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TMCNet:  Pfizer Submits New Drug Application for Palbociclib ; BioBlast Receives Notice Of Allowance From USPTO For Ataxia

[August 18, 2014]

Pfizer Submits New Drug Application for Palbociclib ; BioBlast Receives Notice Of Allowance From USPTO For Ataxia

(BioMed Reports Via Acquire Media NewsEdge) Below is a look at some of the headlines for companies that made news in the healthcare sector on August 18, 2014.

{nfg}Pfizer Inc. (PFE:NYSE) announced it has completed the submission of a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for palbociclib. This NDA requests FDA approval of palbociclib, in combination with letrozole, for the treatment of postmenopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received previous systemic treatment for their advanced disease. The submission is based on the final results of PALOMA-1, a randomized, Phase 2 trial comparing palbociclib plus letrozole versus letrozole alone in this population of patients.Palbociclib received Breakthrough Therapy designation from the FDA in April 2013, for the first-line systemic treatment of women with advanced or metastatic ER+, HER2- breast cancer. This designation was based on interim data from the PALOMA-1 trial.The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing. Pfizer will communicate the Agency's decision.“Today's submission marks an important milestone for Pfizer and palbociclib, and a potential advance for women with advanced breast cancer,” said Garry Nicholson, President, Pfizer Oncology.About Palbociclib - Palbociclib is an investigational oral targeted agent that selectively inhibits cyclin-dependent kinases (CDKs) 4 and 6 to regain cell cycle control and block tumor cell proliferation.1Loss of cell cycle control is a hallmark of cancer and CDK 4/6 are overactivated in numerous cancers, leading to loss of proliferative control.2,3 CDK 4/6 are key regulators of the cell cycle that trigger cellular progression from growth phase (G1) into phases associated with DNA replication (S).4,5 CDK 4/6, whose increased activity is frequent in estrogen receptor-positive (ER+) breast cancer (BC), are key downstream targets of ER signaling in ER+ BC.6,7 Preclinical data suggest that dual inhibition of CDK 4/6 and ER signaling is synergistic, and it has been shown to stop growth of ER+ BC cell lines in the G1 phase.Palbociclib is not approved for any indication in any market.About PALOMA-1 - PALOMA-1 (also known as Study 1003 and TRIO-18) is a Phase 2 trial designed to assess progression-free survival in post-menopausal women with ER+, HER2- advanced breast cancer receiving palbociclib (125 mg once daily for three out of four weeks in repeated cycles) in combination with letrozole versus letrozole alone (2.5 mg once daily on a continuous regimen). Final results from PALOMA-1 were presented at the American Association for Cancer Research (AACR) Annual Meeting 2014. PALOMA-1 was conducted in collaboration with the Jonsson Cancer Center's Revlon/UCLA Women's Cancer Research Program, led by Dr. Dennis Slamon.Palbociclib Development Program in ER+, HER2- Breast Cancer - Pfizer has worked closely with investigators and international breast cancer experts to establish a robust development program for palbociclib in ER+, HER2- breast cancer across stages and treatment settings.Pfizer has initiated two Phase 3 studies of palbociclib in advanced/metastatic breast cancer. PALOMA-2 (also known as Study 1008) is a randomized (2:1), multi-center, double blind Phase 3 study that evaluates palbociclib in combination with letrozole versus letrozole plus placebo as a first-line treatment for post-menopausal patients with ER+, HER2- advanced breast cancer. PALOMA-3 (also known as Study 1023) is a randomized (2:1), multi-center, double blind Phase 3 study that evaluates palbociclib in combination with fulvestrant versus fulvestrant plus placebo in women with hormone receptor-positive (HR+), HER2- metastatic breast cancer whose disease has progressed after prior endocrine therapy.Additional, investigator-led studies of palbociclib in advanced/metastatic breast cancer and in early breast cancer are open and enrolling patients, including the PEARL and PENELOPE-B studies. PEARL, sponsored by Grupo Español de Investigación en Cáncer de Mama (GEICAM, Spanish Breast Cancer Research Group), with participation