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  • Analysis Of The Near-Term Value Drivers Of Spectrum Pharmaceuticals [View article]
    I'd like to add an other explanation concerning mistrust you mention in your very interesting analysis: the huge bonus (0.9 M$) for Dr. Raj after an horrible year.
    Mar 7 10:11 AM | 1 Like Like |Link to Comment
  • 10 Reasons To Buy Durect Right Now [View article]
    Clear and well argumented analysis. I'm in too.
    Feb 13 01:07 PM | 1 Like Like |Link to Comment
  • Spectrum's Failure To 'Give Back' Continues To Hurt Its Stock [View article]
    Thanks Brian for this very interesting article.
    Would you be so kind to comment Raj's sentence talking about Apaziquone "we are planning to have a meeting with the FDA sometime in the future and see what strategy we can develop" ?
    On April 5th announcing the results of Apaziquone trial they said "The company is considering to request a meeting with the FDA to discuss future steps." After 7 months I'm very disappointed to listen Raj saying "sometime in the future" and none of the analyst asking further clarification . How long does it take to plan a meeting with FDA ?
    Nov 9 04:45 AM | Likes Like |Link to Comment
  • Spectrum Will Sink Until 2013 [View article]
    leucovorin shortage is not over
    http://1.usa.gov/HAcfYg

    see also http://seekingalpha.co...
    Apr 13 11:53 AM | Likes Like |Link to Comment
  • Vanda: Acquisition in the Works? [View article]
    any news from Novartis on Fanapt sales ?
    Feb 2 01:43 AM | Likes Like |Link to Comment
  • Spectrum Pharma Ranks 23rd on 2010 Fast 500 => Rx Investors.com  [View instapost]
    BALTIMORE, MD -- A federal judge could decide as early as Wednesday whether a Baltimore drug manufacturer must cancel a long-planned winter shutdown to make hundreds of thousands of doses of a colorectal cancer treatment.
    But if the judge’s candid comments at the end of Tuesday’s hearing are any indication, Cangene bioPharma’s plans to close its doors on Dec. 3 appear more certain than Spectrum Pharmaceuticals Inc.’s future supply of Fusilev — or the health of patients who depend on it.
    After the full-day hearing in U.S. District Court in Baltimore, Senior Judge Marvin J. Garbis said he would like to order Cangene to stay open and churn out batches of Fusilev, itself a replacement for another drug in short supply. Without a sound legal basis, though, such a ruling would be “like a snowball on a hot seat in Richmond,” he said, referring to the 4th U.S. Circuit Court of Appeals.
    “I’ve got to get [Cangene] liable to do it,” Garbis told Spectrum attorney, Mark A. Pals, at the end of the hearing on the preliminary injunction. “I’m trying to make them liable.”
    Humanitarian urges aside, Garbis had serious concerns about Cangene’s obligation to produce several batches of Fusilev on short notice under its May 2008 Master Supply Agreement with Irvine, Ca.-based Spectrum.
    Spectrum, as it was obligated to do under the contract, predicted in November 2009 that it would need one batch — usually 34,800 vials — in the third quarter of 2010 and one more batch in the fourth quarter.
    But when it learned in June of a shortage of Leucovorin, the main colectoral cancer chemotherapy rescue drug, it immediately sent orders to Cangene, its only supplier, for 10 smaller batches of Fusilev, or 190,000 vials.
    Pals said that was adequate notice under the agreement.
    “It’s no notice at all,” Garbis said.
    Spectrum has continued to request more Fusilev — nearly 700,000 vials as of Nov. 10.
    Cangene has produced 145,000 vials but says it cannot meet Spectrum’s demand, despite offers of more money from Spectrum.
    “Nothing would please Cangene more than to do this,” said its lawyer, Frederick L. Whitmer. “We can’t do it.”
    Cangene, the 100-employee division of the Canadian company of the same name, told its 30 customers in January about its plans to shut down in order to check its air filtration system, install a second lyophilizer (which freeze-dries the drugs) and run other tests.
    It expects to reopen in March and promised to put Spectrum’s order at the front of the line, but the California company is not satisfied.
    While the lawyers argued about whether the contract is one for goods, to be governed by the Uniform Commercial Code, or for services, there is also the question of what happens to the ultimate consumers.
    Colorectal cancer is the second-leading cause of cancer deaths in the U.S., according to Spectrum’s lawsuit, and will ** more than 50,000 Americans in 2010 alone.
    Leucovorin is approved to “prolong patient survival as part of a palliative course of treatment,” the suit says. While Fusilev is “not indicated or marketed” for that purpose, it is often prescribed as a substitute.
    There are no alternatives to Fusilev currently available, said George F. Tidmarsh, Spectrum’s chief scientific officer.
    “Patient lives will be shortened,” he testified. “People will die.”
    Whitmer argued Spectrum was not obligated to make Cangene its sole supplier and that Cangene can’t drop everything for one customer when its other customers also make important drugs and have to deal with the shutdown as well.
    “What happened here is a classic example of why there are forecast provisions in the contract,” he said.
    Spectrum’s vice president of business solutions and government affairs testified that through May, the company had sold fewer than 30,000 units of Fusilev.
    From June, when the Food and Drug Administration announced the Leucovorin shortage, through November, it has sold more than 234,000 doses to its wholesalers, who supply it to physicians and hospitals.
    Ricardo J. Gonzalez, Spectrum’s vice president, said its current supply won’t last until Christmas. He estimated a five-month delay before it can get more Fusilev “will permanently damage our relationships and good will.”
    From the start of the hearing, Garbis said he had a good handle on the balance of the harms to the companies and the public interest calculations inherent in deciding whether an injunction was in order. He wanted to hear about the contract and what it obligated Cangene to do at Spectrum’s direction.
    “If there’s no legal obligation, you can turn it into a slot machine parlor,” he said, perhaps a reference to the ongoing fight to build a slots parlor less than half-mile south on Russell Street.
    Recognizing the controversy as a “matter in which there is great urgency,” Garbis said if he can’t deliver a decision before Thanksgiving, he would have one by noon Monday.
    Spectrum, publicly traded on Nasdaq as SPPI, closed at $4.51 on Tuesday, down 9 cents on the day.
    Cangene Corp., Cangene’s parent company, closed unchanged at $3.10 Canadian.
    Nov 24 12:52 AM | 1 Like Like |Link to Comment
  • Spectrum Pharma Ranks 23rd on 2010 Fast 500 => Rx Investors.com  [View instapost]
    but do they have money to refund the monetary damage ?
    Nov 19 11:22 AM | 1 Like Like |Link to Comment
  • Spectrum Pharma Ranks 23rd on 2010 Fast 500 => Rx Investors.com  [View instapost]
    Baltimore’s Cangene Biopharma sued over cancer drug’s production glitch Baltimore Business Journal
    by Gary Haber Date: Thursday, November 18, 2010, 6:20pm EST .Related:

