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Pharmaxis (NASDAQ:PXSL) – Phase II Trial of Bronchitol Successful
August 12, 2008 — stockmd
August 12, 2008
On 8/11/2008, Pharmaxis (NASDAQ:PXSL) declared success in its Phase II trial of DPM-CF-202, a unique agent that has shown efficacy in the treatment of patients with cystic fibrosis. Cystic Fibrosis is a genetic disorder that commonly leads to decrease in lung funtion. At the end of two weeks of treatment with DPM-CF-202 (Bronchitol), cystic fibrosis patient displayed an increase in lung function. In the late 90’s It was estimated that the cost of patients with cystic fibrosis was $314 million per year in 1996 dollars. Twelve years later there has been no significant breakthrough and the cost of Cystic Fibrosis patients is most likely close to half a billion dollars a year. If Bronchitol passes through it’s phase three clinical trials and gets placed on Pharmaceutical Markets Worldwide it may lead to hundreds of millions of dollars in revenue for Pharmaxis. An increase in revenue may lead to an increase in stock price for Pharmaxis.
Biotech Stocks Follow the Cool Rules.
August 12, 2008 — stockmd
The
Nasdaq Biotech index continues to increase although the market in general appears to be catching up to it. Note that since July 15 the Nasdaq Composite, Dow Jones and the S & P 500 have corrected their downward trend and are now arching upward. For the stock market this is good news as gas prices have been falling as of late and shipping costs become less prohibitive to business. Nonetheless, Biotech still appears to be leading the way as far as stock price is concerned in the face of rising losses. However, these losses are primarily secondary to advancement of its pipeline which is critical for growth in any corporation that produces a product. And often the pipelines of these Biotech Companies are exceptional in that they have products that address unique disorders. Now more the an ever: Biotech is Cool. For example Chelsea Therapeutics (Nasdaq: CHTP) and GTX, Inc (Nasdaq: GTXI) both have unique products and both have seen an uptrend in its stock price over the last 3 weeks. As of late, Chelsea has started to eat into its gain in stock price, most likely because of increasing losses in the second quarter of this year. Chelsea reported a net loss of 7.3 million in the second quarter of 2008 as compared to its second quarter loss in 2007, which was only 3.8 million. However, it still acquires interest because of its innovative pipeline. CHTP has increased from 4.46 on 07/02/2008 to 5.46 on 8/11/2008. Chelsea Therapeutics received the go ahead from the UK’s Medicines and Healthcare products Regulatory Agency, the MHRA for the beginning of a phase II trial for Droxidopa. Droxidopa has been developed to treat Fibromyalgia. Fibromyalgia is unique because as I diagnosis it is somewhat amorphous. Some Medical Doctors actually do not believe the disease exists. However, designing a drug that decreases is symptoms with or with out carbidopa is a unique niche that is without doubt under exploited. Moreover, Toremifene, one of its GTx’s key products in development, met its Phase III goals back in 2/2008. As of August 5th 2008 GTX announced that its phase III trial of Toremifene is on course. If all goes well, Toremifene, may be on the market as early as 2010. GTX, Inc posted a $26 million loss as compared to a net loss of $17.3 million for the first 6 months of 2007 but its stock price has risen steadily from 14.35 on 06/30/2008 to 18.02 as of 8/11/2008. Both GTX, Inc and Chelsea Therapeutics have the Biotech “Cool Factor” which allows them to enjoy a gradual increase, while displaying rising losses. The shroud of Health protects and nourishes Biotech during recession times while other industries continue to crumble.
Should Biotech Do Drugs?
July 23, 2008 — stockmd
The world is reeling now that Roche has encroached and intends to buy out Genentech. It was predicted as outlined in my previous article Pharmaceutical Companies have been watching Biotech. Big Pharma to Biotech is like IBM to Microsoft. However, Big Pharma may be attempting to eat its young, just as IBM did not and Microsoft has done.
