Alexza Receives Response Letter for Adasuve; Oxygen Secures Clinical Supply of Oxycyte(R) Print E-mail
By Staff and Wire Reports   
Thursday, 03 May 2012 18:15
Below is a look at some of the headlines for companies that made news in the healthcare sector on May 2, 2012.

Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced it has received a Complete Response Letter (CRL) from the U.S. FDA regarding its New Drug Application (NDA) for ADASUVE™ (loxapine) inhalation powder, 5 mg and 10 mg.  

The CRL was issued by FDA's Center for Drug Evaluation and Research indicating that the NDA review cycle is complete and the application is not ready for approval in its present form.  ADASUVE is being developed for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.



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Oxygen Biotherapeutics, Inc. (Nasdaq: OXBT) announced it has achieved the critical milestone of securing an exclusive supply of cGMP-compliant Oxycyte®, the Company's proprietary perfluorocarbon based emulsion, that will take the Company through the current Phase II clinical trial for traumatic brain injury (TBI) and well into Phase III trials.

Key to this recent development was the signing of a contract with the manufacturer of cGMP-compliant FtBu, the proprietary, patent-protected active pharmaceutical ingredient in Oxycyte. Per the agreement, Oxygen Biotherapeutics has the exclusive rights to the supply of FtBu manufactured by this supplier. In addition, the Company is now aligned with a California-based contract manufacturer that will produce Oxycyte based on the Company's new scaled-up process for making the emulsion. Results from recent engineering batches made by this new supplier demonstrate that Oxycyte continues to meet all required specifications for product release.



Also Thursday:



Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced its financial results for the first quarter ended March 31, 2012.

Affymetrix, Inc., (NASDAQ:AFFX)
today reported its operating results for the first quarter of 2012.

Alkermes plc (NASDAQ: ALKS)
today announced that data from several company-sponsored studies of naltrexone for extended-release injectable suspension (XR-NTX) are scheduled to be presented at the 2012 American Psychiatric Association (APA) Annual Meeting in Philadelphia, May 5-9, 2012. XR-NTX is marketed by Alkermes as VIVITROL® and is approved in the U.S. for the treatment of alcohol dependence and opioid dependence, following opioid detoxification.

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY)
, a leading RNAi therapeutics company, today reported its consolidated financial results for the first quarter 2012, and company highlights.

Anika Therapeutics, Inc. (Nasdaq: ANIK)
, a leader in products for tissue protection, healing, and repair, based on hyaluronic acid (“HA”) technology, today reported financial results for the quarter ended March 31, 2012.

ArQule, Inc. (NASDAQ: ARQL)
today announced its financial results for the first quarter of 2012.

Arrowhead Research Corporation (NASDAQ:ARWR)
today announced that senior management will present data for its Dynamic PolyConjugate™ (DPC) delivery platform for siRNA delivery including its RNAi therapeutic candidate for the treatment of hepatitis B virus (HBV) at several upcoming scientific conferences.

Assisted Living Concepts, Inc. (NYSE: ALC)
announced that it will delay its previously announced May 3, 2012 earnings release and conference call discussion regarding its 2012 first quarter financial results.

AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO)
today reported consolidated financial results for the first quarter of 2012 and reviewed key first quarter accomplishments.

Biovest International, Inc. (OTCQB:BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (OTCQB:ABPI), today announced that new data from the BiovaxID® Phase II mantle cell lymphoma clinical trial conducted by the U.S. National Cancer Institute (NCI) will be presented by the NCI at the 2012 American Society of Clinical Oncology Annual Meeting (ASCO 2012).

Catalyst Health Solutions, Inc. (NASDAQ: CHSI), today announced its financial results for the first quarter ended March 31, 2012.

CorMedix Inc. (NYSE Amex: CRMD), a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardiorenal disease, today announced the appointment of Randy Milby as its Chief Operating Officer.

Covidien (NYSE: COV) and GE Healthcare (NYSE: GE), leading global providers of healthcare products and recognized innovators in patient monitoring and respiratory care devices, today announced a five-year, global collaboration to incorporate Covidien measurement technologies into GE Healthcare patient monitors.

Emergent BioSolutions Inc. (NYSE: EBS) announced today its financial results for the first quarter ended March 31, 2012.

Exelixis, Inc. (NASDAQ:EXEL) today announced a broad expansion of the cabozantinib development program under a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute’s Cancer Therapy Evaluation Program (NCI-CTEP), with the approval of the initial program of 12 proposed clinical trials under the agreement.

