|Vical reports positive test results; Judge orders SIGA to split smallpox drug profits; Shire seeks hearing.|
|By Staff and Wire Reports|
|Thursday, 22 September 2011 19:29|
Shares of Vical (NASDAQ:VICL), closed at 2.72+0.29 (up 11.93%) after the company announced a recent animal study revealed positive synergistic improvement in efficacy using a combination of Allovectin and an anti-CTLA-4 antibody for the treatment of cancer. Vical said treatment with Allovectin plus anti-CTLA-4 antibody provided a synergistic reduction of tumor growth compared to either treatment alone.
The study, carried-out on mice, tracked growth of implanted melanoma tumors and survival. The study included untreated mice, mice treated with Allovectin and mice treated with a combination of Allovectin and the anti-CTLA-4 antibody. Dosing for Allovectin was a single cycle of once per day for the first four days, while dosing for the anti-CTLA-4 antibody was once every three days for the duration of the study.
Allovectin is being studied as a gene therapy to treat cancers, such as malignant melanoma. The plasmid based immunotherapeutic that express two genes (HLA-B7 and ß2 microglobulin) that together form an MHC I class. It increases the ability of the immune system to recognize cancer cells and kill them.
Shares of SIGA Technologies (NASDAQ:SIGA) tanked while PharAthene Inc.'s (AMEX:PIP) stock rallied Thursday afternoon on news of a Delaware court had ruled in favor of PharmAthene in a dispute involving SIGA's smallpox drug ST-246. Back in December of 2010, BioMedReports invited PharmAthene CEO, Eric I. Richman to speak with us exclusively about his company and to share with us some of his perspective of the events surrounding this very issue and pending court battle. We were joined on the call by Jordan Karp, J.D.- the Senior Vice President, General Counsel for PharmAthene. Even then, PharmAthene's management felt they were headed to victory against SIGA.
The court ruled that while SIGA can keep the first $40 million in net profit from sales of ST-246, they must hand over 50% of the net profits to PharmAthene for the next ten years. In a statement, SIGA said it is considering appealing the "unfavorable aspects" of Thursday's decision.
Today Eric I. Richman, President and Chief Executive Officer of PharmAthene, Inc. (NYSE Amex: PIP) issued the following statement regarding the PharmAthene versus SIGA Technologies court decision on the ST-246 smallpox antiviral drug:
"The Court's favorable ruling on behalf of PharmAthene is a tremendous victory for our company and shareholders. Based upon today's ruling, PharmAthene was awarded 50% of net profits for worldwide sales of ST-246, an orally available smallpox antiviral drug candidate, for ten years pursuant to SIGA receiving $40 million in upfront payments. ST-246 represents a high value, high priority medical countermeasure with significant commercial potential, as evidenced by the U.S. government’s decision to award an initial procurement contract for ST-246 valued at $433 million. The addition of ST-246 royalties firmly establishes PharmAthene as a leading biodefense contractor with a fully integrated development and commercial portfolio of best-in-class, next generation medical countermeasures targeting the highest priority U.S. government biodefense requirements.”
Shares of SIGA dropped 35% to $3.05, while PharmAthene shares shot up 21% to $2.74.
Shire plc, (NASDAQ:SHPGY) the global specialty biopharmaceutical company, announces an update on the approval status and availability of ProAmatine® (midodrine HCl), a medicine approved for the treatment of symptomatic orthostatic hypotension (SOH). Shire has engaged in consistent dialogue with the U.S. Food and Drug Administration (FDA) for the past 12 months in the hopes of either securing final FDA approval of this medicine based on the data submitted following two post-marketing clinical trials, or establishing an agreed development plan for conducting additional clinical trials.
ProAmatine remains available to patients today as discussions between FDA and Shire continue concerning the status of its NDA. Shire, the NDA holder for ProAmatine, remains committed to ensuring midodrine remains available for patients who critically need this medicine and who would be left without alternative treatments should it be withdrawn from the market.
ProAmatine was approved in 1996 under Subpart H (an accelerated approval process) for the treatment of SOH, with a post-approval commitment to conduct two clinical trials to verify the clinical effect of midodrine. The initial approval was based on ProAmatine's demonstrated ability to significantly raise blood pressure in patients with SOH. In 2000, Shire acquired ProAmatine and completed two clinical post-marketing trials as required and submitted the results to FDA in 2005. FDA took the position that these trials were inconclusive and requested that additional trials be completed. Shire disagrees with the FDA and believes that these trials, together with 15 years of clinical experience, have established the clinical efficacy of ProAmatine and provide the necessary data to support the full approval of ProAmatine.
