FDA Approves Addition to Cialis Product Label; FDA panel backs Gilead hepatitis C drug sofosbuvir Print E-mail
By Staff and Wire Reports   
Friday, 25 October 2013 18:59

Below is a look at some of the headlines for companies that made news in the healthcare sector on October 25, 2013. Eli Lilly and Company (NYSE: LLY) announced that Alfonso "Chito" Zulueta will be promoted to senior vice president and president of the Emerging Markets business effective Jan. 1, 2014. Zulueta will replace Jacques Tapiero who will retire Jan. 31, 2014, after 31 years of service to the company. Zulueta has been president and general manager of Lilly Japan since 2008. In his new role, he will lead the company's efforts in many of the world's fastest-growing markets in Asia, Latin America, Middle East and Africa, plus Russia and Turkey. Zulueta will report to John Lechleiter, Ph.D., chairman, president, and CEO, and will serve on the company's executive committee.

Tapiero joined Lilly in 1983 as a financial analyst. He became president of Emerging Markets in 2009. Prior to that, he had served as president of the intercontinental region for Lilly, which comprised offices in Asia, Australia, Africa, the Middle East, Canada, Latin America, and Russia, and had been general manager of several affiliates. "Jacques Tapiero has made extraordinary contributions to our company throughout his 31-year career with Lilly, culminating in 2009 with his appointment to lead our important Emerging Markets business," Lechleiter said. "Jacques' leadership has been characterized by strong operational skills and a keen focus on the development of Lilly people around the world. Jacques has been an exemplar of our values of integrity, excellence, and respect for people." Born in the Philippines, Zulueta received a bachelor's degree in economics from De La Salle University in the Philippines in 1982 and an MBA from the University of Virginia in 1987. In his 25 year career with Lilly, Zulueta has held several sales and marketing leadership positions in the United States before becoming general manager for the Philippines affiliate in 1995. He served as president of Asian operations prior to being promoted in 2008 to his current role as president and general manager of Lilly Japan, the company's second largest market and affiliate behind only the U.S. "I am delighted to welcome Chito Zulueta to the company's top management team," said Lechleiter. "Chito's previous Lilly assignments have provided him with the global experience necessary for his new role as head of our Emerging Markets business.

Chito's business savvy, his insights into diverse markets and cultures, and his passion for the patients whom we serve have enabled him to deliver outstanding results throughout his career. He is the ideal candidate to assume this important position." About Eli Lilly and Company Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com. C-LLY


==================

A federal advisory panel recommended on Friday that the U.S. Food and Drug Administration approve Gilead Sciences Inc's (NASDAQ:GILD) experimental hepatitis C drug sofosbuvir, paving the way for a treatment that is more effective than current therapies and takes less time.  The FDA advisory panel voted 15 to 0 in favor of approval of the drug in patients with two variants of the liver-damaging disease - genotype 2 and genotype 3 - in combination with an existing treatment, ribavirin.

If approved, it will be the first all-oral treatment for genotypes 2 and 3, obviating the need for the injectable drug interferon, which can cause debilitating side effects. Panelists called the vote "historic" and a "game-changer."   "Our patients have been waiting for this for a long time," said Dr. Curt Hagedorn, chief of medicine service at the Central Arkansas Veterans Healthcare Service.

The panel also voted unanimously to approve the drug in patients with genotype 1 and genotype 4 variants in combination with ribavirin and interferon in patients who have not received prior therapy.  Genotype 1 accounts for roughly 70 percent of hepatitis C cases. The FDA is not bound to follow the advice of its panels but typically does so.  "We'd already built in 100 percent chance of approval into our valuation for the company," said Karen Andersen, an analyst at Morningstar. "Gilead is still really in the prime position looking ahead in the hepatitis C market."  Panelists also appeared to support the use of sofosbuvir in patients who failed prior treatment, even though the company has little hard data to support such a claim.

"I did think there was a surprise upside result by the end of the panel," said Michael Yee, an analyst at RBC Capital Markets.  Bristol-Myers Squibb Co and Abbvie Inc have advanced all-oral clinical trial programs in late-stage development, using a variety of so-called direct acting antivirals, which directly interfere with the virus's ability to replicate. But Gilead is widely seen to be in the lead.

