|BioCryst releases positive results from Gout study. Enco receives delisting notice after the bell|
|By BioMedReports.com Staff|
|Wednesday, 28 April 2010 18:17|
Below is a list of the companies that made news in the healthcare sector on Wednesday, April 28, 2010.
Encorium Group, Inc. (Nasdaq:ENCO), fell sharply after the bell when the company announced that it received a NASDAQ staff determination letter on April 22, 2010 notifying the Company that it did not comply with the minimum $2,500,000 stockholders' equity requirement for continued listing on The NASDAQ Capital Market as set forth in Listing Rule 5550(b)(1). In accordance with the notice, the Company will request an appeal by April 29, 2010 which should allow trading of the Company's common stock to continue during the appeal process. Shares fell 72 cents or 19% to $3.06 in the after hours session.
NexMed, Inc. (Nasdaq: NEXM), a specialty CRO with a pipeline of products based on the NexACT technology, today announced after the bell that results from a pre-clinical study showed significant improvement in the delivery and half life of A6, a proprietary peptide treatment for ovarian cancer currently in Phase 2 development by Angstrom Pharmaceuticals. Specifically, the incorporation of NexACT enabled the dose of A6 to be cut by half, or from twice per day to once per day delivered subcutaneously, while achieving the same level of efficacy in the mouse lung metastasis model.
In news from earlier in the day:
BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) soared today after the company announced positive top-line results from a planned interim analysis of its ongoing Phase 2a, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of orally administered BCX4208 in patients with gout.The study’s primary endpoint is the change in serum uric acid concentration after 21 days of treatment compared to baseline concentration prior to treatment. Part one of the study randomized 60 gout patients with serum uric acid concentrations greater than or equal to 8 mg/dL to placebo or to one of three different doses of BCX4208, a purine nucleoside phosphorylase (PNP) inhibitor, administered once-daily for 21 days. All three doses of BCX4208 demonstrated a statistically significant reduction in serum uric acid levels compared to placebo at day 22. Shares surged nearly 14% or 96 cents, closing the day at $7.99.
Abbott (NYSE:ABT) announced today that the U.S. Food and Drug Administration (FDA) approved once-daily dosing of Kaletra (lopinavir/ritonavir) for adult patients with HIV who have previously taken antiretroviral therapy. Kaletra once-daily dosing is already indicated for adult patients new to antiretroviral treatment. This gives treatment-experienced patients who have HIV that responds to Kaletra another dosing option as determined by their physician.
"Adherence to treatment is critical to the effective management of HIV," said Joseph Gathe, M.D., clinical instructor, Department of Internal Medicine, Baylor College of Medicine. "A Kaletra once-daily regimen can simplify HIV treatment and offers greater flexibility for patients."
AVI BioPharma, Inc. (NASDAQ:AVII), a developer of RNA-based drugs, today announced it secured increased funding of up to approximately $4.0 million under its agreement with the U.S. Defense Threat Reduction Agency (DTRA) to develop, in cooperation with the Transformational Medical Technologies Initiative (TMTI) of the Department of Defense, one or more of AVI's nucleotide-based drug candidates targeting the pandemic H1N1 influenza virus (swine flu). The increased funding will support continued preclinical development of AVI's lead influenza drug candidate, AVI-7367, against H1N1 as well as its expanded preclinical evaluation against H5N1 (avian flu) and drug resistant H1N1 and H3N2 flu strains.
Bond Laboratories, Inc. (OTCBB:BNLB), an innovative manufacturer of functional beverages and nutritional products, today announced that its Fusion Premium Beverages division has entered into agreements with Choice Brands of Monroe, LA and Venture Marketing of Lecompe, LA to distribute its successful hangover prevention drink Resurrection.
CryoLife, Inc. (NYSE:CRY), an implantable biological medical device and cardiovascular tissue processing company, announced today its results for the first quarter of 2010. Revenues for the first quarter increased 11 percent to a quarterly record of $29.7 million compared to $26.7 million for the first quarter of 2009. Net income for the first quarter of 2010 was $1.9 million, or $0.07 per basic and fully diluted common share, compared to $1.9 million, or $0.07 per basic and fully diluted common share, for the first quarter of 2009.
Cumberland Pharmaceuticals Inc. (Nasdaq:CPIX) today announced it has entered into an exclusive agreement with Alveda Pharmaceuticals Inc., a Toronto-based specialty pharmaceutical company, for the commercialization of Caldolor (ibuprofen) Injection in Canada. Designed to treat pain and fever in the hospital setting, Caldolor was approved by the U.S. Food and Drug Administration and launched by Cumberland in the United States in 2009.
