Key Developments for Spectrum Pharma, Human Genome Sciences and Hemispherx Biopharma

Readers and know that we have been tracking the developments at Spectrum Pharmaceuticals (Nasdaq:SPPI) via articles and our FDA Decisions and Clinical Trails Calendar for some time.

Our coverage of the stock began in early May when shares were trading at $2.50, with high hopes that shares would continue to rise based on multiple criteria, including the fact that the company had 2 pending FDA decisions. In the last 24 hours, things have gotten even more interesting. The first of two drugs is scheduled to make a decision on July 2 on SPPI's non-Hodgkin’s lymphoma radio-immunotherapeutic, Zevalin, but shares pulled back after the FDA asked for additional information from the company. Since Zevalin is already approved as a treatment for patients with relapsed or refractory, low-grade or follicular B-cell NHL, industry insiders have told us that they feel good about the chances for the drug's approval for the additional use of Zevalin to treat non-Hodgkin's lymphoma [NHL].

Yesterday there was a key development in this story line. Spectrum announced that U.S. health regulators accepted for review the company's response on its experimental cancer drug, Zevalin, as a Class 1 submission -- which typically means the regulators will review the drug within 60 days. The U.S. Food and Drug Administration has now set Sept. 7 as its decision date on the drug, the company said.

On October 8th, SPPI will seek approval for yet another cancer drug, Fusilev. Like Zevalin, Fusilev is also already approved by the FDA for osteosarcoma or bone cancer, which SPPI obtained in early 2008.

Justin Hall has been tracking the company in detail and in his June 12 article for BioMedReports, he indicated the company could likely generate $280 million in annual revenue within the next 12-18 months upon approval of both the company's cancer drugs Zevalin and Fusilev.

BioMedReport's Mike Havrilla weighed in with his own price targets for the company in his article on June 26th.

Yesterday, my own interest in the company was piqued after learning that the U.S. Food and Drug Administration [FDA] has granted Fast Track Designation for the investigation of apaziquone (EOquin[R]) for the treatment of non-muscle invasive bladder cancer, a form of bladder cancer localized in the surface layers of the bladder that has not spread to the deeper muscle layer.

Approximately 70% of all newly diagnosed patients with bladder cancer have non-muscle invasive bladder cancer. More than one million patients in the United States and Europe are estimated to be affected by the disease.

Experienced Biotech investors will tell you that "Fast Track" status is a BIG "go ahead" sign that should make all investors take special notice of the company. To put it in the most simple terms, accelerated review will usually mean that the drug is either "fantastic" or that it can be used with a great deal of restrictions.

In this case, it means that SPPI's apaziquone is getting some terrific results and investors want to own a company whose accelerated review comes from exactly this type of scenario.

"We are pleased that the FDA has accepted apaziquone under its Fast Track program," said Rajesh C. Shrotriya, MD, Chairman, President, and Chief Executive Officer of Spectrum Pharmaceuticals. "In a marker lesion study, where patients had previously failed multiple therapies, apaziquone produced a 67% complete response and was well-tolerated. We look forward to continuing with Phase 3 studies evaluating the efficacy and safety of apaziquone, while working with the FDA to expedite the drug's development, review and approval process so we can help address the substantial unmet needs of patients suffering from non-muscle invasive bladder cancer."

Fast Track designation is also designed to facilitate drug development and expedite the review of drugs intended to treat serious conditions and demonstrate the potential to address unmet medical needs. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious diseases. Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication facilitates the sponsor's ability to expeditiously address questions and issues.

A drug that receives Fast Track designation is eligible for a Rolling Review, which means that a drug company can submit completed sections of its New Drug Application [NDA] for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed. NDA review usually does not begin until the drug company has submitted the entire application to the FDA.

I urge you to become familiar with SPPI, just as I told you to do with Human Genome Sciences Inc. (NASDAQ:HGSI) weeks ago.

If you missed it, HGSI shares shot up from the $3 range to over $12 yesterday, after the company announced that its BENLYSTA[TM] met the primary endpoint in BLISS-52, the first of two pivotal Phase 3 trials in patients with serologically active systemic lupus erythematosus [SLE].

