TheStreet Search RSS Feed: Adam Feuerstein

Worth Repeating: Vertex Is the Next Gilead Sciences

Fri, 19 Apr 2013 14:51:30 GMT

CAMBRIGE, Mass. (TheStreet) -- Vertex Pharmaceuticals shares are soaring 60% to $84.87 Friday morning following an announcement last night that its cystic fibrosis drug Kalydeco combined with an experimental drug VX-661 significantly improved the lung function of patients in a mid-stage clinical trial.

Analysts are rushing to upgrade and slap triple-digit price targets on Vertex because it now appears more likely that the company's cystic fibrosis drug franchise will prove effective for a large swath of the 70,000 people with the genetic lung disease worldwide. Peak sales could easily top $5-6 billion.

Last May, when Vertex released interim results from its combination therapy for cystic fibrosis, I wrote a column explaining why investors should look at Vertex as the next Gilead Sciences . Like Gilead dominates HIV therapy (and perhaps hepatitis C therapy soon), Vertex will now dominate cystic fibrosis. ...

Click to view a price quote on GILD.

Click to research the Drugs industry.

2013 FDA Drug Approval Decision Calendar

Wed, 19 Dec 2012 14:12:30 GMT

BOSTON (TheStreet) -- Here's an updated list of biotech and pharmaceutical companies with FDA drug approval decisions expected in 2013.

Biotech and drug stocks below are listed in chronological order based on the closest regulatory catalyst -- FDA drug approval decisions and advisory panels.

Johnson & Johnson Drug/indication: Canagliflozin for diabetes. FDA advisory panel: Jan. 10 Approval decision date: March 29 ...

Click to view a price quote on PATH.

Click to research the Drugs industry.

Vertex Enters New Hep C Collaborations With J&J, Glaxo

Thu, 01 Nov 2012 12:09:03 GMT

CAMBRIDGE, Mass. (TheStreet) --Vertex Pharmaceuticals is pairing up with Johnson & Johnson and GlaxoSmithKline in separate collaborations that will study new all-oral combination therapies for hepatitis C, the companies said Thursday.

All three companies are trying to catch up with Gilead Sciences and Abbott, which are well ahead in the race to develop all-oral hepatitis C therapies.

Both new collaborations involve Vertex's nucleotide "nuc" polymerase inhibitor VX-135, formerly known as ALS-2200. ...

Click to view a price quote on VRTX.

Click to research the Drugs industry.

Medivation Prostate Cancer Drug Launches Hot

Thu, 01 Nov 2012 11:10:24 GMT

SAN FRANCISCO (TheStreet) --Medivation's marketing partner Astellas reported Xtandi sales of $14 million for the third quarter and forecast $100 million in sales for the newly launched prostate cancer drug through the end of its fiscal year on March 31, 2013.

Xtandi was developed by Medivation but is being sold by the Japanese drug maker Astellas, which reports sales.

Gauging a consensus for early Xtandi sales has been difficult but $14 million in third-quarter revenue is definitely higher than the Street expected given that Astellas only started selling the drug in the middle of September. Assume that a good chunk of third-quarter sales is wholesaler inventory stocking. ...

Click to view a price quote on MDVN.

Click to research the Drugs industry.

Biotech Stock Mailbag: Catalyst Pharma, Amarin, Star Scientific

Fri, 26 Oct 2012 12:00:00 GMT

BOSTON (TheStreet) -- The Biotech Stock Mailbag is open for business.

@scramjet asks, "How do you feel about $CPRX?"

Ambivalent. The upcoming phase IIb study of CPP-109 (vigabatrin) in cocaine addiction is an important catalyst for Catalyst Pharmaceutical Partners but guessing the outcome is challenging. Results from the study, even if positive, may be hard to interpret. ...

Click to view a price quote on CPRX.

Click to research the Drugs industry.