    Technology ...A California company that sells a drug commonly used to care for patients with advanced colorectal cancer has sued to force Baltimore’s Cangene Biopharma to continue manufacturing the treatment.

    Spectrum Pharmaceuticals Inc., of Irvine, Calif., filed suit against Cangene Biopharma on Nov. 10 in U.S. District Court in Baltimore. It alleges the contract biomanufacturer breached its 2008 contract with Spectrum to make Fusilev, an injectable cancer drug marketed by Spectrum.

    The suit also alleges Cangene Biopharma failed to produce all of the drug that Spectrum had ordered within the 60 days the contract requires, leaving Spectrum unable to fill orders for about 40,000 vials.

    Spectrum said it would be further damaged by Cangene Biopharma’s plans to temporarily close its Baltimore manufacturing plant for an undetermined period of time for plant maintenance and renovation, the lawsuit said. It is seeking an unspecified amount of monetary damages and a court order forcing Cangene Biopharma to continue to manufacture Fusilev.

    After the suit was filed, lawyers for Cangene Biopharma and Spectrum agreed that Cangene Biopharma would keep its plant open through the close of business on Dec. 3.

    Cangene Biopharma’s lawyer and the company’s plant manager could not be reached for comment. Lawyers for Spectrum also could not be reached for comment.

    According to Spectrum’s lawsuit, Fusilev is in high demand because of a shortage of leucovorin, another colon cancer drug. Cancer doctors are instead using Fusilev as a treatment for colorectal cancer. The U.S. Food and Drug Administration has asked Spectrum to ensure it can provide an adequate supply of Fusilev to meet the demand.

    Cangene Biopharma is the only company currently making Fusilev, the suit said. It would take Spectrum between a year and 18 months to obtain an alternative source of Fusilev, the company said in its lawsuit.

