Amgen submits BLA for XGEVA

Image via WikipediaTHOUSAND OAKS, Calif., June 27, 2011 /PRNewswire/ --

Amgen (NASDAQ: AMGN) today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) to expand the indication for XGEVA® (denosumab) to treat men with castrate-resistant prostate cancer to reduce the risk of developing bone metastases. If approved, XGEVA would be the first therapy licensed to prevent or delay the spread of cancer to the bone.

The sBLA submission is based on a pivotal Phase 3 Study ('147) evaluating XGEVA versus placebo in 1,432 men with castrate-resistant prostate cancer. Results of the '147 study demonstrate that XGEVA significantly prolonged bone metastasis-free survival by more than four months compared with placebo (29.5 versus 25.2 months, respectively) in men with castrate-resistant prostate cancer that had not yet spread to the bone.

 Bone metastasis-free survival is a composite measure of the development of bone metastases or death.
"The successful outcome of this study provides clinical evidence supporting the view that tumors activate the RANK Ligand pathway to penetrate bone," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen.  "XGEVA has the potential to become a significant advance for patients with castrate-resistant prostate cancer who currently have no treatment options to help prevent the spread of cancer to their bones."

Continued

Human Genome Sciences Shares Decline After FDA Recommend Benlysta

Elmo the Investment Banker is killing traders. 
Stick to Sesame Street Elmo. 
You aren't cut out for Wall St.

Just after Tuesday's FDA Recommendation for Human Genome Sciences' Lupus Therapy Benlysta, Citigroup and Bank of America downgraded the stock.  Obviously, they mistakenly shorted the stocks and wanted to get their money back after guessing wrong on the FDA decision.  The drug was recommended by a 13-2 vote.  It is very similar to other cases in recent FDA Approvals, where the stock has actually has gone down on good news, not up.

Manipulating shorts cover their positions by making sure they got analysts on their side to downgrade a stock in case a Panel vote goes against them. Here is a perfect example of how Hedge Fund Shorts cover their positions:

Two downgrades Wednesday morning, one each from Citi and Bank of America/Merrill Lynch, reflected these new concerns and sent Human Genome shares down 7% to $23.98 in early trading.

An advisory panel convened by the U.S. Food and Drug Administration voted 13-2 Tuesday night to recommend Benlysta's approval as the first new lupus therapy in 50 years.

Tuesday's FDA Panel Review for Human Genome Science's Benlysta

Purple Walk for Lupus Awareness

Everything you need to know about Tuesday's FDA panel recommendation for Human Genome Sciences therapy for Lupus, Benlysta.  If approved Benlysta would be the first approved therapy in 50 years for Lupus.  Friday the FDA released the notes for the upcoming panel review Tuesday, November 16th.  Concerns for the panel Tuesday were an increased risk of suicide, risk of infection, and decreased efficacy in African-American patients, who are more prone to Lupus.  Forbes' The Medicine Show Blog with Matthew Herper highlighted some of these concerns.  Benlysta is teamed up with Glaxo SmithKline and if approved Human Genome Sciences will share marketing costs and profits.  The expected market is anywhere between 1-3 Billion.

I think the benefits for the drug outweigh any concerns and it could be approved December 9th by the FDA.  With that being said though, the FDA has rejected a lot of drugs this year and is very conservative.  There are some concerns and more clinical trials could be advised before approval.  We will have to see.  Today's FDA review notes had concerns with the drug's suicide rate and it's efficacy for African-Americans, who are more likely to have Lupus.  The concerns dropped the stock and has investors spooked, but I still think that it will be recommended.  I hope I am not wrong on this one. 

For more information about Human Genome Sciences visit their website HGSI.com. 

Learn more about Lupus (SLE), please visit their website at Lupus.org.

Wikinvest--Human Genome Sciences (HGSI)

Wikinvest--Glaxo (GSK)

Yahoo Finance--HGSI

Yahoo Finance--GSK

For more on Tuesday's Decision

Comprehensive List of Drug Approvals From 2009

Image by boodoo via Flickr I found a nice list of all the drugs approved in 2009 and their respectable companies.

Those of note were Glaxo SmithKline (GSK) with HPV vaccine, H1N1, seasonal flu vaccine, renal carcinoma, and lymphocyte leukemia.

Novartis (NVS) for H1N1, seasonal flu vaccine, MS, malaria, and schizophrenia.