On June 24th, 2008 the NBI (Nasdaq Biotech Index) started to move positively as compared to the SP, Dow and Nasdaq composite which decreased on that day. Specifically, On 06/24/2008 investors began to worry about the effect of high fuel costs on customers and Wall Street’s profits. The Dow Jones decreased 0.29%, to close at 11,807.43, the Nasdaq composite Index dropped 0.73%, to 2,368.28, and the S & P 500 slipped 0.28%, to 1,314.29. Crucially, crude oil prices rose 26 cents to settle at $137.00 a barrel on the New York Mercantile Exchange.
Up until the present the Nasdeq biotech index has been arching upwards, while the other indices have been trending downwards. Pharmaceuticals are constant as life is constant, thus fuels costs are negligible. Fuel means nothing without life. Luxuries on the other hand will suffer. What is necessary for life?
The big three: Food, Clothing and Shelter. Anything besides food, clothing and shelter is expendable and now in the midst of a mortgage crisis, poison jalapeno peppers and the trade deficit even those may be compromised.
Americans may not want to pay for health care but they will invest in it when all else fails. More precisely, Biotech may represent both a good investment for long-term growth but also a good investment in case of buy outs by Pharmaceutical giants.
Roche is attempting to buy out Genentech, which is considered by most to be the Bellwether and most prominent and successful of all biotechcompanies throughout the world. This move is consistent with the trend that I spoke of in my last article.
Often, when a corporation buys out another corporation through stock acquisition the price of the corporation that is being purchased rises. This rise leads to a possible profit for those individuals that own and or recently purchased the stock of the corporation that is going to be bought.
Pharmaceutical Companies have been funding biotech companies for years. Now it appears that at least Roche wants to complete this trend by a frank buy out. However, the question now emerges: Are Pharmaceuticals good for Biotech? Zeus devours his mate and this leads to the next generation of Gods. What will happen when Big Pharma devours Biotech?
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) – 52% Rate of success in Hepatitis C patients taking Telaprevir.
June 10, 2008 — stockmd
ABOVE: Vertex stock chart over the last 3 Months
06/09/2008: Vertex Pharmaceuticals (Nasdaq: VRTX) announced that telaprevir-based regimen decreased virus blood levels in certain patients with hepatitis C(HCV) that failed previous treatment with the the standard Hepatitis C therapy.
Approximately 4.5 million Americans are estimated to be infected with Hepatitis C, 80% will most likely develop some form or chronic lIver disease. The annual health care cost for patients in the US that develop health issues from hepatitis C is a staggering $9 billion. Vertex will be poised to make several 100 million dollars in revenue if Telaprevir becomes a viable treatment for Hepatitis C. In addition, Telaprivir based treatments may also significantly decrease the cost of treating patients with Hepatitis C if Liver Transplantation can be averted.
Vertex will initiate a Phase 3 Clinical Trial of Telaprevir in the 3rd quarter of 2008. Assuming that Telaprivir continues to be successful, the phase 3, 48 week trial will be the last stepping stone before Telaprivir goes on the market. Thus, the drug may be released late in 2009 or possibly early in 2010.
VRTX closed on June 6th at 32.24 and it subsequently opened higher at 34.48 on June 9th. The 52 week range for VRTX ranges from 13.84 – 41.42. It is difficult to say if this stock will continue to increase at this piont. Its current price is toward inching up towards its 52 week high. It may be prudent to wait until the results of the Phase 3 Clinical Trial on Telaprivir are known which should be available in 2009. Nonetheless, as a potential investment VRTX has significant potential. As a trader, one may want to consider shorting this stock as it approaches its 52 week high if there is no further good news forth coming in the near future.
Merck (NYSE: MRK) & ZymoGenetics (NASDAQ: ZGEN) – Begin Phase II/III Clinical Trial for Lupus Drug
June 8, 2008 — stockmd
ABOVE: MRK Stock Chart over last 3 Months.
ABOVE: ZGEN Stock Chart Over Last 3 Months.
Germany 06/05/2008
Merck (NYSE: MRK) announced that it is partnering with ZymoGenetics, Inc. (NASDAQ: ZGEN) and they have initiated a Phase II/III trial of atacicept in patients with systemic lupus erythematosus (SLE).
There are 1.5 Million Americans with Lupus (SLE) with an annual health cost of appproximately 9 billion dollars. If the trial is successful the revenue for both MRK and ZGEN might be several billion dollars when atacicept hits the market. Assuming that Atacicept gets approved by the FDA it could be on shelves as soon as mid 2010.
