News and Comments

Investors’ Rush To Buy ImmunoGen IMGN

  Friday, March 19, 2010

IMGN soared on Thursday, as investors did not miss the parts related to ImmunoGen in the article Robert Langreth, a senior editor at Forbes wrote about the pharmaceutical company Roche’s status and plans. In the article, Severin Schwan, Roche’s chief executive remind of his firm’s dominant position in the cancer drug market, stressing the fact that Roche’s cancer drug Avastin is hard to beat, regardless of what other pharmaceutical companies claim about their upcoming competing drugs. “In cancer, we are at the beginning,” Schwan told Forbes in an interview yesterday. “The barrier to beat our established drugs is very high. It is extremely difficult to find something better than Avastin whose sales approached $6 billion last year.”

The part related to ImmunoGen, though, came when the article described Roche’s plans. He wrote, “Roche is testing drugs called armed antibodies that combined targeted therapy with traditional toxic cell-killing drugs. The idea is that the antibody will deliver the toxic chemotherapy directly to the tumor, maximizing effectiveness and limiting side effects.” Is this not ImmunoGen’s drug? Indeed it is as investors who read the article confirmed their notion when it mentioned the armed antibody by name “T-DM1”, described it as much as possible, and confirmed that ImmunoGen is the developer of the drug.

Motivating IMGN’s rally yesterday is the part where the writer said, “Roche is in late stage testing of T-DM1 that chemically links Herceptin to a potent chemotherapy toxin. If the drug works, patients will take one drug for breast cancer instead of two or three. Roche, presumably, could charge a higher price for the two-in-one combo, especially if it has fewer side effects.”

Further exciting ImmunoGen’s fans was the part of the text that said, “Schwan swears there are no big more mergers in Roche’s future because we think it destroys a lot of value. We are going for targeted midsize acquisitions.”

Well, well, well. Reading the article’s description of ImmunoGen’s T-DM1 drug was enough for informed investors to connect the dots. ImmunoGen typically fits the description of what Roche is interested in. If taken over, the firm, which is a small size, the premium to be paid in case of acquisition would turn it into a midsize firm. In addition, investors know that ImmunoGen is not a single cancer drug firm, but has a pipeline of several conjugated monoclonal antibodies developed for several cancers. More important, it owns the TAP technology that made possible what defied other firms’ previous attempts, i.e., designing and developing monoclonal antibodies that carry highly toxic payloads, yet leave the normal cells intact because they released their toxic ammunition only inside the cancer cells.

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SEQUENOM (SQNM): Does Anyone Really Believe That Missing Analysts Expectations By Five Cents Should

  Wednesday, March 17, 2010

SEQUENOM (SQNM): Does Anyone Really Believe That Missing Analysts Expectations By Five Cents Should Cause a Sell-Off In A Fundamentally Sound Development-Stage Biotechnology Firm’s Shares?

To those who keep downgrading Sequenom we say, we would love to be your disciples on condition that you do not try to convince us that development-stage firms deserve to be downgraded and their stocks crushed because their quarterly reports show a loss of five cents more than analysts’ expectations. We will become your faithful followers if you tell us in straight sentences that the firm’s scientific fundamentals are dismal – its technologies are not working, its programs are not advancing and its future is bleak, which you certainly did not do yet.

We will do exactly what you recommend if you tell us something more convincing than the story of the five cents. Here is some help:

A few months ago, Sequenom has launched SensiGene™ Cystic Fibrosis (CF) Carrier Screening test.

- Do you believe the test has been launched?
- Do you believe the test is not working? If so, then explain why
- Will the test not sell? If so, why?

In Sequenom’s non-invasive nuclear prenatal program, the firm has launched SensiGene Fetal RHD Genotyping test, which was its first clinical laboratory test to be accomplished through its SEQureDx™ technology.

- Do you believe the test has been launched?
- If so, then do you believe the test is superfluous? If so, then could you please explain why do you think so?

In the same prenatal program, Sequenom has launched another test, the non-invasive SensiGene™ Fetal (XY) (Fetal Sex Determination) test, which is also powered by SEQureDx™ technology.

- Again we ask: Do you believe the firm has launched this test? Do you believe it is safe, accurate and highly specific and has the same accuracy reading the fetus sex early in pregnancy? If not, please explain.

- Do you believe that the test enabled the distinction between maternal and fetal DNA for both male and female fetuses? If so, then do you believe that the test validates the firm’s technologies behind the non-invasive prenatal test program?

Yes, we are ready to follow your negative recommendation about this biotech firm, but first, please tell us what you know and think about Sequenom’s MassARRAY® genotyping system? Do you like it? Do you believe that this system and other few similar systems are making a historical move into the clinical laboratory?

