|RxNews Recap for Wednesday 02-17-10. Cyclacel (CYCC) jumps on breast cancer study. Immunomedics (IMMU) flys on cancer patent.|
|By Mary Davila|
|Wednesday, 17 February 2010 18:47|
Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) today announced that a newly published study demonstrates that the company's seliciclib (CYC202 or R-roscovitine), an orally available inhibitor of multiple cyclin-dependent kinases (CDKs), reversed resistance to the aromatase inhibitor letrozole (Femara®) and killed hormone receptor positive breast cancer cells that had become insensitive to the effects of letrozole. The new study was published in the current edition of Clinical Cancer Research, a journal of the American Association for Cancer Research. Seliciclib is currently in Phase 2 clinical trials for non-small cell lung cancer and nasopharyngeal cancer.
"Resistance to aromatase inhibitors, such as letrozole, is a major challenge for the long-term management of hormone receptor positive breast cancer," said Professor David Glover, Ph.D., Cyclacel's Chief Scientist. "The data published in Clinical Cancer Research are encouraging as they show that seliciclib can kill resistant breast cancer cells by targeting a form of cyclin E that is a major cause of the resistance. This is further evidence that seliciclib's unique mechanism of action can be effective against certain cancer cells, such as breast and lung cancer, that fail to respond to standard cancer treatments."
Shares of Cyclacel jumped 37 cents or 15.42% to close at $2.77 on double the average daily volume.
Immunomedics, Inc. (Nasdaq:IMMU), a biopharmaceutical company focused on developing monoclonal antibodies to treat cancer and other serious diseases, today announced that U.S. patent 7,662,378 was issued covering the use of humanized, chimeric or human antibodies that bind to the carcinoembryonic antigen (CEA) in combination with at least one other therapeutic agent, such as another antibody, a chemotherapeutic agent, a radioactive isotope, an antisense oligonucleotide, an immunomodulator, an immunoconjugate or a combination thereof. The allowed claims also cover methods of treating CEA-expressing cancers, particularly medullary thyroid cancer, non-medullary thyroid cancers, colorectal cancers, hepatocellular carcinoma, gastric cancer, lung cancer, breast cancer and other cancers in which CEA is expressed, using the composition.
"This is another important patent protection around our family of anti-CEA antibodies until the year 2023," commented Cynthia L. Sullivan, President and CEO. "TF2, a new bi-specific antibody construct containing the anti-CEA antibody, is currently in three investigator-sponsored clinical studies in the U.S. and Europe for pretargeted imaging and radioimmunotherapy of colorectal and lung cancers," she added. Ms. Sullivan also remarked: "Our humanized anti-CEA antibody labeled with therapeutic doses of I-131 has also been reported, in a Phase-II study published from Germany, to extend the survival of colorectal cancer patients who had resection of their liver metastases."
Shares rose more than 13% or 40 cents to close the day at $3.45.
In other news Wednesday:
Allscripts (Nasdaq:MDRX) announced today that Danbury Office of Physician Services (DOPS), a physicians group based in Danbury, CT, will expand its deployment of the Allscripts Electronic Health Record (EHR) across its network from its current base of 51 physicians to all of its 238 employed physicians.
Athersys, Inc. (Nasdaq:ATHX) and Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI; TSX: ANP) announced that Athersys has completed patient enrollment for its phase I clinical trial of MultiStem(R), its allogeneic stem cell therapy product, administered to individuals following acute myocardial infarction (AMI), more commonly referred to as a heart attack. Top line results of the trial are expected to be announced midyear, upon completion of the four-month patient follow-up visits and analysis of results. Angiotech and Athersys entered into an agreement in May 2006 to co-develop and commercialize MultiStem(R), Athersys' non-embryonic stem cell platform technology, for use in the indications of AMI and peripheral vascular disease. Upon completion of the Phase I trial, Angiotech will assume lead responsibility for further clinical development. Angiotech also owns marketing and commercial rights with respect to this product candidate.
