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I hold degrees in Biochemistry and Business from NC State University in the heart of RTP, NC. My work experience has been in Microbiology and Pharmacy. I have experience with FDA decisions and Clinical Trials. I seek bargains and low prices, and follow Warren Buffett's principles. At the same... More
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  • Inhibitex Reaching Momentum

    Today we will examine Inhibitex.  Here is Inhibitex's website and Yahoo Finance's Profile:  INHX.

    Inhibitex has 2 upcoming catalysts and is recommended by Zacks Research.  Extensive Recommendations by Zacks can be found in the two articles below.  Find out more Research Tools from Zacks at their website Zacks.com.


     

    Inhibitex Pipeline Moves Forward

    Buy Inhibitex Ahead of Big Catalysts

    A Call for a Stock Double (NASDAQ:INHX)

    November 9, 2010

    Inhibitex Inc.  (NASDAQ: INHX) may be slightly lower after earnings, but an analyst note is endorsing the long-term merits of the company. Zacks Research’s Jason Napodano, CFA, announced that Zacks is recommending the purchase of Inhibitex (INHX) ahead of two major catalysts which are coming down the pipe in the next few months ahead.

    The research notes

    In December 2010, management plans to release top-line data from the ongoing phase II program with FV-100. The trial is designed to show FV-100 superiority to Glaxo’s Valtrex (valacyclovir) in the treatment of herpes zoster (shingles). FV-100, has the potential to be a game changer for the treatment of shingles. The current standard of care, valacyclovir, with an estimated 60% market share, is dosed at 1000mg three times a day. Valtrex has improved lesion healing and pain indication reduction over older drugs Famvir (famciclovir) and Zovirax (acyclovir), but the treatment option can still be improved upon significantly. Inhibitex is developing FV-100, a potential once daily dosing agent, to improve pain scores and speed up lesion healing. Other key endpoints to the trial include reducing incidence of post herpetic neuralgia (PHN) and use of concomitant pain medications. If successful, we believe that Inhibitex’ drug has $500+ million peak sales worldwide. However, even with efficacy only on par with Valtrex, we still believe that FV-100 has commercial potential given the reduction in dosing (improved compliance – especially in the elderly population) from three times daily to once daily. We are optimistic on the data coming next month.

    The second major catalyst for Inhibitex is the release of a phase Ib on INX-189, the company’s phosphoramidate nucleoside analogues, also referred to as pronucleotides or protides, which are prodrugs of nucleosides that target the RNA-dependent RNA polymerase (“NS5b”) of HCV. Preclinical and phase I data suggest INX-189 has favorable pharmacokinetics with high potency anti-viral activity. In November 2010, management initiated a multiple ascending dose clinical trial to assess the ability of once-daily INX-189 to reduce hepatitis-C RNA viral loads in treatment naïve patients with chronic genotype-1 HCV, as well as safety, tolerability, and pharmacokinetics, after seven days of treatment. Inhibitex is studying INX-189 both as a monotherapy and in combination with HCV standard-of-care, ribavirin. Preclinical data suggest significant synergy with ribavirin, making INX-189 an intriguing molecule from a partnering standpoint. Data from this phase Ib program should be available early next year.

    Management should be in position to advance INX-189 in a phase II, 12+ week clinical trial in combination with standard of care and other complementary direct antiviral compounds by the middle of 2011. We expect that management will partner the candidate for the phase II program in 2011 assuming safety and proof-of-concept have been effectively demonstrated. We remind investors that in March 2009, Vertex Pharmaceuticals paid nearly $400 million to acquire privately-held ViroChem and its HCV non-nucleoside N25b polymerase inhibitor, VCH-222. Inhibitex’ nucleosides N25b polymerase inhibitor looks to offer similar potency with potentially less resistance and improved dosing then VCH-222.

    With these two major catalysts on the near-term horizon and the potential to sign two lucrative collaborations in 2011, we recommend investors buy shares of Inhibitex today. Our target is $4 per share. the summary and links can be found here at Zacks.

    Our own observation here about the Zacks report is that it is a very optimistic call because of the implied upside. If you compare the $4 target, that is more than 100% higher than today’s price of $1.94. It is also above the 52-week trading range of $0.67 to $2.95.

    Inhibitex has a mere $120 million market cap and its cash and cash equivalents were listed as $24.2 million as of September 30, 2010.


