch die Big Player Bayer und Novartis gemeinsam an einem Produkt arbeiten das sich auch in Phase 3 befindet . Das interessante an der Story ist das Pulmaquin von der winzigen Aradigm in den vorherigen kleinen Studien gezeigt hat das es noch effektiver ist als das Produkt von Bayer/Novartis .


NEW YORK, NY--(Marketwired - Oct 29, 2013)

"Aradigm's Lipoquin and Pulmaquin inhalable antibiotics are potential best-in-class treatments designed for chronic use and to be effective at treating bacterial infections in patients' lungs, while also minimizing lung irritation that is common in cystic fibrosis and especially bronchiectasis patients," said Andrew I. McDonald, Ph.D., Founding Partner at LifeSci Advisors. "The recent partnership with Grifols provides adequate funding to bring the program through Phase III trials in bronchiectasis and may allow Aradigm to pursue additional indications."
Avatar
Danny767
15.03.16 12:25:41
Beitrag Nr. 3
Aradigm Announces Fourth Quarter 2015 and Full Year Financial Results
Business Wire Aradigm Corporation
20 minutes ago

HAYWARD, Calif.--(BUSINESS WIRE)--

Aradigm Corporation (ARDM) (the “Company”) today announced financial results for the fourth quarter and full year ended December 31, 2015.

Fourth Quarter 2015 Results

Since the Company has utilized the full amount of the $65 million of Grifols-funded budget provided under the inhaled ciprofloxacin collaboration arrangement which is recognized as revenue for reimbursement of its investigational drug Pulmaquin® inhaled ciprofloxacin project-related costs the Company recorded $35,000 in revenue in the fourth quarter of 2015 compared with $8.1 million in revenue in the fourth quarter of 2014. The Company will not be recognizing any future revenue related to the $65 million Grifols-funded budget. Total operating expenses for the fourth quarter of 2015 were $9.4 million, compared with total operating expenses of $8.9 million for the fourth quarter of 2014. The increase in operating expenses was primarily due to higher research and development expenses related to the ongoing Pulmaquin Phase 3 clinical trials. The Company’s net loss for the fourth quarter of 2015 was $9.4 million, or $0.63 per share, compared with a net loss of $0.8 million, or $0.06 per share, for the same period in 2014.

Full Year Results

Revenues for the year ended December 31, 2015 were $23.4 million, compared with revenues of $33.6 million in 2014. The decrease in revenue was due to full utilization in 2015 of the $65 million of Grifols-funded budget for Pulmaquin project-related costs which are recognized as revenue under the Grifols collaboration arrangement.

Total operating expenses for 2015 were $40.6 million, compared with total operating expenses of $37.4 million in 2014. Research and development expenses increased by $4.1 million and general and administrative expenses decreased by $0.9 million. The increase in research and development expenses was due to higher contract manufacturing, contract testing and clinical trial costs related to the Pulmaquin program, higher employee-related expenses due to the addition of staff, offset by a decrease in consulting expenses in support of the Pulmaquin program. The decrease in general and administrative costs was due to lower consulting expenses, lower officer bonuses, lower legal expenses and lower expenses for NASDAQ and public filings offset by an increase in employee-related costs for the addition of staff.

The net loss for the year ended December 31, 2015 was $17.2 million, or $1.17 per share, compared with net income of $4.7 million, or $0.32 per share, in 2014. Net loss increased in 2015 over 2014 due to lower collaboration revenue of $9.7 million, an increase in Pulmaquin-related project expenses of $4.1 million and the one-time, non-cash gain of $8.9 million from the assignment of royalty rights and extinguishment of debt that occurred in 2014, offset by a decrease of general and administrative expenses of $0.9 million.

As of December 31, 2015, cash and cash equivalents totaled $31.5 million.

“The completion of the enrollment of our pivotal Phase 3 clinical program for bronchiectasis last year was a critical achievement for Aradigm. All our efforts are now focused on having the key data analyses for both trials completed this year to enable us to file the US NDA early in 2017, followed by submission for market authorization in the European Union,” said Igor Gonda, CEO and President of Aradigm.

