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regarding 125664
there is no way to differentiate your product under these circumstances. I think trying to sell branded products in India is a pipe dream according to this article.
freedom c had a p value of .07,
I see freedom M met the endpoint.
Freedom-C Trial of Oral Treprostinil in Pulmonary Arterial Hypertension Fails to Meet Primary Endpoint
Preliminary Analysis Demonstrates an 11-Meter Improvement in Six-Minute Walk Distance at Week 16 (p=0.072)
Conference Call to be Held at 9:00 a.m. Eastern Time on November 17, 2008
Silver Spring, MD, November 17, 2008: United Therapeutics Corporation (NASDAQ: UTHR) announced today the results of the FREEDOM-C trial of oral treprostinil, a sustained-release formulation of treprostinil, in pulmonary arterial hypertension (PAH). Preliminary analysis demonstrates that the trial did not achieve statistical significance for the primary endpoint, six minute walk (6MW) distance at Week 16.
The FREEDOM-C trial was a randomized, double-blind, placebo-controlled trial of patients with severe PAH, a chronic, life-threatening illness. The study population consisted of 354 patients who were optimized on an endothelin receptor antagonist, a phosphodiesterase-5 inhibitor, or both. In addition to one of these oral therapy regimens, patients were administered oral treprostinil or placebo twice daily with the dose titrated (increased to tolerability) over the 16-week trial. The majority (~75%) of patients were World Health Organization (WHO) Class III of varied etiologies, including idiopathic or familial PAH (~65%), collagen vascular disease associated PAH (~25%), and PAH associated with HIV or other associated conditions (~10%). Mean baseline walk distance was approximately 345 meters.
The primary efficacy endpoint of the trial was the median change in 6MW distance at 16 weeks relative to baseline. With regard to the primary efficacy results, the placebo-corrected median change in 6MW distance at Week 16 was 11 meters (p=0.072). A statistically significant treatment effect was observed at Week 12, with a placebo-corrected median change of 13 meters (p=0.015).
Exploratory analyses suggest that the inability to dose titrate was a limiting issue that muted the overall treatment effect. Of the 174 patients who received active drug, 135 completed the study, 25 patients discontinued due to an adverse event and 33 patients were unable to titrate their dose above 1 mg twice daily. Accordingly, 58 (33%) patients in the active treatment group did not maintain a dose of oral treprostinil above 1 mg twice daily, and in this study a dose of 1 mg twice daily or less appeared to be a suboptimal dose. These patients had a markedly lower exercise benefit at Week 16 compared to the other patients who received active drug, with an observed median improvement of only 4 meters. Patients achieving a dose of 1.25 mg to 3.25 mg twice daily had a median improvement of 18 meters, and patients achieving a dose of 3.25 mg to 16 mg twice daily had a median improvement of 34 meters.
Adverse events that led to discontinuation or inability to dose-escalate included headache, nausea and vomiting. Dropouts due to adverse events were most common in patients who only had access to 1 mg tablets during the study, which was the lowest strength tablet available at the start of the study. There were no dropouts due to adverse events by patients who had access to the 0.25 mg strength tablet, which was added later in the study.
Preliminary analysis of other secondary efficacy measures, including change in combined 6MW distance and Borg Dyspnea Score rating (shortness of breath test) and Dyspnea-Fatigue index, demonstrated statistically significant improvements (p<0.05) compared to placebo. Other secondary efficacy measures including change in WHO functional class, time to clinical worsening, and PAH signs and symptoms did not differ significantly between oral treprostinil and placebo (p>0.05).
Further review and analysis of the preliminary results and safety data, including adverse events, is ongoing. A summary of the analysis conducted thus far can be accessed via United Therapeutics' website at http://ir.unither.com/events.cfm.
"While we are disappointed we did not achieve a statistically significant result for the primary endpoint, we believe the results fully support the continued development of oral treprostinil, especially when the treatment effect is evaluated based on the dose achieved in the FREEDOM-C study," said Roger Jeffs, Ph.D., United Therapeutics' President and Chief Operating Officer. "We remain excited for the prospects of our Phase 3 study of oral treprostinil, FREEDOM-M, which evaluates the utility of oral treprostinil without the presence of background therapy. This study is fully enrolled, and results are expected to be available at the end of March 2009. Further, we expect enrollment of our Phase 3 study of oral treprostinil, FREEDOM-DR, to commence shortly, which will employ the 0.25 mg tablet for patient dosing. Finally, our inhaled treprostinil study produced highly statistically significant results and is under review by the FDA with an anticipated action date in April of 2009. Submission in Europe via the centralized procedure is expected in January 2009." Dr. Jeffs concluded, "Today's result has not altered the fact that we believe that we have in place today all of the pieces that we need to continue growing our business."
Conference Call
uthr
I am sure the fda is going to love this slide 20
http://files.shareholder.com/downloads/UTHR/1331576172x0x494000/87db0d7e-1d62-4e06-98fd-0e49329eb683/082411%20Slides%20UT-15C%20SR%20Results%20FREEDOM-C2%20(FINAL)1.pdf
Clinical Worsening
Extent of Clinical Worsening
Treatment
n (%)
UT-15C SR
(n = 157)
Placebo
(n = 153)
No Clinical Worsening* 146 (93%) 143 (93%)
Clinical Worsening
Death 6 (4%) 4 (3%)
Hospitalization as a result of PAH 4 (3%) 2 (1%)
Added parenteral PGI2 0 1 (<1%)
>20% decrease in walk and
additional therapy
1 (<1%) 3 (2%)
uthr
why do they think the fda will approve the oral with the failed trial.
