GILEAD SCIENCES 885823 (Seite 331)

[SLGramann]

Sehe das so wie Ulf-Imat. Ein Erfolg dürfte weitestgehend eingepreist sein. (ein, wenn auch unwahrscheinlicher, Misserfolg dementsprechend nicht...) In jedem Fall ist Quad für GILD aber außerordentlich wichtig.

Dynamik wird in den Kurs kommen, wenn das Hep-C-Geschäft mal den Return abzuwerfen beginnt, der erhofft wird.
In einem Jahr dürfte es damit losgehen - oder eben auch nicht.

Ab 2015 könnte dann auch das neue Hematologie-Geschäft den Kurs prägen.

[Ulf-Imat]

anders gesagt:
Am besten mal auf http://finance.yahoo.com/q?s=GILDgehen
linke Spalte > Charts Interactive
Einstellung ggfs.> 1Y (ein Jahr)
oberhalb des Charts: > Events > Key Developments

man kann sehen, daß die Aktie bei Neuigkeiten zu HIV nicht sonderlich reagiert, zumal man dort eh´ Marktführer ist; anders sieht es aus bei Neuigkeiten zu Hepatitis

nur meine 0,02€

[Ulf-Imat]

Eingepreist.

[Freshman308]

wie steht ihr zu der bevorstehenden fda-entscheidung zu quad am 27.08? denkt ihr, dass der kurs dadurch noch einmal ansteigt oder denkt ihr die sehr wahrscheinliche zulassung ist bereits eingepreist?

[SLGramann]

Eine Einschätzung zu den Panel-Empfehlungen aus der letzten Woche:


MINYANVILLE ORIGINAL

Gilead Sciences (GILD) scored a pair of victories last week, showing that it’s still fighting hard to remain the dominant drug maker for HIV treatments.

On Friday, government advisers voted 13-1 to recommend that the Food and Drug Administration approve Quad, Gilead’s experimental four-in-one HIV pill. The agency is scheduled to make its decision by August 27. The endorsement followed a panel vote one day earlier in which FDA advisers supported the use of Gilead’s blockbuster drug Truvada to help prevent HIV infections. (See Gilead Sciences Clears Hurdle for First Pill to Prevent HIV.)

While approval of Truvada as the first drug to prevent HIV would be a significant event, Wall Street analysts consider Quad a greater commercial opportunity. There’s still a sizable population of people who are infected and Quad would provide a new option for patients who want a convenient once-daily therapy.

“It is important that we continue to simplify and improve HIV therapy,” Andrew Cheng, Gilead’s senior vice president for HIV therapeutics and development, says in a statement.

Shares of Gilead rose more than 1% to $52.60 in morning trading Monday. The stock is up more than 6% since last Tuesday.

In studies, Gilead showed that Quad worked at least as well as the company’s top-selling Atripla and was as safe as that drug. There are concerns about Quad’s effect on kidneys, which would require safety monitoring, but the drug doesn’t carry the neurological side effects like insomnia or dizziness seen in Atripla. Like Quad, Atripla is a once-daily pill combining medicines -- two Gilead drugs and Bristol-Myers Squibb’s (BMY) Sustiva. The neurological side effects of Atripla are attributed to Sustiva, which is not included in Gilead’s Quad.

Quad is a combination of four drugs that are all owned by Gilead. That means it would not have to share profit as it does with Atripla, a drug whose sales jumped 10% to $3.2 billion in 2011.

“We expect Gilead to aggressively encourage patients to switch to Quad from Atripla,” Stifel Nicolaus analyst Joel Sendek says in a note Monday morning. With drug patent expirations approaching in the next several years, Gilead would be able to extend market exclusivity for an HIV treatment with Quad, he notes.

Quad is made up two older Gilead drugs -- Viread and Emtriva -- and a couple of experimental treatments. The unapproved medicines are elvitegravir, which is among a new class of drugs known as integrase inhibitors and cobicistat, a booster drug similar to Abbott Laboratories’ (ABT) Norvir. Quad would be used as a first-line treatment for HIV patients.

