Prohost Biotech's Instablog 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 which to invest requires not only an understanding of the company's finances, but also a knowledge of the company's potential and the potential and scientific validity of it's products and technologies.Our MissionProhost evaluates biotechnology companies, their products and technologies, their scientists and managers, as well as their finances. Our goal is to impart our readers with the knowledge and insight so that they may have a heightened understanding and appreciation for the biotechnology industry. We hope this newfound insight can help our readers identify the newest blockbuster technologies and discover the next industry leaders.Company ProfileProhost is the premier biotechnology newsletter. In printed form, The Prohost Biotechnology Newsletter has been in circulation since 1992. Our readers are comprised of fund managers, investors, medical professionals and all kinds of individuals with one common interest, biotechnology.Prohost publishes a monthly Newsletter. The Newsletter is posted on the web in the Members' Area.Prohost is ranked Prohost Biotech http://seekingalpha.com/author/prohost-biotech/instablog DENDREON (DNDN): Lessons from History http://seekingalpha.com/instablog/429422-prohost-biotech/66085-dendreon-dndn-lessons-from-history?source=feed 66085 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]]> Fri, 30 Apr 2010 10:32:15 -0400 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]]> dndn Dendreon Biotech Stocks Biotechnology ADVENTRIX (ANX): A REVERSE SPLIT WITH SOME EXCITING NEWS. http://seekingalpha.com/instablog/429422-prohost-biotech/65719-adventrix-anx-a-reverse-split-with-some-exciting-news?source=feed 65719 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]]> Wed, 28 Apr 2010 14:09:59 -0400 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]]> mstx Biotech Stocks Biotechnology Stocks Adventrix ILLUMINA (ILMN): Today’s News Is What We Want To Hear. http://seekingalpha.com/instablog/429422-prohost-biotech/62383-illumina-ilmn-todays-news-is-what-we-want-to-hear?source=feed 62383 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]]> Thu, 08 Apr 2010 09:24:17 -0400 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]]> ilmn ILLUMINA Biotechnology Bitoech Will LPATH (LPTN.OB) Reap the Fruits Of Its Acknowledged Efforts http://seekingalpha.com/instablog/429422-prohost-biotech/61402-will-lpath-lptn-ob-reap-the-fruits-of-its-acknowledged-efforts?source=feed 61402
     What brought this firm in mind were two press releases posted by the firm on Tuesday March 30.  In the first, Lpath announced positive results of phase 1 clinical trial of its drug ASONEP™ in a wide variety of solid tumors. In the second it demonstrated and explained its dissatisfaction with, and rejection of the decision by its exclusive worldwide licensee of ASONEP™, Merck KGaA (Germany), to extend its license agreement. The news about phase 1 trial Asonep™ informed that the trial has met its primary endpoint of identifying safe dose. The monoclonal antibody drug was well tolerated at all the dose-levels from 1 mg/kg to 24 mg/kg. These results erased doubts about safety evaluating Asonep as a single agent or overlapping toxicity when used in combination with standard therapies. With regard to the drug’s efficacy, the results demonstrate that more than half the patients who completed the initial four-treatment evaluation period showed stable disease, which has been durable in several cases. Important also was the finding that the lymphocyte counts in the vascular space were reduced in a drug dose-related fashion. These results have achieved an objective established by the licensee Merck KGaA (Darmstadt, Germany), which led to a $2 million payment.

      Lpath views these results as validating its drug Asonep™, its bioactive signaling lipid target and its ImmuneY2™ drug-discovery engine.  Lpath viewed them as adding a huge increase in the drug value, which led to reject Merck KGaA’s proposal to continue its partnership in Asonep™ program with the same financial terms, which is now viewed as not in its best interest or the best interest of its shareholders. As a result, Merck KGaA notified Lpath that it will terminate the License Agreement effective April 24, 2010 and return the rights to the cancer drug Asopnep’s program to Elpath. What’s next? First, Lpath promised its shareholders to aggressively seek to re-partner Asopnep™, but with a much favorable deal. Its compelling argument include: First, the strong efficacy signals from Asonep’s preclinical studies in animal models, which involved renal cell carcinoma, prostate cancer, neuroblastoma, ovarian cancer and lung cancer. Second, the successful completion of phase 1 clinical trial that was announced on Tuesday, which offered evidence of biological and therapeutic activity of the drug on human cancer patients.

Some Background About the Drug Target

     To begin with, besides Lpath’s drug, Asonep, no therapeutics exist that that target bioactive signaling lipids for treating human diseases. Validating the firm’s program is the current scientists’ acknowledgement of the fact that changes in lipid metabolism can cause cancers, heart disease, vascular diseases, diabetes, neurodegenerative disorders, immune diseases, pain, mental disorders, eye disorders, and inflammatory diseases. They insinuated that bioactive lipid signaling molecules would make good therapeutic targets.
     It was easy to say it, but not really easy to identify these targets, analyze them and develop drugs that target them. These lipids are minute in size and are not water-soluble, making them extremely hard to understand. Also, the tools usually used to analyze proteins do not work for lipids.
     Using the processes it developed over a substantial amount of time, and its proprietary ImmuneY2™ drug-discovery engine technology, Lpath was capable of breaking the barriers, identifying valid targets for therapeutics: Sphingosine-1-phosphate (S1P) and another one, lysophosphatidic acid (LPA), and develop drugs to target them.    

