|RxNews Recap for Wednesday 03-31-10. ArQule flys on positive lung cancer study results. Isis moves higher on GlaxoSmithKline alliance. After the bell Ardea Biosciences surges as gout study meets goals|
|By BioMedReports.com Staff|
|Wednesday, 31 March 2010 19:39|
Below is a list of the companies that made news in the healthcare sector on Wednesday, March 31, 2010.
ArQule, Inc. (Nasdaq: ARQL) saw its shares explode to the upside today after reporting that ARQ 197, when used in combination with erlotinib, demonstrated a 66% improvement in median Progression-Free Survival (PFS) in patients with advanced, refractory non-small cell lung cancer (NSCLC). The median PFS was 16.1 weeks in the ARQ 197 plus erlotinib arm, compared with 9.7 weeks in the erlotinib plus placebo arm, the company said. Results are from a Phase 2 trial. Shares of the company shot up more than 63% or $2.22 to $5.72. The stock hit an intra-day high of $7.49 before pulling back.
Isis Pharmaceuticals, Inc. (Nasdaq:ISIS) saw its shares move higher today after the company announced a new strategic alliance with GlaxoSmithKline (NYSE:GSK) that will apply the Isis antisense drug discovery platform to seek out and develop new therapeutics against targets for rare and serious disease, including infectious diseases and some conditions causing blindness. Isis will immediately receive a $35 million payment from GSK and is eligible to receive on average up to $20 million in milestones per program up to Phase 2 proof-of-concept (PoC). GSK will have the option to license compounds at PoC, and will be responsible for all further development and commercialization. In total, Isis will potentially be eligible to receive license fees and milestone payments of nearly $1.5 billion, in the event all six programs are successfully developed. Isis will also receive up to double-digit royalties on sales from any product that is successfully commercialized.
Antisense therapies target the proteins that play a role in disease processes through the RNA that is involved in building these proteins. The Isis antisense platform develops specific therapies that bind to messenger RNA (mRNA) and inhibit the production of disease-causing proteins.
Shares of Isis reached an intra-day high of $11.43 and settled the day at $10.93, 63 cents or 6.12% higher than the previous days close.
In news after the bell:
Ardea Biosciences, Inc. (Nasdaq:RDEA) surged after the bell as the company announced positive, preliminary, top-line results from its Phase 2b monotherapy study of RDEA594, its lead product candidate for the treatment of hyperuricemia and gout. RDEA594 met the primary endpoint of the study, showing a significant increase in the proportion of patients with reduced serum urate levels after four weeks of treatment, compared to placebo. "The encouraging safety and efficacy results from this multi-center, randomized study of RDEA594 provide a strong basis to advance this innovative product into Phase 3 clinical development," commented John S. Sundy, MD, PhD, Associate Professor of Medicine and Head of the Section of Allergy and Clinical Immunology in the Division of Pulmonary, Allergy and Critical Care Medicine at Duke University Medical Center. "There is a major unmet medical need for a well-tolerated, orally administered urate-lowering therapy that works by a novel mechanism of action and can be given alone or in combination with other agents to the many patients who are not adequately treated with currently available products." Shares shot up more than 9% in the after hours session, up $1.74.
Adeona Pharmaceuticals, Inc. (AMEX:AEN), a specialty pharmaceutical company developing new medicines for serious central nervous system diseases announced today that it will hold an investor conference call on Thursday, April 1, 2010 at 9:00 a.m. EDT. James S. Kuo, Chairman and Chief Executive Officer of Adeona, will host the call.
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that it plans to stop investing in the clinical development of CB-500,929 (ecallantide) as a therapy to reduce blood loss in patients undergoing cardiac surgery using cardiopulmonary bypass. The company made this decision after reviewing top line efficacy and safety data from the CB-500,929 Phase 2 CONSERV™ 1 and CONSERV 2 trials. This decision does not impact the 2010 R & D cost guidance announced by the company in January 2010 as the guidance did not include costs for potential development of CB-500,929 beyond the CONSERV trials.