Schering-Plough, now Merck (MRK) , for schizophrenia. Schering was bought out for their extensive drug pipeline of numerous upcoming drugs.

Sanofi-Aventis (SNY) had an antiarrhythmic drug, along with another flu vaccine for elderly patients. Sanofi is getting snuffed out with the Genzyme takeover bid but the bidding could still continue.

Others included Takeda Pharmaceuticals (TKPHF), Cypress Biosciences/Forest Labs, Allos Therapeutics, Lilly/Daiichi Sankyo, Gloucester Pharmaceuticals, and Theravance.

Chasing Influenza: History of the Flu

Image via Wikipedia Here is a really informative article on the History of the Flu by Quintiles White Papers. PDF format is the link below. It's Flu season again. Companies are ramping up their stockpiles of Flu Vaccines and you can get the flu shot at Walgreens and CVS these days.

I personally don't believe all the hype and practice safe "People handling" when I go out and use hand sanitizers every chance I get. One day a real Pandemic will emerge like the 1918 Flu and there is not much we can do about it. Novartis, Glaxo SmithKline, Baxter, and MedImmune are your top Flu stocks.

Chasing Influenza

Top BioPharma Performers Thursday August 12th

Image via Wikipedia

Top Biotech Performers for today (aside from the MakeMyTrip IPO up 70% for the Indian IPO) Prices reflect a 2PM stock trading time. Columbia Labs and Vivus have since gone up.

Top Performing Biotech

Biovail, Valeant Pharmaceuticals, GSK gain FDA recommendation for Epilepsy drug Potiga

Image via Wikipedia

Today saw some good news from the FDA as they recommended the joint venture drug, Potiga, by Valeant Pharmaceuticals and Glaxo SmithKline. Valeant is in merger acquisitions with Biovail that should be completed by the year's end.

U.S. Food and Drug Administration advisory committee voted unanimously 11-0 that clinical studies had provided substantial evidence on the safety and effectiveness of ezogabine to treat epilepsy. The Prescription Drug User Fee Act goal date for the FDA to complete its review of the drug’s application is August 30. The drug will be aimed at patients whose other epilepsy medications failed.

Swine Flu Remains Mild as Vaccine Advances

Last week Swine flu stocks slumped so it remains to be seen if they will rise again against a Mild Flu season. The small cap swine flu stocks are very volatile right now. Big players remain strong. Anticipate 3rd and 4th quarterly earnings for GlaxoSmithKline and Novartis to rise. Cel-Sci Corporation's new vaccine production could remain a pivotal turn for the only small cap not to have lost huge returns last week. I am curious to see how this Week on Wall Street pays off. Stocks to watch are Sinovac (SVA), Novavax (NVAX), Novartis (NVS), Glaxo (GSK), and Cel-Sci (CVM).

Swine Flu Remains Mild as Vaccine Advances

Cytokinetics Shows Favorable Phase II results

Cytokinetics (CYTK) is a clinical trial drugmaker that has been making some ground-breaking news this past week. They have numerous clinical trials taking place right now ranging from oncology (breast cancer and non-Hodgkin's lymphoma) to high risk heart failure. Their stock has risen in the past week from 3.50 to a high of 5.00 Monday afternoon 092209. Today the stock is trading at 4.67. Currently, they are recruiting patients for 3 Clinical Trials for their pipeline medications. Here is their ClinicalTrials.gov link: Cytokinetics Trials

Cytokinetics recently announced favorable Phase II data from last week for its Heart Failure medication. Here is the presss release from their website.

Cytokinetics Presents Phase IIa Clinical Trials Data on Omecamtiv Mecarbil at the 2009 Heart Failure Society of America Annual Meeting

Vivus' Qnexa Drug approved by FDA and Seeking a Partner to Sell Its Anti-Obesity Medication

Here are today's articles concerning Vivus Inc's FDA approval for Qnexa. I see this as a blockbuster drug candidate and good news for the nearly 40M Obese Americans. My only caution is later health problems as it uses some form of the fen-phen medication. This as a nice trade right now and in the future. Watch out Alli, Glaxo Consumer Health's obesity drug, here Vivus comes! Glaxo's alli just received health concerns recently over liver failure. In addition to Qnexa, Vivus also has various ongoing Phase III clinical trials for ED medication Avanafil due Oct 2009, with a long term safety study due Oct 2010.