"Myocardial infarction remains one of the leading causes of death and disability in the United States," said William Hunter M.D., President and CEO of Angiotech. "We believe the data reported to date and the completion of Phase I enrollment in this program affirms the value of our partnership with Athersys, and we are looking forward to working with Athersys to formulate the next clinical development steps for this important product candidate."
Auxilium Pharmaceuticals, Inc. (NASDAQ:AUXL), a specialty biopharmaceutical company, today announced financial results for the fourth quarter and the year ended December 31, 2009. The Company also highlighted important commercial, regulatory and clinical development progress during the year 2009, provided selected financial and operational guidance for 2010 and announced the list price to distributors for XIAFLEX?, its recently approved product for Dupuytren's contracture. "We believe 2009 was a great success for Auxilium. We achieved record revenues for Testim® in 2009, advanced XIAFLEX through U.S. regulatory review followed by approval in early 2010 for Dupuytren's contracture and released encouraging XIAFLEX Phase IIb clinical data in Peyronie's disease," commented Armando Anido, Chief Executive Officer and President of Auxilium. "With the recent approval of XIAFLEX for adult Dupuytren's contracture patients with a palpable cord, we believe that XIAFLEX represents a blockbuster opportunity that can provide sustainable long-term growth for the Company."
Celsion Corporation (Nasdaq:CLSN), a leading oncology drug development company, today announced financial results for the fourth quarter and year ended December 31, 2009. Management also highlighted the progress made in clinical trials of ThermoDox®, Celsion's heat activated liposomal encapsulation of doxorubicin, including the Company's pivotal Phase III trial for the treatment of hepatocellular carcinoma (HCC), the most common form of primary liver cancer, and recurrent chest wall breast cancer.
Cerus Corporation (NASDAQ:CERS) announced today that investigators from blood centers in Sweden, Belgium, France and Slovenia will present their experience with the INTERCEPT Blood System for platelets and plasma during a leading international transfusion safety meeting, the XIIth International Haemovigilance Seminar taking place in Dubrovnik, Croatia from February 17 to 19.
Derma Sciences, Inc. (Nasdaq:DSCI), a specialty medical device and pharmaceutical company focused on advanced wound care, today announced the pricing of a public offering of 972,000 shares of DSCI common stock and 324,000 warrants to purchase shares of common stock at a price of $5.50. Each share, together with a warrant to purchase one-third of a share, was priced at $5.00. The Company has granted the underwriters a 45-day option to purchase up to an additional 145,800 shares of common stock and 48,600 warrants to purchase shares of common stock to cover over-allotments, if any.
Javelin Pharmaceuticals, Inc. (NYSE Amex: JAV), a leading developer and marketer of specialty pharmaceutical products for pain management, today announced that its New Drug Application (NDA) submitted on December 2, 2009 to the US Food and Drug Administration (FDA) for its investigational product candidate, Dyloject™ (diclofenac sodium) Injection, has received an FDA PDUFA date of October 3, 2010. This NDA review is in support of US marketing approval and registration of Dyloject for the management of acute moderate-to-severe pain in adults. If approved, Dyloject will be the first IV non-steroidal anti-inflammatory drug (NSAID) marketed in the United States as a single agent for the management of acute moderate-to-severe pain in adults since ketorolac in 1990.
InterMune, Inc. (Nasdaq:ITMN) today announced results from operations for the fourth quarter and 12 months ended December 31, 2009. InterMune also highlighted its recent clinical development and business activities, and previewed upcoming milestones in 2010.
Dan Welch, Chairman, Chief Executive Officer and President of InterMune said, "Fourth quarter and recent events have been highlighted by the very important developments related to the regulatory progress of pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis, or IPF. Our New Drug Application (NDA) for pirfenidone was granted Priority Review status on January 4, and is scheduled to be discussed at an FDA advisory committee meeting on March 9, 2010. If approved by the FDA, pirfenidone would be the first approved medicine for the approximately 100,000 Americans who suffer from this terrible disease. Regarding Europe, we currently expect to submit a Marketing Authorization Application (MAA) for pirfenidone in the European Union in the current quarter."