Probably just to keep the stock up
The above scenario raises the possibility of an asymmetric outcome that would be highly bullish for MNTA: NVS/MNTA’s ANDA is approved as a full-fledged substitutable generic while Teva’s ANDA is approved as a non-substitutable “branded” generic. Under this scenario, I’m pretty sure the contractual terms of the NVS-MNTA partnership would treat Teva’s product as not being a second generic Lovenox, and hence MNTA would enjoy the favorable economic terms of the single-generic case.
Have you ever been able to find out if the contractual terms in the nvs mnta partnership discusses whether a competitor receiving approval as a non substitutable generic would leave mnta's economic terms as they currently are.
Now we see an unexpected consequence of generic pricing.
If the generics come in and cause the drug pricing to become so cheap as to make it uneconomical for companies to keep making the drug then eventually no one will make the drug.
some how they have to now figure out a way that life saving drugs will have some kind of limit of how many generics will be approved, so that the pricing does not get so low as to make the drugs a losing proposition for the manufacturers
it is crazy that spectrum can make a me too of leucovorin and charge 80 times the price of the originator so that they become the only company supplying the drug.
why are you attacking me.
What do you think are the odds of that deal being done in less than two months?...It was a pretty complex transaction
These were stupid purchases for him to make so close the the closing of a material deal.
fwiw
you have got to admire the timing
http://thinklibrary.bluematrix.com/view/DocViewerLibrary?id=036d6601-d072-4334-943d-3bd9bbdf85b7&mime=pdf
the market has gotten killed that is why the stock is down.
the fact that the he made or did not make money isn't the issue.
he was close to having a major deal done and he bought stock in front of it.
did Arry's ceo make a any purchases before the deal he just struck with Genentech?
Normally I would say the regn delay would not be bearish
to be honest if it were a CRL I could see the reason for a conference call. The fact that they are having a conference call for a 3 month delay I find unusual and strange.
add pluristem and mesoblast to your list
The Israeli market went nuts today. I do not think this will be indicative of the markets overnight but who knows
http://www.globes.co.il/serveen/globes/docview.asp?did=1000671232
Panic on TASE as Tel Aviv 25 Index plunges 7%
Investors sold more than NIS 1 billion worth of shares while options trading saw the shekel weaken to NIS 3.6/$.
7 August 11 16:09, Adi Ben-IsraelPanic swept the Tel Aviv Stock Exchange (TASE) today as the Tel Aviv 25 Index fell 7% to 1,074.27 points. The opening of trading was delayed when the automatic shut off kicked, and trading only began at 10:44 am, instead of the usual 9 am. Both the public and institutional investors sold more than NIS 1 billion worth of shares. Trading options in the foreign currency market saw the shekel dollar rate rise to NIS 3.6/$.
Today's panic directly follows the TASE's worst week since 2008. It was exacerbated today by Friday's steep drops in international stock markets and Friday night's credit downgrade of US bonds by Standard & Poor's. Fears that Europe's debt crisis, which led to 12 straight days of losses in European markets, will spread, combined with fears of a slowdown in the US.
Under TASE regulations, trading does not open if the Tel Aviv 25 market swings by more than 2.5% in either direction in premarket trading; trading is delayed by 3-5 minutes. If the swing is 8%, trading is delayed by 45 minutes, and if the swing is 12%, trading is suspended for the day.
The "axe"? Is that a bull who doesn't say, "to da moon!"
No, it must be a bull that sees the problems and stays a bull.
What good did it do to see their reimbursement issues and continue to be a bull?
you have to make a decision based on the facts that you have, not based on what you hope the facts are.
A study by JPMorgan Chase found that there has been a slight rise in rates when countries lost an AAA rating. In 1998, S&P lowered ratings for Belgium, Italy and Spain. A week later, their 10-year rates had barely moved.
A paragraph from the article posted by bladerunner
Everyone is looking short term. the rates in Belgium, Italy and Spain were downgraded and rates didn't move.
Look at those countries now. THIS IS A WARNING USA. Get your fiscal house in order. We need to do something about entitlements now, not add new ones.
I went to a lunch meeting the company did after they went public.
they had the red herring on the table for you to review while they spoke
Everyone of the top executives bought 2 or 3 million dollar homes and borrowed the money from the company to pay for them
It look more like a mortgage finance company prospectus than a drug delivery company.
I have been telling people for a while that it is my belief that the chinese companies were all making a lot of money, even the generic manufacturers and then they did the reverse mergers.
so the companies went public at two and three times earnings.
The first thing the companies all did when they raised the money on the IPO was build new manufacturing.
In essense the chinese govenment allowed the companies to charge higher prices for a couple of years so that they could get an IPO done drawing investment from the US and Europe.
Now that the money is raised the companies will now lower their prices and either make very small profits or lose money. US and European investors sell their stock but the chines govenment doesn't care because they have brand new manufacturing facilities producing drugs for the next thirty years that they didn't pay for.
That is a great business plan
Insmed Dives 53% as Rat Data Prompt Arikace Clinical Hold
It doesn't say in the article if when the two year data was released. did the geniuses at Insmed have this data before the merger was completed.
By Trista Morrison
BioWorld Todsay Staff Writer
Shares of Insmed Inc. dropped 52.5 percent Tuesday after data from a two-year rat carcinogenicity study prompted the FDA to slap a clinical hold on a pair of nascent Phase III trials with lung infection drug Arikace (liposomal amikacin for inhalation).
