|Savient shares rocked. ARIAD drug meets mid-stage goal but shares drop after the bell. Omeros surges, Soligenix falls.|
|By BioMedReports.com Staff|
|Monday, 25 October 2010 18:40|
Shares of Savient Pharmaceuticals, Inc. (Nasdaq:SVNT) were rocked today after the company announced that its previously announced process to identify a strategic transaction for the sale of the Company did not result in a sale of the Company at this time. The board of directors will continue to evaluate strategic alternatives available to the Company to maximize value.
The Company is working toward the commercial launch of KRYSTEXXA, which it expects will be available by prescription in the U.S. later this year. KRYSTEXXA was approved by the FDA on September 14, 2010 for the treatment of chronic gout in adult patients refractory to conventional therapy.
Shares of Savient were halted mid-day Monday and, upon resumption of trading, opened more than 50% lower. Shares closed the day at $12.07, down $9.63, off more than 44% than Friday's close of $21.70.
ARIAD Pharmaceuticals, Inc. (NASDAQ:ARIA) today announced interim results of a randomized, open label, active-control multicenter Phase 2 study of oral ridaforolimus, an investigational mTOR inhibitor, in patients with metastatic or recurrent endometrial cancer. Based on this interim analysis, the study demonstrated a statistically significant improvement in the primary endpoint of median progression-free survival (PFS) in patients receiving single-agent ridaforolimus compared to patients receiving standard-of-care treatment. The data were presented Saturday in the Plenary Session of the 13th Biennial Meeting of the International Gynecologic Cancer Society being held in Prague, Czech Republic. Ridaforolimus is currently being developed by Merck in multiple cancer indications under an exclusive license and collaboration agreement with ARIAD.
"We are very encouraged by the data with oral ridaforolimus, which for the first time demonstrated improvement in PFS in patients with advanced endometrial cancer receiving a targeted therapy in a well-controlled clinical trial," stated Amit Oza, M.D., professor of medicine at the Princess Margaret Hospital, Toronto, Ontario, Canada. "These results support a previous non-randomized study of ridaforolimus in the same patient population."
Shares of Aria shot up as high as $4.49 before falling back and closing the day at $4.10, up 16 cents or 4% on the day. After the bell, shares dropped more than 7% after the company announced its intent to sell 16,000,000 shares of its common stock in an underwritten public offering.
Omeros Corporation (Nasdaq:OMER), a biopharmaceutical company committed to discovering, developing and commercializing products focused on inflammation and disorders of the central nervous system, today announced that it has received $20 million from Vulcan Capital (Vulcan) and a grant award for $5 million from Washington State's Life Sciences Discovery Fund (LSDF) to support the advancement of the Company's G protein-coupled receptor (GPCR) program. In return, Vulcan Capital and LSDF have a right to receive a percentage of net proceeds generated by the GPCR program. Net proceeds include profits from specified partnership arrangements and product sales, net of all research, development and associated commercialization expenses. Additionally, Omeros issued to Vulcan three five-year warrants to purchase common stock, each for 133,333 shares, with exercise prices of $20, $30 and $40 per share, respectively.
"We are impressed with Omeros' team and the technology that it has assembled for its GPCR platform. We believe Omeros' GPCR platform has the potential to accelerate new pipeline development across a broad range of highly attractive drug targets and can make a significant impact on the pharmaceutical industry," said Steve Hall, managing director of Vulcan Capital. "Omeros has already demonstrated the capability to identify compounds that interact with orphan GPCRs, providing the Company multiple opportunities to capitalize on its platform. Vulcan looks forward to participating in the program's continued success."
Shares of Omeros surged more than 12% or 92 cents to $8.22.
Alkermes, Inc. (NASDAQ:ALKS) today announced positive topline results from a phase 1 clinical study of an investigational combination of ALKS 33, one of Alkermes’ proprietary candidates, and buprenorphine, an existing medication for the treatment of opioid addiction, for the treatment of cocaine addiction. Data from the study showed that the combination therapy was generally well tolerated and sublingual administration of ALKS 33 effectively blocked the agonist effects of buprenorphine. Based on these positive results, Alkermes expects to initiate a phase 2a study of the combination therapy in the first half of calendar year 2011. The phase 2a study will be funded through a grant from the National Institute on Drug Abuse (NIDA). NIDA has granted Alkermes up to $2.4 million to accelerate the clinical development of the ALKS 33 and buprenorphine combination therapy. Currently, there are no medications approved for the treatment of cocaine addiction.
Antigenics, Inc. (Nasdaq:AGEN) today announced the expansion of a phase 2 clinical study of HSPPC-96, Antigenics' personalized therapeutic cancer vaccine, in patients with newly diagnosed glioma.
"Early results from this trial in the newly diagnosed setting are very encouraging, and we have seen no treatment-related toxicities," said Andrew T. Parsa, MD, PhD, associate professor in the Department of Neurological Surgery at the University of California, San Francisco and lead investigator in the trial now being expanded. "HSPPC-96 is part of an emerging frontier in personalized medicine for the treatment of cancer. Our data has shown that the vaccine triggers an immune response against the patient's cancer."
After the market close Monday, BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) announced that the Phase III LibiGel (testosterone gel) cardiovascular and breast cancer safety study will continue without modifications and will continue to enroll new subjects as a result of the fourth unblinded review of adverse events and the first unblinded statistical analysis for sample-size determination by its independent Data Monitoring Committee (DMC). The review and statistical analysis were based on 2,500 subjects who have been enrolled in the study. LibiGel is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women, for which there is currently no FDA approved product.
Soligenix, Inc. (OTC Bulletin Board:SNGX.ob), fell 15% today after the company reported preliminary results from its Phase 2 "proof-of-concept" exploratory clinical trial of orBec® for the prevention of acute Graft-versus-Host disease (GVHD) in patients undergoing myeloablative conditioning regimens with initiation of dosing prior to hematopoietic cell transplantation (HCT) and continuing through the post-transplantation period. The preliminary results indicate that orBec® appears safe and well tolerated in this patient population, but did not achieve statistical significance in the primary endpoint, which was the proportion of subjects who developed acute GVHD with severity sufficient to require systemic immunosuppressive treatment on or before day 90 after transplantation. However, an encouraging result was that use of orBec® resulted in fewer cases of more severe acute GVHD grades IIb-IV (21% vs. 33% of patients receiving placebo), although this difference was not statistically significant. This result has the potential to be clinically relevant because GVHD grades IIb-IV are associated with more severe disease involving the skin and liver as well as being associated with poorer outcomes, including mortality rates that approach 100% in the grade IV patient population. Further analysis of the complete dataset continues and is aimed at identifying other potential effects seen with orBec® in preventing acute GVHD.
Titan Pharmaceuticals, Inc. (OTC Bulletin Board:TTNP.ob) today reported that the company expects to receive a royalty payment of approximately $395,000 on third quarter 2010 net sales of Fanapt (iloperidone) of approximately $4.9 million. Prescriptions for Fanapt, an important indicator of market acceptance during product launch, showed a steady growth trend during the third quarter according to analyst reports which showed that total weekly prescriptions for Fanapt grew from approximately 1,200 prescriptions/week at the end of June to about 1,800 prescriptions/week by late September.
Adeona Pharmaceuticals, Inc., (Amex:AEN) announced today that its Chief Executive Officer, James S. Kuo, M.D., M.B.A., will provide the keynote address at the Emerging Biosciences Showcase during the 2010 MichBio Expo & Conference.