MannKind Closes Phase 3 Study of AFREZZA; Alkermes Issues Positive Results of ALKS 5461 Print E-mail
By Staff and Wire Reports   
Friday, 31 May 2013 19:40

Below is a look at some of the headlines for companies that made news in the healthcare sector on May 31, 2013.
MannKind Corporation (Nasdaq: MNKD) announced that all follow-up visits have been completed for the patients enrolled in Study 171, a Phase 3 clinical study of AFREZZA® (insulin human [rDNA origin]) inhalation powder, an investigational, ultra rapid-acting mealtime insulin therapy, administered using MannKind's next-generation inhaler. MannKind expects to release data from this study later this summer.

Study 171 is an open-label study in patients with type 1 diabetes. After a run-in period, during which all patients were optimized on their basal insulin regimen, 518 subjects were randomized to one of three arms for mealtime insulin: a control arm, in which patients utilize injected rapid-acting insulin, or one of two AFREZZA arms, one for the MedTone inhaler and the other for the next-generation inhaler. After the mealtime insulin was titrated, there was a 12-week observation period on stable doses of the mealtime insulin to assess HbA1c levels, which is the primary outcome parameter. Another objective of this study is to compare the safety profile of the two AFREZZA treatment groups.

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Alkermes plc (NASDAQ: ALKS)
announced the presentation of positive phase 2 data for ALKS 5461, a novel opioid modulator, in patients with major depressive disorder (MDD) and inadequate response to standard therapies. In the phase 2 study, ALKS 5461 met its primary endpoint, met key secondary endpoints and demonstrated significant reduction in depressive symptoms versus placebo. The study is being presented in an oral session at the 53rd Annual New Clinical Drug Evaluation Unit (NCDEU) Meeting in Hollywood, Fla., by Maurizio Fava, M.D., of Massachusetts General Hospital and Harvard Medical School.

“The magnitude of effect seen with ALKS 5461 in this study is highly significant. These results are very encouraging for ALKS 5461 as a potential new treatment approach, with substantial reductions in depressive symptoms demonstrated and rapid onset of action observed,” stated Maurizio Fava, M.D., Director of the Depression Clinical and Research Program at Massachusetts General Hospital and Slater Family Professor of Psychiatry at Harvard Medical School.

The phase 2 study of ALKS 5461 utilized a sequential parallel comparison design (SPCD), designed to reduce the impact of clinically meaningful response to treatment with placebo. The study included two four-week, randomized, double-blind stages run in sequence: an Initial Study Stage and a Successive Study Stage. The Successive Study Stage randomized only those patients who were non-responders to placebo in the Initial Study Stage. Both stages of the phase 2 study evaluated two doses of ALKS 5461, a lower dose and a higher dose. Overall, the combined analysis of both doses at both stages showed statistically significant efficacy on multiple endpoints compared to placebo. Overall, the lower dose showed greater efficacy than the higher dose and, as a result, will be the top end of the dose range employed in future studies. Results for the lower dose from the Successive Study Stage of the study included:

* ALKS 5461 significantly reduced Hamilton Depression Rating Scale (HAM-D17) scores from baseline (p=0.013), with a reduction of 5.3 points, compared to a reduction of 1.2 points in the placebo group at the end of the four-week treatment period. ALKS 5461 also significantly reduced Montgomery–Åsberg Depression Rating Scale (MADRS) scores from baseline (p=0.004), with a reduction of 8.7 points, compared to a reduction of 1.8 points in the placebo group at the end of the four-week treatment period. * ALKS 5461 had an onset of effect, as measured by MADRS, evident after one week of treatment.

In the phase 2 results for the overall study population, including both the Initial Study Stage and the Successive Study Stage, patients who received either dose of ALKS 5461 for a treatment period of four weeks showed a significant reduction in depressive symptoms from baseline in HAM-D17 (p=0.026) and MADRS (p=0.004) scores, compared to placebo. The primary endpoint of the phase 2 study was the change from baseline in depressive symptoms over a four-week treatment period in the overall study population, as measured by HAM-D17, compared to placebo. Data from the study showed that ALKS 5461 was generally well tolerated. The most common adverse events observed in the study were nausea, headache and dizziness.

