Gilead Science Inc. (GILD)

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Eitaro
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Eitaro hat am 22.05.2014 - 09:55 folgendes geschrieben:

Gilead hat sich nach dem Kurssturz, ausgelöst u.a. durch die Preisdiskusionen von Sovaldi, gut erholt (was man vom Biotechsektor nicht behaupten kann) und klopft hoffentlich bald am Allzeithoch von 84.88 USD an.

Die Q1 Zahlen waren schlicht überragend und die Verkaufszahlen von Sovaldi (Sofosbuvir ) steigen jede Woche!

Im Herbst stehen zudem gleich vier Zulassungsentscheide in den USA an:

Idelalisib: 11. September 2014 (Leukämie)

Cobicistat: 3. Oktober 2014 (HIV-Behandlung)

Elvitegravir: 4. Oktober 2014 (HIV-Behandlung)

Kombination Ledipasvir/Sofosbuvir 10. Oktober 2014 (Hepatitis C, Genotyp 1)

Das mittlere Kursziel liegt nun bei 100 USD. (Schlusskurs 21.05.14: 81.81 USD)

 

(Keine Kauf- und schon garn nicht eine Verkaufsempfehlung)

 

 

Heute die FDA-Entscheidung über Harvoni (Ledipasvir/Sofosbuvir) Die anderen drei Medikamente wurden druchgewunken!

 

Gruss Eitaro

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News

Möchte das Forum hier wieder mal ein bisschen aufleben lassen.

 

Press Release: European Commission Grants Marketing Authorization for Gilead's Harvoni(R) (Ledipasvir/Sofosbuvir), the First Single Tablet Regimen to Treat the Majority of Chronic Hepatitis C Patients With Genotype 1 and 4
18.11.14 16:07:00- DJGP

European Commission Grants Marketing Authorization for Gilead's Harvoni(R) (Ledipasvir/Sofosbuvir), the First Single Tablet Regimen to Treat the Majority of Chronic Hepatitis C Patients With Genotype 1 and 4

-- Once-Daily Single Tablet Regimen Eliminates the Need for Interferon and Ribavirin for Patients with Genotype 1 and 4 Hepatitis C without Cirrhosis or with Compensated Cirrhosis --

FOSTER CITY, Calif.--(BUSINESS WIRE)--November 18, 2014-- 

Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the European Commission has granted marketing authorization for Harvoni(R) (ledipasvir 90 mg/sofosbuvir 400 mg), the first once-daily single tablet regimen to treat the majority of chronic hepatitis C genotype 1 and 4 infection in adults. Harvoni combines the NS5A inhibitor ledipasvir (LDV) with the nucleotide analog polymerase inhibitor sofosbuvir (SOF), approved by the European Commission under the tradename Sovaldi(R) in January 2014.

Harvoni is indicated for the treatment of chronic hepatitis C virus (HCV) in adults and is recommended in treatment-naïve and treatment-experienced cirrhotic and non-cirrhotic genotype 1 and 4 patients with a treatment duration of 12 or 24 weeks depending on prior treatment history and cirrhosis status. Eight weeks of treatment with Harvoni may be considered in non-cirrhotic treatment-naïve genotype 1 patients. In genotype 1 and 4 patients with decompensated cirrhosis, and genotype 3 patients with cirrhosis and/or prior treatment failure, Harvoni should be used in combination with ribavirin for 24 weeks. Harvoni is also indicated for patients with HCV who have HIV co-infection.

Today's marketing authorization is based on the clinical development program that included more than 2,000 patients with HCV infection, and follows an accelerated assessment by the European Medicines Agency, a designation that is granted to new medicines of major public health interest. It allows for the marketing of Harvoni in all 28 countries of the European Union (EU).

"Genotype 1 patients living with hepatitis C in Europe and the physicians who treat them have been waiting for a treatment advance like this for decades," said Graham Foster, MD, Professor of Hepatology, Queen Mary University of London. "With Harvoni, we have the potential to transform the way we treat people living with the most prevalent form of hepatitis C in Europe. We can now expect very high SVR rates, and for many patients, we can eliminate the need for interferon injections and ribavirin and offer a cure in a once-daily tablet."

The marketing authorization is supported primarily by data from three Phase 3 studies, ION-1, ION-2 and ION-3. These studies evaluated eight, 12 or 24 weeks of treatment with Harvoni, with or without ribavirin, among nearly 2,000 genotype 1 HCV patients with compensated liver disease.

These studies included non-cirrhotic treatment-naïve patients (ION-3), cirrhotic and non-cirrhotic treatment-naïve patients (ION-1) and cirrhotic and non-cirrhotic patients who failed prior therapy with an interferon-based regimen, including regimens containing an HCV protease inhibitor (ION-2). The primary endpoint for each study was sustained virologic response (HCV undetectable) 12 weeks after completing therapy (SVR12). Patients who achieve SVR12 are considered cured of HCV. In these studies, ribavirin was not shown to increase response rates. Trial participants in the ribavirin-free arms (n=1,080) achieved SVR12 rates of 94 to 99 percent.

The approval was also supported by preliminary data from the SOLAR-1 trial, which evaluated difficult to treat patients with decompensated cirrhosis and patients who have undergone liver transplantation, and from the ERADICATE trial, which evaluated genotype 1 HCV patients co-infected with HIV. The primary endpoint in these studies was SVR12. At the time of submission, only preliminary results were available. In the SOLAR-1 trial, participants with decompensated cirrhosis receiving a 12-week treatment regimen of Harvoni plus ribavirin had an SVR4 rate of 90 percent (n=45/50). In post-liver transplant patients without decompensated liver disease, SVR4 rates were greater than 95 percent (n=109). In an interim analysis of the ERADICATE trial, 40 of the 50 patients had reached 12 weeks post treatment and had SVR12 rates of 98 percent (n=39/40).