2015 Highlights

October 2015 – The Company announced the completion of enrollment in the ORBIT-3 trial, the second of the two fully enrolled Phase 3 pivotal clinical trials of Pulmaquin for the treatment of patients with non-cystic fibrosis bronchiectasis who have chronic lung infections with Pseudomonas aeruginosa. ORBIT-3 is a worldwide, double-blind, placebo-controlled pivotal trial that enrolled 278 patients across 17 countries, including the U.S., Canada, Australia, New Zealand, Israel, South Korea, Taiwan, South Africa and countries in Europe.
September 2015 – The Company announced the completion of enrollment in the ORBIT-4 Phase 3 pivotal clinical trial of Pulmaquin, Aradigm’s proprietary investigational formulation of inhaled ciprofloxacin, for the treatment of patients with non-cystic fibrosis bronchiectasis who have chronic lung infections with Pseudomonas aeruginosa. ORBIT-4 is one of two Phase 3 pivotal clinical trials Aradigm is conducting with Pulmaquin in this patient population with an unmet medical need. The worldwide, double-blind, placebo-controlled pivotal trial enrolled 304 patients across 16 countries, including the U.S., Canada, Australia, New Zealand, Israel, South Korea, Peru and countries in Europe.
July 2015 - The United States Patent and Trademark Office issued a composition of matter patent (U.S. Patent No. 9,078,897) covering formulations of liposomal and free ciprofloxacin, including Aradigm’s lead product candidate, Pulmaquin. This represents the sixth issued U.S. patent covering Aradigm’s liposomal ciprofloxacin formulations.
May 2015 – The Company announced that scientists from the Oregon State University, Corvallis and Aradigm demonstrated that Aradigm’s investigational drugs Lipoquin and Pulmaquin significantly reduced the growth of pulmonary non-tuberculous mycobacteria (PNTM) after 3 weeks of once daily respiratory tract dosing in a mouse model. The number of colony forming units of Mycobacterium Avium Subsp Hominissuis was reduced by 79% and 77% by Lipoquin and Pulmaquin, respectively (p<0.05) compared to saline controls. In contrast, unencapsulated ciprofloxacin had no effect. The detailed description of this research and its findings was presented at the American Thoracic Society 2015 International Conference in Denver, CO.
About Pulmaquin

Pulmaquin is a dual release formulation composed of a mixture of liposome encapsulated and unencapsulated ciprofloxacin. Ciprofloxacin, available in oral and intravenous formulations, is a widely prescribed antibiotic. It is used to treat acute lung infections and is often preferred because of its broad-spectrum antibacterial activity against various bacteria, such as Pseudomonas aeruginosa. Pulmaquin is being evaluated in two ongoing Phase 3 studies to determine its safety and effectiveness as a once-a-day inhaled formulation for the chronic treatment of patients with non-CF BE who have chronic lung infections with Pseudomonas aeruginosa.

Following Phase 2a development of the liposomal portion of Pulmaquin (Lipoquin®) and Phase 1 development of Pulmaquin, the Phase 2b study ORBIT-2 with Pulmaquin was a 24-week multicenter, randomized, double-blind, placebo-controlled trial in 42 adult non-CF BE subjects. This study demonstrated a significant reduction in P.aeruginosa sputum activity (p=0.002) and a decrease in time to first exacerbation in the per protocol population (p=0.046) and the mITT (p=0.057) populations in the Pulmaquin treated subjects compared to placebo. Overall, the incidence of all treatment emergent adverse events was similar between groups. The most frequently reported treatment related adverse events (reported by ≥ 3 patients in either treatment group) included product taste abnormal and nausea in the Pulmaquin group and wheezing in the placebo group. No serious adverse events were considered treatment related. There were no deaths reported during ORBIT-2.

The Phase 3 clinical program for Pulmaquin in non-CF BE consists of two worldwide, double-blind, placebo-controlled pivotal trials (ORBIT-3 and ORBIT-4) that are identical in design except for a pharmacokinetics sub-study to be conducted in one of the trials. Each trial has enrolled patients (278 in ORBIT-3 and 304 in ORBIT-4) into a 48-week double-blind period consisting of 6 cycles of 28 days on treatment with Pulmaquin or placebo plus 28 days off treatment, followed by a 28 day open label extension in which all participants will receive Pulmaquin (total treatment duration approximately one year). The superiority of Pulmaquin vs. placebo during the double-blind period is being evaluated in terms of the time to first pulmonary exacerbation (primary endpoint), while key secondary endpoints include the reduction in the number of pulmonary exacerbations and improvements in the quality of life measures. Lung function is being monitored as a safety indicator.

Aradigm has been granted orphan drug designations for liposomal ciprofloxacin as well as for ciprofloxacin for inhalation for non-CF BE in the U.S. In addition, the U.S. Food and Drug Administration (FDA) has designated Pulmaquin as a Qualified Infectious Disease Product (QIDP). The QIDP designation is granted for treatment of non-CF BE patients with chronic lung infections with Pseudomonas aeruginosa. The QIDP designation made Pulmaquin eligible for Fast Track designation which was granted by the FDA in September 2014.

