Below are four companies with market caps under $200 million (all financial data current as of 6/9/09 during intraday trading) which have pending FDA decisions and/or clinical trial results that may have a major impact on each of the underlying stock prices. A high risk/reward trading approach to consider for speculative traders is investing a small amount of money that you can afford to lose in a basket of stocks included in
<font> Extreme FDA and Clinical Trial Calendar Trades </font> , which are highlighted in periodic articles at BioMedReports.com. Another approach is to simply buy such companies well ahead of their expected catalyst dates for a possible stock price increase as the date approaches and trading activity increases.
1.) Angiotech Pharma (NASDAQ:ANPI) – currently trading at $2.14, market cap = $182 million
ANPI has an FDA-approved dialysis catheter (HemoStream) that is sold through its direct sales force. The Company has identified 5-Fluorouracil (“5-FU”), a drug previously approved by the FDA for treatment of various types of cancer, as a compound that may help to prevent certain types of infection in patients receiving selected types of implantable devices, including certain dialysis catheters. ANPI is currently developing this 5-FU anti-infective technology for its HemoStream dialysis catheter line, and expects to file for a 510(k) clearance to market this product candidate in the U.S. during 2009.
On 5/8/09, ANPI provided an update in its SEC 10Q filing for the Zilver PTX paclitaxel-eluting peripheral vascular stent, which is currently being evaluated in multiple clinical trials by partner Cook Medical, Inc. as a specialized stent product incorporating Angiotech's proprietary paclitaxel technology that is designed for placement in diseased arteries in the limbs to restore blood flow. In July 2007, Cook announced that the first U.S. patients in a randomized pivotal human clinical trial of Zilver PTX were treated in a study that is designed to randomize patients to receive either the Zilver PTX stent or balloon angioplasty. Data from this clinical trial is intended to be used to support submission to the FDA for approval in the U.S. to market the device.
In September 2008, Cook announced it had completed enrollment in its pivotal human clinical trial for the Zilver PTX. The 420 patients enrolled in Cook’s randomized trial include peripheral artery disease patients treated in Germany, the U.S., and Japan. On the same date, Cook announced that it had enrolled an additional 780 patients in the E.U, Canada, and Korea in a clinical registry to evaluate the safety of the Zilver PTX device. Those data have been used for submission in Europe for CE Mark approval to market the device in the E.U. while a submission with the FDA is pending.
On 3/9/09, ANPI presented complete data for the Bio-Seal study at the 2009 Society of Interventional Radiology in San Diego, CA. The trial hit its primary end point with clinical success in 85% of the treatment patients compared to 69% for the control patients (p=0.002). Based on info in the Company's 10Q filing on 5/8/09, data from this clinical trial study has been submitted to the FDA, which has responded to the submission with additional questions about the study.
ANPI has responded to the FDA and upon further review by the agency, ANPI may either receive 510(k) clearance to market Bio-Seal in the U.S. or be required to respond to additional questions or conduct additional clinical studies. The product has already received CE Mark approval for marketing in Europe. The Bio-Seal Lung Biopsy Tract Plug System is a novel technology designed to prevent air leaks in patients having lung biopsies by plugging the biopsy track with an expanding hydrogel plug. On contact with moist tissue, the hydrogel plug absorbs fluids and expands to fill the void created by the biopsy needle puncture.
2.) Acadia Pharma (NASDAQ: ACAD) – currently trading at $2.32, market cap = $86 million
On 5/11/09, ACAD provided the following update along with its quarterly financial results: Enrollment was completed in the Company’s first pivotal Phase 3 trial of pimavanserin in patients with Parkinson’s disease psychosis (PDP) in early May 2009. Top-line results from this trial are expected to be reported by the end of the third quarter of 2009 (3Q09). ACAD is continuing to enroll patients in the second pivotal Phase 3 trial of pimavanserin in patients with PDP. ACADIA also is continuing to conduct an open-label safety extension study pursuant to which eligible patients who have completed either of the two pivotal Phase 3 trials have the opportunity to enroll if, in the opinion of the physician, a patient may benefit from continued treatment with pimavanserin.
3.) Repros Therapeutics (NASDAQ: RPRX) – currently trading at $7.41, market cap = $112 million
On 5/11/09, RPRX reported that its Proellex clinical programs are progressing well and according to plan. RPRX completed enrollment of its first Pivotal Phase 3 clinical trial (ZPU-303) for the chronic treatment of uterine fibroids and expect the first Pivotal Phase 3 clinical trial for the treatment of anemia associated with uterine fibroids (ZPU-301), to be fully enrolled mid-2009, which would then lead to top-line results in each study by the end of this year. RPRX expects top-line results from its other two complementary Pivotal Phase 3 studies, ZPU-302 (anemia) and ZPU-304 (chronic symptoms), during Q1 of 2010 (1Q10).
The two New Drug Applications (NDA) for anemia associated with uterine fibroids and chronic symptoms of uterine fibroids are scheduled to be submitted to the FDA during the second half of 2010 (2H10). The endometriosis program for Proellex has reached the end of Phase 2, and it is Company’s intent to discuss the results of study ZPE-201 with the FDA during an End-of-Phase II Meeting, mid-2009. Taking the feedback and input from the FDA into account, RPRX will then initiate two well-controlled Pivotal Phase 3 studies for the endometriosis indication during the second half of this year.
4.) Santarus, Inc. (NASDAQ: SNTS) – currently trading at $2.32, market cap = $134 million
On 6/9/09, SNTS announced that Schering-Plough (NYSE:SGP) HealthCare Products, Inc. has submitted its response to the FDA complete response letter (CRL) for an over-the-counter (OTC) Zegerid branded omeprazole/sodium bicarbonate product with the dosage strength of 20 mg of omeprazole. Schering-Plough received the complete response letter in January 2009 for its New Drug Application (NDA) seeking approval to sell Zegerid in the U.S. OTC heartburn market. The NDA for OTC Zegerid was submitted by Schering-Plough in March 2008 under the terms of a license agreement signed in October 2006 for OTC proton pump inhibitor products using Santarus’ proprietary technology. If Schering-Plough receives FDA approval of its NDA for an OTC Zegerid product, SNTS will earn a $20 million regulatory milestone.
5.) BioSpecifics Technologies (NASDAQ: BSTC) – currently trading at $19.85, market cap = $119 million
On 4/28/09, the FDA accepted for priority review (six-month) Auxilium's (NASDAQ:AUXL) BLA for Xiaflex (clostridial collagenase for injection) for the treatment of Dupuytren's contracture. AUXL filed the BLA on 2/27/09 and included data from 1,082 subjects and over 2,600 injections. The PDUFA decision date is 8/28/09 for the Xiaflex BLA. If approved by the FDA, AUXL plans to launch Xiaflex in the U.S. within 60 days during 2H09.
On 2/2/09, AUXL announced the completion of enrollment in a randomized, double-blind, placebo-controlled U.S. Phase 2b clinical trial for Xiaflex for Peyronie's disease. Over 120 patients were enrolled and all dosing was completed on 4/30/09 with top-line results from the study expected during 4Q09 based on Auxilium’s guidance provided along with quarterly results on 5/6/09.
On 2/3/09, BSTC received $6.375 million of the $75 million upfront payment paid to AUXL by Pfizer (NYSE:PFE) and will receive 8.5% of the $410 million in potential additional milestone payments that may be made by PFE to AUXL. Of these additional milestone payments, $150 million are tied to regulatory milestones and $260 million are based on sales milestones. In addition, BSTC will continue to receive milestone and royalty payments from AUXL in accordance with its original agreement.
Disclosure: No positions.
$2.3001 (06/09/09)