    Cangene Biopharma’s headquarters and manufacturing operations are in the Carroll/Camden Industrial Park on South Paca Street in South Baltimore. The company manufactures pharmaceuticals for a number of different pharmaceutical companies.

    Cangene Biopharma was founded in 1980 as Chesapeake Biological Laboratories. Cangene Corp., of Winnipeg, Canada, bought Chesapeake Biological in 2001. It changed the company’s name to Cangene Biopharma in December 2009.
    ..

    Read more: Baltimore’s Cangene Biopharma sued over cancer drug’s production glitch | Baltimore Business Journal
    Nov 19 08:52 AM | 1 Like Like |Link to Comment
  • A Look Back: Dr. Piro's Take on Spectrum's Zevalin ===> Rx Investors.com [View instapost]
    Justin,
    any comment on Jeffries 2010 presentation ? In the final part of his presentation dr. Shotryia is announcing belinostat NDA for 2012.
    Wasn't it expected for 2011 ?
    Oct 5 10:01 AM | 1 Like Like |Link to Comment
  • Spectrum Pharmaceuticals: Looking Ahead at Continued Growth [View article]
    new company presentation.
    Zevalin: anticipate 2010 sales between 27 -29 M$

    www.spectrumpharm.com/...
    Sep 1 07:05 AM | 1 Like Like |Link to Comment
  • 8 STRONG BUYS => Rx Investors.com [View instapost]
    SPPI - any comment on the unexpected exit of two top managers, (Sandler and Sing) ?
    Furthermore me and other Italian shareholders have often tried invain to get some clarifications from IR : no feedback at all.
    Have you ever had the same problem ?
    thank you
    Jul 12 03:03 AM | 1 Like Like |Link to Comment
  • 10 PLAYS for ASCO 2010 [View instapost]
    www.cnbc.com/id/158402...

    Morgan Joseph's 2009 Stellar Six greatly outperformed the S&P Index, most notably IMAX [IMAX 19.72 -0.58 (-2.86%) ], up 112 percent for the year.

    Many of the 2010 selections have fared particularly well within their respective industries.

    And as the economy continues on its path of recovery and the government increases program spending, Morgan Joseph analysts anticipate these six names to benefit.

    The Stellar Six List:

    - Cree [CREE 76.00 0.01 (+0.01%) ] with $100.00 price target

    - Great Lakes Dredge & Dock [GLDD 5.65 0.29 (+5.41%) ] with $7.00 price target — This dredging company plays in an industrial sector with very high barriers to entry and holds 45 percent of the U.S. market share.

    "It has a hiccup in the first quarter based on weather," Kestenbaum said. "So we see an buy opportunitity here."

    - LodgeNet Interactive [LNET 6.84 0.23 (+3.48%) ] with $8.50 price target — Despite being dependant on the hotel industry that struggled through the recession, this media services provider managed to generate $65 million in free cash flow.

    "It did well in the difficult hotel environment," Kestenbaum said. "With the free cash flow and paying down their debt, their equity will rise."

    - Mattel [MAT 23.65 0.41 (+1.76%) ] with $28.00 price target

    - Spectrum Pharmaceuticals [SPPI 5.15 0.34 (+7.07%) ] with $8.00 price target — This small-cap biotechnology firm is an "incredible story," according to Kestenbaum.

    Unlike other small industry players that focus on one drug, Spectrum has four in the pipeline: Two approved and ready to roll out and another two that he says will likely be approved early next year.

    - Volcano Corporation [VOLC 23.61 0.64 (+2.79%) ] with $26.00 price target

    courtesy of meteofinanza.com
    Apr 30 04:56 AM | 2 Likes Like |Link to Comment
  • Spectrum Pharmaceuticals: Looking Ahead at Continued Growth [View article]
    Thank you Justin for this interesting article. Have you any additional comment on Fusilev/FDA situation ?
    Apr 22 06:11 AM | 1 Like Like |Link to Comment
  • Notable earnings before Tuesday's open: ARIA  [View news story]
    estimates
    investing.businessweek...
    Mar 16 04:06 AM | Likes Like |Link to Comment
  • InvestAlert©: Ariad Pharma Q4 2009 Results -- 3.16.10 [View instapost]
    ARIAD Pharmaceuticals, Inc. at Cowen and Company Healthcare Conference Wednesday, March 10, 2010 8:00 a.m. ET
    Mar 10 11:56 AM | 1 Like Like |Link to Comment
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