|XOMA soars on deal with French drug company. CPEX Pharma climbs on takeover offer. Positive ID surges on deal with Siemens|
|By Mary Davila|
|Tuesday, 04 January 2011 19:50|
After the bell Tuesday, Anadys Pharmaceuticals, Inc. (Nasdaq:ANDS) announced that it has initiated the planned Phase IIb study of ANA598 in combination with pegylated interferon and ribavirin. The protocol for the study has been cleared by the United States Food and Drug Administration and Health Canada. Patient screening has begun and patient dosing is expected to commence within the next several weeks. In the study ANA598 will be tested in both treatment-naive patients and treatment-experienced patients who failed a prior course of therapy with interferon and ribavirin. ANA598 is the Company's direct-acting antiviral, or DAA, being developed for the treatment of hepatitis C.
Shares of XOMA Ltd. (Nasdaq:XOMA) have caught fire once again. Today the company announced a partnership with Les Laboratoires Servier (Servier), France's largest privately-held pharmaceutical company, to develop and commercialize XOMA 052, XOMA's anti-inflammatory drug candidate, in multiple indications. The drug is designed to inhibit the pro-inflammatory cytokine interleukin-1 beta that is believed to be a primary trigger of pathologic inflammation in multiple diseases.
Under the terms of the agreement, XOMA will receive approximately $35 million upfront and up to approximately $470 million in milestone payments and tiered royalties. XOMA will retain the U.S. and Japan development and sales rights for Bachet's uveitis and other inflammatory and cancer indications. Servier will have similiar rights around the rest of the world. Servier will fund the initial $50 million of the developmental costs and 50% of expenses for the Bechet's uvetis indication, an inflammation of the eyes, for which XOMA 052 is expected to advance into Phase III trials in 2011.
Said Steven B. Engle, Chairman and Chief Executive Officer, XOMA, "This agreement substantially increases our cash resources while reducing future cash requirements, provides a pathway to commercialization of XOMA 052 in the near term, and supports development in diabetes and cardiovascular disease while maintaining our ability to participate in these programs."
XOMA surged $2.00 or 38% to $7.30.
CPEX Pharmaceuticals, Inc. (Nasdaq:CPEX), announced today that it has agreed to be acquired by holding company, Footstar, Inc. for about $76.6 million in cash or $27.25 per share.
CPEX engages in the research, development, licensing, and commercialization of pharmaceutical products utilizing its validated drug delivery platform technology. Its drug delivery technology, CPE-215 technology, enhances permeation and absorption of pharmaceutical molecules across biological membranes, such as the skin, nasal mucosa, and eye. CPEX shares have risen nearly 50% since a failed takeover of the company in April 2010.
Shares of CPEX gained $2.16 or 8.8% on the news.
Shares of PositiveID Corporation (Nasdaq:PSID) surged today after the company announced that it has entered into an agreement with Siemens AG related to its Wireless Body(TM) platform. The license agreement allows PositiveID to expand its personalized medicine and smart healthcare applications for next generation patient monitoring and includes granting PositiveID rights to utilize key intellectual property, and, in particular, Siemens' Patent No. 7,650,888, titled "Method and System for Identification of a Medical Implant" using RFID.
PositiveID's focus is to use the technology to improve disease management and overall wellness through the effortless identification of implantable medical devices within the body. This application expands PositiveID's Wireless Body, an integrated, in vivo and external, smart healthcare communication system that has the ability to deliver personalized medical solutions wirelessly.
Shares of Positive ID surged 18 cents or 29% to close the day at $.80
As reported earlier today on BioMedReports, ImmunoCellular Therapeutics, Ltd. (OTC.BB:IMUC.ob), a biotechnology company that is developing immune-based therapies for the treatment of various forms of cancer, today announced that the U.S. Food and Drug Administration has approved the Company’s Investigational New Drug amendment to conduct a Phase II clinical trial in the U.S. of ICT-107, the company's dendritic cell based cancer vaccine candidate for the treatment of glioblastoma multiforme (GBM). "GBM is a highly aggressive disease for which new and better treatments are urgently needed," said Manish Singh, Ph.D. President and CEO. "ICT-107 has demonstrated significant early promise in extending both progression-free and overall survival in patients with GBM, with no serious adverse events reported to date. We look forward to further investigating the therapeutic potential of ICT-107 in a controlled clinical setting."
Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), a leading RNAi therapeutics company, today presented new clinical data from its ALN-VSP Phase I liver cancer trial in a presentation at the Dana-Farber Cancer Institute in Boston. Results from molecular analysis of human biopsy samples showed achievement of pharmacologically relevant siRNA drug levels in tissues. In addition, using a highly precise polymerase chain reaction (PCR)-based technique known as 5’- rapid amplification of cDNA ends, analysis of human tissue samples showed proof of RNAi-mediated target mRNA cleavage, and thus RNAi in man with the systemically delivered RNAi therapeutic. These results provide significant human proof of concept for Alnylam’s efforts in advancing RNAi therapeutics to patients.
LifeVantage Corporation (OTC Bulletin Board:LFVN.ob), announced today that a new peer-reviewed study involving its flagship product, Protandim, sponsored by the American Heart Association and the National Institutes of Health, was published in the scientific journal Free Radical Biology and Medicine. The study, conducted by researchers at The Ohio State University, examined the biochemical mechanisms that underlie the ability of Protandim to suppress intimal hyperplasia (over-proliferation of cells that line the vessel wall), a common adverse event that limits the effectiveness of several types of vascular surgery. Protandim, a patented dietary supplement comprised of five highly synergistic herbal ingredients, has been shown in earlier studies to activate the transcription factor Nrf2, a signal to the cell's DNA to regulate a network of protective genes. This new study further investigates Protandim's ability to increase production of the body's Nrf2-regulated protective genes, sometimes referred to as "survival genes", which include most of the antioxidant enzymes. Shares rose 10% on the news.
Spectrum Pharmaceuticals (NasdaqGS:SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, today announced it submitted a supplemental New Drug Application with the U.S. Food and Drug Administration for a Ready-to-Use formulation of FUSILEV (levoleucovorin) for Injection. This submission is in support of FUSILEV’s use in colorectal cancer, which is currently under review by the FDA with a Prescription Drug User Fee Act (PDUFA) action date of April 29 2011. FDA has up to 60 days to formally accept the submission.
Adherex Technologies Inc. (TSX:AHX) (PINK SHEETS:ADHXF) a biopharmaceutical company focused on the development of eniluracil and 5-fluorouracil, today announced that Rosty Raykov, Chief Executive Officer, will present at the Sidoti & Company, LLC Semi-Annual New York Micro-Cap Conference at 10:00 am on Monday, January 10, 2011 in the Estate 4/Carnegie Hall room at the Grand Hyatt New York Hotel, Park Avenue at Grand Central Station.
Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board:ADLS), a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, today announced that it will present at the Biotech Showcase 3rd Annual Healthcare Conference held January 10-12th in San Francisco.