|RxNews Recap for Tuesday 02-16-10. Discovery Labs (DSCO) up on positive FDA guidelines. Sequenom (SQNM) leaps on launch of test|
|By Mary Davila|
|Tuesday, 16 February 2010 18:50|
Below is a list of the companies that made news in the healthcare sector on Tuesday, February 16, 2010.
Discovery Laboratories, Inc. (Nasdaq: DSCO ) saw its shares jump as the company announced today that, in response to written guidance recently received from the U.S. Food and Drug Administration (FDA), it will now focus on a pathway that would entail solely performing additional preclinical work, instead of conducting a limited clinical trial, to potentially gain FDA marketing approval for Surfaxin® (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants. Based on prior guidance received from the FDA, Discovery Labs expected that a limited, pharmacodynamic-based (PD) clinical trial in preterm infants would be required to address the sole remaining Chemistry, Manufacturing & Control (CMC) issue regarding the final validation of a fetal rabbit Biological Activity Test (BAT, an important quality control release and stability test) necessary for Surfaxin approval. The recently-received guidance from the FDA advises that since an acceptable and well-established animal model (preterm lamb) of RDS already exists and this model could be used as an acceptable alternative to a clinical trial in human preterm infants, that a PD clinical trial approach is not appropriate. Compared to the conduct of a PD clinical trial, a comprehensive preclinical program, if successful, presents an opportunity to significantly reduce the time and expense required to gain potential Surfaxin approval and Discovery Labs believes a Complete Response could be submitted to the FDA in the first quarter of 2011.
Shares closed up 11.82% to 74 cents.
Sequenom, Inc. (Nasdaq:SQNM) shares shot up today as the company announced the launch of the SensiGeneFetal(XY) (Fetal Sex Determination) test by Sequenom's CAP accredited and CLIA-certified laboratory, Sequenom Center for Molecular Medicine (Sequenom CMM). This is the company's second laboratory developed test powered by its SEQureDx technology. The benefits of the SensiGene Fetal(XY) Fetal Sex Determination test include: * Noninvasive and safe. The test requires only a simple blood sample from the mother. * Early detection: first trimester fetal sex determination. * Highly specific allows the distinction between maternal and fetal DNA for both male and female fetuses. * Physician-ordered. "The launch of the SensiGene Fetal(XY) test represents another successful noninvasive prenatal test demonstrating the utility of using maternal blood to determine fetal status," said Lee P. Shulman, MD, Professor of Obstetrics and Gynecology and Chief of the Division of Clinical Genetics at the Feinberg School of Medicine at Northwestern University. "This is a great leap forward in delivering a test with a high degree of accuracy, using cutting-edge technology which has been rigorously evaluated through blinded studies, performed in collaboration with internationally recognized prenatal diagnosticians. This test adds to the physicians' prenatal diagnostic arsenal by providing for safe and accurate noninvasive fetal testing."
Shares of Sequenom lept over 16% or 74 cents as the stock closed at $5.26.
In news from after the bell:
Amicus Therapeutics (Nasdaq: FOLD) today announced financial results for the fourth quarter and full year 2009. The Company also provided an update on advancements in its product pipeline related to its key strategic priorities for 2010. Additionally, the Company stated that it believes it is well positioned to achieve its key milestone of completing enrollment for its Phase 3 study of Amigal(migalastat HCl) to support approval in the U.S. (Study 011) by year end.
CombinatoRx, Incorporated (NASDAQ: CRXX) today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for review of the Exalgo™ (hydromorphone HCl) extended-release tablets New Drug Application (NDA) from Monday, February 22, 2010 to Monday, March 1, 2010 due to federal government closings.
The U.S. rights to Exalgo tablets were acquired from Neuromed by Mallinckrodt Inc., a Covidien company (NYSE:COV), in June, 2009. Neuromed acquired the U.S. marketing rights to Exalgo tablets from ALZA Corporation in April 2007 and was responsible for clinical development and regulatory filings. Covidien is responsible for all commercialization activities for Exalgo in the U.S., including marketing, sales and all post-approval FDA regulatory filings, and will now own the intellectual property for the product. ALZA is responsible for manufacturing, packaging and supply of the product. CombinatoRx and Neuromed merged on December 21, 2009.
Myriad Pharmaceuticals, Inc. (Nasdaq:MYRX) after the bell today reported financial results for its second fiscal quarter ended December 31, 2009.