Gilead already commands about 80% of the market for initial HIV treatments, Sendek says. He estimates that about 190,000 first-line patients in the US are now being treated with Atripla and 220,000 people are taking Truvada or a combination therapy that includes the drug.

If approved this year, Quad may be an almost $1 billion a year drug by 2014, Sendek says. He predicts the drug may reach $3.8 billion by 2017, though his numbers are a bit higher than some other analyst projections.

Gilead begins losing patent protection on HIV drugs in 2016 (Atripla is expected to lose exclusivity in the US in 2021). The company’s future growth may be hepatitis C treatments following an almost $12 billion takeover of Pharmasset earlier this year but Quad may be an important near-term growth vehicle for Gilead.

http://www.minyanville.com/business-news/editors-pick/articl…

[SLGramann]

Antwort auf Beitrag Nr.: 43.157.204 von SLGramann am 12.05.12 17:43:23

Link zur Quelle vergessen:

http://www.hammerstockblog.com/gilead%E2%80%99s-hematology-p…


Noch eine Anmerkung dazu:

Gilead paid for Pharmasset ($11B) vs. $375M for Calistoga. Pharmasset had additional clinical stage assets, including the all-important NS5a inhibitor, yet it is hard to justify the 30-fold difference between the two acquisitions.


Ich will gar nicht bestreiten, dass dieser Übernahmepreis sehr extrem war und als ich zum ersten Mal davon las, habe ich nur den Kopf geschüttelt.

Bei näherem Nachdenken bin ich aber zu dem Ergebnis gekommen, dass, wenn man schon so einen Schritt macht, man ihn richtig machen muss. Das heißt, man muss am besten den Kandidaten kaufen, mit dem man sowohl first-in-class als auch best-in-class ist.
Hier aus Sparsamkeitsgründen nach Kompromissen zu suchen, führt am Ende wahrscheinlich ins Nirgendwo. Dann lässt man es lieber ganz sein.
Ob der HCV-Markt am Ende hält, was sich Gilead verspricht, wird man sehen müssen. Aber wenn schon in das Haifischbecken rein, dann genau so!

[SLGramann]

Und hier ein Beitrag zur zweiten neuen Stoßrichtung Hämatologie:
(aus dem extrem lesenswerten Blog von Ohad Hammer)


Gilead’s Hematology Pipeline - Transformative and Under-appreciated


Gilead (GILD) is garnering a huge amount of attention from investors owing to the hepatitis C virus (HCV) pipeline it got from the Pharmasset acquisition. As the market is occupied with the company’s HCV programs, investors seem to ignore additional promising assets in Gilead’s pipeline. GS-1101, which started phase III in leukemia last week, is a good example. I have no intention to downplay Gilead’s HCV pipeline, however, the minimal attention given to GS-1101, one of the promising hematology agents in development, seems unjustified.

Another multi-billion opportunity

Gilead got GS-1101 through the $600M ($375M in cash+ $225M in milestone payments) acquisition of Calistoga last year. At the time, the drug generated preliminary but exciting results in various blood cancers, positioning it as one of the big promises in the industry. The medical community was taken by GS-1101 as a highly effective, safe oral drug. It is viewed as the main competitor to Pharmacyclics’ (PCYC) closely watched Ibrutinib (formerly PCI-32765).

From a market potential perspective, GS-1101 is targeting a market which is at least as big as the HCV market (the best benchmark is Rituxan with $6B in sales last year) but with some advantages. The business case for GS-7977 in HCV will heavily depend on diagnosing patients who do not even know they are sick and convincing them to get treatment. In contrast, leukemia or lymphoma patients are well aware of their condition and most importantly, do not need to be convinced to get treated.

GS-1101’s main disadvantage is the lack of meaningful clinical data for over a year in bright contrast to Pharmacyclics that is constantly releasing more promising results. This, combined with a slightly inferior safety profile, makes Pharmacyclics’ ibrutinib the more preferred drug. Still, as both drugs are still at an early stage, it is hard to tell how they perform when they reach the market.

Immuno-kinase inhibitors as a strategic area

Just as Gilead identified the focal point in HCV with the Pharmasset acquisition, it identified one of the most promising areas in the hematology and autoimmune diseases. GS-1101 inhibits a specific subtype of PI3 kinase (delta isoform). This target belongs to a group of kinases that are pivotal in the function of immune cells, referred to as “immune-kinases”.