This just in to the Wall Street Journal: Vivus CEO Ready To Roll Up Sleeves In Finding Qnexa Partner
As Vivus Inc. (VVUS) moves forward with developing its experimental weight-loss treatment Qnexa, Wall Street will be focused on the next step for the small drug developer: Finding a partner to sell the drug.

PR Newswire: VIVUS Announces Positive Results From Two Phase 3 Studies; Obese Patients on Qnexa Achieve Average Weight Loss up to 14.7% and Significant Improvements in Co-Morbidities

Results of EQUIP and CONQUER Phase 3 Studies Exceed FDA Benchmarks for Obesity Treatments, Demonstrate Positive Safety Profile

MOUNTAIN VIEW, Calif., Sept. 9 /PRNewswire-FirstCall/ -- VIVUS, Inc. (Nasdaq: VVUS) today announced positive results from two final, phase 3 pivotal 56-week studies, EQUIP (OB-302) and CONQUER (OB-303), evaluating the safety and efficacy of Qnexa(TM), an investigational drug, in more than 3,750 patients across 93 sites. The EQUIP and CONQUER studies met all primary endpoints by demonstrating statistically significant weight loss with all three doses of Qnexa, as compared to placebo. Patients taking Qnexa also achieved significant improvements in cardiovascular and metabolic risk factors including blood pressure, lipid levels, and type 2 diabetes.


Vivus Soars After Drug Hits U.S. Weight-Loss Targets
Sept. 9 (Bloomberg) -- Vivus Inc. rose 71 percent, the most in about a decade, after the biotechnology company said its weight-loss drug met U.S. guidelines in two large human trials.

Vivus climbed $4.89 to $11.80 at 4 p.m. New York time in Nasdaq Stock Market composite trading, its biggest gain since Dec. 22, 1999, when the Mountain View, California-based company asked U.S. regulators to clear an erectile dysfunction drug.

Vivus is competing with Orexigen Therapeutics Inc. and Arena Pharmaceuticals Inc., both of San Diego, to introduce a new diet drug in the U.S., a market that might be worth $10 billion annually for a safe therapy that helps patients lose 10 percent of their weight in a year, said Needham & Co. analyst Mark Monane. Global obesity levels, linked to rising rates of diabetes and heart disease, will swell 75 percent to 700 million people by 2015, according to the World Health Organization.

“We would market this drug to people with significant obesity and co-morbidities,” such as diabetes, high cholesterol and high blood pressure, said Leland Wilson, Vivus’s president and chief executive, in a telephone interview today. “This is serious medicine for those with serious disease.”

The Vivus drug, Qnexa, could generate sales of $3 billion by 2016, said Michael King, a New York-based analyst for Merriman Curhan Ford & Co., in an Aug. 20 telephone interview.

“Obesity is one of the last true, broad-based consumer markets where you can get significant revenue,” King said.

Study Results

Two 56-week studies counted patients on Qnexa who lost at least 5 percent of their weight, compared with how many on a placebo pill did the same. In one study, 67 percent of people taking the drug achieved that goal, compared with 17 percent on placebo. In the other trial, it was 70 percent, compared with 21 percent.

The Vivus studies reported today are the final stage of clinical trials generally required to seek U.S. regulatory clearance. The company said it will seek permission to sell Qnexa by the end of the year.

Patients who finished both studies followed a low-calorie diet and lost an average of 6 pounds after a year with a placebo. In one of the two studies, called Equip, people on the highest dose of Qnexa lost an average of 18 pounds when they completed the trial. In the second study, called Conquer, average weight loss on the higher dose of Qnexa was 30 pounds.

Heart and Metabolism

The study also showed “significant improvements” in cardiovascular and metabolic risk factors, including blood pressure, cholesterol levels and type 2 diabetes, Vivus said in a statement.

“To get payers in the health care system to want to pay for these drugs you need to have real benefit in altering these co-morbidities,” Wilson said in the interview. “It puts obesity into a serious disease category that insurers, employers and government want to treat in order to save money, lives and improve quality of life.”

The trials “demonstrated remarkable safety,” Wilson said.

Qnexa combines a generic form of the appetite suppressant phentermine, a commonly prescribed obesity drug that was an ingredient in the recalled diet pill known as fen-phen, with the anticonvulsant drug topiramate, the generic form of Johnson & Johnson’s Co.’s Topamax, which is used to treat epilepsy and migraine headaches.