The ELECTRON-2 trial, a Phase 2 open-label study, provided preliminary data on genotype 3 infected HCV patients demonstrating 100 percent (n=26/26) SVR12 when Harvoni was used in combination with ribavirin for 12 weeks.

In these clinical studies, fatigue and headache were more common in patients treated with Harvoni compared to placebo.

Harvoni was approved by the U.S. Food and Drug Administration and Health Canada in October 2014 and in New Zealand in November 2014. Regulatory submissions for Harvoni are pending in Japan and Switzerland. Sovaldi as a single agent is approved for use in the European Union and in the United States, Canada, Australia, New Zealand, Egypt, Switzerland and Turkey.

Important Safety Information

The summary of product characteristics of co-prescribed medicinal products should be consulted before starting therapy with Harvoni.

Harvoni should not be administered concomitantly with other medicinal products containing sofosbuvir.

In clinical studies, fatigue and headache were more common in patients treated with Harvoni compared to placebo.

Contraindications include hypersensitivity to the active substances or to any of the excipients. Co-administration with rosuvastatin or St. John's wort (Hypericum perforatum) is contraindicated. Co-administration with certain P-glycoprotein (P-gp) inducers (e.g. rifampicin, carbamazepine and phenytoin) is not recommended. Monitoring of digoxin and dabigatran is recommended when used with Harvoni. Caution and frequent renal monitoring is recommended for co-administration with certain HIV antiretroviral regimens. Safety has not been established in patients with severe renal impairment. For patients on statins dose reduction should be considered and careful monitoring for statin adverse events (myopathy and rhabdomyolysis) should be undertaken. A Summary of Product Characteristics is available at www.ema.europa.eu.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North and South America, Europe and Asia Pacific.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that physicians and patients may not see advantages of Harvoni over other therapies and may therefore be reluctant to prescribe the product, and the risk that private and public payers may be reluctant to provide coverage or reimbursement for the product. Further, additional studies of Harvoni may produce unfavorable results. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended September 30, 2014, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

Harvoni and Sovaldi are registered trademarks of Gilead Sciences, Inc., or its related companies

 

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Sind hier noch welche investiert?

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Hublot_BB hat am 25.11.2014 - 16:04 folgendes geschrieben:

Sind hier noch welche investiert?

also ich bin vor einiger zeit mal raus, da ich EP von ~60 hatte. Hab sie aber weiterhin auf watch.

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2brix hat am 25.11.2014 - 18:22 folgendes geschrieben:

Hublot_BB hat am 25.11.2014 - 16:04 folgendes geschrieben:

Sind hier noch welche investiert?

also ich bin vor einiger zeit mal raus, da ich EP von ~60 hatte. Hab sie aber weiterhin auf watch.

Kurs wäre eigentlich gut, nur fällt der Kurs auch in einem sehr positiven Restumfeld, was mir Sorgen bereitet.

So mies waren die Zahlen ja auch wieder nicht und die Pipeline ist m.M. nach immernoch unterschätzt. Bin auch draussen, will mich aber bei passenden Kursen wieder positionieren.

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genau sehe ich auch so.

Ich warte den nächsten downer ab, wenn dann endlich mal einer kommt und steig dann ggf wieder ein.

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GILD

Ich bin wieder mit einer kleinen posi dabei. war unmittelbar vor den letzten qartalszahlen komplett ausgestiegen. für einmal lag ich da richtig... bin auch zuversichtlich, was gilead und die pipeline betrifft! die zulassung von abbv's hepatitis c medis und einen allfälliger preiskampf könnte sich allerdings kurzfristig negativ auf den aktienkurs auswirken....

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Kurse unter 100$ sehe ich wieder als Kaufgelegenheit. Die Story stimmt, die Pipeline ist auf Kurs. Das mit AbbVie sehe ich nicht so eng, ferner Gilead ja breiter aufgestellt ist als nur auf Hep. C.  (Natürlich kanns da mal noch bisschen drücken)

Bin nun wieder mit mittlerem Engagement an Bord und hoffe natürlich Gilead beschert mir frohe Weihnachten Smile

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UBS Rating 1.12.14

Gerade ein neuer UBS Research-Bericht veröffentlich worden:

Sie betonen ihr Kursziel von 125$ und sehen nun Kaufgelegenheiten.

 

Full transcript inside (starts p3) from our call with Norbert Bischofberger

Although we already published our quick takeaways from our UBS Leaders in Biotech series conference call with Gilead's R&D Head Norbert Bischofberger (see HERE), in this note, we provide the full transcript from the ~60min call that went into considerable detail on the next steps for the Gilead HCV franchise, its effort in NASH, as well as its programs in cardiovascular and oncology. Reading through the transcript, we're struck by the R&D rigor that isn’t reflected in the GILD valuation (10x forward),in our view.

Key datapoints on 2015 pipeline events

It is known that in 2015, ph3 data from SOF/GS-5816 (next-gen NS5A) will be available across genotypes, as will be short-duration ph2 data with a triple regimen. However, the next-gen PI (GS-9857), which is as efficacious as high-dose MK-5172, will be in triple combos with SOF/GS-5816 by mid-15e as well. Simtuzumab is going to print not only 48-week data in two NASH studies 2H15e (in line) but also an interim analysis in IPF 2Q15e (sooner than we thought). The TAF single pill (ECF-TAF) should be approved by YE15e, and the Truvada-TAF (F-TAF) will complete switch studies mid-year, while negotiations are ongoing with JNJ on a PI-TAF single pill regimen. GS-5745 (anti-MMP9) should read out 3 ph2 studies in solid tumors and one in ulcerative colitis.