Chronic hepatitis C affects at least 3 million people in the United States, according to the U.S. Centers for Disease Control.  Analysts on average expect Gilead's drug to generate sales of $1.73 billion in 2014, according to Thomson Reuters data.

Current standard treatments for genotype 1 often include a protease inhibitor. These are oral drugs that include Merck & Co Inc's Victrelis and Vertex Inc's Incivek.  Gilead acquired sofosbuvir, known as a nucleotide analogue inhibitor, with its $11 billion purchase of Pharmasset Inc in 2012.

Panelists urged Gilead to make the drug available to other companies to study in combination with other oral regimens waiting in the wings.  Bristol-Myers (NYSE:BMY) is expected to present data from a late-stage clinical trial of its interferon-free treatment of genotype 1 patients at next month's meeting of the American Association for the Study of Liver Diseases in Washington, D.C.  The FDA is due to rule on whether to approve the drug by December 8.



Also Friday:



Abaxis, Inc. (NasdaqGS: ABAX)
, a medical products company manufacturing point-of-care blood instrumentation and consumables to the medical, research and veterinary markets, and privately-held LamdaGen Corporation, an optical biosensor company, announced today an R&D agreement to integrate LamdaGen's high-sensitivity Plasmonic ELISA technology on the Abaxis Piccolo and VetScan rotors.  System feasibility testing is currently underway.

AbbVie (NYSE: ABBV)
today announced financial results for the third quarter ended Sept. 30, 2013.

Antares Pharma, Inc. (NASDAQ: ATRS)
today announced the issuance of U.S. Patent number 8,562,564, entitled “Prefilled Syringe Jet Injector”.

The NASDAQ OMX Group, Inc. (Nasdaq:NDAQ)
announced that trading of Aerie Pharmaceuticals, Inc. (Nasdaq:AERI), a clinical stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with glaucoma and other diseases of the eye, commenced on The NASDAQ Stock Market on October 25, 2013.

Authentidate Holding Corp. (Nasdaq:ADAT)
, a provider of secure web-based software applications and telehealth products and services for healthcare organizations, today announced that O'Connell "Ben" Benjamin, CEO, will participate in the AMIZINO Fall 2013 Small Cap/Micro Cap Investment Conference on October 29, 2013.

Baptist Memorial Health Care has joined Premier, Inc.'s (Nasdaq:PINC) QUEST® collaborative of nearly 350 hospitals across nearly 40 states that are setting new standards in healthcare.

Bioheart, Inc. (OTCQB: BHRT)
, a biotech company focused on the discovery, development and commercialization of autologous cell therapies for the treatment of chronic and acute heart damage as well as severe peripheral vascular disease announces that it has entered into an agreement with Anosis, a company organized in Turkey.

Caliber Imaging & Diagnostics (OTCQB:LCDX)
, formerly Lucid, Inc., is exhibiting at the 64th American Association for Laboratory Animal Science National Meeting on October 27-31 in Baltimore, Maryland.

Can-Fite BioPharma (TASE: CFBI) (OTCQB: CANFY)
, a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, announced today it has successfully closed on a public offering of its common shares on the Tel Aviv Stock Exchange in the amount of approximately U.S. $6,000,000 with an over-subscription of 300%.

Daxor Corporation, (NYSE MKT: DXR)
-- A study utilizing blood volume measurement from College of Physicians & Surgeons at Columbia University was published in the October 2013 issue of the Journal of Cardiac Failure(Differences in Blood Volume Components Between Hyporesponders and Responders to Erythropoietin Alfa: The Heart Failure With Preserved Ejection Fraction (HFPEF) Anemia Trial: Margarita Borovka, BS, Mathew S. Maurer, M.D., et al.).

Eli Lilly and Company (NYSE: LLY)
today announced the U.S. Food and Drug Administration (FDA) approved a product label addition for CIALIS to include data from a 26-week study that showed CIALIS 5 mg for once daily use started in combination with finasteride significantly improved the signs and symptoms of benign prostatic hyperplasia (BPH) as early as 4 weeks, compared to placebo with finasteride, in men with BPH and an enlarged prostate.

Fibrocell Science, Inc. (NYSE MKT:FCSC)
, an autologous cell therapy company primarily focused on developing innovative products for skin diseases and conditions, today announced the company was honored with a Partners in Progress Award from the Dystrophic Epidermolysis Bullosa Research Association of America (DEBRA).