Greater Effect

While each of the ingredients in Qnexa has some weight-loss impact, the combination of the two “has a greater effect than either of the individual components,” King said.

The positive study data will allow Vivus to accelerate discussions with “major pharmaceutical partners,”, Wilson said in the interview. That partner needs to be in place about six months before the product launch, expected in early 2011, he said.

Arena Pharmaceuticals may be the first of the three companies to ask U.S. regulators to approve its obesity treatment, lorcaserin, when it files “late this year,” Chief Executive Officer Jack Lief told analysts during an Aug. 3 conference call. The company expects to release in September the results of the second of two pivotal, late-stage studies of lorcaserin that will be used to seek approval of the drug.

Lorcaserin is similar to, but chemically different from, fenfluramine, an ingredient in Wyeth’s combination diet-drug known as fen-phen, which was taken off the market in 1997 after being linked to heart and lung problems. Studies so far have demonstrated the Arena drug is well-tolerated by patients and shows no evidence of the heart-valve damage seen in fen-phen users, the company said.

Arena Data

Experimental data released by Arena in June showed lorcaserin met one of two benchmarks required by the U.S. Food and Drug Administration to show a drug’s effectiveness. The treatment helped 48 percent of patients -- or more than twice the comparable placebo result -- lose more than 5 percent of their total body weight, the study found.

The average weight loss after one year for lorcaserin was 3.6 percent more than that of patients on a placebo. The results failed to meet a second FDA standard that an obesity drug has at least a 5 percentage point difference in weight loss between the drug and a placebo.

About 32 percent of Americans adults are obese, according to data from the Centers for Disease Control and Prevention in Atlanta. Medical spending for obesity was $147 billion in 2008, an 87 percent increase over the past decade, according to a government study published July 27 in the journal Health Affairs.

Sanofi Drug

Paris-based drugmaker Sanofi-Aventis SA withdrew its weight loss drug Acomplia from the market in Europe last year after it was rejected by the U.S. Food and Drug Administration over reports of increased psychiatric disorders. New York-based Pfizer Inc. and Merck & Co. of Whitehouse Station, New Jersey halted development of similar drugs.

Amylin Pharmaceuticals Inc., of San Diego, is working on a drug that combines pramlintide, the active ingredient in its diabetes drug Symlin, with leptin, a hormone tied to hunger.


Merriman Curhan Sees Another 20% Upside In Vivus (VVUS)
September 9, 2009 2:51 PM EDT
Merriman Curhan issued some bullish comments on Vivus (Nasdaq: VVUS) which is up 70% todya following positive Phase III results of Qnexa in Obesity, saying the stock could push toward a $1 billion market cap.

Merriman analyst Michael G. King commented in a report this afternoon saying "Vivus, with the issuance of top-line data from its Phase III trials, Equip and Conquer, has shifted the landscape for the treatment of obesity to a new level. These results open the door to a new frontier in which safe and effective pharmacotherapy for obesity now becomes the new normal. On the basis of the anticipated continued positive news flow, we would expect the shares to push their way toward a $1B market cap.

Even with today's 70% surge the market capitlization of Vivus is about $825 milion, which leaves more room to continue to Buy the shares Merriman said.

A $1 billion market cap would push shares of VVUS to about $14.30 each, based on the current 70 million share outstanding at this point. That would suggest another 19% upside!

Glaxo's cancer vaccine inches toward approval--Merck's Cervarix vs GSK Gardasil.

By MATTHEW PERRONE - AP Business Writer
Published: Fri, Sep. 04, 2009

WASHINGTON -- Federal regulators said Friday that a GlaxoSmithKline vaccine prevents the leading cause of cervical cancer in women, bringing the company one step closer to competing with Merck's blockbuster Gardasil, which has controlled the U.S. market for three years. GlaxoSmithKline(GSK) Google Finance

In documents posted online, the Food and Drug Administration said Cervarix - Glaxo's vaccine against human papilloma virus or HPV - successfully blocked the two leading strains of the virus nearly 93 percent of the time.

But even as the British drugmaker moves closer to competing in the U.S., Merck is poised to begin marketing Gardasil to boys and men. In a separate review, the FDA said that vaccine prevented genital warts in males 90 percent of the time.

The agency will ask a panel of vaccine experts next week to weigh in on both vaccines. The FDA is not required to follow the group's advice, though it usually does.