There are currently 4 hot immune-kinase targets: Jak, Syk, Btk and PI3K-gamma/delta. Drugs for each of the 4 targets have already demonstrated remarkable activity across many indications, usually with a superb safety profile and convenient oral dosing. As a result, these drugs are expected to become central players in indications representing tens of billions of dollars in commercial opportunity.

The initial markets for Jak inhibitors are myelo-proliferative diseases such as myelofibrosis (MF) and rheumatoid arthritis (RA), the initial market for Syk inhibitors is RA. The initial markets for Btk and PI3K-delta inhibitors are chronic lymphocytic leukemia (CLL) and various subtypes of lymphoma.

Immuno-kinase programs in development

Jak inhibitors are the furthest along in development, with Incyte’s (INCY) and Novartis’ (NVS) ruxolitinib (brand name, Jakafi), already approved for MF, and Pfizer’s (PFE) tofacitinib, which is expected to be approved for RA later this year. Several other programs are in mid- and late stage development, with different selectivity profiles towards the three Jak subtypes (Jak1, Jak2, Jak3). This could affect efficacy but also safety profile, which might end up as the key differentiator. 2 notable programs are Galapagos’ selective Jak1 inhibitor, hailed as potentially the safest treatment in RA and YM Biosciences’ (YMI) CYT378 with a controversial, unexplained anemia resolution effect in MF.

Syk inhibitors are next on the list, led by Rigel (RIGL) and AstraZeneca’s (AZN) fostamatinib also in RA. Biogen-Idec (BIIB) has high hopes for the Syk inhibitor it recently licensed from Portola. Rigel has additional Syk programs for inhibitors given by inhalation or administered directly on the skin for asthma and lupus, respectively.

Btk and PI3K-delta inhibitors are 1-2 years behind, led by Pharmacyclics/J&J and Gilead, respectively. As discussed, they appear more effective as single agents in blood cancers and are yet to be rigorously evaluated in autoimmune diseases. Celgene (CELG), which acquired Avila in 2012 has the only other Btk inhibitor in clinical testing.

It is not surprising that all targets are aggressively pursued by multiple companies in various blood cancers and autoimmune diseases. It is also not surprising to see many acquisition and licensing deals around immune-kinase assets. 2 recent huge deals are Galapagos’ deal with Abbott (ABT) and Pharmacycls’ deal with J&J.







Gilead beats Pharmacyclics to phase III

Gilead and Pharmacyclics (with its partner J&J), are running neck and neck towards FDA approval in CLL. Gilead beat Pharmacyclics by a month or two in starting a phase III CLL trial, but the two drugs are expected to reach the market in the same time frame.

CLL is considered an ideal bridge head for GS-1101 and ibrutinib given the impressive effect in the vast majority of patients tested to date and the high bar in terms of safety (many patients are elderly and cannot tolerate chemotherapy). In addition, CLL is not as crowded as other blood cancers and as an indolent disease it is more suitable for chemo-free regimens.

Whereas the patient population targeted by the two companies and the primary endpoint (progression free survival) are similar, the clinical protocols have several differences. Gilead’s trial is a double blind trial evaluating GS-1101 in combination with Rituxan vs. Rituxan + placebo. Pharmacyclics will evaluate Ibrutinib as a single agent versus Arzerra (similar mechanism to that of Rituxan). Notably, this trial will be an open label study, so patients and physicians will know what each patient gets. Theoretically, this could confound PFS assessment. Another potential issue is the potential of patients dropping out of the study if they are randomized to the control arm.

From a registration and marketing perspective, both approaches have pros and cons. Gilead is pursuing approval in combination with Rituxan. This regimen is likely to be more active than single agent GS-1101 but it involves an injectable agent and cost could also be an issue. Pharmacyclics uses Arzerra as a control treatment and compares Ibrutinib against it. Ibrutinib has a good chance of showing superiority and could be well positioned as an oral treatment for CLL, however, its efficacy could be inferior to Gilead’s combination regimen.