Did you know that by using Sequenom MassARRAY® genotyping, Children’s Hospital Oakland Research Institute and the University of Minnesota Cancer Center were able to find out that donors who have natural killer cell immunoglobulin-like receptor (KIR) haplotypes, would significantly improve treatment in patients with acute myelogenous leukemia (AML) who received hematopoietic cell transplantation (HCT) therapy. As a matter of fact, the AML patients who received T-replete hematopoietic cell transplantation therapy1 based on Sequenom MassARRAY® genotyping had significant survival benefit.

1. The complete results from the study are published in Blood (Volume 113, Number 3), the journal of the American Society of Hematology.

If you still believe that the five cent story that ate over 25% of SQNM’s price in two days based on your preaching is more important than the above story, then here is another story: Using an assay exclusively licensed from Sequenom, researchers published a study by the University of Michigan, which demonstrates that around 15% of women determined to be negative human papillomavirus (HPV) in the cervix with the standard HPV DNA test may actually be infected with the virus. Sequenom assay was able to detect the presence of high-risk HPV in 46.7% of women who tested negative by the commonly used Hybrid Capture 2 (HC2) test.

WOW!

You know what? Those who continue to believe that the missed five cents in the quarterly results of a firm that is still building its programs cannot be but irrational. You know how we know? Because the missed five cents are spent on the firm’s programs. Development-stage firms have to spend on building their programs before they cash in on them. By the way, the aforementioned test is another example of how the genomic knowledge is entering the clinic through new advanced DNA sequencers. In the meantime, it further validates Sequenom’s technology.

Sequenom is in the process of researching and evaluating a potential molecular diagnostic for the assessment of risk in developing age-related macular degeneration (AMD).

With regard to the T21 (Down syndrome) test, Sequenom said it is committed to the development of the noninvasive T21 test.

Prohost Word: Until the bearish on Sequenom convince us that they are not playing a game, and their concerns about Sequenom’s science, technology and products are real, we continue to believe that the future of medicine and agriculture is now in the hands of the genomic group. Sequenom is, indeed, a member of this group with advanced standing. The genomic firms’ technologies, tools and discoveries are the engines of the revolution in medicine and in the discovery and development of breakthrough drugs. (Read the article entitled Genomics in Prohost Newsletter for subscribers only.)

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INTERMUNE: Pulmonary Fibrosis Drug Will Open the Door to A large Product Pipeline

  Thursday, March 11, 2010
The FDA Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted 9-3 to recommend approval of Esbiet® (pirfenidone) developed by the biotech firm Intermune (ITMN) for idiopathic pulmonary fibrosis (IPF). The same drug is approved in Japan for IPF and sold under the trade name Pirespa® by Shionogi in that country. Both Intermune and Shionogi had licensed pirfenidone from Marnac and its co-licensor, KDL GmbH.  More...

ISIS (ISIS): Lou Gehrigs Disease Antisense Drug Has Reached Clinical Trials

  Monday, March 08, 2010
Isis initiated a Phase 1 study of its antisense drug ISIS-SOD1Rx in patients with an inherited, aggressive form of Lou Gehrig\'s disease also known as familial amyotrophic lateral sclerosis. (ALS). As ISIS-SOD1Rx selectively inhibits the production of SOD1, it is expected to benefit the cases of familial ALS that are related to mutant forms of superoxide dismutase, or SOD1, which constitutes approximately 20% of ALS patients suffering from familial ALS.  More...

ON SEQUENOM (SQNM)

  Tuesday, March 02, 2010

On September 22, Prohost wrote:  More...

Time To Appreciate ISIS PHARMACEUTICALS (ISIS)

  Tuesday, March 02, 2010

OSI (OSIP): Congratulation Prohost Subscribers. A Take Over with over 40% Premium.

  Monday, March 01, 2010

OSI (OSIP): Congratulation Prohost Subscribers. A Take Over with over 40% Premium.  More...

CADENCE (CADX): The FDA Complete Response is good rather than bad news

  Tuesday, February 16, 2010

CADENCE PHARMACEUTICALS (CADX): The FDA decision to deny approval of Cadence’s drug Ofirmev™ (IV acetaminophen) was positive rather than negative news. The contents of the FDA Complete Response letter, rather insinuate that the product has passed the tests of safety and efficacy and the only problem are deficiencies the FDA observed in the manufacturing facility. The manufacturing deficiency will be taken care of by Cadence manufacturer and Cadence will request a meeting with the FDA to ensure that the deficiencies have been adequately addressed.  More...

XOMA: Past, Present and Future.

