Portola Phramaceuticals (PTLA)

[DewDiligence]

Those dates have evidently slipped; according to PTLA’s 1Q15 CC, patient enrollment will not be complete until the end of 2015:

http://seekingalpha.com/article/3150046-portola-pharmaceuticals-ptla-ceo-william-lis-on-q1-2015-results-earnings-call-transcript

We are evaluating betrixaban for extended duration VTE prophylaxis in a global pivotal Phase 3 APEX study, a landmark trial that will advance the field of thrombosis to a precision-based medicine. The trial is over 80% enrolled in more than 450 global sites. Importantly, we remain on track to complete enrollment by year end as planned.

[ridinbulls]

Sorry catching up here...is "the Apex Study" for VTE due for top line results here shortly. I see on clinical trials that's what it states but it has been a while since it was updated on the site.
TIA

https://clinicaltrials.gov/ct2/show/NCT01583218

[DewDiligence]

PTLA presents final phase-3 results on Annexa-A in Eliquis reversal:

#msg-114807697

[DewDiligence]

Please elaborate.

[Prana1]

This guy is well known for mergers and stuff

[DewDiligence]

Are you referring to hiring of CCO? That's a routine move, IMO.

[Prana1]

What do you make of it dew?

[DewDiligence]

PTLA hires CCO:

http://finance.yahoo.com/news/portola-pharmaceuticals-appoints-industry-leader-120000669.html

[Prana1]

I have been following your posts very regularly believe me. I was more interested in andexanet than their anticoagulant.
But u have planted seeds of doubt in my mind.

[DewDiligence]

Here’s a partial list of prior posts…

Betrixaban (which was dumped by MRK):
#msg-105048954
#msg-89332563
#msg-89331093
#msg-89329551

Andexanet alfa:
#msg-108867394
#msg-106932252
#msg-104066689
#msg-89624322

[Prana1]

Oh wow. Bearish. Why may I ask?
I would like to hear your thoughts

[DewDiligence]

I don't know. I'm bearish on PTLA generally, although not with respect to the cancer program in particular.

[Prana1]

Have u been following this one ?
If yes why is management selling before asco ?

[DewDiligence]

Yes!

[Prana1]

Hello anyone here

[Andco]

What a move! $$$43's!!!

[coupleofsnipes]

Nice to see this baby moving. Go PTLA!!

[DewDiligence]

Info on other FXa antidotes…

PFE/BMY:
http://finance.yahoo.com/news/anticoagulant-effect-eliquis-apixaban-reversed-183000000.html

JNJ:
#msg-89624322

Perosphere/Daiichi Sankyo:
http://perosphere.com/content/media/releases/042513.htm
#msg-106932252

Regards, Dew

[Andco]

I'm up 40% so I'm a little impressed :)

Thanks for the DD. I'm actually more focused on Andexanet. GLTY.

Didn't see that Eliquis has an approved antidote? Would like to see a link if you have time. Thanks.

[DewDiligence]

Not impressed: #msg-110608087.

[Andco]

http://finance.yahoo.com/news/portolas-factor-xa-inhibitor-betrixaban-210654904.html

[Andco]

Portola Announces Phase 3 ANNEXA-R Study of Andexanet Alfa and Factor Xa Inhibitor XARELTO(R) (rivaroxaban) Met Primary Endpoint With High Statistical Significance

SOUTH SAN FRANCISCO, Calif., Jan. 9, 2015 (GLOBE NEWSWIRE) -- Portola Pharmaceuticals (PTLA) today announced topline results from the first part of the Phase 3 ANNEXA(TM)-R (Andexanet Alfa a Novel Antidote to the Anticoagulant Effects of FXa Inhibitors -- Rivaroxaban) study, which is evaluating the safety and efficacy of andexanet alfa with the Factor Xa inhibitor XARELTO(R) (rivaroxaban). Results showed that the study met its primary endpoint with high statistical significance. Andexanet alfa administered as an intravenous (IV) bolus significantly and immediately reversed the steady-state anticoagulation activity of XARELTO(R) and was well tolerated. The Company expects to present the full data set at the American College of Cardiology's (ACC) 64th Annual Scientific Session in San Diego on Monday, March 16 at 11:30 a.m. PT in an oral session titled "Highlighted Original Research: Acute Coronary Syndromes and the Year in Review." The second part of the ANNEXA-R study, which is evaluating a bolus plus a continuous infusion of andexanet alfa to sustain reversal, is ongoing.