"We are pleased with the progress we have made over the past seven months," said Adrian N. Hobden Ph.D., President and CEO of Myriad Pharmaceuticals, Inc. "We continue to advance the development of our three clinical drug candidates, MPC-4326 for the treatment of HIV and Azixa and MPC-3100 for the treatment of cancer, having recently initiated our Phase 2b Study of MPC-4326 in a genetically-identified responder population. Most notably during the quarter, on December 18, 2009, we entered into a definitive agreement and plan of merger with Javelin Pharmaceuticals. The proposed merger will create a company with a product pipeline that includes an NDA-filed product candidate, DylojectTM, and a portfolio of early-, mid- and late-stage drug candidates in cancer, HIV and pain. During the next 12 months we look forward to completing the merger; preparing for potential FDA approval and the commercial launch of Dyloject; and furthering the development of our clinical pipeline."
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced that on March 19, 2010 it will redeem the outstanding $32.1 million aggregate principal amount of 4.75% Convertible Senior Subordinated Notes due 2013, in accordance with the terms of the indenture governing those notes. Since Vertex's common stock is currently trading above the conversion price, Vertex expects that holders of the notes will choose to convert their notes into common stock at a conversion rate of approximately $23.14 per share rather than accept redemption. The holders may convert the notes into common stock until the close of business on March 18, 2010. If all notes are converted, Vertex will issue an aggregate of approximately 1.4 million shares of common stock, increasing the Company's total shares outstanding to approximately 202 million. Vertex will pay the holders of those notes not converted into shares a redemption price equal to 102.85% of the outstanding principal amount of the notes, plus accrued and unpaid interest to, but excluding the redemption date.
Big movers with no news as the overall market recovered today:
Adeona Pharmaceuticals (AMEX: AEN) was up 30 cents or 40% on nearly double the daily volume. The stock closed at $1.05 as 1.3 million traded hands.
GenVec (Nasdaq: GNVC) jumped 35 cents or 17% to close at $2.40 on nearly triple the daily volume.
InsMed Inc (Nasdaq: INSM) shot up 14 cents or 16.95% to 98 cents. Volume of 4.5 million was more than 7 times the daily average.
Jazz Pharmaceuticals Inc (Nasdaq: JAZZ) closed up $1.16 or 12.42% to close at $10.50. Volume was nearly 2.5 times the daily average.
Rexahn Pharmaceuticals Inc (Amex: RNN) continued its run once again today closing up 23.77% or 29 cents to end the day at $1.51. Shares are now up over 100% since BioMedReports featured them last week.
XOMA LTD (Nasdaq: XOMA) was up 10.68% or 4 cents on double the daily average volume.
In other news from the day:
AGA Medical Holdings (NASDAQ: AGAM), a leading developer of interventional medical devices for the minimally invasive treatment of structural heart defects and vascular abnormalities, today reported financial results for the fourth quarter and full year ended Dec. 31, 2009.John Barr, President and Chief Executive Officer of AGA Medical, commented, "As our first full quarter as a public company, we are pleased to report that the fourth quarter was the strongest sales quarter in AGA’s history. Clearly, we are seeing the benefit of our investment in our sales channels with balanced growth across all geographies. In addition, our vascular business grew substantially, led by the European launch of our AMPLATZER® Vascular Plug 4, which was a strong contributor to our highly successful quarter."
Alkermes, Inc. (NASDAQ: ALKS) today announced positive topline data from a phase 1 clinical study of ALKS 37, an orally active, peripherally-restricted opioid antagonist with potential to block the effects of opioid agonists on gastrointestinal motility, commonly referred to as opioid-induced constipation (OIC). Data from the study showed that ALKS 37 was generally well tolerated and as predicted, demonstrated low systemic exposure across a wide range of doses. Based on these positive results, Alkermes expects to initiate a multi-dose phase 1 study in March 2010 as well as a phase 2 study to assess safety, tolerability and efficacy of ALKS 37 in individuals with OIC by the end of the first half of calendar 2010.
Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that it will host an investor/analyst meeting on Thursday, February 18, 2010 from 9:00 a.m. - 12:00 p.m. ET, in New York City.
Amgen Inc. (Nasdaq:AMGN ) and Centocor Ortho Biotech Products, L.P., today announced that the U.S. Food and Drug Administration (FDA) has approved the Risk Evaluation and Mitigation Strategy (REMS) for erythropoiesis-stimulating agents (ESAs), which include Aranesp® (darbepoetin alfa), EPOGEN® (Epoetin alfa) and PROCRIT® (Epoetin alfa). The FDA has determined that a REMS is necessary for ESAs to ensure the benefits of these drugs outweigh the risks of shortened overall survival and/or increased tumor progression or recurrence as identified in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid and cervical cancers.
