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Allos Therapeutics' Pralatrexate Granted Orphan Medicinal Product Designation for the Treatment of Cutaneous T-Cell Lymphoma by the European Commission
http://finance.yahoo.com/news/Allos-Therapeutics-bw-2984653801.html?x=0&.v=1
11:45AM Allos Therapeutics FOLOTYN shows activity and tolerability in Phase 1 dose finding study in patients with relapsed or refractory CTCL (ALTH) 6.76 -0.01 : Co announced updated data from its ongoing dose finding Phase 1 study of FOLOTYN(R) (pralatrexate injection) in patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL). FOLOTYN was well tolerated at the optimal dose, with forty-eight percent (11/23) of patients experiencing at least one adverse event.
Allos Therapeutics Reports New Data Demonstrating that Responses to FOLOTYN are Correlated with Prolonged Survival in Patients with Relapsed or Refractory PTCL
http://finance.yahoo.com/news/Allos-Therapeutics-Reports-bw-933981734.html?x=0&.v=1
8:00AM Allos Therapeutics' pralatrexate granted FDA orphan drug designation for the treatment of bladder cancer (ALTH) 7.23 :
Allos Therapeutics Reports First Quarter 2010 Financial Results
-- Conference Call Scheduled for Today at 4:30 p.m. ET --
Press Release Source: Allos Therapeutics, Inc. On Wednesday May 5, 2010, 4:00 pm
WESTMINSTER, Colo.--(BUSINESS WIRE)--Allos Therapeutics, Inc. (Nasdaq: ALTH - News) today reported financial results for the first quarter ended March 31, 2010.
First Quarter Financial Highlights:
•In January 2010, Allos commenced the commercial launch of FOLOTYN® (pralatrexate injection) in the United States for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma.
•Non-GAAP gross product sales, or sales to pharmaceutical wholesale distributors, were $8.7 million for the first quarter of 2010. Allos sells FOLOTYN to distributors who then resell FOLOTYN to patients’ health care providers.
•GAAP gross product sales, or sell-through sales from distributors to health care providers, were $8.2 million for the first quarter of 2010. Given the limited sales history for FOLOTYN, Allos currently cannot reliably estimate expected returns at the time of shipment to its distributors. Therefore, in accordance with GAAP, Allos defers revenue recognition of sales to distributors until the product is sold through its distributors to health care providers. As such, Allos’ deferred revenue increased by $0.5 million during the first quarter of 2010, which represents the difference between non-GAAP gross product sales and GAAP sell-through sales for the first quarter 2010. As of March 31, 2010, Allos has recorded total deferred revenue of $1.2 million.
•GAAP net product sales were $7.4 million for the first quarter of 2010, which represents the $8.2 million of sell-through sales net of $0.8 million of gross to net sales adjustments. Gross to net sales adjustments consist of distributor service fees and estimated accruals for government rebates and chargebacks.
“We are pleased with the first quarter of our U.S. commercial launch of FOLOTYN for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma,” said Paul L. Berns, president and chief executive officer of Allos Therapeutics. “During the quarter, we made significant progress implementing our FOLOTYN brand campaign, and we are encouraged by the level of awareness and use of FOLOTYN this early in the commercial launch. For the remainder of 2010, we will continue to focus on driving growth in U.S. sales of FOLOTYN for relapsed or refractory PTCL, as well as exploring the potential utility of FOLOTYN in additional indications.”
For the quarter ended March 31, 2010, Allos reported a net loss of $20.5 million, or $0.20 per share. Total operating costs and expenses for the first quarter of 2010 were $28.0 million, including stock-based compensation expense of $2.9 million. Cost of sales for the first quarter of 2010 were $0.7 million and consisted of royalties under Allos’ license agreement for FOLOTYN and costs for warehousing and shipping. Research and development expenses for the first quarter 2010 were $9.3 million. Selling, general and administrative expenses for the first quarter 2010 were $17.9 million.
Net cash used in operating activities for the first quarter 2010 was $23.3 million. As of March 31, 2010, Allos’ cash, cash equivalents and investments totaled $137.5 million.
Non-GAAP financial information is utilized by Allos’ management to provide a useful measure of operating performance of the company. Non-GAAP financial information herein includes the effect of deferred revenue related to gross product sales. Reconciliation between the non-GAAP and the GAAP financial measures is included in the narrative above.
Financial Guidance for 2010
Allos reaffirms prior financial guidance that total operating costs and expenses for 2010 are expected to approximate $120 to $130 million, excluding non-cash stock-based compensation expense. Stock-based compensation expense is expected to approximate $13 to $15 million.
Actual financial results for 2010 will vary based upon many factors, including the growth of FOLOTYN sales and rate of patient enrollment in FOLOTYN clinical trials that are ongoing and planned for initiation in 2010.
Clinical Development Update:
•Allos is updating its timeline for reporting top line results from the Company’s randomized Phase 2b non-small cell lung cancer trial of FOLOTYN. Allos now expects to report top line results from this investigational Phase 2b trial in the third quarter of 2010. The objective of the trial is to assess the treatment effect of FOLOTYN in certain pre-defined cohorts of patients with advanced NSCLC where FOLOTYN may have the potential to provide clinical benefit relative to erlotinib. The outcome of this study is intended to inform the design of a potential Phase 3 registration trial.
•Allos recently initiated a Phase 2 open label, multi-center, international trial of FOLOTYN in female patients with advanced or metastatic breast cancer who have failed prior chemotherapy. The primary endpoint is objective response. The study will seek to enroll approximately 30 patients.
