|RxNews Recap for Thursday 02-18-10. XenoPort (XNPT) rocked by FDA denial, DepoMed (DPMD) drops as well. Jazz (JAZZ) up after the bell on NDA submission|
|By Mary Davila|
|Thursday, 18 February 2010 19:13|
XenoPort Inc. (Nasdaq: XNPT) saw its shares plummet to an all-time low Thursday after the drug developer and its partner GlaxoSmithKline (NYSE:GSK) said the Food and Drug Administration is delaying approval of the restless leg syndrome drug Horizant.
The companies said they received a Complete Response Letter (CRL) from the FDA regarding the New Drug Application (NDA) for Horizant Extended-Release Tablets, an investigational non-dopaminergic treatment for moderate-to-severe primary Restless Legs Syndrome. GSK and XenoPort are currently evaluating the CRL, in which the FDA indicated that a preclinical finding of pancreatic acinar cell tumors in rats was of sufficient concern to preclude approval of Horizant for RLS at this time. The FDA acknowledged that similar findings were known for gabapentin at the time of its approval for refractory epilepsy, but concluded that the seriousness and severity of refractory epilepsy justified the potential risks. The companies are assessing the appropriate next steps and will be communicating with FDA. Shares of XenoPort dropped 65.97% or $12.93 to close the day at $6.67.
DepoMed, Inc ( DEPO), shares were also hit hard today on the XenoPort news, dropping more than 19%. The FDA's rejection of Horizant could possibly spell approval problems for one if not two of the companies gabapentin based drug's. The company is working on an FDA approval for Serada, which is intended to treat menopausal hot flashes and postherpetic neuralgia. DepoMed's other gabapentin based drug in their pipeline is DM-76 for the treatment of nerve damage caused by shingles. Serda is in late stage Phase III trials while DM-76 has completed Phase III and has been licensed to Solvay (Brussels: SOLB.BR). DepoMed shares closed down 61 cents to end the day at $2.49.
Jazz Pharmaceuticals, Inc. (Nasdaq:JAZZ) shares jumped after the bell as the company announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for JZP-6 (sodium oxybate) for the treatment of fibromyalgia. Based on a standard 10-month review, the target date for the FDA to complete its review of the NDA under the Prescription Drug User Fee Act (PDUFA) is October 11, 2010.
The submission is based on a comprehensive clinical development program including results from two Phase III clinical trials. In both trials, sodium oxybate significantly decreased pain and fatigue as well as improved daily function, patient global impression of change, and sleep quality. Sodium oxybate was generally well tolerated, with the majority of adverse events reported being mild to moderate in nature and similar to those seen in previous trials with narcolepsy. Sodium oxybate has not been evaluated by regulators for the treatment of fibromyalgia and is not approved for this use.
Shares were trading higher in the after hours session, up 46 cents or 4.49%.
In other news after the bell:
Endologix, Inc. (Nasdaq:ELGX), developer of minimally invasive treatments for aortic disorders, today announced financial results for the three and twelve months ended December 31, 2009.
John McDermott, Endologix President and Chief Executive Officer, said, "The fourth quarter marks the close of a significant year for Endologix. In 2009, we launched our new delivery systems, IntuiTrak™ and IntuiTrak Express, which simplify AAA procedures for physicians and give us the lowest profile device available in the U.S. to treat large neck aneurysms. We strengthened our domestic sales force, continued to expand in international markets, generated positive cash flow and raised additional capital so we can continue investing in the growth of our business. In November, we became the first and only company to receive FDA approval for a fully percutaneous EVAR clinical trial. Overall, we are in an excellent position to execute on our growth strategy in 2010."
Genentech, Inc., a wholly owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), and Biogen Idec (Nasdaq: BIIB) announced today the U.S. Food and Drug Administration (FDA) approved Rituxan® (rituximab) in combination with fludarabine and cyclophosphamide (FC) for people with previously untreated and previously treated CD20-positive chronic lymphocytic leukemia (CLL).
"Rituxan with chemotherapy can delay the need for additional treatment because it significantly extends the time people with CLL live without the disease worsening," said Hal Barron, M.D., executive vice president, Global Development and chief medical officer, Roche and Genentech. "This approval provides an important option and new hope to the many people with this incurable cancer."