While Merck has suggested the approval for boys could double the potential market for Gardasil, Leerink Swann analyst Seamus Fernandez said the benefit likely will be minimal.

Genital warts caused by HPV usually clear up by themselves, and the cancers caused by the virus are extremely rare in men.

"If it's not preventing something serious like cervical cancer and there are questions about safety, I think parents' acceptance of the vaccine in young boys might be less urgent than for their girls," said Fernandez.

Glaxo has won a number of government contracts for Cervarix in Europe, but its U.S. launch was delayed in 2007 when the FDA said it needed more data about the vaccine. Earlier studies of Cervarix showed a higher number of muscular and neurological problems among patients who used the vaccine compared with an alternate treatment.

The FDA said Friday that outside experts have now determined Cervarix did not cause those problems.

"The conclusion in the case of each of these efforts was that the data are not sufficient to establish a link," the agency said in its review.

FDA reviewers also noted a slightly higher rate of miscarriages in women taking Cervarix, but said "the data do not establish a causal relationship."

Glaxo wants its vaccine approved for girls and women ages 10 to 25. The FDA is expected to make a decision on the vaccine later this year, but analysts say London-based Glaxo may still have trouble making inroads into the U.S. market.

Gardasil and Cervarix both defend against HPV strains 16 and 18, which cause about 70 percent of cervical cancer cases. But Merck's vaccine also defends against two other HPV types that cause 90 percent of genital warts, something Cervarix does not target.

The most common side effects with both vaccines were pain and swelling at the injection site.

Gardasil became an early success story for Merck after its 2006 launch, achieving sales that are rare for a vaccine. The company has sold about 50 million doses worldwide, with more than $1.4 billion in revenue last year.

But sales have been slowing amid questions about the longevity of the vaccine's effect and its price tag of nearly $400. In the most recent quarter, Gardasil sales fell to $268 million, down 18 percent from the prior year period.

A government-funded study last year found that the HPV vaccine is cost-effective for young teens, but not for women in their 20s. And labeling for the vaccine notes that the "duration of protection of Gardasil has not been established." Company trials have only tracked immunity out to five years after receiving the three-injection regimen.

Whitehouse, N.J.-based Merck will make the case on Sept. 9 for approving the vaccine for boys and men ages 9 to 26.

Related articles by Zemanta

• Gardasil Vaccine Associated With 28 Deaths In 2008 According To Judicial Watch Report (drug-injury.com)
• HPV vaccine Cervarix approved by WHO (cbc.ca)
• Human papillomavirus (HPV) vaccination (alanhealthupdate.blogspot.com)
• Study Suggests HPV Vaccine Is Safe, but Doctors Still Wary (time.com)

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

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

Human Genome Sciences Lupus News and Stock Future.

With the news of Human Genome Science's Lupus drug, HGSI stock soared to about 275% the previous value. This is reminiscent of Dendreon's huge gain with their Prostate Cancer drug. With this said I am sceptical of the overall longevity of this trade and with so many cashing out I see a huge fallout, as this is simply a Phase III clinical trial and another phase must be acheived before FDA approval. I see this stock dropping like a rock and many late investors will lose a lot of money tomorrow. Usually after a huge spike the stock has to come down. It's a simple supply and demand chart when it comes to stocks and this one is not any different than the price of gas, or the value of the dollar. I wasn't the best at Econ101 in college as I'm more of a finance person but this stock is going down.

Although I feel the drug will eventually be approved, this could be years down the road. With Human Genome's shaky past I see this as a longshot for longevity. So buyer beware. I too have taken the plunge and followed eagerly on Clinical Trial news like this only to see the stock dropping heavily in the days to weeks to come. Still this is great news for the biotech community and we should be focused on the treatment of Lupus but if you are in it for a quick buck, you've missed out. I still like the long option of HGSI but for day trading its too late and you need to be careful on following the hype and look for the next Human Genome Science or Dendreon out there. Check the FDA calendars and follow closely with the news and PR newswires and another will come along. With that said, it can take years to manufacture a drug for a biotech and many problems can arise even after the drug's approval.

I've seen it all when it comes to biotech manufacturing. The molecule can drop out of solution producing low yeilds. The manufacturing facility can have sterility issues. This is very common although we won't admit it. Sure the final product is sterile, but what did they have to do to acheive this? So many things can go wrong. I'm not saying they will, I'm just saying they can. It takes a considerable amount of time before the molecule hits the market and the company makes a profit. HGSI is not out of the woods just yet. Wait for it to drop and buy it up for the next round.