Building two franchises in parallel

Gilead is branching out of the HIV segment, establishing leadership in HCV and hematology simultaneously. It is interesting to see the same strategy employed by Gilead in both cases. In both cases, Gilead acquired companies with a single lead asset that had already undergone clinical proof of concept with the potential of revolutionizing their respective fields. Importantly, Gilead chose assets that can reach the market ahead of the competition.

With GS-7977, the goal is creating an effective interferon-free all-oral regimen whereas with GS-1101 it is having an effective chemo-free regimen. There is a lot of competition in both segments, which is why Gilead is very aggressive with both programs. One difference between the drugs is that GS-7977 is considered the best drug in its field while GS-1101 is viewed as less promising than Pharmacyclics’ ibrutinib. Another difference is the high price Gilead paid for Pharmasset ($11B) vs. $375M for Calistoga. Pharmasset had additional clinical stage assets, including the all-important NS5a inhibitor, yet it is hard to justify the 30-fold difference between the two acquisitions.

[SLGramann]

Ein Beitrag zur ersten neuen "Stoßrichtung" Hepatitis:

(diese Hep-C-Sache ist ja inzwischen das Einzige, was die Finanzanalysten bei Gilead interessiert. Wahrscheinlich wird damit der Hep-C-Markt genauso überschätzt, wie der "Rest" von Gilead unterschätzt wird...)


Grading Hep C Stocks Exiting EASL Confab

By Nathan Sadeghi-Nejad


BARCELONA (TheStreet) -- Wow, it's been a busy few days at the European Association for the Study of the Liver (EASL) annual meeting in this beautiful Catalan capital. Investors obsessed with emerging hepatitis C therapies had plenty of new data to analyze.

Let me make one general observation about the future of hepatitis C treatment before I recap and grade each of the companies with a significant presence at the EASL meeting. Interferon -- the injectable immune system booster saddled with troublesome side effects -- is dead. The future of hepatitis C therapy belongs to interferon-free regimens. Physicians at the conference talked about interferon as if it were invented in medieval times. It's clear that any company seeking a role in hepatitis C going forward must develop or acquire an effective interferon-free regimen or face irrelevance.

Let's move to the winners and losers of EASL 2012.

Gilead Sciences(GILD):

Grade: A-

Gilead was the big story of the conference. The company emphatically reclaimed the driver's seat in HCV, at least for now, with a combination of solid scientific results and ruthless, strategic maneuvering.

In a crowded Thursday session, anxious Wall Streeters awaited new data for Gilead's GS-7977, a once-daily nucleotide polymerase inhibitor, or "nuc." Despite impressive early data -- which prompted the undeniably expensive $11 billion Pharmasset acquisition -- subsequent results from a GS-7977 trial called ELECTRON showed the drug to have little effect in "null" responders and generated lots of investor anxiety. I was no exception. Despite my favorable disposition towards GS-7977, I wanted confirmation of the early data; most investors I spoke with shared my view.

We got what we were looking for.

An impressive 88% of treatment-naive patients in ELECTRON achieved sustained virologic response four weeks after stopping treatment (an early indication of "cure" known as SVR4) with 12 weeks of GS-7977 and ribavirin (RBV), a companion drug used in hepatitis C. Expectations leading into EASL were for an SVR4 of 70%.

At the same time, Gilead issued a press release containing preliminary data from QUANTUM, an ongoing study in treatment-naive patients also using the GS-7977 plus ribavirin combination therapy. The SVR4 rate in this study was 59%, lower than ELECTRON due to enrollment of more difficult-to-treat patients. [84% of QUANTUM patients had unfavorable "non-CC" genetics, versus 56% in ELECTRON.]

Results from the ELECTRON AND QUANTUM studies of GS-7977 were important but not the star of EASL. What got everyone really excited were data from the mid-stage study combining GS-7977 with Bristol-Myer Squibb's(BMY_) NS5A replication complex inhibitor daclatasvir. Among the patients with genotype 1 hepatitis C, GS-7977 plus daclatasvir resulted in an SVR4 rate of 100%. Yes, the combination therapy cured all treated patients. These data literally elicited high fives from several of the generally reserved hedge fund analysts in attendance. It's hard to argue with an SVR4 of 100%, but longer-term follow-up data are needed to confirm these results. Physicians traditionally use SVR12 (12 weeks) or SVR24 (24 weeks) as a final indication of cure, although recent data show a strong correlation between SVR4 and later follow up assessments.

