Depends on how deal is structured. If they are launching Q1 of 2013, big pharma will want to see market response to product/uptake. If good & on-going studies look good...maybe. I'm sure WP will work hard to get a buyer- they made some bad deals that cost WP millions. I just hope the buy-out happens at aggressive PPS so shareholders benefit. SD has 1 million shares in tlon, so my hope is he will push to get top $.

Wonder who they are in talks with & what deal looks like. IMO stock should climb slowly until partnership announcement/2013 launch. Then...finally some real momentum. All speculative...

Launch not until 1Q13? With who as partner?

WP has made some costly mistakes this last year. They need this to workroom off-set some bad investments they made. SD has 1 million shares tied up in this company. He is going to make this work, I have no doubt about that. My opinion is that no one has offered a high enough PPS for buyout & given the niche mkt for Marqibo, it isn't getting as many suitors as SD would like. By the end of the year, I am guessing we will see pull through

I cannot wait until CC

I agree that $4-5 sound more like it, but I think we may see higher on a BO. It depends on the company acquiring - if someone like Amgen, I would bet higher than $4-5.

Roche paid 46.8 Billion or $95 PPS for Genentech to own full rights to Avastin, Herceptin & Rituxan - all oncology drugs. Now it is true that Genentech had a high PPS prior to the deal with an existing portfolio of ONC drugs...but for big pharma - it is cheaper to acquire a compound than develop your own. This is the way pharma is moving today...

Time will tell on this one. But a synergistic effect with an Amgen drug would mean big money. Pure speculation.

USA-based Amgen (Nasdaq: AMGN), the world's largest independent biotech firm, has announced updated results from a Phase II study that showed treatment with blinatumomab (AMG 103) helped achieve a high-rate of complete response (CR) in 72% of adult patients with relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL) treated in the study.

Blinatumomab is the first of a new class of agents called bi-specific T cell engagers (BiTE) antibodies, designed to harness the body's cell-destroying T cells to kill cancer cells. It is the lead compound of Micromet (Nasdaq: MITI), which entered a collaboration with Amgen last year worth a potential $990 million to Micromet for BiTE antibodies against three undisclosed solid tumor targets (The Pharma Letter July 12, 2011). However, Amgen decided to acquire Micromet, a $1.16 billion transaction (TPL January 27) which completed in March.[color=red][/color]

Marilyn - I'll join you in a cheer. This is exciting both for us as investors and the cancer community. Truly a blessed feeling today...

However, I will say that I am curious & looking forward to what happens with potential partners due to this statement:

Deitcher said he expects Marqibo to eventually be combined with biologic drugs being developed for treatment of ALL, such as Amgen Inc's experimental antibody blinatumomab.

If there is a synergistic effect of combination therapy and Amgen came courting, you can bet the PPS will be significant.

I think the $45 potential PPS is way off base. Sure, I'd love it but we need to operate in a rational manner. $45 PPS is not rational - certainly not at this juncture.

I think the $45 potential PPS is way off base. Sure, I'd love it but we need to operate in a rational manner. $45 PPS is not rational.

Ongoing study... But baby steps. FDA response is huge win. This is big, especially if they can get a significan number of patients to transplant. Talon got the break it needed. Quite frankly WP needed as well with huge losses they incurred this year.

Have faith...and hold on for the ride.

 
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FDA NEWS RELEASE
For Immediate Release: Aug. 9, 2012
Media Inquiries: Stephanie Yao, 301-796-0394, stephanie.yao@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
 
FDA approves Marqibo to treat rare type of leukemia
Orphan drug approved under agency’s accelerated approval program
 
The U.S. Food and Drug Administration today approved Marqibo (vincristine sulfate liposome injection) to treat adults with a rare type of leukemia called Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia (ALL).
 
ALL is a rapidly progressing form of blood and bone marrow cancer that is more commonly diagnosed in children than adults. According to the National Cancer Institute, an estimated 6,050 men and women will be diagnosed with ALL and 1,440 will die from the disease this year.
 
Marqibo is approved for patients whose leukemia has returned (relapsed) two or more times, or whose leukemia has progressed following two or more regimens of anti-leukemia therapy. Marqibo contains vincristine, a commonly used anti-cancer drug, encased within a liposome, a drug delivery vehicle composed of material similar to that of cell membranes. It is an injection administered once a week by a health care professional.
 