Conference Call Information
Allos will host a conference call to review its first quarter 2010 financial results on Wednesday, May 5, 2010 at 4:30 p.m. EDT. Participants can access the call at 1-877-941-0844 (U.S. and Canada) or +480-629-9644 (international). To access the live audio webcast or the subsequent archived recording, visit the “Investors - Presentations and Events” section of Allos’ website at http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.allos.com&esheet=6279048&lan=en_US&anchor=www.allos.com&index=1&md5=58de20afbb5a2b882edf897a40dbc985. Webcast and telephone replays of the conference call will be available approximately two hours after the completion of the call. Callers can access the replay by dialing 800-406-7325 (domestic) or 303-590-3030 (international). The passcode is 4285655#. The webcast will be recorded and available for replay on Allos’ website until May 19, 2010.
Looking for continued up trend, ALTH will be at ASCO:
http://events.jspargo.com/asco10/public/Booth.aspx?IndexInList=14&FromPage=ExhibitorSearch.aspx&BoothID=167860
Allos Extends Losses
By Zacks Equity Research , On Tuesday March 2, 2010, 8:31 am
Allos Therapeutics’ (NasdaqGM: ALTH - News) fourth quarter loss per share came in at 22 cents, worse than the Zacks Consensus Estimate of 20 cents and a loss of 18 cents reported in the year-ago period. For 2009, the company reported a loss per share of 81 cents compared to 69 cents in 2008.
In Sep 2009, Allos received accelerated approval from the US Food and Drug Administration (FDA) for Folotyn for the treatment of patients with relapsed or refractory PTCL. During the third quarter conference call, the company stated the pricing of the drug - the average wholesale acquisition cost as $3,125 for the 20 mg vial and $6,250 for the 40 mg vial.
Allos has agreed to conduct additional clinical trials to further verify the benefit of Folotyn. The requirement of additional trials comes with accelerated FDA approval as the agency requires further studies after the launch to confirm the drug's benefits to patients. The drug was launched commercially in Jan 2010 although it has been made available to patients since Oct 2009. Allos recorded $3.6 million in revenues for the fourth quarter and the full year.
A 73.5% rise in operating expense during the quarter was primarily responsible for the increased losses. Following the approval of Folotyn, Allos has done the necessary preparations for its commercial launch. This led to a 149% increase in selling, general and administrative expenses. However, research and development expenses recorded a 1.4% decline to $7.9 million.
Allos exited 2009 with $158.5 million in cash, cash equivalents and investments in marketable securities. In Oct last year, the company received net proceeds of approximately $93 million from a public offering of 14 million shares. Allos had to raise funds to support the commercial launch of Folotyn in addition to carrying out its other clinical trials.
For 2010, Allos expects its total operating costs in the range of $120 - $130 million. The company has not provided any revenue guidance. A marketing authorization application of Folotyn is expected to be submitted in Europe by the fourth quarter of 2010. We have a Neutral recommendation on the stock.
ALLOS THERAPEUTICS INC (ALTH): Read the Full Research Report
Zacks Investment Research
I sold about 2/3 today. ALTH is strong, but we are back in the bear market that started DEC 07. Hello, via OBAMA puppet, plan for destruction of the USA and a one world government.
I took profits on some ALTH today, still holding a 1/3 of my position since biotech is still strong & money seems to be running into it with the overall market falling.
Allos Therapeutics ALTH JP Morgan stated with Overweight
Allos Therapeutics to Present at J.P. Morgan Healthcare Conference
Press Release Source: Allos Therapeutics, Inc. On Wednesday January 6, 2010, 8:00 am EST
WESTMINSTER, Colo.--(BUSINESS WIRE)--Allos Therapeutics, Inc. (NASDAQ: ALTH - News), a biopharmaceutical company committed to the development and commercialization of innovative anti-cancer therapeutics, today announced that members of the Company’s senior management will present on Wednesday, January 13, at 10:00 a.m. PST at the J.P. Morgan 28th Annual Healthcare Conference taking place at the Westin St. Francis in San Francisco.
There will be a live webcast of the presentation, which will be accessible through a link available on the home page and investor relations section of the Allos website. The webcast will be available for replay for 90 days.
Good, and the shorts get a little squeezed.............
ALTH may be setting up for a breakout at $6.90 & at the 200DMA at $6.96
12/21/2009 08:22 -0800 / M2 PRESSWIRE / BUYINS.NET /
www.squeezetrigger.com is monitoring ALLOS THERAPEUTIC (NASDAQ:ALTH)
in real time and just received an alert that is crossing above its
primary SqueezeTrigger Price, the price that a short squeeze can start
in any stock. There are 8510700 shares that have been shorted at the
volume weighted average SqueezeTrigger Price of $6.143. To access
SqueezeTrigger Prices ahead of potential short squeezes beginning,
visit http://www.squeezetrigger.com .
>From January 2005 to November 2009, an aggregate amount of 82550613
shares of ALTH have been shorted for a total dollar value of
$495,303,678.00. The ALTH SqueezeTrigger price of $6.143 is the
volume weighted average price that all shorts are short in shares of
ALTH. There is still approximately $52,340,805.00 of potential short
covering in shares of ALTH.
Medical Tech Stock Letter Dec 17
Allos(ALTH)
Allos’stock came out of ASH bruised and beaten as first The New York Times slammed them for high pricing and then CELG bought their potential competitor, Glouchester. The Times touched on the 30K monthly price tag for Folotyn despite the fact that it will mostly be used at most for two months leading to an annual price of 60K, certainly within the bounds of recently approved cancer drugs. Then some analysts concluded that CELG bought Glouchester because it has a better drug than ALTH which added to the pressure on the stock price.
