Jazz Pharma and Azur Pharma Agree to Combine; Aastrom Announces Positive 12-Month Safety And Efficacy Data Print E-mail
By Staff and Wire Reports   
Monday, 19 September 2011 19:54
Below is a look at some of the headlines for companies that made news in the healthcare sector on September 19, 2011.

Jazz Pharmaceuticals, Inc.  (NASDAQ:JAZZ) and Azur Pharma Limited announced that the companies have agreed to combine in an all-stock transaction that creates a specialty pharmaceutical company incorporated in Ireland with a diversified portfolio of products currently marketed in the United States (US).

The combined company would be named Jazz Pharmaceuticals plc. Azur Pharma is a privately-held, profitable specialty pharmaceutical company headquartered in Dublin, Ireland with US operations in Philadelphia .

Upon completion of the merger, shareholders of Jazz Pharmaceuticals, Inc. would own slightly under 80 percent of Jazz Pharmaceuticals plc, and Azur Pharma shareholders would own slightly over 20 percent. Shareholders of Jazz Pharmaceuticals, Inc. would receive one ordinary share of Jazz Pharmaceuticals plc in exchange for each share of Jazz Pharmaceuticals, Inc. common stock they own at closing.

The transaction, which has been approved by the boards of directors of both companies, is subject to approvals by Jazz Pharmaceuticals, Inc.

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Aastrom Biosciences, Inc.  (NASDAQ:ASTM) announced that 12-month follow up data from the IMPACT-DCM clinical trial for ixmyelocel-T showed that treatment was well-tolerated and that efficacy observations were consistent with improved function of impaired myocardium in patients with dilated cardiomyopathy (DCM) including ischemic cardiomyopathy (ICM) and idiopathic dilated cardiomyopathy (IDC).

Results were reported today by Amit N. Patel, associate professor of surgery at the University of Utah School of Medicine and national principal investigator for Aastrom's U.S. Phase 2 IMPACT-DCM clinical trial, in a poster presentati. In the study, 40 patients diagnosed with ICM or IDC were randomized 3 to 1 to either a single administration of ixmyelocel-T or standard of care and were followed for 12 months.

In the ixmyelocel-T treatment group, bone marrow cells were cultured using Aastrom's technology to expand the number of mesenchymal cells, monocytes and macrophages while retaining many of the mononuclear cells. This combination has been associated with biological activity that promotes tissue remodeling, immunomodulation, and promotion of angiogenesis. Twenty-one of the 25 (84%) ixmyelocel-T patients completed the 12-month visit. Seven of 15 (47%) of the control patients completed the 12-month visit, while an additional 5 of 15 (33%) of the control patients enrolled into the extension phase of the study and received ixmyelocel-T treatment.


Also Monday:  


AdCare Health Systems, Inc. (NYSE Amex: ADK), a leading provider of skilled nursing and assisted living for seniors, has been invited to present at the JMP Securities 6th Annual Healthcare Conference.

Alkermes plc (NASDAQ: ALKS) today announced the establishment of its corporate operations in Ireland, with new headquarters located in Dublin.

Amgen (NASDAQ: AMGN) today announced new long-term data showing that Prolia® (denosumab) treatment for up to eight years in postmenopausal women with low bone mass or osteoporosis was associated with a continued increase in bone mineral density (BMD), an important determinant of bone strength, and a persistent reduction in markers of bone turnover.

BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) today announced the presentation of data related to intravenous (i.v.) peramivir for the treatment of influenza at the 51stAnnual Interscience Conference on Antimicrobial Agents & Chemotherapy (ICAAC) in Chicago, Illinois.

BioRestorative Therapies, Inc. (OTCQB: BRTX) formerly known as Stem Cell Assurance, Inc., today announced that its common stock is now trading on the OTCQB market under its new name, BioRestorative Therapies, Inc., and that the trading symbol for its common stock has been changed from "SCLZ" to "BRTX."

Biovest International, Inc. (OTCQB: BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (OTCQB: ABPI), today announced that the Naval Health Research Center (NHRC) and Biovest are continuing an ongoing collaboration to study Biovest's hollow fiber technology.

Cannabis Science, Inc. (OTCBB: CBIS), a pioneering US biotech company developing pharmaceutical cannabis products, is pleased to announce that Robert Kane, formerly of Stifel Nicolaus (NYSE:SF), has been retained by Cannabis Science in the capacity of Investor Relations Management to increase Company exposure, access to capital, and ultimately increase shareholder value.

Eli Lilly and Company (NYSE: LLY) will bring one of its patient education programs to Washington, D.C., September 21-24 during the 2011 Annual Legislative Conference presented by the Congressional Black Caucus Foundation at the Walter E. Washington Convention Center.

