Sinovac Biotech China's Premiere Vaccine Maker

Breaking news was reported Friday as Sinovac wins Beijing Public Health Bureau's bid to supply seasonal flu vaccine Anflu(R) to Beijing citizens on August 28, 2009. China-based Sinovac is one of four companies that won supplier contracts for seasonal flu vaccines. Sinovac (SVA) is China's premiere vaccine maker that focuses on the research, development, manufacture and commercialization of vaccines that protect against human infectious diseases. Current Vaccines produced by Sinovac include vaccines for Hepatitis A and B, Influenza, and H5N1(Avian Flu) pandemic flu for government stockpiling.

This is reminescent of Novavax's (NVAX) bid to supply Spain's vaccine for H1N1 swine flu. On June 30th 2009 Spanish officials committed €60 million to develop vaccines and establish the country's first vaccine plant to be built in Granada. This news sent the stock up 31% up 0.78 to 3.28. News from that can be found here titled Novavax in multi-million Spanish deal on vaccines. Since this announcement Novavax's stock has climbed to Friday's high of 5.89 +0.24.

Sinovac is a flourishing stock that was trading around 1.50 in April and month by month has a steady climb to today's 6.32 trade value. Q2 2009 saw 20.02M in revenue compared to 6.57M in Q1 2009. Gross profit rose to 16.25M with Net Income of 5.81M and a market cap of 268.12M. Sinovac has 46.70 million in current cash. Total Assets were 116.81M with Total Liabilities of 61.45M. Total Debt rose considerably to 26.30M.

But what about the future of Sinovac? I think that this year's flu season will not reach pandemic state as predicted but a slightly elevated outbreak status. I could be wrong but schools and the public will eventually start taking precautions to stop the epidemic. It will get bad but not as bad as the news is making it out to be. However, I do see the financials of this company improving and it could easily be trading around the 10-12 range during this flu season. However, after that it might drop considerably until the next pandemic arrives.

I think it would be a smart play to place a limit order on SVA at a discounted price and see if it falls a bit before investing right away. A note of caution before investing, there are another 10 Chinese drug companies that will obtain the flu strain samples "NYMCX-179A" from the WHO. China has a total of 11 drug companies that can produce seasonal flu vaccines, but Sinovac Biotech Company is the only one that can make pandemic flu vaccines. They are producing 5 million doses right now and under Pandemic status can produce up to 20 million doses.

A nice look at their previous pipeline and sales data from 2006 can be found here from China Analyst. Recent positive news from their current clinical trial can be found on News-Medical.net from August 19, 2009. The clinical trial is active currently and the estimated completion is January 2010. A closer look at the trial can be found on ClinicalTrials.gov as it is in Phase IV and is seeking approval for Swine Flu H1N1 influenza vaccine.

Another article on Swine Flu was published on USA Today titled US: 160M doses of swine flu vaccine due in Oct. from July 23, 2009. The article discusses Swine Flu vaccines due in October and the rush to get them to the public. It also mentions the state of the Flu season in the Southern Hemisphere.

Disclosure: Long SVA


Mylan Pharmaceuticals Stock Analysis

Mylan Pharmaceuticals (Nasdaq:MYL) keeps coming up on my radar so I would like to take the time to analyze the stock and give some recommendations on it. Mylan is approaching its 52 week high so is it a buy or not? In October 2008, they reached a 52 week low of 5.75 and today is trading at 14.88. So that old adage of Buy Low-Sell High is coming into play. In these economic times many rules of trading are finding exceptions to that rule. Mylan's Financial picture can be found on Google Finance here. I see a good exception to Mylan's future, and see the company's stock rising based on FDA approvals that have come in over the past few months.

I really like the generic market right now. With patents expiring you can literally gauge how much a generic will make based on the patents expiring in the next few months. These generics are the hyenas in a pack of lions that have a good way of scavenging for their food in the Serengeti. The hyena has a distinct relationship with the Lions. The lions kill much of the food the hyena scavenges. But then there are vultures too so we will end this charade and get to the point. They may not come up with the drugs but they are definitely going to make a nice profit from them. But the competition is fierce these days. Some competitors in the generic market include Watson (WPI), Teva (TEVA) , Dr Reddy's Labs (RDY), Hi-Tech Pharmacal (HITK), Par Pharmaceuticals (PRX), and Caraco (CPD).

Recent news has cleared Mylan's name from their Morgantown, WV 483 letter fiasco. Mylan's stock went from 13.85 to 12.10 based on the news on July 27th. The Post Gazette article can be found here titled Adverse reaction: The FDA probes quality control at Mylan. It is funny how quick we come to judgement over initial accusations. With that said, the Pittsburgh Post Gazette published allegations of profound quality control issues that got the attention of the FDA to investigate their plant. No 483 letter was issued and Mylan has since sued the Newspaper over the SOP deviation document stories. FDA cleared Mylan and Mylan Pharmaceuticals Receives Final FDA Report and Reaffirms Its 48-Year Exemplary Record of Quality on August 13th.

But to run a business in a lower economic area like West Virginia can be profitable, if they can handle their quality control issues. They can pay employees less based on the economic value of the area and can make more money. I have seen this first-hand by working outside of Raleigh in a rural area and finding out how much less we were making than those in the RTP area. Anyways, they choose these sites for a reason. I love West Virginia and have rafted the Upper and Lower Gauley myself. People in West Virginia definitely need the jobs.

Anyways, is this company going to make money or not? I say yes. Going through PR Newswire recently, Mylan continues gaining FDA approval for marketing for key generics. Here is a list compiled from the last few months for FDA approvals.

1. August 27, 2009 Mylan Begins Marketing First Generic Version of BenzaClin(R) Acne Treatment

2. August 18, 2009 Mylan's Matrix Receives First and Only Tentative FDA Approval Under PEPFAR for Generic Version of Atripla(R) HIV Treatment

3. August 10, 2009 Mylan Receives FDA Approval for Generic Version of Migraine Treatment Imitrex(R)

4. July 20, 2009 Mylan Receives FDA Approval for Additional Strengths of the Antipsychotic Haloperidol---> Key News from the article. Currently, Mylan has 119 ANDAs pending FDA approval representing $84.7 billion in annual brand sales, according to IMS Health. Thirty-five of these pending ANDAs are potential first-to-file opportunities, representing $16.6 billion in annual brand sales, according to IMS Health.

5. July 16, 2009 Mylan Receives FDA Approval for Generic Version of Thyroid Deficiency Treatment Cytomel

6. July 7, 2009 Mylan Receives FDA Approval for Generic Version of Prostate Cancer Treatment Casodex

7. June 17, 2009 Mylan Receives FDA Approval for Additional Strength of Generic Restoril(R)

8. May 29, 2009 Mylan Receives Tentative FDA Approval for Generic Version of Singulair(R)

9. May 7, 2009 Mylan Receives Final FDA Approvals for Generic Versions of Anti-Rejection Medication CellCept(R)

10. April 14, 2009 Mylan Confirms First-to-File Patent Challenge Relating to Xeloda(R) Cancer Treatment

But with the good I would like to investigate their financials a little closer. They have a Market Cap of 4.54 Billion. For the six months ended June 30, 2009, Mylan reported total revenues of $2.48 billion compared to $2.28 billion in the same prior year period. This represents an increase of $199.3 million or 8.8%. Net revenues increased $174.5 million, while other revenues increased $24.8 million. The increase in net revenues is due to higher third-party sales in all three of the Company's segments. The Generics Segment accounted for the majority of the increase ($131.3 million) followed by the Matrix Segment ($25.2 million) and the Specialty Segment ($18.0 million). On a constant currency basis, total revenues increased by approximately 17%. Their August 3rd quarterly report can be found here.