Portola is developing andexanet alfa, a U.S. Food and Drug Administration (FDA)-designated breakthrough therapy, as a universal antidote for patients treated with oral and injectable Factor Xa inhibitors who are experiencing a major bleeding episode or who require emergency surgery. Andexanet alfa has been studied in more than 140 volunteers in clinical studies.

"The statistically significant Phase 3 ANNEXA-R study data, together with results presented previously with apixaban, provide compelling evidence that this groundbreaking agent could serve as a universal antidote for Factor Xa inhibitor anticoagulants," said John T. Curnutte, M.D., Ph.D., executive vice president, research and development for Portola. "Andexanet alfa is unique among the other reversal agents in development in that it has been the only agent to immediately and significantly reverse all of the key pharmacodynamic measurements of coagulation that have been agreed to with the FDA for accelerated approval. These include anti-Factor Xa levels, thrombin generation and unbound anticoagulant (free fraction). This has been demonstrated with all of the Factor Xa inhibitors studied to date -- apixaban, rivaroxaban, edoxaban and enoxaparin."

ANNEXA-R Study Design and Results

The randomized, double-blind, placebo-controlled Phase 3 ANNEXA-R study is evaluating the safety and efficacy of andexanet alfa in reversing XARELTO(R) -induced anticoagulation in healthy volunteers ages 50-75 years. Efficacy is being evaluated using biomarker endpoints, with anti-Factor Xa levels as the primary endpoint. Secondary endpoints include plasma levels of plasma unbound (free fraction) of XARELTO(R) and thrombin generation levels.

In the first part of the ANNEXA-R study, reported today, 41 healthy volunteers were given XARELTO(R) 20 mg once daily for four days and then randomized in a 2:1 ratio to receive at Cmax either andexanet alfa administered as an 800 mg IV bolus (n=27) or to placebo (n=14). The study achieved its primary endpoint with high statistical significance. Results showed that andexanet alfa significantly and immediately reversed the anticoagulation activity of XARELTO(R). Andexanet alfa was shown to be well tolerated.

In the second part of the ANNEXA-R study, approximately 40 healthy volunteers will be given XARELTO(R) 20 mg once daily for four days and will then be randomized in a 2:1 ratio to receive either andexanet alfa administered as an 800 mg IV bolus followed by a continuous infusion of 8 mg/min for 120 minutes or to placebo. Data from this part of the study are expected in mid-2015.

About the Need for a Factor Xa Inhibitor Antidote

Currently, millions of patients are treated with Factor Xa inhibitors for short-term use or chronic conditions, and the anticoagulant market is expected to continue to grow. Recent patient datai confirm earlier clinical trial results showing that, annually, between 1-4 percent of patients treated with Factor Xa inhibitors may experience major bleeding and an additional 1 percent may require emergency surgery. Development of a specific antidote designed to reverse the anticoagulant activity of Factor Xa inhibitors may provide an important treatment option for patients who experience a major bleeding event or require emergency surgery.

About Andexanet Alfa

Andexanet alfa acts as a Factor Xa decoy that targets and sequesters with high specificity both oral and injectable Factor Xa inhibitors in the blood. Once bound, the Factor Xa inhibitors are unable to bind to and inhibit native Factor Xa, thus allowing for the restoration of normal hemostatic processes. Andexanet alfa has the potential to address numerous clinical scenarios where an antidote is needed by allowing for flexible and controlled reversal. This can be short-acting through the administration of an IV bolus or longer-acting with the addition of an extended infusion.

Andexanet alfa is the only compound being studied as a reversal agent for Factor Xa inhibitors that directly and specifically corrects anti-Factor Xa activity -- the anticoagulant mechanism of these agents.

About the Andexanet Alfa Clinical Development Program

Portola is evaluating andexanet alfa in randomized, placebo-controlled Phase 3 ANNEXA(TM) (Andexanet Alfa a Novel Antidote to the Anticoagulant Effects of fXA Inhibitors) registration studies using pharmacodynamic endpoints agreed to with the FDA, such as anti-Factor Xa inhibitor units, to demonstrate efficacy.

