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

Pfizer's To Present Lung Cancer Data July 3-7

Image via CrunchBase Pfizer Inc. will present early and mid-stage data from its lung cancer portfolio, including PF-00299804 (PF-299) an investigational, oral, pan-HER inhibitor;¹ and crizotinib, an investigational, oral, first-in-class compound that inhibits the anaplastic lymphoma kinase, or ALK,² at the International Association for the Study of Lung Cancer’s (IASLC) 14^th World Conference on Lung Cancer (WCLC), July 3-7 in Amsterdam, The Netherlands.

“While lung cancer remains a difficult-to-treat disease, we’re learning more about how therapies like crizotinib and PF-299 may be able to specifically target ALK or the HER pathway, respectively, and how this may lead to more rationally selected and personalized therapy,” said Maurizio Voi, MD, Thoracic Tumor Strategy Lead, Pfizer Oncology. “Data being presented show survival outcomes for PF-299 and crizotinib, as well as quality-of-life or patient-reported outcomes after treatment for patients with non small cell lung cancer, which represent important considerations in determining the best treatment option for these patients.”

First Presentation of PF-299 Preliminary Overall Survival Data

Continued....

Bristol melanoma drug extends survival in study

By Bill Berkrot

NEW YORK | Mon Mar 21, 2011 6:37pm EDT

(Reuters) - Bristol-Myers Squibb Co's eagerly anticipated experimental drug ipilimumab extended survival of previously untreated patients with advanced melanoma in a late stage study, the company said.

Details of how much longer patients who were suffering from the deadly skin cancer lived after taking the highly promising Bristol drug will be unveiled at a major medical meeting in June.

Bristol-Myers shares were up 4.3 percent at $27.10 in extended trading from their New York Stock Exchange close at $26. They initially jumped 5.7 percent after news of the clinical trial's success was reported.

Extending overall survival -- the primary goal of the study -- is considered the gold standard for cancer drug trials.

U.S. health regulators are expected to approve ipilimumab this week based on results of a different study of patients who had received prior treatment for advanced melanoma.  In that study the Bristol-Myers drug extended survival by an average of four months, which was seen as a major advance for a disease littered with drug failures and for which there are really no effective treatment options.

The Food and Drug Administration in November delayed its approval decision to give it more time to review data on the medicine, setting a new action date of March 26. "Ipilimumab is an exciting drug, especially given the dearth of effective therapies for this bad form of cancer," Sanford Bernstein analyst Tim Anderson said in a research note.Advanced melanoma is one of the deadliest cancers and can quickly spread from the skin to internal organs, such as the brain. Once melanoma spreads to other organs the average survival is typically only six to nine months.

Spectrum Pharmaceuticals is Making Headlines in Early 2011

Spectrum Pharmaceuticals Submits Supplemental New Drug Application (sNDA) For Ready-to-Use Formulation Of FUSILEV(R) In Colorectal Cancer

Main Category: Colorectal Cancer
Also Included In: Cancer / Oncology

Article Date: 06 Jan 2011 - 1:00 PST
Spectrum Pharmaceuticals (Nasdaq: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, announced it submitted a supplemental New Drug Application with the U.S. Food and Drug Administration (FDA) for a Ready-to-Use formulation of FUSILEV (levoleucovorin) for Injection. This submission is in support of FUSILEV's use in colorectal cancer, which is currently under review by the FDA with a Prescription Drug User Fee Act (PDUFA) action date of April 29 2011. FDA has up to 60 days to formally accept the submission.

"If approved, we believe a RTU formulation of FUSILEV, as the name implies, will be more convenient for the staff and easy to use. RTU formulation requires no reconstitution, and since it will also be of a higher strength than the currently available lyophilized formulation, the healthcare provider's time to administer FUSILEV to colorectal cancer patients will be considerably reduced," said Rajesh C. Shrotriya, MD, Chairman of the Board of Directors, Chief Executive Officer, and President of Spectrum Pharmaceuticals.   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.