     

    Tags: INHX, Inhibitex
    Jan 27 4:11 PM | Link | Comment!
  • Aastrom Biosciences for CLI

    Good and Bad news for Aastrom Biosciences today.  Shares dropped heavily after Reuters reports that Aastrom's potential stem cell therapy did not meet a secondary endpoint for it's Phase II clinical trial for the treatment of Critical Limb Ischemia which can cause amputation in those who suffer from the disease.  I have seen this a few times lately, where a stock receives generally positive news, only to come crumbling down.  Aastrom simply rose too fast, too soon.

    Aastrom Ischemia Therapy Data Disappoint; Shares Tank

    *  Says study meets main safety and efficacy goal

    *  Did not show significant amputation free survival

    *  Shares fall 36 pct

    Nov 18 (Reuters) - Aastrom Biosciences Inc (ASTM.O) reported its experimental ischemia treatment met its main goals, but the company's shares, which had soared in anticipation of the data, crashed as the secondary goal of the trial was not met.

    The study met the primary goals of safety and efficacy in patients with critical limb ischemia (NYSE:CLI), a cardiovascular condition that often leads to amputation of the limbs.

    CLI is a painful condition caused by obstructions in the arteries that decreases blood flow to the limbs with no medical therapy available at present.

    Interim data from the second mid-stage trial failed to show statistically significant amputation-free survival in patients, although data published in June from an earlier mid-stage study had shown promising results. [ID:nSGE65A0F9]

    McNicoll, Lewis &; Vlak analyst George Zavoico said the discrepancies with the earlier data was due to the size and scope of the trial.

    "Its too small a trial, its underpowered and I think people are forgetting that. You have tremendous variations with fewer patients," he said.

    The analyst said data on the time to treatment failure events, which include amputation, deepening of wounds and gangrene, was encouraging.

    "The phase 2 trial did exactly what it was supposed to do, that is inform on the phase 3 trial plan," analyst Zavoico said.

    Last month, the company submitted a special protocol assessment (NYSE:SPA) to U.S. health regulators for a late-stage trial on the drug and said it plans to initiate the study in early 2011

    The stem cell research company's tissue repair cell technology (NYSE:TRC) delivers the patient's own bone marrow directly to the damaged tissues.

    A special protocol assessment provides the company with a written agreement that the design and analysis of the trial are adequate to support a marketing application submission.

    The company's shares, which have more than doubled in value the last one month, closed down 36 percent at $2.71 Thursday on Nasdaq.  They had touched a 52-week high of $4.45 prior to the announcement.

     (Reporting by Krishnakali Sengupta in Bangalore;Editing by Prem Udayabhanu) (krishnakali.sengupta@thomsonreuters.com; within U.S. +1 646 223 8780; outside U.S. +91 80 4135 5800

    Reuters Messaging: krishnakali.sengupta.reuters.com@reuters.net))

    More From Reuters

    Stocks   Global Markets    Healthcare

    Investors buy ASTM on rumor, sell on news that study met main safety and efficacy goal

    Shares were halted this afternoon for Aastrom Biosciences, Inc. (Nasdaq:ASTM), the regenerative medicine company engaged in the development of autologous cell products for treatment of severe, chronic cardiovascular diseases as the company announced that an interim analysis of all 86 patients enrolled in the company's Phase 2b RESTORE-CLI clinical trial shows that the study achieved both its primary safety endpoint and primary efficacy endpoint of time to first occurrence of treatment failure.

    The findings were statistically significant (p=0.0132) and close analyses showed a clinically meaningful reduction of 56% in treatment failure events. The RESTORE-CLI trial is the largest fully controlled cell-therapy study ever conducted in critical limb ischemia (CLI)- a severe blockage in the arteries of the lower extremities, which markedly reduces blood-flow. It is a serious form of peripheral arterial disease. The most prominent features of critical limb ischemia are severe pain in the legs and feet while a person is not moving, or non-healing sores on the feet or legs. ASTM is the first company to make it this far in clinical trials with such positive results.

    Shares had climbed significantly in advance of today's news presentation but most investors chose to take profits off the table upon release of the data when Reuters reported that the study failed to meet a key secondary goal- something which the study was not designed to demonstrate. That data showed a clinically meaningful reduction in event rates (amputation) of 24% but did not show statistical significance. Phase III will be designed to focus on that secondary data, but at least momentarily the article panicked investors and sent shares tumbling. Others swooped in for the suddenly discounted shares and took them back from $2.86 to the $3.85 range. Moments later, shares continued a slow decline as investors began to digest the news and try to decide how to best intrepret the study data over the next few days.

