This is the forth update to the summary threads I have been posting. This update includes some additional information about APPA's phase III study, fixed typos and the reorganization of the information.
I encourage everybody to do their own due diligence and make their own decisions about their investments and finances. Nobody knows your own finances and investment comfortability better than yourself. Never take another message board user's word at face value for anything (including my own). Double check. Do your own due diligence. Make your own decisions. If you like what you see, please help me keep this bumped to the top of the first page by making occasional replies.
This update will be even longer than the previous summary thread. It will have to be broken up into different replies because Yahoo! has a 4,000 character limit on all posts. This part will be the Introductory. All other parts will be shown directly under this as replies.
Part One will cover a brief summary of APF530 and what its for.
Part Two will cover the details of the APF530 Phase III Study and APF530's advantages other drugs.
Part Three will cover APPA itself; the company, its executives and its finances.
(Part One Continued Below)
Thank you for the convenient summary. Perhaps the most critical point for evaluating APPA is how they plan to realize value for their product (assuming approval)? There are at least 3 possible mechanisms: sell the company; partner with larger pharma co with sales/marketing capability; and alliance with a CSO. Each of these routes can have different implications for APPA sp. Compare recent CRXX and DDSS approvals as examples of different marketing paths.
Would you care to share your view on what APPA will do with its approved product?
Not having a label for the delayed onset highly emetogenic subset is really moot for both Aloxi and APF-530, because when highly emetogenic chemo agents are used these days, a steroid (dexamethasone) is routinely given concommitantly with the 5HT3 drug. This is why the complete response rates in the Phase 3 were actually better in the delayed highly emetogenic subset than in the delayed moderately emetogenic subset, for both APF-530 and Aloxi (APF-530 -- 68.3% vrs 59.0%, and for Aloxi -- 66.4% vrs 57.7%).
So both Aloxi and APF-530 are/will be routinely used for delayed onset highly emetogenic chemo. Technically they'll be used 'off label', but with the concommitant use of dexamethasone (the inclusion of which is the standard of care), both Aloxi and APF-530 work extremely well for the delayed highly emetogenic subset.
(PART THREE - THE COMPANY. THE EXECUTIVES. THE FINANCES.)
APPA's top two executives collectively have experience managing the development of drugs, securing company financing, progressing drug trials and playing a major role in the successful completion of the sale of a company.
President and CEO Roland J. Prentki has over thirty years of experience in the pharmaceutical industry. Prentki joined APPA on July 7, 2008. He was previously the President of Progenics Pharmaceuticals for seven years (1998-2005). While he was the President, he played a major role in the development of Progenics's drug, RELISTOR (which was later FDA approved in 2008).
Vice President and CFO John B. Whelan joined APPA in February of 2009. He was previously the Chief Operating Officer and Chief Financial Officer of Raven Biotechnologies. At Raven Biotechnologies, he oversaw the finances of the company. While there, he secured financing, helped advance its cancer drug program into Phase 2 clinical trials and helped negotiate and complete the sale of the company to MacroGenics, Inc., which acquired Raven Biotechnologies in a company buyout.
APPA has a fairly low share float and has a good amount of insider ownership. APPA put into place a new management team in late 2008. That new management team has done an amazing job with the company. Last October, one of APPA's directors, Kevin C. Tang, purchased 2,443,181 shares of his company (which put the total amount of shares he personally owns at 10,436,506). Other company insiders have also acquired additional shares of the company throughout last year. APPA also has a nice amount of institutional ownership. The top two institutional owners both have a low turnover rating. Barker Bros Advisors increased their holdings by 137.88% back in December when they bought an additional 3,977,272 shares (for a total of 6,861,818 shares). Tang Capital Management has a total of 11,224,968 shares.
APPA has saved up a fair amount of cash. According to their own estimates, they should have enough cash to fund their operation through 2010. They pocketed 8.1 million dollars though a private placement deal last October. And on January 11th of this year, they received a non-dilutive milestone payment of 2.5 million dollars from one of their affiliates. They are due an additional non-dilutive future milestone payment of 2.5 million dollars from that same affiliate as well.