Portola reported statistically significant results from the first part of the Phase 3 ANNEXA-A study, which evaluated andexanet alfa administered as a single intravenous (IV) bolus dose with Bristol-Myers Squibb Company and Pfizer Inc.'s direct Factor Xa inhibitor apixaban, and from the first part of the Phase 3 ANNEXA-R study with Bayer HealthCare and Janssen's direct Factor Xa inhibitor rivaroxaban. The second parts of the ANNEXA-A and ANNEXA-R studies are ongoing and are evaluating a bolus plus a continuous infusion of andexanet alfa to sustain the reversal of anticoagulation activity.

These studies are designed to support the Company's BLA filing for Accelerated Approval. As part of the Accelerated Approval process, a Phase 4 confirmatory patient study evaluating clinical outcomes with andexanet alfa is planned.

Results from four separate Phase 2 proof-of concept studies with apixaban, rivaroxaban, edoxaban and enoxaparin, a low molecular weight heparin and indirect Factor Xa inhibitor, in healthy volunteers demonstrated that andexanet alfa immediately reversed the anticoagulation activity of each Factor Xa inhibitor and that the reversal could be sustained. Andexanet alfa has been shown to be well tolerated in clinical studies, which have included more than 140 healthy volunteers. No thrombotic events or antibodies to Factor Xa or Factor X have been observed.

A Phase 2 proof-of-concept study with Portola's investigational Factor Xa inhibitor betrixaban is planned.

Portola Pharmaceuticals, Inc.

Portola Pharmaceuticals is a biopharmaceutical company developing product candidates that could significantly advance the fields of thrombosis and other hematologic diseases. The Company is advancing its three wholly-owned programs using novel biomarker and genetic approaches that may increase the likelihood of clinical, regulatory and commercial success of its potentially life-saving therapies. Portola's partnered program is focused on developing selective Syk inhibitors for inflammatory conditions.

Betrixaban

Portola's wholly-owned, oral, once-daily Factor Xa inhibitor betrixaban is being evaluated in the only biomarker-based Phase 3 study for hospital-to-home prophylaxis of venous thromboembolism (VTE) in acute medically ill patients. Betrixaban's distinct properties may have the potential to allow the agent to demonstrate efficacy without the significant increase in the rate of major bleeding that was seen in this patient population with other Factor Xa inhibitors. If approved, betrixaban could be the first anticoagulant for both hospital and post-discharge VTE prophylaxis and the standard of care in this large market of more than 20 million patients in the G7 countries alone.

Andexanet Alfa

Andexanet alfa, a recombinant modified human Factor Xa molecule, has the potential to be a first-in-class antidote to reverse the effects of Factor Xa inhibitors in patients who suffer a major bleeding episode or who require emergency surgery. Andexanet alfa has been designated as a breakthrough therapy by the U.S. Food and Drug Administration. Portola has entered into Phase 3 clinical collaboration agreements with all of the manufacturers of direct Factor Xa inhibitors -- Bristol-Myers Squibb and Pfizer (Eliquis [apixaban]), Bayer HealthCare and Janssen Pharmaceuticals (XARELTO(R) [rivaroxaban]), and Daiichi Sankyo (edoxaban) -- while retaining all commercial rights to andexanet alfa. The Company is currently evaluating andexanet alfa in the Phase 3 ANNEXA(TM) (Andexanet Alfa a Novel Antidote to the Anticoagulant Effects of fXA Inhibitors) registration studies.

Cerdulatinib

Portola's product candidate in the area of hematologic cancer, cerdulatinib, is an orally available molecule that uniquely inhibits two validated tumor proliferation pathways -- spleen tyrosine kinase (Syk) and janus kinase (JAK). It is currently being evaluated in a Phase 1/2a proof-of-concept study in patients with B cell leukemias or lymphomas with a focus on genetically-defined subtypes, as well as in patients who have failed therapy due to relapse or acquired mutations.

[DewDiligence]

Eliquis has an antidote and it’s not Andexanet alfa: #msg-108867394.