Revenue is up and gross profit is up too. However, so was their operating expenses. Earnings per share were 0.19, slightly down from Q1, but not a loss. That is good news. I see their generic market for HIV medications as their key growth. President Clinton and Mylan Chairman and CEO Robert J. Coury Announce New Agreement to Lower Price of Treatment for Patients with Drug-Resistant HIV in Developing Countries.

What does it take to get a little respect from google

Enjoy the google girls. Hot chicks are great marketing tools. And it's a break from my normal business posts. Google Girl and Google Apple Chicks of the day.

Well I have reached a nice target audience on Seeking Alpha and my posts have a high page ranking from their site but what does it take to get my blog noticed by google. I just don't know. I'm gonna keep trying though and eventually good things will come.

I post the same articles on this site as I do Seeking Alpha but google neglects to notice my little blog. I am working on creating a new site and getting a web host so hopefully I can get that up and running soon. For those who are following me on here I appreciate the audience. More posts will come. Click on a Google Ad or two. It won't kill ya. Thanks for listening.
BioPharma Investor.

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Gaucher Disease and FDA Fast Track for Protalix

On August 25th Protalix Biotherapeutics announced they have received FDA fast track status for their Gaucher treatment called prGCD. You may not know much about Protalix but they are an Israeli BioPharma which produces therapeutics from plant origins. Teva Pharmaceutical Industries Ltd. and Protalix Biotherapeutics Ltd. have a collaboration agreement for the development of two biopharmaceuticals, based on Protalix's recombinant plant cell expression technology.

After gaining nearly 30% August 17th, Protalix (PLX) is trading right now at 6.04 and was up only 1% today on the news. This could be due to a couple of reasonings.

1. Genzyme will eventually deal with the contamination and begin producing Cerezyme again within 6-8 weeks.

2. Shire Pharmaceuticals (SHPGY)has also been given FDA fast track status. Shire Gaucher Drug Passes Key Trial

3. Protalix had a astronomical stock meltdown in 2007 by having a public offering of only 5/share when shares were trading around 35-40. There was no valid reasoning behind the offering according to Protalix management in 2007

But the good news is that Cerezyme sales where 1.24 Billion in 2008. Gaucher disease is more common in those with Jewish ancestry so being an Israeli company this could help future sales of Protalix's prGCD compound. Currently, the disease is rare and affects around 1 in 50,000 to 100,000 people. The treatment must be taken on a life-long basis. Marketwatch published an article August 18th on the Protalix's David vs. Genzyme's Goliath

David Aviezer, the chief executive of Protalix, said in an interview on Tuesday that many doctors around the world have asked his company to supply them its medicine, due to shortages of Cerezyme. "Plant cells cannot be affected by human or mammalian viruses, like incidents that happened with Genzyme," he said. "We have a built-in biological firewall protecting against such situations." Aviezer said recent actions by the FDA, in approving the compassionate-use protocol and granting prGCD fast-track status, suggest the agency considers prGCD "a valid option." "We're confident in the way the drug is moving ahead, and are confident in our ability to compete with Cerezyme. We're building up our credibility."

Reuter's announced on August 17th the Protalix update for the approved treatment protocol. Another update was announced on August 25th for the FDA's Fast Track Status. Protalix Chief Executive David Aviezer says, "We expect to conclude our Phase III pivotal study next month and are looking forward to announcing top-line results from this study in October. We anticipate filing an NDA with the FDA by the end of this year."

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Market Rumors Human Genome Sciences as a takeover target

Rumors of Glaxo's takeover of Human Genome Sciences for $30/share have pushed the stock up considerably today. Human Genome Sciences stock (HGSI) was up $2.03 to $19.21 per share in afternoon trading with a gain of 11.79%. Aftermarket trading is up +0.46 to 19.66, another gain of 2.40%. I see this as only a rumor but it does make some since as Human Genome and Glaxo have been partner's since 1993. Human Genome Sciences worked together and received royalties from Glaxo in 2006 for the Diabetes medication Syncria. April 2008 saw HGSI reacquiring the rights for the HGS-ETR1 and HGS-ETR2 oncology programs from Glaxo.

So what is going on here? Has Glaxo seen results from their second set of pivotal Phase III trial and are ready to make a deal? Results are set to be released in November for their Lupus drug BENLYSTA. HGSI press releases from their website can be found here Benlysta Results. For more takeover target information check out the Washington Biz Journal's article HGSI:a takeover target?. MedicalNewsToday posted an article in June announcing the Lupus drug's positive results on Benlysta.

Regardless, I see this as positive financial news for Human Genome Sciences which once traded in March around 0.45. I'm not sure I believe the hype in the rumor but I do like the news coming in and anticipation for results in November. Many analysts see this stock as undervalued and have a target range around 26/share.

Human Genome Sciences has declined to comment on the rumor. Human Genome corporate leaders have stated in the past that they are seeking independence in approval of these 2 trials and have no reason to change that. This was quoted by CEO Tom Watkins in July: “We’re really focused on getting the drugs to patients. We think we have the capability and wherewithal to do it on our own, and we don’t see any reason why that would change.”

With that said I don't know. I've seen CEOs take the money and run but I don't think this is the case. Just a hunch. Rumors have surrounded Spectrum Pharma as a takeover target for Bayer AG recently and those did not fall through either. It is a good marketing tool to push the stocks price up and it works pretty well. Needless to say I like Human Genome's chances with their Phase III results in November. I do see the stock price going higher with positive results and after all is said and done with this rumor I see the price will value out and be a good buy. Just a reminder not to chase stocks. Buy at a valued price and good things will happen.

Disclosure: Long Human Genome Sciences


Big Money in Swine Flu Stocks

Today was a good day for Swine flu stocks. Most small caps were up 5 to 10% today alone. So lets go over today's Swine Flu winners. Many investor's still think this is a lot of hype but with Flu season coming around the corner, I see things only getting worse. I have been a Microbiologist by trade and do see this as an outbreak, maybe not a pandemic, but anything is possible. The US government is spending Billions on getting vaccines ready for Flu Season. I am only including the small caps here but Novartis, Glaxo, Baxter, Roche and Gilead are the big players in the market.

BioCryst Pharmaceuticals (BCRX) 12.60 +2.55 up 25.37%
Hemispherx Biopharma (HEB) 2.22 +0.32 up 16.84%
Sinovac Biotech Ltd. (SVA) 5.47 +0.54 up 10.95%
Novavax, Inc. (NVAX) 5.21 +0.45 up 9.45%
CEL-SCI Corp. (CVM) 0.475 +0.0273 up 6.10%

All this is based on a report out from the President's Panel earlier today. The Washington Post article is titled Swine Flu Could Infect Half of U.S. Population, Report Says. Understood is the fact that no one can predict how good or bad the Flu season will be, but I see it above average at minimum. Most schools and colleges are starting back in the next couple of weeks if not already and anyone with kids knows how easy germs spread with children. Colleges are just the same. Colleges can be breeding grounds for these outbreaks to occur.

Most of these profits are on hype and you should take caution with investments based on volatility alone. However, I see these as strong buys coming into flu season. Wait for them to come down just a bit before investing with a limit order at a set price. As always, do your homework and check the companies financial information before investing.

Doing some research on the H1N1 outbreak here are some good links.