Thoughts on the stock: A good time to buy

Coming out of AASLD, we readjusted our expectations on 4Q sales and headline risk of ABBV approval and pricing in HCV (see the 8 debates on the stock HERE). However, we see the current purgatory as a particularly good time to buy, as we believe that [1] Gilead is run by top-shelf mgmt.; [2] there remains upside to 2015-16 numbers, in our view; [3] there is evidence of pipeline emergence in 2015, as described above; [4] cheap on earnings and cashflow. Near term, we think ABBV will NOT be disruptive in pricing, relieving an overhang. Further, we think the stock can bounce back in 1H15e on Rx trends, and increasing visibility into pipeline development and share repurchases.

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Mylan Signs Agreement with Gilead

Noch mehr News:

 

PITTSBURGH and HYDERABAD, India, Dec. 1, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Laboratories Limited has entered into an agreement with Gilead Sciences, Inc. under which Mylan has licensed the non-exclusive rights to manufacture and distribute Tenofovir Alafenamide (TAF) as both a single agent product and in combination with other drugs. Tenofovir Alafenamide (TAF) is an investigational antiretroviral drug for the treatment of HIV-1 infection.

The license being granted to Mylan extends to 112 countries, which together account for more than 30 million people living with HIV, representing 84% of those infected globally.(1)

Mylan CEO Heather Bresch said, "Mylan's mission is to provide the world's 7 billion people access to high quality medicines and set new standards in health care. By working with partners like Gilead to help ensure access to innovative new products such as Tenofovir Alafenamide (TAF) in the countries hardest hit by this disease, we can help stem the tide of HIV/AIDS around the world."

As part of the licensing agreement, on U.S. Food and Drug Administration (FDA) approval, Mylan will receive a technology transfer from Gilead, enabling the company to manufacture low-cost versions of Tenofovir Alafenamide (TAF), if approved as a single agent or in approved combinations containing Tenofovir Alafenamide (TAF) for developing markets.

Phase III trials by Gilead Sciences met their primary objective supporting the potential for Tenofovir Alafenamide (TAF) to provide a new treatment option for individuals living with HIV.

This press release includes statements that constitute "forward-looking statements," including with regard to the company's strategy, future growth and performance. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: the impacts of competition; changes in economic and financial conditions of the company's business; strategies by competitors or other third parties to delay or prevent product introductions; risks inherent in legal and regulatory processes; risks associated with international operations; uncertainties and matters beyond the control of management; and the other risks detailed in the company's filings with the Securities and Exchange Commission. The company undertakes no obligation to update these statements for revisions or changes after the date of this release.

Mylan is a global pharmaceutical company committed to setting new standards in health care. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 1,300 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately 40% of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in approximately 140 countries and territories. Our workforce of more than 20,000 people is dedicated to improving the customer experience and increasing pharmaceutical access to consumers around the world. Learn more at mylan.com.

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Update

Heute ausnahmsweise relativ stabil um die +1% im Vergleich zu den anderen Biotech-Titel.

In Anbetracht der letzten Daten von Harvoni scheint es absolut plausibel zu sein, dass Harvoni die Zulassungsdaten von Sovaldi (>140k im 2014) noch um einiges übertreffen kann. 

Hoffen wir auf keinen Preiskampf mit AbbVie (was ich nicht erwarte) und dass die Bremsen nun langsam gelöst werden. Spätestens mit den Zahlen im Januar rechne ich mit dem nächsten Schub.

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Barrons Blog hat auch viel Lob übrig für Gilead. Schön zu hören:

 

Gilead has transitioned from a dominant HIV company to a leader in the exploding field of HCV antivirals. We expect that 2015 will see the company at its strongest, with significant growth in the market in the US, rapid increases in patient volume and revenue in Europe and initial sales in Japan and other markets.

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Estimize 04.12.14

Gilead Sciences in particular grew a whopping 254% on the bottom-line, and 117% on the top-line. Results were bolstered by continued progress of the company’s Hep C drug, Slovaldi, which saw sales of $2.8B. In October, the company introduced Harvoni - a single tablet regimen for the treatment of Hepatitis C, expected to follow in the footsteps of Slovaldi’s success. Contributors on the Estimize platform anticipate the company will post earnings per share of $2.33 in the fourth quarter in comparison to Wall Street’s estimate of $2.21. If the company does come in with $2.33 a share, it would represent YoY growth of 348%, while the current revenue consensus of $6.85B would indicate growth of 120%. Strong Q4 expectations have the overall health care earnings and revenue growth rates currently seated at 54% and 36%, respectively.

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Danke Hublot_BB für die Infos.

Möchte auch wieder einsteigen, bin aber momentan auf anderen Hochzeiten am Tanzen.

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@2brix, na dann viel Spass auf deinen Hochzeiten! 

Gilead seit langem wieder mit einem Tagesgewinn mit Substanz, der nicht gleich wieder Flöten ging. Charttechnisch gesehen fehlt dem RSI die Abwärtsdynamik. Weiteres Potenzial nach oben.

J.P. Morgan erhöhen zudem ihr Kursziel von 110$ auf 121$:

http://www.i3investor.com/servlets/fdnews/182603.jsp

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3 Reasons Gilead Sciences Could Soar in 2015

There's no doubt that 2014 was very kind to Gilead Sciences (NASDAQ: GILD  ) investors. Shares in Gilead surged 36% this year thanks to blockbuster sales of Sovaldi, the hepatitis C drug the company launched last December.

However, shares have been slipping recently over worries that new competition from AbbVie(NYSE: ABBV  ) could cut into Gilead Sciences hepatitis C market share in 2015. Although AbbVie's hepatits C drug is likely to win some revenue that would otherwise have gone to Gilead Sciences, here are three reasons that investors may want to stick with the company.

1. Good not great

AbbVie's hepatitis C drug cocktail is a good therapy, but it's arguably not as great as Gilead Sciences' next generation hepatitis C drug, Harvoni. Harvoni won FDA approval in October, and more prescriptions are being written for Harvoni than were being written for Sovaldi at the same point during its launch.