Additional analyses from the PROPEL trial, as well as, new data evaluating Folotyn in cancers other than PTCL were presented at American Society of Hematology's 51st Annual Meeting over the weekend. This was complimented by launching a global COMPLETE registry trial at 75 sites and announcing a named patient program in Europe that will make PDX available to patients outside the U.S. beginning in January 2010. Overall, the data were incrementally positive with the most important data being new analyses in patient with highly refractory disease while emphasizing the protocol-specified dose modification to minimize side-effects such as mucositis. More important, is that the venue allowed Allos to build awareness for Folotyn prior to the full launch in late January 2010.
We are certainly disappointed in the stock’s price action as we expected ASH to be a positive event for the company. We believe that the current valuation does not reflect the commercial potential of Folotyn or any of its potential in other cancers. The recent weakness also increases the odds that a premium takeover will occur. ALTH is a buy under $8. Target $15 Rating : 7
NEW ORLEANS, La. (TheStreet) -- Allos Therapeutics(TICKER Quote) executives hit the phones Monday to defend the company's lymphoma drug Folotyn and take some not-to-subtle jabs at a potential competing lymphoma drug just acquired by Celgene(CELG Quote).
Monday's acquisition of Gloucester Pharmaceuticals, Celgene will soon launch Istodax as a treatment for cutaneous T-cell lymphoma (CTCL). But what has investors somewhat unsettled about Allos this morning is that Istodax may become a direct competitor to Folotyn in the peripheral T-cell lymphoma market (PTCL). Allos shares were down 14% to $5.71 in recent trading, which no doubt prompted the company's executives to pick up the phone to defend their drug.
"We have the first and only approved drug for PTCL in Folotyn and the reception for the drug here at ASH this weekend has been very strong," said Allos' chief commercial officer Jim Caruso, in a phone interview.
By ASH, Caruso is referring to the annual meeting of the American Society of Hematology, the largest annual gathering of doctors and researchers of blood-related cancers. Allos is using this year's meeting to introduce doctors to Folotyn, which received Food and Drug Administration approval in September.
A full-scale commercial launch for Folotyn will begin in January, after the FDA-imposed restrictions on promotional advertising expire.
As the only approved drug in PTCL, Folotyn will have a big head start over Istodax in PTCL, assuming the drug is ever approved for this indication, says Caruso.
He adds that Folotyn is administered through an infusion taking no more than five minutes while Istodax's infusion takes four hours -- a lengthy procedure which Caruso calls a "non starter commercially," especially for busy doctors who work in community-based hospitals.
http://www.thestreet.com/_yahoo/story/10639915/1/allos-defends-lymphoma-drug-biobuzz.html?cm_ven=YAHOO&cm_cat=FREE&cm_ite=NA
Allos Therapeutics' FOLOTYN Demonstrates Activity in Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma Treated with Stem Cell Transplant
-- New Analysis of Pivotal PROPEL Trial Presented at 51st ASH Annual Meeting --
Press Release
Source: Allos Therapeutics, Inc.
On 10:00 am EST, Monday December 7, 2009
NEW ORLEANS & WESTMINSTER, Colo.--(BUSINESS WIRE)--Allos Therapeutics, Inc. (Nasdaq: ALTH - News) today reported a new analysis of data from the Company’s pivotal PROPEL trial of FOLOTYN™ (pralatrexate injection) in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is based on overall response rate. Clinical benefit such as improvement in progression free survival or overall survival has not been demonstrated. The analysis evaluated the outcomes of patients who received a stem cell transplant (SCT) before or after treatment with FOLOTYN. The results demonstrate that FOLOTYN may be a potential treatment option for patients who have progressed after receiving a prior autologous SCT and may also be a potential bridge to an autologous or allogeneic SCT following response to FOLOTYN therapy. These data were presented during a poster session at the 51st Annual Meeting of the American Society of Hematology (ASH) in New Orleans, LA.
Among the 109 patients in the PROPEL trial evaluable for response, 18 (17%) had received autologous SCT previously, including 8 (7%) who underwent autologous SCT as the most recent therapy prior to study enrollment. Sixty-three percent (5/8) of patients who received autologous SCT as their most recent therapy responded to treatment with FOLOTYN, including two complete responses (CRs). In patients who underwent autologous SCT at any time prior to treatment with FOLOTYN, an overall response rate (ORR) of 33% (6/18) was observed, suggesting single agent FOLOTYN can be an effective therapeutic option for patients who have progressed after being exposed to an intense transplant regimen. Importantly, the ORR to FOLOTYN for patients who had progressed after prior SCT was comparable to that of the ORR of 29% (32/109) observed in the overall PROPEL population.
Additionally, the data demonstrated that promising results were observed in patients who responded to treatment with FOLOTYN and proceeded to receive SCT as initial subsequent therapy. Of the 109 patients evaluable for response, 6 proceeded to SCT after responding to FOLOTYN. Four of the 6 patients had responded according to independent central review and 2 of the 6 patients had responded according to investigator assessment. Thus, responses to FOLOTYN permitted patients to proceed to a potential curative transplant option.