Sphingosine-1-phosphate (S1P) - a bioactive lipid (a key component of the sphingolipid signaling cascade) acts on a complement of five G-protein Coupled Receptors (GPCRs) to promote cell proliferation, migration, and protection from cell death (apoptosis) – all are characteristics of cancer. S1P has many actions, possibly causing many diseases, including inflammation, pathogenic fibrosis, and cancer. S1P is, in fact, a pleiotropic tumorigenic growth factor that promotes tumor growth by stimulating cell proliferation and metastasis. Recent studies indicate that S1P promotes tumor angiogenesis. Importantly, sphingosine kinase (SPHK), the enzyme responsible for S1P production, is an oncogenic protein, further suggesting that S1P is a potential therapeutic target for cancer.

Lpath Pipeline

Asonep™:     (Systemic formulation of humanized Sphingomab™)

Target:     Sphingosine 1 Phosphate (S1P)
Indications:     Cancer, Inflammation
Development:     Phase 1 Partnered with Merck-Serono

isonep™:     (Ocular formulation of humanized Sphingomab™)

Target:     Sphingosine 1 Phosphate (S1P)
Indications:     AMD, Diabetic Retinopathy, Glaucoma, Others
Development:     Phase 1

Lpathomab       

Target:     Lysophosphatidic Acid (LPA)
Indications:     Cancer, Fibrosis, Neuropathic Pain
Development;  Late Preclinical

Nextomabs:     

Target:     (Other bioactive lipid targets)
Indications:     Inflammation, Cancer, Asthma, Sepsis, Others
Development:     In discovery

Sphingomab™: This Lpath’s monoclonal anti-S1P antibody functions as a therapeutic molecular sponge to selectively absorb S1P, thus lowering the effective extracellular concentrations of this tumor-facilitating factor. The drug is expected1 to reduce tumor volume and metastatic potential as well as cause blockage of new blood vessel formation that feed cancers. Lpath also hypothesize that the drug would reverse the ability of S1P to protect cells from apoptosis.
     Lpath has developed murine and humanized monoclonal antibodies to S1P. The MAb is highly specific to S1P. It does not cross react with other structurally similar bioactive lipid mediators. Utilizing BIAcore technology, the affinity (Kd) of Sphingomab™ for S1P has proven to be much higher than most therapeutic antibodies, particularly other molecular sponges.

1. The expectations are based on animal results where data have demonstrated compelling efficacy results. The drug has significantly reduced tumor volumes and weights in human models of lung cancer in mice, including ovarian, breast, lymphoma, myeloma, lung and melanoma cancers. It significantly reduced new blood vessel formation in mice cancer and significantly reduced circulating levels of the pro-angiogenic growth factors, VEGF, IL8, and IL6 in tumor mice. In cell culture, the ability of cancer cells to release these growth factors is reduced by Sphingomab™.  
 
 There is a lot of science, a lot of experimentations and a lot of hypothesis and good results. There are many promising results and promises by the company. There is a lot of effort spent, a lot of pain and a lot of patience. The concept is a breakthrough, as the targets are lipid instead of
proteins like usual. The drugs are the outcome of the efforts and capability of solving the problem of understanding the lipid targets, which is a hard task. Lpath is one of the few, it not rare, penny stocks that are so serious, so scientific and so promising. We wish its efforts would become fruitful.  The odds for a successful outcome are mounting.   


Disclosure: No Positions]]> Wed, 31 Mar 2010 11:35:36 -0400
     What brought this firm in mind were two press releases posted by the firm on Tuesday March 30.  In the first, Lpath announced positive results of phase 1 clinical trial of its drug ASONEP™ in a wide variety of solid tumors. In the second it demonstrated and explained its dissatisfaction with, and rejection of the decision by its exclusive worldwide licensee of ASONEP™, Merck KGaA (Germany), to extend its license agreement. The news about phase 1 trial Asonep™ informed that the trial has met its primary endpoint of identifying safe dose. The monoclonal antibody drug was well tolerated at all the dose-levels from 1 mg/kg to 24 mg/kg. These results erased doubts about safety evaluating Asonep as a single agent or overlapping toxicity when used in combination with standard therapies. With regard to the drug’s efficacy, the results demonstrate that more than half the patients who completed the initial four-treatment evaluation period showed stable disease, which has been durable in several cases. Important also was the finding that the lymphocyte counts in the vascular space were reduced in a drug dose-related fashion. These results have achieved an objective established by the licensee Merck KGaA (Darmstadt, Germany), which led to a $2 million payment.

      Lpath views these results as validating its drug Asonep™, its bioactive signaling lipid target and its ImmuneY2™ drug-discovery engine.  Lpath viewed them as adding a huge increase in the drug value, which led to reject Merck KGaA’s proposal to continue its partnership in Asonep™ program with the same financial terms, which is now viewed as not in its best interest or the best interest of its shareholders. As a result, Merck KGaA notified Lpath that it will terminate the License Agreement effective April 24, 2010 and return the rights to the cancer drug Asopnep’s program to Elpath. What’s next? First, Lpath promised its shareholders to aggressively seek to re-partner Asopnep™, but with a much favorable deal. Its compelling argument include: First, the strong efficacy signals from Asonep’s preclinical studies in animal models, which involved renal cell carcinoma, prostate cancer, neuroblastoma, ovarian cancer and lung cancer. Second, the successful completion of phase 1 clinical trial that was announced on Tuesday, which offered evidence of biological and therapeutic activity of the drug on human cancer patients.