Partly because of the recent decrease in stock prices (Dow down nearly 400 pionts, June 6th), both MRK and ZGEN decreased in price. MRK’s 52 week range of stock price varied from 36.80-61.62, on June 6th it was down 1.40 and closed at 37.49. Therefore, MRK is near its 52 week low and this may represent a good chance to buy and establish a long position as an investor. As well, ZGEN has ranged from 8.09 to 16.28 over the last 52 weeks and it also closed down .50 on June 6th at 8.51. As with MRK, this may be a good time to go long and buy ZGEN as an investment.
GlaxoSmithKline (NYSE:GSK) – Continued Good News for ASCI
June 3, 2008 — stockmdABOVE: GSK Stock Chart
GlaxoSmithKline (NYSE:GSK) – Continued Good News for ASCI
(Data Released 5/30/2008)
New data presented by GlaxoSmithKline (NYSE:GSK) emphasized the possible promise of MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (ASCI). MAGE-A3 results were presented within three studies evaluating highly targeted immunotherapy as a treatment for metastatic melanoma and non-small cell lung cancer (NSCLC). This amalgam of data was presented at the 2008 American Society of Clinical Oncology (ASCO) Annual Meeting.
A randomised, open label (not blind) Phase II study designed to evaluate two different formulations of the MAGE-A3 ASCI in patients with metastatic melanoma has been conducted. ASCI is a composite of MAGE-A3 recombinant protein and a GSK Adjuvant System. ASCI was evaluated and the numbers suggest the possibility of a salutary clinical response. The capacity of this study to reveal meaningful use for ASCI is limited because of its design. However, if the aforementioned study is taken together with the positive findings in the, double-blind, placebo-controlled Phase II study as well as the subsequent creation of the current Phase III safety and efficacy trial in MAGE-A3-positive NSCLC patients (stage IB, II and IIIA), then the data is encouraging.
I have engaged in scientific research throughout my career in medicine. As well, I am an American trained physician that practices medicine and has also engaged in clinical research. However just as important, I am a successful real estate and stock investor. In my opinion, the data presented about ASCI appears to be favorable. GSK may very well increase its profitability through the success of ASCI in the market place.
Immunomedics, Inc. (Nasdaq: IMMU) – Veltuzumab: Non-randomized results for Phase II Clinical Trial
June 2, 2008 — stockmdABOVE: IMMU’s Stock Chart.
Immunomedics, Inc. (Nasdaq: IMMU) announced that veltuzumab mounted a comparatively high complete response rate of 27% in patients with follicular lymphoma, and that such results were achieved even when given at doses about 75% lower than rituximab’s (a rival agent) approved dose.
The results were obtained from an open-label (non-randomized, not blinded), multi-center, Phase II Clinical trial in which 82 adult patients with Non-Hodgkin’s Lymphoma (NHL), most of whom had relapsed after prior therapies.
I have engaged in scientific research throughout my career in medicine. As well, I am an American trained physician that practices medicine and has also engaged in clinical research. Although this study seems impressive, in my opinion, it is not.
IMMU may very well have a good therapeutic premise in developing therapeutic antibodies. In addition, veltuzumab may prove to be an effective treatment for lymphoma but this study does not prove it. First of all, this study is open label and not “blind”. In an open label (not blind, non-randomized) study the people that are administering the drug know that it is an experimental agent. Open label studies induce bias because the personnel that are giving the drug may act differentially than they might act if they were dispensing a placebo. Moreover, the fact that many of the study subjects were previously treated brings in the question what is being tested? Are you testing the response of veltuzumab in treating lymphoma or are you testing the response that both agents have on lymphoma? Is there a cross reaction or a temporal relationship that allows veltuzumab to be more effective after a patient has been treated with rituxmab?
I would continue to watch this stock for upcoming results on Phase III, randomized, clinical trials before assuming that Veltuzumab will increase IMMU’s bottom line.
New Drug Discovery Pact with GVK BIO allows Wyeth to increase its Biotechnical Capacity.
May 29, 2008 — stockmdABOVE: WYE’S Stock Chart.