Vertex Cystic Fibrosis Combo Therapy Passes Key Confidence Test

Thu, 11 Oct 2012 18:42:52 GMT

ORLANDO (TheStreet) -- Checking in from the 2012 North American Cystic Fibrosis Conference, where Vertex Pharmaceuticals presented more detailed data on the VX-809/Kalydeco combination therapy:

Wall Street came into Thursday's presentation seeking greater confidence that VX-809 and Kalydeco worked synergistically to improve lung function in cystic fibrosis patients with the common F508del mutation; and that 600 mg of VX-809 was the most effective dose to move forward into the phase III study. What investors feared was data previously undisclosed that would cast significant doubt on the future of the VX-809/Kalydeco program.

Mission accomplished, for the most part. The data presented were positive and largely in line with expectations, not perfect but without major red flags. ...

Click to view a price quote on VRTX.

Click to research the Drugs industry.

NPS Pharma: Gattex FDA Panel Preview

Thu, 11 Oct 2012 10:57:33 GMT

BEDMINSTER, NJ (TheStreet) -- NPS Pharmaceuticals has two major questions to tackle at next week's FDA advisory panel that will review Gattex for the treatment of patients with short bowel syndrome.

1. Does Gattex cause cancer?

2. Does a reduction in intravenous feeding (but not necessarily a cessation of intravenous feeding) represent a significant and meaningful clinical benefit for patients with short bowel syndrome? ...

Click to view a price quote on NPSP.

Click to research the Drugs industry.

Threshold Pharma Seeks to Erase Doubts About Pancreatic Cancer Drug

Mon, 01 Oct 2012 10:23:50 GMT

VIENNA (TheStreet) -- Threshold Pharmaceuticals presented new data Saturday showing how pancreatic cancer patients who "crossed over" in a mid-stage clinical trial of TH-302 may have hampered the drug's ability to demonstrate a stronger improvement on overall survival.

When these crossover patients were excluded from the analysis of the phase II study, the survival benefit attributable to TH-302 improved.

The new analysis was an effort by Threshold to alleviate investor concerns about the future of TH-302. The company's stock price has fallen by 20% over the past two weeks because of worries that TH-302 would not help patients live longer in a larger, phase III trial scheduled to start soon. ...

Click to view a price quote on THLD.

Click to research the Drugs industry.

Celgene's Abraxane Is Talk of European Cancer Confab

Mon, 01 Oct 2012 10:22:18 GMT

VIENNA (TheStreet) -- Celgene hasn't yet announced results from the Abraxane phase III study in pancreatic cancer but the drug generated a lot of positive buzz at this weekend's European Society of Medical Oncology (ESMO) conference.

Cancer consultant guru and blogger Sally Church, in attendance at ESMO, notes oncologists who specialize in pancreatic cancer are typically a dour lot because of the paucity of effective therapies at their disposal. But she was surprised to see these experts in an "excited and feisty mood" Friday because of Abraxane data expected very soon.

On the timing of Celgene announcing results from the Abraxane phase III study, Church writes: ...

Click to view a price quote on CELG.

Click to research the Drugs industry.

Biotech Stock Mailbag: YM Bio, Hemispherx, Navidea

Fri, 28 Sep 2012 11:00:00 GMT

BOSTON (TheStreet) -- This week's Biotech Stock Mailbag opens with a question from Jeff N. "Adam, I wanted to get your feedback on your prediction for a takeout of YM BioSciences."

Whoa, slow down, Jeff. Let's not set the bar for YM Bio at an unattainable height. Investors are anxious enough already over the interminable wait for YM Bio to negotiate a partnership for the myelofibrosis drug CYT387.

On the partner front, YM Bio CEO Nick Glover says the company continues to "conduct a robust business development campaign aimed at exploring potential opportunities to further develop and commercialize the drug with other companies ..." ...

Click to view a price quote on YMI.

Click to research the Drugs industry.

Peregrine Pharma: Cash Crisis and Exaggerated Survival Benefit

Thu, 27 Sep 2012 12:43:49 GMT

TUSTIN, Calif. (TheStreet) --Peregrine Pharmaceuticals is now dealing with a financial crisis on top of a discredited lung cancer drug.