Some Background About the Drug Target

     To begin with, besides Lpath’s drug, Asonep, no therapeutics exist that that target bioactive signaling lipids for treating human diseases. Validating the firm’s program is the current scientists’ acknowledgement of the fact that changes in lipid metabolism can cause cancers, heart disease, vascular diseases, diabetes, neurodegenerative disorders, immune diseases, pain, mental disorders, eye disorders, and inflammatory diseases. They insinuated that bioactive lipid signaling molecules would make good therapeutic targets.
     It was easy to say it, but not really easy to identify these targets, analyze them and develop drugs that target them. These lipids are minute in size and are not water-soluble, making them extremely hard to understand. Also, the tools usually used to analyze proteins do not work for lipids.
     Using the processes it developed over a substantial amount of time, and its proprietary ImmuneY2™ drug-discovery engine technology, Lpath was capable of breaking the barriers, identifying valid targets for therapeutics: Sphingosine-1-phosphate (S1P) and another one, lysophosphatidic acid (LPA), and develop drugs to target them.    

Sphingosine-1-phosphate (S1P) - a bioactive lipid (a key component of the sphingolipid signaling cascade) acts on a complement of five G-protein Coupled Receptors (GPCRs) to promote cell proliferation, migration, and protection from cell death (apoptosis) – all are characteristics of cancer. S1P has many actions, possibly causing many diseases, including inflammation, pathogenic fibrosis, and cancer. S1P is, in fact, a pleiotropic tumorigenic growth factor that promotes tumor growth by stimulating cell proliferation and metastasis. Recent studies indicate that S1P promotes tumor angiogenesis. Importantly, sphingosine kinase (SPHK), the enzyme responsible for S1P production, is an oncogenic protein, further suggesting that S1P is a potential therapeutic target for cancer.

Lpath Pipeline

Asonep™:     (Systemic formulation of humanized Sphingomab™)

Target:     Sphingosine 1 Phosphate (S1P)
Indications:     Cancer, Inflammation
Development:     Phase 1 Partnered with Merck-Serono

isonep™:     (Ocular formulation of humanized Sphingomab™)

Target:     Sphingosine 1 Phosphate (S1P)
Indications:     AMD, Diabetic Retinopathy, Glaucoma, Others
Development:     Phase 1

Lpathomab       

Target:     Lysophosphatidic Acid (LPA)
Indications:     Cancer, Fibrosis, Neuropathic Pain
Development;  Late Preclinical

Nextomabs:     

Target:     (Other bioactive lipid targets)
Indications:     Inflammation, Cancer, Asthma, Sepsis, Others
Development:     In discovery

Sphingomab™: This Lpath’s monoclonal anti-S1P antibody functions as a therapeutic molecular sponge to selectively absorb S1P, thus lowering the effective extracellular concentrations of this tumor-facilitating factor. The drug is expected1 to reduce tumor volume and metastatic potential as well as cause blockage of new blood vessel formation that feed cancers. Lpath also hypothesize that the drug would reverse the ability of S1P to protect cells from apoptosis.
     Lpath has developed murine and humanized monoclonal antibodies to S1P. The MAb is highly specific to S1P. It does not cross react with other structurally similar bioactive lipid mediators. Utilizing BIAcore technology, the affinity (Kd) of Sphingomab™ for S1P has proven to be much higher than most therapeutic antibodies, particularly other molecular sponges.

1. The expectations are based on animal results where data have demonstrated compelling efficacy results. The drug has significantly reduced tumor volumes and weights in human models of lung cancer in mice, including ovarian, breast, lymphoma, myeloma, lung and melanoma cancers. It significantly reduced new blood vessel formation in mice cancer and significantly reduced circulating levels of the pro-angiogenic growth factors, VEGF, IL8, and IL6 in tumor mice. In cell culture, the ability of cancer cells to release these growth factors is reduced by Sphingomab™.  
 
 There is a lot of science, a lot of experimentations and a lot of hypothesis and good results. There are many promising results and promises by the company. There is a lot of effort spent, a lot of pain and a lot of patience. The concept is a breakthrough, as the targets are lipid instead of
proteins like usual. The drugs are the outcome of the efforts and capability of solving the problem of understanding the lipid targets, which is a hard task. Lpath is one of the few, it not rare, penny stocks that are so serious, so scientific and so promising. We wish its efforts would become fruitful.  The odds for a successful outcome are mounting.   


Disclosure: No Positions]]> lptn Biotechnology Stocks Biotech LPath ASONEP ON SEQUENOM (SQNM) http://seekingalpha.com/instablog/429422-prohost-biotech/56867-on-sequenom-sqnm?source=feed 56867
Hello future.
 
It did not take us long to welcome the arrival of what many have expected from Sequenom and many have doubted. The expected has, indeed, begun to show, and the doubt that should disappear will stay as long as the skeptics of Wall street are ideologists whose ideology is cynicism. Nevertheless Sequenom has, indeed, launched its first laboratory test, SensiGene™ Cystic Fibrosis (CF) Carrier Screening test. We went on to describe the carrier screening tests and stress the fact that healthy individuals with no family history of a genetic diseases and have healthy children, may still be carriers of a genetic disorder like cystic fibrosis. 