CDC's 2009 H1N1 Flu (Swine Flu)

CDC's Weekly Flu View

Google News Search Swine Flu

CNN Swine Flu Goes To College

Google News Search H1N1

Southern Hemisphere's swine flu experience holds hints of what may be ahead

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Novartis recieves $690 million order for H1N1

Swiss company Novartis (NYSE: NVS) received an order for $346 million for antigen and $343.8 million for adjuvant totalling $690 million in July. Currently, Novartis is building a vaccine facility in Holly Springs and is hiring right now for validating the buildings and getting them up and running. So there are plenty of jobs created from their vaccine business and profits to come. Validation of buildings and facilities can be a pain-staking process but I expect them up and running by late 2009 Q4, if not sooner.

Current trading for Novartis is up around the 44-46 range. This is from their low point earlier this year with the global economic downturn, where their stock was trading around their 52 week low of 33.34. Their 52 week high is 56.23. It achieved this level twice in August 2008 and November 2006. So they are about midway to their highpoint and that is good news. I really don't see why a year from now they wouldn't be trading in the 60 point range again if not sooner. They have a healthy order of 690 million from the US government and are the striving to be the top vaccine maker in their sector.

What I like most about Novartis is that they have 337 open studies actively recruiting patients according to ClinicalTrials.gov. This is where their future lies. According to their website Novartis.com they have 155 projects in various stages of clinical trial. Here is a link to their 2009 and >2012 Novartis Pipeline. Most importantly, there are over 40 biologic molecules in the Novartis pipeline, and Novartis Biologics is growing. Roughly, 25% of their pipeline is in biologics. This is healthy for profits and for Novartis' future.

August 17, 2009 found FDA approval for the drug Extavia® (interferon beta-1b), the first in a new planned portfolio of multiple sclerosis (MS) medicines from Novartis to help patients manage this devastating disease. Extavia will be available to patients in the US this fall. The European Union has already approved Extavia in 12 countries.

Looking over their financials they are in good shape for the future. Most importantly, they own Sandoz, their $7.6 billion in 2008 sales Generic drug manufacturer. This is key for the future as many drugs are expiring and entering the generics market. They have a current market cap of 103Billion and 2Q 2009 profits of 2.044 billion and earnings of 0.90 per share. This wasn't as high as expected due to the fall in the dollar. Read more about the second quarter prospectus here: Novartis Q2 2009 Report. Although the global economic crisis was going on Novartis increased sales in various sectors. Most impressive sales included the oncology market and Diovan, a high blood pressure medication. Full sales data for Novartis can be found here for 2008: Novartis Product Sales

Gleevec/Glivec (USD 1.9 billion, +15% lc), a targeted therapy for certain forms of chronic myeloid leukemia(CML) and gastrointestinal stromal tumors (GIST), has achieved sustained double-digit growth based on its leadership position in treating these cancers backed by new clinical data and regulatory approvals. Glivec received European regulatory approval in May 2009 as a post-surgery (adjuvant setting) therapy for GIST following Swiss (February 2009) and US (December 2008) approvals.

So I really like the future and growth of Novartis. At their mid range of 45.49, I see it as a buy with long-term potential and plenty of room to grow for the future.

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Doing the Math on Merck's merger with Schering

I was doing some homework on the Merck-Schering merger and thought what would you make if the deal took place today. Merck and Schering-Plough expect to complete the transaction in the fourth quarter of 2009. The details of the merger states for every 1 share Schering, shareholders would receive 0.5767 shares of Merck + 10.50 in cash. You have to look back at March to see Schering's price in the 15-20 range. Investors who got in early and had Schering stock then are doing ok with the deal, but for those looking at the prices today be careful. I wouldn't be buying up Schering shares right now just to get some Merck stock.

So lets calculate this at today's rates. Schering closed at 28.24 (however after hours has dropped to 27.38) and Merck closed at 32.56 (dropping to 32.21 afterhours). 100 shares bought of Schering is $2824. 0.5767 X 32.56 of Merck is 18.78. 18.78 x 100 is $1878. Plus %10.50 x 100 is %1050. So 1878 + 1050 is $2928. A net profit of (2928-2824) $104. So you are receiving considerably less equity with only 57.67 shares of Mrk and 104 bucks in your pocket. For a thousand shares Schering you would make 1037.35 but would have to fork out $28240. The deal would net you a profit of 3.67%. Hmmm 3.67 percent is the going savings rate these days at the bank.

Is it really worth the trouble here? I really don't know. Merck does have a higher yield dividend than Schering but unless you are a huge owner of Schering shares I don't see the value in buying up a ton of Schering stock at this price. If the stock for Schering goes any higher I can actually see some losing cash. So unless Merck's share price goes up considerably in the next few months I'd say put your money in the bank or buy some nice bonds these days. Sure Scherings price was a lot lower in March in the lower 15 dollar range but for investors getting in late on the deal it's not worth it.


Go Go Gadget Spectrum

Spectrum Pharma has a new article on BioMedReports.com. The article states that a decision on SPPI's(Nasdaq:SPPI) drug Zevalin should have a decision made on September 7th. The article tagged Spectrum Pharma can be found at the following link: Spectrum Pharma The Labor Day Catalyst

This is good news for investors looking for the next breakout stock. Trading at around 6.30 earlier today and currently +0.19 at 6.47. Every analyst predicts if approved this could rocket the stock up to around 20-30 point range over the next year. Also, with acquisition rumors bumping the stock up too, I really see this as the opportunity to invest in a breakout winner. My only caution is that the FDA has recently tabled Savient(SVNT), Matrixx Initiatives(MTXX), and Dendreon (DNDN). This was pointed out exclusively in another article on Seeking Alpha titled 3 reason's not to predict FDA action.
One company left out of that list is Hemispherx Bio (HEB) Hemispherx has been trying to have their drug Ampligen for Chronic Fatigue Syndrome and was initially reviewed for approval. Hemispherx is struggling to stay afloat while waiting for this delay in approval. Hopefully good news will come this fall.

Spectrum should be granted approval for non-Hodgkin’s lymphoma (NHL) radio-immunotherapeutic (RIT), Zevalin. Also note that it has already been approved for a last resort for NHL but they are seeking approval as a first line consolidation therapy. They are working on the disuses of Zevalin in treatment with Physicians and pricing concerns with Medicare. Good news came in Q2 2009 with a 25% increase in sales.

These are great indicators to investors that they are doing everything possible to generate a profit and keep Zevalin a success. They are working on raising their market cap into the billion dollar range and have worked with their sales force to market the drug better. These are all excellent indicators for growth and success as an organization and the potential for acquisition from Big Pharma. I am sure Cell Therapeutics is kicking themselves for having to sell their stake in Zevalin in February. Read more about that here: Cell Therapeutics sells remaining stake to Spectrum 022009

Investment Report for Spectrum Pharmaceuticals Inc. >(SPPI)

Spectrum Pharmaceuticals Inc. (SPPI), a commercial-stage biotechnology company with a focus on oncology, develops and commercializes a portfolio of drug products. Its marketed products include ZEVALIN, a form of cancer therapy called radioimmunotherapy for the treatment of non-Hodgkin’s Lymphoma (NHL), and FUSILEV, which is indicated after high-dose methotrexate therapy in patients with osteosarcoma.

The Company is also developing apaziquone for the treatment of non-muscle invasive bladder cancer. Its phase II products include Ozarelix, a drug being investigated for benign prostatic hypertrophy (BPH), a non-cancerous enlargement of the prostate, and hormone dependent prostate cancer; and Ortataxel, a third-generation taxane.

The Company was formerly known as NeoTherapeutics Inc. and changed its name to Spectrum Pharmaceuticals Inc. in December 2002. Founded in 1987, SPPI is based in Irvine, California.

Financial Summary

SPPI grew revenues 274.41% from $7.67 million to $28.73 million, year on year, while net income improved from a loss of $34.04 million to a smaller loss of $15.47 million.