MDRNA, Inc. (NASDAQ:MRNA), a leading RNAi-based drug discovery and development company, today reported data demonstrating greater efficacy in tumor reduction in an orthotopic model of bladder cancer with multiple combinations of two UsiRNAs as compared to single target therapy."Advances in molecular biology and gene profiling have revealed fundamental changes in cancer cells and the potential need to inhibit multiple targets to achieve maximum therapeutic benefit," stated Barry Polisky, PhD, Chief Scientific Officer at MDRNA, Inc. "RNAi provides a highly potent and highly specific therapeutic approach for knocking down multiple targets in a single compound. Our DiLA2 platform readily allows for formulation of two UsiRNAs into a single formulation and permits functional delivery to tumor cells. A multi-target approach is likely to be required for treatment of many cancers, and thus will be a key part of MDRNA's oncology pipeline."
Mylan Inc. (Nasdaq:MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Tamsulosin Hydrochloride Capsules USP, 0.4 mg, the generic version of Boehringer Ingelheim's benign prostatic hyperplasia (BPH) treatment, Flomax.
Tamsulosin Hydrochloride Capsules had U.S. sales of approximately $2.2 billion for the 12 months ending Dec. 31, 2009, according to IMS Health. Mylan has started shipping this product.
Osiris Therapeutics, Inc. (NASDAQ:OSIR), announced today that it has achieved a $1 million milestone payment from its Japanese commercial partner, JCR Pharmaceuticals, for development progress made advancing Prochymal for the treatment of acute graft vs. host disease (GvHD) in Japan.
In 2003, Osiris formed a partnership with JCR Pharmaceuticals focusing on the commercialization of Prochymal in Japan for the treatment of patients with GvHD. The collaboration provides for additional milestone payments for regulatory and sales milestones, as well as significant royalty payments on sales of the drug in Japan.
Pain Therapeutics, Inc. (Nasdaq:PTIE), today reported first quarter 2010 financial results. Net loss for Q1 2010 was $1.0 million, or $0.02 per share, compared to a net loss of $1.8 million, or $0.04 per share, for Q1 2009.
At March 31, 2010 Pain Therapeutics had cash and cash equivalents of $175.5 million, or about $4.12 per share, no debt and approximately 42.6 million shares outstanding. We continue to expect our net cash requirement in 2010 will be under $10.0 million.
"Pain Therapeutics continues to make meaningful advancements across its business," said Remi Barbier, chairman, president and chief executive officer of Pain Therapeutics. "Importantly, our commercial partner for REMOXY, King Pharmaceuticals, Inc. continues to guide for a year-end resubmission of a New Drug Application for REMOXY."
PolyMedix, Inc. (OTC BB: PYMX), an emerging biotechnology company focused on developing new therapeutic drugs to treat acute cardiovascular disorders and infectious diseases, has initiated a Phase 1B/2 dose-ranging clinical study with its anticoagulant reversing agent, PMX-60056. The study is intended to demonstrate the safety and efficacy of PMX-60056 in reversing varying heparin levels, including the highest levels commonly used in surgical settings. Results from this Phase 1B/2 study are expected by the end of the second quarter of 2010.
pSivida Corp. (NASDAQ:PSDV)(ASX:PVA), moved higher today after the developer of ophthalmic sustained release drug delivery products, reported that it had received full payment of a $15 million note, including an additional $225,000 in accrued interest, from Alimera Sciences, Inc., pSivida’s licensee developing Iluvien for the treatment of diabetic macular edema (DME).
Dr. Paul Ashton, CEO of pSivida Corp. said, "We congratulate Alimera on its successful IPO and look forward to Alimera’s filing of the NDA for Iluvien for the treatment of DME." Alimera has stated that it intends to file the NDA for Iluvien this quarter and to seek priority review, which, if granted, is expected to result in a response from the FDA in the 2010 fourth quarter. If the FDA approves Iluvien for the treatment of DME, pSivida is due to receive a $25 million milestone payment from Alimera. pSivida would also be entitled to receive 20% of the net profits of sales of Iluvien.
Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced the Food and Drug Administration has issued a complete response letter regarding the New Drug Application for GIAZO (balsalazide disodium) Tablets 1.1 g. for the treatment of mild-to-moderate active ulcerative colitis in patients 18 years and older.
