|Orex rises from "the brink of disintegration"|
|By Staff and Wire Reports|
|Tuesday, 20 September 2011 20:07|
Orexigen Therapeutics Inc (Nasdaq:OREX) saw shares jump after hours to $2.73 1.26 (85.71%) after the company said it plans in 2012 to begin a large heart-safety trial of its experimental Contrave obesity drug, and that favorable results could win over regulators who rejected the pill early this year.
Orexigen said its pill could be approved as soon as 2014 if the study involving thousands of patients resolves concerns about the drug's cardiovascular safety.
"We're still three years and a hundred million dollars away from approval, but we've just gone from a company on the brink of disintegration to something that should yield outsize returns for those willing to be patient," Jefferies & Co analyst Corey Davis told Reuters.
Last June, the company said it would not seek U.S. approval for the highly anticipated pill because of the government's "unprecedented" demands for additional safety studies. The effort to develop weight loss drugs has been plagued by safety concerns for decades.
But the company said late Tuesday that the Food and Drug Administration has now agreed to a study which could be completed and reviewed by 2014. The study would involve 10,000 patients and take two years to gather the necessary data on heart side effects, according to the company.
"Orexigen believes that these design requirements are reasonable and feasible and provide the certainty required to reinitiate development of Contrave," the San Diego-based drugmaker said in a statement.
Despite improved prospects for Contrave, if approved it could be several years behind Qnexa, a rival weight loss pill being developed by Vivus Inc. (Nasdaq:VVUS) Vivus last week said it plans to resubmit by October a U.S. marketing application for its product, which the U.S. Food and Drug Administration spurned a year ago, also due to heart-safety concerns.---
Alkermes plc (NASDAQ:ALKS) announced the establishment of its corporate operations in Ireland, with new headquarters located in Dublin.
Alkermes plc was created following the merger of Alkermes, Inc. with Elan Drug Technologies (EDT), the profitable, world-class drug formulation and manufacturing business unit that was formerly a part of Elan Corporation, plc (NYSE:ELN).
Marking its first day of operations in Ireland, Alkermes has announced a multiyear, multimillion dollar manufacturing agreement with one of the world’s top ten pharmaceutical companies. Under the terms of the agreement, Alkermes will manufacture the company’s finished pharmaceutical product, which will be produced at Alkermes’ Athlone, Ireland facility.
Alkermes expects this agreement to generate $15 million to $20 million in annual manufacturing revenues by 2016. The Athlone facility is one of three major manufacturing plants owned by Alkermes plc at which the company produces proprietary, partnered and contract-manufactured drug products.
Applied DNA Sciences, Inc. (OTCBB: APDN), a provider of DNA-based anti-counterfeiting technology and product authentication solutions, will be a Silver Sponsor of a major Intellectual Property Crime conference, to be held in Madrid on September 20-22.
Baxter International (NYSE:BAX), will host a quarterly conference call to discuss its third quarter 2011 financial results on Thursday, October 20, 2011, at 8:30 a.m. Eastern Time (7:30 a.m. Central Time).
BIOLASE Technology, Inc. (NASDAQ: BLTI), the World's leading dental laser manufacturer and distributor, announced today that that management is scheduled to make investor presentations at two upcoming investment conferences.
Furiex Pharmaceuticals, Inc. (Nasdaq: FURX) today confirmed that Takeda Pharmaceutical Company Limited (“Takeda”) has launched two dosages of LIOVEL®, a fixed dose combination tablet of NESINA® (alogliptin) and ACTOS® (pioglitazone HCL), in Japan for the treatment of Type 2 diabetes.
Neurologix, Inc. (OTCBB: NRGX), a biotechnology company engaged in the development of innovative gene therapies for disorders of the brain and central nervous system, announced today that Adrian Adams has been appointed Company Chairman and Chief Executive Officer (CEO) effective immediately.
Orexigen® Therapeutics, Inc. (Nasdaq: OREX) announced today that following a recent meeting with senior officials in FDA's Office of New Drugs (OND), the Company received written correspondence detailing OND's design requirements for a cardiovascular outcomes trial (CVOT) for Contrave® that would address the Complete Response Letter (CRL) received in January 2011.
Pfizer Inc. (NYSE: PFE) and Icagen, Inc. (NASDAQ: ICGN) announced today the expiration of the subsequent offering period of the cash tender offer by Pfizer’s wholly-owned subsidiary, Eclipse Acquisition Corp. (“Eclipse”), for all of the outstanding shares of common stock of Icagen for $6.00 per share, paid to the seller in cash, without interest thereon, less any applicable withholding and transfer taxes.
Quantum Materials Corporation (Pink Sheets: QTMM) Quantum Materials Corp. and Nanoaxis, LLC announce the formation of a technology alliance combining Quantum Materials tetrapod quantum dot mass production technology with Nanoaxis advanced research expertise and intellectual property in gene therapy biomedical nanotechnology.
Radient Pharmaceuticals Corporation (OTCQX: RXPC) (PINKSHEETS: RXPC), a developer and marketer of In Vitro Diagnostic (IVD) cancer tests, today announced it has submitted two scientific abstracts to the American Society of Clinical Oncologists (ASCO).
Rock Creek Pharmaceuticals, a subsidiary of Star Scientific, Inc. (NASDAQ: CIGX), announced that on September 19, 2011 a utility patent application was filed with the Patent and Trademark Office ("PTO").
Santarus, Inc. (NASDAQ: SNTS), a specialty biopharmaceutical company, today announced that analysis of top-line safety data from a double blind, multicenter 12-month extended use study in patients treated daily with either the investigational drug budesonide MMX® 6 mg or placebo will be provided as support for the company’s planned submission of a New Drug Application (NDA) for budesonide MMX 9 mg to the U.S. Food and Drug Administration (FDA) for the induction of remission of mild or moderate active ulcerative colitis.
Simulations Plus, Inc. (NASDAQ: SLP), a leading provider of consulting services and software for pharmaceutical discovery and development, today announced that it has submitted a bid to purchase substantially all of the assets of Entelos, Inc., in an auction supervised by and in accordance with certain bidding procedures approved by the United States Bankruptcy Court for the District of Delaware and pursuant to the provisions of Section 363 of the U.S. Bankruptcy Code.
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 it received approximately $25 million in proceeds from the exercise of long-term warrants issued in 2005.
Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) (SPI), an international pharmaceutical company, today announced that Greg Deener has joined Sucampo Pharma Americas, Inc. (SPA), its wholly-owned subsidiary, as Vice President of Marketing, Strategy & Implementation.