Whether or not AbbVie will be able to dislodge Harvoni will probably stem from price, rather than efficacy. During trials, the one-pill-once-daily Harvoni cleared hepatitis C from up to 99% of patients over 12 weeks. In the more common and tougher-to-treat genotype 1a variant of the disease, Harvoni boasted cure rates in the mid-90% range. For comparison, AbbVie's 3 pill-a-day therapy had cure rates in genotype 1a of around 90% and it wasn't until side-affect laden ribavirin was added that cure rates in that genotype spiked up into the high 90% range. Given AbbVie's arguably more onerous dosing and its potential reliance on ribavirin for many patients, it remains to be seen just how often doctors prescribe it over Harvoni. Regardless, Harvoni is likely to remain a blockbuster drug that generates billions of dollars in sales for Gilead Sciences next year.


 

2. Strengthening its core
Much of Gilead Sciences' long-term success has stemmed from its market share leadership in treating HIV patients. The company boasts some of the best-selling HIV therapies available, including five separate drugs that could hit billion-dollar blockbuster status this year.

Two of those drugs, Complera, which was launched in 2011, and Stribild, which won the FDA go-ahead in 2012, are growing sales quickly. In the third quarter, Complera's sales jumped 57% to 330 million and Stribild's sales soared 128% to $328 million.

In the next year, Gilead Sciences' HIV product lineup should become even stronger, given that the company filed for FDA approval of a newly formulated version of its top-selling HIV drug Viread, which offers a better safety profile. If approved, Gilead Sciences is likely to begin replacing Viread in its multi-drug HIV combination therapies.

3. Broadening its reach
This year, Gilead Sciences won approval for Zydelig, its first oncology drug. That drug is approved as a treatment for relapsing chronic lymphocytic leukemia, or CLL, relapsing follicular B-cell non-Hodgkin lymphoma and relapsing small lymphocytic lymphoma. Gilead is also conducting late-stage studies on Zydelig as a front-line therapy in those indications.

Deeper down the pipeline, Gilead is not only developing a slate of potential Harvoni successors for hepatitis C, but is developing drugs for hepatitis B, too. The company also has phase 2 trials under way in pancreatic cancer, colorectal cancer, cardiovascular disease, and respiratory disease as well. If any of these studies pan out as hoped, then investor enthusiasm could drive share prices higher.

And another thing
The FDA is set to make a decision on AbbVie's hepatitis C cocktail this month, and if it's approved, Gilead Sciences shares may come under pressure. But long-haul investors should remember that in addition to Harvoni arguably being a superior drug in terms of efficacy, the hepatitis C treatment market is massive. There are over 150 million people infected with hepatitis C worldwide, and this year Gilead Sciences has treated just 117,000 of them. As Gilead Sciences wins approval for its hepatitis C treatments in other markets, such as Japan, and its launches in Europe pick up momentum, there are a lot of drivers that could support hepatitis C revenue growth next year. Investors should also recognize that the next battleground for hepatitis C market share likely won't focus on cure rate, but on treatment duration. Arguably, Gilead Sciences pipeline is the best prepared to reduce treatment time below the eight and 12 weeks required for Harvoni.

Outside of hepatitis C, Gilead Sciences appears to be on pace to eclipse $10 billion in annual sales of its HIV drugs, and the company could soon see cancer drug sales begin to contribute in 2015, too. For those reasons, investors may want to look beyond the short-term risk and maintain a long-term view when it comes to Gilead Sciences.

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NY (The Street):

Cramer Says It May Finally Be Time to Buy Laggard Gilead Sciences

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Gilead Presents Follow-up Data from Zydelig

Gilead Presents Follow-up Data from Zydelig Registrational Studies in Patients with Chronic Lymphocytic Leukemia, Follicular Lymphoma and Small Lymphocytic Lymphoma

-- Results Describing Long-Term Safety and Disease Control Presented at the 56(th) American Society of Hematology Annual Meeting --

SAN FRANCISCO--(BUSINESS WIRE)--December 08, 2014-- 

Gilead Sciences, Inc. (NASDAQ: GILD) today announced long-term follow-up results from the registration studies further describing the duration of response, progression-free survival (PFS) and safety profile for Zydelig(R) (idelalisib) in relapsed patients with chronic lymphocytic leukemia (CLL) and two types of indolent non-Hodgkin lymphoma (iNHL). The findings are being presented this week at the Annual Meeting of the American Society of Hematology (ASH).

Zydelig is indicated in the United States as monotherapy for patients with relapsed follicular B-cell non-Hodgkin lymphoma (FL) and small lymphocytic lymphoma (SLL) who have received at least two prior systemic therapies, and in combination with rituximab for patients with relapsed CLL for whom rituximab alone would be considered appropriate therapy due to comorbidities. Accelerated approval was granted for FL and SLL based on overall response rate; improvement in patient survival has not been established.

Indolent NHL and CLL are slow-growing, incurable blood cancers occurring typically in older individuals and can lead to life-threatening complications such as anemia, serious infection and bone marrow failure. Relapse commonly occurs after initial chemoimmunotherapy and many patients with relapsed disease are unable to tolerate chemotherapy, which may limit their treatment options.

"The results presented this week demonstrate the long-term benefit of Zydelig in patient populations that often have limited or no treatment options due to age or lack of response to existing therapies," said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. "As part of our ongoing effort to further define the safety and efficacy profile of Zydelig, we are continuing to pursue long-term follow-up studies and larger Phase 2 and Phase 3 clinical trials in combination with existing treatment regimens in both relapsed and first-line CLL and iNHL."

