Pfizer Expands Clinical Trial Data Access Policy; MiMedx Issues Update on Next Steps Following Discussions with FDA Print E-mail
By Staff and Wire Reports   
Wednesday, 04 December 2013 20:32

Below is a look at some of the headlines for companies that made news in the healthcare sector on December 4, 2013. Pfizer Inc. (NYSE: PFE) announced an update of its clinical trial data access policy that will simplify and broaden access to information gathered in Pfizer-sponsored clinical trials. The updated policy builds upon and expands the company's established methods of clinical trial information sharing, including Pfizer's long track record of submitting for publication results from all interventional clinical trials in patients and its pioneering efforts to provide clinical trial results and data to study participants.

Pfizer's updated policy meets or exceeds the “Principles for Responsible Data Sharing” issued by the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) in July 2013.

Key elements of Pfizer's expanded policy, effective January 1, 2014, are:

  • Pfizer's INSPIIRE public web portal for investigator-initiated research (iirsubmission.pfizer.com) will offer qualified researchers a standard form and process for requesting access to anonymized patient-level data from Pfizer-sponsored trials of approved (or discontinued) products/indications posted on clinicaltrials.gov that have been complete for 24 months.
  • An external Independent Review Panel will consider all requests denied or only partially approved by Pfizer and make a final decision.
  • Pfizer will publish, on Pfizer.com, synopses of clinical study reports (CSRs) filed with regulatory agencies for approved products for which basic results are posted in the clinicaltrials.gov registry (dating back to September 2007). These CSR synopses will include summary results for all primary and secondary endpoints; any data that could be used to identify individual patients will be removed.
  • Pfizer will produce and distribute lay-language summaries of clinical trial results to trial participants who wish to receive them, starting with trials that begin enrolling in 2014, in countries where regulations permit.
  • Pfizer is piloting the use of “Blue Button™” technology (launched by the U.S. Departments of Veterans Affairs and Health and Human Services) to enable Pfizer trial participants to download their own electronic clinical data collected in the trial.
  • Pfizer's expanded clinical data access policy also reinforces the company's current practice of submitting for publication manuscripts for all interventional clinical trials in patients, regardless of outcomes, within 18 months of study completion, and the company's commitment to register and post summary results for interventional human clinical trials to clinicaltrials.gov in the United States and to registries outside the United States as required.


“Increasing use of new analytical tools and processes to better understand patient outcomes suggests that broadening access to information from clinical trials, including patient-level data, when done responsibly, may benefit medical research and public health,” said Freda Lewis-Hall, M.D., Pfizer's executive vice president and chief medical officer. “Pfizer's expanded policy is part of a larger and evolving effort by those who create and use clinical data to arrive at a transparent, harmonized process to expand access in ways that protect patient privacy, respect the regulatory process and maintain incentives to conduct new research.”

Pfizer has put in place a number of safeguards designed to protect patient privacy and commercially confidential information, and will ask those requesting patient-level data to sign a data-sharing agreement. All research proposals will be assessed to ensure there is scientific rationale for the research, a well-documented and rigorous statistical analysis plan, and a commitment to publish any resulting findings. Any proposals not fully approved by Pfizer will go to an Independent Review Panel for review and final decision.


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MiMedx Group, Inc.  (NASDAQ: MDXG)
, an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, provided an update on its continuing discussions with the Food & Drug Administration (FDA) regarding the regulatory classification of its micronized products. 

The Company received a communication from the FDA explaining the basis for the Agency's position regarding the micronized products.  The Company has responded to the FDA that while it does not agree with the Agency's position, it understands the Agency's interest in further regulating this emerging technology.  Accordingly, the Company has proposed to the FDA that it will pursue the Investigational New Drug (IND) and Biologics License Application (BLA) process for certain micronized products, and, in parallel, also proposed to enter into negotiations with the FDA on a plan to transition the micronized products to licensed biological products and continue to market the micronized products under specific conditions.  The Company has informed the FDA that it is ready to immediately commence discussions regarding this transition plan.  While there is no guarantee that the FDA would agree to any particular transition plan, the Company is hopeful that it can reach a mutually satisfactory agreement with the FDA in this regard.