In 2008, the Company increased its cash reserves by 764.15%, or $8.72 million. Cash Flow from Financing totaled $41.50 million or 144.47% of revenues. The Company used $8.01 million for operations while cash used for investing totaled $24.78 million.

SPPI has a Debt to Total Capital ratio of 0.37%, little changed from the previous year’s 0.00%.

On May 18, 2009, the Company reported first quarter 2009 earnings of $0.02 per share, exceeding the -$0.11 consensus loss of the two analysts covering the company, and underperforming last year’s first-quarter results by $0.30. First quarter 2009 revenues came in at $14.16 million, better than the $6.93 million consensus of the two analysts covering the Company, and 75.96% above the prior year’s first-quarter results.

The next earnings announcement is expected August 17, 2009


Top 10 Drug Sales Charts and Forecasts 2014 & Generic Drug Superstars

Recently a top 10 drug list was forecast for the year 2014. 5 years down the road. So lets take a look at them. The list was provided by Evaluate Pharma and its a great tool for forecasting stock futures. The list is not perfect. The ones at the top tend to stay there for a reason. Nonetheless, I like the forecast. It's heavy on the Biotech sector and most on the 2014 forecast list are Cancer Therapeutics. Biotech is set to go from 28% of sales today to close to 50% in 2014. Seven of the top 10 drugs in 2014 are forecast to be biotech in origin. This is especially important with pharmaceuticals as biologics are hard to make into generics.

Patent law changes could occur and drug makers are forced to come up with new ways to generate profit. So it's really important to forecast when patents expire and also include generic makers into this list. Teva, Watson(WPI), Mylan(MYL), , K-V, Hi-Tech(HITK), Caraco(CPD), and Sandoz are some of the major generic makers today. Projected sales for the year 2012 are around $30 Billion. My only problem with generic makers, recently has been their quality contol issues. Both Mylan and Caraco have had major setbacks with the FDA this year. If they can control this they should be fine. Often quality control issues and deviations can really hurt companies and must be addressed quickly and ethically.

Major hits to big pharma include the following.

1. Fentanyl--Mylan
Launched: January 2005
2008 sales: $900 million
Branded equivalent: Duragesic, by Janssen (JNJ), 2008 sales of $1.1 billion

2. Amlodipine besylate and benazepril hydrochloride---Teva
Launched: July 2007
2008 sales: $779 million
Branded equivalent: Norvasc, by Pfizer (PFE, Fortune 500), 2008 sales of $2.2 billion

3. Metoprolol succinate---K-V
Launched: May 2008
2008 sales: $675 million
Branded equivalent: Toprol, by AstraZeneca (AZN), 2008 sales $807 million

4. Lamotrigine---Teva
Launched: February 2005
2008 sales: $671 million
Branded equivalent: Lamictal, by GlaxoSmithKline (GSK), 2008 sales $1.6 billion

6. Omeprazole---Watson
Launched: July 2008
2008 sales: $609.8 million
Branded equivalent: Prilosec, by AstraZeneca, 2008 sales $1.1 billion

7. Azithromycin---Teva, & Sandoz
Launched: November 2005
2008 sales: $599 million
Branded equivalent: Zithromax, by Pfizer, 2008 sales $429 million

8. Budeprion---Anchen, IMPAX Laboratories, & Teva (Joint Effort although new lawsuit pending)
Launched: December 2006
2008 sales: $521 million
Branded equivalent: Wellbutrin, by Biovail (BVF), 2008 sales $579 million

With that said of generics, Big Pharma will find ways to address and consolidate their earnings, including buying up generic makers. The next wave of mergers could be in the generic industry. We will have to see. But biologics are where the future lies. Biologics are tough to reproduce and Big Pharma is finding ways to improve their current patents and processes.

One example that I have seen is Talecris' viral inactivated therapeutics of some of thier processes to insure safety of their product and essentially marketability. If Big Pharma can make ways to improve their medication then they can keep making a profit. Look for Talecris' IPO in the near future. Their products are derived from Human Blood Plasma. The various proteins extracted from plasma can be used to treat a variety of diseases including immune deficiencies, genetic emphysema, and hemophilia. This viral inactivation process is key to their marketability and profits. Check out their pipeline at the following link: http://www.talecris.com/talecris-research-development-pipeline.htm

Now its charts charts and more charts. But the charts should help you in your forecasting for your own stocks. I like Roche,Novartis and Pfizer. I also think that Merck will be a huge player in the future with the acquisition of Schering-Plough and Schering's recent acquisition of Organon Biosciences. Schering has added a nice pipeline with their acquisition and now Merck will reap the benefits of this. Do not forget to look at the top 10 R&D chart. It's key to understanding and forecasting. Blockbusters can be made overnight through good R&D.

The Roche-Genentech takeover will be huge as Biologics will become the drugs of the future. Genomic science is key to understanding and creating new drugs and Genentech is king in the Genomic world. The only shocker that could top Roche would be a Merger between Pfizer and Novartis. Or really Novartis and anybody in the top 10. Pigs will fly and OJ will go to jail. Oh wait OJ is already in jail. Lets just wait and see.

NOTE: Click on the Chart If It Is Hard To See.
Here are the top 10 products by sales for 2008

And now here are the top 10 products forecast for 2014

Top Drugs and their estimated expiration date through 2012

Top 15 Companies estimated from 2007 for 2014

Top 10 Oncology Sales from 2007 forecast for 2014

Top 10 Research and Development by Therapeutic Area

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10 Rules of Investing BioPharma

So the stock market has taken a beating the past two sessions and investors are panicking. What to do???

Here it is, the 10 Rules of Investing Biopharma.

Here's my advice on the stock market. With sessions down right now its a good time to buy people. Trust in your investments. Stocks always tend to take a beating in the spring and summer months. That's just history speaking. But no need to panic.

10 Rules of Investing BioPharma

1. Do your homework.

2. Resist the urge to constant buying and selling

3. The age old adage, Buy Low-Sell High.

4. Follow the Clinical Trial Process.

5. Don't stock chase your investments.

6. Reinvest your profits. Be Frugal.

7. Seek out proven winners.

8. Beware of the pump and dump!!!

9. If you don't understand the stock sector don't invest in it.

10. Only invest what you are willing to lose.

With that said lets look a little closer at my advice and what it means.

1. Do your homework.

There are plenty of research tools available on the internet. Use them to your advantage. Sites like Google Finance, Yahoo finance, Marketwatch, Forbes, Bloomberg, Wikinvest are great sites. A business professor of mine suggested a subscription to the Wall Street Journal and follow it for a year before investing. Look up a quote and find news wires and check their financial information. For the biopharma market seek biopharma specific sites. SeekingAlpha is great. BioMedReports, MedicalNewsToday, the whole line of FierceBiotech/Pharma. PR Newswires and Reuters are good newswires to give you up to the minute information. Warren Buffet's BusinessWire is a great tool. I stick to Healthcare sites and BioPharma sites for obvious reasons. It's what I'm good at and it is what I know the best. Find your market sector and stick to it.

But if you are new to the game. Take some business finance classes at a local college. These can help you understand the investment lingo, and the balance sheets and see where companies are hurting or if the are actually making a profit. For BioPharma, learn about the Clinical Trial Process and what the different phases mean. Understand the risks too of those Clinical Trials. Read up on Clinical Trial Data. Go on the FDA's website and look for drugs in the pipeline and drugs that have been approved for various clinical trials.