“Stem cell transplant may be offered with curative intent in patients with PTCL,” said Barbara Pro, M.D., associate professor, T-cell Lymphoma team leader at The University of Texas M D Anderson Cancer Center in Houston. “Patients with PTCL are recognized as having a poor prognosis; therefore, it is important to identify new tolerable agents with the ability to induce a response for relapsed or refractory patients. This analysis underscores the important role FOLOTYN may play for PTCL patients who have failed to respond to prior therapies, progressed after prior autologous stem cell transplant and as a bridge to stem cell transplant for patients who respond to FOLOTYN therapy.”
CORRECTED - UPDATE 2-Celgene to buy Gloucester in cancer drug deal
Mon Dec 7, 2009 9:44am ESTStocks
Celgene Corporation
* Celgene to pay $340 mln cash, $300 mln in milestones
* Gloucester lymphoma drug won U.S. approval last month
* Celgene shares slightly lower (Recasts, adds details on deal, analyst comment, share moves, byline)
By Lewis Krauskopf
NEW YORK, Dec 7 (Reuters) - U.S. biotechnology company Celgene Corp (CELG.O) will buy privately held Gloucester Pharmaceuticals for as much $640 million to expand its arsenal of cancer medicines, the companies said on Monday.
Celgene, which announced the deal ahead of the release of important data for its Revlimid blood cancer drug, will gain Gloucester's just-approved Istodax lymphoma drug.
Istodax won U.S. clearance last month for treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior therapy. Gloucester has anticipated seeking approval next year for Istodax for peripheral T-cell lymphoma (PTCL), a larger market.
New Jersey-based Celgene will pay Gloucester $340 million cash and make future payments of up to $300 million if various milestones are reached.
Analysts praised the acquisition, saying Celgene could leverage its marketing infrastructure to sell Istodax.
"We believe this acquisition makes sense on multiple fronts and we view it as a smart use of Celgene's war chest of cash," Wells Fargo analyst Aaron Reames said in a research note.
CTCL is a rare type of non-Hodgkin's lymphoma that can cause skin plaque and involve the blood and other organs. Istodax sales for the CTCL market in the United States could reach $200 million annually, according to JP Morgan analyst Geoff Meacham. He projected annual Istodax sales of $300 million for the PTCL market.
Meacham said the acquisition looks like a "good strategic fit" for Celgene, which also sells the blood disorder drug Vidaza.
Istodax poses a competitive threat for Allos Therapeutics' (ALTH.O) newly approved Folotyn that could become more imposing with Celgene's marketing muscle behind it, analysts said. Folotyn won approval in September for treatment of PTCL.
"The acquisition introduces a deeper-pocket competitor into the field and makes Istodax a more viable threat," Leerink Swann analyst Joshua Schimmer said in a research note.
Shares of Allos, which also released data on Folotyn over the weekend, fell 10 percent in premarket trade.
How much do you think the price will effect the company? Will they need to lower it? The drug has only a 60% success rate, if I read the data right?
<<A newly approved chemotherapy drug will cost about $30,000 a month, a sign that the prices of cancer medicines are continuing to rise despite growing concern about health care costs
The price of the new drug, called Folotyn, is at least triple that of other drugs that critics have said are too expensive for the benefits they offer to patients. The colon cancer drug Erbitux, for instance, costs $10,000 a month and the drug Avastin about $8,800 when used to treat lung cancer. The price of Folotyn “seems way higher than I heard of before,” Robert L. Erwin, president of the Marti Nelson Cancer Foundation, a patient advocacy group. “I can’t imagine there not being a backlash against the pricing.”
Drug makers in general have been raising prices sharply in advance of the possible passage of health care overhaul legislation, according to various studies. But the price of cancer drugs has been an issue for several years. >>
Allos Therapeutics Reports New Analyses of Data from Pivotal PROPEL Trial of FOLOTYN at 51st ASH Annual Meeting
http://finance.yahoo.com/news/Allos-Therapeutics-Reports-bw-3584383413.html?x=0&.v=1
8:01AM Allos Therapeutics announces an agreement with Idis for a named patient program for FOLOTYN (ALTH) 6.46 : Co announces the execution of a collaborative agreement with Idis, a UK-based company, to manage the named patient program for FOLOTYN outside of the United States. The FDA has granted accelerated approval for FOLOTYN for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma. This indication is based on overall response rate. Clinical benefit such as improvement in progression free survival or overall survival has not been demonstrated. Allos retains exclusive worldwide rights to develop and commercialize FOLOTYN in all indications. FOLOTYN has been available to patients in the U.S. since October 2009, and is expected to be available under the named patient program outside the U.S. beginning in January 2010.
JMP Securities "ALTH - Our Top Pick into ASH. ASH provides early opportunity to gauge potential launch utilization; reiterate Market Outperform and $20 price target on Allos Therapeutics"
JMP Securities
Biotechnology – Update
Allos Therapeutics, Inc. (1,3)
Our Top Pick into ASH
MARKET OUTPERFORM
Target Price $20.00
INVESTMENT HIGHLIGHTS
o ASH provides early opportunity to gauge potential launch utilization; reiterate Market Outperform and $20 price target on Allos Therapeutics. This weekend, we will be in attendance at the 51st American Society of Hematology Annual Meeting in New Orleans, LA. At the meeting, Allos will launch FOLOTYN to physicians who will likely be the highest prescribers of the drug initially. Six abstracts will be presented including one oral presentation. Perhaps more importantly, the company will have a booth in the exhibit hall where we believe a wider audience of physicians can be captured. In our view, this meeting will provide an opportunity to gauge reaction of these key physicians with potential read through to early utilization of the product. We reiterate our Market Outperform rating and 12-month price target of $20, which is derived by applying a 30x multiple to our 2013 EPS estimate of $1.00, discounted at 15%.
o Data presentations provide incremental positives. The six abstracts contain incremental new data for FOLOTYN, with four poster presentations containing new analyses and updated efficacy results from the PROPEL trial. Although none of these presentations contains data that have the potential to significantly change perception, they provide further support for the benefit of the drug. In our view, the most interesting data to be presented will be in oral abstract 919, a trial in patients with cutaneous T-cell lymphoma (CTCL). This abstract may only show dose-ranging data; however,an encouraging signal of efficacy was seen with an objective response rate of 58% (10 of 18 patients) in patients who received drug at a dose intensity of 15 mg/m2 every 3-4 weeks or greater.