The article proceeded into stating that the launch of this test marks the first test launched by its own lab, the Sequenom Center for Molecular Medicine. Read the article in Seeking Alpha  and the Prohost website.

On October 8, 2009, Under the title: Who Sold Sequenom On Thursday August 6 and Why? Prohost wrote:

Sequenom’s (SQNM) recent stock decline looked as if a program was set for selling SQNM as soon as the financial results were announced. The point is that the firm’s financial results had nothing to do with SQNM price move, neither during the rally that took the stock up from a mid one-digit price to over $25, nor during the stock plummeting from around $15 in April to less than $4 overnight. So, it does not make sense that, all of a sudden, the financial results would have such a huge negative impact on the stock.
 
The reason for the rally was investors’ enthusiasm about the firm’s non-invasive prenatal program, especially the expected launch of non-invasive test for Down syndrome. On the other hand, the reason for the stock losses that followed was the skepticism towards the program when news announced that some employees mishandled the R&D Down syndrome test data and results and were under investigation. This incident led investors to become skeptical towards the firm’s pre-natal program.

The recent rebounding in the stock occurred as investors began to regain confidence that Sequenom will, indeed, be capable of putting several prenatal non-invasive tests on the market, including the Down syndrome test. This is what Sequenom has confirmed time and time again from the day the mishandling of the data was announced until now.

Besides the prenatal program, recently, results from a study published by the University of Michigan demonstrate that thanks to using Sequenom MassARRAY system, its scientists were capable of detecting the presence of high-risk human papillomavirus (HPV) in women in nearly half (46.7%) of those who tested negative with the standard of care conventional test. HPV causes cervical cancer in women. As a matter of fact, around 9,000 American women are diagnosed with cervical cancer each year despite regular cervical screening with the current test. The results of the MassARRAY test will be published in the September 2009 edition of Journal of Virological Methods. The assay used in this study is exclusively licensed by Sequenom.  

Sequenom, SEQureDx™, is a revolutionary approach to genetic screening. Rather than resorting to amniocentesis, i.e., entering the uterus to sample the amniotic fluid surrounding the baby, SEQureDx Technology extracts DNA material safely and comfortably from the blood of the mother. It is a simple process where SEQureDx™ utilizes circulating fetal DNA in pregnant women’s blood to examine the fetus’ genetic status. This effective screening does not entail the risks associated with disturbing the amniotic fluid that surrounds the baby in the uterus.

In addition to Down syndrome, Sequenom’s SEQureDx Technology promises detecting a number of other genetic defects. An example is the analysis of fetal RhD. RhD disease that occurs when the blood of an expectant mother is incompatible with her unborn child. RhD incompatibility affects approximately one in one thousand live born infants and can lead to jaundice, anemia, brain damage, heart failure and death. Many other possibilities for Sequeom’s non-invasive tests are being studied.
 
Sequenom’s technological capabilities and its revolutionary approach to genetic screening are the reasons for investors’ enthusiasm for the firm, not its current finances before it puts its tests on the market.  As a matter of fact, nothing in its most recent financial statement is so bad as to result in a sell off.

We appreciate this firm’s technologies and believe its prenatal program will put breakthrough tests in the hands of physicians who badly need them.

On June 10, 2009, Prohost wrote an article entitled Sequenom: Why have Short-sellers Panicked? In this article Prohost wrote:

The Sequenom (SQNM) story is written now by short-sellers who are really not sure why they short this firm, except that it is their way of investing. The title we suggest for the short selling story is “gamble based on deadlines and rely on the plenty of gossipers who love bad news and perpetrate them."

In the case of Sequenom, negative investors rely on the fact that the deadline indicated by Se-quenom to validate its Dawn syndrome's non-invasive diagnostic test is near year end. From now until that time, they will rely on making sure that hundreds of articles will be posted against the firm, its management and its Dawn syndrome test on the internet. They will make sure that nothing will be said about two other embryonic tests that are no less important than the Dawn syndrome non invasive diagnostic test. 

To the bad luck of those who shorted Sequenom, the news that came this time  (true or false it does not matter) was positive for the company. The reaction of negative investors cannot be described except as reflecting panic. They rushed to protect their investment, buying the stock like crazy, hence causing the rally themselves. They are now selling at the higher price, taking profit, and shorting again.  Good for them. Read the rest of this article in Prohostbiotech.com.

In the Past Prohost Newsletter #298, under “URGENT” Prohost wrote:

Crossing the Border of Skepticism

SEQUENOM (SQNM)

This firm is speeding towards erasing two thirds of investors’ skepticism towards its technological capability. In the past month Sequenom launched SensiGene™ Fetal RHD Genotyping test, the firm’s first laboratory test powered by its SEQureDx™ technology. This launch was followed by the launch of the SensiGene™ Fetal(XY) (Fetal Sex Determination) test.  This test is the second laboratory developed test powered by its SEQureDx™ technology.SensiGene™ Fetal (XY) is non-invasive and safe. As the firm stated time and time again, it requires a simple blood sample from the mother. The test has proven to be highly specific.

The test enables the distinction between maternal and fetal DNA for both male and female fetuses. It determines the fetus sex as early as the first semester of pregnancy.