FDA Approves Avanir and Forest Labs Treatments for PBA and Bacterial Infections

FDA Ends October With Drug Approvals

BOSTON (TheStreet) -- U.S. regulators ended October with two drug approvals, clearing an antibiotic from Forest Labs(FRX_) and a first-time treatment for a neurological disorder developed by Avanir Pharmaceuticals(AVNR).

Investors are still waiting on the fate of Biodel's (BIOD) fast-acting insulin Linjeta. The U.S. Food and Drug Administration was expected to issue an approval decision Friday, but the news could come Monday.

October was a busy but tough month for new drug approvals at the FDA. Regulators rejected seven new drugs, including a diabetes drug from Amylin Pharmaceuticals (AMLN) and weight-loss drugs from Arena Pharmaceuticals (ARNA) and Vivus (VVUS), respectively.

The FDA approved four drugs: the two mentioned above plus drugs from Questcor Pharmaceuticals(QCOR) and Alkermes (ALKS).

Bull or Bear? Vote in Our Poll

The Forest Labs (FRX) injectable antibiotic Teflaro approved Friday will be used to treat patients with pneumonia and bacterial skin infections, including methicillin-resistant Staphylococcus aureu, or MRSA.

Avanir and Exact Sciences Crash in Afterhours Trading

Exact Sciences (EXAS)  has crashed steadily since yesterday's close of 8.57.  It has slumped to the 6.90 range after yesterday announcing Positive Study News.  Unfortunately, this is just a study which will lead into a lengthy clinical trial that will cost money.  I think investors have been misled by this news and now they don't know what to do and are panicking.  Hey Stop Panicking.

Exact's stock is rated a buy and will soon return to the 9-10 range in a few months and could skyrocket to 13 with Positive Clinical Trial News.  There really is no quick buck when it comes to stock investing.  It happens, and it can happen, but more times than not, these things take time. 

On other news Avanir's Stock (AVNR) has declined sharply in afterhours saying they have not heard from the FDA and is anticipating news concerning their approval for psuedobulbar affect.  I am expecting a CRL from the FDA and no approval and this would be devastating to Avanir Shareholders.  But it could get approved.  It does have a fighting chance. 

In other news Vivus receives a CRL for Qnexa and the share price has gone up.  That one I really don't get but investors sometimes don't know what they are getting themselves into.  Sure if approved it would be monumental, but I don't see that happening anytime soon.  Vivus' shares are up 26.43% at 7.75.  Today it gained 1.62 points.  I don't see this ride ending well for investors but what do I know.  I am baffled at the stock market right now.

Wikinvest--Exact Sciences (EXAS)
Wikinvest--Avanir (AVNR)
Wikinvest--Vivus (VVUS)

Boehringer Gains Approval To Market Blockbuster Blood Thinner Which Works Better

Image via WikipediaBoehringer Beats Bayer, J&J to Market With Pradaxa

By Naomi Kresge and Catherine Larkin

(Adds executive comment from fifth paragraph, closes Bayer shares in the seventh paragraph.)


Oct. 20 (Bloomberg) -- Boehringer Ingelheim GmbH won U.S. approval to sell Pradaxa, beating drugmakers including Bayer AG and Johnson & Johnson to the market with the first rival to the half-century-old blood thinner warfarin.

The Food and Drug Administration cleared the drug for patients with an irregular heartbeat that may raise the risk of a stroke, the agency said yesterday in a statement.

Put Calls Anyone?

Image via Wikipedia Arena Pharmaceuticals is in a tough spot as the FDA rejects their weight loss drug lorcaserin, apparently one of the safer of the 3 up for approval.

Here is the link to investors. 

This decision was expected and predicted in my past articles on the Obesity Drug Market.  We all saw it coming.  I'm sorry if you didn't.  But expect loses for Orexigen, and Vivus with their upcoming FDA decisions.   I can only see gains made with shorting the stocks.  Those that had are sitting pretty right now.  It's a gamble but sometimes these gambles pay off.  I expect more loses to mount for these companies in the near future.  Arena Pharmaceuticals, Vivus Inc., and Orexigen Therapeutics.

