|POZEN gets FDA nod, shareholders hang on for wild ride. After the bell, Middlebrook Pharmaceuticals files chapter 11|
|By BioMedReports.com Staff|
|Friday, 30 April 2010 19:39|
Below is a list of the companies that made news in the healthcare sector on Friday, April 30, 2010.
POZEN Inc. (NASDAQ: POZN) saw it shares take a wild ride today, a ride which was reminiscent of Dendreon's now famous trading day back in April 2009. Expecting news on its PDUFA date, investors drove shares of Pozen to an intra-day high of $12.68 today before a sudden surge of sell orders, at approximately 12:30 PM EDT, sent shares tumbling to an incredible daily low of $5.50. The drop was brief however and, in less than a minute, the stock rallied back although it never returned to the high of the day, instead settling at $10.85, down 10%.
Then, about 35 minutes into the after hours session news of FDA approval leaked out and the stock spiked back up, hitting $13.91 before settling at $13.15. The stock was then halted per Nasdaq code T1 (pending news) and has not traded since. It is anticipated that shares will re-open Monday morning significantly higher.
Pozen and partner AstraZeneca (NYSE:AZN) submitted the NDA last year for the arthritis/pain relief drug Vimovo. With today's approval, Pozen is in line to receive a $20 million milestone payment from AstraZeneca and may also qualify for $25 million more in the coming months.
In addition, the company is expecting approval of Vimovo by the EU in the next couple of months. Pozen's CEO believes that Vimovo could reach blockbuster status.
MiddleBrook Pharmaceuticals, Inc. (NASDAQ: MBRK) after the bell reported that the company has filed a voluntary petition for relief under Chapter 11 of the United States Bankruptcy Code. "During this process, we remain committed to continuing to promote MOXATAG through our third party partner’s electronic promotion program and maintaining product availability to our trade customers," said David Becker, MiddleBrook Executive Vice President and Chief Financial Officer, and Acting President and Chief Executive Officer. In March the company announced a reduction in force which included the resignation of its CEO John Thievon. After closing the day at 30 cents, shares fell more than 60% in the after hours session, dropping 18 cents to 12 cents.
Other news after the bell:
Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP), announced after the market closed that it received a complaint filed by Celgene Corporation seeking a declaration from the court that four Cyclacel-owned patents, which claim the use of romidepsin injection in T-cell lymphomas, are not infringed by Celgene's products and are invalid. Cyclacel and its counsel have not had an opportunity to thoroughly review these filings.
The four patents cited in the complaint do not involve Cyclacel's clinical development candidates nor its commercial products.
Geron Corporation (Nasdaq:GERN) announced today that the Board of Patent Appeals and Interferences of the U.S. Patent Office has reversed an earlier decision from the Patent Office reexamination division that had upheld the claims of U.S. Patent Number 7,029,913. The patent, which is assigned to the Wisconsin Alumni Research Foundation ("WARF") and licensed to Geron, covers human embryonic stem cells and is one of three WARF patents which were upheld in earlier reexamination proceedings. The immediate effect of the BPAI decisions is that WARF will have the opportunity to continue examination of the claims of the ‘913 patent at the examination level of the Patent Office.
"This is not a final rejection of the patent claims," noted David J. Earp, J.D., Ph.D., Geron’s chief patent counsel and senior vice president of business development. "We are confident that WARF will make a strong case in support of the patentability of these claims in continued examination."
In other news Friday:
Advaxis, Inc., (OTCBB: ADXS) reported today that it is advancing the clinical development of its lead prostate cancer immunotherapeutic toward clinical trials.
The company is collaborating with Dr. Chandan Guha at the Albert Einstein College of Medicine and Montefiore Medical Center to develop ADXS31-142 in human trials. Following the completion of manufacturing trials, the company intends to conduct a Phase 1 study with Dr. Guha.
Regarding Advaxis’ prostate initiative, Dr. John Rothman, Executive VP of Science and Operations said, "Prostate cancer is an excellent target for immunotherapy. We believe our approach compares favorably with the recently approved Provenge treatment. Advaxis’ vaccine is simple and less expensive, as it is comprised of three (3) vaccinations, which attack all prostate cancer without the need to be patient specific."
ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) edged higher today after the company reported financial results for the three months ended March 31, 2010.