In this complete response letter there are no requests for new pre-clinical or clinical trials. The sole issue raised in this letter concerns a deficiency of the manufacturing facility for this application. The manufacturer has responded to the FDA and continues to work with the FDA to resolve the matter. The facility only manufactures COLAZAL Capsules and GIAZO Tablets for Salix.
Valeant Pharmaceuticals International (NYSE:VRX) today announced that its wholly owned subsidiary, Valeant Canada Limited, has signed an agreement to acquire Vital Science Corp., a leading over-the-counter (OTC) dermatology company located in Toronto, Ontario, Canada for approximately C$10.5 million. Vital Science currently has annualized sales of approximately C$11 million and the transaction is expected to be accretive in 2010. "Combining another attractive dermatology company with the Dr. Renaud portfolio we acquired last year is another significant step in our Canadian strategy," said J. Michael Pearson, chairman and chief executive officer.
Vitro Diagnostics, Inc. (OTC.BB:VODG), dba Vitro Biopharma, announced that it signed a contract to jointly manufacture and distribute stem cell analysis tools with HemoGenix®, Inc., a leading firm known for its pioneering analysis of stem cells.
VIVUS, Inc. (Nasdaq:VVUS) today announced that data on Qnexa, its lead investigational drug candidate, will be presented at the American Society of Hypertension 25th Annual Scientific Meeting and Exposition in New York, NY. Suzanne Oparil, MD, professor of medicine, physiology and biophysics and director, vascular biology and hypertension program, division of cardiovascular disease, department of medicine at the University of Alabama at Birmingham, will make an oral presentation."We are pleased to have a presence at this year's ASH meeting, and that Dr. Oparil will be sharing these analyses highlighting the impact of Qnexa treatment and the resulting improvement in blood pressure in obese hypertensive patients with our colleagues in the medical community," stated Leland Wilson, chief executive officer of VIVUS. "This is an exciting time for VIVUS. We believe that Qnexa, if approved, may play a significant role in the treatment of patients living with co-morbidities that result from their obesity.
Wellstar International Inc. (OTCBB: WLSI) has announced they will be installing a TMI Imaging system in a Doctor’s office in Beverly Hills, California. The system will be used primarily for the early detection of women having metabolic changes in her breast that often times leads to breast cancer. The practice specializes in treating patients for overall health problems and maintaining a healthy lifestyle. The physician is currently using an infrared system, but will replace it with a TMI System. The reason for the change is that the TMI system uses a software written with algorithms that automatically interpit the image taken and does not allow any image to be manipulated as other Thermography systems do.
Cell Therapeutics, Inc. (Nasdaq and MTA: CTIC) today reported recent accomplishments and financial results for the first quarter ended March 31, 2010.
China Jo-Jo Drugstores, Inc. (NASDAQ:CJJDD) which operates a retail pharmacy chain in the People’s Republic of China, today announced that it closed its previously announced public offering of 3.5 million shares of common stock.
Genta Incorporated (OTCBB: GETA) announced today that the Company will provide an overview of corporate activities at the BIO Business Forum during the 2010 BIO International Convention.
China Pediatric Pharmaceuticals, Inc. (OTCBB:CPDU) announced today that its company information will be made available via Standard & Poor's Market Access Program, an information distribution service that enables subscribing publicly traded companies to have their company information disseminated to users of Standard & Poor's Advisor Insight.
Santarus, Inc. (NASDAQ:SNTS), a specialty biopharmaceutical company, today announced that it will release first quarter 2010 financial results after market close on Thursday, May 6, 2010.
Targacept Inc. (NASDAQ: TRGT), a clinical-stage biopharmaceutical company developing novel NNR Therapeutics (TM), today announced that it will report financial results for the first quarter ended March 31, 2010 on Wednesday, May 5, 2010, after the U.S. financial markets close.
Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) today announced U.S. Food and Drug Administration (FDA) approval and commercial launch of its generic version of Boehringer Ingelheim's Flomax® (tamsulosin hydrochloride) Capsules, 0.4 mg, a product indicated for the treatment of signs and symptoms of benign prostatic hyperplasia (BPH).
WuXi PharmaTech (Cayman) Inc. (NYSE:WX), a leading pharmaceutical, biotechnology and medical device R&D outsourcing company with operations in China and the United States, today announced that it will release financial results for the first quarter of 2010 after the New York Stock Exchange closes on Tuesday, May 11, 2010 (which will be Wednesday morning, May 12, 2010 Shanghai time).
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