Exact Sciences Corp. (Nasdaq: EXAS) today announced after the bell that it has been invited to deliver a talk at the World Organization of Digestive Endoscopy’s (OMED) Colorectal Cancer Screening Committee Meeting. OMED is a nonprofit, world federation of 97 national digestive endoscopy societies. The meeting is being held in New Orleans on Saturday, May 1, in conjunction with Digestive Disease Week 2010, the world’s largest gathering of physicians and researchers in the fields of gastroenterology, endoscopy and related disciplines.
Immucor, Inc. (Nasdaq:BLUD), a global leader in providing automated instrument-reagent systems to the blood transfusion industry, reported financial results for its fiscal 2010 third quarter ended February 28, 2010. Revenue for the third quarter of fiscal 2010 was $80.5 million, up 7% from $75.3 million in the prior year quarter. "We had an exciting quarter with the European launch of our fourth generation automated instrument, the Neo," stated Dr. Gioacchino De Chirico, Immucor's President and Chief Executive Officer. "The introduction of the Neo demonstrates our commitment to bringing innovative automation to the market that improves our customers' operations and patient outcomes."
K-V Pharmaceutical Company (NYSE: KVa/KVb) announced that it has reduced its work force by 289 employees, or approximately 42%, in order to lower its operating costs. The reduction in the Company's work force is a part of the Company's efforts to manage its cash and financial resources while it continues working with the Food and Drug Administration (the "FDA") to return its products to market.
"Although this type of action is always difficult, we believe it is a necessary step to preserve our capital resources and to re-size our company to be in line with our current expectations of when and how we will be able to return to market," said David Van Vliet, interim CEO of the Company. "Despite this reduction in our work force, we believe we have retained the capabilities and the overall level of employees needed to effectively support our future re-entry into the market."
Omeros Corporation (Nasdaq:OMER), a biopharmaceutical company committed to discovering, developing and commercializing products focused on inflammation and disorders of the central nervous system, today announced financial results for the fourth quarter and year ended December 31, 2009. "2009 was a significant year for Omeros with the announcement of positive milestones for several of our programs as well as having completed a successful IPO. This funding provided us with the resources necessary to advance our pipeline and move our Phase 3 product candidate toward commercialization," said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "2010 will be an exciting year for Omeros. We expect to announce the results from the Phase 3 clinical trials of our lead PharmacoSurgery™ product, OMS103HP for arthroscopy. In addition, we expect to find compounds that interact with, or 'unlock,' at least one orphan GPCR in the second quarter, which could begin a cascade of wholly new drug targets introduced to the market by Omeros."
Orexigen® Therapeutics, Inc. (Nasdaq:OREX) announced that the Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Contrave® (naltrexone SR/bupropion SR), its investigational drug for the treatment of obesity. The NDA is based on a substantial body of evidence gathered through the Contrave Obesity Research (COR) clinical program, which included over 4,500 patients. Mike Narachi, President and CEO of Orexigen.
Response Genetics, Inc. (Nasdaq: RGDX), a company focused on the development and sale of molecular diagnostic tests for cancer, announced consolidated financial results for the fourth quarter and year ended December 31, 2009, as well as an update on the Company’s ResponseDX™ sales activities. "2009 was a very exciting year for Response Genetics as we saw significant growth and acceptance of our ResponseDX™ diagnostic tests. This trend has continued into 2010, with approximately 800 tests sold in March alone," said Kathleen Danenberg, Response Genetics president and CEO. "We continue to execute on our successful growth strategy; expanding our sales force, strengthening our balance sheet and establishing an international distribution network. For the coming year, we look forward to building on the momentum we have gained to further increase sales of our diagnostic tests and to advance our pipeline of products."
Solta Medical (Nasdaq:SLTM), a global leader in the medical aesthetics market added a new $10 million term loan to existing credit facilities through Silicon Valley Bank, financial partner to technology and life science companies of all sizes . The additional term loan increases Solta Medical's credit facilities with Silicon Valley Bank to a total of $22 million. Solta Medical would expect to use the additional facility to pursue strategic initiatives.
