|Positron recaps press conference, confirms partnership. Aeterna Zentaris receives orphan-drug designation. After the bell FDA panel gives Questcor thumbs up|
|By BioMedReports.com Staff|
|Thursday, 06 May 2010 17:47|
Below is a list of the companies that made news in the healthcare sector on Thursday, May 06, 2010.
Questcor Pharmaceuticals, Inc. (Nasdaq:QCOR) jumped higher in the after hours market after an FDA advisory panel on Thursday determined that Acthar gel is safe and effective for treating seizures in infants. The panel voted 22-1 in favor of the drug's efficacy in treating spasms in infants and voted 20-1, with two members abstaining, in a vote pertaining to the drug's safety. The FDA PDUFA date for Acthar gel is scheduled for June 11. Shares of Questor were up $1.17 to $10.34 in the after hours session.
Also after the bell:
Dynavax Technologies Corporation (NASDAQ:DVAX) today reported completing the first immunizations of over 2,000 subjects enrolled in its large-scale Phase 3 study of HEPLISAV. This starts a 12-month follow-up on these subjects and sets the study's completion for May 2011. Dynavax said this event supports its goal of a BLA submission for HEPLISAV in the second half of 2011.
inVentiv Health, Inc. (Nasdaq:VTIV), a leading provider of end-to-end clinical development, launch and commercialization services to the global pharmaceutical and healthcare industries, today announced that it has entered into a definitive agreement to be acquired by Thomas H. Lee Partners, L.P. (THL), a leading private equity firm, for approximately $1.1 billion.
Under the terms of the agreement, which has been approved by inVentiv's board of directors, inVentiv shareholders will receive $26.00 in cash for each share of VTIV common stock they hold, representing a 52% premium over the $17.15 closing stock price on March 25, 2010, the day before inVentiv announced that it had been approached by financial investors regarding a potential transaction and had formed a special committee to engage financial advisors and evaluate possible courses of action. After the bell shares of inVentiv were up $1.33 to $25.25.
NexMed, Inc. (Nasdaq:NEXM), a specialty CRO and a developer of products based on the NexACT technology, today announced the appointments of Jack A. Reynolds, Ph.D and Daniel R. Salomon, M.D., to its newly formed Scientific Advisory Board (SAB), expanding the SAB to four members.
ThermoGenesis Corp. (Nasdaq:KOOL), a leading supplier of innovative products for processing and storing adult stem cells, announced today it has signed a non-exclusive distribution agreement with GE Healthcare for its Res-Q™60 BMC (Res-Q), a device used to prepare cell concentrates, including stem cells, from bone marrow. "This new agreement with GE Healthcare represents a major milestone in our bone marrow strategy. We believe they can leverage their strong presence in markets such as cardiology to expand the use of our Res-Q System beyond orthopedics and into indications where the use of stem cells as therapy is growing," said J. Melville Engle, Chief Executive Officer of ThermoGenesis.
In news from earlier in the day:
Aeterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ), jumped 24% today after the late-stage drug development company specialized in oncology and endocrinology, today announced that it has received from the U.S. Food and Drug Administration, orphan-drug designation for AEZS-108, its doxorubicin targeted conjugate compound, for the treatment of ovarian cancer. AEZS-108 is currently in a Phase 2 trial in advanced ovarian and advanced endometrial cancer in Europe.
Juergen Engel, Ph. D., President and CEO of Aeterna Zentaris stated, "We are very pleased with AEZS-108 gaining orphan-drug designation for ovarian cancer from the FDA as it would provide it with extra market exclusivity protection. We look forward to reporting the final results from our ongoing European Phase 2 study in ovarian and endometrial cancer, later this year."
Shares opened higher and held on during the mid-day market drop, finishing up 30 cents to $1.54.
Positron Corporation (OTCBB:POSC) announced the highlights from the Company’s presentation before NASDAQ on May 5, 2010.
The Company set out to explain the foundation of its business, the confirmation of a strategic partnership and potential revenue. Management discussed most all aspects of the Company’s plans which it was at liberty to disclose. A transcript of the presentation will be filed with the Securities and Exchange Commission on a Form 8-K immediately when it becomes available in coming days.
Positron representatives did confirm an agreement with an industry leading strategic partner that will give the Company the ability to greatly expand the Company’s revenue stream and it's position in the molecular imaging market by offering imaging systems and radiopharmaceutical distribution. Patrick Rooney, Positron Corporation’s CEO states, "We would have liked to introduce a certain synergistic business partner as was stated in the press; however it was the recommendation of both companies to not disclose further details due to a potential expansion relationship and certain strategic competitive advantages. We anticipate additional information will be disclosed in the near future."
Positron also gave guidance as to its target revenue. Based on the Company’s research and unique positioning in the marketplace, Positron projects significant sales growth quarter over quarter, year over year. Positron projects that in the next 5 years the nuclear cardiology market will approach $1.5 Billion in revenue annually. The projections reflected sales from Positron’s PET device and radiopharmaceutical devices and services. Positron may potentially achieve greater revenue as it expands into new markets with broader indications that they expect will be fully supported by Medicare and private payers.
