Portola Pharmaceuticals (PTLA) announced that it will host a webcast and conference call to provide an update on its anticoagulant Factor Xa inhibitor Bevyxxa® (betrixaban) launch plans, the validation of the commercial manufacturing process and drug release timing.
Conference Call Details: The live conference call will be held today, Tuesday, September 5, 2017, at 4:30 p.m. Eastern Time (1:30 p.m. PT). It can be accessed by phone by calling (844) 452-6828 from the United States and Canada or 1 (765)-507-2588 internationally and using the passcode 75259872. The webcast can be accessed live on the Investor Relations section of the Company’s website at http://investors.portola.com. It will be archived for 30 days following the call.
At the sight of the news, a selloff of the stock occurred, especially that the live conference call will be held following the market hours. Many are expecting more delays in Bevyxxa’s launch, which could be caused by the firm’s outsourced manufacturer for various reasons, one of them could be its refusal to do an extra work Portola’s asking him do do in compliance with the FDA request.
Regardless of whether this is what Portola intended to say, or not, we would like the readers to re-read the Prohost article posted under Today Highlights in the Prohost Biotech Website on August 15, 2017. Here is what we wrote:
“Portola Pharmaceuticals’ stock had deservedly rallied following the FDA approval of its unique Factor Xa inhibitor anticoagulant product Bevyxxa. In mid last week, however, the stock price took a beating, following the firm’s announcement of its Q2 financial results reporting a quarter loss of $69.5 million — $1.22 per share. Of course, like usual, the results did not meet analysts’ expectations as they had forecasted an average loss of $1.10 per share not $1.22 as the firm’s announced.”
After talking about the pattern created by traders to slash development-stage stocks during quarterly results, we went on to add that, “For some investors and critics, it is the the delay of the product’s launch that made them nervous, hence, selling the stock.”
“Is there an explanation for that delay?”
“Portola has, indeed, offered two explanations, the first was following the FDA approval stating that the launch will be between late August and November, i.e., a few months following the approval. The reason for the small delay as stated by Portola was to hire and train the medical marketing team and to validate its commercial manufacturing process. The second time the firm talked about the launch was during the Q2 2017 earnings conference, stating that it was on track with regard to hiring and training the medical marketing team. However, with regard to the validation of the commercial manufacturing process, the task, although can also be accomplished on time, yet, it might take longer due to a modification the firm has decided upon regarding the product specification.
Obviously, this last statement has confused and angered investors, causing them to sell PTLA.
Prohost then cited top of the clinical trial results of Bevyxxa trial, which demonstrated the product’s efficacy, citing its indication as a prophylaxis of venous thromboembolism (VTE) in adult patients who are hospitalized for an acute medical illness, which puts them at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE.
We then added: “We should not forget that we are expecting another approval for an important product AndexXa® (andexanet alfa), which was designed as an antidote to Factor Xa inhibitor anticoagulant drugs, which enables stopping bleedings when they occur.
“The U.S. Food and Drug Administration (FDA) has found Portola’s resubmitted Biologics License Application (BLA) for its Factor Xa antibodies antidote AndexXa® (andexanet alfa) to be acceptable for review, with an action due date of February 2, 2018.”
“As we explained in previous articles and Prohost Letters, AndexXa is an antidote for patients anticoagulated with an oral or injectable Factor Xa inhibitor who experience a serious uncontrolled or life-threatening bleeding event or who require urgent or emergency surgery. The BLA seeks initial approval of AndexXa for reversal of the anticoagulant effects of apixaban and rivaroxaban in patients experiencing uncontrolled or life-threatening bleeding.
In 2016, approximately 90,000 patients in the U.S. treated with oral Factor Xa inhibitors were subsequently admitted to the hospital due to bleeding. Including patients taking the injectable Factor Xa inhibitor enoxaparin, it is estimated that more than 150,000 U.S. patients could benefit from an antidote annually. Currently, there are no approved Factor Xa inhibitor antidotes.
The investigational drug AndexXa is the first compound being studied as an antidote for Factor Xa inhibitors that directly and specifically reverses anti-Factor Xa activity, which is the anticoagulant mechanism of these agents.”
Prohost Opinion Today
– As we mentioned in a recent Prohost Letter, Portola’s antidote is the real big treasure in its pipeline and we continue to consider this fact as part of our positive opinion on PTLA.
– We are still convinced that PTLA’s selloffs offer opportunities to accumulate the stock at a better price.
– We stick to the Prohost target as it is in the Prohost Portfolio, which was published at the end of the most recent Prohost Letter #412.
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