|RxNews Recap for Monday 03-08-10. FDA approves Cell Therapeutics production facility, shares soar. ImmunoGen jumps after hours with Orphan Drug designation.|
|By BioMedReports.com Staff|
|Monday, 08 March 2010 19:41|
Below is a list of the companies that made news in the healthcare sector on Monday, March 8, 2010.
Cell Therapeutics, Inc. (Nasdaq and MTA: CTIC) surged after the company announced this morning that the U.S. Food and Drug Administration has completed its inspection of the facility at NerPharMa (a pharmaceutical manufacturing company belonging to Nerviano Medical Sciences Srl, in Nerviano, Italy), which manufactures the CTI's drug pixantrone and has found the site in compliance and acceptable for continued manufacturing of the drug product. CTI has a New Drug Application under review at the FDA for pixantrone to treat relapsed/refractory aggressive non-Hodgkin's lymphoma. As previously announced, the FDA's Oncologic Drugs Advisory Committee will review the NDA for pixantrone on March 22, 2010 and the FDA is expected to make a final decision on approval by April 23, 2010.
"FDA approval of the NerPharMa facility to manufacture our drug product is a major milestone in the drug approval process and we are pleased that our manufacturing partner is prepared to provide commercial supplies when pixantrone is approved," said Craig W. Philips, President of CTI. Shares of Cell Therapeutics moved 28.42%, soaring 25 cents to close the day at $1.15. The stock continued to move another 2.61% in the after hours market.
After the market closed:
ImmunoGen, Inc. (Nasdaq: IMGN), today jumped after the market closed following the announcement that the US Food and Drug Administration (FDA) has granted orphan drug designation to its IMGN901 compound when used for the treatment of Merkel cell carcinoma (MCC). Through a separate process, the European Union (EU) Committee for Orphan Medicinal Products (COMP) concurrently also granted IMGN901 orphan medicinal product designation for the treatment of MCC.
"IMGN901 has shown promising activity among the small number of MCC patients treated to date, suggesting this is a potential registration path for the compound," commented Daniel Junius, President and CEO. "Metastatic MCC is a rare and highly aggressive cancer with no approved treatments today. We are preparing to be ready to initiate pivotal testing of IMGN901 in MCC in 2011 and will make the final decision based on expanded clinical experience and regulatory input. Gaining orphan drug designation for IMGN901 in the US and Europe is an important step in this process." Shares of ImmunoGen added 42 cents in the after hour session.
Also after the bell:
Acura Pharmaceuticals, Inc. (NASDAQ:ACUR) and King Pharmaceuticals, Inc. (NYSE:KG) today announced after the bell top-line results from Study AP-ADF-114 ("Study 114") titled "A Randomized, Double-Blind, Placebo- and Active-Controlled Study to Assess the Relative Abuse Potential of Acurox® (oxycodone HCl and niacin) Tablets in Non-Dependent Recreational Opioid Users." Study 114 top-line results demonstrate that two different potentially abused excess oral doses of Acurox® Tablets are significantly disliked compared to equivalent excess oral doses of oxycodone HCl tablets alone (without niacin). All five co-primary endpoints comparing the like/dislike of excess doses of Acurox® Tablets with the like/dislike of excess doses of oxycodone HCl tablets alone (without niacin) each achieved statistical significance (p < 0.0001). Study 114 primary endpoint results are supplemented by multiple independently measured secondary endpoints, all of which achieved statistically significant results (p < 0.05). Shares of Acura were trading higher in the after hour session.
Alexza Pharmaceuticals, Inc. (Nasdaq:ALXA) reported today financial results for the fourth quarter and year ended December 31, 2009 and provided a general corporate update. The net loss for the quarter and year ended December 31, 2009, as reported in accordance with accounting principles generally accepted in the United States (GAAP), was $19.8 million and $56.1 million, respectively, compared to a net loss of $17.9 million and $77.0 million in the comparable periods in 2008. Alexza had consolidated cash, cash equivalents and marketable securities at December 31, 2009 of $19.9 million.
"In 2009, we capped off a very productive year with the submission of our first NDA for AZ-004 (Staccato® loxapine). We continued on the path toward AZ-004 commercialization with the announcement of our Biovail collaboration for AZ-004 in the U.S. and Canada in early February," said Thomas B. King, President and CEO of Alexza. "A majority of our focus and effort in 2010 will be on executing a successful NDA review, finalizing the commercial manufacturing process scale-up for AZ-004 and supporting our Biovail collaboration."
Exelixis, Inc. (Nasdaq:EXEL) announced after the market closed today a restructuring as a consequence of its continued strategy to focus resources on the development of its key late-stage compounds. As its first priority, the company will aggressively advance XL184, XL147 and XL765, each of which is the subject of a large clinical development program. Additionally, Exelixis retains a fully integrated R&D organization, and will continue to advance new compounds into development, although the number will be reduced for the foreseeable future. Exelixis has retained the ability to meet all of its obligations to existing partners. Further, as a result of its retained R&D capabilities and its numerous unpartnered clinical and preclinical compounds, the company expects that its ongoing and future business development discussions will be unaffected.