    Aastrom Biosciences has become is a strong stem cell play, but fear of dillution has also impacted shares after a mid-November registration with the U.S. Securities and Exchange Commission to sell, from time to time, up to $75 million of Common Stock, Preferred Stock, Debt Securities, Warrants, Units, or any combination thereof. It appears that the fear that the company could sell shares on the good news played a role in the mass exodus.

    The company has made great strides in their pipeline and over the next few months are scheduled to share more information with the investment community about their break-through treatment candidates. According to the their latest shareholder presentation, in December they are expecting to announce the complete enrollment in Phase II for their DCM (Dilated Cardiomyopathy catheter trial along with:

    Phase 2 Surgical-DCM 6-month results in January,

    SPA negotiations for Phase 3 in CLI with FDA between now and early 2011

    Phase 2b CLI 12-month results in Q2

    Phase 2 Surgical-DCM 12 month results in Q2/Q3

    The value of Aastrom’s pipeline will be more clear going forward, as these results and other news start to trickle in. Success in CLI has set ASTM apart from other stem cell companies as other pharmaceutical and biotechnology firms have recently abandoned programs aiming to treat CLI.

    In February 2010, Aastrom had reported results from an interim analysis of data from this trial that showed a statistically significant clinical benefit favoring Aastrom's autologous cellular therapy for the first 46 patients enrolled in the trial, in both time to first occurrence of treatment failure (a composite endpoint consisting of major amputation of treated leg, all-cause mortality, doubling of total wound surface area from baseline and de novo gangrene; p=0.005) and amputation-free survival (p=0.038).

    Results of the second interim analysis were presented today in a non-CME satellite session of the VEITHsymposium(NYSE:TM) in New York City by principal investigator Richard Powell, M.D., chief of vascular surgery at Dartmouth-Hitchcock Medical Center in Lebanon, NH. An archived webcast of the presentation will be available at aastrom.com/investor.cfm.

    "I am very optimistic about the treatment response rates we have seen in patients in this trial so far. These interim data suggest that there is a clear and clinically meaningful therapeutic effect at work in treated patients. I look forward to examining the benefits of this treatment in the context of a larger Phase 3 study," said Dr. Powell.

    The two interim analyses were done to provide information to support the design and execution of Aastrom's Phase 3 CLI program. In October, Aastrom announced plans to initiate a Phase 3 CLI clinical development program under special protocol assessments (SPA) with a Fast Track designation by the FDA.

    "We believe these interim results provide further evidence supporting the use of our autologous cell therapy to treat patients with this devastating disease," said Tim Mayleben, president and CEO of Aastrom Biosciences. "As expected, these data provide essential guidance as we refine and finalize the sample sizes and patient selection criteria for our Phase 3 program."

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    Jan 27 4:07 PM | Link | Comment!
  • Spectrum Pharmaceuticals in 2011

    Spectrum Pharmaceuticals Submits Supplemental New Drug Application (sNDA) For Ready-to-Use Formulation Of FUSILEV(NYSE:R) In Colorectal Cancer

    Main Category: Colorectal Cancer

    Also Included In: Cancer / Oncology

    Article Date: 06 Jan 2011 - 1:00 PST

    Spectrum Pharmaceuticals (Nasdaq: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, announced it submitted a supplemental New Drug Application with the U.S. Food and Drug Administration (FDA) for a Ready-to-Use formulation of FUSILEV (levoleucovorin) for Injection. This submission is in support of FUSILEV's use in colorectal cancer, which is currently under review by the FDA with a Prescription Drug User Fee Act (PDUFA) action date of April 29 2011. FDA has up to 60 days to formally accept the submission.
     

    "If approved, we believe a RTU formulation of FUSILEV, as the name implies, will be more convenient for the staff and easy to use. RTU formulation requires no reconstitution, and since it will also be of a higher strength than the currently available lyophilized formulation, the healthcare provider's time to administer FUSILEV to colorectal cancer patients will be considerably reduced," said Rajesh C. Shrotriya, MD, Chairman of the Board of Directors, Chief Executive Officer, and President of Spectrum Pharmaceuticals.  