Accelr8 Technology Corporation (NYSE Amex: AXK) announced that Accelr8 and SCHOTT Technical Glass Solutions, GmbH (Jena, Germany) have renewed Accelr8’s license to SCHOTT for Nexterion® microarraying slides using OptiChem® biocoatings.
Advanced Cell Technology, Inc. (OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that it has received clearance from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) to begin treating patients as part of a Phase 1/2 clinical trial for Stargardt’s Macular Dystrophy (SMD) using retinal pigment epithelium (RPE) derived from human embryonic stem cells (hESCs).
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that it will present at the Jefferies 2011 Global Healthcare Conference in London. Harvey J. Berger, M.D., chairman and chief executive officer, will provide an overview of the Company’s robust oncology pipeline and progress on its three lead compounds on Wednesday, September 28 at 8:40 a.m. local time.
Biodel Inc. (Nasdaq: BIOD) today announced that Dr. Errol De Souza, President and Chief Executive Officer, will be presenting at the 6th Annual JMP Securities Healthcare Conference at the St. Regis Hotel in New York.
Bristol-Myers Squibb Company (NYSE: BMY) and Ambrx, Inc. today announced a collaboration under which Bristol-Myers Squibb will receive exclusive worldwide rights to research, develop and commercialize biologics based on Ambrx’s research surrounding the Fibroblast Growth Factor 21 (FGF-21) protein, for potential use in treating type 2 diabetes, and the Relaxin hormone, for potential use in treating heart failure.
Cambridge Heart, Inc. (OTCBB: CAMH), a developer of non-invasive diagnostic tests for cardiac disease, today announced that it has executed an exclusive agreement with EO Medical Pte Ltd to distribute its HearTwave II System and proprietary Microvolt T-Wave Alternans™ (MTWA) software and Micro-V Alternans Sensors in Singapore upon regulatory approval.
Columbia Laboratories, Inc. (Nasdaq: CBRX) (the “Company”) today announced that its Board of Directors on September 16, 2011, adopted amendments to its Stockholder Rights Plan (the “Rights Plan”), adopted March 12, 2002, to extend the expiration date of the Rights Plan from March 12, 2012, to July 3, 2013, to preserve the value of significant tax assets associated with the Company’s tax net operating loss carryforwards (“NOLs”) under Section 382 of the Internal Revenue Code.
Covidien plc (NYSE: COV) today announced that its Board of Directors has declared a 12.5% increase in the quarterly dividend rate, from $0.20 per ordinary share to $0.225 per ordinary share.
Dr. Reddy’s Laboratories (NYSE: RDY) announced today that it has launched Rivastigmine Tartrate Capsules (1.5 mg, 3 mg, 4.5 mg and 6 mg), a bioequivalent generic version of EXELON®* Capsules in the US market on September 15, 2011 following the approval by the United States Food & Drug Administration (USFDA) of Dr. Reddy’s ANDA for Rivastigmine tartrate capsules.
Easton Pharmaceuticals Inc (OTC:EAPH), a specialty pharmaceutical company that designs, develops, and markets topically-delivered healthcare products, announces it has retained Winston & Strawn LLP as its patent attorneys for a patent application submission directed to its Viorra brand product and proprietary transdermal technology.
Enzon Pharmaceuticals, Inc. (Nasdaq: ENZN) today announced that it is implementing a plan to reduce its workforce and operating costs to more closely align its resources with the Company’s research and development activities.
EnteroMedics Inc., (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced its intention to offer, subject to market and other conditions, shares of its common stock and warrants to purchase common stock in an underwritten public offering.
Exelixis, Inc. (NASDAQ:EXEL) announced today that Michael Morrissey, PhD, the company’s president and chief executive officer, will present at the JMP Securities Healthcare Conference at 11:30 a.m. EDT / 8:30 a.m. PDT on Tuesday, September 27, 2011, in New York.
Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biopharmaceutical company developing and commercializing products targeting the extracellular matrix, today announced that management will be presenting at the JMP Securities Healthcare Conference in New York.