Symbollon Pharmaceuticals, Inc. (OTC.BB:SYMBA) announced financial results for the year ended December 31, 2009. The Company reported a net loss of $(692,372), or $(0.03) per share, compared with a net loss of $(1,784,105), or $(0.11) per share, in the prior year. The decreased loss resulted primarily from decreased clinical development expenses related to Iogen, consulting related expenses, investor relations expenses and compensation related to equity grants, partially offset by the writeoff of certain capitalized patent costs. "Our current focus is to expand the sales of Iogen™ through both online and other retail outlets," stated Paul C. Desjourdy, President and Chief Executive Officer of Symbollon. "We continue to pursue additional retail distribution channels for Iogen™. We are committed to making Iogen™ available in as many outlets as possible so every woman who has interest in improving her breast health has easy access to Iogen™."
In news earlier in the day Wednesday:
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that the Japanese Patent Office has granted claims in a second patent application for the Tuschl II patent series, entitled "RNA Interference Mediating Small RNA Molecules." In May 2008, the Japanese Patent Office granted a related set of claims in the Tuschl II patent series. The Tuschl II patent series provides broad exclusivity for small interfering RNAs (siRNAs), the molecules that mediate RNAi, in the world’s top pharmaceutical markets, which include the U.S., the European Union, China, and Japan. The Tuschl II patent is exclusively licensed to Alnylam for RNAi therapeutics on a worldwide basis through an agreement with Max Planck Innovation GmbH, the licensing agent for the Max Planck Society.
Cell Therapeutics, Inc. (Nasdaq and MTA:CTIC) today announced that it has entered into an agreement to sell $20 million of shares of its Series 4 Preferred Stock and warrants to purchase shares of its common stock in a registered offering to three institutional investors. Each share of Series 4 Preferred Stock is convertible at the option of the holder, at any time during its existence, into 2,000 shares of common stock at a conversion price of $0.50 per share of common stock, for a total of 40,000,000 common shares.
Celsion Corporation (Nasdaq:CLSN) announced today that after reviewing safety data from the 40mg/m2 cohort, the DIGNITY Study Drug Safety Monitoring Board (DSMB) has recommended that Celsion continue to enroll patients in the trial and that new patients be treated at a ThermoDox® dose of 50mg/m2. The DSMB for the DIGNITY Trial is comprised of an independent group of medical experts who are responsible for reviewing and evaluating patient safety and efficacy data. The DSMB reviews safety data at regular intervals with the mandate to ensure patient safety and monitor the quality of the study. The study design for the Phase I/II ThermoDox trial incorporates a planned increase in dosage, from 40 to 50mg/m2 if supported by safety data.
Cypress Bioscience, Inc. (NASDAQ:CYPB) reported today financial results for the quarter and year ended December 31, 2009. The company said its fourth-quarter loss narrowed, mainly due to sales of its treatment for fibromyalgia, a medical disorder that causes pain in the muscles and connective tissue. The company lost $5 million, or 13 cents per share, in the three months that ended Dec. 31, compared to a loss of $7.2 million, or 19 cents per share, in the final quarter of 2008. Revenue jumped to $8.1 million from $949,000 in 2008. Most of this revenue gain came from the launch of Savella, which is marketed by Forest Laboratories as a treatment for Fibromyalgia. It received $2.1 million in royalty revenue and $4.6 million in sales force reimbursement related to the drug.
Genta Incorporated (OTCBB: GETA) announced that the Company has initiated a confirmatory Phase 2b trial of tesetaxel in patients with advanced gastric cancer. Tesetaxel is the Company’s newest clinical-stage small molecule. As a late Phase 2 oncology product, tesetaxel is the leading oral taxane currently in clinical development.
Omeros Corporation (Nasdaq:OMER) shares surged today after the company announced that a Phase 2 clinical trial of OMS103HP, its PharmacoSurgery™ product candidate for arthroscopy, demonstrated that patients treated with OMS103HP during arthroscopic knee meniscectomy surgery achieved statistically significant clinical benefits. OMS103HP is an investigational drug product that is added to arthroscopic irrigation solution and is designed to improve postoperative joint function and motion and reduce postoperative pain. "We are pleased with the clinical results of this Phase 2 trial, which show that OMS103HP significantly improved patients' functional scores, increased their knee flexion and decreased their pain after arthroscopy," stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "These data are not only consistent with those from our earlier Phase 2 arthroscopic ACL trial that demonstrated functional improvement over a 30-day course of physical therapy, they showed sustained clinical benefit throughout an even longer 90-day follow-up period." Shares moved higher by $1.01 or 16.75%, closing the day at $7.04.
