|Affymax soars on drug candidate update. After the bell: Depomed in deal with J&J unit|
|By BioMedReports.com Staff|
|Thursday, 05 August 2010 18:32|
Depomed, Inc. (Nasdaq:DEPO) after the bell today announced that Janssen Pharmaceutica N.V. has licensed worldwide rights to Depomed's Acuform gastric retentive drug delivery technology to be used for the non-exclusive development of a fixed dose combination formulation of canagliflozin, a Sodium Glucose Transport 2 (SGLT2) inhibitor, and extended-release metformin. Janssen Pharmaceutica has also been granted a right of reference to the GLUMETZA NDA and associated data for use in developing the combination product.
Under the terms of the service agreement, Depomed will formulate the fixed dose combination product. Janssen Pharmaceutica will have the commercialization rights for the combination product. Depomed will receive a $5 million upfront license fee, plus reimbursements for its formulation work on the project and an additional $5 million license fee following completion of Depomed's formulation work. Depomed is eligible for an additional milestone plus a royalty on potential future net sales.
In extended trading shares of Depomed were trading up more than 13 cents.
Earlier in the day:
Affymax, Inc. (Nasdaq:AFFY) and Takeda Pharmaceutical Company Limited (TSE:4502), today announced that the companies have decided on a preliminary strategic path forward for the investigational drug, Hematide/peginesatide, for the treatment of anemia in chronic renal failure patients in the United States.
Affymax and Takeda are continuing to conduct further analysis of the PEARL and EMERALD studies which evaluated the efficacy and safety of Hematide in chronic renal failure patients with anemia. Before year end, the companies plan to discuss with the FDA the U.S. registration strategy for Hematide. Subject to feedback from the FDA, the plan is to pursue a New Drug Application (NDA) for treatment of anemia in dialysis patients, while continuing to evaluate the non-dialysis indication. The timeline for possible submission of the NDA will be aimed for first half of 2011, but will be finalized after the FDA meeting.
Shares of Affymax jumped more than 26%, surging higher by $1.70 to close the day at $8.13.
NewCardio, Inc., (OTC Bulletin Board:NWCI.ob) announced today that QTinno, NewCardio's automated cardiac safety software solution, has been licensed for use in connection with the first, of what is anticipated to be multiple Phase 1 studies, by the U.S. subsidiary of a large global pharmaceutical company.
The total revenue to NewCardio from this initial study, including the license and related professional services, will be approximately $225,000-$275,000, with most of the revenue expected to be recognized during the current quarter ending September 30, 2010.
Vincent Renz, NewCardio's President and Chief Executive Officer, commented, "We are excited to participate in this study. It is significant that the methodology for this study was selected by the pharmaceutical company, who specifically identified QTinno for part of the ECG analysis. We have already implemented and validated QTinno in preparation for processing the ECGs from the study which has already commenced."
Aeterna Zentaris Inc. (TSX: AEZ; Nasdaq: AEZS) a late-stage drug development company specialized in oncology and endocrine therapy, today announced that the National Institutes of Health ("NIH") has awarded Dr. Jacek Pinski, Associate Professor of Medicine at the Norris Comprehensive Cancer Center of the University of Southern California, a grant of about US$1.5 million over three years to conduct a Phase 1/2 study in refractory prostate cancer with the Company's doxorubicin LHRH receptor targeted conjugate compound, AEZS-108.
The study, entitled "A Phase I/II Trial of AN-152 (AEZS-108) in Castration- and Taxane-Resistant Prostate Cancer", will enroll up to 55 patients and will be conducted in two portions: the first portion will be an abbreviated dose-escalation followed by a single arm, Simon Optimum two-stage design Phase 2 study using the dose selected in the Phase 1 portion. The primary objective of the Phase 2 portion is to evaluate the clinical benefit of AEZS-108 in men with castration- and taxane-resistant metastatic prostate cancer, for which the presence of LHRH receptors has been confirmed.
