|RxNews Recap for Tuesday 02-02-10. Compugen (CGEN) soars on protein discovery. Myriad (MYGN) up as it beats estimates|
|By Mary Davila|
|Tuesday, 02 February 2010 18:55|
Compugen Ltd. (Nasdaq: CGEN) announced today the discovery and experimental validation of CGEN-15001 for the treatment of autoimmune disorders. CGEN-15001 is the extracellular region of a previously unknown membrane protein in the B7/CD28 family. The existence and potential utility of the newly discovered parent protein from which CGEN-15001 is derived was predicted in silico utilizing Compugen’s LEADS Platform and other proprietary algorithms.Shares of Compugen rose more than 18% on heavy volume to close at $4.67 on the day.
Autoimmune diseases develop when defects in the immune system lead the body to attack its own cells, tissues, and organs and include more than 80 chronic, and often disabling, illnesses. Among the most common autoimmune diseases are rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease, and type 1 diabetes. Collectively, autoimmune diseases are among the most prevalent diseases, affecting an estimated 25 million people in the U.S.
Compugen Ltd. develops products using computer-based discovery platforms, as well as through analyzing DNA or RNA sequences, gene expression data, protein network data, data related to drugs in development, and drugs already being commercialized.
Myriad Genetics, Inc. (Nasdaq:MYGN) today reported financial results after the bell for its second fiscal quarter and the six-month period ended December 31, 2009. Shares were up in after hours trading by more than 6% as the report exceeded concensus estimates.
Revenues rose 11% to $92.8 million for the three-month period ended December 31, 2009, from $84.0 million in the same three months of the prior fiscal year and increased 9% on a sequential quarterly basis. Myriad attributes this growth primarily to increased sales and marketing efforts that improved physician acceptance and adoption of the Company's products.
Net income for the second quarter of fiscal 2010 rose 67% to $35.4 million, or $0.36 per diluted share, compared with $21.2 million, or $0.22 per diluted share, in the same quarter of the prior year, which included a loss of $15.6 million from discontinued operations related to the Company's former research and pharmaceutical businesses. Continued efficiency improvements in the Company's molecular diagnostics laboratory, including an increase in gross profit margin from 87% to 88% in the second quarter of fiscal 2010, compared to the first quarter of fiscal 2010 was an important contributor to the Company's profitability.
Said Peter Meldrum, President and Chief Executive Officer of Myriad Genetics, Inc "Improvements in the overall economy as well as recent Company-specific strategic initiatives, allowed us to generate solid year-over-year revenue growth and a return to sequential revenue growth. I am also pleased to report that we will announce the launch of our eighth molecular diagnostic product at Myriads Investor Day in New York City on March 3, 2010."
The company completed its spin-off in June of 2009 of its former research and drug development businesses, which now make up a separate publicly traded company called Myriad Pharmaceuticals.
In other news Tuesday:
Aetna (NYSE: ΑET) announced today that it has signed a three-year agreement with Grove City Medical Center, expanding network access for its members in Western Pennsylvania’s Mercer County.
BSD Medical Corp. (Nasdaq: BSDM) shares soared over 35% today as the company announced a publication of a news article by the Journal of the National Cancer Institute on the evolving role of hyperthermia in cancer therapy titled, “International Study of Hyperthermia Spurs Hope in U.S.” (J. Natl. Cancer Inst. 2010 102: 79-81; doi:10.1093/jnci/djp530). The article reviews the history of hyperthermia in cancer therapy, including the challenges faced by hyperthermia advocates and the progress that has been made in addressing these challenges. In the article it states that, “Successful use of targeted heat therapy with chemotherapy in treatment of soft-tissue sarcoma has given U.S. advocates of local hyperthermia new hope that the treatment they so believe in will now be taken seriously.”
The article quoted Rolf Issels, M.D., Ph.D., a professor of medical oncology at Klinikum Grosshadern Medical Center at the University of Munich and the lead researcher on the Phase III sarcoma study, who stated that the findings, “provide a new standard treatment option, and we believe they are likely to change the way many specialists treat these tumors.” Dr. Issels discussed the impact of the results of the Phase III sarcoma study on the field of hyperthermia and concluded, “…the implications of these findings are more far-reaching.” “This is also the first clear evidence that targeted heat therapy adds to chemotherapy.”
The author of the article, Renee Twombly, interviewed leading hyperthermia researchers for the publication. Two leading hyperthermia researchers from Duke, Dr. Zeljko Vujaskovic and Dr. Mark Dewhirst, discussed the history and clinical application of hyperthermia. Jacoba van der Zee, M.D., Ph.D., the Erasmus MC–Daniel den Hoed Cancer Center in Rotterdam, a leader in the field of hyperthermia, stated that, “With all the efforts to find new treatments that are more tumor selective and less toxic, it is astonishing that an existing treatment that is relatively tumor selective, has a low toxicity, and that in clinical studies has been shown to result in considerable benefit, receives so little attention."
Elizabeth A. Repasky, Ph.D., of Roswell Park Cancer Institute, Buffalo, N.Y., and president of the Society for Thermal Medicine stated, "We are on a verge, I think, of a major new adjuvant cancer therapy that will not replace chemotherapy or radiation, but will make them work a lot better." The Society for Thermal Medicine promotes research into the clinical application of hyperthermia.
