Eli Lilly Disappointed in Medicare's Decision on Beta-Amyloid Imaging Agents; Ampio Announces Positive Results for Ampion(TM) Print E-mail
By Mary Davila   
Monday, 30 September 2013 19:47
Below is a look at some of the headlines for companies that made news in the healthcare sector on September 30, 2013.

Eli Lilly and Company (NYSE: LLY)
is disappointed that the Centers for Medicare & Medicaid Services (CMS) has denied patient access to beta-amyloid imaging agents, such as Amyvid™ (Florbetapir F 18 Injection). This final decision is not only contrary to expert opinion and published Appropriate Use Criteria previously recommended by the Alzheimer's Association and the Society of Nuclear Medicine and Molecular Imaging, but contradicts the statutory authority CMS has over coverage determinations for diagnostics. Denying appropriate patient access is also in conflict with the administration's National Alzheimer's Project Act.1 CMS participated in creating this plan aimed at developing new and innovative ways to diagnose, support and treat patients suffering from Alzheimer's Disease1—yet the same agency is challenging the value of the only technology approved by the Food and Drug Administration (FDA) for estimating beta-amyloid neuritic plaque density in the living brain, which can aid in helping doctors make a more informed diagnosis.2

Amyvid is a beta-amyloid imaging agent for use in adults with thinking or memory problems who are being assessed for Alzheimer's Disease or other causes of these symptoms. Amyvid is used by doctors in combination with other tests. A positive Amyvid scan does not diagnose Alzheimer's Disease or other thinking or memory disorders. Amyvid is not approved to predict the development of dementia or other brain conditions in the future or for monitoring the effectiveness of treatments. Amyvid for intravenous use is supplied in 10 mL, 30 mL, or 50 mL multidose vials containing 500-1900 MBq/mL Florbetapir F 18.2

"Coverage with Evidence Development as proposed by CMS does not provide patients appropriate access to these amyloid imaging brain scans. Instead, it creates additional complexity for the broader community in determining the best path forward for patients," said Eric Dozier, senior director, Alzheimer's Business Division, Eli Lilly and Company. "As we continue to review the final decision memo, we will be evaluating all available options to ensure patients and physicians can gain access to this innovative diagnostic tool as soon as possible."


Ampio Pharmaceuticals (NYSE: AMPE)
announced additional positive results from the SPRING study (clinicaltrials.gov NCT01839331) of Ampion™ for the treatment of osteoarthritis of the knee (OAK). In this study of 329 patients, patients treated with a single intra-articular injection of Ampion™ achieved a clinically meaningful reduction in pain. Ampio announced on August 14, 2013 that the SPRING study met its primary and key secondary endpoints.

Dr. Vaughan Clift, Ampio's Chief Regulatory Officer, explained "The previously reported achievement of primary end point efficacy for pain (WOMAC A, p=0.0038), function (WOMAC C, p=0.04) and Patient Global Assessment (PGA, p=0.01) at 12 weeks following a single intra-articular injection is now augmented by significant results from secondary end points. The newly announced positive results include:

The reduction in pain compared to the vehicle control (saline) was also significant across/over the whole twelve-week period and not just at the 12 weeks end point (p=0.01). This study demonstrated that a single intra-articular (IA) injection of Ampion™ resulted in a clinically and statistically significant reduction in pain, with an estimated difference from control at the study endpoint of -0.25 on the WOMAC A scale (95% CI: -0.41 to -0.08, p=0.004), corresponding to a 42.3% improvement in pain at 12 weeks in patients treated with Ampion™. Note: In contrast, despite recommendations against their use, Hylan G-F 20 is the current treatment of choice in patients who cannot be managed with analgesics. In the pivotal trial of a single IA injection of 6 ml Hylan G-F 20, a borderline statistically significant reduction in pain was demonstrated, with an estimated difference from control of -0.15 (95% CI: -0.30 to -0.002, p = 0.047), corresponding to a 31.3% improvement in pain over 26 weeks in patients treated with Hylan G-F20.

Note: The accepted threshold for a Minimum Clinically Important Improvement (MCII), defined as the smallest change in a measurement that signifies important improvement in a patient's symptom, is -40.8% [Ann Rheum Dis. 2005;64:29-33 Tubach F, Ravaud P, Baron G, et al. Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement] in WOMAC A pain change from baseline with knee OA, which only Ampion exceeded as an intra-articular injection.

The Ampion™ SPRING study included "all comers", including Kellgren-Lawrence IV patients that make up a significant portion of the "real world" osteoarthritis patients (19% in the SPRING study). Ampion™ was not only effective overall (p=0.004) as previously reported, but was specifically effective in the subset of patients with severe osteoarthritis (Kellgren-Lawrence IV, p=0.017) who currently face a severe unmet medical need. Note: In contrast pivotal trials for the approved hyaluronic acid and derivatives, which commonly exclude patients with severe osteoarthritis (Kellgren-Lawrence IV stage of disease), these patients are sometimes considered "intractable" due to lack of efficacy of any approved therapy (NSAIDS, hyaluronic acid and steroids). The only accepted therapy is joint replacement, which is not only a significant patient burden but also has significant morbidity associated with it and is contraindicated in many patients with comorbidities.