On Wednesday, Peregrine's lenders filed a notice of default that forced the company to repay immediately a $15 million loan plus interest and fees. "Major discrepancies" in the conduct of Peregrine's bavituximab lung cancer study, disclosed Monday, caused the company to violate the terms of its loan agreement, the creditors said.

Peregrine now has only enough cash on hand to fund operations until April 2013 -- the end of the company's fourth quarter of fiscal year 2013. Peregrine could try to raise more cash via an existing At-The-Market (ATM) equity facility, but such stock sales now are unlikely to due the risk of legal liabilities. ...

Click to view a price quote on PPHM.

Click to research the Drugs industry.

Hemispherx's Ampligen Rehash Unlikely to Impress FDA

Thu, 27 Sep 2012 11:00:00 GMT

PHILADELPHIA (TheStreet) --Three years after being rejected by U.S. Food and Drug Administration, Hemispherx Biopharma is back seeking regulatory approval for Ampligen, its controversial therapy for chronic fatigue syndrome.

Everyone loves a comeback story with a happy ending, but Hemispherx's second attempt won't turn out any happier than the first. FDA is likely to reject Ampligen again because Hemispherx ignored the agency's demand to run a new clinical trial in chronic fatigue syndrome.

Instead, Hemipsherx has spent the past three years doing essentially nothing but re-analyzing data from the old Ampligen phase III trial completed in 2004. FDA reviewed the original study already, deeming it "lacking credible evidence of efficacy of Ampligen." ...

Click to view a price quote on HEB.

Click to research the Drugs industry.

Vertex Advances One of Two Hep C Drugs

Tue, 25 Sep 2012 13:36:01 GMT

CAMBRIDGE, Mass. (TheStreet) --Vertex Pharmaceuticals is advancing one experimental hepatitis C drug into mid-stage clinical trials while shutting down work on a second drug due to poor efficacy, the company announced Tuesday.

Both Vertex drugs, ALS-2200 and ALS-2158 belong to the class of hepatitis C drugs known as nucleotide (or nucleoside) polymerase inhibitors -- commonly referred to as "nucs" -- which have the potential to become the backbone of new, all-oral combination regimens.

The current superstar of the "nuc" drug class is Gilead Sciences' GS-7977, but Bristol-Myers Squibb was forced to abandon its nuc BMS-094 because it caused heart failure. The fallout from Bristol's drug has since spread to Idenix Pharmaceuticals and its nuc IDX-184, which is on clinical hold until U.S. regulators are assured the drug is safe. ...

Click to view a price quote on VRTX.

Click to research the Drugs industry.

Peregrine Pharma Stock Craters on Lung Cancer Drug Blowup

Mon, 24 Sep 2012 13:52:19 GMT

TUSTIN, Calif. (TheStreet) --Peregrine Pharmaceuticals threw out previously reported results -- including the survival benefit -- from a mid-stage study of its lung cancer drug bavituximab because of "major discrepancies" in the study's conduct, the company said Monday.

Shares of Peregrine plunged $3.89 , or 72%, to $1.48 in early trading. The stock has now given back nearly all its gains of the summer, driven by speculation and hype around the bavituximab lung cancer data.

During the course of preparing for a meeting with the U.S. Food and Drug Administration, Peregrine says it discovered differences between the results reported for some patients and their "treatment code assignments" -- whether or not patients were being treated with bavituximab or a placebo. ...

Click to view a price quote on PPHM.

Click to research the Drugs industry.

Spectrum Pharma Not Ready to Call Lymphoma Study a Win

Mon, 24 Sep 2012 10:00:00 GMT

HENDERSON, Nev. (TheStreet) --Spectrum Pharmaceuticals and TopoTarget are collaborating on the development of the lymphoma drug belinostat, but the partners aren't on the same page over the outcome a pivotal study -- yet.

On Friday morning, TopoTarget, a Danish drug firm, announced that the primary endpoint had been meet for the belinostat phase II trial for patients with peripheral T-cell lymphoma (PTCL).

