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The enormous advancement in the biological sciences that is taking place has begun to change the traditional way of practicing medicine. Far-reaching biological products are being approved and news about breakthroughs are occupying the headlines. However, selecting the biotechnology firms in... More
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  • DENDREON (DNDN): Lessons from History

    Are we lovers of redundancy? No. We are lovers of fairness and the lack of it cannot be visualized unless what goes on wrong gets caught and documented by history. Dendreon’s (DNDN) history, as written in the Prohost news on Prohost website, illustrates how unfair has been Wall Street evaluation to clinical-stage firms during the past decade and how tremendous  were the opportunities investors have let escape from hand by relying on misleading evaluations.  If you Search Dendreon on Prohost website and start to read the articles from bottom up, you will read:  

     

    March 14, 2006

     

    DENDREON (DNDN): The stock had a negative performance because analysts expected a fourth-quarter loss of 34 cents, which the firm exceeded by a couple of pennies! The share lost $1.36 when analysts expected $1.31 loss per share! The stock was sold because revenues were less than analysts’ expectations. (How wise is it to buy and sell development-stage biotechs that have no products on the market based on revenues?) Dendreon’s value, stock price and its whole future depends on its investigational drugs, especially Provenge. All the other factors mean nothing.   

     

    March 20, 2007

     

    We are at the end of the road with Dendreon’s (DNDN) prostate cancer product Provenge. Before the end of this month, the FDA advisory panel will discuss and debate the drug and vote on whether it recommends approval or not.

     

    We are at the end of the road with Dendreon’s (DNDN) prostate cancer product Provenge. Before the end of this month, the FDA advisory panel will discuss and debate the drug and vote on whether it recommends approval of Provenge. The firm’s actions taken in the past year make us believe that it is highly optimistic about the drug and expects  ….. 

     

    Regardless. The firm’s mood and of its shareholders will depend on the FDA Committee this month, but its fate, will lie in the hands of the FDA, which will issue its verdict on May 15. Nobody will be interested in knowing whether the $120 million in cash and investments the firm still has is sufficient to carry it through the year or through two years. An approval will turn this sum of money into extra-money. If Provenge will be approved, Dendreon will no more be called development stage that spends without revenues. The published results that we saw look promising. Yet, after March 28, the stock price will depend on the Committee’s decision and two months later, it will depend on the FDA's decision, which will be the maker, or the breaker of this great firm. We wish the best for the prostate cancer patients and for Dendreon and its shareholders.

    You have then to read Prohost Letter to learn how furious we were against the decision made against approving the drug, especially that the FDA appointed committee voted almost unanimously in favor of approval. In the Prohost issues, we openly pinpointed to the corruption of specialists whose actions were flagrantly misleading investors and affecting the FDA decision. Those people looked determined to bring the stock down at whatever cost. (The issues can be viewed by subscribers on the website) 

     

    March 25, 2009

     

    Here we go again.  ……  we begin to hear noises around the drug’s approvability. This time, it is not about whether the vaccine prolongs life or not, but about technicality!

    Now it is  Dendreon that has imperiled the its therapeutic vaccine study. How? By the firm issuing a press release last October, demonstrating that Provenge cuts patients' death rates by 20% compared to placebo. The release, the writer said, contained statistical details that made good results seem likely when final results are released in April.

     

    So, according to the negative article introduction, one can understand that even if the drug demonstrates prolonging lives of condemned patients, the FDA may choose to deprive other condemned patients from having the effective vaccine. Why? Because of technicality?!

     

    To make their point, the article presented four statisticians stating what can be summed up as follows: “Dendreon may have compromised the integrity of the trial by putting out the release”. We also read, “It was unorthodox for Dendreon to even know such a detailed result, much less to publicize it.” The statisticians have also stressed the reasons why the FDA should reject the vaccine. Please read what they said, “The company, patients or doctors might have changed what they were doing once they knew how the study was going. If the final outcome is only marginally statistically significant, it might be tossed, putting Dendreon and its drug back at square one.” Hello there. Are you paying attention to the reason why the FDA should reject the vaccine?