from the Central European Cooperative Oncology Group (CECOG), is a randomized (1:1), multi-center, open-label Phase 3 study evaluating palbociclib in combination with exemestane versus capecitabine in post-menopausal women with ER+, HER2- metastatic breast cancer whose disease was refractory to previous non-steroidal aromatase inhibitors (letrozole or anastrozole). PENELOPE-B is a randomized (1:1), double blind, placebo-controlled Phase 3 study comparing palbociclib plus standard endocrine therapy to placebo plus standard endocrine therapy in patients with HR+, HER2- early-stage breast cancer with certain features that suggest an increased risk for recurrence after completing pre-operative chemotherapy followed by surgery. This international study is sponsored by the German Breast Group (GBG).=============================BioBlast Pharma Ltd, (Nasdaq: ORPN)a clinical-stage biotechnology company committed to developing clinically meaningful therapies for patients with rare and ultra-rare genetic diseases, announced today it has received a notice of allowance from the United States Patent and Trademark Office (USPTO) on a composition-of-matter patent for its novel fusion protein for Friedrich's Ataxia (referred to as BB-FA) that is built on its mitochondrial protein replacement (mPRT) platform. The Company's breakthrough platform technology has produced drug candidates that have demonstrated efficacy in several mitochondrial protein deficiencies in cell and animal models."BB-FA for Friedrich's Ataxia is our most advanced mPRT preclinical program. We have developed this platform based on a recombinant protein containing targeting signals," stated Dalia Megiddo, MD, MBA Chief Executive Officer of BioBlast. "We are pleased to have received this notice of allowance which covers the significant innovations we have made in the delivery of therapeutic proteins into the mitochondria. We look forward to making further progress toward providing a therapy to help Friedrich's Ataxia patients in need of treatment."Friedrich's Ataxia is an inherited disorder characterized by progressive deterioration of the muscular and nervous system that begins in the first or second decade of life and results in gait disturbance (ataxia), cognitive impairment, progressive heart disease and diabetes. According to Friedrich's Ataxia Research Alliance (FARA), about 1:50,000 people in the U.S. suffer from Friedrich's Ataxia. Most patients are wheelchair-bound within 15 years of diagnosis. Most patients do not survive beyond the fourth or fifth decade of life.Also Monday:Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines to meet the needs of patients, today announced the launch in Germany of Vitaros®, Apricus' novel topical on-demand treatment for erectile dysfunction ("ED"), by Hexal AG, an affiliate within the Sandoz Division of the Novartis Group of Companies ("Sandoz"). Auspex Pharmaceuticals, Inc. (Nasdaq:ASPX), a late clinical stage biopharmaceutical company focused on developing and commercializing novel medicines for the treatment of orphan diseases, today announced that it has completed the enrollment of the planned 90 patients in its Phase 3 registration clinical trial (First-HD) of SD-809 for the potential treatment of chorea associated with Huntington's disease (HD). BioBlast Pharma Ltd, (Nasdaq:ORPN)a clinical-stage biotechnology company committed to developing clinically meaningful therapies for patients with rare and ultra-rare genetic diseases, announced today it has received a notice of allowance from the United States Patent and Trademark Office (USPTO) on a composition-of-matter patent for its novel fusion protein for Friedrich's Ataxia (referred to as BB-FA) that is built on its mitochondrial protein replacement (mPRT) platform. BioCorRx, Inc. (BICX), developer of the Start Fresh Program, announces expansion into Illinois with the opening of a Start Fresh Recovery clinic in the Chicago area by Dr. George Fallieras. Cancer Genetics, Inc. (Nasdaq:CGIX), an emerging leader in DNA-based cancer diagnostics, today closed the announced acquisition of BioServe Biotechnologies (India) Pvt. Ltd., a premier genomics services provider serving both the research and clinical markets in India.Cellectar Biosciences, Inc. (Nasdaq:CLRB), a biopharmaceutical company developing innovative agents for the detection and treatment of cancer, announced