Vertex Pharmaceuticals Inc. (Nasdaq: VRTX): Successful Phase 3 clinical trial for Telaprivir

April 23, 2008 – Vertex has shown that Telaprevir-Based PROVE Phase 3 Clinical Studies have displayed significantly Higher SVR (Sustained Virologic Response) Rates in the treatment of certain Hepatitis C patients.  Sustained Virologic response means that the levels of the virus remain relatively low for a specific period of time (ie 12-24 weeks) as compared to before treatment.  This aforementioned SVR was for a certain subset of Hepatitis C patients known as Naive (Never exposed to telaprevir), Genotype 1 Hepatitis C Patients.  What is so striking about the prove study is that it decreased the viral load and sustained the those low levels in half the time of contemporary standered treatments. 

     

Telaprivir based treatments of Hepatitis C may very well lead to increase revenues for Vertex.  Of note the price of Vertex stock decrease today.  This makes since if one considers the old trading axiom “buy the rumor and sell the news”.  Today was the sell the news day for Vertex.

Genetech (NYSE: DNA) and Biogen (Nasdaq: BIIB) – A “NO GO” for Rituxan for treating Primary Progressive Multiple Sclerosis.

 

 April 14, 2008 –  Genentech, Inc. (NYSE: DNA) and Biogen Idec, Inc. (Nasdaq: BIIB) announced that a Phase II/III study of Rituxan(rituximab) (a synthetic antibody effective in the treatment of Non Hodgkin’s Lymphoma) was completed and unfortunately did not prove to be effective in the treatment of primary-progressive multiple sclerosis (PPMS).  In this particular study Rituxan was unable to halt disease progression of PPMS by the 96-week treatment period.  These results may lead to decreased revenues for these respective companies in the long run.

Of note: Over the last 5 days Genentech has decreased in price while Biogen has increased in price.  The etiology of this divergence in stock price is not immediately obvious.  However, it may be a case of The Market selling the rumors (bad rumors in this case) as far as Genentech is concerned.  Paradoxically, The Market has treated Biogen more favorably as it has seen an increase in stock price over the last 5 days.

Immunomedics Inc. (IMMU): Up from 2.3 to 2.9 since March 11, 2008

IMMU continues to show upward momentum in its stock price.  The niche involving drug/antibody complexes (Immunoconjugates) to fight cancer has shown promise in phase I and II clinical trials and is steadily drawing attention.  IMMU should remain on our watch list.  Phase III clinical trials will be forthcoming if the final results of Phase II trials are encouraging.

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) – New Drug VX-770 Shows Promise.

Mar 27, 2008 — Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today released results for the interim analysis of a Phase 2a clinical trial in patients who carry a specific genetic  mutation know known as the “G551D mutation” in the gene that causes cystic fibrosis (CF).  The trial involves treatment of CF by a proposed drug named VX-770.  

Cystic Fibrosis is a disease that leads to a deterioration of lung function.  The interim analysis showed that VX-770 has the correct dosing , when taken by mouth, to improve lung function after 14 days of treatment.  As well the data showed that VX-770 also improved the function of the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) protein, which is the structurally abnormal protein that leads to Cystic Fibrosis.

If VX-770 continues to do well in clinical trials then it may represent an economic boost for Vertex and it may eventually lead to an uptick in stock price.

Immunomedics, Inc. (Nasdaq: IMMU) – Patent Application for New Medical Agents Issued.

 

April 8, 2008 — IMMU is a unique biopharmaceutical company that is chiefly involved in creating therapeutic agents that primarily involve monoclonal antibody technology.  IMMU has modified a known drug that destroys cancer cells (new SN-38 derivatives).  It has attached this molecule to an antibody it has designed to find and attach to pancreatic, lung and colon cancer cells (Immunoconjugate). 

IMMU’s patent application for “Use of immunoconjugates to enhance the efficacy of multi-stage cascade boosting vaccines” has been issued as U.S. patent no. 7,354,587.  This patent will theoretically allow IMMU to “corner” the market involving immunoconjugate technology for the treatment of specific diseases by delivering vaccines (multi-stage boosting vaccines) into patients.  If the immunoconjugates combat disease successfully then this may very well represent a unique and lucrative opportunity for IMMU.

 

Immunomedics, Inc. (Nasdaq: IMMU) – Veltuzumab Well Tolerated in Phase I/II Clinical Trial.

April 9, 2008 – Immunomedics, Inc. (Nasdaq: IMMU): IMMU announced that patient dosing has begun in a Phase I/II study of veltuzumab (potential new drug).  Patient dosing is the process of selecting the correct dose of a potential new drug that will not hurt patients.  In the aforementioned trial veltuzumab will be given under the skin (subcutaneous) in patients with a unique form of non-Hodgkin’s lymphoma (NHL) or chronic lymphocytic leukemia (CLL), solid and liquid blood cancers, respectively. 

A single subcutaneous dose of 80 mg of veltuzumab, caused circulatory B-cell  (these type of cells can turn to cancer and lead to NHL) levels were reduced to less than 1% compared to their normal levels of B-cells.  These results indicate that veltuzumab, when administered subcutaneously, is spread throughout the body  in a similar fashion as compared to formula when it is given through an intravenous route (given through and “IV”).  If Veltuzumab continues to do well it may very well lead to greater revenues for IMMU.