(Part TWO - PHASE III STUDY AND APF530'S ADVANTAGES)
APPA is attempting to get approval from the FDA for APF530 by showing non-inferiority to Aloxi. Non-inferiority means that a new treatment is equivalent or better than an existing treatment. APPA's double-blind Phase 3 trial results appear to indicate that they have accomplished that goal. APPA has also shown that there is no significance difference to Aloxi in regard to adverse effects. APF530 was even found to be statistically better than Aloxi in the averse effects areas of moderate and severe headaches. If the FDA agrees with APPA's findings, APF530 should be approved. And if approved, APF530 will be only one of two FDA approved drugs for the treatment of both acute onset CINV and delayed onset CINV.
APPA's APF530 is looking for FDA approval in three separate and specific areas: (One) Prevention of acute onset CINV following the administration of moderate emetogenic chemotherapy; (Two) Prevention of acute onset CINV following the administration of highly emetogenic chemotherapy; and (Three) Prevention of delayed onset CINV following the administration of moderate emetogenic chemotherapy. Acute onset CINV is nausea and vomiting up to 24-hours after a chemotherapy treatment. Delayed onset CINV is nausea and vomiting that happens more than 20-hours after treatment. Moderate emetogenic chemotherapy is a form of chemotherapy that is likely to cause nausea and vomiting. Highly emetogenic chemotherapy is a form of chemotherapy that is highly likely to cause nausea and vomiting.
APPA's APF530 has a few advantages over Aloxi in the way it is administered to the patient. One of these advantages APF530 has over Aloxi is that it addresses the issue of Aloxi requiring an intravenous (IV) line to deliver the drug into the patient's bloodstream. Not all chemotherapy treatments are administered intravenously, so having Aloxi, that can only be delivered through an IV line, can be an issue. APPA's APF530 is administered via a simple single subcutaneous injection (a shot) and is designed to treat and prevent CINV for at least 5-days with that single injection (maintaining therapeutic levels for those 5-days). Delayed onset CINV can last anywhere from 24-hours to a few days. In addition, APF530 has shown in their Phase 3 trial results to have a tendency to be even more effective over multiple treatment cycle.
APF530's Complete Response percentage has been shown to be better than Aloxi Complete Response percentage, indicating that it is more effective than Aloxi in the areas of acute and delayed CINV for both moderate emetogenic chemotherapy treatment and highly emetogenic chemotherapy treatment. APF530's CR percentage for acute onset CINV following moderate emetogenic chemotherapy is better than Aloxi's CR percentage (77.9% for APF530 vs. 75% for Aloxi). APF530's CR percentage for delayed onset CINV following moderate emetogenic chemotherapy is better than Aloxi's CR percentage (81.3% for APF530 vs. 80.7% for Aloxi). APF530's CR percentage for acute onset CINV following highly emetogenic chemotherapy is better than Aloxi's CR percentage (59% for APF530 vs. 57.7% for Aloxi). APF530's CR percentage for delayed onset CINV following highly emetogenic chemotherapy is better than Aloxi's CR percentage (68.3% for APF530 vs. 66.4% for Aloxi).
(Part Three Continued Below)
(PART ONE - SUMMARY OF APF530: ITS PURPOSE AND ITS FDA FILING)
APPA's drug, APF530, is up for FDA approval. APF530 targets the 1 billion dollar CINV market (chemotherapy-induced nausea and vomiting market). The PDUFA date for APF530, scheduled by the FDA, is set for March 18, 2010. If approved, APF530 is scheduled to launch later this year.
Chemotherapy-induced nausea and vomiting (CINV) remains one of the major adverse effects of chemotherapy. Chemotherapy patients usually cite poorly controlled and poorly managed CINV has one of the adverse effects of chemotherapy they dread the most. Poorly controlled chemotherapy-induced nausea and vomiting interferes with physical, emotional, cognitive and role functioning. What APF530 treats is that nausea and vomiting that results as one of the harsh side effects of chemotherapy treatment.
A similar drug to APPA's APF530 (Aloxi) has already approved by the FDA. Aloxi contains the 5-HT3 antagonist palonosetron. APF530 contains the 5-HT3 antagonist granisetron. (These 5-HT3 antagonists are what are used to treat and prevent nausea and vomiting.) What APPA is trying to do it to create a new version of a similar approved FDA drug. APPA's NDA was submitted under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act. A section 505(b)(2) NDA is much easier to get approved than a normal NDA filing for a new chemical entity. APPA will rely on previous FDA safety and efficacy findings for main ingredient granisetron, which has already been found by the FDA to be safe and effective.
(Part Two Continued Below)