Amylin Pharmaceuticals, Inc. (Nasdaq:AMLN), Eli Lilly and Company (NYSE:LLY) and Alkermes, Inc. (Nasdaq:ALKS) today announced that the U.S. Food and Drug Administration (FDA) has classified the BYDUREON (exenatide for extended-release injectable suspension) complete response as a Class 2 resubmission and assigned a new Prescription Drug User Fee Act (PDUFA) action date of October 22, 2010.
"If approved, BYDUREON will be the first once-weekly treatment for type 2 diabetes, and we are committed to making this important therapeutic option available to patients as soon as possible," said Orville G. Kolterman, M.D., senior vice president of research and development, Amylin Pharmaceuticals. "We will continue to work closely with the agency through this final stage of the review process."
The new drug application (NDA) for BYDUREON was submitted in May 2009 and was based on data from the DURATION clinical trial program, as well as more than seven years of clinical experience with BYETTA (exenatide) injection. The agency issued a complete response letter to the companies in March 2010 and the companies responded to that letter in April 2010.
CPEX Pharmaceuticals Inc., (NASDAQ: CPEX) today announced that it recommends CPEX shareholders reject the unsolicited $16.00 per share tender offer commenced by RSR Acquisition Company, a subsidiary of Shelter Bay Holdings, LLC whose principal is Richard Rofé, to acquire all of the outstanding shares of CPEX. The Board reviewed the offer with the assistance of CPEX management and legal and financial advisors. The Board has determined that the offer is inadequate and substantially undervalues the Company’s current business and future prospects. Accordingly, the Board recommends that CPEX shareholders not tender any of their shares into the offer and withdraw any previously tendered shares. The Board also announced that it intends to explore strategic alternatives to maximize shareholder value, including, but not limited to, a sale, merger or other business combination of the Company with a third party or a monetization of the Company’s assets including its rights to receive royalties and milestone payments. CPEX closed the day sharply higher, gaining $2.72 or 12% to $25.90.
Genzyme Corp. (NASDAQ: GENZ) today announced that its Board of Directors has voted to pursue several actions to increase shareholder value. The company will initiate a $2 billion stock buyback, under which $1 billion of stock will be repurchased in the near term and financed with debt. The additional $1 billion of stock will be repurchased during the next 12 months.
The company also plans to pursue strategic alternatives for its Genetic testing, Diagnostic products and Pharmaceutical intermediates businesses. Options could include divestiture, spin-out, or management buy-out.
Intellect Neurosciences, Inc. (OTCBB:ILNS), a biopharmaceutical company focused on development of disease-modifying therapeutic agents for Alzheimer's disease, announced today that it has reached a debt settlement agreement with CARBOGEN AMCIS AG, one of Intellect's largest trade creditors, in connection with prior services rendered. As a result of the settlement agreement, CARBOGEN will remain a key supplier of Intellect's lead internal drug candidate, OXIGON(TM) (OX1), which has potential for the treatment of Alzheimer's disease and other important indications.
Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) pushed higher today after the company announced today the initiation of its short-term Phase 3 study of Zerenex™ (ferric citrate), the Company's iron-based phosphate binder for the treatment of elevated serum phosphorous levels, or hyperphosphatemia, in patients with end-stage renal disease on dialysis. The initiation of this study marks the commencement of the Company's Phase 3 registration program for Zerenex, which is being conducted in accordance with a Special Protocol Assessment (SPA) agreement with the FDA. Pursuant to the Company's SPA agreement, the Zerenex Phase 3 registration program will consist of the short-term efficacy study initiated today, and 58-week long-term safety and efficacy study, to be initiated in the third quarter of 2010.
MDRNA, Inc. (NASDAQ:MRNA), a leading RNAi-based drug discovery and development company, today reported on advances made with the Company's proprietary UsiRNA construct for RNA interference (RNAi). The term UsiRNA denotes inclusion of unlocked nucleobase analogs (UNA) in the double-stranded oligonucleotide construct. UsiRNAs demonstrate enhanced specificity and efficacy in comparison to standard siRNAs. Today's data add to previously reported data on microarray analysis indicating the UsiRNA construct not only significantly eliminates off-target events, but does so with no apparent new off-target silencing. That is, UNA's improve the efficacy of the siRNA construct without further off-target activity related to the UNA chemistry.
Obagi Medical Products, Inc. (NASDAQ:OMPI) today reported net revenue for the first quarter ended March 31, 2010 increased 13.6% to $25.7 million, from $22.6 million in the first quarter of 2009. The increase was due primarily to improvements in the economy and willingness of consumers to spend in the aesthetics space, along with success of the Company’s promotional activities.
POZEN Inc. (NASDAQ: POZN) today announced that results of a Phase 1 Trial of PA65020, a combination of enteric-coated aspirin (EC-ASA) and immediate-release (IR) omeprazole, show PA65020 significantly reduces the incidence of gastrointestinal (GI) mucosal damage compared to EC-ASA (650 mg twice daily) in healthy adults treated for one month. Patients receiving analgesic doses of EC-ASA were five times more likely to experience significant GI mucosal damage than patients receiving PA65020. The study concluded that PA65020 may provide an important therapeutic option for at-risk patients who require analgesic doses of aspirin.