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 an article published yesterday in Blood described a mechanism by which epratuzumab affects B cells.

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 4 presentations on studies of epratuzumab in systemic lupus erythematosus (SLE) will be presented at the 2013 Annual Meeting of the American College of Rheumatology (ACR) to be held in San Diego, CA, from October 26 – 30, 2013.

ImmunoGen, Inc. (Nasdaq: IMGN)
, a biotechnology company that develops novel anticancer therapeutics using its antibody-drug conjugate (ADC) technology, today reported financial results for the three-month period ended September 30, 2013 – the first quarter of the Company’s 2014 fiscal year.

Impax Laboratories, Inc. (NASDAQ: IPXL)
today confirms that it has initiated a challenge of the patents listed in the Orange Book in connection with Atelvia® (Risedronate sodium) delayed-release tablets, 35 mg.

Laboratory Corporation of America® Holdings (LabCorp®) (NYSE: LH)
announced today the nationwide availability of QIAGEN’s therascreen® KRAS RGQ PCR Kit, a new FDA-approved companion diagnostic for certain colorectal cancer patients.

LDR Holding Corporation (Nasdaq:LDRH)
, a global medical device company focused on designing and commercializing novel and proprietary spinal surgical technologies, announced that Dr. Hyun Bae, Medical Director and Director of Spine Education at Cedars-Sinai in Los Angeles, CA presented 48-month safety and efficacy data of both one-level and two-level cervical disc replacement with Mobi-C® compared to traditional anterior cervical discectomy and fusion (ACDF).

LeMaitre Vascular, Inc. (Nasdaq:LMAT)
is presenting at the Canaccord Genuity Medical Technology & Diagnostics Forum at the Westin Grand Central in New York, NY, on Thursday, November 14, 2013.

Medical Marijuana, Inc. (OTC Pink:MJNA)
is pleased to inform shareholders and the general public that HempMedsPX™—a corporate portfolio company of Medical Marijuana Inc. and the exclusive master distributor and contracted marketing company for CannaVest Corp. and Medical Marijuana, Inc.—that BBC World News is airing a feature with Cheryl Shuman on Friday, October 25.

MEDIFIRST SOLUTIONS, INC. (OTCQB: MFST)
is pleased to announce that it will begin offering its LED Botanical Light Therapy Systems and services in its new Marlboro, New Jersey office located in Monmouth County.

MELA Sciences, Inc. (Nasdaq:MELA)
, the medical device company that has developed and is commercializing MelaFind®, the first and only FDA approved optical diagnostic device for melanoma detection used by dermatologists in their fight against melanoma, today announced that the company will be participating in the Washington D.C. Dermatological Society's Fall Clinical Conference taking place October 26, 2013 in Falls Church, Virginia.

Micro Imaging Technology, Inc. (OTCQB: MMTC)
announced today that it will collaborate with the Northern Michigan University (NMU) Department of Biology to expand MIT's technology to identify and differentiate Staphylococcus aureus(S. aureus) and Methicillin Resistant Staphylococcus aureus (MRSA).

Santarus, Inc. (NASDAQ:SNTS)
today announced that data from its Phase I clinical study with its investigational drug SAN-300, a novel antibody that inhibits very late antigen-1 (VLA-1; α1β1 integrin), will be featured in a poster presentation at the 2013 American College of Rheumatology.

Sunshine Heart, Inc. (Nasdaq:SSH)
, today announced that on October 21, 2013, the Compensation Committee of its Board of Directors approved five equity awards under Sunshine Heart's New-Hire Equity Incentive Plan, as material inducements to five individuals' entering into employment with the Company.

TheDirectory.com, Inc. (PINKSHEETS: SEEK)
, an emerging leader in the Local search space, today announced plans to attend two of the largest annual category specific conferences in 2014. www.TheDirectory.com will exhibit at the 2014 Florida Podiatric Medical Association (FPMA) Science and Management Symposium (SAM) in Orlando, Florida January 15th through the 19th, the Company will be promoting its industry-leading local podiatry directory www.PodiatristProfiles.com.

 




"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'.

Add this page to your favorite Social Bookmarking websites
Digg! Reddit! Del.icio.us! Mixx! Google! Live! Facebook! Technorati! StumbleUpon! MySpace! Yahoo!

blog comments powered by Disqus
 

Newsletter