[pistol1p]

"These highly statistically significant Phase 3 ANNEXA-A data demonstrate that andexanet alfa has the potential to be the first agent approved as a universal Factor Xa inhibitor antidote. We anticipate filing a Biologics License Application with the FDA for Accelerated Approval at the end of 2015," said John T. Curnutte, M.D., Ph.D., executive vice president of research and development for Portola.

The two small phase 3 trials are going well and the 1st trial reported good results described above. But both of the small phase 3 trials have been on health volunteers. Will and how will Portola test andexanet alfa on actual patients with critical bleeds on anticoagulation therapy?

In the statement above, made by the executive vice president, it says that the filing with the FDA for the BLA will not happen for a year.

The need is certainly there for this product, but what will the FDA require for approval?

[DewDiligence]

CEO exercised &sold $800K of stock 11/13/14 thru 11/171/14 under 10b5-1 plan:

http://www.sec.gov/Archives/edgar/data/1269021/000120919114069292/xslF345X03/doc4.xml

[Andco]

Portola Pharmaceuticals Announces Phase 3 ANNEXA(TM)-A Study of Andexanet Alfa and Eliquis (Apixaban) Met Primary and Secondary Endpoints With High Statistical Significance

For those who have a little patience, this will be a 100.00 + stock IMHO.

http://finance.yahoo.com/news/portola-pharmaceuticals-announces-phase-3-120000960.html;_ylt=AwrBT7pr9itU5eYA83lXNyoA

[DewDiligence]

PTLA reg flag wrt APEX study: #msg-105048954.

[stocktrademan]

Portola Pharmaceuticals, Inc. [$PTLA] due diligence

bullish

$PTLA

DD Notes ~ http://www.ddnotesmaker.com/PTLA

##### recent news/filings ~ source: finance.yahoo.com

Wed, 02 Jul 2014 20:58:36 GMT ~ PORTOLA PHARMACEUTICALS INC Files SEC form 8-K, Entry into a Material Definitive Agreement
read full: http://biz.yahoo.com/e/140702/ptla8-k.html
*********************************************************

Wed, 02 Jul 2014 12:40:24 GMT ~ Portola: A Small Biotech Stock That Could Double - And Then Double Again
read full: http://seekingalpha.com/article/2294645-portola-a-small-biotech-stock-that-could-double-and-then-double-again?source=yahoo
*********************************************************

Wed, 18 Jun 2014 10:57:41 GMT ~ Portola Pharmaceuticals, Inc. (PTLA) in Focus: Stock Up 5.72%
read full: http://finance.yahoo.com/news/portola-pharmaceuticals-inc-ptla-focus-105741811.html
*********************************************************

Thu, 12 Jun 2014 20:00:00 GMT ~ Portola Pharmaceuticals to Present at the 2014 Wells Fargo Securities Healthcare Conference
[GlobeNewswire] - SOUTH SAN FRANCISCO, Calif. -- Portola Pharmaceuticals today announced that William Lis, chief executive officer, will present at the 2014 Wells Fargo Securities Healthcare Conference on Wednesday, June ...
read full: http://finance.yahoo.com/news/portola-pharmaceuticals-present-2014-wells-200000241.html
*********************************************************

Thu, 12 Jun 2014 12:55:35 GMT ~ Can the Rally in Portola Pharma (PTLA) Shares Continue?
read full: http://finance.yahoo.com/news/rally-portola-pharma-ptla-shares-125535457.html
*********************************************************

##### chart ~ source: stockcharts.com



Portola Pharmaceuticals, Inc.
270 East Grand Avenue
South San Francisco, CA 94080
United States - Map
Phone: [phone]
Fax: [phone]
Website: http://www.portola.com

##### company info ~ source: otcmarkets.com

Link: http://www.otcmarkets.com/stock/PTLA/company-info
Ticker: $PTLA
OTC Market Place: Not Available
CIK code: not found
Company name: Portola Pharmaceuticals, Inc.
Incorporated In:

##### extra dd links

Latest filings: http://www.otcmarkets.com/stock/PTLA/filings
Latest financials: http://www.otcmarkets.com/stock/PTLA/financials
Latest news: http://www.otcmarkets.com/stock/PTLA/news - http://finance.yahoo.com/q/h?s=PTLA+Headlines