Furthermore, the abstract provides the opportunity to point to FOLOTYN’s potential activity in other hematological indications. We note that as well as the CTCL trial, the drug is also being assessed for the treatment of Non-Hodgkin’s lymphoma (NHL). A summary of the abstracts to be presented, as well as presentation times and locations, is provided in Figure 1.
· Historical oncology launches point to upside potential. We analyzed the launches of six products in oncology indications over the past four years (Figures 2 and 3). Several of these products were launched into indications with very small patient populations (fewer than 50,000 patients) and yet achieved sales of approximately $100MM in the first four quarters in the market. We would again highlight that FOLOTYN is the only approved product for PTCL, a rapidly fatal disease with no other approved treatment options. In our view, this unmet medical need combined with the compelling efficacy data make the likelihood of fast adoption high for FOLOTYN despite its roughly $120k annual price tag.
It was up last week on heavy volume, hopefully it will reverse by the close today. Too many shorts in the stock for it not to move higher into Fridays close.
No wonder the stock is down today. Too much good news.
13 Biotechs to Watch for at Hematology Conference
http://seekingalpha.com/article/175681-13-biotechs-to-watch-for-at-hematology-conference?source=yahoo
Allos Therapeutics Announces Issuance of U.S. Patent for FOLOTYN
Press Release
Source: Allos Therapeutics, Inc.
On 8:00 am EST, Monday November 30, 2009
WESTMINSTER, Colo.--(BUSINESS WIRE)--Allos Therapeutics, Inc. (Nasdaq:ALTH - News) today announced that the United States Patent and Trademark Office has issued a patent for the use of FOLOTYN™ (pralatrexate injection) for the treatment of T-cell lymphoma. U.S. Patent No. 7,622,470 was issued to Memorial-Sloan Kettering Cancer Center, SRI International and Southern Research Institute, and expires on November 24, 2025. Allos holds an exclusive worldwide license from these institutions to develop and market FOLOTYN for all indications.
“We are pleased to add this important patent to our intellectual property portfolio for FOLOTYN,” said Marc H. Graboyes, senior vice president, general counsel of Allos Therapeutics. “Patent protection is an essential component of our product life cycle management strategy, and this patent further strengthens the FOLOTYN franchise.”
Looks like that rating had a positive effect.
Allos Therapeutics Announces New Data on FOLOTYN to be Presented at the American Society of Hematology Meeting
Press Release
Source: Allos Therapeutics, Inc.
On 8:00 am EST, Wednesday November 11, 2009
Companies:Allos Therapeutics, Inc.
WESTMINSTER, Colo.--(BUSINESS WIRE)--Allos Therapeutics, Inc. (Nasdaq: ALTH - News) today announced that abstracts from studies of FOLOTYN™ (pralatrexate injection) were accepted for presentation at the 51st Annual Meeting of the American Society of Hematology (ASH) to be held at the Ernest N. Morial Convention Center in New Orleans, La., from December 5-8, 2009.
Four poster presentations will summarize new analyses of data and updated efficacy results from the Company’s pivotal PROPEL study, which served as the basis for U.S. Food and Drug Administration’s accelerated approval of FOLOTYN™ on September 24, 2009, for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). In addition, there will be a poster summarizing results of a Phase 1 study of FOLOTYN in combination with gemcitabine in patients with relapsed or refractory lymphoproliferative malignancies, and an oral presentation highlighting results of a multicenter, dose-finding study of FOLOTYN in patients with cutaneous T-cell lymphoma (CTCL).
Information regarding the ASH presentations is below and full abstracts can be viewed on the ASH website at www.hematology.org and will be published in the Blood Abstract Book.
