Pfizer Says CHMP Confirms Prior Opinion on Xeljanz in Europe; BioMarin Provides BMN 673 Program Update Print E-mail
By Staff and Wire Reports   
Thursday, 25 July 2013 20:25
Below is a look at some of the headlines for companies that made news in the healthcare sector on July 25, 2013.

Pfizer Inc. (NYSE: PFE) announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has confirmed its April 25, 2013, opinion to recommend against approval of XELJANZ® (tofacitinib citrate) for the treatment of adult patients with moderate-to-severe active rheumatoid arthritis (RA). After re-examination of the application as requested by Pfizer, the CHMP is of the opinion that XELJANZ does not demonstrate a favorable benefit:risk profile.

While the CHMP considered that treatment with XELJANZ resulted in reduction in the signs and symptoms of RA and improvement in the physical function of patients, it has outstanding concerns on safety, including serious infections.

The Company is currently evaluating the feedback from the CHMP and will determine next steps to resubmit a MAA to the EMA.

“We are disappointed in the outcome of the re-examination process. A narrow majority of the CHMP felt there is too limited experience in the patient population to fully characterize the profile of XELJANZ and the Committee did not recommend approval at this time,” said Dr. Steven Romano, senior vice president and the head of the Medicines Development Group for Pfizer Specialty Care. “The clinical experience with XELJANZ to date, which includes data from approximately 5,000 patients treated for RA, demonstrates a consistent efficacy and safety profile across a range of patient types and a risk profile that is familiar to rheumatologists who have experience utilizing the range of treatments available to treat this disease. We believe that the benefit:risk profile of XELJANZ is favorable, and we remain committed to working with the EMA to make XELJANZ available to appropriate patients in Europe.”

About the Marketing Authorization Application -- The MAA included data from the comprehensive, global, multi-study clinical development program for XELJANZ, which included approximately 5,000 patients across Phase 2 and Phase 3 trials in more than 40 countries, resulting in 7,000 patient-years of exposure at the time of regulatory submission. The application was based on the same pivotal efficacy and safety data package that was provided to regulatory agencies around the world.



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BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) provided an update on its ongoing Phase 1/2 study for its poly ADP-ribose polymerase (PARP) inhibitor BMN 673 for the treatment of solid tumors. As of July 24, the RECIST response rate from the ongoing trial is nine out of 18 breast cancer patients, or 50 percent, including one confirmed complete response. This response rate includes three additional confirmed responses since the last update at the ASCO Annual Meeting, and two new patients are yet to be confirmed. Four patients are ongoing with stable disease with potential for additional responses. The study is still ongoing, and the company will provide additional updates later this year, including data in ovarian cancer, Ewing's sarcoma and small cell lung cancer.

Since the ASCO Annual Meeting, the company has met with the FDA and MAA to review its planned clinical program in deleterious gBRCA mutation metastatic breast cancer. At those meetings, health authorities confirmed that a primary endpoint of Progression Free Survival (PFS) could serve as the basis for a potential approval. BioMarin now expects to initiate a Phase 3 trial for BMN 673 in deleterious gBRCA mutation metastatic breast cancer in late third quarter of 2013, earlier than previously announced at the ASCO Annual Meeting in early June.

National Breast Cancer Coalition (NBCC) has announced its intention to assist BioMarin's development of the PARP inhibitor for the treatment of hereditary breast cancer with BRCA mutations. NBCC intends to participate with BioMarin on enrollment initiatives in the United States and around the world. In addition, NBCC will be a resource on study design, implementation and execution.

"NBCC is an organization committed to ending breast cancer in large part by participating in and contributing to the scientific process. The application of drug development science to well-defined problems is an important step in our mission. Therefore, we are pleased to collaborate with BioMarin to develop BMN 673 as a potential first and/or best in class PARP inhibitor for patients with hereditary forms of cancer, namely BRCA mutations. This project offers the hope of improving the length and/or quality of life for patients," said Fran Visco, President of the National Breast Cancer Coalition.

"We look forward to conducting a world-class study, in collaboration with the finest clinical investigators in the world to evaluate the safety and efficacy of BMN 673 in the metastatic setting. Our advocates are poised to change the world through our actions. Ultimately, we hope to prevent women from getting breast cancer and prevent it from spreading outside the breast," Visco added.

"BioMarin is an organization that wants to make big differences in the lives of patients. The data emerging from the ongoing BMN 673 study is progressively more encouraging. We are committed to the successful execution of the Phase 3 program in hopes of offering patients a safe and easily administered pill, which is an effective treatment option," said Hank Fuchs, M.D., Chief Medical Officer of BioMarin. "We are honored to include a seat at the table for our colleagues from NBCC. The purpose of our efforts is best served hearing their voice from the beginning and taking action together."



Also Thursday:



Adept Technology, Inc. (Nasdaq:ADEP)
, a leading provider of intelligent robots and autonomous mobile solutions and services, today announced that it has delivered a new generation of RoboCourierTM to Swisslog Healthcare Solutions (HCS) for use in hospitals, clinical laboratories and pharmacies for the transport of specimens, medications and supplies.

Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) announced today that it has received commitments from institutional investors to purchase US$7.8million of securities in a registered direct offering.

Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) today announced that BELVIQ® (lorcaserin HCl) has been nominated for the 2013 Prix Galien USA Award in the Best Pharmaceutical Agent category.

Baxano Surgical, Inc. (Nasdaq:BAXS) announced today that it plans to release second quarter 2013 financial and operating results after market close on Thursday, August 8, 2013.

BIOLASE, Inc. (NASDAQ: BIOL)
, the world's leading manufacturer and distributor of dental lasers, and a pioneer in laser surgery in other medical specialties, announced today that it has entered into a strategic agreement with Valam Corporation ("Valam") to develop, market, and sell office-based laser systems to otolaryngologists (also known as "Ear, Nose, and Throat" or "ENT" doctors).

Boston Scientific Corporation (NYSE: BSX) generated sales of $1.809 billion and adjusted earnings per share of $0.18 for the second quarter ended June 30, 2013.  The company reported GAAP earnings of $0.10 per share.

BIOLASE, Inc. (NASDAQ: BIOL)
, the world's leading dental laser manufacturer and distributor, and a pioneer in laser surgery in other medical specialties, announced today that the Company will host a conference call on Wednesday, August 7th, at 4:30 p.m. Eastern Daylight Time to discuss its operating results for the second quarter ended June 30, 2013, and to answer questions.

The NASDAQ OMX Group, Inc. (Nasdaq:NDAQ) announced that trading of Cellular Dynamics International, Inc. (Nasdaq:ICEL), a developer and manufacturer of fully functioning human cells in industrial quantities to precise specifications, commenced on The NASDAQ Stock Market on July 25, 2013.

Cepheid (Nasdaq: CPHD)
today announced it has received market authorization from the U.S. Food & Drug Administration (FDA) for its Xpert® MTB/RIF test.

Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today reported net income for the quarter ended June 30, 2013 of $94 million, or $0.82 per diluted share, compared to net income of $68 million, or $0.57 per diluted share, for the same period in 2012.

eHealth, Inc. (NASDAQ: EHTH)
, the nation's first and largest private health insurance exchange, announced today its financial results for the second quarter ended June 30, 2013.

EnteroMedics Inc. (NASDAQ: ETRM)
, the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's Premarket Approval (PMA) application for approval of the Maestro® Rechargeable System's VBLOC® vagal blocking therapy as a treatment for obesity.

Mauna Kea Technologies (NYSE Euronext: MKEA), leader in the optical biopsy market and developer of Cellvizio®, the fastest way to see cancer, has entered several distribution agreements for its line of Cellvizio LAB products, including the Cellvizio Dual Band, for pre-clinical research.

Medistem, Inc. (PINKSHEETS: MEDS)
, reminds investors that its Chief Executive Officer, Alan J. Lewis, Ph.D., will host a conference call today at 4:30 pm Eastern time (1:30 pm Pacific time).

NeoGenomics, Inc. (NASDAQ: NEO), a leading provider of cancer-focused genetic testing services, announced today that it has validated and launched a number of clinical molecular tests for the comprehensive profiling of myelodysplastic syndrome (MDS).

Nuvilex, Inc. (OTCQB: NVLX) is currently preparing the way to challenge Eli Lilly's blockbuster cancer drug, Gemzar, and doing so with the knowledge that in two independent mid-phase clinical trials, the company's treatment involving its proprietary living cell encapsulation technology has outperformed the pharmaceutical giant.

Goldman Small Cap Research, a stock market research firm focused on the small cap and microcap sectors, notes that Plandai Biotechnology Inc.'s (OTCQB: PLPL) flagship product, Phytofare™ Catechin Complex, might prove its effectiveness in targeting the ubiquitous cold and flu ailments which costs Americans billions each year.

The Pulse Beverage Corporation (OTCQB: PLSB)
, makers of PULSE® brand of functional beverages and Natural Cabana® Lemonade, today announced it has secured distribution into Sacramento for both PULSE® and Natural Cabana® through Senuca Beverages, Inc, a rapidly growing distributor that continually expands their network of convenience and grocery stores, powerfully increasing their foothold in the greater Sacramento areas of California. John Senuca, owner of Senuca Beverages, is excited to add Pulse's entire line up of PULSE® brand of functional beverages and Natural Cabana® Lemonade to their product offerings.

TheDirectory.com, Inc. (PINKSHEETS: SEEK)
an emerging leader in the Local search space, today announced that it has entered into a partnership with leading Internet technology firm Yola.com to offer its website builder technology to clients of TheDirectory.com.

United Therapeutics Corporation (NASDAQ: UTHR)
today announced its financial results for the second quarter ended June 30, 2013.

ViroPharma Incorporated's (Nasdaq: VPHM)
second quarter financial results for 2013 are expected to be released on Thursday, August 1, 2013 before the open of the U.S. financial markets.



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