Biotechnological Products have been emerging rapidly in the US/global drug market ever since the emergence of Genetech (ticker:DNA) and its break out drugs Rituxan (rituximab) and TNKase (tenecteplase). Since then, both brandname (ie Pfizer and Merck) as well as large generic pharmaceutical companies have been looking to strategically ally themselves with talented, emerging biotechnological companies. For more information on emerging biotechnological companies please refer to http://stockmd.wordpress.com/.
Wyeth Pharmaceuticals (WYE) is chiefly involved in creating, developing, producing, distributing, and the sale of drugs, consumer healthcare products as well as animal health products. WYE is segmented into 3 Basic Divisions namely, Pharmaceuticals, Consumer Healthcare, and Animal Health.
The Drug or Pharmaceutical Division offers human pharmaceuticals, biotechnology agents, vaccines, and nutritional products. Its primary focus are neuroscience therapeutics, gastrointestinal pharmaceuticals, Infectious disease agents, vaccines, musculoskeletal treatements, nutritional products, anti-cancer drugs, hematologic therapeutics, immunological products as well as women’s health care products. However, its most profitable drug is Effexor, an antidepressant. Effexor resulted in $3.8 billion in sales in 2005 for Wyeth, this translatesw into an annual growth rate of 1.2 percent.
Despite WYE’s strength it is notably deficiant in Bio technical drugs and it wishes to beef up its resume in this department. In fact, WYE has already taken steps before this new relationship with GVK BIO to achieve these ends. Most notably, Enbrel, the monoclonal antibody that can treat rheumatoid arthritis is currently marketed by Wyeth and Amgen (Nasdaq: AMGN). In addition, WYE has tagged $40 million for investment in Trubion, which has pledged $800 million in hopes of achieving a healthy Bio-technical product line.
Therefore, Wyeth creating an alliance with GVK BIO, a company with bio-technical capacity as well as the ability to produce more traditional pharmaceutical agents, is competely straightforward and predictable. WYE’s stock price increased 0.57% on 5/29/2008. WYE may see increased profitability in the future because of it’s new drug discovery pact with GVK BIO.
Immunomedics, Inc. (Nasdaq: IMMU) – Will Present Data on 4 New Agents in Development
May 27, 2008 — stockmd
ABOVE: IMMU Stock Chart for the Last 5 days.
May 27, 2008: Immunomedics, Inc. (Nasdaq: IMMU) announced that it will present data on four clinical studies involving drugs that it has in development at the 2008 Annual Meeting of the American Society of Clinical Oncology (ASCO).
Companies usually do not present negative studies at scientific meetings. Negative studies are clinical studies or investigations that fail to show any benefit of the drug in question as opposed to the standard treatment. This finding in general implies that the drug will not prove to be lucrative to the company.
Therefore, when a company plans to present the results of a new drug that is in clinical trials it implies that the new agent is working as expected and may increase the profitability of the company.
Please Note: IMMU’s stock has increased in price from 2.3 to 2.65 in the last two trading days, an increase of 15%.
The following studies/new agents will be presented by IMMU at the 2008 Annual Meeting of the American Society of Clinical Oncology (ASCO):
Anti-CD20-veltuzumab in the treatment of lymphomas (solid blood cancer) and how the treatment success is different from rituximab (a rival, older drug)
131-iodine-labetuzumab (phase II study) as a therapy for colorectal liver metastases (colon cancer that has spread to the liver) as compared to the results of the more traditional treatment i.e. single dose RadioImmunotherapy (RAIT)
The ability to combat diffuse large B-cell lymphoma (a solid blood cancer) with Epratuzumab and rituximab in combination with cyclophosphamide, doxorubicin, vincristine and prednisone chemotherapy (ER-CHOP)
DOTA-conjugated, anti-CD22 IgG, epratuzumab (a novel agent) and Fractionated radioimmunotherapy as therapy for NHL (Non Hodgkin’s Lymphoma, a solid blood cancer). The results of the new agent will be compared to those of high cumulative doses of 90Y, a more traditional therapy for NHL.
It would be unusual for all of these agents to not show promise. Why would a company present four failed experimental treatments at a major medical conference? IMMU should be observed for an increase in stock price and/or an increase in revenues in the future.