Until then, Insmed had been having a pretty good year.
When the Monmouth Junction, N.J.-based biotech revealed plans to merge with privately held Transave Inc. last December, investors were uninspired, pushing the stock down about 7 percent. But the deal gave Insmed control of the merged company and a new lead product – Arikace – to replace Iplex (mecasermin rinfabate), which had failed a Phase II trial for muscular dystrophy the year before. (See BioWorld Today, June 26, 2009, and Dec. 3, 2010.)
Investors seemed to warm to the merger this year, amid the presentation of positive Phase II data for Arikace, progress moving into Phase III trials and a 1-for-10 reverse stock split that avoided Nasdaq delisting.
While shares often fall after a reverse split, Insmed's gained 137 percent over the last 4.5 months, closing at $11.35 on Monday.
By Tuesday, the shares (NASDAQ:INSM) had fallen $5.96 to close at $5.39.
Investors were clearly spooked by the clinical hold, which was based on the FDA's initial review of interim data from a long-term carcinogenicity study, in which rats received daily doses of Arikace by inhalation for up to two years.
The agency requested additional information on Arikace and data from the rat study, which Insmed anticipates being able to supply within 30 days.
Until the FDA is satisfied, however, recruitment and enrollment of patients into a Phase III trial for Pseudomonas lung infections associated with cystic fibrosis and a separate Phase III trial for nontuberculous mycobacterial lung disease are on hold. No patients have been dosed.
Insmed was unable to comment further on the hold due to an earnings-related quiet period, but the company plans to provide additional information in its second-quarter conference call, on Aug. 8.
Even if the clinical hold takes a bit longer to resolve than anticipated, Insmed should have enough cash to keep itself afloat. The company reported $104.9 million in cash, equivalents, short-term investments and CDs as of March 31 and had previously projected that the two Phase III trials would cost about $75 million.
The danger, of course, is that Insmed might not be able to get the program back on track. Rat carcinogenicity data have felled many a drug development program in the past; such data led to last year's complete response letter for Arena Pharmaceuticals Inc.'s obesity drug lorcaserin. (See BioWorld Today, Oct. 26, 2010.)
But while lorcaserin is a completely novel compound, Arikace is a reformulation of a well-known drug: the FDA-approved antibiotic amikacin. In its injectable form, amikacin is used to treat Gram-negative infections such as Pseudomonas. It carries a warning about ototoxicity and nephrotoxicity, but its label says nothing about carcinogenicity.
It could be that the carcinogenicity issue is related to Insmed's liposomal formulation, which is intended to provide a longer-acting effect. Insmed executives had previously predicted Arikace could be the first inhaled antibiotic to be administered once daily.
Or perhaps the inhaler itself could be to blame. Before Pfizer Inc. pulled its inhaled insulin product Exubera off the market, the company revealed that six of 4,740 patients treated with the drug had developed lung cancer, although the big pharma concluded that there were too few cases to determine whether the cancer was related to Exubera.
Arikace uses an eFlow Nebulizer System from PARI Pharma GmbH, of Gräfelfing, Germany.
Or maybe the carcinogenicity data will turn out to be a red herring. Cancer signals in animals don't always translate to human risks. Only time – and more data – will tell.
Assuming Arikace continues on its development path, the product would eventually compete against existing inhaled antibitoics such as TOBI (tobramycin solution for inhalation, Novartis AG) and Cayston (inhaled aztreonam lysine, Gilead Sciences Inc.).
Additionally, Mpex Pharmaceuticals Inc., which was acquired earlier this year by Axcan Holdings Inc., is in Phase III with Aeroquin (aerosol levofloxacin) for pulmonary infections in cystic fibrosis patients, and Aradigm Corp. recently reported good Phase IIb data with ARD-3100 (inhaled ciprofloxacin) in noncystic fibrosis bronchiectasis.
Nektar Therapeutics Inc. and Bayer AG are partnered on a Phase II inhaled amikacin product for pneumonia as well.
Published: August 3, 2011
It sounds to me like dendreon is losing money on every sale so they may as well put through a promotion where they guarantee the doc will be paid and put the docs on a 90 day payment scedule.
if the doc dosen't get paid dndn handles the paperwork to get reimbursed. They would have specialists that do that.
Hell, they don't know what their breakeven point is anyway.
Q (from DNDN’s CC today): “At what sales level of Provenge will the company be cash-flow positive?”
A: Blah, blah, great question, blah, we need more experience with the manufacturing ramp before we can answer, blah, we have to think seriously about that, blah, we actually, blah, have no freaking idea.
Most companies can usually come close to what their breakeven point is.
I guess they figured they would never come close so they didn't bother trying to figure it out. They figured they would sell their stock first, then worry about it.
August 3, 2011 From Alex To -- CLDX: The Value Proposition
• The common pushback against CLDX's investment case is that the company has no
near-term data flow. The bull case for the stock is that, net of $71 million cash on the
balance sheet, at a $70 million enterprise value, CLDX is a steal considering the large
portfolio of clinical-stage products and the technology platform in immunotherapy and
antibody engineering.
