FDA Calendar Updates: Acusphere, AspenBio, Alkermes

by: Mike Havrilla

Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.

Acusphere (OTCPK:ACUS): In February, ACUS.PK amended its New Drug Application (NDA) for Imagify (Perflubutane Polymer Microspheres) for Injectable Suspension as a cardiac imaging agent for the detection of coronary artery disease. The amended indication would be limited to subsets of patients undergoing pharmacologic stress techniques compared to original request for more widespread use.
On 3/11/09, Acusphere received a complete response letter (CRL) from the FDA which stated that additional clinical studies would be necessary for the Company's original broad label of use claim.
The goal of the amended NDA and narrower claim for Imagify is to improve the risk/benefit ratio for the cardiac imaging agent by limiting its use to patients undergoing pharmacologic stress tests so that additional clinical studies are not required as outlined in the CRL from the FDA. The last update from Acusphere indicated that the Company was invited by the FDA to discuss alternatives and is in the process of scheduling such a meeting. In addition, Acusphere has implemented cost-cutting measures, including a workforce reduction of 40 people (about two-thirds of all employees), moving the stock listing to the pink sheets, suspending SEC reporting obligations, and terminating the Company's Watertown, MA headquarters lease and relocating all personnel to its facility in Tewksbury, MA.
The previous estimated decision date for Acusphere in the BioMedReports.com FDA calendar for Imagify was 5/31/09. However, since the FDA issued a CRL on 3/11/09 for the original NDA with a broad claim of use label, the exact timeline for a new decision on the amended NDA with a narrower claim is still pending. The aggressive cost-cutting initiatives by the Company provide expected liquidity to fund operations into 3Q09, which provides time for Acusphere to explore strategic partnerships and financing arrangements as discussions continue with the FDA to clarify the timeline for a new decision on the amended NDA.
A.P. Pharma (NASDAQ:APPA): On 5/18/09, APPA announced that it has submitted a NDA for its lead product (APF530) to the FDA for the prevention of chemotherapy-induced nausea and vomiting. APF530 is a long-acting formulation of granisetron that utilizes the Company’s proprietary Biochronomer drug delivery system.
The NDA was submitted under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act, whereby the Company can rely upon the FDA’s prior safety and efficacy findings for APF530's active ingredient, granisetron (which is already approved and marketed as Kytril). The FDA is expected to determine whether to accept the NDA for filing within 60 days, and to notify the Company of its determination within 14 days thereafter. If the NDA is accepted for filing, under the Prescription Drug User Fee Act (PDUFA) guidelines, it is expected that the FDA will complete its review and provide an action letter with respect to the NDA within 10 months following NDA submission.
AspenBio Pharma (NASDAQ:APPY): Following analysis of the Company's AppyScore pivotal FDA clinic trial completed earlier this year, APPY continues to advance the test toward a submission for FDA approval with an expected 510(k) filing by the end of 2Q09. Recently, Dr. John F. Bealer presented a paper titled, 'S100A8/A9: A Sensitive Diagnostic Blood Marker for Acute Appendicitis,' at the Society for Academic Emergency Medicine's 2009 Annual Meeting, which took place May 14-17.
APPY expects that the product indication will be as an, "Aid in the Diagnosis of Appendicitis," to be used in conjunction with other physical and laboratory tests. The clinical trial data analysis supports that the AppyScore analyte MRP8/14, provides valuable clinical information in the diagnosis of patients with lower right quadrant abdominal pain. AspenBio believes that the AppyScore test, upon commercialization,will have a sensitivity and negative predictive value of greater than 90%. Data from the pivotal trial also demonstrated that when the AppyScore is interpreted in combination with other commonly used indicators, such as white blood count (WBC), the sensitivity and negative predictive value will be higher.
Alkermes (NASDAQ:ALKS), Johnson & Johnson (NYSE:JNJ): A division of JNJ received expanded FDA approval for Risperdal Consta (risperidone long-acting injection) as both a monotherapy and adjunctive therapy to lithium or valproate in the maintenance treatment of bipolar I disorder. The drug was already approved for the treatment of schizophrenia and ALKS receives royalties on sales of the product because it utilizes the Company's proprietary drug delivery technology. Below is a Denmark-based pharmaceutical company awaiting a FDA decision for a new treatment option for schizophrenia.
H. Lundbeck (OTC:HLUKY) announced yesterday that it has not yet received an action letter from the FDA for its Serdolect (sertindole) NDA for the treatment of schizophrenia. The FDA informed the Company that they would issue an action letter as soon as possible. Below is the BioMedReports.com FDA Calendar entry for Serdolect:
On 4/7/09, a FDA Advisory Panel voted 8-2 (three panelists abstained from the vote) in favor of FDA approval for Serdolect (sertindole) among certain patients (such as those who do not respond to other treatments) despite concerns about heart-related risks. The Company proposed that Serdolect reduced suicide attempts, which is a major risk for patients with schizophrenia. However, the panel rejected this notion in a 12-1 vote based on a lack of convincing evidence to support the claim. The PDUFA decision date for an expected FDA decision on Serdolect is 5/15/09.
Shire (SHPGY) has an expected PDUFA decision date during 2H09 for its NDA resubmission to the FDA in late January 2009 for marketing approval of Intuniv (guanfacine extended release – a non-controlled drug that is already available in regular formulations on a generic basis, but is dosed multiple times per day on this basis) for the proposed treatment of attention deficit hyperactivity disorder (ADHD) in children. If FDA approval is received, Shire expects to launch Intuniv in the U.S. during 4Q09.
On 5/18/09, Shire announced new clinical data on Intuniv in children aged 6-12 years with a diagnosis of ADHD and the presence of oppositional symptoms. In this randomized, placebo-controlled, flexible-dose study, Intuniv demonstrated significant ADHD symptom improvement in patients with oppositional symptoms as measured by the ADHD Rating Scale-IV (ADHD-RS-IV), a scale frequently used in ADHD clinical trials. Intuniv is currently being studied as a once-daily, extended release formulation of guanfacine designed to provide steady delivery of drug throughout the day.
Disclosure: No positions.