2. Resist the urge to constant buying and selling.

OK many people think day trading is where it's at but you can't make sound investments overnight. Yeah it might go up that day, but after the hype it tends to settle off. Buy and hold for long term investment is the key to making a profit for later on. Investments are meant to be held for over a year. That's really how you make your profit. 10 years from now you will be kicking yourself when you find that your stock you sold now is making a big name for themselves and you sold out a long time ago. You should seek out stocks for dividends. Dividends are what you can retire on someday and can sit back and drink Pina Colada's in the Caribbean with your special someone while still earning an income. I haven't reached that level yet but I'm working on it. It really does take money to make money. You need capital for these investments so that you can really buy large quantities of these great stocks and earn a hefty return on your investment.

3. Buy Low-Sell High.

Good lord how many times do we have to say it. If a stock is reaching its 52 week high, it might go up but for how long. Some make it, but the market fluctuates over time. It goes up and down. You have to learn to read the charts and see a trend. Buy in the trough of that trend. Sell at its peak. But when investing in small caps and penny stocks, its hard to see that trend. The company is struggling to reach that 15 to 20 to 30 point range so it takes time. Buy when the stock is down. For example, buy today after the market took a pummeling. Most stocks went down today. Buy Buy Buy!!! Seriously, learn about limit orders and stick to your guns. Buy when they take a hit. You will shoot yourself in the foot if you don't. With Biopharma stocks this isn't always the rule though. To some extent but not always. Stocks like google have shown that sometimes that stock really never comes down.

4. Follow the Clinical Trial Processes.
Companies with Multiple Clinical trials are the answer. Pfizer I think has like 1600drugs in clinical trial right now. Glaxo has 1800. Novartis has 1300. You get the picture.

It comes down to the clinical trials and the drug data. Will that drug be approved? Will it fail? Will it be approved and suddenly someone dies from that medication and there are huge lawsuits to be settled? Most investigative drugs fail. It's very close to 1 in a 1000 that make it for approval. Throughout the clinical trial process many fail in Phase I and II. Out of that there usually is a 10% failure in Phase III. This is important to know. ClinicalTrials.gov is a good site to find some helpful info on drugs in the pipeline.

5. Don't stock chase your investments.

Stock chasing is when you try to get in when it's too late. Chasing that stock. It can be a risky gamble. You invest on that Hot Tip.

Many people think stock market investing is all about getting good tips. But this is a fool’s game—better for fun and stimulation than for producing meaningful long term growth in your stock market portfolio.

The financial media is full of stock market investing tips. Go to any newsstand and you can find magazines full of interesting company profiles and interviews with investment advisers offering their latest hot stock market tips.

If your investing orientation is pursuing hot tips, most stock market brokers will happily play your game. It’s their business to push certain stocks that their firms want to sell; and it’s easy to justify their commissions when you think you’re investing in a hot stock that could soar in value.

6. Reinvest your profits. Be Frugal.

These are some of Warren Buffett's Golden Rules. Keep investing. Stock trading should be done for long term investments. Read up on his strategies and be a stock trading superstar. He didn't become a billionaire by going out and buying a new car or playstation after every successful trade.

Be frugal. Save Save Save. If we have learned anything buy this economic crisis in America, it's that we are not saving enough. Save 10-15 percent of your income is a good rule of thumb. Use your companies 401k plan and at minimum use the company match of 6 percent. Stock investments can be a good saving tool for the future. But when you have made a profit, buy more or buy different stocks. Diversify your portfolio and seek dividends for early retirement.

If you already have a 401k plan, start an IRA. Open a online trading account. There are plenty to choose from. Roth IRA's are very popular and tax friendly. But continue to save and reinvest. It's the only way to generate more capital. It really does take money and capital to make money. You can start small, Buffet invested at an early age but he used these principles to get where he is today.

In Buffett’s own words:
I’m 15 percent Fisher and 85 percent Benjamin Graham. (Buffett's Mentors at Columbia University)
The basic ideas of investing are to look at stocks as business, use the market's fluctuations to your advantage, and seek a margin of safety. That’s what Ben Graham taught us. A hundred years from now they will still be the cornerstones of investing.

7. Seek out proven winners in management.

Good management goes a long way. Large cap BioPharma companies got there for a reason. They know what they are doing. They have large capital to buy small companies and ideas. But the same applies for small cap. A good CEO and finacial team can ride out the tough times. Many small companies are hiring proven management teams from these large companies and paying them large salaries. This is why Forbes has a list. Look into their lists and see why these executives get paid the big bucks. Especially now with so many mergers and corporate takeovers.

I worked under Fred Hassan at Schering-Plough. He can take a company, mold it and transform it and then sell it to Merck for a huge profit. I didn't like it but hey I can't blame the guy. But he did that for years at Sandoz and Wyeth. Why would he stop now. Others include James Cornelius CEO, Bristol-Myers Squibb, Richard Clark CEO, chairman, and president, Merck & Co., and Tony Zook CEO and president, AstraZeneca US. But there will be others. Look into who is working for the company. See what their credentials are.

This also goes with Ethics. Pharmaceuticals are governed by the FDA. Falsifying data, clinical trials, and critical financial information can really hurt the investor.

8. Beware of the pump and dump!!!

Ah the great investing Pump and Dump. Its been around for decades and now with the information age and internet it's thriving like the plague. It's like Bernie Madoff and his Ponzi Scheme. It's been around for a long time and we fall for it every time. It's really just hype. A company gets great marketing tools available and markets the hell out of the stock. We read these articles and are like Whoa, I gotta have it, I have to get in now. The NY times prints an article, CBS does a 60 minute special, Yahoo has it all over the internet. The stock goes up and up. Hits a peak, then crashes and burns in flames. Sometimes it's legitimate information. But these weasels are in serious debt. They have to find a way to keep their investor's happy so they come up with a great Pump and Dump scheme. This usually is for Penny Stocks and Small Caps. Most large cap stocks are legit. But beware!!! All that hype will bite you in the A@@ so fast you will go home crying to mommy. Where's my money?

Best advice do your homework, check their financial information, and look into their clinical trial data. But just be aware that it's out there. I've been watching Pawn Stars on the History Channel and they are good at seeing through the hype and spotting a fake. Trust no one. Just because so and so said it, doesn't make it true. The Pawn Stars have experts to come in and evaluate what's real and what's fake. But it's the same with the financial world too. And even the experts get burned too. So just use your got. Don't stock chase and look at the charts before you buy into the hype.

9. If you don't understand the stock sector don't invest in it.

I modified Buffett's rule number one of investing from business to stock sector. Hey pick a sector and run with it. Mine is the Health/BioPharma industry. I know the ins and outs of Biotech/Pharmaceutical industry. I have worked for Contract Manufacturing companies and see what goes on and the business behind it. I have a degree in Biochemistry and understand the science. I have worked on Clinical trials and know the process. That's me. That's what I do. But it's my passion and it is what I understand. I'm not on here just hyping companies up that I know nothing about. I think I have proven that.

I know a little bit about the other sectors but I stick with BioPharma. I know that I can find new companies and new investments at anytime and there are great opportunities out there. I know the Big Pharma's are stocks you can retire on with high dividends. With the science today it's a good time for the BioPharma industry. But find a sector and stick to it.

10. Only invest what you are willing to lose.

This probably should be rule number one, but as with many things a 1 and a 10 can mean many things on different scales. Do not invest any money that you are not willing to lose everything. Clinical Trials fail, stock markets crash, terrorist fly planes into the World Trade Center. It's a risky choice to make. Don't invest your lunch money if you aren't willing to go hungry. The market is not a get rich quick scheme. I promise. The market does tend to go up, but as with the financial times right now, anything and anything can go belly up. Just look at Bear Stearns, AIG, all the TARP banks, and the car companies. This is a good time to get in, don't get me wrong, but if a dirty bomb goes off in the US, the market will fall. We are at war, and in a long term recession. Marshall law might not be declared tomorrow but Russia is back in the game. They have resumed their Cold War bombing raids and anything can happen.