"We ended the first quarter with a strong balance sheet reflecting $19.8 million in cash, against quarterly operating expenses of $2.4 million," said Brian M. Culley, ADVENTRX's Chief Executive Officer. "This capital will support our operations while we conduct stability studies from the intended commercial manufacturer of ANX-530, or Exelbine, which is required to file the Exelbine New Drug Application, and also further the development of our detergent-free reformulation of the blockbuster chemotherapy drug, Taxotere.
"We look forward to resubmitting our first NDA later this year, as well as meeting with the Food and Drug Administration to discuss the results of our bioequivalence study of ANX-514," Mr. Culley continued. "In addition, we have begun to review opportunities to enhance our product pipeline with additional drug development programs."
AstraZeneca (NYSE:AZN) is relaunching The Bipolar Journey: Living With Bipolar Depression interactive exhibit in a second tour to patients and caregivers across America. The national 10-city tour will kick off at the Depression and Bipolar Support Alliance (DBSA) 2010 National Conference on April 29 in Itasca, Illinois. Those who have been touched by bipolar depression -- the depressive phase of bipolar disorder -- are encouraged to learn more about living with and managing this disease by visiting a nearby exhibit site and engaging with the interactive materials, activities, and informative Web sites.
AVANIR Pharmaceuticals, Inc. (NASDAQ: AVNR) announced the submission of its Complete Response to the October 2006 Approvable Letter issued by the U.S. Food and Drug Administration for Zenvia for the treatment of pseudobulbar affect (PBA). AVANIR expects the FDA to classify the response as a Class 2 resubmission, which would result in an expected review period of 180 days and potential approval of Zenvia in the fourth quarter of 2010. In the Approvable Letter of 2006, the FDA cited safety concerns related to the original Zenvia 30/30 mg dose formulation. After discussions with the FDA, the company agreed to reformulate and conduct a confirmatory Phase III trial (STAR trial) under a Special Protocol Assessment (SPA) testing new lower dose 30/10 mg and 20/10 mg formulations of Zenvia designed to enhance the safety and tolerability profiles while maintaining clinically meaningful and statistically significant efficacy. After opening the day higher, shares of Avanir closed down 17 cents to $3.22.
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) moved higher today after the company announced that it will present a BioSante cancer vaccine portfolio update at the BIO International Convention, which will take place May 3-6 in Chicago, Illinois.
Stephen M. Simes, BioSante’s president & CEO, will speak on Wednesday, May 5, 2010 at 3:15 pm local time. He will provide a status report on BioSante’s portfolio of cancer vaccines in clinical development, as well as an update on LibiGel (testosterone gel) in clinical development for the treatment of female sexual dysfunction.
BioSante’s GVAX cancer vaccines currently are in several Phase II clinical trials in various cancer types including vaccines for the treatment of leukemia, breast cancer and pancreatic cancer, and to date have received FDA orphan drug designations for GVAX AML for the treatment of acute myeloid leukemia and GVAX Pancreas for the treatment of pancreatic cancer.
Depomed, Inc. (NASDAQ:DEPO) Thursday after the bell reported financial results for the first quarter ended March 31, 2010.
Revenue for the three months ended March 31, 2010 was $15.4 million compared to $9.9 million for the three months ended March 31, 2009. The 56% increase in revenue year-over-year was primarily attributable to a $5.8 million increase in Glumetza product sales. "In the first quarter, we made significant advances in our development programs in DM-1796 for postherpetic neuralgia and Serada for menopausal hot flashes. Abbott Products Inc. filed an NDA for DM-1796 in March, and we look forward to the FDA’s acceptance of the NDA for filing later this quarter. We received encouraging guidance on Serada’s development program in the quarter, and expect to initiate one additional Phase 3 clinical trial very soon," noted Carl A. Pelzel, president and chief executive officer of Depomed.
EpiCept Corporation (Nasdaq and Nasdaq OMX Stockholm Exchange: EPCT) today announced that Jack Talley, President and CEO, will be presenting at the BIO International Convention on May 4, 2010 at 10:30 AM local time at the McCormick Place Convention Center. Mr. Talley will present a company overview.
Immucor, Inc. (Nasdaq:BLUD), a global leader in providing automated instrument-reagent systems to the blood transfusion industry, today announced that its fourth generation automated instrument, NEO, has been cleared for marketing in the U.S. by the Food and Drug Administration. NEO is a fully automated blood bank instrument designed to meet the needs of high volume laboratories.