“ALKS 5461 reflects a new approach to the treatment of major depressive disorder based on modulation of the opioid system in the brain. With these compelling data in hand, we are planning to meet with the U.S. FDA as we work to advance ALKS 5461 to pivotal clinical development,” stated Elliot Ehrich, M.D., Chief Medical Officer of Alkermes. “ALKS 5461, one of several product candidates in our advancing clinical pipeline, is an excellent example of how Alkermes is leveraging our unique understanding of opioid biology and pharmacology to develop medications that address unmet medical needs for central nervous system disorders.”

Study Design--This phase 2, randomized, double-blind, multicenter, placebo-controlled study assessed the efficacy and safety of once-daily ALKS 5461 as adjunctive treatment in 142 patients with MDD who had an inadequate response to a stable dose of either a selective serotonin reuptake inhibitor (SSRI) or a serotonin-norepinephrine reuptake inhibitor (SNRI). Two doses of ALKS 5461 were evaluated, each with a 1:1 ratio of buprenorphine and ALKS 33 (lower dose of 2mg/2mg and higher dose of 8mg/8mg). The primary endpoint of the study was the change from baseline in depressive symptoms over a four-week treatment period, as measured by HAM-D17. Secondary endpoints included additional analyses of patient responses based on HAM-D17, MADRS and Clinical Global Impression – Severity Scale (CGI-S) scores.

The study utilized a sequential parallel comparison design (SPCD), a design developed ten years ago by Drs. Fava and Schoenfeld at Massachusetts General Hospital and now widely utilized in clinical trials. A SPCD trial involves two randomized, double-blind stages run in sequence. In the Initial Study Stage (stage 1), patients are randomized to either drug treatment or placebo. In the ALKS 5461 phase 2 study, the Initial Study Stage was a four-week treatment period. At the end of the Initial Study Stage, patients were reassigned treatment groups for the Successive Study Stage (stage 2), which in the ALKS 5461 phase 2 study was a second four-week treatment period. In the Successive Study Stage, patients who had been on drug in the Initial Study Stage were put on placebo. Patients who had been administered placebo in the Initial Study Stage were determined to be either responders, i.e., they responded positively to placebo treatment, or non-responders. Placebo responders were assigned to remain on placebo in the Successive Study Stage. Placebo non-responders were re-randomized to either placebo or drug treatment in the Successive Study Stage. SPCD studies are particularly useful in studies of depression, anxiety and other difficult psychiatric diseases to reduce the impact of placebo effect on the assessment of treatment response.


Also Friday:

Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH), a biopharmaceutical company focused on developing and commercializing products to treat autoimmune diseases, announced today that Paul F. Truex, President and Chief Executive Officer, and Dr. Colin Hislop, Senior Vice President and Chief Medical Officer, will present a corporate update at the 2013 Annual Jefferies Global Healthcare Conference.

Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL)
today announced that executive management will participate in the Jefferies 2013 Healthcare Conference to be held June 3-6, 2013 at the Grand Hyatt in New York City.

Celsion Corporation (NASDAQ: CLSN)
today announced that it has received commitments from institutional investors to purchase an aggregate of approximately $9.83 million of the Company's common stock in an at-the-market registered direct offering led by a dedicated health care fund.

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ: CELG), today announced that the European Medicines Agency’s (EMA): Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Pomalidomide Celgene in combination with dexamethasone for the treatment of relapsed and refractory multiple myeloma (rrMM) in patients who have received at least two prior therapies, including both lenalidomide and bortezomib, and have demonstrated disease progression while on their last therapy.