As Hemispherx Biopharma's (AMEX:HEB) Dr. William Carter would say, there are "multiple shots on goal" here.

Speaking of Dr. Carter, his company announced yesterday that it will provide an update on its Influenza research initiatives via teleconference. Initiatives to be discussed will include experimental programs planned or underway in Pacific Rim countries, Australia, South America and the United States. Background information may be sourced at Wall Street Journal, July 18/19, 2009, p. A3. Shares of the company could see another rise, depending on the specific items and revelations that may be made during the call. Hemispherx's Medical Director and the Managing Director of the Sage Group, a health care consulting firm retained by HEB, will participate in the call as well.

There has been much discussion about the participation of Hemispherx's Ampligen[r] (poly I: poly C12U) role in the N1H1 Flu pandemic, not as a vaccine, which some biotech writers still don't seem to understand, but as a possible adjuvent (booster) to a vaccine.

According to the company, investigational products and protocols to be discussed will also include Hemispherx's Ampligen(r) (poly I: poly C12U), and Alferon N (a natural cocktail of alpha 2 type interferons, FDA approved for treatment of refractory HPV) and Alferon LDO, an experimental formulation of Alferon-N for oral delivery.

The teleconference will take place on Wednesday, July 22, 2009, at 10:00 AM EDT. Initiatives to be discussed will include experimental programs planned or underway in Pacific Rim countries, Australia, South America and the United States. Background information may be sourced at Wall Street Journal, July 18/19, 2009, p. A3.

The company is still waiting for a decision from the FDA on the approval of Ampligen as a treatment for Chronic Fatigue Syndrome. The FDA has not asked the company for additional information or data in regards to that pending NDA decision.

Disclosure: Long SPPI

Comments

[hanumanhojo:]

HEB is a stock watering scam. Why is it even being mentioned on Seeking Alpha? Pump and dump?

Jul 22 12:19 PM

[HA65MPH:]

HEB ..IS A WINNER...YOUR EYES ARE WIDE SHUT !

Jul 22 12:43 PM

[pennycarl75:]

seems the fda hav to clean their glasses. remember dndn

Jul 22 09:04 PM

[georgestu:]

Anyone who calls Hemispherx a scam needs to take a second look at their most recent research. Their chief drug, Ampligen, not only has orphan drug status for CFS, it has been identified by the Japanese as the best vaccine adjuvant anywhere in the world. The BIKEN corporation is ramping up its manufacturing capacity in Japan to produce a vaccine containing Ampligen as it number one weapon against the swine flu.

Jul 30 10:59 AM

[260736:]

Comments requested from author on the article "Spectrum a Takeover Target for Bayer? Color Me Skeptical!" -- Written by Adam Feuerstein in Boston at the Street.com

"The rumor mill is churning with this: If Spectrum wins the new Zevalin approval (the decision is expected Sept. 7), Bayer will want to buy the company so it can control worldwide rights to the drug.

Really? The problem with this rose-colored scenario is that Bayer shows very little interest in Zevalin today. The company barely markets the drug in Europe despite already having the expanded NHL approval there. (Bayer doesn't even break out Zevalin sales every quarter because the drug is barely a rounding error on its income statement.)"

". . . an amateur stock picker writing for Seeking Alpha predicts 7,500 patients and Zevalin sales of $180 million within 18 months of the FDA approving the expanded label."

www.thestreet.com/stor...

Aug 05 10:44 AM

[dreamdivers:]

Georges, will all due respect your comments are inaccurate and misleading. Orphan drug status in itself means nothing, it is an almost automatic designation by the US FDA when a disease indication has a small patient population. The "Japanese" have not called ampligen the best vacine adjuvant anywhere in the world, an article by a specific researcher called it among the most promising mucosal adjuvants in research, note the emphasis on mucosal. And finally, Biken may be expanding its manufacturing site in Japan, but there is no evidence or statement from Biken that this is being done in order to produce a vaccine containing ampligen for swine flu. Ampligen-containing vaccines have not even started human clinical trials yet.

Aug 10 05:50 PM