     

    You know what? We understand the meaning of malignant insinuations and the direct and indirect messages the insinuators send and why they do so. Such negative hinting has become part of our natural environment. However, we do not find it smart trying to insinuate that publishing the results of Dendreon's study, which deals with survival, would enable the firm and the physicians, let alone the patients, to change the outcome of the study at the last minute.

        As for the suggestion that the patients are among the conspirators, the only possibility for them to conspire is that the dead among them would pretend they are still living. And so forth.

     

    Are we witnessing the same happening now against development-stage biotech firms? Of course we are and we write about it all the time. Recently, articles disguised in scientific robes have been surfacing, confirming that no therapeutic vaccines will be approved in this decade, if at all. Recently, we have seen Gilead Sciences’ (GILD) cremated because it generated product sales, revenues and income more than ever before, and we witnessed development-stage biotech stocks being subjected to sell-offs because of missing analysts expectations by a couple of cents.

     

    Anyway. All we can say now is congratulate Dendreon and its shareholders. They struggled together for long and, now, they triumphed together. They deserve to celebrate. More important than all is that late-stage condemned prostate cancer patients received a great gift. 

     

    A new hope.

     

    Longer On Dendreon



    Disclosure: LONG DNDN
    Apr 30 10:32 AM | Link | Comment!
  • ADVENTRIX (ANX): A REVERSE SPLIT WITH SOME EXCITING NEWS.

    Despite the emergence of new biological treatments for cancer, Chemotherapy is still essential, and indispensable as a major treatment for malignancies. The adverse events caused by these chemicals were found to be acceptable as a risk versus the great reward of using chemotherapy.  The technological evolution that took place in the past decade and the surfacing of state-of-the-art technologies such as nanotechnology, scientists believed possibilities exist now for improving the adverse effect profiles of these therapeutic molecules. Reformulating the existing products has become an increasingly common product lifecycle-management technique. We read that a   2004 report on the U.S. drug market from BCC, Inc. projected that reformulations would grow from 62% of the market in 2003 to 79% in 2008. Finding ways to modify and improve existing products’ side effect profiles has become feasible after being essential but unreachable goal.       


    Among today’s news,
    ADVENTRIX (ANX) announced that, based on information received from the FDA, it decided to resubmit its New Drug Application (NDA) for ANX-530 (vinorelbine injectable emulsion), or Exelbine™, a novel emulsion formulation of the approved cancer chemotherapy drug vinorelbine for approval for the sake of improving its side effects of the marketed drug.  From the same press release we understood that the firm has met with the FDA and clarified certain matters regarding stability data necessary to file the Exelbine NDA and that the studies are ongoing and the emerging data will enable the firm to resubmit the NDA in the fourth quarter of this year. 

     

    Background: Adventrix had submitted an NDA for ANX-530 to the FDA in December 2009. The In March 1, 2010 it announced that it had received a refusal-to-file letter from the FDA regarding that submission. In the letter, the FDA indicated that the data included in the December 2009 NDA submission from the intended commercial manufacturing site was insufficient to support a commercially-viable expiration dating period. The FDA identified only this one chemistry, manufacturing and controls (CMC) reason for the refusal to file. No clinical or nonclinical issues were otherwise identified.

     

    The Drug: ANX-530 is a novel emulsion formulation of the chemotherapy drug vinorelbine. Navelbine®, a branded formulation of vinorelbine, which is approved in the U.S. to treat advanced non-small cell lung cancer as a single agent or in combination with cisplatin, and approved in the European Union, or EU, to treat non-small cell lung cancer and advanced or metastatic breast cancer. Adventrix’ formulation emulsifies vinorelbine into a homogeneous suspension of nanoparticles that protect the venous endothelium during administration into a peripheral vein, thereby reducing irritation associated with administration of the drug. ANX-530 is supposed to lower the risk of phlebitis, erythema and pain at the site of injection, which occur in one third of patients treated with Novelbine, or its generic version. 

     

     There is more hope now in FDA approval of Adventrix’ drug ANX-530. We wish that firms with technologies capable of improving existing drugs would apply their technologies more frequently in making them as safer as they are effective. Better even would be that those firms who have very promising investigational drugs, but have nasty side effects to try to resort to firms that can reformulate them into safer drugs.

     

    Adventrix’ stock is subjected to a 1-for-25 reverse stock split, which became effective on April 26, 2010.