But if you are willing to take that risk, you have a least a chance for success. Same with Poker, Same with the Lottery, and Same with Wall Street. Anything can happen.

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Human Genome Sciences Lupus Drug looks promising

Breaking News for Human Genome Sciences. Lupus drug mets primary endpoints for Phase III clinical trials. I like the stock. I see genomics research as the future for the Biotech industry and Lupus is a debilitating disease that is life threatening. This is promising news for investors and I see this as a good long term investment. HGSI

From MedicalNewsToday.com
Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced its Phase 3 clinical development program for LymphoStat-B(TM) (belimumab) in patients with active systemic lupus erythematosus (SLE).

"Advancing LymphoStat-B to Phase 3 development is a critically important step in the evolution of HGS into a commercial organization," said H. Thomas Watkins, President and Chief Executive Officer, Human Genome Sciences. "We have worked closely with our collaborator GlaxoSmithKline over the past months to analyze and assess the data from our Phase 2 study, and we share a vision of the important role that LymphoStat-B may play for patients with SLE."

HGS designed the Phase 3 program in collaboration with GlaxoSmithKline (GSK) and leading international SLE experts, and expects to initiate Phase 3 trials of LymphoStat-B before the end of 2006. HGS has met with both the U.S. Food and Drug Administration (FDA) and the European Agency for the Evaluation of Medicinal Products (EMEA), and has received agreement on the major components of the Phase 3 program, including the primary efficacy endpoint, target patient population, and dose selection. HGS plans to submit the final LymphoStat-B Phase 3 protocols to FDA soon for a Special Protocol Assessment (SPA).

"We are encouraged by our discussions with regulatory authorities both in the U.S. and in Europe, and by their positive response to our proposed Phase 3 trial design, especially the target patient population and primary efficacy endpoint," said David C. Stump, M.D., Executive Vice President, Drug Development, Human Genome Sciences. "The design of the LymphoStat-B Phase 3 development program includes a primary efficacy endpoint that emerged directly from the results of our Phase 2 clinical trial. The endpoint is a combined patient response rate that includes elements of the SELENA SLEDAI and BILAG disease activity indices, as well as the Physician's Global Assessment index. These measures are well known to clinical investigators with experience in SLE. The Phase 2 results show that LymphoStat-B, as measured by this combined response rate, significantly reduced disease activity in serologically active patients. We look forward to moving ahead with site activation and patient enrollment over the next few months."

"It has been nearly forty years since a new drug has been approved by the FDA for lupus," said Sandra C. Raymond, President and Chief Executive Officer, Lupus Foundation of America. "Lupus is a life-threatening and devastating chronic illness. We need safer and more effective therapies. We will be following the LymphoStat-B Phase 3 clinical trials with great interest, both because of the significant unmet medical need that exists and because LymphoStat-B is being studied as a treatment for the underlying disease of lupus, rather than for the treatment of individual symptoms."

About the Design of the LymphoStat-B Phase 3 Development Program

As proposed by HGS, the Phase 3 development program for LymphoStat-B will include two double-blind, placebo-controlled, multi-center Phase 3 superiority trials that will evaluate the efficacy and safety of LymphoStat-B plus standard of care, versus placebo plus standard of care, in the treatment of patients with active SLE. The primary efficacy endpoint of both studies is the patient response rate at Week 52, as defined by: a reduction from baseline in the SELENA SLEDAI score of at least 4 points; no worsening in Physician's Global Assessment (with worsening defined as an increase in PGA of more than 0.30 points from baseline); no new BILAG A organ domain score and no more than 1 new BILAG B organ domain score from baseline.

The total duration of the two studies will differ, at 76 weeks and 52 weeks, respectively. Aside from duration, the two studies will have similar protocols. In each of the two Phase 3 trials, approximately 810 patients will be enrolled and randomized to 1 of 3 treatment groups (1 mg/kg LymphoStat-B, 10 mg/kg LymphoStat-B, or placebo). Patients will be dosed intravenously on Days 0, 14 and 28, then every 28 days. To be eligible for enrollment in the Phase 3 trials, patients must be serologically active, with unequivocal antinuclear antibody (ANA) test results assessed at 2 independent time points (HEp-2 ANA > 1:80 and/or anti-dsDNA > 30 IU/mL). Patients also must be on a stable SLE treatment regimen for a period of at least 30 days prior to Day 0.

Important secondary endpoints will include the patient response rate at Week 76, the SF-36 Health Survey physical component summary score, fatigue measures, and the percentage of patients with reduction from baseline in average prednisone dose at Weeks 40-52. Safety and tolerability will be evaluated by an independent Data Monitoring Committee throughout both studies.

About the Phase 2 Trial Results Reported in June 2006

In June 2006, HGS reported the full presentation of data from a Phase 2 clinical trial of LymphoStat-B in 449 patients with active SLE. The Phase 2 study was designed as a randomized, double-blind, placebo-controlled, dose- ranging superiority trial to evaluate the safety, tolerability and efficacy of LymphoStat-B plus standard of care, versus placebo plus standard of care. Participants were randomized to receive one of three different doses of LymphoStat-B or placebo (1, 4 or 10 mg/kg) administered intravenously over a 52-week treatment period, in addition to standard-of-care therapy.

The Phase 2 results show that LymphoStat-B produced statistically

significant reductions in disease activity versus placebo, exhibited clinically relevant biological activity, and was safe and well tolerated. Among the Phase 2 study findings was a significantly improved response rate among seropositive patients at Week 52, as defined by an improvement in SELENA SLEDAI score of 4 points or greater, no BILAG worsening, and no worsening in Physician's Global Assessment (46% for LymphoStat-B versus 29% for placebo, p<0.01). (Seropositivity is defined by baseline HEp-2 ANA >1:80 and/or anti- dsDNA >30 IU/mL.) The Phase 2 results support the further evaluation of LymphoStat-B in Phase 3 clinical trials.

About the Collaboration with GSK

In July 2005, GSK exercised its option under a June 1996 agreement to co- develop and co-commercialize LymphoStat-B with HGS throughout the world. HGS and GSK have now entered into a definitive co-development and co- commercialization agreement under which HGS will have responsibility for conducting the LymphoStat-B Phase 3 trials, with assistance from GSK. HGS will receive a $24 million payment from GSK in the third quarter of 2006, in consideration of GSK's right to co-develop and co-commercialize LymphoStat-B. The companies will share equally in Phase 3/4 development costs, sales and marketing expenses, and profits of any product commercialized under the agreement.

About LymphoStat-B

LymphoStat-B is a human monoclonal antibody that specifically recognizes and inhibits the biological activity of B-lymphocyte stimulator, or BLyS(TM). BLyS is a naturally occurring protein discovered by HGS that is required for the development of B-lymphocyte cells into mature plasma B cells. Plasma B cells produce antibodies, the body's first line of defense against infection. In lupus, rheumatoid arthritis, and certain other autoimmune diseases, elevated levels of BLyS are believed to contribute to the production of autoantibodies -- antibodies that attack and destroy the body's own healthy tissues. The presence of autoantibodies appears to correlate with disease severity. Preclinical and clinical studies demonstrate that B-cell antagonists can reduce autoantibody levels and help control autoimmune disease activity.