• Both arguments are correct, at least considering rindo, CLDX's lead drug candidate
for brain tumors. Now that rindo's Phase 3 trial is starting, it will be at least 2 years
before we will see the results. But, we could see a major clinical read-out in the next
12 months from the breast cancer trial of CDX-011. CDX-011 is an antibody conjugate
targeting GPNMB. The study is on track to fully accrue by year-end 2011. We would expect
some sort of interim data in 1H 2012. Not exactly near term, but within the next 12
months. The stock impact, however, could be significant should the CDX-011 trial be
positive. The percentage of breast cancers with GPNMB expression exceeds those with HER2
expression. So, conceivably, CDX-011 could garner commercial sales similar to Herceptin
(ROG.VX), which exceeds $4 billion. One can imagine the market getting excited should the
Phase 2 trial yields robust results. The wild card is partnering. It is conceivable in
the next 12 months CLDX will find partner(s) for one or more of its many drug candidates.
Who is to say, during partnership discussions, that one of the larger companies will not
find CLDX's whole portfolio and technology platforms attractive and end up buying the
company?
Alex To, MD
Managing Member
Cross Current Research, LLC
2 Research Way, 2nd Floor
Princeton, NJ 08540
Nektar Therapeutics (NKTR: Buy' $20 Target Price) - We View Nektar As Significantly Undervalued Investment Summary
It is a 20 sum of the parts not 50
http://www.capmarkets.com/ViewFile.asp?ID1=390641&ID2=432748277&ssid=2&directory=653&bm=0&filename=NKTR_080111.pdf
We firmly believe that the steady valuation slide for Nektar has gotten a bit out of hand. Taking a look at the parts we easily arrive at $20 per share, especially considering the relatively low clinical risk associated with Nektar’s products given that they are all improved versions of approved active agents.
§Below we list the parts on which we have chosen to focus and arrive at a valuation that is more than double the present valuation. Note that we have excluded the following: (1) NKTR-119, (2) NKTR-171 (late preclinical candidate for neuropathic pain – a drug where restricting it from the CNS would be a major safety enhancement), (3) NKTR-061 (Phase 3 ready once the inhalation device is perfected), (4) all other preclinical candidates, (5) unlikely but potential 5% peginesatide royalties, (6) NKTR-105, (7) CDP791, and (8) any potential business development income from future licensing deals.
Exhibit 1: Sum of the parts valuation
Source: Brean Murray Carret & Co research
Exhibit 2: Catalyst calendar
Source: Company documents
§Valuation. Our target price is derived using a sum-of-the-parts valuation, primarily by summing up most of the clinical-stage products and the approved products, the bias being toward products that carry, or are expected to fetch, far higher royalties than the legacy products.
§Risks. Risks to investing in Nektar include market adoption, business development, competition, and high stock price volatility.
Price
$ 6.44
52-Week High/Low
$ 16.06 - 6.20
Shares Outstanding ( mm )
113.75
Market Cap. ( mm )
$ 732.55
Average Daily Volume ( mm )
0.99
4 Biotech Sleepers With Over 100%
by: Michael Lee Wealth Advising August 1, 2011 | includes: ANX, CBP, DSCO, IGXT.OB
Biotech industry has had its fair share of winners this year with names like Ariad Pharmaceuticals Inc. (ARIA), Oncothyreon Inc. (ONTY), Vical Inc. (VICL), Jazz Pharmaceuticals Inc. (JAZZ), Pluristem Therapeutics Inc. (PSTI), Heska Corp. (HSKA), Genetic Technologies Ltd. (GENE) and Questcor Pharmaceuticals Inc. (QCOR) all currently posting returns of over 100% year to date (YTD). But what about the sleepers-- those stocks that have yet to dish out those big returns that analysts are expecting?
Here is a look at 4 Biotech micro caps that could very well be next in line to produce 100% returns, or more:
1. China Botanic Pharmaceutical Inc. (CBP) develops, manufactures, and distributes botanical products, bio-pharmaceutical products, and traditional Chinese medicines in the People's Republic of China. The company's botanical anti-depression and nerve-regulation products include Acanthopanax and Tianma. According to China Botanic Pharmaceutical Inc., Acanthopanax is a Siberian Ginseng that regulates the nervous system, delays aging process, strengthens the body, and treats neurasthenia, insomnia, cerebrovascular and cardiovascular diseases and fatigue. Tianma is a botanic drug used for treating headaches and regulating nerves.
The company recently received a patent for its proprietary process to separate and extract effective parts of Siberian Ginseng, Acanthopanax. As stated in a recent Yahoo Finance article:
"The patent for 'Extraction of Effective Parts of Siberian Ginseng and their Preparation and Application' is the catalyst that will continue to drive the development of the Company's innovative Acanthopanax series. Among recent successes using these processes are Lyophilized Syringin Powder and Total Flavonoids capsules. These medicines are powerful new tools in combating depression and senile dementia and have been recognized as 'class one new drugs' and 'innovative drugs' by the State Food and Drug Administration of China. The patent covers a wide variety of possible Siberian Ginseng extraction methods and applications, creating a high barrier to entry for competitors seeking to develop similar Siberian Ginseng products, and, as a result, it confers significant independent intellectual property rights on the Company."
China Botanic Pharmaceutical Inc.'s stock has struggled over the past year, falling from a $2.80 high last November to a recent 52-week low of $0.71 in late June. News of the above-mentioned patent approval, however, has driven the stock back up to a current $1.09, 53.52% above its price just one month ago. The company has a current analyst rating of one strong buy with a price target of $4.88. Based on this target, the stock has an upside potential of 347.71% and may very well continue to produce significant returns, similar to those experienced over the past month.