    Read Elan In the Prohost Letter #301 that will be posted tomorrow, Wednesday April 28, 2010. 



    Disclosure: No Positions
    Apr 28 2:09 PM | Link | Comment!
  • ILLUMINA (ILMN): Today’s News Is What We Want To Hear.

    Those who follow on the advancement of biotechnology achievements wake up every day looking for specific news about breakthrough treatments for cancer and chronic devastating diseases, not for just a modest improvement of drugs, or me-too drugs that do little against the diseases and a lot in devastating the healthcare budget. The more we see breakthroughs, the more we get greedy, asking or at least hoping for more treatments that work at the root-cause of diseases, personalized medicine, where patients are protected from treatments that promise better disease management, but are themselves etiologies of new diseases, adding different pathologies and devastation than the diseases they are supposed to treat. 

     

    We don’t want today’s news coming from Illumina to be missed by those who are interested in the advancement of molecular biology, computer science and biotechnology in general. We want to bring this news to the patients who suffer the adverse events of their treatments in addition to the devastation of their diseases. We want to bring it to the researchers in pharmaceutical and biotechnology companies who dream about cutting the enormous expenses of clinical trials and shortening the time required to take their molecules from the preclinical laboratory to the market.

     

    In a press release Illumina (ILMN) announced the launch of its VeraCode ADME Core Panel designed to help researchers study genetic predispositions for differential drug response and adverse events. The Panel offers the most complete representation of the key biomarkers associated with drug absorption, distribution, metabolism and excretion (ADME) as standardized by pharmaceutical industry experts in the PharmADME Core List. Researchers using the product can analyze key ADME content in as little as one day, which never happened before.

     

    Dan Masys, M.D., chair of Bioinformatics at Vanderbilt University said, “We selected the ADME Core Panel for its multiplex coverage of the key biomarkers associated with drugs in our initial study, and for its efficiency in processing samples. We are looking for a set of variants that reliably predict an adverse effect from a medication, and have over 80,000 DNA samples with matched, de-identified medical records to support the study.” Dr. Masys is leading the Vanderbilt Electronic Systems for Pharmacogenetic Assessment study using the VeraCode ADME Core Panel to generate an extensive pharmacogenetic database. This database will be widely used to link genotypes to drug response phenotypes extracted from electronic health record data.

     

    What does the VeraCode ADME Core Panel offers? According to the firm’s press release, it offers the following:

     

    The VeraCode ADME Core Panel contains 184 biomarkers in 34 genes, with the highest coverage of the PharmADME Core List. This list, produced by the PharmADME Working Group of industry and academic experts, provides comprehensive coverage of the most biologically relevant biomarkers spanning complex regions of the genome.

     

    Rapid and precise genotyping assay: Using a highly specific and streamlined chemistry, DNA can be genotyped within 8 hours with less than 2.5 hours of hands-on time, enabling researchers to complete studies faster than ever before.

     

    Data precision with an excellent call rate. The supporting software for VeraScan offers a convenient user interface that manages user authentication, logs system activity, and automatically translates genotype data into the star nomenclature used by researchers to analyze pharmacogenetic data.

     

    “Understanding genetic variability associated with drug response and disposition is a key step toward the realization of personalized medicine, and the VeraCode ADME Core Panel will help enable this exciting transformation,” said Jay Flatley, president and CEO of Illumina. “With the cost of bringing a new medicine to market now exceeding $1 billion and over $220 billion spent annually on medications in the U.S., it is critical that we look for savings in all stages of drug development. With its emphasis on rapid operation and high-quality data, the VeraCode ADME Core Panel can help bring safe and effective therapies to patients as quickly as possible.“

     

    That is what we precisely expect from the biogenetic revolution. Far-reaching, but safe drugs, personalized medicine, using computers, instead of torturing animals and bringing down the healthcare cost. You know what? If we don’t bring down the cost of developing new drugs, we will end up not able to use them at the time they reach the market, let alone developing them.   

     

    Thank you ILLUMINA. 

     

    For more information visit www.illumina.com/VeraCodeADME.



    Disclosure: No Positions
    Apr 08 9:24 AM | Link | Comment!
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