In 2013, Aradigm granted an exclusive, world-wide license for the Company’s inhaled liposomal ciprofloxacin product candidates for the indication of non-CF BE and other indications to Grifols S.A. More information on the terms of this license may be found in the Company’s Annual Report on Form 10-K for the year ended December 31, 2013 filed with the SEC on March 13, 2014.

About Non-Cystic Fibrosis Bronchiectasis

Non-CF BE is a severe, chronic and rare disease characterized by abnormal dilatation of the bronchi and bronchioles, frequently associated with chronic lung infections. It is often a consequence of a vicious cycle of inflammation, recurrent lung infections, and bronchial wall damage. Non-CF BE represents an unmet medical need with high morbidity and mortality that affects more than 110,000 people in the U.S. and over 200,000 people in Europe. There is currently no drug approved for the treatment of this condition.

About Aradigm

Aradigm is an emerging specialty pharmaceutical company focused on the development and commercialization of drugs for the prevention and treatment of severe respiratory diseases. Aradigm is currently in Phase 3 development of Pulmaquin (an investigational proprietary formulation of ciprofloxacin for inhalation) for the treatment of non-cystic fibrosis bronchiectasis. Aradigm’s inhaled ciprofloxacin formulations are also product candidates for treatment of patients with cystic fibrosis and non-tuberculous mycobacteria, and for the prevention and treatment of high threat and bioterrorism infections, such as inhaled tularemia, pneumonic plague, melioidosis, Q fever and inhaled anthrax. In addition, Aradigm has a pipeline composed of programs to prevent diseases in tobacco smokers through smoking cessation and a diagnostic program to detect aspirations of gastrointestinal fluid into the respiratory tract.

More information about Aradigm can be found at www.aradigm.com.

Forward-Looking Statements

Except for the historical information contained herein, this news release contains forward-looking statements that involve risk and uncertainties, including those related to the ORBIT-3 and ORBIT-4 clinical trials and the ability to continue successful product development of our potential product candidates, including Pulmaquin, as well as the other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 10-K for the year ended December 31, 2014 filed with the SEC on March 18, 2015, and the Company’s Quarterly Reports on Form 10-Q.

Aradigm, Pulmaquin, Lipoquin and the Aradigm Logo are registered trademarks of Aradigm Corporation.


ARADIGM CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)

Three months ended Year ended
December 31, December 31,
2015 2014 2015 2014

Revenue:
Contract revenue – related party $ - $ 8,050 $ 23,372 $ 33,038
Grant revenue 35 18 57 323
Royalty revenue - - - 200
Total revenues 35 8,068 23,429 33,561
Operating expenses:
Research and development 8,281 7,673 35,276 31,172
General and administrative 1,093 1,201 5,294 6,226
Restructuring and asset impairment 2 4 11 19

Total operating expenses 9,376 8,878 40,581 37,417

Loss from operations (9,341 ) (810 ) (17,152 ) (3,856 )

Interest income 7 9 29 17
Interest expense - - - (288 )
Other expense, net (18 ) (30 ) (86 ) (85 )
Gain on assignment of royalty interests - - - 5,823
Gain from extinguishment of debt - - - 3,041
Net income (loss) and comprehensive income (loss) $ (9,352 ) $ (831 ) $ (17,209 ) $ 4,652

$
(0.63 ) $ (0.06 ) $ (1.17 ) $ 0.32
Basic net income (loss) per common share

Diluted net income (loss) per common share $ (0.63 ) $ (0.06 ) $ (1.17 ) $ 0.32

Shares used in computing basic net income (loss) per common share 14,761 14,726 14,747 14,700
Shares used in computing diluted net income (loss) per common share 14,761 14,726 14,747 14,726


ARADIGM CORPORATION
CONSOLIDATED BALANCE SHEETS
(In thousands)

December 31, December 31,
2015 2014

ASSETS
Current assets:
Cash and cash equivalents $ 31,462 $ 47,990
Restricted cash - 250
Receivables 150 1,058
Prepaid and other current assets 3,634 1,207

Total current assets 35,246 50,505
Property and equipment, net 299 502
Other assets 81 2,956

Total assets $ 35,626 $ 53,963
LIABILITIES AND SHAREHOLDERS' EQUITY

Current liabilities:
Accounts payable 1,789 2,706
Accrued clinical and cost of other studies 4,315 2,070
Accrued compensation 1,159 819
Deferred revenue – related party - 790
Deferred rent 37
Facility lease exit obligation 104 193
Other accrued liabilities 112 191