“Marqibo’s approval demonstrates the FDA’s commitment to the development and approval of drugs that address serious, unmet medical needs,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Marqibo provides an additional option for Philadelphia chromosome negative acute lymphoblastic leukemia patients whose disease is unresponsive to available therapies.”
 
Marqibo is approved under the FDA’s accelerated approval program, which allows the agency to approve a drug to treat a serious disease based on clinical data showing that the drug has an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients. This program provides earlier patient access to promising new drugs while the company conducts additional clinical studies to confirm the drug’s clinical benefit and safe use. Marqibo also received orphan-product designation by the FDA because it is intended to treat a rare disease or condition.
 
The drug’s effectiveness was evaluated in a single clinical trial in adult patients whose leukemia had relapsed at least two times despite standard treatments, and who had at least one previous treatment response lasting at least 90 days. The study objective was to determine the response rate to Marqibo, as either a complete remission (CR) or a complete remission with incomplete blood count recovery (CRi). Of 65 patients enrolled, 10 patients, or 15.4 percent, responded with either a CR or CRi. In the 10 patients achieving CR or CRi, the median duration of documented remission was 28 days. The median time to the first event of relapse, death, or next therapy was 56 days.
 
The safety of Marqibo was evaluated in two single-arm trials of 83 patients who received the clinical treatment regimen. Serious adverse events such as low white blood cell counts with fever, low blood pressure, respiratory distress and cardiac arrest occurred in 76 percent of the patients studied. The most common side effects observed during clinical studies include constipation, nausea, low blood cell counts, fever, nerve damage, fatigue, diarrhea, decreased appetite, and insomnia.
 
Prescribing information for Marqibo will carry a Boxed Warning alerting patients and health care professionals that the drug must be administered only through a vein (intravenously) because it is deadly if administered in other ways, such as into the spinal fluid. The Boxed Warning also states that Marqibo has different dosage recommendations than vincristine sulfate injection alone. To avoid overdose, it is important for health care professionals to verify the drug name and the dose before administration. Special requirements for preparation of the drug are detailed in the label.
 
Marqibo is marketed by Talon Therapeutics Inc., based in South San Francisco, Calif.
 
For more information:
FDA: Office of Hematology and Oncology Products
FDA: Approved Drugs: Questions and Answers
 
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
 
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Read our Blog: FDA Voice
 

Congrats to Talon & congrats to fellow shareholders. Bear raiders eat your shorts!!!!!

If I could write code, I would create GuruFocus for Washington. Bye bye insider info. The market gets a whole lot more transparent.

I think you are right. Manipulating the stock like what has happened here should be criminal. Trading is full of shady characters who are nothing but greedy. Hopefully they don't develop some of the disease states that these fledgling companies are trying to bring to market, which actually save lives. It is egregious when you mess with people's lives to make a buck.

"We have corrected flaws in vincristine ... Our doses are two to three times larger," said Talon Chief Executive Steven Deitcher in an interview. "We can dose intensify with a side effect profile comparable to the original drug."

This is the basis for my dosing comments. The FDA may agree with how the study was powered, but clearly they are looking for more information on something. I can only say in my experience what that ususally means in labeling negotiations.

I stand corrected on Peds - not part of Aug. PDUFA date.

On labeling negotiations - My question is why did Talon dose first patient post May PDUFA extension and why is the confirmatory study powered for superiority?

Trust me, any drug company with a pending drug under FDA review & pre-approval cannot give specifics. Labeling negotiations is even more that I think is appropriate, but no one besides the FDA & Talon knows what that means. Coould be dose related, indications, post marketing...

I am with you - I hope we are right on this & by the end of next week we are all saying - why were we even concerned in the first place?? ;)

A win for the cancer community is a win for us. Go TLON Go!

Agreed. The mere fact that the purpose of Marqibo is to get the patients enough time to get to transplant is a valid argument in a highly terminal patient population. The fact that 2 patients were able to successfully get to transplantation is a new milestone in this group. If the committee does not approve this, it will be a signifcant loss for the cancer community.