2. IntelGenx Technologies Corp. (IGXT.OB) is currently awaiting approval of its new drug, CPI-300. CPI-300 is a novel, high strength dosage of Bupropion Hydrochloride (HCl), the active ingredient in Wellbutrin XL®. Valeant Pharmaceuticals International Inc. (VRX), the current manufacturer of Wellbutrin XL®, has been unable to successfully develop a single dose 450mg (must take multiples of lower strengths). IntelGenx Technologies Corp., however, has found success in producing this higher dosage with the help of its VersaTab technology, a cutting edge, multilayer, controlled-release tablet. IntelGenx Technologies Corp. is expecting approval of its CPI-300 tablet on the FDA decision date, November 13, 2011.
IntelGenx Technologies Corp. is currently trading at $0.80, 128.57% above its $0.35 price level a year ago. The stock's volume has also increased significantly in the past year, from a 5k daily average to a current 500k daily average. The company currently holds one buy analyst recommendation with a price target of $2.06, 157.50% above the stock's current price. All things considered, IntelGenx Technologies Corp. looks to have a bright future ahead and, if all goes to plan with its new drug, CPI-300, is very likely to produce significant returns.
3. Adventrx Pharmaceuticals Inc. (ANX) is a specialty pharmaceutical company focused on acquiring, developing, and commercializing proprietary product candidates. The Company's lead product candidates are Exelbine™, or ANX-530, a novel emulsion formulation of the chemotherapy drug Vinorelbine (Navelbine®); ANX-514, a novel, detergent-free emulsion formulation of the chemotherapy drug Docetaxel (Taxotere®); and ANX-188, a novel, purified, rheologic and antithrombotic compound initially being developed as a first-in-class treatment for pediatric patients with sickle cell disease in acute crisis.
Adventrx Pharmaceuticals Inc. is currently in its second attempt to gain approval for its leading candidate drug, Exelbine™. As stated in a recent article from The Motley Fool, "In late 2009, Adventrx submitted its application for Exelbine, but the agency refused to accept the application. The FDA wanted stability data to set the expiration dates, which took about a year to assemble and refile."
According to Adventrx Pharmaceuticals Inc., however, the drug's 12-month data were consistent with the six-month and nine-month time points. The 2009 refusal doesn't say much about the approvability of the drug and, as the FDA is requesting proven stability of Exelbine™, the above data should provide the agency with the required information. In other words, the approval of Exelbine™, though not yet certain, is likely.
This time last year Adventrx Pharmaceuticals Inc. was trading at $2.00; now trading at $2.95, the stock holds a current one year price return of 47.50%. Volume has also increased, year over year, from a 250k daily average to a current 1 million daily average. The company currently holds a strong buy analyst recommendation with a $16.00 price target, a very significant 442.37% above its current price. With strong price performance, likely approval of its new drug, Exelbine™, and significant analyst confidence, Adventrx Pharmaceuticals Inc. is definitely a stock to watch.
4. Discovery Laboratories Inc. (DSCO) develops surfactant therapies to treat respiratory disorders and diseases based on its KL4 surfactant and capillary aerosol-generating technologies. Its development stage products include Surfaxin, a synthetic, peptide-containing surfactant in phase III clinical trial for the prevention of respiratory distress syndrome in premature infants; Surfaxin LS, a Phase III trial product to improve ease of use for healthcare practitioners; and Aerosurf, an aerosolized KL4 surfactant that has completed first pilot Phase II clinical trial for the treatment of respiratory distress syndrome in premature infants.
Surfaxin, the company's first drug product candidate, has gone seven years without approval. But the company is still very confident in its drug's future. As stated in a recent Philadelphia Business Journal article, Discovery Laboratories Inc.'s Chairman and CEO, Thomas Amick, believes that "...the elusive approval could occur as early as the first quarter of 2012."
“We have made considerable progress in our comprehensive preclinical program intended to gain FDA approval for Surfaxin,” Amick said.
Surfaxin aside, the company has also made significant progress with its aerosolization research program, yielding a new experimental drug-delivery device named Afectair, a disposable adapter that simplifies the delivery of any aerosolized medication to critical-care patients requiring ventilatory support from either intermittent mechanical ventilation or continuous positive airway pressure.
Discovery Laboratories Inc.'s stock has fallen from $4.07 a year ago to a current price of $2.47, yielding a dismal -39.01% yearly return. But after hitting its $1.71 52-week low in March of this year, the stock has since rebounded, yielding a 44.44% return. Analyst opinion currently stands at one buy recommendation with a $5.00 price target, 102.43% above the stock's current price. Though it may not happen in the immediate future, progress on the Surfaxin approval and Afectair development should push this stock closer to analyst expectations.
In conclusion, with a combined, average upside potential of 262.63%, these four Biotech sleepers may not be dormant for much longer.
Jazz Pharma (JAZZ): After ~5,000% Return, Upgrade to Buy
Rating BUY (from HOLD)
Price Target $52.00 (from $29.00)
Price $40.47
Key Takeaway
The new Xyrem marketing initiatives that Jazz revealed at Jefferies HC Conference in June to grow patients, increase compliance, and increase Rx fill-rates has now paid off. Q2 already showed surprising volume growth, and we believe it’s sustainable, yielding dramatic upside to our Xyrem/EPS estimates. With JAZZ’s operating leverage, and unlikely Xyrem generics, a premium multiple and further stock appreciation is justified.