Repros Therapeutics Inc. (NasdaqCM:RPRX) moved higher today after the company announced that it is sending a reply to the FDA’s Division of Metabolism and Endocrinology Products following the Company’s receipt of FDA’s comments on the proposed Phase II study of Androxal® (enclomiphene) in the treatment of Type II diabetes under Repros' open IND. On February 2, 2010 the Company announced that Repros received confirmation from the Agency that the new IND is effective. Joseph S. Podolski, President and CEO of Repros noted, "We believe the FDA critique of our Phase II protocol is very constructive. We will incorporate their recommendations. If the study is successful, incorporating the FDA’s recommendations will facilitate Phase III studies. In agreement with the FDA we believe the protocol we have designed will determine if there is a clinically significant signal that warrants further development." He commented that before proceeding with the study the Company must raise additional capital and is currently evaluating several different financing options, in addition to the recently announced ATM financing.
STAAR Surgical Company (Nasdaq:STAA), a leading developer, manufacturer and marketer of minimally invasive ophthalmic products, today announced that STAAR and all other parties to the matters Parallax Medical Systems v. STAAR Surgical Company and Scott C. Moody, Inc. v. STAAR Surgical Company entered into a Stipulation for Settlement that globally resolves all pending disputes among them. This settlement satisfies in full the $4.9 million judgment against STAAR in the Parallax matter and the $6.5 million judgment against STAAR in the Moody matter. In exchange for complete mutual releases, the Stipulation provides for payment by STAAR of $4 million as its contribution to the global settlement. The funds will be paid from the deposit made by STAAR with the court in June 2009. The balance of those funds, approximately $3.4 million, will be returned to STAAR.
Vitro Diagnostics, Inc. (OTC.BB:VODG), dba Vitro Biopharma, moved higher today after the company announced recent research results that reveal a simplified method for production of induced pluripotent stem cells or IPS cells. IPS technology allows the use of reprogrammed adult cells to achieve properties of embryonic stem cells including the ability to differentiate into any type of cell in the body. Many research groups focus specifically on IPS technology because it allows for the generation of stem cells with the primary properties of embryonic stem cells without sacrifice or use of embryos. Use of IPS technology completely avoids ethical and religious controversies surrounding the use of embryonic stem cells. Shares moved up more than 38% on the news.
ViroPharma Incorporated (Nasdaq:VPHM) today announced that it has initiated an open-label, single-dose Phase 2 study to evaluate doses of Cinryze™ (C1 esterase inhibitor [human)] for treatment of acute angioedema attacks in children less than 12 years of age with hereditary angioedema (HAE). Cinryze was approved by the U.S. Food and Drug Administration in October 2008 for routine prophylaxis against angioedema attacks in adolescent and adult patients with HAE. Cinryze is not approved in the US for acute treatment of attacks or in pediatric patients below the age of 12 years.
VIVUS, Inc. (Nasdaq:VVUS) today announced that it has terminated the Development and Commercialization Agreement with FemPharm Pty Ltd. (a wholly owned subsidiary of Acrux Limited) for Luramist™, a metered dose transdermal application of testosterone for women. The Agreement with FemPharm was originally signed in 2004 along with the agreement to develop Evamist, a metered dose transdermal estradiol spray for menopause. The company will return rights to Luramist to FemPharm and focus its efforts on its late stage investigational product candidates: Qnexa for obesity and avanafil for erectile dysfunction.
"The decision to terminate the agreement was made in view of the significant long-term safety requirements for the approval of testosterone products in women," stated Peter Tam, president of VIVUS. "We believe it is in our shareholders' best interests to pursue other therapeutic candidates."
Affymax, Inc. (Nasdaq: AFFY) today announced the promotion of Sylvia Wheeler to vice president, Corporate Communications.
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