"We believe there is a significant market opportunity for NEO and we are very excited about achieving 510(k) clearance from the FDA," stated Dr. Gioacchino De Chirico, Immucor's President and Chief Executive Officer. "NEO is the most recent example of Immucor's commitment to deliver products that improve patient safety and the practice of transfusion medicine."
Inergetics, Inc. (OTCBB:MBTG), a leader in targeted product development for the Clinical Nutrition and Sports Supplement Markets, today announced that the Company has agreed in principle with Windmill Health Products to a three year exclusive distributor relationship to sell and market its Surgex(TM) sports supplement across multiple classes of trade worldwide. Mark Mirken, CEO of Inergetics, Inc., commented, "There is no other sports nutritional product on the market today that contains Surgex's patent-protected nutritional composition combined with the product's published trials. With this distribution agreement in place, along with other developing opportunities, we project that our sports product line will penetrate 1% to 2% of the worldwide nutritional supplement markets by 2012."
MannKind Corporation (Nasdaq:MNKD) today reported financial results for the first quarter ended March 31, 2010. For the first quarter of 2010 total operating expenses were $40.6 million, compared to $57.8 million for the first quarter of 2009. Research and development (R&D) expenses were $30.5 million for the first quarter of 2010 compared to $42.9 million for the same quarter in 2009, a decrease of $12.4 million. This 29% decrease in R&D expense was primarily due to reduced costs associated with the clinical development of AFREZZA after the submission of its NDA in March 2009. General and administrative expenses decreased by $4.8 million to $10.1 million for the first quarter of 2010 compared to $14.9 million in the first quarter of 2009. This 32% decrease in G&A expense was mainly due to decreased salary related costs resulting from the April 2009 reduction in force and the non-recurrence of costs related to the negotiation of the transaction with Pfizer, which occurred during the first quarter of 2009. "The most significant event of the first quarter was clearly the FDA’s response to our NDA for AFREZZA," said Alfred Mann, Chairman and Chief Executive Officer. "Since that time, we have been preparing for an upcoming meeting with the agency and readying a submission that is intended to address the FDA’s questions about AFREZZA.
NeurogesX, Inc. (Nasdaq:NGSX), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, announced today that that it has entered into a $40 million royalty financing agreement with Cowen Healthcare Royalty Partners, L.P. The agreement creates a debt obligation that will be repaid through and secured by royalties and future milestone payments payable to NeurogesX under its distribution, marketing and license agreement with Astellas Pharma Europe Ltd. for NeurogesX Qutenza 8% patch, a dermal delivery system containing prescription strength capsaicin. Shares of NeurogesX were unchanged on the day.
Neuralstem, Inc. (NYSE Amex: CUR) announced Friday that its stem cell treatment for ALS (Amyotrophic Lateral Sclerosis, or Lou Gehrig's disease), currently in a FDA-approved Phase I clinical trial, was featured on CNN Thursday night with Dr. Sanjay Gupta, in the piece entitled "Stem Cell Medical Breakthrough." The segment featured the first footage of the procedure, in which Neuralstem's spinal cord stem cells are injected directly into the gray matter of the patient's spinal cord.
Questcor Pharmaceuticals, Inc. (Nasdaq:QCOR) jumped more than 11% today after the company, after the bell Thursday, reported improved year-over-year financial results for the first quarter ended March 31, 2010. The Company's financial performance was driven primarily by: * a 197% increase in the number of new paid Acthar prescriptions for the treatment of multiple sclerosis (MS) exacerbations as compared to the first quarter of 2009. *a reduced rebate liability to U.S. government insurance plans due to improved Tricare pricing and a provision in the recently passed Patient Protection and Affordable Care Act of 2010.
Repligen Corporation (Nasdaq:RGEN) announced today that the United States Patent and Trademark Office has granted a Notice of Allowance of a patent covering the use of uridine in the treatment of patients with bipolar disorder. The patent, which upon issue will remain in force until 2025 prior to any patent term extensions, covers the use of an effective dose of a uridine composition to improve one or more of the symptoms of bipolar disorder including depression, mania, mixed episodes, hypomania and anxiety. Repligen is currently enrolling patients in a Phase 2b clinical trial of RG2417, an oral formulation of uridine, to assess its impact on the symptoms of acute depression. This study is designed to confirm and extend the results of a Phase 2a study in which 6 weeks of treatment with RG2417 improved the symptoms of bipolar depression when compared to placebo as measured by the Montgomery-Asberg Depression Rating Scale.