Study 101-09 in iNHL

Study 101-09 (Abstract #1708) is a single-arm Phase 2 study evaluating idelalisib monotherapy in 125 patients with previously treated iNHL that is refractory both to rituximab and to alkylating-agent-containing chemotherapy, a patient population that has few if any treatment options. At the most recent data analysis cutoff (June 2014), 72 patients (58 percent) had responded to therapy, including 12 (10 percent) who have achieved a complete response--an increase from seven (six percent) complete responses reported initially and which were published earlier this year in The New England Journal of Medicine. The median duration of response for all patients at the most recent data cutoff was 12.5 months. The median duration of response among patients in the FL (n=40) and SLL (n=17) subgroups was 10.8 months and 12.5, respectively.

The most common Grade >=3 adverse events among all patients were diarrhea/colitis (19 percent) and pneumonia (12 percent). Grade >=3 transaminase elevations occurred in 14 percent of patients.

Long-Term Data in CLL

Additional long-term data are being presented from Study 116 of idelalisib in previously treated CLL patients.

Study 116 (Abstract #330) was a randomized, placebo-controlled study evaluating idelalisib plus rituximab versus rituximab alone in 220 patients with relapsed CLL who were not able to tolerate standard chemotherapy. Patients in this study were eligible to continue receiving idelalisib therapy in an open-label extension study (Study 117). Results from the primary and the extension study show that among the 110 patients randomized to receive idelalisib plus rituximab, the median PFS has now been reached, and is 19.4 months.

In Study 116/117 the most common Grade >=3 adverse events in patients receiving idelalisib plus rituximab were diarrhea/colitis (16 percent) and pneumonia (13 percent). Grade >=3 transaminase elevations occurred in 6 percent of patients.

The Zydelig U.S. Prescribing Information includes a BOXED WARNING regarding fatal and serious toxicities of hepatotoxicity, severe diarrhea/colitis, pneumonia, and intestinal perforation; see below for Important Safety Information.

About Zydelig (idelalisib)

Zydelig is an oral inhibitor of phosphoinositide 3-kinase (PI3K) delta, a protein that plays a role in the activation, proliferation and viability of B cells, a critical component of the immune system. PI3K delta signaling is active in many B-cell leukemias and lymphomas, and by inhibiting the protein, Zydelig blocks several cellular signaling pathways that drive B-cell viability.

On July 23, 2014, Zydelig received accelerated approval from the U.S. Food and Drug Administration as monotherapy for patients with relapsed FL or SLL who have received at least two prior systemic therapies, and full approval in combination with rituximab for patients with relapsed CLL for whom rituximab alone would be considered appropriate therapy due to comorbidities. On September 19, 2014, the European Commission granted marketing authorization for Zydelig as monotherapy in FL patients who are refractory to two prior lines of treatment, and in combination with rituximab for CLL patients who have received at least one prior therapy, or in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemoimmunotherapy.

The clinical development program for idelalisib currently includes six ongoing or completed Phase 3 clinical trials for B-cell cancers. Additional information about clinical studies of idelalisib and Gilead's investigational cancer agents can be found at www.clinicaltrials.gov. 

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A Strong Buy (by Uri Gruenbaum):

Gilead Sciences is a research-based biopharmaceutical company known for developing treatments for life-threatening diseases, specifically focusing on therapies for HIV/AIDS, liver diseases, and cancers. The biopharmaceutical company recently launched a hepatitis C treatment called Sovaldi.

Demand for the hepatitis C drug has been outstandingly high from doctors and patients all over the world. In fact, Gilead sold over $5 billion worth of the drug in its first 6 months on the market, earning the title of this year’s top selling medicine so far and the only medicine to reach such high sales so quickly.

Gilead Sciences has been rated 15 times over the past year, with 14 bullish recommendations and 1 neutral rating. Gilead was last recommended on December 5th by 4- Star J.P Morgan analyst Cory Kasimov, who reiterated an Overweight rating. He reasoned, “We estimate that Gilead could generate in excess of $30B in cash in the next two years alone, and potentially $80B+ over the next 5 years. Put into perspective, that’s ~$15B more than the current combined cap of our entire small- & mid-cap coverage universe comprised of 20 companies.” Gilead Sciences is currently valued at $157.79 billion.

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Heute im "Der Aktionär":

Star-Investor Jim Cramer meldet sich in einem TV-Interview zu Wort: Für ihn sei jetzt die Zeit gekommen den Nachzügler Gilead Sciences zu kaufen. Gilead Sciences als Nachzügler im Vergleich zu Biogen, Celgene zu bezeichnen verblüfft schon. Mit einer Jahresperformance von 42 Prozent hat Gilead, Celgene (38 Prozent) und Biogen (22 Prozent) klar geschlagen. Cramer begründet seine positive Einstellung aber auch mit Zahlen: „Gilead wird in den nächsten zwei Jahren 30 Milliarden und über die nächsten fünf Jahre 80 Milliarden Cash generieren. Investoren sollten sich nicht mit der Behandlungsmethode von Abbvie’s Hepatitis C Behandlungsmethode beschäftigen. Es ist Zeit für für Gilead die Konkurrenten einzuholen und höher zu notieren.“

Auch charttechnisch scheint der Titel wieder in Fahrt zu kommen. An der Unterstützungszone bei 100 Dollar kämpft sich Gilead Sciences wieder nach oben. Der langfristige Aufwärtstrend ist wieder aufgenommen worden. Der Ausbruch aus der Seitswärtsrange zwischen 100 und 110 Dollar dürfte nur eine Frage der Zeit sein.

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Da hat sich GILD gestern im Vergleich zu anderen Bio's doch recht gut gehalten! Schade zogs zum Schluss den Nasdaq ordentlich runter.

 

Anyway: Gilead Sciences-Aktie: Anstieg der Hep.-Umsätze erwartet

New York (www.aktiencheck.de) - Gilead Sciences-Aktienanalyse von Analyst Matthew Harrison von Morgan Stanley:


Der Aktienanalyst Matthew Harrison vom Investmenthaus Morgan Stanley empfiehlt laut einer aktuellen Aktienanalyse bei den Aktien des US-Biotechkonzerns Gilead Sciences Inc. (ISIN: US3755581036, WKN 885823, Ticker-Symbol: GIS, Nasdaq-Symbol: GILD) weiterhin eine Gleichgewichtung.