As if that weren't enough excitement, Gilead also generated some drama at the meeting -- and elicited a "patients-not-profits" rebuke from my colleague Adam Feuerstein -- when word got out that the company had refused an offer from Bristol-Myers to collaborate on further development of GS-7977 and daclatasvir. Although Gilead insists it hasn't made a final decision, I'm guessing management will try to combine GS-7977 with GS-5885, an early-stage drug candidate in the same NS5A class as daclatasvir. Obviously, Gilead wants to keep all the profits from a highly potent, all-oral hepatitis C therapy for itself.

In GS-7977, Gilead appears to control a strong, future "backbone" for any next-generation hepatitis C regimen. I have mixed feelings about Gilead's apparent desire to deny Bristol-Myers access to the drug and therefore prevent a daclatasvir-GS-7977 regimen from reaching the market. Patients and their advocates will probably be justifiably upset that such this apparently highly effective regimen won't be developed further. I understand that. Interestingly, physicians I spoke with at the meeting didn't care either way. That surprised me; I would have expected more complaints.

As an investor, I don't fault Gilead for angling to maximize profits -- I've never subscribed to the biotechnology industry's cloying "patients first" rhetoric. However, the move does increase the company's clinical risk in hepatitis C. Even though initial GS-5885 data look clean, a problem could still emerge and daclatasvir is far more established. Essentially, management is betting that the promise (and eventually, the reality) of an "all Gilead" HCV regimen outweighs additional R&D expenses and near-term clinical risks.

That seems like a reasonable bet, and I think the stock will continue to work -- Gilead is still only trading at around 13 times estimates 2012 earnings.

............

http://www.thestreet.com/story/11503957/1/grading-hep-c-stoc…

[SLGramann]

Antwort auf Beitrag Nr.: 43.155.678 von Ulf-Imat am 11.05.12 23:10:17

Du bist seit 12 Jahren dabei? Beeindruckend. Ich seit ca. 12 Tagen...

Gilead generiert tatsächlich sehr viel Cash und könnte eigentlich Dividenden ausschütten. Das Management sieht das Unternehmen aber offenkundig weiter als Wachstumsunternahmen und hat das mit der leicht wahnsinnig anmutenden Übernahme von Pharmasset auf krasse Weise unter Beweis gestellt.

Das Management will das Unternehmen in eine neue Dimension führen und versucht derzeit aggressiv durch Übernahmen in die Bereiche Hepatitis und Hämatologie vorzustoßen.

Ich muss auch zugeben, dass es genau dieser aggressive Vorstoß ist, der mich jetzt zu der Aktie geführt hat, weil ich glaube, dass das Management hier alles richtig gemacht hat und die Erfolgsaussichten gut sind (Garantien gibts hier natürlich nicht).

Möglicherweise wird es nicht bei den Bereichen Hepatitis und Hämatologie bleiben. Möglicherweise will Gilead weitere Übernahmen durchführen.
Für Dividenden habe ich für die nächsten Jahre kaum Hoffnungen, denke aber, dass die Aktie in Zukunft wieder beachtliche Kursgewinne aufweisen könnte.

Ich stelle mal gleich zwei Blog-Beiträge rein, aus denen sich die Strategie von Gilead und deren fähige Umsetzung ergibt.

[Ulf-Imat]

Die Verbindlichkeiten sind im letzten Jahr durch die 11-Mrd.$-Übernahme von Pharmasset zwar deutlich gestiegen, ansonsten ist Gilead operativ eine Gelddruckmaschine http://www.finanzen.net/bilanz_guv/Gilead_Sciences
Ich bin aber durchaus sauer, daß die Firma, nachdem ich sie vor 12 Jahren gekauft habe, immer noch keine Dividende zahlt, obschon sie als Big Pharma bewertet wird.