Total current liabilities 7,516 6,769
Accrued clinical and cost of other studies, non-current - 33
Deferred rent, non-current - 97
Facility lease exit obligation, non-current - 104
Deferred revenue – related party, non-current 5,000 7,845
Shareholders' equity 23,110 39,115

Total liabilities and shareholders' equity $ 35,626 $ 53,963


View source version on businesswire.com: http://www.businesswire.com/news/home/20160315005671/en/

Contact:
Aradigm Corporation
Nancy Pecota, 510-265-8800
Chief Financial Officer
Avatar
Biohero
15.03.16 14:55:24
Beitrag Nr. 4
Antwort auf Beitrag Nr.: 51.982.703 von Danny767 am 15.03.16 12:25:41Dieser Auszug unten hätte gereicht oder einfach zu der News verlinken ist besser als die langen postings die den thread unnötig füllen .


As of December 31, 2015, cash and cash equivalents totaled $31.5 million.

“The completion of the enrollment of our pivotal Phase 3 clinical program for bronchiectasis last year was a critical achievement for Aradigm. All our efforts are now focused on having the key data analyses for both trials completed this year to enable us to file the US NDA early in 2017, followed by submission for market authorization in the European Union,” said Igor Gonda, CEO and President of Aradigm.

About Non-Cystic Fibrosis Bronchiectasis

Non-CF BE is a severe, chronic and rare disease characterized by abnormal dilatation of the bronchi and bronchioles, frequently associated with chronic lung infections. It is often a consequence of a vicious cycle of inflammation, recurrent lung infections, and bronchial wall damage. Non-CF BE represents an unmet medical need with high morbidity and mortality that affects more than 110,000 people in the U.S. and over 200,000 people in Europe. There is currently no drug approved for the treatment of this condition.
Avatar
Biohero
16.03.16 15:13:07
Beitrag Nr. 5
Antwort auf Beitrag Nr.: 51.984.173 von Biohero am 15.03.16 14:55:24Das ist der grund warum ich low floats so mag es braucht nur wenig Volumen um die Aktie in die höhe zu treiben . Man kann sich also vorstellen was hier passiert wenn die Phase 3 Daten gut ausfallen . Nichtsdestotrotz ist ARDM nichts anderes wie lotto spielen nur mit etwas bessere chancen auf gewinne .
Avatar
Biohero
16.03.16 20:40:15
Beitrag Nr. 6
Antwort auf Beitrag Nr.: 51.993.227 von Biohero am 16.03.16 15:13:07Hab vorhin ein teil verkauft um mit einem anderen Biotech zu zocken bei der schon in April news anstehen die stelle ich eventuell morgen vor falls ich zeit habe .
Avatar
Biohero
17.03.16 13:14:10
Beitrag Nr. 7
Eine gute Nachricht für ARDM ... Wenn Pulmaquin erfolgreich die P3 Studien abschließen sollte dann braucht die Firma nur einen Zulassungsantrag bei der EMA einzureichen um in alle EU Staaten die Zulassung zuerhalten anstatt dies bei jedem einzelnen Staat zu tun .


Aradigm Announces Decision for Centralized Review of Pulmaquin by the European Medicines Agency
http://finance.yahoo.com/news/aradigm-announces-decision-cen…
Avatar
bluebirdnr1
21.03.16 08:57:26
Beitrag Nr. 8
hallo @Biohero bei welcher bio stehen denn schon im april news an? danke für die rückmeldung
Avatar
Maggi110
21.03.16 15:24:15
Beitrag Nr. 9
Danke für die ganzen Infos!
Avatar
tupper
22.03.16 23:17:50
Beitrag Nr. 10
Antwort auf Beitrag Nr.: 52.026.593 von Maggi110 am 21.03.16 15:24:15Kann mir das mal jemand erklären:
In conjunction with the licensing agreement, Grifols acquired 35% of Aradigm's common stock on a fully diluted basis at a price per share of $0.124 for a total investment of approximately $26 million.

Außerdem findet sich auf der Homepage von Aradigm eine Meldung vom 12. Dezember 2012, die die Ausgabe von 50 Mio Aktien a 0,12 $ anzeigt.
Eine Meldung über einen evtl. Resplit oder eine Kapitalherabsetzung finde ich allerdings nicht.

Bei Pulmaquin habe ich auch noch einige Zweifel: Der Wirkstoff, Ciprofloxacin, ist ja schon lange bekannt und vielfach wirksam in oraler Verabreichung. Vielleicht wirkt ein Aerosol bei Lungenproblemen direkter, dürfte aber bei der Dosierung Probleme bereiten. So etwas hatten wir doch schon mal mit inhalierbarem Insulin?


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