"This approval in CLL reinforces the importance of Rituxan in hematologic cancers," said Greg Reyes, M.D., Ph.D., senior vice president, Oncology Research and Development, Biogen Idec. "We are very pleased that Rituxan, either alone or in combination, has now achieved its fifth approval for the most common forms of non-Hodgkin’s lymphoma and adult leukemia."
GlaxoSmithKline (NYSE:GSK) said after the market closed Thursday that the company is reviewing label changes proposed today by the US Food and Drug Administration (FDA) for asthma medications containing long-acting beta-agonists (LABAs), such as GSK's Advair (salmeterol / fluticasone propionate). GSK and makers of the other affected medicines containing LABAs have 30 days to agree with the proposed changes or state why they are not warranted.
"We will work with FDA to ensure that the final label for these products protects the interest of patients who suffer with this chronic and serious disease," said Dr. Katharine Knobil, vice president for respiratory clinical research at GSK. "It is important that doctors have flexibility to make the proper clinical decisions to help patients gain and maintain optimal control of their asthma."
Earlier in the day the U.S. Food and Drug Administration issued a statement that indicated that drugs in the class of long-acting beta agonists (LABAs) should never be used alone in the treatment of asthma in children or adults. Manufacturers will be required to include this warning in the product labels of these drugs, along with taking other steps to reduce the overall use of these medications.
Gen-Probe Incorporated (Nasdaq:GPRO) today reported financial results for the fourth quarter of 2009, with record product sales and total revenues driving non-GAAP earnings per share (EPS) of $0.52 and GAAP EPS of $0.48.
"Gen-Probe posted strong financial results in the fourth quarter of 2009 based on balanced performance across our key product areas: women's health, infectious diseases, blood screening and transplant diagnostics," said Carl Hull, the Company's president and chief executive officer.
Novavax, Inc. (Nasdaq:NVAX) announced today that it received a notice of deficiency, as expected, from the NASDAQ Stock Market (NASDAQ) listing qualifications department. As a result of the election of Stanley C. Erck as the Executive Chairman Novavax is no longer in compliance with the NASDAQ requirement set forth in Listing Rule 5605(b)(1), which requires that the company's Board of Directors be comprised of a majority of independent directors.
Novavax has 45 days to submit a plan to NASDAQ to regain compliance. The notification has no immediate effect on the listing of Novavax's common stock on The NASDAQ Global Market. The Company's common stock continues to trade on The NASDAQ Global Market under the symbol "NVAX".
Repros Therapeutics Inc. (Nasdaq: RPRX) announced after the market closed today that it has established an at-the-market program through which it may sell, from time to time and at its sole discretion, shares of its common stock having an aggregate offering price of up to $10 million. Ladenburg Thalmann & Co. Inc., a subsidiary of Ladenburg Thalmann Financial Services Inc. (NYSE Amex: LTS), is acting as sales agent on the program. Based upon regulatory limitations, Repros estimates that it will be limited to selling no more than approximately $7.8 million worth of its shares at this time, due to the Company’s estimate of its current public float.
Stocks up no news Thursday:
Insmed, Inc. (Nasdaq:INSM) shares shot up 13 cents or 12.87% to $1.14 on no apparent news. Shares have traded higher on heavy volume three days straight this week.
Molecular Insight Pharmaceuticals, Inc. (NASDAQ:MIPI), a biopharmaceutical company discovering and developing targeted therapeutic and imaging radiopharmaceuticals for use in oncology, was up 47% or 56 cents to close the day at $1.75. Volume was 3.4 million shares, nearly 20 times the daily average. Shares at one point hit $2.30 during todays trading session.
In other news from Thursday:
Aastrom Biosciences, Inc. (Nasdaq:ASTM) today reported that its previously announced one-for-eight reverse stock split of the company's issued and outstanding common shares is now effective. This reverse split is intended to increase the per share trading price of Aastrom's common stock to satisfy the $1.00 minimum bid price requirement for continued listing on NASDAQ and to attract greater institutional ownership of the company's shares. As a result of the reverse stock split, every eight shares of the company's common stock that were issued and outstanding immediately prior to the opening of trading today will automatically be combined into one issued and outstanding share without any change in the par value of such shares and the number of authorized but unissued shares of the company's common stock will be proportionally reduced.