Here is a nice article on Human Genome Sciences found on Barron's website.

http://online.barrons.com/article/SB124809851547865115.html?ru=yahoo

MONDAY, JULY 20, 2009
BARRON'S TAKE

What's Next for High-Flying Human Genome Sciences? By TERESA RIVAS | MORE ARTICLES BY AUTHOR

Positive results for the company's experimental lupus drug sent shares skyrocketing on Monday.
HUMAN GENOME SCIENCES (ticker: HGSI) investors don't have a case of the Monday blahs. With a 231% gain in mere hours, how could they?

Before the bell Monday, Human Genome and GlaxoSmithKline (GSK) announced that the experimental lupus drug Benlysta showed promise in treating the stubborn autoimmune disease in its first Phase III trials.

The results were huge news -- the FDA has not granted approval for a new lupus treatment in half a century -- and investors' reactions were even bigger. Human Genome shares more than tripled in early afternoon trading, up $7.68, or 231%, to $11.

There's no doubt that Benlysta could be enormously important for Human Genome and lupus sufferers worldwide, but given past volatility and uncertainty, investors might want to take profits in light of today's phenomenal pop and look to pick up shares later, and ostensibly at a lower price, before Benlysta makes it to market.

Benlysta, although promising, still has to pass the second Phase III trial in November to assess its long-term effectiveness. Given the nature of the disease, many lupus sufferers will likely relapse over time, meaning that the November trial may not be as resounding a success as the first, according to Thomas Weisel analyst Ian Somaiya.

Somaiya thinks that the strength of the first Phase III trial alone, combined with the current antiquated lupus treatment, should be enough for approval. However, one might expect that with a stock that has risen so dramatically, investors may not read into the nuances of a less than stellar November trial.

Even taking Benlysta's approval for granted, the drug will likely not make it to market until 2011. That leaves Human Genome the rest of 2009 and all of 2010 without the benefit of its sales. Analysts do not expect the company to turn a profit either year, with losses projected to jump from 13 cents this year to well over $1 in 2010. And before today's pop, Human Genome's more than $580 million in debt well outstripped its market cap.

Additionally, Human Genome has a history of hype without results. In 2004, the company was touted as the one of the main beneficiaries of Project Bioshield, a government program aimed at developing and stockpiling vaccines and antidotes to bioweapons, but enthusiasm quickly faded.

Likewise, in March shares lost more than half their value in one day, when Albuferon, Human Genome's Hepatitis C drug, was trumped by Roche's (RHHBY) competing treatment in a late-stage trial, despite meeting other trial goals.

Not to mention that it is difficult to justify chasing a stock that has risen from 45 cents in March to a high of just over $11 in midday trading today (a 2,349% rise in four months), especially months before an FDA decision and more than a year before any sales start rolling in.

That said, Lazard Capital Markets analyst Terence Flynn pegs the global lupus market as a $2.9 billion opportunity, given the paucity of treatments. Flynn notes that when Benlysta finally hits the market in 2011, it will likely see sales of $207 million, eventually hitting the $1 billion mark in 2014. Still, he doesn't see the stock running much further than today's price, putting its fair value at $10.

Therefore, Benlysta is undoubtedly a boon for the five million lupus sufferers worldwide, and may eventually reward investor as well. But given the stock's furious run-up, history of volatility, interim earnings losses, and the time lapse before the drug's first sales, it seems wise to take profits. Investors should have plenty of time to pick up the shares cheaper and still benefit from Benlysta's promise.


Another good article is on Bloomberg at the following link.

http://www.bloomberg.com/apps/news?pid=20601085&sid=am8d7NnxYQ9Y

Human Genome Science Triples on Success of Lupus Drug (Update3)

By David Olmos and Lisa Rapaport

July 20 (Bloomberg) -- Human Genome Sciences Inc. more than tripled in New York trading after the company and GlaxoSmithKline Plc said their experimental lupus drug reduced patients’ symptoms in a yearlong study.

Human Genome Sciences leaped $9.19 to $12.51 at 4 p.m. in Nasdaq Stock Market composite trading, its greatest single-day rise since shares began trading in December 1993. London-based Glaxo’s American depositary receipts rose 4 percent, or $1.45, to $37.81 in New York Stock Exchange trading, after the study raised hopes of the first new therapy in more than 50 years for the autoimmune disease.