The SensiGene Fetal(XY) (Fetal Sex Determination) Test detects circulating cell-free fetal (ccff) DNA in maternal blood. The test interrogates male specific targets on the Y chromosome.  It is performed using Sequenom’s proprietary MassARRAY® system, which allows direct mass measurement of nucleic acids.

Bringing two successive accurate non-invasive fetal tests in one month through the Sequenom’s SEQureDx™ technology should confirm the capability of the firm’s technology in making prenatal diagnostic tests, which was questioned following the mistake, or wrong handling of the Down syndrome test results by people in the firm’s R&D department. The tests have been rigorously evaluated through blinded studies, performed in collaboration with internationally recognized prenatal diagnosticians.  As with the SensiGene Fetal RHD Genotyping test, more than 500 clinical samples were tested during the course of feasibility, optimization, verification and validation.

In the final blinded validation study, over 200 samples were evaluated. The test was performed in conjunction with the Fetal Medicine Foundation, and un-blinding was performed by Dr. Arnold Cohen, chairman of obstetrics and gynecology at the Albert Einstein Medical Center, in Philadelphia.

In this validation study, the SensiGene Fetal Sex Determination test demonstrates:

Sensitivity of  97.9% (92.5% – 99.4% at a 95% confidence interval).
Specificity of 100%   (96.9% – 100%  at a 95% confidence interval).

Is this something?

You bet.

We started by stating Hello Future, and we end saying, We are in the future.



Disclosure: Long Sqnm]]> Tue, 02 Mar 2010 12:33:33 -0500
Hello future.
 
It did not take us long to welcome the arrival of what many have expected from Sequenom and many have doubted. The expected has, indeed, begun to show, and the doubt that should disappear will stay as long as the skeptics of Wall street are ideologists whose ideology is cynicism. Nevertheless Sequenom has, indeed, launched its first laboratory test, SensiGene™ Cystic Fibrosis (CF) Carrier Screening test. We went on to describe the carrier screening tests and stress the fact that healthy individuals with no family history of a genetic diseases and have healthy children, may still be carriers of a genetic disorder like cystic fibrosis. 

The article proceeded into stating that the launch of this test marks the first test launched by its own lab, the Sequenom Center for Molecular Medicine. Read the article in Seeking Alpha  and the Prohost website.

On October 8, 2009, Under the title: Who Sold Sequenom On Thursday August 6 and Why? Prohost wrote:

Sequenom’s (SQNM) recent stock decline looked as if a program was set for selling SQNM as soon as the financial results were announced. The point is that the firm’s financial results had nothing to do with SQNM price move, neither during the rally that took the stock up from a mid one-digit price to over $25, nor during the stock plummeting from around $15 in April to less than $4 overnight. So, it does not make sense that, all of a sudden, the financial results would have such a huge negative impact on the stock.
 
The reason for the rally was investors’ enthusiasm about the firm’s non-invasive prenatal program, especially the expected launch of non-invasive test for Down syndrome. On the other hand, the reason for the stock losses that followed was the skepticism towards the program when news announced that some employees mishandled the R&D Down syndrome test data and results and were under investigation. This incident led investors to become skeptical towards the firm’s pre-natal program.

The recent rebounding in the stock occurred as investors began to regain confidence that Sequenom will, indeed, be capable of putting several prenatal non-invasive tests on the market, including the Down syndrome test. This is what Sequenom has confirmed time and time again from the day the mishandling of the data was announced until now.

Besides the prenatal program, recently, results from a study published by the University of Michigan demonstrate that thanks to using Sequenom MassARRAY system, its scientists were capable of detecting the presence of high-risk human papillomavirus (HPV) in women in nearly half (46.7%) of those who tested negative with the standard of care conventional test. HPV causes cervical cancer in women. As a matter of fact, around 9,000 American women are diagnosed with cervical cancer each year despite regular cervical screening with the current test. The results of the MassARRAY test will be published in the September 2009 edition of Journal of Virological Methods. The assay used in this study is exclusively licensed by Sequenom.  

Sequenom, SEQureDx™, is a revolutionary approach to genetic screening. Rather than resorting to amniocentesis, i.e., entering the uterus to sample the amniotic fluid surrounding the baby, SEQureDx Technology extracts DNA material safely and comfortably from the blood of the mother. It is a simple process where SEQureDx™ utilizes circulating fetal DNA in pregnant women’s blood to examine the fetus’ genetic status. This effective screening does not entail the risks associated with disturbing the amniotic fluid that surrounds the baby in the uterus.

In addition to Down syndrome, Sequenom’s SEQureDx Technology promises detecting a number of other genetic defects. An example is the analysis of fetal RhD. RhD disease that occurs when the blood of an expectant mother is incompatible with her unborn child. RhD incompatibility affects approximately one in one thousand live born infants and can lead to jaundice, anemia, brain damage, heart failure and death. Many other possibilities for Sequeom’s non-invasive tests are being studied.
 
Sequenom’s technological capabilities and its revolutionary approach to genetic screening are the reasons for investors’ enthusiasm for the firm, not its current finances before it puts its tests on the market.  As a matter of fact, nothing in its most recent financial statement is so bad as to result in a sell off.

We appreciate this firm’s technologies and believe its prenatal program will put breakthrough tests in the hands of physicians who badly need them.