Concurrent with the effectiveness of the reverse stock split, the ticker symbol will change from ASTM to ASTMD. The ticker symbol will revert to ASTM on Thursday, March 18, 2010. Shares of the company rose 21 cents or 13.81% to close at $1.73.
BioDelivery Sciences International, Inc. (Nasdaq:BDSI) announced today that the Company will host a conference call and live webcast on Thursday, February 25, 2010 at 11:00 AM Eastern Time.
Biogen Idec (NASDAQ: BIIB) and Swedish Orphan Biovitrum (STO: BVT) today announced that they have restructured the collaboration agreement for the companies’ long-acting, recombinant Factor VIII Fc fusion protein (rFVIIIFc) in hemophilia A patients and the recombinant Factor IX Fc fusion protein (rFIXFc) in hemophilia B patients.
Under the amended agreement, Biogen Idec will assume full development responsibilities and costs, as well as manufacturing rights for the rFVIIIFc and rFIXFc programs. Biogen Idec also gains marketing responsibility for the rest-of-world territories that had previously been shared between the two companies, in addition to its existing commercial rights in North America. Swedish Orphan Biovitrum will retain commercial rights in Europe, Russia, Turkey and the Middle East. The cross-royalty rate has been reduced for both companies. The royalty rates will be further adjusted until Biogen Idec’s increased costs are reimbursed.
BSD Medical Corporation (NASDAQ: BSDM) announces the installation of the advanced BSD-2000/3D Hyperthermia System at the Department of Radiation Oncology of Kantonsspital Aarau (KSA), Aarau, Switzerland. The BSD-2000/3D at KSA will be used to deliver targeted hyperthermia to deep pelvic and abdominal tumors, using focused phased array RF energy, in order to enhance treatment with radiotherapy and chemotherapy. The purchase of the BSD-2000/3D adds sophisticated technology to KSA’s hyperthermia cancer therapy program. KSA had already joined BSD’s family of customers with the purchase of a BSD-500 superficial hyperthermia system.
CPEX Pharmaceuticals Inc. (NASDAQ: CPEX) today announced it has received notice from Arcadia Opportunity Master Fund, Ltd. that it has withdrawn its intention, as stated in a filing with the Securities and Exchange Commission (SEC) on January 14, 2010, to propose numerous amendments to CPEX’s bylaws and to nominate a slate of directors to CPEX’s Board of Directors at the Company’s 2010 Annual Meeting.
"CryoLife is continuing to thrive in very demanding economic conditions. In addition to reporting record revenues and continued, consistent profitability, our ability to significantly increase our cash balances over the past year is a very encouraging sign of the health of our business. Looking ahead, we expect to achieve record revenues and operating earnings in 2010 by continuing to execute on our strategy and invest in our growth," stated Steven G. Anderson, president and chief executive officer. Shares rose 62 cents or 9.75% to close at $6.98 on triple the daily average volume.
Curis, Inc. (NASDAQ: CRIS), a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced that Chugai Pharmaceutical Co., Ltd. (TSE: 4519) has exercised its right of first refusal for the development and commercialization in Japan of GDC-0449, a Hedgehog pathway inhibitor, under an existing agreement with F. Hoffmann-La Roche, Ltd (SIX: RO, ROG; OTCQX: RHHBY). GDC-0449 is being developed by Genentech, Inc., a wholly owned member of the Roche Group, under the 2003 collaboration agreement between Genentech and Curis.
The company also announced that it will release its fourth quarter financial results on Thursday, February 25, 2010 before the market opens.
Derma Sciences, Inc. (Nasdaq:DSCI), a specialty medical device and pharmaceutical company focused on advanced wound care, today announced that it has signed an exclusive distribution agreement with Medline Industries for sales of one of its key products – BIOGUARD™ Barrier Dressing – into the acute care market. Medline is the 2nd leading provider of traditional wound care products into Acute Care facilities, with over 800 sales representatives. Sales will begin this month.
Discovery Laboratories, Inc. (Nasdaq:DSCO) today announced that it has priced an underwritten public offering of 27,500,000 units at a price to the public of $0.60 per unit for gross proceeds of $16,500,000. Each unit consists of one share of common stock and a warrant to purchase 0.50 of a share of common stock. The shares of common stock and warrants are immediately separable and will be issued separately such that no units will be issued. The warrants are exercisable immediately upon issuance, have a five-year term and an exercise price of $0.85. Net proceeds, after estimated underwriting discounts and commissions and other estimated fees and expenses, and assuming the Warrants are not exercised, will be approximately $15.1 million. The offering is expected to close on or about February 23, 2010, subject to satisfaction of customary closing conditions. Shares fell 23% on the news.