The positive results for Benlysta were unexpected by analysts who cited disappointing data in earlier clinical trials and a history of failures for treatments of lupus, which triggers the immune system to attack healthy cells. Ten of 12 analysts rated Human Genome a “hold” or “sell” as of July 17, according to Bloomberg data. No cure exists for the disease, which affects about 5 million people worldwide.

“The lupus community has really been on tenterhooks waiting for a positive announcement,” Sandra Raymond, chief executive of the Lupus Foundation of America, a Washington, D.C.-based patient advocacy group, said in a July 17 telephone interview, before the results were announced. “Since lupus was first discovered over a century ago, there has never been a drug specifically developed for lupus.”

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Human Genome Sciences Up over 200 percent Monday July 20, 2009

This has been one of my favorites for awhile after learning about Craig Venter and Sequencing the Human Genome. Craig partnered with Human Genome Sciences but you can learn more by reading Craig Venters A Life Decoded Biography which shows the ups and downs a scientist can have especially when dealing with the Government and the Human Genome Project.

Wikipedia on Human Genome Sciences.
The company was founded by William A. Haseltine, a noted Harvard professor and AIDS researcher. HGS had a partnership for several years after its founding with Craig Venter and his non-profit TIGR to begin sequencing and submitting patents on hundreds of thousands of protein-encoding DNA fragments. In 2000, Haseltine said that his work "speeds up biological discovery a hundredfold, easily." He talked of finding in genes "the fountain of youth" in the form of "cellular replacement" therapies. More than $2 billion in investments was raised by the company by 1999-2000. Two initial drugs failed in clinical trials, and the stock share price declined from its highs. For example, in September 2000, the company reported that it had found a way to treat large, painful sores that often plague elderly patients, using a protein spray called repifermin, made by a human gene called keratinocyte growth factor-2. In February 2004, the company said that it was ending the development of repifermin because it showed no more benefit than a placebo in clinical trials.


On 7/20/09, Human Genome Sciences (NASDAQ:HGSI) and GlaxoSmithKline (NYSE:GSK) announced that Benlysta (belimumab, formerly LymphoStat-B) met the primary endpoint in BLISS-52, the first of two pivotal Phase 3 trials in patients with serologically active systemic lupus erythematosus (SLE). In the placebo-controlled BLISS-52 study, the results showed that Benlysta plus standard of care achieved a clinically and statistically significant improvement in patient response rate at Week 52, compared with standard of care alone. Study results also showed that belimumab was generally well tolerated, with adverse event rates comparable between belimumab and placebo groups. Assuming positive results in November 2009 from a second Phase 3 trial of Benlysta, the companies plan to submit marketing applications in the United States, Europe, and other regions during 1H10.




Human Genome Sciences, Inc. (Nasdaq: HGSI) and GlaxoSmithKline PLC (GSK) today announced that BENLYSTA(TM) (belimumab, formerly LymphoStat-B(R)) met the primary endpoint in BLISS-52, the first of two pivotal Phase 3 trials in patients with serologically active systemic lupus erythematosus (SLE). In the placebo-controlled BLISS-52 study, the results showed that belimumab plus standard of care achieved a clinically and statistically significant improvement in patient response rate at Week 52, compared with standard of care alone. Study results also showed that belimumab was generally well tolerated, with adverse event rates comparable between belimumab and placebo treatment groups. "The BLISS-52 results demonstrated that BENLYSTA has the potential to become the first new approved drug in decades for people living with systemic lupus," said H. Thomas Watkins, President and Chief Executive Officer, HGS. "Given the limited treatment options currently available, patients would benefit greatly from potential new treatments. BENLYSTA is an outstanding example of the type of treatment HGS is working to develop and bring to patients. Assuming positive results in November from our second Phase 3 trial of BENLYSTA, we and GSK plan to submit marketing applications in the United States, Europe and other regions in the first half of 2010."
Belimumab is an investigational drug and the first in a new class of drugs called BLyS-specific inhibitors. No new drug for lupus has been approved by regulatory authorities in more than 50 years. Belimumab is being developed by HGS and GSK under a co-development and commercialization agreement entered into in August 2006.