Biovest International, Inc. (OTCQB: BVTI), a biotechnology company advancing its personalized cancer vaccine targeting non-Hodgkin’s lymphoma, today announced that the Company has retained the investment banking firm, ROTH Capital Partners, LLC (ROTH). ROTH has been engaged to assist Biovest in raising capital as the Company prepares to emerge from Chapter 11 reorganization.
Dyax Corp. (NASDAQ: DYAX) announced today that results from EDEMA3, the Company’s first Phase 3 trial evaluating KALBITOR (ecallantide) for the treatment of acute attacks of hereditary angioedema (HAE), were published in the August issue of The New England Journal of Medicine. KALBITOR, discovered and developed by Dyax, is available in the United States for the treatment of acute attacks of HAE in patients 16 years of age and older.
EDEMA3 was the first of two Phase 3 trials evaluating KALBITOR for the treatment of acute HAE attacks. Results showed a statistically significant improvement of HAE attack symptoms with KALBITOR treatment versus placebo.
Hana Biosciences (OTCBB:HNAB), a biopharmaceutical company focused on strengthening the foundation of cancer care, today announced the appointment of Robert (Bob) Spiegel, M.D., FACP, to the Company's Board of Directors. Dr. Spiegel was employed at Schering Plough for 26 years where he was deeply involved in clinical research culminating with his position as Chief Medical Officer.
Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that it will collaborate with Perrigo Company with respect to the development and commercialization of two extended topical drug products. The products and terms of the agreement were not disclosed.
Chris Mengler, president of Global Pharmaceuticals, said: "We are excited to collaborate with Perrigo on two extended topical products as we continue to execute our strategy of diversifying our product base. Our business development activities will continue to focus on delivering growth from high-value products, technologies, and businesses in complementary dosage forms."
Opexa Therapeutics, Inc. (NASDAQ: OPXA), a company developing Tovaxin, a novel T-cell therapy for multiple sclerosis (MS), today announced it has reconstituted its Scientific Advisory Board with notable key opinion leaders in the MS field. Members of the Advisory Board include Dawn McGuire, M.D. (Chair); Doug Arnold, M.D.; Edward Fox, M.D., Ph.D; Hans-Peter Hartung, M.D.; Clyde Markowitz, M.D.; Paul O’Connor, M.D.; Chris H. Polman, M.D. and Arthur Vandenbark, Ph.D.
"Opexa is developing Tovaxin, a novel immunotherapy for multiple sclerosis, and this board of advisors represents some of the best and most highly regarded neurologists and immunologists in the world. Each has developed substantial expertise relevant to the further development of Tovaxin including designing and participating in numerous MS clinical trials, understanding U.S. and EU regulatory requirements, new product development, and T-cell immunology and their guidance will be instrumental in our ongoing plans to advance Tovaxin," said Neil K. Warma, President and Chief Executive Officer.
Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has issued a positive opinion for RELISTOR (methylnaltrexone bromide) subcutaneous injection in pre-filled syringes. The CHMP is responsible for reviewing medicinal product applications for safety, quality and efficacy. The CHMP's positive opinion for RELISTOR will now be forwarded to the European Commission for a final decision.
Progenics is also seeking approval to market RELISTOR in pre-filled syringes in the U.S. and awaits FDA action. Pending respective approvals in the E.U. and U.S., Progenics expects that pre-filled syringe commercial launches would occur in the United States and European Union in the second quarter of 2011.
YM BioSciences Inc. (NYSE Amex:YMI, TSX:YM), announced the conclusion of dose-escalation in the Phase I portion of its Phase I/II clinical trial of CYT387 at Mayo Clinic in patients with myelofibrosis. In total, 21 patients were treated in Phase I, with no voluntary withdrawals reported. CYT387 has shown significant activity in reducing spleen size and controlling constitutional symptoms in these patients. To date, 15 patients have been enrolled into the Phase II portion of the study. Given the favourable biological activity and safety data, the Company intends to expand the present program from 60 to 120 patients at up to six centers in the United States, Canada and Australia, subject to regulatory approval. Detailed safety and activity data for CYT387 are planned to be presented at the American Society of Hematology (ASH) meeting in Orlando, Florida in December this year.
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