Spectrum, however, chose not to participate in TopoTarget's announcement. Instead, Spectrum filed an 8-K Friday evening, characterizing the belinostat study results as "preliminary" and said a definitive verdict wouldn't be determined until final data are collected and analyzed at the end of the fourth quarter. ...

Click to view a price quote on SPPI.

Click to research the Drugs industry.

Biotech Stock Mailbag: Pending Sarepta Results, Cyclacel

Fri, 21 Sep 2012 12:16:14 GMT

BOSTON (TheStreet) -- I want to use this week's Biotech Stock Mailbag to reiterate and expand upon some of the discussions during Wednesday's Biotech Stock Live Chat.

Sarepta Therapeutics could release the 48-week data from the phase II study of eteplirsen in Duchenne muscular dystrophy any day. These data are scheduled for presentation at the World Muscle Society meeting on Oct. 13, but Sarepta will probably issue a press release announcing the eteplirsen results in advance.

To prepare for this important catalyst, let's first review the previous eteplirsen data released last April and then more recently on July 24. ...

Click to view a price quote on SRPT.

Click to research the Drugs industry.

Biotech Stock Live Chat: Fall Preview

Wed, 19 Sep 2012 15:53:40 GMT

Biotech Stock Live Chat

BOSTON (TheStreet) -- Welcome to September's Biotech Stock Live Chat. The floor is yours.

It's been a while since I did one of these chats, so a review of the ground rules: I'm here for the next 90 minutes to answer your biotech-investing questions and, hopefully, spark some interactive debate on the hot topics of the day. This chat only works if you participate, so please keep the questions and comments flowing. ...

Click to view a price quote on AMRN.

Click to research the Drugs industry.

The Targacept Secret That Wall Street Doesn't Want You to Know About

Tue, 18 Sep 2012 11:48:54 GMT

WINSTON SALEM, NC (TheStreet) -- Why is mutual fund giant Fidelity and a well-known healthcare hedge fund buying more Targacept despite the company's miserable drug development track record? Yet another of Targacept's clinical trials ended in failure Monday.

The answer: Alzheimer's disease. More specifically, there's a drug sitting in Targacept's pipeline that could one day treat Alzheimer's and maybe schizophrenia, too. Billion-dollar plus markets, both.

Targacept shares trade at $4.31 even though the company has $205 million in cash on hand, worth roughly $6 per share. At that steep discount to cash value, Targacept shareholders get the Alzheimer's/schizophrenia drug, known as TC-5619, essentially for free. ...

Click to view a price quote on TRGT.

Threshold's Pancreatic Cancer Drug Boosts Survival -- With an Asterisk

Mon, 17 Sep 2012 16:22:19 GMT

Updated with new information.

SOUTH SAN FRANCISCO (TheStreet) -- Threshold Pharmaceuticals' TH-302 boosted the survival of pancreatic patients, but data from the mid-stage study raised concerns and caused the stock to fall.

At the median, TH-302 survival data are impressive. The combination of a higher dose of TH-302 plus gemcitabine yielded a median overall survival of 9.2 months versus 6.9 months for gemcitabine alone. That's a median survival benefit of 2.3 months, which is meaningful for any pancreatic cancer trial. Consider that Roche and Astellas' Tarceva was approved in pancreatic cancer based on a two-week survival benefit. ...

Click to view a price quote on THLD.

Vivus Beats Arena Pharma With Obesity Drug Launch

Mon, 17 Sep 2012 13:54:05 GMT

MOUNTAIN VIEW (TheStreet) - Vivus announced the commercial launch of its weight-loss pill Qsymia Monday, beating rival Arena Pharmaceuticals to first reach the bulging waistbands of obese Americans.

Qsymia hits (mail order) pharmacy shelves at an opportune time, coming just as doctors who treat obesity are gathering in San Antonio later this week for the Obesity Society annual meeting. Both Vivus and Arena are expected to have a presence at the meeting but only Vivus will have a new weight-loss pill available for doctors to prescribe once they return home to their patients.