LymphoStat-B is a Human Genome Sciences drug, created through a collaboration with Cambridge Antibody Technology. It has received a Fast Track Product designation from the FDA for its potential use in treating SLE and has been selected for participation in the FDA's Continuous Marketing Application Pilot 2 Program.

About Systemic Lupus Erythematosus

Systemic lupus erythematosus (SLE) is a chronic, life-threatening disease. Between 200,000 and 500,000 people are diagnosed with SLE in the United States alone. The Lupus Foundation of America estimates that approximately 1.5 million Americans suffer from various forms of lupus, including SLE. Lupus can occur at any age, but appears mostly in young people between the ages of fifteen and forty-five. About 90 percent of the individuals diagnosed with lupus are women. African-American women are about three times more likely to develop lupus, and it is also more common in Hispanic, Asian and American Indian women. Symptoms may include extreme fatigue, painful and swollen joints, unexplained fever, skin rash, and kidney problems. Lupus can lead to arthritis, kidney failure, heart and lung inflammation, central nervous system abnormalities, inflammation of the blood vessels, and blood disorders. For more information on lupus, visit the Lupus Foundation of America at http://www.lupus.org, or the National Institute of Arthritis and Musculoskeletal and Skin Diseases at http://www.niams.nih.gov.

From BioMedReports

Human Genome Achieves Lupus Drug Goals With DSG's EDC
Sunday, 16 August 2009 22:30

MALVERN, Pa.--Human Genome Sciences (HGS: NASDAQ: HGSI) announced that BENLYSTA™ met the primary endpoint in BLISS-52, the first of two pivotal Phase 3 trials in patients with serologically active systemic lupus erythematosus (SLE). These results show that BENLYSTA™ has the potential to become the first new approved drug in decades giving hope to people living with systemic lupus. DSG supports HGS on four global Phase 3 studies concurrently, providing data capture and supporting data management through its function rich eCaseLink™ EDC software.

“Our clinical trial data management and collection process is essential in a large and complex Phase 3 trial. DSG’s technology leadership and project management ensured that our subject data was accurate, complete and timely,” said Pierre Verroye, Executive Director of Clinical Data Management and Clinical Programming, HGS. “This was our first experience with EDC and DSG really helped lead the way. During the live study, DSG solved emerging, unprecedented challenges through innovation and by adding completely new functionality to HGS’ system. Sites and CRAs gave us a lot of positive feedback about the eCaseLink™ system.”

The study included nearly 400 electronic case report forms per subject, which were highly complex in design and had nearly 1,200 edits per screen. DSG provided critical data reporting tools based on study requirements, allowing HGS data management personnel to continually monitor and efficiently insure data quality.

HGS used DSG’s proprietary Data Management Dashboard within eCaseLink™ to rapidly identify any outstanding items needing attention during the global database lockdown. The DM Dashboard, developed with HGS to fill their unique needs won the 2008 Society for Clinical Data Management (SCDM) Data Driven Innovation Award and is now an integral part of DSG’s eCaseLink™ product.

DSG software allowed HGS to integrate a licensed Clinical Trial Management System (CTMS), and a third-party Interactive Voice Response System (IVRS) with eCaseLink™, ensuring an efficient and timely exchange of critical information.

“We are extremely pleased and excited to hear that HGS continues to make headway toward controlling SLE and has placed its faith in the technology and experience of DSG. We feel very proud not only being associated with this success but also for being a critical part of its success,” said Tony Varano, CEO, DSG, Inc. “DSG currently supports HGS with our global experience and presence on four Phase 3 studies concurrently with eCaseLink™ software. It’s very satisfying to solve such a complex problem with such a high level of technological sophistication and support service. The end result is a database lock that went very well and according to plan.”

About Systemic Lupus Erythematosus

Systemic lupus erythematosus (SLE) is a chronic, life-threatening autoimmune disease. Approximately five million people worldwide, including approximately 1.5 million in the United States, suffer from various forms of lupus, including SLE. Lupus can occur at any age, but appears mostly in young people ages 15 to 45. About 90 percent of those diagnosed with lupus are women. African-American women are about three times more likely to develop lupus, and it is also more common in Hispanic, Asian and American Indian women. Symptoms may include extreme fatigue, painful and swollen joints, unexplained fever, skin rash and kidney problems. Lupus can lead to arthritis, kidney failure, heart and lung inflammation, central nervous system abnormalities, inflammation of the blood vessels and blood disorders. For more information on lupus, visit the Lupus Foundation of America at www.lupus.org, the Lupus Research Institute at www.lupusresearchinstitute.org, the National Institute of Arthritis and Musculoskeletal and Skin Diseases at www.niams.nih.gov, or Lupus Europe at www.elef.rheumanet.org.

About Human Genome Sciences

The mission of HGS is to apply great science and great medicine to bring innovative drugs to patients with unmet medical needs. The HGS clinical development pipeline includes novel drugs to treat hepatitis C, lupus, inhalation anthrax and cancer. For more information about HGS, please visit the company’s Web site at www.hgsi.com.

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BioElectronics Extreme Penny Stock Trade

BioElectronics (BIEL) is a hot trade right now. At 0.08 I see it as a nice trade with huge potential. I don't exactly like their financials too much after seeing their Balance Sheet from March but could be a good trade for long term growth, if they can stay afloat. Here are two articles on them for their two products available, Allay and Actipatch therapies. This is a risky trade but most are. I actually see them pulling through their financial woes with their new add campaign's and infomercials coming out this fall. Also note that they do have a competitor with other larger companies that can produce the same therapies and have their own research available. With that said, I like their marketing campaign and I do see the potential for the pain therapy.

A link to their financial situation can be found here:

On 6/19/09, (5) BioElectronics (BIEL.PK) ($0.056) announced a corporate update, including the filing of two applications with the FDA earlier in the week. The first of these was for 510(k) marketing clearance for its Allay Menstrual Pain Relief Patch product seeking OTC marketing clearance and an indication for pain reduction associated with dysmenorrhea (period pain and cramps). The second FDA filing was for a reclassification of the company's technologies from Class III to Class II. On 6/15/09, BIEL announced that it is filing an application with the FDA for 510(k) clearance to market its Allay Menstrual Pain Relief Patch product. The Allay Menstrual Pain Relief Patch is drug-free and is based on Pulsed Electromagnetic Field (PEMF) therapy, which applies advanced semiconductor and micro-battery technologies into a very small form factor that has been packaged into a wafer thin patch that can be worn directly on the skin.

On 7/29/09, BIEL.PK announced that preliminary data on a heel and foot pain study show strong efficacy and 100% safety using the ActiPatch device. The study also showed study participants were able to significantly reduce their use of acetaminophen (Tylenol) and non-steroidal anti-inflammatory drugs (NSAIDs). Clinical studies in the areas of breast augmentation, Cesarean section, Uveitis, and several areas of surgical recovery are quickly coming to a close with data expected over the coming months. With the data provided by the Genecov study, the management team plans to accelerate its FDA 510(k) pre-marketing clearance filing for general musculoskeletal complaints designed to lead to over-the-counter approval. In addition, the company will soon submit an additional application of 510(k) pre-marketing clearance for general surgical recovery.