Hubei Minkang Pharmaceutical Ltd. (OTCBB:HBMK) is pleased to announce that on September 21, 2011, the Company completed the share exchange agreement (the "Share Exchange Agreement"), dated July 8, 2011, entered into between the Company, HBMK Pharmaceutical Limited ("HBMK"), a BVI corporation, and all the shareholders of HBMK (the "Vendors"), whereby the Company acquired 100% of the issued and outstanding shares in the capital of HBMK from the Vendors in exchange for the issuance of 33,500,000 shares of our common stock to the Vendors on a pro rata basis in accordance with each Vendor's percentage ownership in HBMK.
Impax Laboratories, Inc.(NASDAQ: IPXL) today announced that the Company will present at the Jefferies 2011 Global Healthcare Conference on Tuesday, September 27, at 1:00 pm BST (8:00 a.m. ET). The conference will be held at the Waldorf Hilton in London.
Medistem Inc. (PINKSHEETS: MEDS) announced today approval from the FDA to initiate a dose-escalating clinical trial in patients with critical limb ischemia using its Endometrial Regenerative Cell (ERC) stem cell product.
Neoprobe Corporation (NYSE Amex: NEOP), a diversified developer of innovative oncology surgical and diagnostic products, today announced that Brent Larson, Neoprobe’s Senior Vice President and Chief Financial Officer, will deliver a presentation to institutional investors at 1:00 PM ET, Wednesday, September 28, 2011 at the JMP Securities Healthcare Conference, taking place at The St. Regis, New York.
Neogen Corporation (NASDAQ: NEOG) has developed a quick and easy new test for aflatoxin, a toxin considered by many to be the most potent, naturally-occurring carcinogen. The toxin is a by-product of mold growth in a wide range of commodities, including corn.
Neoprobe Corporation (NYSE Amex: NEOP), a diversified developer of innovative oncology surgical and diagnostic products, today announced that Dr. Mark Pykett, Neoprobe’s President and Chief Executive Officer, will deliver a presentation to institutional investors at 1:50 PM ET, Wednesday, September 28, 2011 at the Credit Suisse 2nd Annual Small & Mid Cap Conference, taking place at Le Parker Meridien Hotel, New York.
Osiris Therapeutics, Inc. (NASDAQ: OSIR), the leading stem cell company focused on developing and marketing products to treat medical conditions in inflammatory and cardiovascular disease areas and wound healing, announced today that Stephen Potter, Senior Vice President of Operations and Corporate Development, is scheduled to present at the Sixth Annual JMP Securities Healthcare Conference on Tuesday, September 27, 2011 at 3:30 p.m. ET in New York City.
Palatin Technologies, Inc. (NYSE Amex: PTN), a biopharmaceutical company developing bremelanotide for sexual dysfunction indications and PL-3994 for acute asthma and other indications, today announced results for its fourth quarter and fiscal year ended June 30, 2011.
Pfizer Inc. (NYSE:PFE) will announce new one-year results from the Selective estrogens, Menopause, And Response to Therapy [SMART]-5 Phase 3 study of the safety and efficacy of the investigational tissue selective estrogen complex (TSEC) bazedoxifene/conjugated estrogens (BZA/CE) at the 22nd annual meeting of the North American Menopause Society (NAMS), September 21-24 in Washington, D.C.
A team of researchers from Roche (SIX: RO, ROG; OTCQX: RHHBY), including scientists from Roche Pharma Research and Early Development and Roche NimbleGen, reported inGenome Research (1) that they have generated the first draft genome sequence of the cynomolgus monkey (Macaca fascicularis) and developed a novel microarray design for in depth expression profiling for use in preclinical drug safety research.
Stevia Corp.(OTCBB: STEV) ("Stevia Corp." or the "Company"), a Company incorporated in the state of Nevada, wishes to advise that pursuant to the close of a voluntary share exchange transaction with Stevia Ventures International Ltd. (Stevia Ventures), the Company's operations now consist of the business and operations of Stevia Ventures.
Today, www.WorldStreetFundamentals.com released its industry report highlighting Teva Pharmaceutical Industries Ltd (ADR) (NASDAQ: TEVA) and HEALTHSOUTH Corp. (NYSE: HLS). Full fundamental and technical analysis is available at www.WorldStreetFundamentals.com/Reports.php?id=TEVA+HLS.
Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that Momenta Pharmaceuticals, Inc. and Sandoz Inc. have filed suit against Amphastar Pharmaceuticals, Inc. and Watson on September 21, 2011 in the United States District Court for the District of Massachusetts.