ISTA Pharmaceuticals, Inc. (Nasdaq:ISTA), today announced the Company's supplemental New Drug Application (sNDA) for once-daily XiDay™ (bromfenac ophthalmic solution) has been accepted for review by the U.S. Food and Drug Administration (FDA). The FDA has granted XiDay a standard review time of ten months, assigning ISTA a Prescription Drug User Fee Act (PDUFA) action date of October 16, 2010. ISTA's request for a shorter, six-month priority review is still under consideration by the FDA.
VIVUS, Inc. (Nasdaq:VVUS) today reported its financial results for the fourth quarter and year ended December 31, 2009."This past year was transformational for VIVUS given the significant achievements in both the Qnexa and avanafil investigational product programs, which are being developed to address the obesity and erectile dysfunction markets with highly differentiated products that address unmet needs," stated Leland Wilson, chief executive officer of VIVUS. "We look forward to continued clinical and regulatory momentum in 2010 as we continue to work with the FDA during the review of the Qnexa NDA and as we report additional avanafil pivotal data."
Watson Pharmaceuticals, Inc. (NYSE:WPI), a leading specialty pharmaceutical company, today confirmed that its subsidiary, Watson Laboratories, Inc., has been sued by Endo Pharmaceuticals Inc. and Penwest Pharmaceuticals Co. in connection with the filing of Watson's Abbreviated New Drug Application (ANDA) for Oxymorphone Hydrochloride Extended-Release Tablets, 40mg. Watson's Oxymorphone Hydrochloride Extended-Release Tablets product is a generic version of Endo's Opana® ER which is indicated for the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time. Opana® ER had approximately $245 million in brand sales for the twelve months ending December 31, 2009, according to IMS Health.
WuXi PharmaTech (Cayman) Inc. (NYSE:WX), a leading research and development outsourcing company serving the pharmaceutical, biotechnology, and medical device industries, with operations in China and the United States, today announced its financial results for fourth-quarter and full-year 2009. "WuXi had a strong fourth quarter and a successful 2009," said Dr. Ge Li, Chairman and Chief Executive Officer. "We achieved all of our publicly stated financial goals. We were able to achieve solid revenue growth in 2009, led by a strong performance by our China-based Laboratory Services business, which achieved revenues at the top of its guidance range. Full-year 2009 adjusted EBITDA(1) exceeded our expectations.
News from earlier in the day:
Enzon Pharmaceuticals, Inc. (Nasdaq: ENZN) today announced the results from the recent tender and increased conversion periods of the 4 percent convertible notes due in 2013. As a result of the sale of the specialty pharmaceutical business on January 29, 2010, the Company was required to offer to repurchase for cash any and all of its convertible notes at face value. This offer expired on March 5, 2010 and no notes were tendered.
Harbor BioSciences Inc. (Nasdaq:HRBR) said today it had reported encouraging data from its ongoing Phase I/IIa clinical trial with Apoptone(R) (HE3235) for castration resistant prostate cancer (CRPC) -- also referred to as hormone resistant prostate cancer -- at the ASCO Genitourinary Cancers Symposium in San Francisco on March 6, 2010. Preliminary results from this study, conducted with participating member sites of the Prostate Cancer Clinical Trial Consortium (PCCTC), were first reported on November 16, 2009. Apoptone is a novel steroid analog of a dihydrotestosterone metabolite that has been found to induce cell death (apoptosis) in prostate tumors.
Isis Pharmaceuticals, Inc. (Nasdaq:ISIS) announced today that it has earned a $6 million milestone payment from Bristol-Myers Squibb Company (NYSE:BMY) related to the acceptance of initial regulatory filings to begin Phase 1 clinical studies for BMS-PCSK9Rx. BMS-PCSK9Rx is an antisense drug that arose out of the ongoing collaboration between Bristol-Myers Squibb and Isis to identify antisense drugs targeting PCSK9 to lower low-density lipoprotein (LDL) cholesterol.
Lexicon Pharmaceuticals, Inc. (Nasdaq:LXRX) today announced that it is offering to sell, subject to market and other conditions, $95,000,000 of its common stock pursuant to an effective shelf registration statement in an underwritten public offering. Lexicon also intends to grant the underwriters a 30-day option to purchase up to an additional $14,250,000 of common stock to cover over-allotments, if any. All of the shares in the offering are to be sold by Lexicon. Morgan Stanley & Co. Incorporated and J.P. Morgan Securities Inc. will be acting as joint book-runners for the offering, with Cowen and Company, LLC and Thomas Weisel Partners LLC acting as co-managers.
Nabi Biopharmaceuticals (Nasdaq:NABI) announced today that the closing requirements set forth in the exclusive option and license agreement for NicVAX(R) (Nicotine Conjugate Vaccine), dated November 13, 2009 with GlaxoSmithKlineBiologicals S.A. (GSK) have been met and the companies have closed the agreement. As a result, Nabi is entitled to receive an upfront payment of $40 million and GSK has been granted an option to exclusively in-license NicVAX on a worldwide basis and a license to develop next-generation nicotine vaccines using Nabi's intellectual property. In addition, Nabi is eligible to receive up to $460 million in potential option fees and regulatory, development and sales milestones for NicVAX and follow-on nicotine vaccines. Nabi will also receive royalties on global sales of NicVAX should GSK exercise its option, as well as royalties on global sales of next generation nicotine vaccines developed by GSK based on intellectual property licensed from Nabi.