BioElectronics Launches Direct Response Television Initiative
Thursday, 13 August 2009 01:32

FREDERICK, MD--(Marketwire - August 13, 2009) -BioElectronics Corp. (PINKSHEETS: BIEL), the maker of inexpensive, disposable drug-free anti-inflammatory devices, today announced it is launching a direct response television (DRTV) initiative to market its ActiPatch® Therapy and Allay™ brands to the mass market. BioElectronics has retained industry leader, Schulberg MediaWorks as its marketing partner.Work on the DRTV spots has already begun with initial airing expected within 60 days.Initially, the Canadian and selected other English speaking markets will be targeted, but the U.S. market will also be heavily targeted once FDA clearance is received.
"We have selected SMW (Schulberg MediaWorks) as our partner based on its impressive record of both success and integrity.SMW, which is one of the pioneers in infomercial advertising, has an impressive track record with more than $700 million in DRTV sales and more than one billion viewers of its innovative programs," commented Andrew Whelan, CEO of BioElectronics. "In addition to impressive creative and video production capabilities, they also bring to the table extensive operational expertise in media buying, web design, order processing, and fulfillment.Our management team and board of directors are pleased that a DRTV firm of SMW's quality has agreed to be our partner.We are expecting this initiative to be a major revenue generator for the Company."

"We believe ActiPatch Therapy and Allay are strong brands for DRTV marketing," commented Jon Schulberg, President of Schulberg MediaWorks. "The issue of the potential dangers of Tylenol® and acetaminophen is already resonating with the public and we believe many consumers are looking for drug-free alternatives.We will be working closely with the BioElectronics team to help communicate the message to the public that the ActiPatch Therapy and Allay products are effective alternatives to taking potentially dangerous medications.We look forward to making this initiative a success for BioElectronics and its shareholders."

About BioElectronics Corporation

BioElectronics Corporation is the maker of ActiPatch® Therapy, RecoveryRx™ Devices, HealFast™ Therapy (www.healfasttherapy.com) and the Allay™ family of inexpensive, disposable drug-free anti-inflammatory devices. For more information please see

More info about Bioelectronics therapies can be found through NC State's Bioinstrumentation Website or searching google for Bioelectronics Pain Therapies. Here's NC States Electrical and Computer Engineering information on Bioinstumentation.

Bioinstrumentation is the use of bioelectronic instruments for the recording or transmission of physiological information. Biomedical devices are an amalgamation of biology, sensors, interface electronics, microcontrollers, and computer programming, and require the combination of several traditional disciplines including biology, optics, mechanics, mathematics, electronics, chemistry, and computer science. Bioinstrumentation teams gather engineers that design, fabricate, test, and manufacture advanced medical instruments and implantabe devices into a single, more productive unit.

Bioelectronics have a wide variety of applications, including: electrocardiographs, cardiac pacemakers and defibrillators, blood pressure and flow monitors, and medical imaging systems. The field of bioinstrumentation has seemingly endless possibilities because of its fusion of different fields for the common purpose of developing new and exciting ways of managing and treating disease and disabilities. A few emerging technologies include implantable sensors to monitor treatment effectiveness, anti-stuttering aids, blood vessel compliance measurement, distributed sensor networks for home healthcare, and electronic aids for the five human senses.

The Department of Electrical and Computer Engineering at North Carolina State University's bioinstrumentation concentration is uniquely designed to give students undergraduate experience in bioelectronic conceptions, design, and implementation. In addition, our proximity to Research Triangle Park provides students with direct access to local bioelectronic employers such as Sicel Technologies, Gilero, and Glaxo-Smith-Kline.

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Acadia Pharma looks strong so far

So Acadia is moving like a freight-train through its Phase III trial in hope for FDA approval. I luckily got in somewhat early but eager to buy more. I am thinking it is time to re-up and go for another round as they seek approval for their Parkinson's Disease medication Pimavanserin. Here is the info from their website. Current trading is up 15.5% at 6.11 up 0.82 today alone. So look forward to approval soon and happy trading. If approved I see the stock going between the 9-11 point range. Results could be higher or lower but just a hunch as Parkinson's Disease patients do not react well to the anti-psychosis medication currently available.

Pimavanserin is a small molecule product candidate that we discovered and have advanced to Phase III development as a treatment for patients with Parkinson's disease psychosis. Pimavanserin can be taken orally and blocks the activity of the 5-HT2A receptor, a key serotonin receptor that plays an important role in the treatment of various psychiatric disorders. Parkinson's disease psychosis is a debilitating psychiatric disorder that occurs in up to 40 percent of patients with Parkinson's disease. The development of psychosis in patients with Parkinson's disease is associated with increased caregiver burden, nursing home placement, and increased mortality.

Currently there is no therapy in the United States approved to treat Parkinson's disease psychosis. Physicians may attempt to address this disorder initially by decreasing the dose of the dopamine replacement drugs, which are administered to patients to manage the motoric symptoms of Parkinson's disease. However, this approach is generally not effective in alleviating psychotic symptoms in most patients and is often associated with the significant worsening of motor function in these patients.

Despite substantial limitations, currently marketed antipsychotic drugs also may be used off-label to treat patients with Parkinson's disease psychosis. Because antipsychotic drugs block dopamine receptors, which may counteract the dopamine therapy used to manage the motoric symptoms of Parkinson's disease, these drugs are generally not well tolerated by patients with Parkinson's disease at doses required to achieve antipsychotic effects. Current antipsychotic drugs also are associated with a number of side effects, which can be especially problematic for elderly patients with Parkinson's disease. In addition, antipsychotic drugs have a black box warning for use in elderly patients with dementia-related psychosis due to increased mortality and morbidity. We believe that pimavanserin has the potential to be the first-in-class treatment for this disorder, which may effectively treat Parkinson's disease psychosis without impairing motor function, thereby significantly improving the quality of life for patients with Parkinson's disease.

We believe that pimavanserin has the potential to address a range of central nervous system indications with large unmet medical needs. Together with Biovail, we plan to leverage our Phase III program in Parkinson's disease psychosis to develop and commercialize pimavanserin for multiple neurological and psychiatric indications that are underserved by currently marketed antipsychotics, including psychosis in patients with Alzheimer's disease.

Development Status
We are currently conducting a number of studies in our Phase III program with pimavanserin for Parkinson's disease psychosis, including two pivotal trials, an open-label safety extension study, and other NDA supporting studies.

We have completed a Phase II clinical trial in which pimavanserin demonstrated motoric tolerability and antipsychotic effects in patients with Parkinson's disease, and was safe and well tolerated in the study.

In addition, we have reported positive results from a Phase II clinical trial with pimavanserin as a co-therapy in schizophrenia. The results of this trial demonstrated several advantages of co-therapy with pimavanserin and a sub-maximal dose of risperidone, a commonly prescribed antipsychotic drug, including enhanced efficacy, a faster onset of antipsychotic action, and an improved side effect profile. We also have completed a proof-of-concept clinical study in which pimavanserin induced a significant increase in slow wave sleep in older healthy volunteers.

In other news here is a clip from earlier last week.

Acadia Pharma to slash 50% of workforce
Marketwatch Aug 5, 2008, 7:01 p.m. EST

(8:55 AM ET) BOSTON (MarketWatch) -- Acadia Pharmaceuticals /quotes/comstock/15*!acad/quotes/nls/acad (ACAD 6.15, +0.04, +0.66%) said Tuesday that it plans to slash about 50% of its workforce, bringing its headcount down to around 65 employees. The drug developer said that the restructuring will allow it to focus on its lead drug candidate pimavanserin, a treatment for psychosis associated with Parkinson's disease. The product is currently in Phase III testing. Acadia will also continue two early-stage drug development programs that are currently being funded by Allergan Inc. /quotes/comstock/13*!agn/quotes/nls/agn (AGN 54.65, -0.14, -0.26%) . Earlier Tuesday, Acadia reported a second-quarter loss of $18.3 million, or 49 cents a share, compared with a loss of $10.8 million, or 29 cents a share, for the same quarter last year. Revenue fell to $177,000 from $2.1 million, due primarily to the completion of two collaborative agreements and lower revenue from its Allergan partnership.

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