Arena and its marketing partner Eisai are expected to launch Belviq early next year. ...

Click to view a price quote on VVUS.

Click to research the Drugs industry.

Biotech Stock Mailbag: Navidea, Celsion, Raptor and Threshold

Fri, 14 Sep 2012 10:00:00 GMT

BOSTON (TheStreet) -- This week's Biotech Stock Mailbag is open for business.

@shakes2222 asks, "Why no follow-up after Navidea's conference call yesterday Tuesday? Do you have an opinion on FDA approvability of Lymphoseek? Timeline?"

Lymphoseek would have been approved this week had it not been for an unresolved problem at the third-party manufacturing facility that makes the lymph node mapping agent for Navidea Biopharmaceuticals. From what I heard Tuesday, FDA doesn't appear to have any issues with Lymphoseek's efficacy or safety, a positive. A rule of thumb is to allow six months for manufacturing issues to be resolved, so Navidea has a shot at Lymphoseek approval in the second quarter of 2013. ...

Click to view a price quote on NAVB.

Click to research the Health Services industry.

Amarin NCE Delay is Bad News For Fish-Oil Pill

Tue, 11 Sep 2012 13:55:41 GMT

BEDMINSTER, NJ (TheStreet) --The U.S. Food and Drug Administration approved Amarin's Vascepa on July 26 yet almost two months later, regulators still can't decide if the prescription fish-oil pill deserves five years of market exclusivity as a New Chemical Entity (NCE).

The latest "non decision" on Vascepa's NCE status was disclosed Monday night in an Amarin regulatory filing.

Amarin has a serious problem here, folks. ...

Click to view a price quote on AMRN.

Click to research the Drugs industry.

Peregrine Pharma: The Partner Guessing Game

Mon, 10 Sep 2012 17:55:11 GMT

TUSTIN, Calif. (TheStreet) --Further thoughts on Peregrine Pharmaceuticals following its conference call Monday discussing the bavituximab lung cancer data:

Peregrine says the bavituximab survival benefit observed in the phase II study is "similar" in patients across geographies. No details were offered, however, nor did the company say when we might see those data.

"We couldn't have conducted a more well-balanced clinical trial," company executives said. ...

Click to view a price quote on PPHM.

Click to research the Drugs industry.

Geron Stung by Cancer Drug Blowup

Mon, 10 Sep 2012 12:43:33 GMT

MENLO PARK, Calif. (TheStreet) -- Geron's lead cancer drug imetelstat was dealt a serious setback Monday after a mid-stage breast cancer study was stopped early for futility. A second study in lung cancer is continuing even though results are only expected to be "modest," the company said.

Without imetelstat, Geron's drug pipeline wears dangerously thin. The company's controversial embryonic stem cell programs were abandoned last year, leaving Geron with just an experimental drug for brain metastases in early phase II studies.

Geron shares are down $1.44, or 50%, to $1.46 in Monday pre-market trading. ...

Click to view a price quote on GERN.

Click to research the Drugs industry.

Peregrine Pharma's Lung Cancer Drug: Boffo Survival Benefit, but How Real?

Sun, 09 Sep 2012 16:22:26 GMT

TUSTIN, Calif. (TheStreet) -- The results presented Friday on Peregrine Pharmaceuticals' lung cancer drug bavituximab -- a jaw-dropping doubling of survival compared to a control arm -- were spectacular. But are the data from the midstage study credible?

Every cell in my body screams, "No!!!" The idea that Peregrine, a dismissed biotech penny stock as recently as two months ago, might be sitting on one of the most effective lung cancer drugs ever developed, doesn't just strain credulity, it beats credulity to death with a baseball bat.

Still, Peregrine's bavituximab lung cancer data look awesome. Second-line nonsmall-cell lung cancer patients treated with a combination of bavituximab and docetaxel reported a median overall survival of 12.1 months compared to 5.6 months for patients treated with docetaxel and a placebo. ...

Click to view a price quote on PPHM.

Click to research the Drugs industry.