Exelixis, Inc. (Nasdaq: EXEL) today reported financial results for the quarter ended March 31, 2012.

Fluidigm Corporation (NASDAQ:FLDM) today announced that it will report its first quarter 2012 financial results on May 10, 2012, after close of market.

Furiex Pharmaceuticals, Inc. (NASDAQ: FURX) today reported its financial and operating results for the quarter ended March 31, 2012.

Idera Pharmaceuticals, Inc. (NASDAQ: IDRA)
today announced top-line results of a randomized, controlled Phase 2 clinical trial of IMO-2055, the Company’s investigational oncology product candidate targeting Toll-like Receptor 9 in combination with Erbitux® (cetuximab) for the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) in patients who previously progressed on chemotherapy.

NPS Pharmaceuticals, Inc. (NASDAQ: NPSP), a specialty pharmaceutical company developing orphan therapeutics for rare gastrointestinal and endocrine disorders, today reported its results for the first quarter of 2012.

NPS Pharmaceuticals, Inc. (NASDAQ: NPSP), a specialty pharmaceutical company developing innovative therapeutics for rare gastrointestinal and endoccrine disorders, today reported that four additional patients have successfully achieved independence from parenteral nutrition (PN) and intravenous (IV) fluids while on long-term Gattex® (teduglutide) therapy in STEPS 2, a 24-month open-label study in adult short bowel syndrome (SBS).

Obagi Medical Products, Inc. (Nasdaq:OMPI)
, a leader in topical aesthetic and therapeutic skin health systems, today reported that net sales for the first quarter ended March 31, 2012 rose 16% to a record $30.8 million from $26.5 million a year ago.

Oncolytics Biotech Inc. (“Oncolytics”) (TSX:ONC, NASDAQ:ONCY) announced today that it has entered into an agreement whereby the NCIC Clinical Trials Group (CTG) at Queen's University in Kingston, Ontario, will sponsor and conduct a randomized Phase II study of REOLYSIN® in patients with advanced or metastatic colorectal cancer.

Osiris Therapeutics, Inc. (NASDAQ: OSIR) today announced that it will report its financial results for the first quarter ended March 31, 2012, on Friday, May 11, 2012. C. Randal Mills, Ph.D., President and Chief Executive Officer, and Philip R. Jacoby, Jr., Chief Financial Officer, will provide a company update and discuss results via a webcast and conference call on Friday, May 11, 2012 at 9:00 a.m. ET.

Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) today announced that it has secured a $27.5 million debt financing facility through Oxford Finance. Pacira will use the proceeds from this financing to refinance the remaining principal of its outstanding term loan and for general corporate purposes.

pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, today announced that its financial results for the third quarter of fiscal year 2012 will be released before the market open on Wednesday, May 9, 2012, followed the same day by a conference call and live webcast scheduled for 8:30 a.m. ET.

Repligen Corporation (NASDAQ:RGEN) today reported results for its first quarter ended March 31, 2012. Total revenue for the first quarter of 2012 was $12,824,000 compared to total revenue of $5,906,000 for the same period in 2011.

Rite Aid Corporation (NYSE: RAD) today announced sales results for April.

Rite Aid Corporation (NYSE: RAD) announced today the pricing of an offering of an additional $421.0 million aggregate principal amount of 9.25% senior notes due 2020 (the “Notes”) at a price of 101.25% which will result in total proceeds of approximately $426.3 million.

Simulations Plus, Inc. (NASDAQ: SLP), a leading provider of simulation and modeling software and consulting services for pharmaceutical discovery and development, announced today the release of Version 3.0 of its MedChem Studio™ and Version 2.0 of its MedChem Designer™ cheminformatics software programs.

Synta Pharmaceuticals Corp. (NASDAQ: SNTA) today provided a clinical program update and reported financial results for the quarter ended March 31, 2012.

Targacept, Inc. (NASDAQ: TRGT), a clinical-stage biopharmaceutical company developing novel NNR Therapeutics™, today reported its financial results for the first quarter ended March 31, 2012.

Walgreens (NYSE: WAG) (NASDAQ: WAG)
had April sales of $5.78 billion, a decrease of 3.7 percent from $6.0 billion for the same month in fiscal 2011.

Zalicus Inc. (NASDAQ: ZLCS) today reported financial results for the first quarter ended March 31, 2012.



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