Major holdings: http://data.cnbc.com/quotes/PTLA/tab/8.1
Insider transactions (1): http://finance.yahoo.com/q/it?s=PTLA+Insider+Transactions
Insider transactions (2): http://www.secform4.com/insider-trading/PTLA.htm
Insider transactions (3): http://www.insidercow.com/history/company.jsp?company=PTLA

RegSho: http://www.regsho.com/tools/symbol_stats.php?sym=PTLA&search=search

DTCC: http://search2.dtcc.com/?q=Portola+Pharmaceuticals%2C+Inc.&x=10&y=8&sp_p=all&sp_f=ISO-8859-1
Spoke company information: http://www.spoke.com/search?utf8=%E2%9C%93&q=Portola+Pharmaceuticals%2C+Inc.
Corporation WIKI: http://www.corporationwiki.com/search/results?term=Portola+Pharmaceuticals%2C+Inc.&x=0&y=0

Short Sales: http://www.otcmarkets.com/stock/PTLA/short-sales
Insider Disclosure: http://www.otcmarkets.com/stock/PTLA/insider-transactions
Research Reports: http://www.otcmarkets.com/stock/PTLA/research
Historical Prices: http://finance.yahoo.com/q/hp?s=PTLA+Historical+Prices
Basic Tech. Analysis: http://finance.yahoo.com/q/ta?s=PTLA+Basic+Tech.+Analysis
Company Profile: http://finance.yahoo.com/q/pr?s=PTLA+Profile
Key Statistics: http://finance.yahoo.com/q/ks?s=PTLA+Key+Statistics
Industry: http://finance.yahoo.com/q/in?s=PTLA+Industry
Insider Roster: http://finance.yahoo.com/q/ir?s=PTLA+Insider+Roster
Income Statement: http://finance.yahoo.com/q/is?s=PTLA
Balance Sheet: http://finance.yahoo.com/q/bs?s=PTLA
Cash Flow: http://finance.yahoo.com/q/cf?s=PTLA+Cash+Flow&annual
Market Watch: http://www.marketwatch.com/investing/stock/PTLA
Bloomberg: http://www.bloomberg.com/quote/PTLA:US
Morningstar: http://quotes.morningstar.com/stock/s?t=PTLA
Bussinessweek: http://investing.businessweek.com/research/stocks/snapshot/snapshot_article.asp?ticker=PTLA
Barchart: http://www.barchart.com/quotes/stocks/PTLA
OTC Short Report: http://otcshortreport.com/index.php?index=PTLA
Investopedia: http://www.investopedia.com/markets/stocks/PTLA/?wa=0

http://www.pennystocktweets.com/stocks/profile/PTLA

##### last known share structure ~ source: otcmarkets.com

Market Value: Not Available
Shares Outstanding: Not Available
Float: Not Available
Authorized Shares: Not Available
Par Value: Not Available

##### business description ~ source: otcmarkets.com



DD Notes ~ http://www.ddnotesmaker.com/PTLA
cond

[DewDiligence]

Musings on the FDA-approval plan for andexanet alfa: #msg-99274632.

[surf1944]

8:18AM Portola Pharma enters second clinical collaboration agreement with Bristol-Myers Squibb (BMY) and Pfizer (PFE) to study Andexanet Alfa, Investigational factor Xa inhibitor reversal agent, with Eliquis (PTLA) 27.92 :

PTLA announced that it has entered into a second clinical collaboration agreement with Bristol-Myers Squibb Company (NYSE:BMY) and Pfizer Inc. (NYSE:PFE) to study Portola's investigational Factor Xa inhibitor reversal agent, andexanet alfa, with the oral Factor Xa inhibitor Eliquis.
The original agreement, announced in November 2012, covered the conduct of a Phase 2 proof-of-concept study. Results of the Phase 2 study were presented at the 2013 Congress of the International Society on Thrombosis and Haemostasis and demonstrated andexanet alfa's ability to produce an immediate and either temporary or sustained reversal of the anticoagulation activity of Eliquis. The new clinical collaboration agreement will be in effect through Phase 3 studies with Eliquis and any potential U.S. and EU regulatory approval of andexanet alfa. The Phase 3 studies are expected to start in the first half of 2014.
Under this non-exclusive collaboration agreement, Portola will receive an upfront payment and is eligible to receive additional development and regulatory milestone payments. Bristol-Myers Squibb and Pfizer will continue to provide development and regulatory guidance for the program. Portola retains full, worldwide commercial rights to andexanet alfa, which was designated as a breakthrough therapy by the FDA in November 2013 and for which Portola is pursuing an Accelerated Approval pathway.