Dendreon Corporation (NASDAQ: DNDN)
announced today that four abstracts featuring PROVENGE® (sipuleucel-T) data from ongoing Phase II sequencing studies and the PROCEED registry, and two abstracts highlighting preliminary Phase II data of DN24-02, an investigational active cellular immunotherapy in patients with surgically resected HER2+ urothelial cancer, will be presented at the 49th Annual Meeting of the American Society of Clinical Oncology (ASCO) from May 31-June 4, 2013 in Chicago, IL.

Exelixis, Inc. (NASDAQ:EXEL)
today announced it has initiated METEOR, a phase 3 pivotal trial comparing cabozantinib to everolimus in patients with metastatic renal cell carcinoma (mRCC) who have experienced disease progression following treatment with at least one prior VEGFR tyrosine kinase inhibitor (TKI). The primary endpoint for the trial is progression-free survival.

Generex Biotechnology Corporation (OTCBB: GNBT)
today highlighted advantages of its AE37 cancer vaccine and technology in the context of a positive cancer immunotherapy forecast recently issued by Citigroup analysts.

Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX)
announced today that Arthur Sands, M.D., Ph.D., president and chief executive officer, will present at the Jefferies Global Healthcare Conference on Tuesday, June 4, at 9:00 AM ET in New York City.

Milestone Scientific Inc.(OTCQB: MLSS)
, the recognized leader in advanced, computer-controlled injection technologies, today announced that Joseph D'Agostino, Chief Financial Officer & Chief Operating Officer, will present at the upcoming SeeThruEquity Second Annual Investor Conference on June 4, 2013 at 2:30 p.m. Eastern Time at the Penn Club in New York City.

NuVasive, Inc. (NASDAQ: NUVA), a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, is excited to announce the global launch of its Maximum Access Surgery Posterior Lumbar Interbody Fusion (MAS® PLIF) procedure.

QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA)
today announced two agreements adding promising new biomarkers involving glioblastoma, lymphoma and other cancers to QIAGEN's expanding portfolio of potential companion diagnostics that is being developed to help doctors use a patient's genomic information to guide treatment decisions.

Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX)
today announced that it will hold a conference call to discuss data presented at an ASCO plenary session from the DECISION study, a Phase 3 trial investigating the use of Nexavar® (sorafenib) tablets in patients with locally advanced or metastatic radioactive iodine-refractory (RAI) differentiated thyroid cancer.

PROLOR Biotech, Inc. (NYSE MKT: PBTH)
, a clinical stage company developing next generation biobetter therapeutic proteins, today announced that company management will give a corporate presentation at the Jefferies 2013 Global Healthcare Conference, being held at the Grand Hyatt Hotel in New York City.

Royalty Pharma is today issuing a presentation outlining why it believes Elan's (NYSE: ELN) valuation of Tysabri, as set out in materials released by Elan on 29 May 2013, is far too high.

Spectrum Pharmaceuticals (NasdaqGS: SPPI)
, a biotechnology company with fully integrated commercial and drug development operations and a primary focus in oncology and hematology, today announced key presentations of clinical data that included: three ZEVALIN® (ibritumomab tiuxetan)-related poster presentations, and one oral presentation and two poster presentations of clinical data for belinostat at the American Society of Clinical Oncology (ASCO) Annual Meeting, being held in Chicago, Illinois, from May 31 to June 4, 2013.

Synageva BioPharma Corp. (NASDAQ:GEVA)
, a biopharmaceutical company developing therapeutic products for rare diseases, announced three poster presentations at the National Lipid Association (NLA) annual meeting held in Las Vegas, Nevada, May 30- June 2, 2013, as well as a Synageva-sponsored satellite symposium held on Friday, May 31, 2013.

University General Health System, Inc. (OTCQB: UGHS)
, a diversified, integrated multi-specialty health care delivery system, today announced that it will be presenting at the Sidoti & Company Semi-Annual Micro-Cap Conference on Friday, June 7, 2013.

Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA)
, a biopharmaceutical company focused on the development and commercialization of products for the treatment of central nervous system disorders, today announced that it will deliver a corporate presentation at the Jefferies Global Healthcare Conference in New York City on Thursday, June 6, 2013 at 2:30 p.m. Eastern Time.




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