What they chose to do next is anyones guess.  The technology could be sold off for further research.  And the company enters bankruptcy court.  Nonetheless just passing on the news.  I'm not always right but some are easier to pick than others.  Last weeks news of Amylin, Alkermes, and Eli Lilly and Company for their diabetes medicine was a heartbreaker for those who thought it would go the other way.  But there are always more to look at.  Keep looking forward and use it as a lesson.

Arena Pharmaceuticals Enters FDA Purgatory

Welcome to FDA purgatory, Arena Pharmaceuticals. It could be a long wait.

The Short-Seller Who Got Amylin Right

Image via WikipediaNEW YORK (TheStreet) -- Not all investors are shocked and upset about the decision by U.S. regulators to reject Amylin Pharmaceuticals' (AMLN) diabetes drug Bydureon. Short-sellers -- investors who bet that Amylin shares would fall -- are positively giddy and making money.

Amylin shares are down $10.35, or 50%, to $10.14 in Wednesday trading.

How did the shorts get Amylin right when a majority of investors believed Bydureon was going to be approved? I spoke with one Amylin short early Wednesday about his bear thesis. This hedge fund manager asked to remain anonymous because the rules of his fund forbid him to speak publicly about his investments.

"I always believed that Amylin and Eli Lilly (LLY) were taking shortcuts to get Bydureon through the FDA" and the agency was going to have problems with this approach, said this short seller.

Why the FDA Won't Approve Lorcaserin and Qnexa (Yet)

Hot Air Images via WikipediaI don't see much hope for Arena Pharmaceuticals, Vivus, or Orexigen at gaining FDA approval at this time.  I see it as a bunch of hot air and will not be approved with this conservative FDA panel right now.  That's not to say a CRL is necessarily a bad thing but at what point does the funding run dry?  Shorting these stocks wouldn't be a bad idea.  Especially, Vivus and Orexigen.  At a lofty 5 and 6 points it won't take much time to take the plunge to 2.

Wikinvest--ARNA, VVUS, OREX

By Brian Orelli
More Articles

October 19, 2010
 
After months of speculation and a pair of Food and Drug Administration advisory panels, FDA decisions for Arena Pharmaceuticals' (Nasdaq: ARNA) lorcaserin and VIVUS' (Nasdaq: VVUS) Qnexa are finally upon us.

Arena's PDUFA date is Oct. 22, while VIVUS' date with destiny is six days later on the 28th. The Prescription Drug User Fee Act (PDUFA) sets the goal for the FDA to make a decision by then, but the FDA is free to make a decision at any point before or after that date. A decision on lorcaserin especially could be delayed since the FDA advisory panel met just last month.

What's the chance of lorcaserin and Qnexa gaining FDA approval? I'd put it somewhere between unlikely and nonexistent.

If you would like more Subscribe To BioPharma Investor for everyday stock news and up to date FDA decisions.  Biopharma Investor

Alkermes Gains FDA Approval For Vivitrol, Anticipating Oct 22 Approval with Amylin Pharmaceuticals

Image via CrunchBase

Again another winning prediction from my FDA calendar for October.  Expect large gains for Alkermes tomorrow.  I wouldn't sell the stock as they have another approval up on Oct. 22nd in conjunction with Amylin and Eli Lilly for Bydureon, a weekly injectible diabetes medication.  I expect a FDA approval for that one too.  But you never know with the FDA.  Amylin already has approvals for daily injections but has modified the technology for weekly injections, so again I anticipate its approval as well.  Good news for Alkermes.