On June 10, 2009, Prohost wrote an article entitled Sequenom: Why have Short-sellers Panicked? In this article Prohost wrote:

The Sequenom (SQNM) story is written now by short-sellers who are really not sure why they short this firm, except that it is their way of investing. The title we suggest for the short selling story is “gamble based on deadlines and rely on the plenty of gossipers who love bad news and perpetrate them."

In the case of Sequenom, negative investors rely on the fact that the deadline indicated by Se-quenom to validate its Dawn syndrome's non-invasive diagnostic test is near year end. From now until that time, they will rely on making sure that hundreds of articles will be posted against the firm, its management and its Dawn syndrome test on the internet. They will make sure that nothing will be said about two other embryonic tests that are no less important than the Dawn syndrome non invasive diagnostic test. 

To the bad luck of those who shorted Sequenom, the news that came this time  (true or false it does not matter) was positive for the company. The reaction of negative investors cannot be described except as reflecting panic. They rushed to protect their investment, buying the stock like crazy, hence causing the rally themselves. They are now selling at the higher price, taking profit, and shorting again.  Good for them. Read the rest of this article in Prohostbiotech.com.

In the Past Prohost Newsletter #298, under “URGENT” Prohost wrote:

Crossing the Border of Skepticism

SEQUENOM (SQNM)

This firm is speeding towards erasing two thirds of investors’ skepticism towards its technological capability. In the past month Sequenom launched SensiGene™ Fetal RHD Genotyping test, the firm’s first laboratory test powered by its SEQureDx™ technology. This launch was followed by the launch of the SensiGene™ Fetal(XY) (Fetal Sex Determination) test.  This test is the second laboratory developed test powered by its SEQureDx™ technology.SensiGene™ Fetal (XY) is non-invasive and safe. As the firm stated time and time again, it requires a simple blood sample from the mother. The test has proven to be highly specific.

The test enables the distinction between maternal and fetal DNA for both male and female fetuses. It determines the fetus sex as early as the first semester of pregnancy.

The SensiGene Fetal(XY) (Fetal Sex Determination) Test detects circulating cell-free fetal (ccff) DNA in maternal blood. The test interrogates male specific targets on the Y chromosome.  It is performed using Sequenom’s proprietary MassARRAY® system, which allows direct mass measurement of nucleic acids.

Bringing two successive accurate non-invasive fetal tests in one month through the Sequenom’s SEQureDx™ technology should confirm the capability of the firm’s technology in making prenatal diagnostic tests, which was questioned following the mistake, or wrong handling of the Down syndrome test results by people in the firm’s R&D department. The tests have been rigorously evaluated through blinded studies, performed in collaboration with internationally recognized prenatal diagnosticians.  As with the SensiGene Fetal RHD Genotyping test, more than 500 clinical samples were tested during the course of feasibility, optimization, verification and validation.

In the final blinded validation study, over 200 samples were evaluated. The test was performed in conjunction with the Fetal Medicine Foundation, and un-blinding was performed by Dr. Arnold Cohen, chairman of obstetrics and gynecology at the Albert Einstein Medical Center, in Philadelphia.

In this validation study, the SensiGene Fetal Sex Determination test demonstrates:

Sensitivity of  97.9% (92.5% – 99.4% at a 95% confidence interval).
Specificity of 100%   (96.9% – 100%  at a 95% confidence interval).

Is this something?

You bet.

We started by stating Hello Future, and we end saying, We are in the future.



Disclosure: Long Sqnm]]> sqnm SQNM Sequenom Biotech Stocks Biotechnology OSI (OSIP): Congratulation Prohost Subscribers. A Take Over with over 40% Premium. http://seekingalpha.com/instablog/429422-prohost-biotech/56631-osi-osip-congratulation-prohost-subscribers-a-take-over-with-over-40-premium?source=feed 56631 It was easy to predict and Prohost did not miss.  Prohost did not predict the name of the buyer, but has predicted a take over and kept reminding its shareholders about this prophecy in each and every Prohost Letter, together with the same for other firms. Remember the two letters TA, which are there in the Prohost tables (Target for acquisition) that are there since several months    reminding you about the articles predicting the acquisitions so you do not forget.

 

Yesterday the news announced that the Japanese firm Astellas Pharma will commence a tender offer to acquire all outstanding shares of common stock of OSI Pharmaceuticals (OSIP) for $52.00 per share in cash, or an aggregate of approximately $3.5 billion on a fully diluted basis. The premium is significant reaching of over 40% on the closing price of OSI's common stock of $37.02 per share on February 26, 2010, a 53% premium to the stock three-month average of $34.01.  

 

OSI is the developer of the famous lung cancer drug Targeva (erlotinib). The firm’s pipeline is impressive and the transaction offers Astellas marketed products and a superior pipeline of oncology, diabetes, and obesity products. The marketed products include Tarceva - a small molecule drug, which inhibits the receptor tyrosine kinase activity of the protein product of the HER1/EGFR gene and Novantrone, a mitoxantrone for injection concentrate.

 

Astellas is inheriting also OSI-906, an oral small molecule IGF-1R inhibitor for various cancers, including NSCLC, breast, pancreatic, prostate, colorectal, adrenocortical, hepatocellular carcinoma, and ovarian; PSN821, an oral small molecule drug with anti-diabetic and appetite suppressing effects for type 2 diabetes; and OSI-027, a small molecule TORC1/TORC2 inhibitor to supersede first generation mTOR inhibitors. Other drugs include OSI-296, a novel tyrosine kinase inhibitor (TKI) that blocks compensatory signaling in epithelial tumor cells; OSI-930, a multi-targeted TKI that acts as a potent co-inhibitor of the receptor tyrosine kinases c-kit and the vascular endothelial growth factor receptor-2; PSN602, a novel dual serotonin and noradrenaline reuptake inhibitor for the long-term treatment of obesity; and OSI-632, an inhibitor of VEGFR-2.