Mr. Welch continued, "We were pleased to report in January promising top-line results of the multiple-ascending-dose study of ritonavir-boosted RG7227 (ITMN-191) with standard of care, and look forward to providing further data on RG7227 during the year."
Life Technologies Corporation (NASDAQ: LIFE) today announced it will present at the Cowen and Company 30th Annual Health Care Conference on Wednesday, March 10, at 9:30 a.m. EST at the Boston Marriott Copley Place.
MedCath Corporation (Nasdaq:MDTH) and its physician partners announced today that they have entered into a definitive agreement to sell substantially all the assets of Heart Hospital of Austin to St. David's Healthcare Partnership, L.P. The transaction is expected to close during MedCath's third fiscal quarter of 2010, subject to customary closing conditions and regulatory requirements.
Medical Nutrition USA, Inc. (NASDAQ:MDNU), a developer and distributor of uniquely engineered, nutrition-medicine products, reported preliminary, unaudited fourth quarter and full year sales and preliminary earnings for the fiscal year ended Jan. 31, 2010. "This is our third consecutive quarter of greater than 20% increases in branded product sales and we expect that momentum to carry forward into the next fiscal year," Medical Nutrition USA Chairman and Chief Executive Officer Frank A. Newman said. The Company had previously forecast revenue growth of 16 to 18 percent for the year.
Merck & Co., Inc. (NYSE:MRK) announced today that in new Phase III data, GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] was 77.5 percent (95 percent CI: 39.6, 93.3) efficacious against anal intraepithelial neoplasia (AIN) associated with human papillomavirus (HPV) types 6, 11, 16 and 18 in 16-to-26 year-old men who have sex with men. The data were presented at the European Research Organization on Genital Infection and Neoplasia (EUROGIN) conference in Monte Carlo, Monaco.
Merge Healthcare (NASDAQ: MRGE) announced today that it has signed a reseller agreement with Orion Health, a leading provider of clinical workflow and integration solutions in healthcare. Orion Health has licensed Merge technology to bring medical images and information into its physician portal solutions.
Microfluidics International Corporation (OTC Bulletin Board: MFLU) announced today the Company will release fourth quarter and year-end 2009 financial results on Tuesday, February 23, 2010, at 8:30am ET.
NMT Medical, Inc. (NASDAQ: NMTI) today announced that it has completed a private placement of its common stock and warrants to purchase additional shares of common stock to existing and new stockholders for aggregate proceeds of approximately $5.8 million. The proceeds will be used to fund NMT’s ongoing clinical trials and development programs, primarily its pivotal patent foramen ovale (PFO)/stroke and transient ischemic attack (TIA) trial in the United States, CLOSURE I.
Rosetta Genomics, Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostics, announced today that the results of a joint study with the NYU Langone Medical Center were published online on February 16th, 2010, and are set to be published in the March 1st issue of the American Association for Cancer Research’s journal, Cancer Research. The study, "Hsa-Mir-29c* is Linked to the Prognosis of Malignant Pleural Mesothelioma," demonstrates the potential of a single microRNA to act as an independent prognostic factor for time to progression as well as survival after surgery.
Santarus, Inc. (NASDAQ: SNTS), a specialty biopharmaceutical company, today announced that it will release fourth quarter and full year 2009 financial results after market close on Wednesday, March 3, 2010.
Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) was up 60 cents to $7.66 , 8.47% on no news and heavier than normal volume.
Walgreen Co. (NYSE: WAG)(NASDAQ: WAG): “By combining the strengths of our two companies, we can improve our position as the most convenient provider of consumer goods and services, and pharmacy, health and wellness services in the country.”
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