Shares of St. Jude Medical, Inc. (NYSE:STJ) ended Friday session in green amid volatile trading. The shares closed up +0.54 points or 0.69% at $79.19 with 2,393,616 shares getting traded. Post opening the session at $78.67, the shares hit an intraday low of $78.27 and an intraday high of $79.35 and the price vacillated in this range throughout the day. The company has a market cap of $22.72 billion and the numbers of outstanding shares have been calculated to be 284.93 million shares.
St. Jude Medical, Inc. (STJ) on September 1, 2016 announced the start of the St. Jude Medical AMPLATZER™ Amulet™ IDE trial, which will evaluate the safety and effectiveness of the company’s AMPLATZER™ Amulet™ Left Atrial Appendage Occluder used to close the left atrial appendage (LAA) in patients diagnosed with non-valvular atrial fibrillation (AF). The first implant of the study took place at North Mississippi Medical Center in Tupelo, Mississippi by Dr. Jim Stone.
In most people, the LAA — a small appendage connected to the left atrium — does not increase the risk of adverse health effects, but in some patients with atrial fibrillation, the LAA does not contract effectively and it can become a source of blood clots. These clots can then be released into the heart and enter the bloodstream, where they can travel to the brain and cause a stroke. Currently, patients with AF at risk of stroke are often prescribed blood-thinning medication, but this treatment approach comes with a lifetime of medical management and the risk of major bleeding. By closing the LAA with the AMPLATZER Amulet occluder, physicians can “seal off” the LAA and potentially reduce the risk of stroke.
The AMPLATZER Amulet occluder works by blocking the LAA at its opening, which minimizes the opportunity for blood clots to form in the LAA and migrate into the bloodstream. The AMPLATZER Amulet occluder, the second-generation St. Jude Medical LAA occlusion device, is built with a longer lobe and waist than the previous version and designed to allow for easier and more stable placement, which could result in shorter procedure times for patients. The AMPLATZER Amulet device is also offered in eight sizes to accommodate varying anatomies.
“There’s a real need within the United States medical community for a left atrial appendage occluder that addresses a wider range of complex patient anatomies,” said Dr. Dhanunjaya Lakkireddy, Professor of Medicine and the Director of the Center for Excellence in Atrial Fibrillation and Complex Arrhythmias at the University of Kansas. “The Amulet device has been used successfully in Europe, and I see this IDE trial as the right step toward providing patients with atrial fibrillation the optimal level of care to further reduce the risk of stroke.”
Shares of Spectrum Pharmaceuticals, Inc. (NASDAQ:SPPI) ended Friday session in red amid volatile trading. The shares closed down -0.03 points or -0.62% at $4.82 with 2.38 million shares getting traded. Post opening the session at $4.84, the shares hit an intraday low of $4.75 and an intraday high of $5.01 and the price vacillated in this range throughout the day. The company has a market cap of $384.25 million and the numbers of outstanding shares have been calculated to be 80.22 million shares.
Spectrum Pharmaceuticals, Inc. (SPPI) on August 10, 2016 announced financial results for the three-month period ended June 30, 2016.
“I am very pleased with the progress we have made on our pipeline and our commercial portfolio,” said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. “Our advanced development pipeline includes treatments for chemotherapy-induced neutropenia, breast cancer, and bladder cancer. The success of any of these drugs could transform the company. We are currently enrolling patients in the pivotal program for SPI-2012, which we believe has shown a compelling clinical profile in Phase 2 studies. In addition, Poziotinib has the potential to be a best in class pan-HER inhibitor, and we recently started enrolling breast cancer patients who have failed other HER2-directed therapies in a Phase 2 trial. Qapzola for post-surgical treatment of non-muscle invasive bladder cancer is under FDA review and we look forward to presenting our case to an FDA advisory panel next month. We are making advances in our pipeline that could lead to novel cancer therapies that would benefit both patients and shareholders.”
- SPI-2012 (eflapegrastim), a novel long-acting GCSF: A pivotal Phase 3 study was initiated under a Special Protocol Assessment (SPA) from the FDA in Q1 2016 to evaluate SPI-2012 in the management of chemotherapy-induced neutropenia in approximately 580 patients with breast cancer. Enrollment is on track and the company expects to file a BLA in 2018. Moderate to severe neutropenia is a serious side effect of certain chemotherapeutic agents which can lead to infection, hospitalization, and even death. The Phase 2 data demonstrated that SPI-2012 was non-inferior to pegfilgrastim at the middle dose tested, and statistically superior in terms of duration of severe neutropenia at the highest dose tested. SPI-2012 was also shown to have an acceptable safety profile with no significant dose-related or unexpected toxicities.
- Poziotinib, a potential best-in-class, novel, pan-HER inhibitor: Spectrum is continuing to enroll a Phase 2 breast cancer program in the U.S., based on promising Phase 1 efficacy data in breast cancer patients who had failed multiple other HER2-directed therapies. In addition, multiple Phase 2 studies are being conducted in South Korea by Hanmi Pharmaceuticals and National OncoVenture.
- Qapzola, a potent tumor-activated drug being investigated for non-muscle invasive bladder cancer: The FDA is expected to make a decision on Qapzola’s approval by the PDUFA date of December 11, 2016. The FDA plans to hold an advisory committee meeting on September 14, 2016. The Company is actively enrolling an additional randomized, placebo-controlled Phase 3 trial under a SPA agreement. The Phase 3 study has been specifically designed to build on learnings from the previous studies, as well as recommendations from the FDA.
Three-Month Period Ended June 30, 2016 (All numbers are approximate)
Total product sales were $30.9 million in the second quarter of 2016. Product sales in the second quarter included: FUSILEV® (levoleucovorin) net sales of $10.5 million, FOLOTYN® (pralatrexate injection) net sales of $11.0 million, ZEVALIN® (ibritumomab tiuxetan) net sales of $2.8 million, MARQIBO® (vinCRIStine sulfate LIPOSOME injection) net sales of $2.1 million, BELEODAQ® (belinostat for injection) net sales of $3.7 million and EVOMELA® (melphalan) for injection net sales of $0.9 million.
Spectrum recorded net loss of $24.3 million, or $(0.35) per basic and diluted share in the three-month period ended June 30, 2016, compared to net loss of $2.3 million, or $(0.04) per basic and diluted share in the comparable period in 2015. Total research and development expenses were $14.3 million in the quarter, as compared to $9.6 million in the same period in 2015. Selling, general and administrative expenses were $27.6 million in the quarter, compared to $22.6 million in the same period in 2015.