I agree...it is frustrating to see the drop below $1. My guess is Talons financials are weak, the patient population is niche, and investors are concerned about the cost of marketing this drug vs. profit to keep the other asset studies ongoing. I speculate a price spike will occur post approval & conference call if marketing announcements are made. It would be smart for Talon to pick 2 established oncology partners to co-market Marqibo, paying a licensing fee & royalties. In picking 2 partners, it eliminates some marketing risk/acceptance of drug in ONC community & would infuse cash immediately into Talon with an ongoing source of revenue via royalties. I don't want to see them take on an internal sales force - too much infrastructure, too much cost in the infancy of Marqibo's life cycle.

ODAC accepted the story of Marqibo’s potential to get
responses that could allow patients to move on to transplantation.
“I felt that this drug was able to convert the patients who
were in a palliative setting to a potentially curative setting,” said ODAC member Mikkael Sekeres, associate professor of medicine at the Cleveland Clinic Taussig Cancer Institute Department of
Hematologic Oncology and Blood Disorders, at the meeting March 21. “That’s a meaningful change in goals of therapy for patients.”
These responses were seen in a 65-patient study. Five of
the patients who responded moved on to transplantation, and, for
two of them, the transplants were beneficial.

One other thing to note is that the dosing trial that is ongoing may not get enough patients enrolled before Aug. PDUFA. The study was powered for superiority between Marqibo and standard viscrinstine. It could be true that the board was unimpressed with 15% responder rate in the study. However, talon tweaked dosing to max dose for efficacy while minimizing side effects to that of the original form of vincristine. Remember, this is an orphan drug for a patient population that once other anti-leukemia options are explored & have failed, are sent home to die. Would the board halt giving 15% of that patient population the chance to extend their life? I doubt it, when there is no other drug on the horizon for these patients. If standard viscrinstine could have done the job, wouldn't Eli Lilly keep the asset? Talon licensed Marqibo in 2006 after the FDA in 2005 turned down an application for the drug, filed by two other companies, to treat relapsed non-Hodgkin’s lymphoma.

The drug is toxic, and a max dose gives efficacy but side effects, especially toxicity to organs is a concern. So, fine tuning the dosing and administration (infused how quickly) can alleviate toxicity.

I believe the delay was due to dose/infusion rates and ped dosing. I don't think they will wait for confirmatory phase III. Unfortunately, these patients die, not from Marqibo, but from a very aggressive form of cancer. Marqibo, to those patients, gives them the ability to extend the inevitable. Obviously you want the patient to be comfortable after dosing and have improved QOL or outcome.

I hope that helps.

Yes...I think you are right. I am betting on conservative PPS post PDUFA. I think it is the details afterwards that are announced via conference call(perhaps) Monday that will send PPS higher. It will hinge on the marketing/partner or buyer of this drug that will make us money - not PDUFA in my opinion.

I don't think we will see a huge bump. Maybe $1.75 - $2
That will go up depending on:
1) If TLON hires own sales force and uptake is significant in Oncology
2) If they have an established partner - they could be long term buyer. Get a partner like Amgen or Genentech...this will go higher

That is the downside of charting. There are way more factors involved when a WP is involved. A lot of hidden gems are available on message boards, websites and news sites. Kinda like a puzzle - putting the pieces together takes time but can give you a much better clue about what you really want to know.

I don't chart, so don't quote me here :) That being said, I am going off what I read, who they hire to market the drug, that person's experience, and if I knew who might be buying, I could be more definitive. My guess? $3.50-$4.50 on acquisition deal.

I agree Bio. I think this is going to be a really interesting ride.

Here is what went wrong with Allos - interesting that Allos had an orphan drug with limited patient pop. like TLON

The company's business strategy may have been a major factor. While Folotyn proved to be a relatively successful drug, Allos wasn't following a business plan that would allow for the company to be markedly successful, said Michael Becker, a partner at boutique cancer consulting firm MD Becker Partners.

Allos' business model appeared to replicate that of a larger company, such as Amgen Inc., which has drugs with high volume sales that target large patient populations. However, Allos' Folotyn was a niche drug -- technically designated an orphan drug by the FDA. That means it targets a patient population of fewer than 200,000, which likely limited sales, Becker said.

WP potential losses from Allos deal with Spectrum

Published April 9, 2012 at 5:06 PM

Private equity investor Warburg Pincus, an active investor in biotech, is taking a multimillion-dollar loss on its seven-year-old investment in Allos Therapeutics Inc., which agreed to be acquired by Spectrum Pharmaceuticals Inc. for $206 million.