"Lupus is a chronic, often debilitating, and sometimes fatal illness that affects an estimated five million people worldwide and can have a devastating effect on both patients living with the disease and their families," said Carlo Russo, M.D., Senior Vice President, Biopharm Development, GSK. "BENLYSTA is the first medicine being developed specifically for lupus that has reached this late stage of clinical development with positive results. We look forward to completing the pivotal studies, with the hope of bringing this potentially important therapeutic advance to patients suffering from SLE."

Key Findings from BLISS-52

"The BLISS-52 results support and extend the findings that emerged in the serologically active subgroup of SLE patients at Week 52 in our Phase 2 trial," said David C. Stump, M.D., Executive Vice President, Research and Development, HGS. "We are delighted to report that the efficacy of treatment with BENLYSTA plus standard of care was superior in this study to that of placebo plus standard of care, while the safety profile was comparable overall to placebo. BENLYSTA met the primary endpoint in this Phase 3 study at a robust level of statistical significance. BENLYSTA also significantly reduced SLE disease activity versus placebo based on a number of other measures, including SELENA SLEDAI and Physician's Global Assessment. Of note, a greater percentage of patients receiving BENLYSTA achieved a clinically meaningful reduction in steroid dose. We hope to have a full presentation of BLISS-52 results at an appropriate scientific meeting later in 2009."

About the BENLYSTA (belimumab) Phase 3 Development Program

The Phase 3 development program for belimumab includes two double-blind, placebo-controlled, multi-center Phase 3 superiority trials - BLISS-52 and BLISS-76 - to evaluate the efficacy and safety of belimumab plus standard of care, versus placebo plus standard of care, in serologically active (i.e., autoantibody-positive) patients with SLE. This is the largest clinical trial program ever conducted in lupus patients. BLISS-52 randomized and treated 865 patients at 90 clinical sites in 13 countries, primarily in Asia, South America and Eastern Europe. BLISS-76 enrolled and randomized 826 patients at 133 clinical sites in 19 countries, primarily in North America and Europe. The design of the two trials is similar, but the duration of therapy in the two studies is different - 52 weeks for BLISS-52 and 76 weeks for BLISS-76. The data from BLISS-76 will be analyzed after 52 weeks in support of a potential Biologics License Application in the United States and Marketing Authorization Application in Europe and other regions. HGS designed the Phase 3 program for belimumab in collaboration with GSK and leading international SLE experts, and the program is being conducted under a Special Protocol Assessment agreement with FDA.

The primary efficacy endpoint of BLISS-52 and BLISS-76 is the patient response rate at Week 52, as defined by: (1) a reduction from baseline of at least 4 points on the SELENA SLEDAI disease activity scale (which indicates a clinically important reduction in SLE disease activity); (2) no worsening of disease as measured by the Physician's Global Assessment (worsening defined as an increase of 0.30 points or more from baseline); and (3) no new BILAG A organ domain score (which indicates a severe flare of lupus disease activity) and no more than one new BILAG B organ domain score (which would indicate a moderate flare of disease activity). Analysis for the primary endpoint is based on intention-to-treat (ITT) and adjusted for baseline stratification factors, including SELENA SLEDAI score, proteinuria and race.

In each of the two Phase 3 trials, patients were randomized to one of three treatment groups: 10 mg/kg belimumab (BLISS-52, n=290), 1 mg/kg belimumab (BLISS-52, n=288), or placebo (BLISS-52, n=287). Patients are dosed intravenously on Days 0, 14 and 28, then every 28 days thereafter for the duration of the study. All receive standard of care therapy in addition to the study medication. Safety is reviewed by an independent Data Monitoring Committee throughout both studies.

About BENLYSTA (belimumab)

Belimumab is an investigational human monoclonal antibody drug that specifically recognizes and inhibits the biological activity of B-lymphocyte stimulator, or BLyS(R). 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 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 suggest that belimumab can reduce autoantibody levels in SLE. BLISS 52 results suggest that belimumab can reduce SLE disease activity, and a second Phase 3 trial, BLISS-76, is underway to confirm these results.

About the Collaboration with GSK

In August 2006, HGS and GSK entered into a definitive co-development and co-commercialization agreement under which HGS has responsibility for conducting the belimumab Phase 3 trials, with assistance from GSK. The companies will share equally in Phase 3/4 development costs, sales and marketing expenses, and profits of any product commercialized under the current agreement.

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.