Dynavax Technologies Corporation (NASDAQ:DVAX) shares rose today as the company announced the selection of a candidate for clinical development in its endosomal Toll-like Receptor (TLR) inhibitor collaboration with GlaxoSmithKline (NYSE:GSK). The selected molecule DV1179, a bifunctional TLR inhibitor, has moved into advanced preclinical IND-enabling studies that could allow clinical development to begin as early as this year. Dynavax and GlaxoSmithKline are collaborating to develop novel inhibitors of endosomal TLRs for the treatment of multiple autoimmune and inflammatory diseases. TLRs are key receptors of the innate immune system.
Under the collaboration, Dynavax has been conducting research primarily in the area of autoimmune and sterile inflammatory diseases. GSK has a right to exercise its exclusive option to license each program upon achievement of proof-of-concept or earlier upon certain circumstances. After exercising its option, GSK will carry out further development and commercialization of these products. Dynavax will receive tiered royalties, up to double-digits, on sales and has retained an option to co-develop and co-promote one specified product. Dynavax received an initial payment of $10 million when the collaboration was announced in December 2008 in exchange for which GSK received an exclusive option over four programs targeting autoimmune and inflammatory diseases such as lupus, psoriasis, and rheumatoid arthritis. Shares of DVAX closed up 5.33% to settle at $1.58.
Emerging Healthcare Solutions, Inc. (Pinksheets: EHSI) stated that they were encouraged by a new report that parallels the company’s conclusions about the new potential for business in the current healthcare marketplace.
GeoVax Labs, Inc. (OTC Bulletin Board:GOVX.ob), an Atlanta-based, biopharmaceutical company developing vaccines for diseases caused by HIV-1 (Human Immunodeficiency Virus), today announced that it presented the results of a preclinical study on a prototype HIV/AIDS vaccine at the Conference on Retroviruses and Opportunistic Infections (CROI) in San Francisco.
IMS Health (NYSE: RX), the world’s leading provider of market intelligence to the pharmaceutical and healthcare industries, today announced the launch of IMS, Aggregate Spend Compliance Services, a comprehensive set of solutions to help pharmaceutical and medical device companies comply with the growing number of federal and state transparency and marketing disclosure laws in the U.S., known as “aggregate spend” reporting regulations.
Paul A. Friedman, M.D., Incyte's President and Chief Executive Officer, stated, "We achieved all of our corporate goals in 2009 including the initiation of a global Phase III program for our lead compound, INCB18424, for myelofibrosis, the completion of a successful corporate financing and the establishment of two major alliances with top-tier pharmaceutical firms. Consequently, we are in a strong position to advance our pipeline and prepare for the potential launch of INCB18424 in myelofibrosis.
"Key objectives for 2010 include completing our US Phase III registration trial for INCB18424 in myelofibrosis, determining product registration requirements for INCB18424 as a treatment for polycythemia vera and possibly essential thrombocythemia, and reporting Phase II results for INCB28050 for rheumatoid arthritis which we expect will support moving forward into a larger Phase IIb trial with our partner, Eli Lilly."
Lannett Company, Inc. (NYSE AMEX: LCI) today announced Arthur Bedrosian, president and chief executive officer, purchased 2,000 shares of the company’s common stock in the open market on February 16, 2010.
Oncothyreon Inc. (Nasdaq:ONTY) today announced that it has entered into an agreement pursuant to which it will sell its interests in Oncothyreon Canada Inc., an indirect wholly owned subsidiary, and 0811769 B.C. ULC, an indirect wholly owned subsidiary and the parent corporation of Oncothyreon Canada Inc., for approximately Cdn $8.425 million to Gamehost Income Fund. Prior to the sale, Oncothyreon Canada Inc. will be reorganized into an Alberta ULC and 0811769 B.C. ULC will be reorganized into a limited corporation and each will distribute its business assets (and related intellectual property) to a subsidiary of Oncothyreon Inc. The consideration to be paid by Gamehost will consist of Cdn $7.825 million cash being paid at closing of the Arrangement with Cdn $600,000 being delivered through retained equity in post-arrangement Gamehost. The Arrangement also forms part of Gamehost's planned conversion from an income trust structure to a corporation.