Athersys, Inc. (Nasdaq:ATHX) today announced that it has completed patient enrollment for its phase I clinical trial of MultiStem®, 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.
AVI BioPharma, Inc. (NASDAQ:AVII), a developer of RNA-based drugs, today announced that CureDuchenne and the Foundation to Eradicate Duchenne (FED), each awarded grants of $250,000 to AVI BioPharma to support continued research and development of the Company's exon skipping drug candidates for the treatment of Duchenne Muscular Dystrophy (DMD), a genetic muscle wasting disease caused by failure to produce dystrophin. Cure Duchenne and FED are US not-for-profit foundations fully dedicated to supporting the research and development of a cure for DMD.
The Board of Directors of Baxter International Inc. (NYSE:BAX) today declared a quarterly dividend of $0.29 per share of Baxter common stock.
Bioject, Inc., (OTC BB: BJCT.OB) a Portland OR-based drug delivery company, soared today after a device they developed with Merial, a world-leading animal health company, has gained full-licensure from the U.S. Department of Agriculture for ONCEPT Canine Melanoma Vaccine. ONCEPT is a breakthrough vaccine indicated for aiding in extending survival of dogs with stage II or stage III oral canine melanoma, a common yet deadly form of cancer in dogs. ONCEPT is the first and only USDA-approved, therapeutic vaccine for the treatment of cancer in either animals or humans
The USDA issued a conditional U.S. Veterinary Biological Product License for ONCEPT in 2007. During the period of conditional licensure, ONCEPT was available to veterinary oncologists as Merial conducted additional research to further support the safety and efficacy of the vaccine.
The results of that research led to the full licensure of ONCEPT. Merial obtained licensing rights from Memorial Sloan-Kettering and Dr. Philip Bergman, and, using their access to and experience with DNA vaccine technology licensed from Vical Incorporated (Nasdaq:VICL), completed the industrialization and regulatory requirements for full licensure. The vaccine will be administered via a Canine Transdermal Device, which delivers the vaccine without the use of a needle.
Bioject jumped 71% or 10 cents to close at 24 cents on the day. Volume was 8 times the average daily. Vical was up 25 cents or 7.84% to close at $3.44.
Bio-Solutions Corp. (OTCBB: BISU), today announced that it has joined www.StockProfile.com, a customized web-based platform showcasing emerging growth stocks. StockProfile.com provides the investing public with a free unique information portal for investors who like to conduct their own research and make their own investment decisions.
Celldex Therapeutics, Inc. (NASDAQ: CLDX ) today announced that it has received a sublicense income payment of $3 million from TopoTarget A/S (NASDAQ-OMX: TOPO.CO) as a result of the recent co-development and commercialization agreement between TopoTarget and Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI) for Belinostat, a novel histone deacetylase (HDAC) inhibitor for the treatment of cancer. In this transaction, TopoTarget granted Spectrum a license for the co-development and commercialization of Belinostat in North America and India, with an option for the Chinese rights, in exchange for an upfront cash payment of $30 million.
Based on an April 2008 agreement in which a Celldex-acquired company, CuraGen Corporation, sold the Belinostat rights to TopoTarget, Celldex is entitled to, among other provisions, 10% of any sublicense income received by TopoTarget for Belinostat up to $6 million in the aggregate. Celldex acquired CuraGen in October 2009. Under the April 2008 agreement, TopoTarget assumed all financial and operational responsibility for the clinical development of Belinostat.
CEL-SCI Corporation (AMEX: CVM) reported financial results for the quarter ended December 31, 2009.
Geert Kersten, Chief Executive Officer said, "We concluded December 31, 2009 quarter in the strongest financial condition ever, with more than $36 million in cash and cash equivalents, allowing us to self-fund our upcoming pivotal Phase III study with our cancer drug Multikine. We are excited that we are in position to move Multikine through the clinic without losing rights to any of the major markets and to continue to develop our L.E.A.P.S. technology platform in areas such as H1N1 and Rheumatoid Arthritis." In Phase II clinical trials Multikine was shown to be safe and well-tolerated, and to improve the patients' overall survival by 33% at a median of three and a half years following surgery. The U.S. Food and Drug Administration (FDA) gave the go-ahead for a Phase III clinical trial with Multikine in January 2007 and granted orphan drug status to Multikine in the neoadjuvant therapy of squamous cell carcinoma (cancer) of the head and neck in May 2007. Thereafter CEL-SCI built a dedicated manufacturing facility for Multikine which is now completed and fully validated.
China Nepstar Chain Drugstore Ltd. (NYSE:NPD) ("China Nepstar" or the "Company"), the largest drugstore chain in China based on the number of directly operated stores, announced today that the company will report the fourth quarter and fiscal year 2009 financial results ended December 31, 2009, before the market opens on Tuesday, March 2, 2010.