Generex Biotechnology Corporation's (OTCBB: GNBT) (www.generex.com) wholly-owned subsidiary, Antigen Express, Inc. (www.antigenexpress.com), today announced that AE37, a novel HER-2/neu-targeted vaccine for the treatment of breast, prostate, and other cancers, is reviewed in the September 2011 issue of Expert Opinion on Biological Therapy, a peer-reviewed, international journal publishing review articles and original papers on all aspects of biological therapy, providing expert opinion on the scope for future development.

Genesis Biopharma, Inc. (OTCBB: GNBP), a biotechnology company developing targeted cancer immunotherapies, today announced the engagement of four senior industry consultants.

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the second pivotal Phase 3 clinical trial (Study 103) of its investigational fixed-dose, single-tablet “Quad” regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate, being evaluated for HIV-1 infection in treatment-naïve patients, met its primary objective of non-inferiority at week 48 as compared to ritonavir-boosted atazanavir plus Truvada® (emtricitabine/tenofovir disoproxil fumarate) based on the proportion of subjects who achieved HIV RNA levels (viral load) of less than 50 copies/mL.

Human Genome Sciences, Inc. (NASDAQ: HGSI) announced today that its presentation at the UBS Global Life Sciences Conference will be webcast and may be accessed at www.hgsi.com.

InVivo Therapeutics (OTC/BB: NVIV) congratulates Robert S. Langer, Sc.D., InVivo co-founder and member of the Company’s Scientific Advisory Board, for his selection as the recipient of the 2011 Warren Alpert Foundation Prize.

Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) and Azur Pharma Limited today announced that the companies have agreed to combine in an all-stock transaction that creates a specialty pharmaceutical company incorporated in Ireland with a diversified portfolio of products currently marketed in the United States (US).

Keryx Biopharmaceuticals (Nasdaq: KERX) today announced completion of patient enrollment in the long-term study component of its Phase 3 registration program of Zerenex™, the Company's ferric iron-based phosphate binder for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with end-stage renal disease (ESRD) on dialysis.

MMRGlobal, Inc. (OTCBB: MMRF)
, a leading provider of Personal Health Records, MyEsafeDepositBox storage solutions and electronic document management systems for healthcare professionals, today announced that it has signed the first set of definitive sales agreements with 13 individual surgery centers as a result of the Company's previously announced relationship with JERCS, Inc., a private healthcare revenue cycle management group (JER).

NeuroMetrix, Inc. (Nasdaq: NURO)
today reported the initiation of commercial shipments of NC-stat® DPNCheck™, a fast, accurate and quantitative point-of-care test for the evaluation of systemic neuropathies such as diabetic peripheral neuropathy (DPN).

NHS Health Solutions, Inc. (PINKSHEETS: NHSH) has formally entered into a binding Letter of Intent with Mineseeker Operations Overseas Limited (hereinafter, "Mineseeker") in order to fully acquire Mineseeker as a wholly owned subsidiary.

Opexa Therapeutics, Inc. (NASDAQ: OPXA), a company developing Tovaxin®, a novel T-cell therapy for multiple sclerosis (MS), today announced that Neil K. Warma, Opexa’s President and Chief Executive Officer, has been invited to deliver a presentation at The Phacilitate Cell & Gene Therapy Forum Asia 2011 at the Marina Bay Sands Hotel in Singapore.

Pacific Biosciences of California, Inc. (NASDAQ: PACB), provider of Single Molecule Real Time (SMRT®) sequencing products, announced today that the company has partnered with Cycle Computing to optimize the PacBio RS SMRT Analysis software for the cloud. Preliminary demonstrations of the solution will be presented this week by Cycle Computing at the Bio-IT World Cloud Computing conference on September 20 in La Jolla, California and the Amazon Web Services Genomics Event on September 22 in Seattle, Washington.

Palatin Technologies, Inc. (NYSE Amex: PTN) will announce its fourth quarter, fiscal year 2011 financial results on Thursday, September 22, 2011 before the open of the U.S. financial markets.

Pegasystems Inc. (NASDAQ: PEGA), the leader in Business Process Management (BPM) and software for customer centricity, today announced it will host the Collaborative Healthcare Summit at the Park Plaza Hotel in Boston on October 19, 2011.

Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced that top-line data from part one of a two-part Phase 1 study of SPI-1620 in combination with docetaxel was presented in an oral presentation at the 12th International Conference on Endothelin, held in Cambridge, United Kingdom, from September 11-14, 2011.

Unigene Laboratories, Inc. (OTCBB: UGNE) a leader in the design, delivery, manufacture and development of peptide-based therapeutics announced today that its licensee, Tarsa Therapeutics (Tarsa), presented positive Phase 3 data from its ORACAL trial of OSTORA™ during the annual American Society for Bone and Mineral Research (ASBMR) 2011meeting on September 18.



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