The agreement is subject to court approval in Alberta and the approval of Gamehost's securityholders. Oncothyreon is a biotechnology company specializing in the development of innovative therapeutic products for the treatment of cancer. Oncothyreon's goal is to develop and commercialize novel synthetic vaccines and targeted small molecules that have the potential to improve the lives and outcomes of cancer patients.
Opko Health Inc (NYSE Amex: OPK) today announced that it has completed the acquisition of Pharmacos Exakta, S.A. de C.V., a privately-owned Mexican pharmaceutical company engaged in the manufacture, marketing and distribution of ophthalmic and other pharmaceutical products for government and private markets since 1957. OPKO acquired Pharmacos Exakta, including a manufacturing facility owned by an affiliate, for cash and shares of OPKO Common Stock.
Phillip Frost, OPKO’s Chairman and Chief Executive Officer, commented, "We believe this acquisition will provide OPKO with an excellent platform to expand manufacturing and distribution capabilities for a wide range of products while, at the same time, maintaining our original interest in ophthalmology. It also furthers our strategy of expanding commercial activities while we continue to develop our important diagnostic and therapeutic products, as well as our flu vaccine."
Perrigo Company (Nasdaq: PRGO) today announced that it has received final approval from the U.S. Food and Drug Administration to manufacture and market Ciclopirox Shampoo, 1%, a generic version of LOPROX® Shampoo. Shipments will begin immediately.
LOPROX® (Ciclopirox Shampoo, 1%) is an antifungal indicated for the treatment of seborrheic dermatitis of the scalp in adults. Estimated annual brand sales for the product during the last twelve months were $26 million, according to Wolters Kluwer data.
Perrigo's Chairman and CEO Joseph C. Papa stated, "This approval is another example of Perrigo's commitment to expand our portfolio and bring new products to market. It further demonstrates our strategy to deliver quality affordable healthcare for generic prescriptions and over the counter products."
PPD, Inc. (Nasdaq: PPDI) today announced the opening of offices in Manila, Philippines, and Bangalore, India, expanding its Phase II-IV clinical development services in response to growing client demand in Asia Pacific.
At December 31, 2009, cash, restricted cash, and marketable securities totaled $390.0 million compared with $527.5 million at December 31, 2008.
"Regeneron ended 2009 with many late-stage Phase 3 trials, a diversified pipeline, and a healthy balance sheet," said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer. "Our eight drug candidates in development for 17 indications and our expanded antibody collaboration with sanofi-aventis position the Company for continued growth. 2010 should be especially eventful for Regeneron as we anticipate, among other clinical results, Phase 3 data from two of our four trials in gout and from our two studies in wet AMD (age-related macular degeneration), as well as potential interim news from our Phase 3 cancer program." Shares dropped 12.48% or $3.80 or $26.66 as the fourth-quarter loss widened on a surge in research, development and other expenses.
SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) today announced that it plans to report fourth quarter and year-end results for 2009 on Tuesday, March 2, 2010.
Taro Pharmaceutical Industries Ltd. (“Taro,” the “Company,” Pink Sheets: TAROF) today announced that it will discontinue manufacturing operations at the sterile manufacturing facility of its Irish subsidiary, Taro Pharmaceuticals Ireland Limited, in Roscrea, Ireland (“Taro Ireland”).
Vermillion, Inc.(Pink Sheets:VRML.PK), a molecular diagnostics company, today announced that Peter S. Roddy has been elected to its Board of Directors and provided a corporate update.
Additionally, Vermillion announced that along with Quest Diagnostics they are on track to launch OVA1™ in March 2010. The company plans to provide more detail at the time of commercialization. Shares closed up $1.81 or 7.23% to end the day at $26.85.
West Pharmaceutical Services, Inc. (NYSE:WST) today announced its results for the fourth quarter and full year of 2009. The company reported Q4 earnings of $0.67 per share which were $0.02 better than the First Call consensus of $0.65; revenues rose 19.8% year/year to $293.4 mln vs the $272.8 mln consensus. The company also issued in-line guidance for FY10, and sees EPS of $2.19-$2.39 vs. $2.37 consensus; and FY10 revs of $1.09-$1.12 bln vs. $1.09 bln consensus.
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