Merck Announces FDA Acceptance of BLA for Investigational Allergy Tablet; CytRx Provides Update on Clinical Programs Print E-mail
By Staff and Wire Reports   
Wednesday, 08 May 2013 19:08
Below is a look at some of the headlines for companies that made news in the healthcare sector on May 8, 2013.

Merck (NYSE: MRK)
, known as MSD outside the United States and Canada, today announced that the Biologics License Application (BLA) for its investigational ragweed pollen (Ambrosia artemisiifolia) sublingual allergy immunotherapy tablet has been accepted for review by the U.S. Food and Drug Administration (FDA). On March 27, Merck announced that the FDA had also accepted the BLA for its investigational Timothy grass pollen (Phleum pratense) sublingual allergy immunotherapy tablet. Merck expects the FDA's review for both to be completed in the first half of 2014.

The BLA for Merck's investigational ragweed pollen sublingual allergy immunotherapy tablet is supported by five studies evaluating the efficacy and safety of the tablet in adults, 18 years of age or older, with ragweed induced allergic rhinitis (with or without conjunctivitis).

“Merck has a long history of developing new therapies to help patients with allergic rhinitis,” said Jeffrey A. Chodakewitz, M.D., senior vice president, interim franchise head, Respiratory & Immunology, Merck Research Laboratories. “This regulatory milestone for our investigational ragweed pollen sublingual allergy immunotherapy tablet represents another step in our continued commitment to offering potential new options to allergy specialists and their patients.”

Merck's ragweed pollen sublingual allergy immunotherapy tablet is an investigational sublingual dissolvable tablet designed to help treat the underlying cause of allergic rhinitis by generating an immune response to help protect against the targeted allergen. Merck has partnered with ALK-Abello to develop its sublingual allergy immunotherapy tablets for ragweed pollen, timothy grass pollen and house dust mite in North America.


======


CytRx Corporation (NASDAQ: CYTR)
, a biopharmaceutical research and development company specializing in oncology, today announced that it will focus on the clinical development of aldoxorubicin and expansion of its oncology pipeline based on its proprietary linker platform technology, following the recommendation of an independent Data Safety Monitoring Committee (DSMC) to discontinue the Phase 2b clinical trial with tamibarotene as a first-line treatment for patients with advanced non-small-cell lung cancer. The recommendation was based on an interim analysis indicating that patients treated with tamibarotene were unlikely to show improved progression-free survival over treatment with approved chemotherapeutic agents. No safety concerns were raised.

Earlier this week, CytRx announced that the independent DSMC for its Phase 2b clinical trial with aldoxorubicin as a first-line treatment for patients with advanced soft tissue sarcoma found no significant safety issues and recommended that the trial should be continued to completion. The Company expects to report results from the Phase 2b clinical trial in the second half of 2013.

“This is an eventful time as we expect to announce data from three clinical trials with aldoxorubicin this year and are making preparations to begin our first pivotal Phase 3 clinical trial with aldoxorubicin,” said Steven A. Kriegsman, CytRx President and CEO. “We see significant opportunities ahead with potential from multiple drug candidates addressing numerous oncology indications. Aldoxorubicin is its own pipeline with demonstrated efficacy in human tumor models of breast, ovarian, lung and pancreatic cancers and renal cell carcinoma (kidney cancer). Our linker platform can be combined with virtually any chemotherapeutic agent and is designed to improve concentration of drug at the site of tumors.

“We are disappointed by the outcome of the tamibarotene trial for our Company, but more importantly for patients. The trial was well-conducted but the DSMC judged that it would not be able to successfully meet its primary endpoint. We will continue to make tamibarotene available on a compassionate use basis for patients with acute promyelocytic leukemia,” he added.

Update on Aldoxorubicin Development

CytRx is preparing to initiate a global, open-label, randomized pivotal Phase 3 clinical trial comparing treatment with aldoxorubicin with approved chemotherapeutic agents for patients with soft tissue sarcoma who have relapsed or were refractory following prior treatment with chemotherapy. A Special Protocol Assessment (SPA) has been granted by the U.S. Food and Drug Administration (FDA) for the pivotal Phase 3 trial. The SPA indicates that the FDA deems the results from a single Phase 3 clinical trial as acceptable to support the regulatory approval, with final marketing approval dependent on the results of the trial and other accomplishments.

In addition to results from the Phase 2b clinical trial with aldoxorubicin, CytRx expects to report data from two additional clinical trials with aldoxorubicin in 2013, both in the second quarter. The first is a Phase 1b clinical trial in patients with advanced solid tumors to determine the maximum tolerated dose (MTD) of a combination of aldoxorubicin and doxorubicin. The clinical trial will continue with the combination aldoxorubicin and doxorubicin administered at the MTD to an expanded group of patients with chondrosarcomas or chordomas to determine safety and preliminary efficacy in these normally chemotherapy-insensitive malignancies. The purpose of this trial is to extend the Company's patent portfolio and potentially increase market penetration with aldoxorubicin for the treatment of patients with solid tumors. The Company also expects to report pharmacokinetic results from an open-label, single-center Phase 1b clinical trial in patient with metastatic solid tumors.



Also Wednesday:




Abbott (NYSE: ABT)
will present at the UBS Global Healthcare Conference on Wednesday, May 22, 2013. Thomas C. Freyman, executive vice president, finance and chief financial officer, and Brian Blaser, executive vice president, diagnostics products, will present at 7:30 a.m. Central time.

Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ)
(the "Company") announces the results of the vote on directors held earlier today at its annual meeting of shareholders.