Nektar Therapeutics (Nasdaq:NKTR) today announced preliminary progression-free survival data from the first stage of a two-stage Phase 2 clinical study evaluating single-agent treatment with NKTR-102 in women with platinum-resistant ovarian cancer. In the first stage of the study, 39 patients were enrolled with platinum-resistant disease and were evaluable for the secondary endpoint of progression-free survival (PFS).
Novavax, Inc. (Nasdaq:NVAX) announced today that the enrollment of over 3,500 subjects in Mexico has been completed in Stage B of its pivotal 2009 H1N1 virus-like-particle (VLP) pandemic influenza vaccine study. With the 1,000 subjects already enrolled in Stage A of the trial, the enrollment in this pivotal trial is now complete with over 4,500 subjects.
NxStage Medical, Inc. (Nasdaq:NXTM), a leading manufacturer of innovative dialysis products, today announced the latest interim results from its ongoing FREEDOM study, which show the significant improvement of overall sleep quality and marked improvement in Restless Legs Syndrome (RLS) experienced by patients after four months of daily home hemodialysis therapy with the NxStage System One™..
Osteotech, Inc. (Nasdaq:OSTE), a leader in the emerging field of biologic products for regenerative healing, announced today that its MagniFuse™ Bone Graft has generated its first $1 million in revenue during the four month period beginning with the limited launch of the product in late October 2009. Osteotech began the first phase of its strategic limited launch of MagniFuse with the release of three procedure specific forms for posterior cervical and posterolateral spine fusion and spinal deformity procedures. Since that time, the Company has successfully executed its multi-step launch strategy and will highlight a national launch at the upcoming American Academy of Orthopaedic Surgeons Annual Meeting in New Orleans, Louisiana.
Response Genetics, Inc. (Nasdaq:RGDX) announced today that it has entered into a purchase agreement with certain new and existing investors and certain funds managed by Lansdowne Partners Limited Partnership to raise approximately $4 million from the private placement of 3,005,349 newly issued shares of its common stock, at a purchase price of $1.31 per share. Response Genetics is focused on the development and sale of molecular diagnostic tests for cancer.
Stryker Corporation's (NYSE:SYK) Orthopaedics' division today announced at the American Academy of Orthopaedic Surgeons (AAOS) Conference that its recent FDA-monitored Investigational Device Exemption (IDE) study found no statistical difference in clinical outcomes(1,2) between its mobile bearing and traditional fixed bearing knee systems. In contrast, Stryker continues to be very pleased with the success of its fixed bearing Triathlon Knee System with X3 Advanced Bearing Technology, which offers significant advantages over mobile bearing knees on wear rates and overall value.
Synovis Life Technologies, Inc. (Nasdaq: SYNO), a leading biomaterial and surgical products company, today announced that its board of directors has approved a program for the company to repurchase up to 1 million shares of its common stock, in addition to the approximately 66,000 shares remaining to be purchased under an existing share repurchase program approved by the board in September 2009. Synovis plans to make purchases in either the open market or through private transactions from time to time, in accordance with Securities and Exchange Commission regulations. The timing and extent to which the company buys back shares will depend on market conditions and other corporate considerations. The repurchase program does not have an expiration date. As of Jan. 31, 2010, the company had $56.5 million in cash, cash equivalents and investments. This represents the third stock buyback Synovis has announced in less than two years.
VIVUS, Inc. (Nasdaq:VVUS) today announced the issuance of three additional patents by the U.S. Patent and Trademark Office (USPTO) covering Qnexa, an investigational new drug candidate for the treatment of obesity. The three new patents are the second, third, and fourth patents to be granted in a series of patent applications VIVUS has filed that are directed to the Qnexa product and methods of using Qnexa in various therapeutic applications. U.S. Patent No. 7,659,256 affords broad composition-of-matter protection as well as expanded protection on the use of Qnexa to effect weight loss in patients who may be overweight or obese. In addition, U.S. Patent No. 7,674,776 broadly claims Qnexa dosage forms, controlled release formulations, and methods of use, including the treatment of Syndrome X, a common multisymptomatic disorder often found in obese patients, and the treatment of other conditions that can be alleviated with loss of body weight, such as sleep apnea. U.S. Patent No. 7,553,818 also expands on the method-of-use coverage provided by the initial VIVUS patent in this series, U.S. Patent No. 7,056,890, issued June 6, 2006.
Also from Monday:
BioSpecifics Technologies Corp. (Nasdaq: BSTC), a biopharmaceutical company developing first in class collagenase-based products, today announced that XIAFLEX™ is now available in the U.S. by prescription, for the treatment of adult Dupuytren's contracture patients with a palpable cord.
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