Presentation Date/Time: Saturday, December 5, 2009, 5:30-7:30 p.m. (Central)
Poster Title: “Pralatrexate Induces Responses in Patients with Highly Refractory Peripheral T-Cell Lymphoma (PTCL)”
First Author: Kerry J. Savage, MD, British Columbia Cancer Agency
Abstract Number: 1678 (Poster Board I-700)
Location: Hall E of the Ernest N. Morial Convention Center
Presentation Date/Time: Saturday, December 5, 2009, 5:30-7:30 p.m. (Central)
Poster Title: “Safety and Management of Pralatrexate Treatment in Relapsed or Refractory Peripheral T-Cell Lymphoma (PTCL)”
First Author: Lauren Pinter-Brown, MD, University of California at Los Angeles
Abstract Number: 1675 (Poster Board I-697)
Location: Hall E of the Ernest N. Morial Convention Center
Presentation Date/Time: Saturday, December 5, 2009, 5:30-7:30 p.m. (Central)
Poster Title: “Correlation between Baseline Methylmalonic Acid Status and Mucositis Severity in the PROPEL Study: Implications for Vitamin Prophylaxis”
First Author: Barbara Pro, MD, University of Texas M.D. Anderson Cancer Center
Abstract Number: 1681 (Poster Board I-703)
Location: Hall E of the Ernest N. Morial Convention Center
Presentation Date/Time: Saturday, December 5, 2009, 5:30-7:30 p.m. (Central)
Poster Title: “Pralatrexate and Gemcitabine in Patients with Relapsed or Refractory Lymphoproliferative Malignancies: Phase 1 Results”
First Author: Steven M. Horwitz, MD, Memorial Sloan-Kettering Cancer Center
Abstract Number: 1674 (Poster Board I-696)
Location: Hall E of the Ernest N. Morial Convention Center
Presentation Date/Time: Monday, December 7, 2009, 6:00-8:00 p.m. (Central)
Poster Title: “Stem Cell Transplant (SCT) and Pralatrexate Therapy: Outcome of Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma Who Received SCT Prior to or Following Pralatrexate Therapy”
First Author: Leslie Popplewell, MD, City of Hope
Abstract Number: 3420 (Poster Board III-357)
Location: Hall E of the Ernest N. Morial Convention Center
Oral Presentation Date/Time: Tuesday, December 8, 2009, 7:30 a.m. (Central)
Title: “Pralatrexate is Active in Cutaneous T-Cell Lymphoma (CTCL): Results of a Multicenter, Dose-Finding Trial”
First Author: Steven M. Horwitz, MD, Memorial Sloan-Kettering Cancer Center
Abstract Number: 919
Location: 260-262 Ernest N. Morial Convention Center
About Allos Therapeutics
Allos Therapeutics, Inc. (Nasdaq: ALTH - News) is a biopharmaceutical company committed to the development and commercialization of innovative anti-cancer therapeutics. Allos is currently focused on the development and commercialization of FOLOTYN™ (pralatrexate injection), a folate analogue metabolic inhibitor. FOLOTYN is the first and only drug approved in the U.S. for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma. Allos is also developing FOLOTYN in other potential indications. Allos retains exclusive worldwide rights to FOLOTYN for all indications. Allos is headquartered in Westminster, Colo. For additional information, please visit www.allos.com.
Important Safety Information
Warnings and Precautions:
FOLOTYN may suppress bone marrow function, manifested by thrombocytopenia, neutropenia, and anemia. Monitor blood counts and omit or modify dose for hematologic toxicities.
Mucositis may occur. If ≥ Grade 2 mucositis is observed, omit or modify dose.
Patients should be instructed to take folic acid (1.0 -1.25 mg orally on a daily basis) and receive vitamin B12 (1 mg intramuscularly every 8-10 weeks) to potentially reduce treatment-related hematological toxicity and mucositis.
FOLOTYN can cause fetal harm. Women should avoid becoming pregnant while being treated with FOLOTYN, and pregnant women should be informed of the potential harm to the fetus.
Use caution and monitor patients when administering FOLOTYN to patients with moderate to severe renal function impairment.
Elevated liver function test abnormalities may occur and require monitoring. If liver function test abnormalities are ≥ Grade 3, omit or modify dose.
Adverse Reactions:
The most common adverse reactions observed in PROPEL were mucositis (70%), thrombocytopenia (41%), nausea (40%), and fatigue (36%). The most common serious adverse events (>3%), regardless of causality, were pyrexia, mucositis, sepsis, febrile neutropenia, dehydration, dyspnea and thrombocytopenia. Forty-four percent of patients experienced a serious adverse event while on study or within 30 days after their last dose of FOLOTYN. Twenty-three percent of patients discontinued treatment due to adverse reactions.
Drug Interactions:
Co-administration of drugs subject to renal clearance (e.g., probenecid, NSAIDs, and trimethoprim/sulfamethaxazole) may result in delayed renal clearance.
Use in Specific Patient Population:
Nursing mothers should be advised to discontinue nursing or the drug, taking into consideration the importance of the drug to the mother.
For additional important safety information, please see the full prescribing information for FOLOTYN at www.allos.com.
ALTH should have have an upward bias into this meeting:
51st ASH Annual Meeting and Exposition
December 5-8, 2009
Ernest N. Morial Convention Center, New Orleans, LA
http://www.hematology.org/Meetings/Annual-Meeting/
Buy This Cheap Biotech Spec?
Published: Thursday, 5 Nov 2009 | 9:29 PM ET Text Size By: Tom Brennan
Web Editor, Mad Money
Allos Therapeutics “could be an opportunity,” Cramer said Thursday, for investors looking to speculate on the fight against cancer.
The company plans to trade launch Folotyn, a drug for refractory peripheral T-cell lymphoma, to physicians at the American Society of Hematology on Dec. 5, Cramer said, and the meeting could be “a big catalyst” for the stock.
Not to mention, Allos [ALTH 5.89 0.18 (+3.15%) ] is developing Folotyn for multiple indications, “the jackpot when it comes to cancer research,” including CTCL, a rare form of non-Hodgkins lymphoma and lung cancer. Additional data on the trials is due out later this year and in the first half of 2010.
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Folotyn is so potentially big that it makes Allos appear to be “a very cheap stock,” Cramer said. Sales of the drug could reach $300 million in the US, but even if the final tally’s only $150 million, that still adds up to about $5 a share for the stock. And ALTH closed Thursday at $5.89.