Das US-Ministerium für Kriegsveteranen (VA) zahle Gilead Sciences Inc. für die Hepatits C-Medikamente Sovaldi und Harvoni nur die Hälfte des Listenpreises. Der Nettopreis für Sovaldi belaufe sich auf 539 USD pro Tag. Johnson & Johnson's Olysio komme mit dem Abschlag auf einen Preis von 375 USD pro Dosis.

Der Harvoni-Preis könnte eine größere Flexibilität haben. Der Preisaufschlag gegenüber Sovaldi belaufe sich auf 12,5%. Allerdings zahle das VA derzeit einen rund 70%igen Aufschlag für die Sovaldi/Olysio-Kombination gegenüber Sovaldi. Das Ausmaß des nachgefragten Discounts für Harvoni könnte daher geringer ausfallen. Auch unter Berücksichtigung von Victrelis von Merck & Co. scheine das VA auf alle Hepatitis-Medikamente einen Rabatt von rund 50% zu erhalten, so die Analysten von Morgan Stanley.

Abgesehen davon seien die Prognosen zum Preis der Hepatitis-Therapie in den USA pro Patient um rund 15% angehoben worden. Die Schätzung zur Anzahl der behandelten Patienten in 2015 werde dagegen leicht reduziert. Unter dem Strich ergebe sich die Erwartung eines leichten Umsatzanstiegs in den USA.

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Philadelphia's transit agency has sued Gilead Sciences Inc., accusing the company of "price-gouging" on the sale of its $1,000-per-pill hepatitis C drug Sovaldi, the latest salvo in a battle between health-care payers and the pharmaceutical industry over prices.

The Southeastern Pennsylvania Transportation Authority, or Septa, filed the lawsuit on Tuesday in U.S. District Court for the Eastern District of Pennsylvania. The suit seeks class-action status, subject to certification by a judge, on behalf of any person or entity in the U.S. who has paid "excessive" prices for Sovaldi, or was unable to obtain the drug.

The lawsuit seeks monetary damages from Gilead.

According to the lawsuit, Septa, which operates trains, buses and subways in the Philadelphia region, has spent at least $2.4 million on Sovaldi this year for members of the health plans it funds for employees and retirees. Septa didn't say how many plan members have received Sovaldi to treat liver-damaging hepatitis C infections.

A Gilead spokeswoman said Wednesday that the company had no comment because it had just received a copy of the lawsuit.

Previously, Gilead has said the price for Sovaldi, which averages about $84,000 per patient for a standard course of treatment, was justified by the drug's ability to cure a high rate of hepatitis C patients, which can prevent more costly health care services down the line, such as liver transplants.

Nicholas E. Chimicles, an attorney representing Septa in the lawsuit, said the price of Sovaldi is "bleeding health and welfare plans around the country."

The lawsuit follows renewed debate about drug prices, fueled not only by Sovaldi but also by other expensive treatments, such as new cancer medicines from Merck & Co. and Bristol-Myers Squibb Co. The industry argues that the drugs represent medical advances, and that companies need to recoup their investments in expensive research and development, but critics say the prices are straining health-care budgets and impeding patient access to new drugs.

An estimated three million to five million Americans have chronic hepatitis C infection. The virus is transmitted via contact with the blood of an infected patient, including sharing needles.

Since it hit the market in December 2013, Sovaldi has had the best prescription drug launch in history, generating $8.55 billion in sales for the first nine months of this year. In October, U.S. regulators cleared Gilead to sell a new drug, Harvoni, which combines Sovaldi with another drug in a single pill taken once daily and costs about $94,500 for the typical patient treated for 12 weeks.

Administrators of state Medicaid programs and prison systems have expressed concern that the price of Sovaldi is straining their budgets and forcing them to limit the drug's use among Medicaid recipients and inmates.

In July, the U.S. Senate Finance Committee launched an investigation of Gilead's pricing of Sovaldi, sending a letter to the company asking for a wide range of documents on how Gilead set the pricing. Gilead said it is cooperating with the Senate committee.

The Septa lawsuit accuses Gilead of discriminatory pricing for Sovaldi because some customers have received discounts and others haven't. Gilead has taken steps to provide the drug at steep discounts in developing countries, including providing licenses to India-based generic manufacturers to sell lower-cost copies.

"While rolling out its self-congratulatory marketing campaign about how the company is making this lifesaving drug available in third-world countries, Gilead has been simultaneously gouging its U.S.-based consumers and third-party payers of the drug," the Septa lawsuit says. 

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Cheap and Growth

It's unusual for a stock to be a favorite of both growth and value investors -- but then Gilead isn't a typical pharmaceutical company.

Most investors know Gilead Sciences (ticker: GILD) for its blockbuster treatments for HIV and hepatitis C -- and its big swoon this spring when the biotech sector as a whole sold off. While the stock has bounced back strongly, its valuation remains low, even as prospects for its drugs look brighter than ever. The Food and Drug Administration approved its latest hep C, or HVC, drug, Harvoni, in mid-October, and it is expected to log $1.4 billion in sales in the fourth quarter alone.

"A lot of traditional value companies are trading at a higher multiple than Gilead," says Brain Lazorishak, portfolio co-manager of the Chase Growth fund, which recently counted Gilead among its top five holdings. He says that while some discount is warranted given uncertainty about future drug sales, the stock is at an attractive entry point. "If things go right, there's a lot of upside, and with the valuation where it is, it's discounting the possibility of things going wrong."