Also Monday:

Alimera Sciences, Inc. (NASDAQ: ALIM)
(Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that in its Final Appraisal Determination, the United Kingdom's National Institute for Health and Care Excellence (NICE) has recommended ILUVIEN funding for the treatment of pseudophakic eyes in chronic diabetic macular edema (DME) patients that are insufficiently responsive to available therapies.

Cellular Dynamics International (Nasdaq:ICEL)
, a developer and manufacturer of fully functioning human cells in industrial quantities to precise specifications, will be added to the U.S. small-cap Russell 2000® Index on September 30 when Russell Investments reconstitutes its comprehensive family of global indexes.

Celsus Therapeutics (OTCQB:CLSXY)
, an emerging growth, development-stage biopharmaceutical company, announced today that it has closed a previously announced securities purchase agreement for a private placement financing with a select group of institutional healthcare investors.

Complete Genomics, Inc. (formerly NASDAQ: GNOM)
, a wholly-owned subsidiary of BGI-Shenzhen, a leading international genomics organization based in Shenzhen, China, today announced that its highly-accurate whole genome sequencing technology played a pivotal role in identifying a point mutation that causes Prader-Willi Syndrome (PWS). That discovery helped resolve a diagnostic conundrum for four young male patients.

announced today that it expects to report third quarter 2013 financial results before the market opens on Thursday, October 24, 2013, and will also hold a conference call live over the Internet at 10:00 a.m. Eastern Time that same day.

eHealth, Inc. (NASDAQ: EHTH)
, parent company of eHealthInsurance.com, the nation's leading private online health insurance exchange for individual and family health insurance, announced that on October 1, 2013 it will be offering new health insurance plans that meet the requirements of the Affordable Care Act (ACA) for consumers not eligible for Federal subsidies.

Eli Lilly and Company (NYSE: LLY)
will host a meeting for the investment community, including major long-term investors, sell-side analysts, financial media and ratings agency representatives.

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 the beginning of a three-year grant from the Department of Defense (DOD) totaling more than $1.6 million to evaluate milatuzumab as a treatment of patients with lupus.

IsoRay Inc. (NYSE MKT: ISR)
, a medical technology company and innovator in seed brachytherapy and medical radioisotope applications, announced its financial results for the year ended June 30, 2013.

Life Technologies Corporation (NASDAQ: LIFE)
and Advanced Cell Diagnostics, Inc. (ACD), a leader in the field of molecular pathology and developer of cell and tissue-based analysis tools, today announced a global distribution agreement by which Life will distribute ACD's fluorescent RNAscope® portfolio of probes and kits to the research market through its worldwide distribution network.

Omeros Corporation (NASDAQ: OMER)
announced that OMS824, its phosphodiesterase 10 (PDE10) inhibitor, has received orphan drug designation from the U.S. Food and Drug Administration for the treatment of Huntington's disease.

Opexa Therapeutics, Inc. (NASDAQ: OPXA)
, a biotechnology company developing Tcelna®, a patient-specific T-cell immunotherapy for the treatment of multiple sclerosis (MS), today announced that Neil K. Warma, Opexa’s President and Chief Executive Officer, has been invited as a panel member to participate in the 9th Annual Burrill Personalized Medicine Meeting.

OXiGENE, Inc. (Nasdaq:OXGN)
, a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, announced that Peter Langecker, M.D., Ph.D., President and Chief Executive Officer, will provide a corporate overview at the 12th Annual BIO Investor Forum conference on October 8, 2013 at 4:00 PT at the Palace Hotel, San Francisco, California.

Palatin Technologies, Inc. (NYSE MKT: PTN)
, a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential, today announced results for its fourth quarter and fiscal year ended June 30, 2013.

Pinacle Enterprise, Inc. (OTCBB: PINS) (OTCQB: PINS) is pleased to announce that it has completed due diligence regarding the previously announced Letter of Intent to acquire Xtreme Technologies, Inc. ("Xtreme Technologies"), developer and holder of the worldwide intellectual property, patents, and rights to the technologies behind the Company's Alkame™ micro-clustered, alkaline, antioxidant, and oxygenated water.

Premier Diagnostic Health Services Inc. (CNSX:PDH) today announced that it has concluded a debt settlement agreement with Management which provides that Management has purchased $31,075 of the Company's debt that was exchanged for common shares in the capital stock of Premier.

PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that it was included on the list of quarterly initial public offering additions to the Russell 2000® Index to be effective at the close of the U.S. market on September 30, 2013.

Synergetics USA (NASDAQ: SURG)
announced today that Robert H. Blankemeyer has been elected to the Synergetics Board of Directors, effective September 23, 2013.

Verisante Technology, Inc. (TSX VENTURE:VRS) (OTCQX:VRSEF) (FRANKFURT:V3T), a leader in cancer detection technology, announced today that the Company is exhibiting at the 22nd Congress of the European Academy of Dermatology and Venereology ("EADV") in Istanbul, Turkey, from October 3-6, 2013. Over 8,000 participants are expected at the EADV's 22nd Annual Congress.

"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

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