The stock took a hit as a result of Allos’ Oct. 7 secondary offering, Cramer said, and “it’s been all downhill since then.” But the company held $84 million in cash at the end of the quarter, so another raising of cash is most likely out of the question. More importantly, though, investors now have the chance to buy ALTH almost 25% lower than its trading price before Folotyn was approved on Sept. 24.
Once the drug hits the commercial market in January, Cramer said, Allos’ stock “should go higher.” But he wanted to hear from CEO Paul Berns before making the call. Watch the video for the full interview.
http://www.cnbc.com/id/33700383/site/14081545?__source=yahoo%7Cheadline%7Cquote%7Ctext%7C&par=yahoo
http://www.cnbc.com/id/15840232?play=1&video=1320626643&__source=yahoo%7Cheadline%7Cquote%7Cvideo%7C&par=yahoo
It is the whole group that is going down, the 200 biotechs I follow have for the most part been trending down. It isn't an ALTH issue, it feels like a ALTH problem if you own the stock. I owned over 40 biotech stocks until Sept, now I have less than 5 biotech stocks. I just dropped my price point to $6.40 in ALTH & with any big short covering rally I'll be green.
Short % of Float (as of 12-Oct-09)3: 7.70%
Shares Short (prior month)3: 6.34M
With over $96 million in assets, ALLOS THERAPEUTICS, INC. looks good except the share price going down.
Does the company needs sales booked?
Allos Therapeutics, Inc., Q3 2009 Earnings Call Transcript
http://seekingalpha.com/article/171019-allos-therapeutics-inc-q3-2009-earnings-call-transcript?source=yahoo
I don't like to average down but I did with ALTH this morning, news update next week & huge short position should help the PPS soon enough....
Wow...excellent timing on that sell.
This is bad news?
Allos Therapeutics to Report Third Quarter 2009 Results on November 3, 2009
8:00a ET October 26, 2009 (Business Wire)
Allos Therapeutics, Inc. (NASDAQ:ALTH), a biopharmaceutical company committed to the development and commercialization of innovative anti-cancer therapeutics, today announced that Company management will provide a corporate update and review of the third quarter 2009 results via webcast and conference call on Tuesday, November 3, 2009, at 4:30 p.m. ET.
To access the live audio webcast or the subsequent archived recording, visit the "Investors - Presentations and Events" section of the Company's website at www.allos.com. Alternatively, callers may participate in the conference call by dialing 1-877-941-8610 (domestic) or 480-629-9819 (international). Participants should reference the Allos Therapeutics conference call. Webcast and telephone replays of the conference call will be available approximately two hours after the completion of the call through Friday, November 13, 2009. To access the replay, callers should dial 1-800-406-7325 (domestic) or 303-590-3030 (international) and use passcode 4169927#.
About Allos Therapeutics
Allos Therapeutics, Inc. (Nasdaq:ALTH) is a biopharmaceutical company committed to the development and commercialization of innovative anti-cancer therapeutics. Allos is currently focused on the development and commercialization of FOLOTYN(TM) (pralatrexate injection), a folate analogue metabolic inhibitor. FOLOTYN is the first and only drug approved in the U.S. for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma. Allos is also developing FOLOTYN in other potential indications. Allos retains exclusive worldwide rights to FOLOTYN for all indications. Allos is headquartered in Westminster, CO. For additional information, please visit www.allos.com.
Safe Harbor Statement
The 2009 third quarter results press release and conference call will contain forward-looking statements that involve significant risks and uncertainties, including those contained in the "Risk Factors" section of the company's Form 10-Q for the quarter ended June 30, 2009 and in the company's other periodic reports and filings with the Securities and Exchange Commission. Allos is providing the information contained in the press release and conference call as of the date of the release and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise. The Company cautions investors not to place undue reliance on the forward-looking statements contained in the press release or the conference call. No forward-looking statement can be guaranteed and actual events and results may differ materially from those projected.
SOURCE: Allos Therapeutics, Inc.
Allos Therapeutics, Inc.
Monique Greer, 720-540-5268
mgreer@allos.com
Finally up on good volume, nice to see after the IPO completion.
Allos Closes Offering
By Zacks Equity Research
On 9:04 am EDT, Thursday October 15, 2009
Companies:Allos Therapeutics, Inc.
Yesterday, Allos Therapeutics (ALTH) announced the closure of an underwritten public offering of 14 million shares of newly issued common stock at $7.1 per share. The company received net proceeds of $93 million after deducting issue related expenses.
We had forecasted that Allos would need to raise funds based on its cash position and requirements. The proceeds of the issue will be primarily used to support the commercialization of Folotyn (pralatrexate injection), other research and developmental activities and general corporate purposes.
Earlier, in September, Allos received accelerated approval from the US Food and Drug Administration (FDA) for Folotyn for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma. Folotyn is Allos' first drug to receive FDA approval. While the drug will be available to patients in October, the commercial launch is scheduled for January 2010.
Allos is doubling its sales force from the current strength of 25 persons to 50, and making the necessary preparations for its launch. Moreover, the company has agreed to conduct additional clinical trials to further verify the benefit of Folotyn.
The necessity of additional trials comes with accelerated FDA approval as the agency requires further studies after the launch to confirm the drug's benefits to patients. We believe Allos, being in a tight liquidity position is raising funds to meet these expenses. The FDA approval could not have come at a more appropriate time as Allos had been depending heavily on Folotyn.
Since its inception in 1992, the company has not generated any revenue from product sales and has experienced significant net losses and negative cash flows from operations. The successful launch and marketing of the drug in due course should boost the company’s top line in due course. We have a Neutral recommendation on the stock.