Alimera Sciences, Inc. (NASDAQ: ALIM)
(Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, announced today that its United Kingdom subsidiary, Alimera Sciences Limited, has entered into a Loan and Security Agreement with Silicon Valley Bank (SVB) providing for a term loan in the principal amount of $5 million and up to an additional $15 million under a working capital line of credit.

Antares Pharma, Inc. (NASDAQ: ATRS)
today reported operating and financial results for the first quarter ended March 31, 2013.

Array BioPharma Inc. (Nasdaq: ARRY)
today announced that its Chief Executive Officer, Ron Squarer, will present at the Bank of America Merrill Lynch Healthcare Conference in Las Vegas and the UBS Global Healthcare conference in New York City.

BIOLASE, Inc. (NASDAQ: BIOL)
, the world's leading manufacturer and distributor of dental lasers, announced today that the U.S. Food and Drug Administration (the "FDA") has cleared the WaterLase® iPlus® all-tissue laser for use as a surgical instrument for soft-tissue procedures in orthopedic and podiatric surgery.

CytRx Corporation (NASDAQ: CYTR)
, a biopharmaceutical research and development company specializing in oncology, today announced that it will focus on the clinical development of aldoxorubicin and expansion of its oncology pipeline based on its proprietary linker platform technology, following the recommendation of an independent Data Safety Monitoring Committee (DSMC) to discontinue the Phase 2b clinical trial with tamibarotene as a first-line treatment for patients with advanced non-small-cell lung cancer.

Depomed, Inc. (Nasdaq: DEPO)
today reported financial results for the quarter ended March 31, 2013.

Dyadic International, Inc. (OTC Pink: DYAI)
, a global biotechnology company, today announced that it will report its financial results for the first quarter ended March 31, 2013 after market close on Wednesday, May 15, 2013 and will host a conference call that day at 5:00 p.m. Eastern Time to discuss those results.

Enanta Pharmaceuticals, Inc., (NASDAQ: ENTA)
, a research and development-focused biotechnology company dedicated to creating small molecule drugs in the infectious disease field, today reported financial results for its second fiscal quarter and six months ended March 31, 2013.

GW Pharmaceuticals plc (Nasdaq: GWPH, AIM: GWP)
, a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announced today the closing of its previously announced initial public offering of 3,500,000 American Depository Shares (ADSs) at a price to the public of $8.90 per share.

Halozyme Therapeutics, Inc. (NASDAQ: HALO)
today reported financial results for the quarter ended March 31, 2013.

Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in intravascular robotics, today reported recent business highlights and financial results for the first quarter ended March 31, 2013.

Hansen Medical, Inc. (NASDAQ: HNSN)
, a global leader in intravascular robotics, today announced that the Company has reached an agreement in principle to settle the consolidated securities class-action lawsuit related to the restatement of Hansen Medical's financial statements that was first announced in October 2009.

Health Enhancement Products, Inc. (OTCBB: HEPI)
headquartered in Michigan, investigates and licenses high-value bioactive molecules derived from algae that benefit human and animal health.

Idera Pharmaceuticals (NASDAQ: IDRA)
today announced presentation of data from its randomized, double-blind, placebo-controlled Phase 2 trial that showed improvements from baseline of up to 90% in Psoriasis Area Severity Index (PASI) scores in patients with moderate to severe plaque psoriasis following four weeks of treatment with the Toll-like Receptor (TLR) antagonist IMO-3100.

InspireMD, Inc. (NYSE MKT: NSPR)
, a leader in embolic protection stents, today announced financial results for the three month period ended March 31, 2013, the third quarter of its 2013 fiscal year.

Interleukin Genetics, Inc. (OTCQB: ILIU)
announced today the online publication in Osteoarthritis and Cartilage of a study with investigators at the Thurston Arthritis Research Center of the University of North Carolina entitled, “IL-1 receptor antagonist gene as a predictive biomarker of progression of knee osteoarthritis in a population cohort.”

Nanosphere, Inc. (NASDAQ: NSPH)
Nanosphere, a leader in the development and commercialization of advanced molecular diagnostics systems, today reported financial results for the first quarter ended March 31, 2013. In addition, the Company announced that it secured $27 million in new capital.

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB)
, a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced business highlights and consolidated results for the first quarter ended March 31, 2013.

Orexigen® Therapeutics, Inc. (Nasdaq: OREX)
, a biopharmaceutical company focused on the treatment of obesity, today announced financial results for the first quarter ended March 31, 2013.

OxySure® Systems, Inc. (OTCQB: OXYS) ("OxySure," or the "Company"), a medical device innovator of life-saving, easy-to-use emergency oxygen solutions with its "oxygen from powder" technology, today announced that it will hold a webcast at 11:30 am ET on Thursday, May 16, 2013 to discuss its growth strategy.

That loud noise coming from the botanical extract industry is Plandaí Biotechnology, Inc. (OTCQB: PLPL) landing on the scene with three highly bioavailable products that will likely change the way we look at botanical extracts for years to come.

Puma Biotechnology, Inc. (NYSE: PBYI)
, a development stage biopharmaceutical company, announced that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder of Puma, will present an overview of the Company at 4:20 p.m. PDT on Wednesday, May 15, at the Bank of America Merrill Lynch 2013 Health Care Conference.

Sangamo BioSciences, Inc. (Nasdaq: SGMO)
today reported first quarter 2013 financial results and accomplishments.

Zalicus Inc. (Nasdaq Capital Market: ZLCS)
, a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain, today announced that it has entered into a stock purchase agreement with Lincoln Park Capital Fund, LLC (“Lincoln Park”) an institutional investor.



"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