Repros Therapeutics Inc. (NasdaqCM:RPRX) today announced that a teleconference was held with the FDA to review the clinical hold status of Proellex. Previously clinical studies were stopped due to findings of changes in liver enzymes at higher doses of the oral drug resulting in serious adverse events. Proellex is being studied as a treatment for uterine fibroids and endometriosis. Shares opened higher on the day, jumping as high as $1.13 but trended down, closing at 85 cents, down 2 cents.
RIDEX Corporation, (Nasdaq:IRIX) today announced the commencement of commercial shipment of the IQ 532 laser systems. The IQ 532 is a high-power, 532 nm, dual port multi-purpose laser system for use by ophthalmologists to treat sight-threatening eye diseases such as diabetic retinopathy, age-related macular degeneration and glaucoma; and for use by otolaryngologists to correct certain types of conductive hearing loss.
SCOLR Pharma, Inc. (NYSE AMEX: DDD) today reported financial results for the first three months ended March 31, 2010.
Stephen J. Turner, SCOLR Pharma's President and CEO, said, "We're eager to maintain the momentum we have achieved thus far in 2010 on a number of our strategic, operational and financial goals. A majority of our focus and effort in 2010 will be on supporting the launch of several extended release nutritional products through both our direct and indirect sales efforts, executing a successful ANDA review with subsequent commercialization of our 12 hour pseudoephedrine product, and managing our cost structure.
"Additionally, with our recent acquisition of the rights to the Nuprin brand name, we are in a better position to move our ibuprofen product forward in this very large and growing global market, either with a partner, or alone.
Thoratec Corporation (Nasdaq:THOR), surged more than 23% Friday after the leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, reported Thursday after the bell that revenues for the first quarter of 2010 increased 36 percent versus a year ago.
For the quarter ended April 3, 2010, revenues were $121.6 million versus revenues of $89.5 million in the first quarter of 2009. Revenues in the company's Cardiovascular Division increased 54 percent in the first quarter of 2010 versus the same period a year ago. Shares jumped $8.47 to $44.76.
Viking Systems Inc. (OTCBB:VKNG) announced today that it has increased its cash and liquidity position through the issuance of common stock. The Company raised $934,897 by selling an aggregate of 4,398,050 shares of its common stock through its previously announced financing facility with Dutchess Opportunity Fund, II, LP.
Robert Mathews, Executive Vice President and CFO of Viking Systems, Inc. said, "We are very pleased to announce that we have brought significant capital into the Company. Clearly it is very important to have access to capital to fund our strategic plans. We have made great progress towards launching our Next Generation 3DHD System and it is essential to have the financial means to fund the final phases of this effort."
The Company has previously stated, and again reiterated, that it intends to raise a total of $2 million to $3 million during 2010 to fund the development and launch of its Next Generation 3DHD system, anticipated 2010 operating losses and working capital needs.
World Heart Corporation (WorldHeart; Nasdaq: WHRT), a developer of mechanical circulatory systems, announced the appointment of Dr. John Campbell Woodard as Senior Vice President of Scientific Affairs. Dr. Woodard will be responsible for clinical affairs and will also guide the development of World Heart's next- generation technologies. Dr. Woodard most recently served as Chief Scientific Officer for Ventracor Limited: an Australian-based public company focused on the development of left ventricular assist devices for late-stage heart failure patients.
ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP), a biopharmaceutical company that is seeking to develop and commercialize a diverse, risk sensitive portfolio of in-licensed cancer drugs addressing unmet medical needs, today reported its financial results for the three months ended March 31, 2010 and updated the Company’s continued progress with its clinical programs.
In the first quarter of 2010, the Company’s cash burn from operations was $3.8 million, a decrease of $0.8 million from $4.6 million for the same period for 2009. The spending decrease represents a continued focus of resources as well as tight management of operating expenses. The Company ended the March 2010 quarter with cash of approximately $45.0 million. The Company expects its existing cash resources to support operations early into the first quarter of 2012, although this expectation could change based on, among other things, the scope and timing for the Company’s registration trial for palifosfamide.
Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced its financial results for the first quarter of 2010.
Akorn, Inc. (NASDAQ: AKRX) a niche generic pharmaceutical company, today announced that two members of the Company’s Board of Directors, Jerry N. Ellis and Randy J. Wall, have notified the Company that they do not intend to seek re-election at the annual meeting of shareholders on May 21, 2010.
Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) today announced that researchers are scheduled to present clinical and laboratory research on the role of terminal complement inhibition therapy in kidney transplantation patients at high risk for antibody-mediated rejection (AMR) at the American Transplant Congress, being held May 1 to 5, 2010, in San Diego.
Allergan, Inc. (NYSE: AGN) today announced operating results for the quarter ended March 31, 2010. Allergan also announced that its Board of Directors has declare a first quarter dividend of $0.05 per share, payable on June 8, 2010 to stockholders of record on May 18, 2010.
AspenBio Pharma, Inc. (NASDAQ:APPY) announced today that it has entered into definitive agreements with certain new and existing institutional investors to sell an aggregate of 2,409,639 units, with each unit consisting of (i) one share of its common stock, no par value per share ("Common Stock") and (ii) one warrant to purchase 0.285 shares of Common Stock, in a registered direct offering for gross proceeds of approximately $10.0 million, before deducting placement agent's fees and estimated offering expenses.
BioScrip, Inc. (Nasdaq: BIOS) today announced a first quarter net loss of $7.2 million, or $0.18 per share on revenues of $335.1 million.
Biovest International, Inc. (Other OTC: BVTI) today congratulated Dr. Larry Kwak for being named in the "2010 TIME 100" issue of TIME Magazine, recognizing his significant contributions in advancing personalized cancer vaccines for the treatment of cancer.
Bristol-Myers Squibb Company (NYSE:BMY) invites investors and the general public to listen to a webcast of its annual meeting with stockholders at 10 a.m. (ET) on Tuesday, May 4, 2010.
Cleveland BioLabs, Inc. (NASDAQ:CBLI) today announced that an interview with Rachel Levine, Director of Corporate Development and Communications, has been posted to corporateprofile.com.
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that Robert Perez, EVP and COO, will present on Tuesday, May 11, 2010 at 10:40 a.m. Eastern Time at the Bank of America Merrill Lynch 2010 Healthcare Conference at The Grand Hyatt Hotel in New York City.
HST Global, Inc., (OTCBB:HSTC) today was encouraged by news of the FDA approval of Dendreon Corp's (NASDAQ: DNDN) Provenge drug for prostate cancer.
Illumina, Inc. (NASDAQ:ILMN) today announced the appointments of Elizabeth Brady as vice president, Global Supply Chain, and Emily S. Winn-Deen, Ph.D., as vice president, Diagnostics Development.
Inhibitex, Inc. (NASDAQ: INHX) announced today that it will host a conference call on Thursday, May 13, 2010 at 9:00 a.m. EDT to review the Company's first quarter financial results and provide an update on recent corporate developments.
Inovio Biomedical Corporation (NYSE Amex: INO), a leader in DNA vaccine design, development and delivery, announced today that its CEO, Dr. J. Joseph Kim, will present a corporate update on its DNA vaccines for influenza, HIV and cancer and its vaccine delivery technology on May 5th at 2:15 p.m. at the upcoming 2010 BIO International Convention.
Mannatech, Incorporated (NASDAQ: MTEX), a global pioneer in the development of high-quality health, weight and fitness and skin care solutions based on nutritional science, obtained Final Judgments in a lawsuit against EvenBetterNow, LLC, and Oasis Advanced Wellness, LLC (Oasis), prohibiting both companies from the manufacture, use or sale of products infringing Mannatech's patents.
MELA Sciences (NASDAQ: MELA), announced that its stockholders have approved all five proposals voted on at the Company's 2010 Annual Stockholder Meeting held earlier today
Pall Corporation (NYSE: PLL) announced today that it will present at the 2010 Bank of America Merrill Lynch Health Care Conference in NYC on Thursday, May 13, 2010 at 11:20 AM Eastern Time.
Taro Pharmaceutical Industries Ltd. (Pink Sheets: TAROF) today provided preliminary, unaudited and unreviewed information on its financial performance for the year ended December 31, 2009.
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