Delcath Systems, Inc. (Nasdaq: DCTH ), which is testing its proprietary treatment system for metastatic cancers to the liver, announced today that the U.S. Food and Drug Administration ("FDA") will allow the Company to initiate an Expanded Use Intermediate Size Population protocol for the hepatic arterial infusion of melphalan with venous filtration via the Delcath PHP System or patients with ocular and cutaneous melanoma metastatic to the liver. Expanded access programs make certain treatments still being evaluated in late-stage trials available to patients for whom no satisfactory alternatives are available. To grant expanded access, the FDA generally must be satisfied that the potential benefit for the patient justifies the potential risk.
EntreMed, Inc. (Nasdaq: ENMD), today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for the Company's lead oncology drug candidate, ENMD-2076, for the treatment of acute myeloid leukemia (AML).
The FDA accepted EntreMed's application upon review of preclinical data as well as initial data from its ongoing Phase 1 clinical study with ENMD-2076 in patients with relapsed or refractory acute myeloid leukemia (AML). As previously presented, initial results from the Phase 1 study demonstrated that ENMD-2076, administered orally as a single agent, was well tolerated in this patient population. The data for 15 evaluable AML patients showed that one patient achieved a CRi (complete remission with incomplete hematological recovery) and two patients achieved a morphologic leukemia-free state (MLFS). Three additional patients participating in the study experienced 11%, 14%, and 65% reductions in marrow blast count.
Hi-Tech Pharmacal Co., Inc. (NASDAQ: HITK) announced today that its branded marketing subsidiary, ECR Pharmaceuticals will promote Urocit®-K 15mEq, potassium citrate extended release tablets to primary care physicians beginning in April, 2010. Hi-Tech has a license agreement with Mission Pharmacal Company, which will promote the product to Urologists. Indicated for the treatment of kidney stones, UroCit®-K 15mEq is the maximum strength potassium citrate product available, and provides convenient twice-a-day dosing Urocit-K 15 mEq offers kidney stone sufferers the only twice-daily treatment at this dosage strength. The new formulation provides patients with 50 percent more of the active ingredient, potassium citrate, than Urocit-K 10 mEq. ECR Pharmaceuticals will receive a percentage of gross profit based on prescriptions generated by primary care physicians.
"We are pleased to introduce another unique prescription branded product to the primary care market," said David Seltzer, President and CEO of Hi-Tech Pharmacal. "UroCit®-K 15mEq is a highly effective product, available in a convenient dosing regimen which will increase patient compliance."
HST Global, Inc. (OTCBB: HSTC) today announced that it has entered into a formal marketing agreement with Dr. James Forsythe, MD, HMD, board certified oncologist and a member of HST Global Inc.’s Board of Directors and Scientific Advisory Board.
Kensey Nash Corporation (Nasdaq: KNSY), a leading medical technology company that provides innovative resorbable biomaterial solutions for a wide range of medical procedures, announced today that it has received the CE Mark for the Company's Cartilage Repair Device. This approval allows for the marketing and sale of the Device, which incorporates a unique biomaterials technology for treating articular cartilage defects of the knee.
MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) today announced that the Company initiated a trial to compare the pharmacokinetics (PK), safety and metabolic profiles of LEVADEX orally inhaled migraine therapy with intravenous dihydroergotamine mesylate (DHE) in smokers and non-smokers. LEVADEX is a novel orally inhaled migraine therapy that has completed Phase 3 efficacy development for the acute treatment of migraine.
This PK trial is one of two remaining trials to be initiated in support of a New Drug Application (NDA) submission for LEVADEX as previously requested by the U.S. Food and Drug Administration (FDA). In addition to the PK trial, the Company is conducting an ongoing 12 month open-label safety extension of its Phase 3 FREEDOM-301 trial, which has completed enrollment, and also plans to conduct a pharmacodynamic trial. The Company anticipates that patients in these trials will complete treatment in 2010
Merck & Co., Inc. (NYSE: MRK) today announced the appointment of Bridgette P. Heller as Executive Vice President and President, Consumer Health Care, Ms. Heller will succeed Stanley F. Barshay, who had postponed his planned retirement to serve in a transition role following the merger of Merck and Schering-Plough. Effective March 1, 2010, Ms. Heller, 48, will report directly to Richard T. Clark, Merck’s chairman, president and chief executive officer, and will serve on the company’s Executive Committee.