My question is with these margins why wouldn't a company come out with a generic. The drug is off patent
Pricing Power Was Appreciated, Volume Growth Wasn’t. Xyrem pricing headroom has been apparent, but the recent volume growth has been a surprise -- and one we now feel has legs. Y/Y growth had accelerated up through single digits last year, and Q1’11’s 12% benefited from easy comps, so we were startled by the 11% y/y growth in Q2. We had previously modeled only 5% volume growth in ’11-’13, then flat, but we now see higher and more sustainable double-digit volume growth in ’11-’13 and single digit thereafter. Xyrem still has low patient penetration – only 8.700 of the ~50,000 diagnosed (of the ~125-150,000 total U.S. narcoleptics) – and absolute volume growth should be supported by better targeting of new patients (especially Provigil/Nuvigil narcolepsy users), improving compliance given expanded nursing outreach programs, and reduction to the ~20% Rx non-fill rate with the “Patient Connection” program.
Increased Volume Makes Big Difference. Given Xyrem’s high price, and ~96% GM, a little volume goes a long way. We model a further 70% price increase by end'14, yielding an almost $50,000 value/patient/year. At that level, the difference between a 5-year 3% CAGR and our new 9% estimate is >$160M in 2015 sales. That would represent a 25% patient penetration vs. 19% (excluding market growth). With the concurrent op.margin expansion, since SG&A will grow only modestly, this yields >$1.80 EPS upside to our previous ’15 numbers, taking our fully-taxed ’12-’15 EPS CAGR to ~23% from ~9%.
Valuation/Risks
Upgrade to Buy with $52 target. Higher Xyrem, plus extreme operating leverage yields dramatically raised EPS and cash-flow. Jazz is a “one-trick pony”, but we’re confident Xyrem will not go generic anytime soon, hence we think a premium multiple is justified. We apply 19x multiple to taxed ’12 EPS of $2.64 (incl. stock comp) plus ~$2 NOL value. DCF yields same $52 target ($17.50/share net cash+CF through ’15, plus $34.50 terminal value assuming 4% term growth). The obvious downside risk is any Xyrem threat (generic, FDA safety move, etc.). Upside risk presents from potential accretive BD developments.
Corey Davis, Ph.D. *, Equity Analyst
(212) 336-7187 cdavis@jefferies.com
Oren G. Livnat *, Equity Associate
(212) 284-2214 olivnat@jefferies.com
Graig Suvannavejh, Ph.D. *, Equity Associate
(212) 284-2170 gsuvannavejh@jefferies.com
* Jefferies & Company, Inc.
the drug is off patent and easy to make.
I think the Rems is what is protecting it because you can't buy a generic otc or by prescription. what stops a generic from producing the drug and half the price of the drug and go through the same rems as orphan?
Founder of Cryonics Movement Dies, is Frozen at Cryonics Institute
I couldn't let this one go without a mention. I wonder if he has a spot next to Ted William's head
Cryonics Institute On Monday July 25, 2011, 11:15 am EDT
CLINTON TOWNSHIP, Mich., July 25, 2011 /PRNewswire/ -- Robert Ettinger, the founder of the cryonics movement and of the Cryonics Institute, died on Saturday, July 23, at home in Clinton Township, Michigan, and has been frozen at the Institute. The cryonics movement advocates storage at very low temperatures after death in the hope that future technology will permit revival and the cure of aging and disease.
Mr. Ettinger wrote The Prospect of Immortality in 1962, a book advocating and explaining the cryonics thesis. From The Prospect of Immortality:
The fact: At very low temperatures it is possible, right now, to preserve dead people with essentially no deterioration, indefinitely...
The assumption: If civilization endures, medical science should eventually be able to repair almost any damage to the human body, including freezing damage and senile debility or other cause of death. . .
Hence we need only arrange to have our bodies, after we die, stored in suitable freezers against the time when science may be able to help us. No matter what kills us, whether old age or disease, and even if freezing techniques are still crude when we die, sooner or later our friends of the future should be equal to the task of reviving and curing us.
The Prospect of Immortality has been published around the world, with new editions currently in print or planned in South Korea, Taiwan and China.
Mr. Ettinger popularized the cryonics movement in the 1960s and 1970s through appearances on a wide variety of talk shows, including The Tonight Show and the David Frost, Mike Douglas and Merv Griffin programs.
Other books by Mr. Ettinger further discussed the cryonics thesis and the promise of future technology. They include Man Into Superman (1970) and Youniverse (2009). New Asian editions of Man into Superman are also currently planned. The Philosophy of Robert Ettinger (2002) is a collection of academic essays discussing Mr. Ettinger's ideas.
Mr. Ettinger was born in 1918, and served in the U.S. Army in Belgium during World War II, where he was seriously wounded. Mr. Ettinger spent several years in hospitals after the war, and his legs were saved as a result of then innovative bone graft surgery. That sparked Mr. Ettinger's interest in the promise of future medical technology.
Mr. Ettinger founded the Cryonics Institute in 1976 in order to create a non-profit organization that could freeze and store patients at death. CI (www.cryonics.org) has over 900 members worldwide in addition to 106 patients in storage. As advances in research have further confirmed the likelihood of dramatic improvements in future medicine, the cryonics movement has grown to include thousands of supporters worldwide, including organizations in Russia, Australia, Germany and other locations.
Mr. Ettinger also founded the Immortalist Society, an organization devoted to education and research relating to cryonics and life extension.
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The new economy isn't based on producing tractors, something that creates jobs.
It is based on creating a game called farmsville that is somehow tied to facebook, and the earnings from farmville is earned by a company called Zynga which sells vitual tractors so that venture guys can make money from an IPO. In reality nothing is produced.
Money is being created from nothing and the jobs are gone.