[surf1944]

11:01AM Portola Pharma announces new Phase 2 results confirming immediate, dose-dependent and well-tolerated reversal of anticoagulation activity of Xarelto with andexanet alfa, investigational factor xa inhibitor reversal agent (PTLA) 23.85 -0.06 : Co announced additional results of a Phase 2 proof-of-concept study that showed andexanet alfa's ability to immediately reverse the anticoagulation activity of XARELTO(rivaroxaban) through the administration of a short intravenous bolus. The data also showed that this reversal can be prolonged if needed by a continuous infusion. Andexanet alfa was well tolerated, with no serious adverse events reported. The data were presented at the 55th American Society of Hematology (ASH) Annual Meeting in New Orleans.

The randomized, double-blind, placebo-controlled, cohort dose-escalation Phase 2 proof-of-concept study treated healthy volunteers with an oral dose of XARELTO at 20 mg once daily for six days and then randomized 36 volunteers in a 6:3 ratio to andexanet alfa in four different dosing cohorts. The first three cohorts received a single IV bolus of andexanet alfa at 210 mg, 420 mg or 600 mg, respectively. A fourth cohort received a single IV bolus of andexanet alfa at 720 mg followed by a 4 mg/minute infusion for one hour. Immediately following completion of the 210 mg, 420 mg, 600 mg and 720 mg bolus doses of andexanet alfa, anti-Factor Xa activity decreased dose-dependently by 20 percent, 53 percent, 70 percent and 81 percent, respectively, from the pre-andexanet alfa level and returned to placebo levels approximately two hours after treatment. In parallel, the plasma concentrations of unbound XARELTO were decreased by 32 percent, 51 percent, 75 percent and 70 percent respectively, relative to pre-andexanet alfa values. XARELTO-induced inhibition of thrombin generation and prolongation of both prothrombin time and activated clotting time approached normal levels with andexanet alfa in a dose-dependent manner. Safety data showed that andexanet alfa was well tolerated, with no thrombotic events or serious adverse events reported.

[DewDiligence]

PTLA prices offering at 7% discount despite fluff PR: #msg-93094088.

[DewDiligence]

PTLA issues fluff PR with interim “n=6” data: #msg-92994766.

[DewDiligence]

Phase-3 Betrixaban trial has to hit p<0.01 to be deemed a success as the sole phase-3 trial in the program, according to today’s BioCentury webcast.

[DewDiligence]

Comment on today’s MS webcast: #msg-91878053.

[DewDiligence]

PTLA had $235M of cash at 6/30/13: #msg-91050231.

[DewDiligence]

PTLA’s CMO is resigning for no stated reason: #msg-90773754.

[DewDiligence]

PTLA’s presentation at the WF conference contained more than a modicum of spin, IMO:

#msg-89290904

[pistol1p]

If you are referring to the Factor Xa inhibitor reversal agent, only hospital pharmacies will need to stock the product,since they treat patients, on anticoagulation therapy, with uncontrolled bleeding.

Each use of the agent will probably cost in the thousands of dollars, so revenue from initial stocking and, IMO, limited use will still provide substantial revenue for the company.

[DewDiligence]

PTLA will present at the WF conference on 6/18/13:

http://finance.yahoo.com/news/portola-pharmaceuticals-present-wells-fargo-200000957.html

[craig2558]

As soon as their drug gets through phase 3 of testing every pharmacy is going to have to stock it. Could be huge.

[DewDiligence]

PTLA finishes first day of trading at 15.15, +4% from IPO price.

[DewDiligence]

PTLA IPOs at $14.50/share:

http://finance.yahoo.com/news/portola-announces-pricing-initial-public-120000116.html

The enterprise value at the IPO price is about $300M. Please see #msg-88081453 for background info.