    FUSILEV is currently FDA approved and marketed by Spectrum for rescue after high-dose methotrexate therapy in osteosarcoma. FUSILEV is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination, and of inadvertent overdosage of folic acid antagonists

    About FUSILEV® (levoleucovorin) for Injection

    FUSILEV, a novel folate analog, is available in vials as freeze-dried powder. FUSILEV rescue is indicated after high-dose methotrexate therapy in osteosarcoma. FUSILEV is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists. FUSILEV has been marketed outside the United States by Wyeth, Sanofi-Aventis, Takeda, and others for more than 10 years.


     

    Spectrum Pharmaceuticals:  Website  http://www.spectrumpharm.com/

    Product Pipeline for Spectrum Pharmaceuticals

    View drug information on Fusilev.

    UPDATE: Spectrum Pharmaceuticals In Deal With Viropro For Cancer Drug

    DOW JONES NEWSWIRES

    Spectrum Pharmaceuticals Inc. (SPPI) signed a deal with Viropro Inc. (VPRO) to develop a biosimilar version of Swiss pharmaceutical giant Roche Holding AG's (RHHBY, ROG.VX) cancer drug rituximab ahead of its U.S. patent expiration in 2015.

    The agreement comes as many patent expirations loom over large pharmaceutical companies. Rituximab, used in the treatment of many lymphomas, leukemias, transplant rejection and some autoimmune disorders, saw worldwide sales of about $5.6 billion in 2009.

    Financial terms weren't disclosed.

    Viropro, a biotech drug maker, said Spectrum will license the rights to certain technology and it should get milestone payments over 36 months and royalty payments from ensuing sales.

    Biosimilar drugs are officially approved versions of biopharmaceutical products made by a different company as patent and exclusivity expire on the product.

    Biotech company Spectrum, which has a focus on cancer treatment, has been focused on making another push to improve the weak sales of its leading drug Zevalin. In its most recent quarterly results, Spectrum swung to a loss as it spent more to market Zevalin and another drug, Fusilev, which treats a vitamin deficiency in patients who have been treated with chemotherapy for colorectal cancer.

    Meanwhile, Roche, the world's biggest maker of cancer drugs, is facing pressure following the U.S. Food and Drug Administration December decision to revoke approval of blockbuster drug Avastin for the treatment of breast cancer. The company has said it will appeal.

    Spectrum shares were up 4 cents at $6.92. The stock is up 49% over 12 months.

    Spectrum Pharma (NASDAQ: SPPI) Posts Large Volume Increase, Hits $6.34

     

    January 7th, 2011

    Shares of Spectrum Pharma (NASDAQ: SPPI) saw unusually high trading volume on Friday. Approximately 1.492 million shares changed hands during mid-day trading. During the most recent quarter, the stock had an average daily volume of 540,149 shares. The stock last traded at $6.34.

    On a related note, analysts at Zacks Investment Research reiterated a “neutral” rating on shares of Spectrum Pharma in a research note to investors on Wednesday, December 29th. Separately, analysts at Morgan Joseph raised their price target on shares of Spectrum Pharma from $8.00 to $10.00 in a research note to investors on Wednesday, December 8th. They now have a “buy” rating on the stock.

    Spectrum Pharmaceuticals, Inc. ( Spectrum) is a commercial stage biopharmaceutical company, engaged in developing and commercializing therapies with a focus primarily in the areas of hematology-oncology and urology. The Company has a fully developed commercial infrastructure that markets and sells two drugs in the United States, Zevalin and Fusilev. The Company has several drug candidates in development, which include apaziquone (EOquin), which is being studied in two large Phase III clinical trials for non-muscle invasive bladder cancer (NMIBC) under a strategic collaboration with Allergan; and belinostat, a drug partnered with TopoTarget A/S to jointly develop. Belinostat is being studied in multiple indications, including a Phase II registrational trial for relapsed or refractory Peripheral T-Cell Lymphoma (PTCL).

    Spectrum Pharma (NASDAQ: SPPI) traded down 6.45% during mid-day trading on Friday. The stock has a 52 week low of $3.67 and a 52 week high of $7.19. Its 50-day moving average is $5.70 and its 200-day moving average is $4.51. The company has a market cap of $322.1 million and a price-to-earnings ratio of N/A.

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    Jan 27 4:01 PM | Link | Comment!
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