At just 10.3 times forward earnings -- versus 16 times for the Standard & Poor's 500 -- Gilead seems to already reflect significant risk. And even if 2015 earnings per share match the lowest of Wall Street's 27 estimates, the stock, at a recent $104.31, would be at 13.1 times forward earnings. That, too, would be cheap given that earnings per share are projected to rise 27% from this year to next.

Yet Gilead doesn't look poised to deliver a worst-case scenario -- perhaps just the opposite. With first-mover advantage in the HCV space, and less-than-promising results from big pharma peers such as Merck (MRK) and Bristol-Myers Squibb (BMY), Gilead will probably remain the industry leader, especially given the ease of taking Harvoni: just one pill a day.

Moreover, investors seems to be ignoring Gilead's over $9 billion HIV business and its continuing research in other areas. "I would argue that [investors are] paying nothing for the potential upside of Gilead's R&D pipeline," says John Park, portfolio co-manager for the Oakseed Opportunity fund, which recently counted the stock as its seventh-largest position. He notes that Gilead recently submitted a new formulation of its HIV drug tenofovir alafenamide fumarate (TAF) for approval, an important development that's been overshadowed by Harvoni.

To be sure, Gilead still faces a number of risks. Its success in hepatitis C and elsewhere has drawn competitors' attention, and the high price tag of its therapies -- Harvoni costs $1,125 a pill, or $94,500 for a three-month course of treatment -- may draw the ire of policy makers.

But it's hard to ignore Gilead's attractive fundamentals: The company has a strong financial position and is using its robust free cash flow to repurchase shares, it has made smart acquisitions in the past, and is still investing in research.

In addition, Gil-ead's return on equity, is one of the highest in its peer group, as are its gross profit and operating margins.

The company has been reducing its long-term debt, which was just over 20% of its market value at the end of 2013, down from more than half in 2011.

Michael Cuggino, president and portfolio manager at the Permanent Portfolio Family of Funds, says that Gilead meets all his requirements: "It's monetizing [its products], it has leading market share, it's developing successor products to maintain that competitive edge, the market for their products is substantial and they're profitable." 

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Erstmals die 9000er-Marke geknackt. Denke langsam aber sicher ist es Zeit positioniert zu sein Smile

 

Michael J. Yee, Aktienanalyst von RBC Capital Markets, erwartet bei den Aktien des US-Biotechkonzerns Gilead Sciences Inc. nach wie vor eine überdurchschnittliche Entwicklung des Aktienkurses.

Die Harvoni-Gesamtverschreibungszahlen seien in Woche 8 nach der Markteinführung laut den IMS-Daten um 45% auf 5.642 gestiegen. Bei den Neuverschreibungen habe es gegenüber Woche 7 einen Anstieg von 36% gegeben. Harvoni+Sovaldi hätten einen Zuwachs von 39% auf 9.195 verzeichnet.

Investoren sollten im Hinblick auf die Zahlen beachten, dass die Vorwoche von Thanksgiving beeinflusst worden sei. Die Harvoni-Neuverschreibungen würden laut Analyst Michael J. Yee auf Kurs liegen, um die Q4-Konsensprognose für die USA von rund 3 Mrd. USD zu erfüllen.

Die Aktienanalysten von RBC Capital Markets bestätigen in ihrer Gilead Sciences-Aktienanalyse das "outperform"-Rating und das Kursziel von 125,00 USD.

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Fresh off a failed takeover bid that would have lowered its taxes and diversified its product lineup, drug maker AbbVie is hoping for a Christmas gift: regulatory approval of its first significant new product in a decade.
 

Fresh off a failed takeover bid that would have lowered its taxes and diversified its product lineup, drug maker AbbVie Inc. is hoping for a Christmas gift: regulatory approval of its first significant new product in a decade.

The North Chicago, Ill., company is awaiting a decision from the U.S. Food and Drug Administration this month about whether it can start marketing a multidrug regimen for the liver disease hepatitis C.

The decision is crucial because AbbVie today relies on just one drug to generate 63% of its revenue: the anti-inflammatory Humira. It is the biggest-selling drug in the world, with sales this year expected to exceed $12.5 billion, but Humira's patent protection is due to begin eroding in late 2016. Humira may not face heavy copycat competition immediately, but the company can't count on high sales of the drug forever.

The need to expand beyond Humira took on added urgency after AbbVie in October scrapped a $54 billion deal to buy Shire PLC, maker of attention-deficit disorder drugs and treatments for rare diseases. The company had been counting on Shire's pipeline to fuel growth.

Humira's success has obscured the fact that AbbVie's output of new drugs has been minimal, stretching back to before the company was spun off from Abbott Laboratories nearly two years ago. AbbVie was previously the pharmaceutical division of Abbott Labs that generated about 45% of Abbott's total sales before the spinoff. The last Abbott product with a new active ingredient to be approved by the FDA and marketed by Abbott was Humira at the end of 2002.

An FDA approval of AbbVie's hepatitis C regimen "will be a welcome breath of fresh air for a company that hasn't really produced anything for 10 years," said Bernard Munos, a pharmaceutical research-and-development consultant who previously worked at Eli Lilly & Co. "This is certainly going to be a boost for the entire organization," he said.

AbbVie hasn't publicly disclosed the brand name for the multidrug regimen.

AbbVie says it has been rebuilding its R&D pipeline, partly through licensing drugs from other companies or acquiring other companies and inheriting their pipelines. By 2011 it had about 20 compounds in mid- or late-stage development, nearly triple the number a few years earlier.

"We have made progress over the last several years in a wide range of areas," said Michael Severino, the new chief of R&D AbbVie hired earlier this year from Amgen Inc. "I think the labs have been productive. When I look at the pipeline today, I like its focus."

If approved, the new hepatitis C regimen would provide a new option for patients chronically infected by the virus, while posing the first real competitive threat to Gilead Sciences Inc., which now dominates the hepatitis C market with the drugs Sovaldi and Harvoni.