Try Wikinvest here--http://www.wikinvest.com/
Wikinvest---Alkermes (ALKS)
Wikinvest--Amylin Pharmaceuticals (AMLN)

If you would like more Subscribe To BioPharma Investor for everyday stock news and up to date FDA decisions.  Biopharma Investor
 Alkermes addiction drug wins wider U.S. approval

Tue Oct 12, 2010 7:26pm EDT

* Vivitrol already used in U.S. for alcoholics
* Approval may help turn around money-losing drug
* Shares up nearly 69 percent in 2010
* Shares up another 4.2 percent after hours

Disappointing Day For Alexza Pharmaceuticals

Image via CrunchBaseI quietly predicted today's FDA outcome on Alexza and Jazz Pharma's CRL, last week in my FDA Calendar prediction.  Here were My Predictions which stated that investor's should be shorting Alexza last week.  That would have netted a huge profit on Alexza's demise.  I think that shorting stocks or place put call options on FDA catalyst events can be profitable if done properly.  Although Jazz did not go down today, I do not see good things for their future

You really have to know what you are doing though when you make projections like this as is the drugs are approved then you will not be too happy with the results.  It's really a difficult line to cross but I see the value of Shorting Stocks under the Obama FDA panel.  The panel has rejected 4 drugs so far in October. 

That doesn't mean that you should have shorted Hospira or Human Genome Sciences (HGSI) because these are large and mid cap stocks that are affected less by these FDA decisions.  Human Genome has an upcoming drug approval in December for their Lupus therapy and I actually like the stock right now and consider it a buy.  Alexza and Jazz just had too many red flags for me for approvals.  You have to do your homework and look through the clinical trial data available.  Or just follow BioPharma Investor and let me give you helpful advice on these decision. 

Wikinvest--Alexza Pharmaceuticals (ALXA)  Closed:  1.35 Down 1.65 for a 54.46% Loss

Wikinvest--Jazz Pharmaceuticals (JAZZ)  Jazz will probably will be going down with today's CRL.

Jazz Pharmaceuticals Receives FDA Complete Response Letter Regarding JZP-6 for Treatment of Fibromyalgia


FDA O-Fer October Drug Approvals

BOSTON (TheStreet) -- U.S. regulators have to approve at least one new drug in October, right?


The U.S. Food and Drug Administration has a perfect 0-4 record so far this month -- four drug approval decisions, four drug rejections. Monday, Alexza Pharmaceuticals(ALXA) and Jazz Pharmaceuticals(JAZZ) received the bad news. Last week, it was FDA rejections for Human Genome Sciences(HGSI) and Hospira(HSP).

Perhaps the best shot for more positive news will come Tuesday when Alkermes(ALKS) is expecting FDA to rule on its drug for opioid addiction.

Investor's Class Action Lawsuit For Arena Pharmaceuticals: ARNA

Image via Wikipedia

I received a Class Action Notice from William Pratt on Arena Pharmaceuticals.  Plaintiffs have until November 19, 2010 to move to court.  You must have been an investor from December 8, 2009 anytime until September 16, 2010.  I actually sold my shares before the decline so I didn't really lose that much money, but I realize that many people did lose a lot of money over this stock.  I advised people to sell when I didn't like what I saw. 

Numerous Law Firms are Filing Class Action Lawsuits against Arena Pharmaceuticals.  This cannot be good for the future of the company.  I personally did not lose a huge sum of money and warned people against the dangers of the FDA decisions being made or not being made by the FDA.  This actually came down because of an FDA panel lack of recommendation.

 

 

Arena Pharmaceuticals, Inc. Class Action Litigation.: Filed Case  

Spector Roseman Kodroff & Willis, P.C. Announces Class Action Lawsuits Against Arena Pharmaceuticals, Inc. -- ARNA

Roche and Immunogen Develop Highly Targeted Specific Cancer Drugs

Image via Wikipedia

Articles Today about Roche's partnership with ImmunoGen on TDM-1.  TDM-1 is a highly targeted cancer drug for Breast Cancer.

ImmunoGen-(IMGN)

Roche Holdings (RHHBY)

Drugs

ImmunoGen's TDM-1 Looks Strong at ESMO

BOSTON (TheStreet) -- The "armed antibody" drug TDM-1 under development by Roche and ImmunoGen(IMGN) posted a higher response rate and lower toxicity than the blockbuster breast cancer drug Herceptin, according to results from the first head-to-head study of the two drugs to be presented at a European cancer meeting Monday.


The data from the TDM-1 phase II study in front-line breast cancer patients are early and very preliminary, but also encouraging because they suggest TDM-1 may be the next-generation successor to Herceptin that Roche has been looking for.