Warburg, with 24.4% of Allos shares, stands to bring in $47.55 million from the sale to Henderson, Nev.-based Spectrum, which is paying $1.82 a share. Under the terms of the transaction, announced April 6, shareholders could gain $12.5 million more, of which Warburg could take slightly more than $3 million, if Allos achieves a $.11 a share milestone payment by securing European goals for its lymphoma medication Folotyn.

If Allos, a Westminster, Colo.-based biotech company, is able to sell Folotyn in three European markets by 2013, Warburg's loss will be $21.1 million. If Folotyn fails, Warburg's loss would be more than $24 million, or about 33% of its $71.7 million total outlay. It paid an average of $2.68 a share.

http://www.thedeal.com/content/healthcare/warburg-pincus-to-post-a-loss-from-allos-sale-to-spectrum.php#ixzz22yFPtK5y

That is why I wonder if they will sell off the Marqibo asset to big pharma & get a buyer for the pipleline as the year end nears. I agree they aren't going to take a hit on TLON...and perhaps the Allos mishap will help us because if they are smart they will offset Allos losses with TLON gains.

Looks like the deal happened @ April 5th, 2012 for $1.82 in cash and one Contingent Value Right (CVR) per share, given certain criteria were met. Spectrum bought them for $206 million.

In Oct. 2011 prior to the Spectrum deal, another deal was stuck with AMAG Pharmaceuticals to buy Allos for $195 million and $2.44 per share. Shareholders sued, and Allos settled, forgoing the deal which opened the doors for Spectrum.

http://www.bloomberg.com/news/2011-10-14/allos-says-it-settled-lawsuits-contesting-merger-with-amag.htm

I understand your frustration. One thing I understand is big pharma & their assets. Like you, I don't do charting. I look at the 52 w high & low and movement through last 5 years given milestones in asset development. For longs, this may not be a quick recoup. May take time as they sell assets. If WP does not sell Marqibo asset quickly, then they will hold & sell all assets to highest bidder. Because studies are ongoing, that may take more time.

Biotechs & pharma always have a short & long term plan - that I know for certain. WP & DF know what they are going to do & they will make money doing it. Look at their preferred shares price, look at Allos deal & try to guess what margin they are after. They use a formula - so we might get somewhat of a better idea of what that might look like.

Hope so. I am a conservative investor, which has helped me tremendously. I don't have a huge biotech portfolio, as I like to minimize risk, but I work in biotech & love drug development. So, for me this is a hobby that pays.

Yes.

Bio...don't get too discouraged yet. The shares might not rebound the way everyone guessed pre PDUFA, but post PDUFA I am confident we will see increases on share price.

DF & WP have a lot of money tied up in this deal & if you look at what they are financing, TLON is the only stock below $2.00 they currently finance in the biotech sector. So, hold on to that thought until PDUFA comes.

While I noted that Warburg may operate in a way that doesn't necessarily benefit stockholders, I do believe approval will come. The delay signaled to me that the rumors of label negotiation were most likely true. If they had to undergo REMS as requested by the FDA, TLON may have pulled out - cost prohibitive.

What I don't know is what the approval will mean to share price. Clearly big pharma may gobble up this asset (Marqibo), but not acquire Talon in whole. That is what I suspect. It will take more than Marqibo for a merger to happen in my opinion.

The problem with Warburg is that what they did with Allos Theraputics has lead to many investors not getting ROI and a class action lawsuit has been filed. The deal they struck with Spectrum to purchase Allos suited Warburg fine, but to many stockholders, it was a bad deal. It is alleged that Warburg significantly undervalued Allos to get this deal done.
http://www.classactioncentral.com/allos-therapeutics-inc-sued-for-unfair-practices-regarding-spectrum-merger/

So, while I will agree that I like that DF and WP have a lot tied up in TLON, I hope they don't undervalue TLON and cover themselves...leaving those of us who bought in at a higher share price in the dust.
http://www.themarketfinancial.com/understanding-warburg-pincus-strategy-otchnab-nasdaqisph-nasdaqalth-nasdaqzgen-nasdaqeurx-nasdaqitmn-nysewx/93040

What is happening here? How can this recover with 5 days left?