Oncolytics Biotech Inc. (TSX:ONC, NASDAQ:ONCY) today announced that it has received a letter of approval from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) to conduct its Phase 3 trial examining REOLYSIN in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers. This is the same trial that the Company previously reached an agreement on with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process.
"Receipt of this approval clears the way for final preparations at the participating centres in anticipation of the start of enrolment in this trial and we expect to provide an update on timing in the near future," said Dr. Brad Thompson, President and CEO of Oncolytics. "Conducting this trial in both the U.S. and Europe allows us to access many of the physicians that have worked with REOLYSIN previously and, if the trial is successful, provides us with the basis for regulatory submissions in both the key American and European markets."
OPTIMIZERx Corporation (OTCBB: OPRX) announced today that it has signed a agreement with Health Connect Partners as the VIP sponsor of the upcoming 2010 HCP Spring Hospital Pharmacy Conference, April 12-14, 2010 in San Diego.
Rigel Pharmaceuticals (Nasdaq:RIGL) and AstraZeneca (NYSE:AZN) today announced an exclusive worldwide license agreement for the global development and commercialization of fostamatinib disodium (R788), Rigel's late-stage investigational product for rheumatoid arthritis (RA) and additional indications. Fostamatinib disodium, which has completed a comprehensive phase 2 program, is the furthest developed oral Spleen Tyrosine Kinase (Syk) inhibitor being evaluated for RA. Inhibiting Syk is thought to block the intracellular signaling of various immune cells implicated in the destruction of bone and cartilage which is characteristic of RA.
S3 Investment Company, Inc. (PINKSHEETS:SIVC) has posted its consolidated financial report for the period ended December 31, 2009, which shows increases in revenues, assets and gross profit over the same period of the previous year, on the Pink Sheets OTC Disclosure and News Service.
StemCells, Inc. (Nasdaq:STEM) announced today the launch of GS2-M, a new cell culture medium that enables the derivation and long-term maintenance of true (germline competent) mouse induced pluripotent stem (iPS) cells.GS2-M, the latest addition to the Company's growing SC Proven® line of specialty cell culture products, has been shown to increase the efficiency of reprogramming 'pre-iPS' cells to derive fully pluripotent stem cells, and to maintain mouse iPS cells in a definitive pluripotent state in long-term culture.
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) today announced that its subsidiary, Teva Pharmaceuticals USA, Inc., has signed an agreement with Novartis to settle patent litigation involving Teva’s U.S. generic version of Novartis’ Famvir® (famciclovir) 125 mg, 250 mg and 500 mg tablets including all claims for patent infringement and damages. The company also announced announced that Mr. Eli Hurvitz, the Chairman of the Company's Board of Directors, has responded successfully to therapy for a recently diagnosed illness
Vanda Pharmaceuticals Inc. (Nasdaq:VNDA), a biopharmaceutical company focused on the development and commercialization of clinical-stage products for central nervous system disorders, today announced financial and operational results for the fourth quarter and full year ended December 31, 2009. The quarterly loss was wider than expected as the company was hurt by expenses related to its deal with Novartis (NYSE: NVS) for its schizophrenia drug.
In October, the Swiss drug maker agreed to pay $200 million to acquire the rights to sell Vanda's schizophrenia drug Fanapt in the United States and Canada. The company said revenue related to the payment from Novartis will be recognized ratably -- $2.2 million per month -- through May 2017
Vitro Diagnostics, Inc. (OTCBB: VODG), dba Vitro Biopharma, announced that it is co-sponsoring a Keystone Symposium on Molecular and Cellular Biology entitled "Stem Cell Differentiation and De-Differentiation.”
Zygo Corporation (NASDAQ: ZIGO) dropped more than 9% today as the company announced that the company’s Board of Directors has unanimously rejected the January 5, 2010 proposal from II-VI Incorporated (Nasdaq:IVII) for the acquisition of all the outstanding common shares of ZYGO for $10.00 per share. In rejecting the proposal, the Board said that ZYGO is not for sale and that it is in the best interests of its shareholders to allow ZYGO’s newly-named CEO, industry veteran Dr. Chris L. Koliopoulos, to pursue a standalone strategy to increase shareholder value. Dr. Koliopoulos, a recognized leader in the optics industry with an exceptional track record of delivering growth and increasing value at advanced optical instruments companies, was named President and CEO on January 19, 2010 and Chairman on February 12.
Said Dr. Koliopoulos, "The Board strongly believes ZYGO’s shareholders will be best served by keeping the company independent and pursuing its long-term strategy. ZYGO is a great company with industry-leading products and technologies, strong positions in its core optical and metrology markets, and significant growth opportunities. The Board and management team are moving forward quickly to leverage these strengths."
Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.