Parker H. "Pete" Petit, Chairman and CEO said, "We are pleased that the FDA has recently clarified its issue with our micronized products and has continued a dialogue with us to bring this matter to resolution.  We are in agreement with the Agency that this relatively new technology must enter the market in an orderly and safe manner with proper regulatory oversight.  A top priority for us is that the patients who can benefit from our micronized products will have access to these therapies."

The Company's proposal to the FDA was in response to the FDA's explanation to the Company that "[c]ryo-milling cut, dehydrated amniotic/chorionic membrane results in a micron-sized powder and the loss of the tensile strength and elasticity that are essential characteristics of the original amniotic/chorionic tissue relating to its utility to function as a 'physical membrane' (i.e. covering, barrier)."  For this reason, the Agency believes that the micronized products are more than minimally manipulated and the products therefore are not eligible for marketing solely under Section 361 of the Public Health Service Act.  As noted above, the Company disagrees with this analysis.

"As we have previously highlighted, the review by the FDA and its regulatory pathway decision is relevant only to the Company's micronized tissue products and has no applicability to our sheet tissue products, which we will continue to market on the same basis as previously.  We therefore reiterate our revenue guidance for the remainder of 2013 as well as our guidance for 2014," commented Bill Taylor, President & COO.  "In addition, we believe the recent Centers for Medicare and Medicaid Services (CMS) final rule on packaging skin substitutes will provide even greater opportunity for MiMedx than previously anticipated, due to the tiered pricing contained in the final rule and the pass-through status of EpiFix® in 2014.  MiMedx continues to be the industry leader providing advanced wound care solutions that have low 'cost to closure' using our size appropriate grafts that minimize wastage.  The cost and clinical effectiveness of EpiFix was supported by our initial diabetic foot ulcer (DFU) trial, which was the first and only such trial using amniotic tissue published in an indexed peer-reviewed journal," concluded Taylor.


Also Wednesday:


Allerayde SAB Inc. (OTCQB:ASAB)
President and CEO, Michael Rhodes, shares his insight into effective emergency treatment of potentially life-threatening allergic reactions along with strategic directions for the upcoming year in an exclusive interview on CEOinsiderTV.com.

Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL)
announced today that the United States District Court for the District of Delaware ("Court") granted Upsher-Smith Laboratories, Inc.'s ("USL") motion for summary judgment with respect to its attempts to bring a testosterone gel product to market via its 505(b)(2) NDA using Auxilium's Testim® product as its reference listed drug.

BioTelemetry, Inc. (Nasdaq:BEAT)
, the leading wireless medical technology company focused on the delivery of health information to improve quality of life and reduce cost of care, announced that the Centers for Medicare and Medicaid Services has published a reduction to the reimbursement for remote cardiac monitoring services effective January 1, 2014.

Cambrex Corporation (NYSE: CBM)
is pleased to announce that Steven Klosk, President and Chief Executive Officer, will make a presentation on the Company at the Oppenheimer 24th Annual Healthcare Conference on December 10, 2013 at 4:30 p.m. EST, in New York City.

Celldex Therapeutics, Inc. (Nasdaq:CLDX)
today announced the pricing of an underwritten public offering of 7,000,000 shares of its common stock, offered at a price to the public of $24.50 per share for an aggregate offering of $171,500,000 of common stock.

The Jain Foundation, a non-profit organization whose mission is to cure muscular dystrophies caused by dysferlin protein deficiency, today announced the signing of a Master Service Agreement with Cellular Dynamics International (CDI) (Nasdaq:ICEL).

Dehaier Medical Systems Ltd. (Nasdaq:DHRM)
, an emerging leader in the development, assembly, marketing and sale of medical devices and homecare medical products, today announced that it will attend 23th International Zdravookhraneniye'2013 Exhibition for Health Care, Medical Engineering and Pharmaceuticals in Moscow, Russia from December 9 to 13, 2013.

The Ensign Group, Inc. (Nasdaq:ENSG)
, the parent company of the Ensign™ group of skilled nursing, rehabilitative care services, hospice care, assisted living and urgent care companies, announced today that it will participate in the Oppenheimer 24th Annual Healthcare Conference on December 10, 2013, in New York, New York.