Shares were as high as $2.75 earlier in the day and settled at $2.27, up a healthy $.60 from its previous close.
Catalyst Health Solutions, Inc. (NASDAQ: CHSI) announced today that Hai Tran, Chief Financial Officer, and Richard Bates, Executive Vice President, are scheduled to present at the UBS 20th Annual Global Healthcare Services Conference on Tuesday, February 9, 2010, at approximately 8:30 a.m. (ET) in New York City.
CryoLife, Inc. (NYSE: CRY), an implantable biological medical device and cardiovascular tissue processing company, announced today that it has purchased approximately 740,000 additional shares of Medafor's common stock from Medafor shareholders for $2.00 per share. Based on the most recent information available to CryoLife, the company now owns approximately 11 percent of Medafor and continues to be Medafor's largest shareholder. CryoLife has proposed acquiring the remaining outstanding common stock of Medafor for $2.00 per share in a combination of cash and CryoLife stock, subject to completion of reasonable due diligence.With its purchase of these additional shares of Medafor common stock, CryoLife now has the right to call a special shareholders meeting pursuant to Medafor's bylaws. CryoLife remains committed to entering into friendly negotiations with Medafor's board and management; however, in the event that Medafor's board continues to delay, a special shareholders meeting would afford CryoLife the opportunity to seek to replace the Medafor board in order to maximize value for all Medafor shareholders. CryoLife received a letter from Medafor's board on January 22, 2010 that stated that Medafor's board was considering its options. CryoLife has not heard from Medafor's board since that communication.
Hemispherx Biopharma, Inc. (Amex: HEB), announced that the Company, via its manufacturing subcontractor, received a favorable response from the Food and Drug Administration (FDA) Seattle District Office (DO) related to the latest response to the Prior Approval Inspection submitted on Dec.11, 2009, and noted in Hemispherx press release on Dec.16, 2009. The DO has accepted that certain manufacturing issues noted in the pre-approval inspection at the facility have been fully addressed and has made a recommendation for manufacturing approval with the Companys subcontractor listed as a manufacturing site to the FDA Office of Compliance in Washington, DC. The referenced response on Ampligen(R) (Poly I: Poly C12U), an experimental therapeutic being developed for potential treatment of Chronic Fatigue Syndrome (CFS), is the combined work-product of the staffs at Hemispherx and its subcontractor. These favorably resolved manufacturing issues are the same ones sited in the Complete Response Letter from the FDA described in Hemispherx December 1, 2009 press release. The DO recommendations are not binding on the FDA and pertain only to the specific manufacturing issues cited in the Ampligen® manufacturing response. Shares of HEB jumped more than 12% on the news and continued to rise in the after hours market.
Javelin Pharmaceuticals, Inc. (Amex: JAV), in conjunction with Myriad Pharmaceuticals, Inc. (Nasdaq: MYRX) today announced that its New Drug Application (NDA) submitted on December 2, 2009 to the US Food and Drug Administration (FDA) for its investigational product candidate, Dyloject™ (diclofenac sodium) Injection, has been accepted for formal review. The Company expects to learn the Dyloject NDA’s PDUFA date from the FDA in the next few weeks. The NDA is in support of US marketing approval and registration of Dyloject for the management of acute moderate-to-severe pain in adults. If approved, Dyloject will be the first IV non-steroidal anti-inflammatory drug (NSAID) marketed in the United States as a single agent for the management of acute moderate-to-severe pain in adults since ketorolac in 1990.
“Acceptance by the FDA of Javelin’s comprehensive NDA submission for Dyloject marks a significant regulatory milestone towards our goal of commercialization of Dyloject in the U.S. My colleagues and I are proud of this major achievement and are committed with Javelin’s merger partner, Myriad Pharmaceuticals, Inc. to developing and commercializing new alternatives for patients suffering from acute moderate-to-severe pain. We look forward to working with the FDA to facilitate the review of the Dyloject NDA,” stated Eric Lang, MD, VP Clinical Research of Javelin Pharmaceuticals, Inc. Adrian Hobden, PhD, President and CEO of Myriad Pharmaceuticals stated: "We are pleased that the FDA has accepted the Dyloject NDA submission for filing, which is an important milestone in our proposed merger with Javelin Pharmaceuticals, noted "The Javelin team deserves congratulations and credit for assembling a thorough and comprehensive application"
Nutra Pharma Corp. (OTCBB: NPHC), a biotechnology company that is developing treatments for Adrenomyeloneuropathy (AMN), HIV and Multiple Sclerosis (MS), has announced today that sales of its recently launched over-the-counter pain reliever, Cobroxin, totaled $583,955 for the fourth quarter ending December 31, 2009.