 

The pipeline drugs are extremely important and are expected to be used in combination with other approved drugs especially as more and more pathways involved in cancer and other diseases are discovered. (Read Prohost article “Gene-Disease Story” in the upcoming Prohost Letter #299).

 

ASTELLAS BECOMES A STAR.

 

Astella is a real winner. With osi part of it, its financial strength and a product pipeline that fits future demands, adding its strong business operations and experience in the development and sales of new products, the combined company will be exceptionally promising. Astellas has great respect for the OSI organization and expects to integrate the strengths of OSI's business and employees into its operations as it has in the past with similar strategic acquisitions. Astellas will be offering a great investment opportunity. 

 

Astellas will commence a tender offer on March 2, 2010, to purchase all outstanding common stock of OSI for $52.00 per share in cash.  Following successful completion of the tender offer, a merger will be completed at the same price. The complete terms and conditions of the offer will be filed with the U.S. Securities and Exchange Commission and disseminated to OSI stockholders.  Astellas has cash and cash equivalents on hand to complete the transaction.  The offer is not subject to any financing or due diligence conditions, and will be subject only to customary closing conditions, including the tender of a majority of OSI's shares of common stock on a fully diluted basis, and OSI's Board taking all necessary actions to make its stockholder rights plan and Section 203 of the Delaware Corporation Law inapplicable to Astellas' offer.

 

There are no anticipated regulatory hurdles to completion.

 

Citigroup is acting as exclusive financial advisor to Astellas and Morrison & Foerster LLP is acting as legal counsel.

 

Following is a copy of the letter Astellas sent earlier today to Colin Goddard, OSI's CEO:

 

Dear Dr. Goddard:

 

As you know from our meetings, we have a great deal of respect for you and OSI, its employees and what the company has achieved.  We believe there are significant benefits from OSI's acquisition by Astellas and believe that a combined entity would allow us to achieve the goal of discovering, developing and delivering novel medications for patients with unmet needs in the oncology space far better than each of our companies could do independently.

When we met on February 12, 2010, I presented our proposal to acquire all of OSI shares for $52 per share, a 50% premium to the prior day's closing price.  This followed Astellas' numerous attempts to engage in meaningful conversations with OSI over the last 13 months regarding the potential for bringing our two businesses together.  

 

I was hopeful that our February 12th meeting would have finally resulted in a constructive attempt by you and OSI's Board to discuss a transaction and bring value to your stockholders.  Instead, your written response dated February 22nd stated that our proposal "very significantly undervalues" OSI.  It also contained a confidentiality agreement with a two-year "standstill" provision which we believe would not be in your stockholders' best interests, as it would have restricted us from making our offer directly to them.

 

As we have stated to you consistently in our many communications to you over the last 13 months, we believe the acquisition of OSI by Astellas makes for a compelling business proposition and provides a unique opportunity for our respective stockholders, employees and customers. However, because your response indicates that you have no intention to engage in substantive discussions, our Board has authorized me to take our offer directly to OSI's stockholders.

 

We remain enthusiastic about the potential of this transaction to realize the value of OSI's current commercialized products and to ensure the successful development and commercialization of additional products from its pipeline.  We respect your organization very much, and as such we would expect to integrate the strengths of your business and of OSI's employees into our company as we have in the past with similar strategic acquisitions.

 

Our proposal would be subject to standard acquisition conditions, including the removal of your stockholder rights plan, and is not subject to any financing or any due diligence conditions. We do not foresee any regulatory or other impediment to closing.

 

We continue to be excited about the possibility of bringing our two organizations together and we hope that you and your Board will reconsider your position and work with us to achieve a mutually beneficial outcome. Astellas has engaged Citigroup as financial advisor and Morrison & Foerster LLP as legal counsel to assist us in completing this transaction.  We and our advisors stand ready to meet with you and your advisors to answer any questions you may have about our offer.

 

Congratulation Prohost Subscribers. We remind you though that the other firms in Prohost tables that have the two letters (TA), will soon follow.

Disclosure: Long Osip]]> Mon, 01 Mar 2010 09:30:23 -0500 It was easy to predict and Prohost did not miss.  Prohost did not predict the name of the buyer, but has predicted a take over and kept reminding its shareholders about this prophecy in each and every Prohost Letter, together with the same for other firms. Remember the two letters TA, which are there in the Prohost tables (Target for acquisition) that are there since several months    reminding you about the articles predicting the acquisitions so you do not forget.

 

Yesterday the news announced that the Japanese firm Astellas Pharma will commence a tender offer to acquire all outstanding shares of common stock of OSI Pharmaceuticals (OSIP) for $52.00 per share in cash, or an aggregate of approximately $3.5 billion on a fully diluted basis. The premium is significant reaching of over 40% on the closing price of OSI's common stock of $37.02 per share on February 26, 2010, a 53% premium to the stock three-month average of $34.01.  