  Tuesday, February 09, 2010

The firm has encouraging news today. But recently the firm’s stock plummeted for reasons not related to the firm’s technological capabilities, but to a mixture of inherited consequences of bad financial decisions, past unethical behavior and, in some circumstances, bad luck. Investors’ agitation - well reflected in their exaggerated reactions towards some of the firm’s unfortunate news, has also contributed to the stock’s plummeting. The negative chain reaction began a few years ago when Xoma’s investigational drug for sepsis failed to pass the approval test even though it saved children’s lives in clinical trials. The company decided to abandon the drug years before investors learn the news that was never announced. A couple of years after the firm has shelved the drug, investors realized that the drug is not existing in longer in Xoma’s pipeline.  More...

SUNESIS PHARMACEUTICALS (SNSS): RESULTS CANNOT BE IGNORED

  Saturday, January 02, 2010
At the 51st American Society Hematology (ASH) Annual Meeting in New Orleans, LA. Sunesis presented data from two Phase 2 clinical trials of its drug Voreloxin on patients suffering from difficult to treat acute myeloid leukemia (AML). The results, as announced, were positive and demonstrated voreloxin's efficacy and safety when used as a single agent or in combination with chemotherapy.

The lecturer and the firm’s representatives were extremely optimistic during the presentation. The demonstrated safety and efficacy were sufficient to move Voreloxin forward in clinical trials. The high rates of remission demonstrated durable effects and meaningful preliminary overall survival. As a result, Sunesis said it is looking forward to discussing the clinical trial data with the FDA in its End-of-Phase 2 meeting scheduled for the first quarter of 2010.

Could Voreloxin be the drug that offers AML patients what they desperately hope for? All we can say at this point is that in combination regimens of Voreloxin with Cytarabine in phase 1b/2 clinical trial on primary refractory and first relapse AML patients, the drug realized preliminary median overall survival of 7.8 months compared to historical median overall survival of 3.4 to 5.9 months in same category of patients taking currently available chemotherapies. The combination demonstrated meaningful anti-leukemic activity with an acceptable tolerability profile in difficult-to-treat patients. Such results cannot be overlooked.

Good news is that a recommended pivotal dose-regimen of Voreloxin used in combination with cytarabine has been identified.

Phase 2 dose optimization trial (REVEAL-1 Trial) in 113 elderly AML previously untreated patients who are unlikely to benefit from standard induction chemotherapy have demonstrated positive results. In these trials, patients followed three schedules:

Schedule A: Once weekly for three weeks.
Schedule B: Once weekly for two weeks.
Schedule C: On days one and four at either 72 mg/m2 or 90 mg/m2.

Schedule C was the winner and the one to be adopted.

Based on trial results, Schedule C is chosen to be the recommended pivotal dose regimen. In schedule C, response rates (CR and CRp) are 38%; 30- and 60-day. All-cause mortality are 7% and 17% with improved tolerability over Schedule A.

Do we have any reasons for Skepticism? Skepticism in this case has no place, as it can only mean that the data are fabricated, which is irrational.

Conclusion

Do we believe that the drug is, indeed, the miracle that desperate patients are waiting for?

We have many reasons to believe that the results are, indeed, positive and represent genuine clinical evidence. On the other hand, these results are not definitive and still need to be confirmed. The drug has to pass the final phase studies. Nevertheless, the results came from real trials conducted on real desperate patients; some would have been dead if they were treated with the conventional regimens. The mid-phase trial results are in favor of the drug, but no one can really swear that the same results will be duplicated in phase 3 trials.

We are optimistic. We have more confidence than ever in the capability of Sunesis in planning and conducting successful clinical trials. But we cannot speculate over the outcome because in this particular case, although we have incomplete clinical evidence we lack scientific evidence. Voreloxin is not a cancer drug and there is no scientific explanation as of how it does its job on leukemic cells. This is not a hurdle, but something to consider, especially that Voreloxin has never before been considered for cancer treatment and its structure, under various known and unknown circumstances could end up becoming therapeutically futile.

With regard to the stock, we believe what could boost the stock price and double our enthusiasm in the same time is that a deep-pocketed pharmaceutical company comes forwards and hands Sunesis a lucrative contract with a substantial amount of upfront payment to get involved in the drug. As a matter of fact, some analysts and investors expect this scenario to happen anytime soon, which might have added to fuel to the stock’s recent rally.

Do we buy the stock?

We take advantage of the profit-taking to buy a small amount and then wait for the news about the drug and the possible collaborative agreement and then we cross the bridge when we reach it.

This press release may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as “may”, “expects”, “anticipates”, “believes”, and “intends”, and describe opinions about future events. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance or achievements of Compugen to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Some of these risks are: changes in relationships with collaborators; the impact of competitive products and technological changes; risks relating to the development of new products; and the ability to implement technological improvements. These and other factors are identified and more fully explained under the heading "Risk Factors" in Compugen's annual reports filed with the Securities and Exchange Commission. More...

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