that management will host a conference call and live webcast to discuss second quarter 2014 financial results and provide an update on each of its development programs on Wednesday, August 20th at 5:00 PM ET.CONMED Corporation (Nasdaq:CNMD)today announced that it will mail a letter to shareholders in connection with the Company's September 10, 2014 Annual Meeting. CytoDyn Inc. (OTCQB:CYDY), a biotechnology company focused on the development of new therapies for combating infection with human immunodeficiency virus (HIV), today announced that its August 20, 2014 annual meeting of shareholders will be shared live through a webcast that will allow the public to access the audio portion of the meeting, as well as management's presentation.Ebix, Inc. (Nasdaq:EBIX), a leading international supplier of On-Demand software and E-commerce services to the insurance and healthcare industries, today announced that the Company's A.D.A.M. Health Content Division has executed a contract with the Australian Nursing and Midwifery Federation (ANMF) to offer a range of health related continuing professional development (CPD) courses to its members on an annual subscription basis. Egalet Corporation (Nasdaq:EGLT)today announced the completion of a successful end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) regarding Egalet-002, an abuse-deterrent, extended-release, oral oxycodone product in development for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatments are inadequate.LeMaitre Vascular, Inc. (Nasdaq:LMAT)acquired Xenotis, the manufacturer and marketer of the Omniflow II biological graft for peripheral bypass and dialysis access, on August 14th. LHC Group, Inc. (Nasdaq:LHCG), a national provider of home health, hospice and comprehensive post-acute healthcare services, announced today that it has elected Brent Turner to its Board of Directors, effective August 15, 2014. MDxHealth SA (NYSE Euronext: MDXH), a leading molecular diagnostic company that develops and commercializes epigenetic tests to improve the diagnosis and treatment of cancer patients, today announced that one of the ConfirmMDx® for Prostate Cancer epigenetic genes is independently associated with risk of recurrence in patients with early prostate cancer (PCa). MediciNova, Inc. a biopharmaceutical company traded on the NASDAQ Global Market (Nasdaq:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced positive interim results of a Phase 2a clinical trial of MN-166 (ibudilast) in opioid dependence. Prothena Corporation plc (Nasdaq:PRTA), a clinical stage biotechnology company focused on the discovery, development and commercialization of novel antibodies for the potential treatment of diseases that involve protein misfolding or cell adhesion, today announced that Dale Schenk, PhD, the Company's President and Chief Executive Officer, will be presenting at the 2014 Rejuvenation Biotechnology Conference, a SENS Research Foundation Conference, on Friday, August 22, 2014.RedChip Companies, Inc., today announced it has issued a research update on Akers Biosciences Inc. (Nasdaq:AKER), a leading designer and manufacturer of rapid diagnostic screening and testing products.Response Genetics, Inc. (Nasdaq:RGDX), a company focused on the development and sale of molecular diagnostic tests that help determine a patient's response to cancer therapy, today announced that it has been awarded a multi-million dollar research subcontract to support the Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trials (ALCHEMIST). Sabra Health Care REIT, Inc.'s (Nasdaq:SBRA) largest tenant, Genesis HealthCare, announced today that it has signed a definitive agreement to combine with Skilled Healthcare Group, Inc. Tauriga Sciences Inc. (OTCQB:TAUG), a diversified life sciences company with interests in the natural wellness sector and in developing a proprietary synthetic biology platform technology, today announced that the Company's Chief Medical Officer, Lawrence A. May, M.D., F.A.C.P., will make a presentation on Tuesday, September 9th, 2014 at 12:15 PM at Marijuana for Medical Professionals Conference being held at the Sherman St Event Center in Denver, CO. Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL)will announce its interim report for H1 2014 on Thursday 21 August, in accordance with the company's financial calendar.


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