SCOLR Pharma, Inc. (NYSE AMEX: DDD) today announced that it has executed a Licensing Agreement with RedHill Biopharma Ltd. an Israeli corporation, (RedHill), granting RedHill the worldwide rights to market and sell ondansetron tablet formulations based on SCOLR's proprietary extended delivery technology (CDT). Ondansetron hydrochloride is the active ingredient in Zofran®, GlaxoSmithKline's drug to prevent chemotherapy and radiation related nausea and vomiting.
Under the terms of the Licensing Agreement, RedHill has agreed to make up front and additional payments to SCOLR up to $600,000 based on achievement of certain regulatory milestones and the first commercial sale of the product and thereafter make payments to the Company up to a maximum of $30 million based on the aggregate net sales by RedHill of the licensed product over a ten year period.
Syneron Medical Ltd. (NASDAQ:ELOS), a leading global aesthetic device company, today announced the successful resolution of patent litigation against its subsidiary, Candela Corporation, by Cardiofocus, Inc. On April 30, 2010, the United States District Court for the District of Massachusetts approved dismissal with prejudice of all claims made by Cardiofocus against Candela in a lawsuit pending against Candela and other companies.
Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) today announced that Dr. Leonard Bell, Chief Executive Officer of Alexion Pharmaceuticals, will present at the Bank of America Merrill Lynch 2010 Healthcare Conference in New York at 8:00 am Eastern on Thursday, May 13, 2010.
Antares Pharma, Inc. (NYSE Amex: AIS) today announced that it will release its first quarter 2010 financial results after the market closes on Thursday, May 13, 2010, and host a conference call shortly thereafter at 4:30 p.m. ET (Eastern Time) to discuss the results.
ArQule, Inc. (NASDAQ: ARQL) today announced its financial results for the first quarter of 2010.
Aspen Technology, Inc. (NASDAQ: AZPN), a leading provider of software and services to the process industries, today announced financial results for its third quarter of fiscal 2010, ended March 31, 2010.
AVANIR Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced the pricing of a public offering of 10,000,000 shares of its common stock.
Baxter International Inc. (NYSE: BAX) announced today that it will present at the Bank of America Merrill Lynch Health Care Conference on Tuesday, May 11, 2010 at 9:20 a.m. (ET) or 8:20 a.m. (CT).
Biogen Idec Inc. (NASDAQ: BIIB) announced today that its presentation at the Bank of America Merrill Lynch 2010 Healthcare Conference will be webcast live, via the internet, on Tuesday, May 11, 2010 at 4:20 p.m. EDT.
Columbia Laboratories, Inc. (Nasdaq: CBRX) today announced financial results for the three-month period ended March 31, 2010. Key financial results of the quarter and subsequent events include: "Our domestic progesterone business grew dramatically during the first quarter of 2010"
CombinatoRx, Incorporated (NASDAQ: CRXX) today reported financial results for the first quarter ended March 31, 2010.
Dr. Reddy's Laboratories Ltd. (NYSE:RDY) today announced its unaudited financial results for the full year ended March 31, 2010 under International Financial Reporting Standards (IFRS).
Enzon Pharmaceuticals, Inc. (NASDAQ: ENZN) announced today that it will report its financial results for the quarter ended March 31, 2010, on Monday, May 10, 2010 at approximately 8:00 am Eastern Time (ET).
EpiCept Corporation (Nasdaq and Nasdaq OMX Stockholm Exchange: EPCT) today announced operating and financial results for the three months ended March 31, 2010, and provided an update with respect to the Company's key business initiatives.
Incyte Corporation (Nasdaq:INCY) today reported first quarter 2010 financial results and provided an update on recent clinical accomplishments, including positive top-line results from an ongoing six-month, dose-ranging Phase II trial to evaluate INCB28050 in rheumatoid arthritis (RA) patients.
Safeguard Scientifics, Inc. (NYSE: SFE), a holding company that builds value in growth-stage life sciences and technology companies, today announced that aggregate revenue of its partner companies for the three months ended March 31, 2010 was $85.3 million, up 46% from $58.4 million for the same partner companies for the same period of 2009.
Santarus, Inc. (NASDAQ: SNTS), a specialty biopharmaceutical company, today reported financial and operating results for the quarter ended March 31, 2010.
Trimeris, Inc. (Nasdaq: TRMS) today announced financial results for the quarter ended March 31, 2010, reporting net income of $988,000, or $0.04 per share compared with $2.1 million, or $0.10 per share for the quarter ended March 31, 2009.
Walgreens (NYSE: WAG)(NASDAQ: WAG) is providing much-needed water, hygiene products and various medical supplies to a number of local shelters in the Nashville area, to aid flood victims and further support the Nashville community as it works to recover from local flooding.
XenoPort, Inc. (Nasdaq:XNPT) announced today its financial results for the first quarter ended March 31, 2010. Revenues for the quarter were $0.1 million, compared to $26.3 million for the same period in 2009.
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