AbbVie's product stems partly from a 2006 partnership with Enanta Pharmaceuticals of Watertown, Mass. The collaboration produced ABT-450, or paritaprevir, which is known as a protease inhibitor and works with other drugs in the regimen to block replication of the hepatitis C virus. Abbott Labs and now AbbVie have paid $160 million to Enanta in the form of an upfront fee and subsequent research milestone payments, according to Enanta. And AbbVie will pay more if the hepatitis C regimen is approved.

The proposed AbbVie hepatitis C treatment, which contains several drugs including paritaprevir, is an oral regimen of pills that don't need to be taken alongside the injected drug interferon, which some patients find difficult to tolerate. The AbbVie regimen is intended to be given for 12 weeks to patients with the most common subtype of hepatitis C in the U.S., genotype 1.

Convenience could be an issue when patients and doctors choose between AbbVie and Gilead's newest drug, the once-daily pill Harvoni. The AbbVie regimen is taken as either four or six pills a day, depending on which combination of the drugs the patient needs.

AbbVie officials have said they don't expect the number of pills to be much of an issue because of the regimen's effectiveness. In some clinical studies--for example, with patients with cirrhosis or who had tried a prior treatment--the regimen had cure rates ranging from 92% to 100%. The AbbVie regimen hasn't been tested head-to-head against Gilead's drugs, but the cure rates are comparable to Harvoni's.

Analysts don't expect AbbVie to overtake Gilead in the hepatitis C market, but believe it can capture a decent share of a market that continues to grow. AbbVie hasn't disclosed pricing for its regimen, but some expect that the company could gain market share by selectively discounting it versus Gilead's Harvoni, which costs about $94,500 for a 12-week regimen. Gilead's Sovaldi hepatitis C drug, which was introduced a year ago, costs $84,000 for a standard course of treatment.

Cowen & Co. analyst Steve Scala estimates the AbbVie regimen could generate about $3.5 billion in sales next year, which would make it the second-biggest first-year tally for a new drug, behind Gilead's Sovaldi, which had $8.55 billion in sales for the first nine months of 2014. "It's probably the single most important thing to AbbVie right now," he said. 

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UBS Research

Heute wurde ein neuer UBS Research Bericht veröffentlicht. Ihr findet ihn im Anhang.

Möchte das Kursfeuerwerk sehen, falls das Medi von ABBV kein approval erhält Smile Denke abgesehen von der "möglicherweise" kürzeren Behandlungszeit ist Harvoni immernoch das Non Plus Ultra.

Der Anhang wurde vom Moderator auf Wunsch der UBS entfernt, da es sich beim Report um ein Dokument handelt, das Kunden und Investoren vorbehalten und nicht für die Öffentlichkeit bestimmt ist.

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EXCLUSIVE LICENSE AGREEMENT

ONO PHARMACEUTICAL CO., LTD. ("ONO") and Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the companies have entered into an exclusive license agreement for the development and commercialization of ONO-4059, ONO's oral Bruton's tyrosine kinase (BTK) inhibitor for the treatment of B-cell malignancies and other diseases. Under the terms of the agreement, Gilead will pay ONO an upfront payment plus additional payments based upon achievement of certain development, regulatory and commercial milestones. The companies will collaborate jointly on global development of ONO-4059. Gilead will have exclusive rights to develop and commercialize ONO-4059 in all countries of the world outside of Japan, South Korea, Taiwan, China and the Association of Southeast Asian Nations (ASEAN) countries, where ONO retains development and commercialization rights.

ONO-4059 is a selective, once-daily, oral inhibitor of BTK, which has been shown to play a role in the survival and proliferation of malignant B-cells. ONO has presented preliminary Phase 1 data showing clinical activity in chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL) at several scientific conferences. ONO and Gilead plan to develop ONO-4059 for the treatment of B-cell malignancies and other diseases as a monotherapy and in combination with approved and investigational agents, including combinations with kinase inhibitors in Gilead's portfolio.

"We are pleased to partner with Gilead to accelerate worldwide development and commercialization of ONO-4059," said Gyo Sagara, ONO's President, Representative Director and Chief Executive Officer. "Our goal is to bring better therapeutic options as quickly as possible for the patients with B-cell malignancies or other diseases in the world, and we believe we can fulfill the goal by pursuing the development of ONO-4059 with Gilead."

"With this agreement, Gilead now has compounds targeting four unique signaling pathways associated with B-cell malignancies -- PI3K delta, Syk, JAK and BTK," said Norbert W. Bischofberger, PhD, Gilead's Executive Vice President, Research and Development and Chief Scientific Officer. "In addition to evaluating ONO-4059 in combination with standards of care, we believe there is an opportunity to combine this compound with Gilead's other kinase inhibitors with a goal of achieving more pronounced and more durable response rates. We look forward to working with ONO to move the ONO-4059 development program forward as quickly as possible."

About ONO PHARMACEUTICAL

ONO PHARMACEUTICAL, headquartered in Osaka, Japan, is an R&D-oriented pharmaceutical company committed to creating innovative medicines in specific areas. It focuses especially on the diabetes and oncology areas. For more information, please visit the company's website at http://www.ono.co.jp/eng/index.html. 

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Einsame Spitze heute. Schlägt den Gesamtmarkt deutlich!
Nur nicht nachlassen und Grün ins Weekend.

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Pünktlich zum FDA-Approval

Pünktlich zum FDA-Approval von ABBV's Hep C Medi, ein neuer Research-Bericht.

 

Der Anhang wurde vom Moderator auf Wunsch der UBS entfernt, da es sich beim Report um ein Dokument handelt, das Kunden und Investoren vorbehalten und nicht für die Öffentlichkeit bestimmt ist.

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Pre-Market dick im Minus, wie gedacht. Wird sich m.M. nach schnell wieder legen. Pricing von ABBV höher als Street-Consensus.

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