XOMA soars on deal with French drug company. CPEX Pharma climbs on takeover offer. Positive ID surges on deal with Siemens Print E-mail
By Mary Davila   
Tuesday, 04 January 2011 19:50
Below is a look at some of the headlines for companies that made news in the healthcare sector on January 4, 2011.
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.

Earlier Tuesday:

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.

Also Tuesday:

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.

BD (Becton, Dickinson and Company) (NYSE:BDX), a leading global medical technology company, announced today that it will present at the 29th Annual J. P. Morgan Healthcare Conference on Monday, January 10, 2011, at 6:00 p.m. (ET).

Bederra Corporation (PINKSHEETS: BEDA), a diversified medical services provider, retained Rhodes Holdings LLC to assist the Company refine its strategic direction and restructure its balance sheet.

CardioVascular BioTherapeutics, Inc. (Pink Sheets:CVBT) today released summary Phase IIa and Phase IIb clinical trial data for CVBT's biological therapy to treat diabetic wounds, CVBT-141B. CVBT's Phase II data indicates that CVBT's FGF-1 biological drug appears to be delivering efficacy at a level significantly greater than has been seen in any other treatments, for patients suffering from chronic ischemic diabetic wounds.

ChromaDex Corporation (OTC Bulletin Board:CDXC), a leader in the development of phytochemical and botanical reference standards and the creation of associated intellectual property, announced today that the National Science Foundation (NSF) awarded the Company a $500,000 Phase II Small Business Innovation Research (SBIR) Grant to further the commercial development of several plant-based antioxidants called anthocyanins for use in nutraceutical, food, beverage and cosmetic products.

Digirad Corporation (NASDAQ: DRAD) today announced that it has received Conformite Europeene (CE) Mark approval enabling the Company to market and distribute its ergo™ large field-of-view, general-purpose portable imaging system throughout Europe and other countries governed by the CE body.

Edwards Lifesciences Corporation (NYSE:EW), the global leader in the science of heart valves and hemodynamic monitoring, is scheduled to present at the J.P. Morgan Healthcare Conference at the Westin St. Francis in San Francisco, California on Tuesday, January 11, 2011.

First China Pharmaceutical Group, Inc. (OTCBB: FCPG) a rapidly growing pharmaceutical distribution company headquartered in Yunnan, China, wishes to announce the signing of two new distribution agreements bringing the current number of hospital contracts to 17 in just over 60 days of concerted sales efforts.

Genesis Biopharma, Inc. (OTC Bulletin Board:GNBP), a biotechnology company developing targeted cancer therapies, today announced that it closed private offerings in December and October 2010 pursuant to which it entered into definitive agreements with accredited investors to purchase a total of 845,000 shares of the Genesis Biopharma common stock for a purchase price of $1.00 per share.

Gen-Probe Incorporated (Nasdaq:GPRO) announced today that the Company will present at the 29th Annual J.P. Morgan Healthcare Conference in San Francisco on January 10, 2011 at approximately 11:30 a.m. Pacific Time.

Herborium Group, Inc., (PINKSHEETS: HBRM) a Botanical Therapeutics™ company, today announced it has satisfied Pink OTC® Market requirements and now qualifies as a company with Current Information available on pinksheets.com.

IntelGenx Corp. (TSX VENTURE:IGX) (OTCBB:IGXT) today announced that the United States District Court of Delaware has ruled in favor of IntelGenx regarding claim construction for the two patent terms at issue in the patent infringement action brought forward by Biovail Laboratories International SLR under the Drug Price Competition and Patent Term Restoration Act ("Hatch-Waxman Act").

Interleukin Genetics, Inc. (OTC QB: ILIU) announced today that CEO Lewis H. Bender will present at the Biotech Showcase 2011, taking place at the Parc 55 Wyndham San Francisco, January 10-12, 2011.

Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) today announced that Ron Bentsur, the Company's Chief Executive Officer, will be presenting at the 29th Annual J.P. Morgan Healthcare Conference, being held January 10-13, 2011 at the Westin St. Francis Hotel in San Francisco.

Lexicon Pharmaceuticals, Inc. (Nasdaq:LXRX) announced today that Dr. Arthur T. Sands, president and chief executive officer, will present at the JPMorgan Healthcare Conference in San Francisco, California on Monday, January 10, 2011 at 10:30 a.m. Pacific Time.

Micro Identification Technologies, Inc. (OTCBB:MMTC) (MIT) announced that it received the first production MIT 1000 System from OSI Optoelectronics (OSIO), a subsidiary of OSI Systems on December 24, 2010 and stated that initial test results are superb.

Novavax, Inc. (Nasdaq:NVAX) announced today that it has begun patient enrollment in a Phase I clinical trial to assess the safety, immunogenicity and tolerability of a vaccine candidate against respiratory syncytial virus (RSV).

Neogen Corporation (Nasdaq:NEOG) announced today that its net income for the second quarter of FY 2011, which ended Nov. 30, increased 33% from the previous year's second quarter.

NuVasive, Inc. (NASDAQ: NUVA), a medical device company focused on developing products for minimally disruptive surgical treatments for the spine, announced today that Alex Lukianov, Chairman of the Board and Chief Executive Officer, is scheduled to present at the J.P. Morgan Healthcare Conference at the Westin St. Francis Hotel in San Francisco, CA, on Tuesday, January 11, 2011, at 8:30 a.m. PST.

Omni Bio Pharmaceutical, Inc. (OTC Bulletin Board:OMBP), today announced that U.S. Patent No. 7,850,970, entitled "Inhibitors of Serine Protease Activity and Their Use in Methods and Compositions for Treatment of Bacterial Infections," was issued by the United States Patent and Trademark Office (USPTO) on December 14, 2010.

Onyx Pharmaceuticals, Inc. (Nasdaq:ONXX) today announced that it will present at the 29th Annual J.P. Morgan Healthcare Conference on Monday, January 10, 2011 at 1:00 p.m. Eastern Time (10:00 a.m. Pacific Time).

Optimer Pharmaceuticals, Inc. (Nasdaq:OPTR) today announced that fidaxomicin, the Company's lead product candidate, has been granted orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of pediatric Clostridium difficile infection (CDI).

Ophthalmic Imaging Systems (OIS) (OTCBB:OISI), a leading ophthalmic digital imaging and informatics company, today announced that management will present at the 4th annual OneMedForum San Francisco 2011 conference on Tuesday, January 11, 2011, at 9:00 a.m. Pacific time.

PAREXEL International Corporation (Nasdaq:PRXL) announced today it will be presenting at the J.P. Morgan Healthcare Conference in San Francisco.

Protalix BioTherapeutics, Inc. (NYSE-Amex: PLX, TASE:PLX), announced today that it has been invited to deliver an oral presentation on PRX-105, the Company's plant cell expressed pegylated recombinant human acetylcholinesterase in development for use in several therapeutic and prophylactic indications, as well as in a biodefense program and an organophosphate-based pesticide treatment program, at the Biomedical Advanced Research and Development Authority (BARDA) Industry Day.

Sigma-Aldrich Corporation (Nasdaq:SIAL) will be presenting at the JP Morgan 29th Annual Healthcare Conference on Monday, January 10th at 10:00 AM PT in San Francisco, CA.

SciMeDent Health, Corp. f/k/a Trend Exploration, Inc. (PINKSHEETS: TRDX) today announces that Preferred Distribution, Inc., its medical and dental supplies distribution subsidiary is in the process of launching a pharmaceutical distribution division.

Unity Management Group, Inc./MCC (PINKSHEETS:UYMG) is a Health Resource Company specializing in Physician and Hospital Practice Management, Medical Discount Plans, Business Services, Billing Software and Technologies.




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