Galena Biopharma (Nasdaq:GALE)
, a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today announced that Mark J. Ahn, Ph.D., President and Chief Executive Officer, will present a corporate update at the Oppenheimer 24th Annual Healthcare Conference.

Harvard Bioscience, Inc. (Nasdaq:HBIO)
, a global developer, manufacturer, and marketer of a broad range of tools to advance life science research, today announced the realignment of its global operations to create organizational efficiencies and better position the Company for growth.

Immunomedics, Inc. (Nasdaq:IMMU)
, a biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today announced that IMMU-132, the Company's antibody-drug conjugate for solid cancer therapy, has received orphan drug status from the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA) for the treatment of small cell lung cancer (SCLC).

Immunomedics, Inc. (Nasdaq:IMMU)
, a biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today announced that stockholders of the Company, at its 30th annual meeting, elected all six nominees to serve as directors of the Company until the next annual meeting; approved the executive compensation by advisory vote; and ratified the selection of KPMG LLP as the Company's independent registered public accounting firm for the current fiscal year.

Hemispherx Biopharma, Inc. (NYSE MKT:HEB)
announced that the Board has appointed Thomas Equels as the new Chief Financial Officer and Adam Pascale as the new Chief Accounting Officer for Hemispherx Biopharma Inc.

Merrimack Pharmaceuticals, Inc. (Nasdaq:MACK)
today announced that Robert Mulroy, President & CEO, is scheduled to present at the Oppenheimer 24th Annual Healthcare Conference on Wednesday, December 11, 2013 at 8:55 a.m. (ET) at the Crowne Plaza Hotel in New York.   

MiMedx Group, Inc.  (NASDAQ: MDXG)
, an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, provided an update today on its continuing discussions with the Food & Drug Administration (FDA) regarding the regulatory classification of its micronized products.  

Mylan Inc. (Nasdaq: MYL)
today announced that it has completed the acquisition of the Agila injectables businesses from Strides Arcolab Limited (BSE: 532531, NSE: STAR) for up to $1.75 billion, which includes $250 million in contingent consideration.

Myriad Genetics, Inc. (Nasdaq:MYGN)
today announced it will present data from four clinical studies with Prolaris at the 14th Annual Meeting of the Society for Urologic Oncology (SUO) in Bethesda, Md. Prolaris is a prognostic test that accurately predicts cancer-specific disease progression and mortality based on an analysis of 46 cell cycle progression genes.

Neurocrine Biosciences, Inc. (Nasdaq: NBIX)
announced today that Kevin Gorman, President and Chief Executive Officer of Neurocrine Biosciences, will be presenting at Oppenheimer's 24th Annual Healthcare Conference in New York City.  

NeoStem, Inc. (NASDAQ: NBS)
a leader in the emerging cellular therapy industry, today announced that Dr. Robin L. Smith, Chairman and CEO, will be interviewed live tomorrow December 5, 2013 at 3:15pm EST/2:15pm CST on Clear Channel's business talk radio show "The Traders Network" hosted by Michael Yorba.

Oculus Innovative Sciences, Inc. (Nasdaq:OCLS)
, a global healthcare company that designs, manufactures and markets prescription and non-prescription products in 27 countries, today announced that it has received a new 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the company's new Microcyn® Scar Management HydroGel.

OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED)
, a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, today announced that it has started a Phase 1b clinical trial of its first-in-class Wnt-pathway-targeting antibody vantictumab (OMP-18R5) in combination with nab-paclitaxel (Abraxane®) and gemcitabine in patients with Stage IV pancreatic cancer.

Parametric Sound Corporation (NASDAQ: PAMT)
, a leading innovator of audio products and solutions, today announced that Ken Potashner, Executive Chairman of Parametric Sound will present at the Wedbush 14th Annual California Dreamin' Consumer Conference on Tuesday, December 10, 2013.

ProPhotonix Limited (LSE:PPIX) (LSE:PPIR) (OTC:STKR)
, a designer and manufacturer of LED illumination systems, laser diode modules and a laser diode distributor with operations in Ireland and the U.K., provides a 2013 trading update and announces expanded credit facility.

Shareholder rights law firm Robbins Arroyo LLP is investigating potential violations of federal securities laws on behalf of investors of Repros Therapeutics, Inc. (NASDAQ: RPRX).




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