ImmunoGen, as Roche's partner on TDM-1, stands to profit as well if the drug is approved and successful.

Chelsea Therapeutics Rockets Upward on Clinical Trial Data

Image via Wikipedia So yesterday I was cautiously optimistic on Chelsea Therapeutics' 2nd go around with their Phase III Clinical Trial and I will eat crow on that story. I am simply a cautious investor. There is nothing wrong with that. I just want the facts before I jump into an investment.

But if the story had gone the other way, people would have lost a lot of money today upon negative results. I just wasn't so sure it would work this time around. I see now that it will be a good run-up candidate pending FDA approval. The stockcould go down a little after all the hoopla today and when it hits a bottoming price I see it as a buy. I'm not so sure I would be buying it just yet as there will be some selloff after today's news but putting a limit price target on the stock could be a good idea.

Most of the trading was done by Wall Street Investors in Pre-Market hours, so if you bought it this morning you might have lost a small chunk of change. Wall St. has a funny way of controling things before and after trading hits the floor for the everyday investor. They like to control the floor and let the little guy suffer sometimes. I won't go too much into that but you have to be careful when playing with the big boys in this game. Today is a good example if you look at todays stock chart.

Google Finance: CHTP

Here is the news today.

Chelsea Therapeutics 2nd Clinical Trial Pending Results

Image via CrunchBase

From Wikinvest: Chelsea Therapeutics (CHTP) traded higher Friday closing at 5.06 +0.94 for a 22% gain. I am showing some caution for Chelsea Therapeutics as this Clinical Trial was previously rejected last September. News from that rejection from Sept. 2009: Chelsea Therapeutics (CHTP) Dives After Trial Did Not Demonstrate Statistically Significant Improvement Versus Placebo. For more information on the 2009 Clinical Trial you can read more about it here: Chelsea Therapeutics Reports Preliminary Phase III Data of Droxidopa for Treatment of Symptomatic Neurogenic Orthostatic Hypotension

The catalyst that pushed Chelsea higher this past Friday was based on an Upgrade of Chelsea pending a 2nd Phase III clinical trial results.

Alkermes Gains FDA Recommendation For Vititrol

Cover of The Treatment of Opioid Dependence I expect a huge day tomorrow for Alkermes with the FDA recommendation of Vivitrol. PFUDA is Oct. 12, 2010. I expect approval with Vivotrol but you can never be sure with the FDA. Again big day tomorrow for Alkermes.

Wikinvest---Alkermes (ALKS)

Alkermes Announces FDA Advisory Committee Recommends Approval Of VIVITROL® For Opioid Dependence

Alkermes, Inc. (NASDAQ: ALKS) today announced that the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee voted 12 to 1 that VIVITROL ^® (naltrexone for extended-release injectable suspension) should be approved for the treatment of opioid dependence. Alkermes, Inc. (NASDAQ: ALKS) today announced that the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee voted 12 to 1 that VIVITROL ^® (naltrexone for extended-release injectable suspension) should be approved for the treatment of opioid dependence.

FDA rejects Arena's Lorcaserin, Stock Plunges

If you may have noticed, I haven't covered the weight loss drug companies since the panel rejected Vivus' Qnexa. Vivus (VVUS), Orexigen (OREX), and Arena (ARNA) are all horrible stock plays right now with the Ultra Conservative FDA board under the Obama administration right now. Sure the drugs might work., but the FDA isn't going to approve anything that might have any hint of a safety concern. Today is a good example of why that is true.

Savient Pharma Soars on FDA Approval For Gout Treatment



Gout Uric Acid Crystals



From the Wall Street Journal and Reuters: Savient Pharmaceuticals

Wikinvest: (SVNT) Google Finance (SVNT)

Savient shares rally as FDA approves gout drug
Sept 15
Wed Sep 15, 2010 9:15am EDT

The approval is also expected to trigger a renewed interest in the company that has been looking for a strategic deal, and some analysts expect a deal within three to four months.