I am thinking about creating a biotech company that sells virtual drugs over the internet.
The earnings from the virtual drugs will fund clinical trials on real drugs.
Britain's version of Lindsay Lohan found dead
Winehouse had talent
Amy Winehouse found dead aged 27 in London homeMetropolitan police confirm death of singer notorious as much for her off-stage excesses as her music
Share reddit this Cherry Wilson
guardian.co.uk, Saturday 23 July 2011 19.33 BST Article history
Amy Winehouse has been found dead in her London house at the age of 27. Photograph: Rex Features
Singer Amy Winehouse has been found dead at her house in north London She was 27. The award-winning artist, famous for hits including Rehab from the critically acclaimed album Back to Black, was discovered by police in the late afternoon. Her death was being treated on Saturday night as "unexplained" but sources said she had died of a drugs overdose.
The Metropolitan police said: "We were called by London Ambulance Service to an address in Camden Square shortly before 16.05hrs following reports of a woman found deceased. On arrival officers found the body of a 27-year-old female who was pronounced dead at the scene."
Winehouse was last seen with her goddaughter, Dionne Bromfield, earlier last week when the teenager performed at the iTunes festival.
Tributes began to pour in to one of the most celebrated and troubled British artists of recent times. Mark Ronson, who produced Back to Black, said: "She was my musical soulmate and like a sister to me. This is one of the saddest days of my life."
Singer and actress Kelly Osbourne wrote: "i cant even breath right now, im crying so hard i just lost 1 of my best friends. i love you forever Amy & will never forget the real you!"
Rolling Stone Ronnie Wood dedicated his show on Absolute Radio and the reunion performance by his former group the Faces in Hurtwood, Surrey, to Winehouse. "It's a very sad loss of a very good friend I spent many great times with," he said.
Two regulars at Winehouse's local pub, The Hawley Arms in Camden, paid tribute. "Some people might think it shows disrespect to come out drinking tonight but she was such a part of Camden she made it her home and she always got involved," said Mary Gallagher. "Amy even worked behind the bar here. She was such a lovely person and, to be honest, I don't think fame agreed with her. She was an ordinary girl at heart."
Gloria Woods, 26, who works for a record label, said: "There will never be another voice like that in our generation."
A spokesman for the late singer said: "Everyone involved with Amy is shocked and devastated. Our thoughts are with her family and friends."
Winehouse's father, Mitch, returned from New York, where he had been due to perform at the Blue Note jazz club. He said: 'I'm coming home. I have to be with Amy. I can't crack up for her sake. My family need me."
Flowers, teddy bears and candles were left outside her home in Camden Square. One card read: "You will not be forgotten by Camden. We all love you and will continue to love you. Your legend lives on."
Winehouse had suffered a well-publicised battle with drink and drug abuse that saw her withdraw from all of her scheduled performances last month after a series of erratic performances. She started her 12-leg European tour in Belgrade but was booed off the stage after appearing to forget her lyrics. She then pulled out of performances in Istanbul and Athens before she cancelled the tour as fears for her health grew.
A statement released by her spokesman at the time said that she would be given "as long as it takes" to recover. "Everyone involved wishes to do everything they can to help her return to her best," it read.
Winehouse rose to fame with her debut album Frank in 2003, which was feted by music critics in the UK and nominated for the Mercury music prize, but it was her 2006 follow-up album, Back to Black, that catapulted her to stardom and led to five Grammy awards. The album became the third-highest selling album of the 2000s.
pretty amazing
Vicept sold to Allergan for 75 million up front and possible 200 million in milstones
http://www.bizjournals.com/philadelphia/news/2011/07/19/allergan-to-buy-vicept-developer-of.html
vicept was basically formed in 08/09 after the doc in the picture probably licensed the drug from a university for practically nothing and raised 16 million from VC's to run a couple of trials.
http://vicepttx.com/releases/release_063010.html
Bristol-Myers Squibb to Acquire Amira Pharmaceuticals
Acquisition Marks Bristol-Myers Squibb’s Entrance into Fibrotic Diseases, an Area of High Unmet Need that is Complementary to Current Therapeutic Areas of Focus
I was actually on the phone with the cto yesterday discussing the leukotriene program yesterday.
Press Release Source: Bristol-Myers Squibb On Thursday July 21, 2011, 6:48 pm EDT
NEW YORK & SAN DIEGO--(BUSINESS WIRE)-- Bristol-Myers Squibb Company (NYSE:BMY - News) and Amira Pharmaceuticals, Inc., announced today that the companies have signed a definitive agreement under which Bristol-Myers Squibb will acquire privately held Amira Pharmaceuticals, a small-molecule pharmaceutical company focused on the discovery and early development of new drugs to treat inflammatory and fibrotic diseases.
Under the terms of the agreement, Bristol-Myers Squibb will acquire all of Amira Pharmaceuticals’ issued and outstanding shares of capital stock and stock equivalents in an all-cash transaction for a purchase price of $325 million upfront and potential additional milestone payments totaling $150 million. Bristol-Myers Squibb will secure Amira Pharmaceuticals’ fibrosis program, including the lead asset AM152, an orally available lysophosphatidic acid 1 (LPA1) receptor antagonist which has completed Phase I clinical studies and is now poised for Phase IIa proof-of-confidence studies for the treatment of idiopathic pulmonary fibrosis (IPF) and systemic sclerosis (SSc), or scleroderma. Bristol-Myers Squibb will also obtain Amira Pharmaceuticals’ preclinical autotaxin program, which may be useful in the treatment of neuropathic pain and cancer metastases. Bristol-Myers Squibb plans to retain Amira Pharmaceuticals’ scientists who work on both of these programs and they will remain located in San Diego.