 

OSI is the developer of the famous lung cancer drug Targeva (erlotinib). The firm’s pipeline is impressive and the transaction offers Astellas marketed products and a superior pipeline of oncology, diabetes, and obesity products. The marketed products include Tarceva - a small molecule drug, which inhibits the receptor tyrosine kinase activity of the protein product of the HER1/EGFR gene and Novantrone, a mitoxantrone for injection concentrate.

 

Astellas is inheriting also OSI-906, an oral small molecule IGF-1R inhibitor for various cancers, including NSCLC, breast, pancreatic, prostate, colorectal, adrenocortical, hepatocellular carcinoma, and ovarian; PSN821, an oral small molecule drug with anti-diabetic and appetite suppressing effects for type 2 diabetes; and OSI-027, a small molecule TORC1/TORC2 inhibitor to supersede first generation mTOR inhibitors. Other drugs include OSI-296, a novel tyrosine kinase inhibitor (TKI) that blocks compensatory signaling in epithelial tumor cells; OSI-930, a multi-targeted TKI that acts as a potent co-inhibitor of the receptor tyrosine kinases c-kit and the vascular endothelial growth factor receptor-2; PSN602, a novel dual serotonin and noradrenaline reuptake inhibitor for the long-term treatment of obesity; and OSI-632, an inhibitor of VEGFR-2.

 

The pipeline drugs are extremely important and are expected to be used in combination with other approved drugs especially as more and more pathways involved in cancer and other diseases are discovered. (Read Prohost article “Gene-Disease Story” in the upcoming Prohost Letter #299).

 

ASTELLAS BECOMES A STAR.

 

Astella is a real winner. With osi part of it, its financial strength and a product pipeline that fits future demands, adding its strong business operations and experience in the development and sales of new products, the combined company will be exceptionally promising. Astellas has great respect for the OSI organization and expects to integrate the strengths of OSI's business and employees into its operations as it has in the past with similar strategic acquisitions. Astellas will be offering a great investment opportunity. 

 

Astellas will commence a tender offer on March 2, 2010, to purchase all outstanding common stock of OSI for $52.00 per share in cash.  Following successful completion of the tender offer, a merger will be completed at the same price. The complete terms and conditions of the offer will be filed with the U.S. Securities and Exchange Commission and disseminated to OSI stockholders.  Astellas has cash and cash equivalents on hand to complete the transaction.  The offer is not subject to any financing or due diligence conditions, and will be subject only to customary closing conditions, including the tender of a majority of OSI's shares of common stock on a fully diluted basis, and OSI's Board taking all necessary actions to make its stockholder rights plan and Section 203 of the Delaware Corporation Law inapplicable to Astellas' offer.

 

There are no anticipated regulatory hurdles to completion.

 

Citigroup is acting as exclusive financial advisor to Astellas and Morrison & Foerster LLP is acting as legal counsel.

 

Following is a copy of the letter Astellas sent earlier today to Colin Goddard, OSI's CEO:

 

Dear Dr. Goddard:

 

As you know from our meetings, we have a great deal of respect for you and OSI, its employees and what the company has achieved.  We believe there are significant benefits from OSI's acquisition by Astellas and believe that a combined entity would allow us to achieve the goal of discovering, developing and delivering novel medications for patients with unmet needs in the oncology space far better than each of our companies could do independently.

When we met on February 12, 2010, I presented our proposal to acquire all of OSI shares for $52 per share, a 50% premium to the prior day's closing price.  This followed Astellas' numerous attempts to engage in meaningful conversations with OSI over the last 13 months regarding the potential for bringing our two businesses together.  

 

I was hopeful that our February 12th meeting would have finally resulted in a constructive attempt by you and OSI's Board to discuss a transaction and bring value to your stockholders.  Instead, your written response dated February 22nd stated that our proposal "very significantly undervalues" OSI.  It also contained a confidentiality agreement with a two-year "standstill" provision which we believe would not be in your stockholders' best interests, as it would have restricted us from making our offer directly to them.

 

As we have stated to you consistently in our many communications to you over the last 13 months, we believe the acquisition of OSI by Astellas makes for a compelling business proposition and provides a unique opportunity for our respective stockholders, employees and customers. However, because your response indicates that you have no intention to engage in substantive discussions, our Board has authorized me to take our offer directly to OSI's stockholders.

 

We remain enthusiastic about the potential of this transaction to realize the value of OSI's current commercialized products and to ensure the successful development and commercialization of additional products from its pipeline.  We respect your organization very much, and as such we would expect to integrate the strengths of your business and of OSI's employees into our company as we have in the past with similar strategic acquisitions.

 

Our proposal would be subject to standard acquisition conditions, including the removal of your stockholder rights plan, and is not subject to any financing or any due diligence conditions. We do not foresee any regulatory or other impediment to closing.

 

We continue to be excited about the possibility of bringing our two organizations together and we hope that you and your Board will reconsider your position and work with us to achieve a mutually beneficial outcome. Astellas has engaged Citigroup as financial advisor and Morrison & Foerster LLP as legal counsel to assist us in completing this transaction.  We and our advisors stand ready to meet with you and your advisors to answer any questions you may have about our offer.

 

Congratulation Prohost Subscribers. We remind you though that the other firms in Prohost tables that have the two letters (TA), will soon follow.

Disclosure: Long Osip]]> osip alpmf.pk biotech stocks biotechnology stocks osip