Protalix BioTherapeutics, Inc. (Amex: PLX) announced today that, in connection with the New Drug Application (NDA) filed by the Company in December 2009 for taliglucerase alfa for the treatment of Gaucher disease, the U.S. Food and Drug Administration (FDA) has requested additional data regarding the Chemistry, Manufacturing and Controls (CMC) section of the NDA. No additional Clinical or Preclinical information was requested. The request focused primarily on validation of the manufacturing process in the Company's upgraded manufacturing facility. A validation plan for the Company's manufacturing process of taliglucerase alfa has already been established and reviewed by the FDA. The Company is working diligently to provide the requested data to the FDA and anticipates submitting the requested data during the second quarter of 2010.
“The addition of Belinostat addresses our key strategic goal of in-licensing a late-stage anti-cancer compound,” said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. “With this collaboration, we have now completed our strategic initiatives relating to in-licensing of compounds with near term commercialization opportunities. Belinostat’s current registrational program is comprehensive and focused in that it targets key hematological indications such as PTCL and other solid tumor indications. Belinostat has the potential to be a best-in-class HDAC inhibitor for both hematological and solid tumors. We look forward to advancing Belinostat in PTCL and other solid tumor indications, with the goal of providing cancer patients with more effective treatment options as quickly and efficiently as possible. With that goal in mind, we currently expect to file the NDA in PTCL in 2011. TopoTarget has laid a solid foundation from which we will further develop Belinostat.”
“So far, Belinostat has demonstrated some unique and differentiating attributes. If approved, it would give Spectrum access to potentially large markets while allowing for enhanced coordination with our marketed drugs, ZEVALIN and FUSILEV,” added Amar Singh, Spectrum’s Chief Commercial Officer. “The recent expansion of our commercial infrastructure positions us to prepare for another successful launch in the near future”.
“We believe that this partnership will bring together synergies in our combined capabilities that will result in significant efficiencies in Belinostat’s development,” said Professor Peter Buhl Jensen, MD, Chief Executive Officer of TopoTarget A/S. “Spectrum as a partner is ideally suited to exploit the full benefits of the drug for cancer patients.”
Under terms of the agreement, Spectrum licensed the rights to Belinostat for North America and India, and an option for China, in exchange for an upfront cash payment of $30 million, potential milestone payments of up to $320 million, and one million shares of Spectrum common stock based upon the successful achievement of certain development, regulatory and commercial milestones, as well as double-digit royalties on net sales of Belinostat. Spectrum and TopoTarget will jointly fund development activities, whereby clinical trial costs will be 70% borne by Spectrum, and 30% by TopoTarget for new trials to be initiated.
Targacept, Inc. (NASDAQ: TRGT), a clinical-stage biopharmaceutical company developing novel NNR Therapeutics (TM), today announced that J. Donald deBethizy, Ph.D., President and Chief Executive Officer, is scheduled to present at the 12th Annual BIO CEO and Investor Conference at The Waldorf Astoria hotel in New York City on Tuesday, February 9, 2010 at 3:00 p.m. Eastern Standard Time.
Taro Pharmaceutical Industries Ltd. (Pink Sheets: TAROF) reported today that it has received approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Levetiracetam Tablets, 250 mg, 500 mg, 750 mg and 1000 mg (“levetiracetam tablets”).
Taro’s levetiracetam tablets is a prescription product used in the treatment of epilepsy, and is bioequivalent to UCB’s Keppra® Tablets. According to industry sources, levetiracetam tablets had U.S. sales of over $700 million in 2009.
Taro Pharmaceutical Industries Ltd. is a multinational, science-based pharmaceutical company, dedicated to meeting the needs of its customers through the discovery, development, manufacturing and marketing of the highest quality healthcare products.
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing Teva’s Biologics License Application (BLA) for XM02, a granulocyte colony-stimulating factor (G-CSF) for the reduction in the duration of severe neutropenia and the incidence of febrile neutropenia in patients treated with established myelosuppressive chemotherapy for cancer.
XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, today announced the pricing of an underwritten offering of 42 million units at a price to investors of $0.50 per unit for gross proceeds of approximately $21.0 million. After underwriting discounts and commissions and estimated offering expenses payable by the company (and assuming no exercise of the warrants), XOMA expects to receive net proceeds of approximately $19.3 million. The financing is expected to close on or about February 5, 2010, subject to satisfaction of customary closing conditions. Shares of XOMA were hammered on the news, closing down more than 34% to end the regular session at $.4250.
ZymoGenetics, Inc. (NASDAQ:ZGEN), today announced the publication of pooled safety and immunogenicity observations from eight clinical trials of RECOTHROM in the February issue of the Journal of the American College of Surgeons. The authors concluded that RECOTHROM is a well-tolerated topical hemostatic agent in numerous surgical settings and has a low rate of anti-product antibody formation. In the pooled data from all trials, less than one percent of treated patients developed product-specific antibodies. None of the antibodies neutralized native coagulation proteins.
“These pooled safety data are significant, as they provide a robust clinical trial data set for a topical hemostat,” said Fred Weaver, MD, FACS, a study author and Professor of Surgery at USC CardioVascular Thoracic Institute, USC University Hospital, Keck School of Medicine, University of Southern California, Los Angeles, CA. “The adverse events observed were consistent with those expected in the surgical populations studied, and immune response to RECOTHROM was consistently low, with no development of antibodies that neutralized native human thrombin.”
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