“As part of the continued execution of our focused BioPharma strategy, Bristol-Myers Squibb has identified fibrotic diseases as an area of high unmet medical need that complements our research efforts in several of our therapeutic areas,” said Elliott Sigal, executive vice president, chief scientific officer and president, Research and Development, Bristol-Myers Squibb. “The acquisition of Amira Pharmaceuticals represents the latest example of our String of Pearls strategy, a highly targeted set of transactions designed to enrich our innovative pipeline with potential medicines to help patients in need.”
The closing of the transaction is subject to customary regulatory approvals.
“We are pleased to have Bristol-Myers Squibb acquire Amira Pharmaceuticals. Our LPA and autotaxin programs are world leading and will be in excellent hands,” stated Bob Baltera, chief executive officer, Amira Pharmaceuticals. “It has been a pleasure to work with Bristol-Myers Squibb throughout this highly competitive process.”
“Amira Pharmaceuticals’ scientists have been leaders in the research and development of lysophosphatidic acid receptor antagonists for fibrosis,” said Jeremy Levin, senior vice president, Strategic Transactions Group. “We compliment the professional approach of the investors and Amira Pharmaceuticals’ leadership and scientific team who, since 2005, have built a highly innovative company. We will now build on that history and commitment to innovation to discover and develop novel medicines in this important disease area.”
Amira Pharmaceuticals’ exclusive financial advisor for the transaction was J.P. Morgan Securities LLC, while Cooley LLP was its legal advisor. Bristol-Myers Squibb was represented by Covington & Burling LLP.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit http://www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995, regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that the compounds described in this release will move from early stage development into full product development, that clinical trials of these compounds will support a regulatory filing, or that these compounds will receive regulatory approval or become commercially successful products. Nor is there any guarantee that the transaction described in this release will receive the necessary regulatory approvals to close. Forward-looking statements in the press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb’s business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2009, its Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.
About Amira Pharmaceuticals
Founded in 2005 and headquartered in San Diego, Amira Pharmaceuticals is a small molecule pharmaceutical company focused on the discovery and early development of new drugs to treat inflammatory and fibrotic diseases. Amira combines the rigor of a big pharmaceutical company with the ingenuity and energy of a small company, creating an environment for efficient development of novel compounds and effective pre-clinical and clinical program decisions. Our team is building on unparalleled insights into bioactive lipid pathways and complex signaling processes controlling many conditions including asthma, chronic obstructive pulmonary disease, cardiovascular and various fibrotic diseases. Amira has a partnership with GlaxoSmithKline for the development of FLAP (5-lipoxygenase activating protein) inhibitors in respiratory and cardiovascular disease. For more information, visit www.amirapharm.com.
Contact:
Bristol-Myers SquibbMedia:Jennifer Fron Mauer, 609-252-6579jennifer.mauer@bms.comorInvestors:John Elicker, 609-252-4611john.elicker@bms.comorTeri Loxam, 609-252-3368teri.loxam@bms.comorAmira PharmaceuticalsMedia:Ian Stone, Russo Partners, 619-308-6541ian.stone@russopartnersllc.com
benlysta is jumping off of the shelves
According to the NDC monthly sales data published by Wolters Kluwer, Benlysta posted $4.63M sales in the month of June. Adding sales data from April to June from the NDC database, we arrive at $7.37M for 2Q sales of Benlysta. Of note, the NDC data most likely under-reports the sales since a substantial portion of Benlysta is directly shipped from HGSI to infusion sites.
When HGSI reports 2Q results tomorrow after close, we will not be surprised if Benlysta meets or beats the Street consensus of $8.6M.
not a take under based on where the company would be trading if the sec filings didn't tell the market this was coming.
'
stock was trading at 2 dollars before that.
He increased his price target by a dollar which is one quarter in profit.
doesn't make too much sense.
It seems that they are spending a lot of money considering that they aren't working on internal programs and they are waiting for partners.
since the have the employees they may as well move some projects forward.
brett holley of oppenheimer
Momenta Pharmaceuticals, Inc.
Outperform: $23.00
Model Update: NVS Reports Robust M-Enoxaparin 2Q11 Sales
On 7/19, MNTA's partner Novartis reported strong 2Q M-enoxaparin sales of $284M, above 1Q11 sales of $247M. We now estimate 2Q M-enoxaparin revenues to MNTA of ~$86M. We believe today's result confirms that Sandoz/MNTA continue to maximize production efficiency beyond MNTA's prior expectations. We note it has been about 6 months since the FDA minor deficiency letter for TEVA's generic enoxaparin. As additional time passes, we believe approval of TEVA's generic becomes more questionable. However, we continue to conservatively model entry of TEVA's generic in 3Q11. At current levels, we believe MNTA does not fully reflect the value of M-enoxaparin, M356 and MNTA's technology platform. We are adjusting our price target to $23 from $22 on improved M-enoxaparin cash flow.
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View Document
Key changes to our model. Based on 1Q profit share margins, we are increasing our 2Q M-enoxaparin sales estimate to $86M from $75M. We model the entry of TEVA's generic enoxaparin in 3Q. However, we have raised our 3Q M-enoxaparin sales estimate to $32M from $13M, given the lack of additional generic competition in July.
i have
it went from over ten to under nine first thing in the morning and then recovered