When and how did they issue at $7.10 when it was trading below that price? Or did those who bought it at $7.10 just turn around and sell it?
Allos Therapeutics Announces Closing of Public Offering
Date : 10/13/2009 @ 4:05PM
Source : Business Wire
Stock : Allos Therapeutics (ALTH)
Quote : 6.7 0.12 (1.82%) @ 7:22AM
Allos Therapeutics Announces Closing of Public Offering
Allos Therapeutics, Inc. (Nasdaq: ALTH) today announced the closing of its previously announced underwritten public offering of 14,000,000 shares of newly issued common stock at a public offering price of $7.10 per share. The Company received net proceeds from the sale of the shares, after underwriting discounts, commissions and estimated offering expenses, of approximately $93.0 million. Allos has also granted the underwriters a 30-day option to purchase up to an aggregate of 2,100,000 additional shares of common stock to cover over-allotments, if any. Allos currently anticipates using the net proceeds of the offering primarily for activities relating to the commercialization of FOLOTYN™ (pralatrexate injection), preclinical research and clinical development of FOLOTYN, and for general corporate purposes.
14,000,000 primary shares of its common stock at a public offering price of $7.10 per share.
This company already had about $90 million in cash. This offering raises ~$100 million.
5,000 people a year get T-cell Lymphoma and sales of the drug were to be about $200-400 million/year.
Does this spell take over candidate?
Allos Therapeutics Announces Pricing of Public Offering of Common Stock
Press Release
Source: Allos Therapeutics, Inc.
On 6:14 am EDT, Wednesday October 7, 2009
Companies:Allos Therapeutics, Inc.
WESTMINSTER, Colo.--(BUSINESS WIRE)--Allos Therapeutics, Inc. (Nasdaq:ALTH - News) today announced the pricing of an underwritten public offering of 14,000,000 primary shares of its common stock at a public offering price of $7.10 per share. The gross proceeds from the sale of the shares, before underwriting discounts and commissions and other offering expenses, are expected to be approximately $99.4 million. The offering is expected to close on or about October 13, 2009, subject to customary closing conditions. Allos has also granted the underwriters a 30-day option to purchase up to an aggregate of 2,100,000 additional shares of common stock to cover over-allotments, if any. All of the shares in the offering are being sold by Allos.
Allos currently anticipates using the net proceeds of the offering primarily for activities relating to the commercialization of FOLOTYN™ (pralatrexate injection), preclinical research and clinical development of FOLOTYN, and for general corporate purposes.
J.P. Morgan Securities Inc. and Citigroup Global Markets Inc. are acting as joint book-running managers of the offering. Leerink Swann LLC is acting as co-lead manager of the offering. JMP Securities LLC, Needham & Company, LLC, and RBC Capital Markets are acting as co-managers of the offering. A copy of the final prospectus supplement and accompanying prospectus relating to the offering, when available, may be obtained by contacting J.P. Morgan Securities Inc., Attention: Prospectus Department, 4 Chase Metrotech Center, CS Level, Brooklyn, NY 11245 or by calling (718) 242-8002 or Citigroup Global Markets Inc., Prospectus Department, Brooklyn Army Terminal, 140 58th Street, 8th Floor, Brooklyn, NY 11220, (800) 831-9146.
A registration statement relating to these shares was declared effective by the Securities and Exchange Commission on August 28, 2009. Any offer or sale will be made only by means of a written prospectus supplement forming part of the effective registration statement. This press release does not and shall not constitute an offer to sell or the solicitation of an offer to buy Allos’ common stock, nor shall there be any sale of the common stock in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any state.
No new run over 7.25$ but I guess we close around 7.20-7.25$ today and that would give us a good base to rise further tomorrow. This is a good, profitable company now, just wait and let the money roll in.
Go Go, now we take the 7.25$ Wondering why it goes up on fairly bad news, but who cares
I did not see a price for the new shares. So what do you see as the floor?
I got a lot of this percentage wise for me. 3,000 at 7.06 in the account where I have cash sitting. Very happy to see profit.
11 million more shares, by definition is dilution.
The advice I have gotten from those on this board has been very good. My thanks to you all.
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http://www.allos.com/
http://finance.yahoo.com/q/ks?s=ALTH
http://www.form4oracle.com/company?cik=0001097264&ticker=ALTH
Allos Therapeutics, Inc., a biopharmaceutical company, engages in the development and commercialization of small molecule drugs for the treatment of cancer. The company has three product candidates in development: EFAPROXYN (efaproxiral), PDX (pralatrexate), and RH1. Its lead product, EFAPROXYN (efaproxiral), a synthetic small molecule designed to sensitize hypoxic, or oxygen-deprived, tumor tissue during radiation therapy is in phase III clinical program for brain metastases from breast cancer; Phase I clinical program for stage IIIA/IIIB non small cell lung cancer; and Phase Ib/2 clinical program for cervical cancer. The company's PDX (pralatrexate), a small molecule chemotherapeutic agent, which is in Phase I clinical program for stage IIIB-IV non small cell lung cancer; Phase I/II clinical program for non Hodgkin's lymphoma and Hodgkin's disease; and Phase II clinical program for peripheral t-cell lymphomas. Its RH1, a small molecule chemotherapeutic agent bioactivated by the enzyme DT-diaphorase, which is in Phase I clinical program for solid tumors. Allos Therapeutics was founded in 1992. It was formerly known as HemoTech Sciences, Inc. and changed its name to Allos Therapeutics, Inc. in 1994. The company is headquartered in Westminster, Colorado.
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