Loading ...
Sorry, an error occurred while loading the content.

STEMGEN/Coulter PRs

Expand Messages
  • Janice and Ben Haines
    Greetings, Here are 3 press releases, another one on STEMGEN and a couple from Coulter showing financials and a stock offering to gear up for Bexxar. Regards,
    Message 1 of 1 , Jul 31, 1998
    • 0 Attachment
      Greetings,
      Here are 3 press releases, another one on STEMGEN and a couple from Coulter
      showing financials and a stock offering to gear up for Bexxar.

      Regards,
      -Ben(KIA)
      Note: ANYTHING of personal nature (i.e. requests for information) MUST use
      'X-no-archive: yes' This is clearly documented in the INFO you receive
      when you subscribed. If you lost it, in a message send:

      info nhl-low

      to: nhl-low@...


      Thank you,
      -Ben(KIA)..."Keep the focus"...."Expect to win"

      ---8<----8<---

      Thursday July 30, 10:45 pm Eastern Time

      U.S. FDA panel backs Amgen's Stemgen

      BETHESDA, Md., July 30 (Reuters) - Amgen's latest drug Stemgen (ancestim)
      won the backing of federal advisers on Thursday, paving the way to U.S.
      Food and Drug Administration (FDA) approval.

      The panel agreed that the drug produced enough good cells in patients to
      ensure a transplant would work, but said Amgen did not prove its claim that
      Stemgen reduced the number of procedures needed to get the cells.

      Some panelists were worried about safety.

      ``You haven't proven there's enough benefit to outweigh the risks of
      anaphylaxis,'' said panelist Abby Meyers of the National Organization for
      Rare Disorders.

      But other panelists recommended approval anyway.

      The FDA generally follows its panels' advice.

      The drug, also called stem cell factor, helps mobilize young blood cells,
      normally found in the marrow, into the bloodstream so they can be more
      easily harvested.

      They are kept outside the body while the patient undergoes high-dose
      chemotherapy.

      The cells are then reinfused to give the patient a headstart on rebuilding
      immunity. Only about 12,000 of these procedures are done each year, usually
      in very sick patients.

      Two growth factors, Amgen's Neupogen (filgrastim) and Immunex's Leukine
      (GM-CSF), are FDA approved for helping mobilize these early blood cells.
      Amgen tested Stemgen in combination with Neupogen, with the goal of
      increasing the number of cells available for harvest and improving chances
      the re-implanted cells will survive.

      In three studies in breast and bone cancer and lymphoma, the combination
      produced better results than Neupogen alone, said Amgen. It reduced the
      number of procedures (called aphereses) necessary to harvest cells and
      increased the number of cells available in a majority of patients.

      FDA medical reviewer Richard Steffen said the agency saw no difference.
      ``We feel that adding SCF to G-CSF has a small but negligible effect on
      reducing the number of aphereses to reach the target,'' he said.

      The agency had safety concerns, saying 33 of 654 patients studied overall
      had ``anaphylactic'' reactions to Stemgen, with 76% of those reactions
      being severe.

      Amgen said the reactions were not caused by the same biological mechanism
      as anaphylaxis, and said symptoms could be minimized with antihistamine and
      other drug treatment.

      About 81 percent of patients had reactions at the injection site and 15
      percent had mild to moderate allergic reactions including rashes and
      itching elsewhere on their bodies.

      ---8<----8<---

      Friday July 31, 7:59 am Eastern Time

      Coulter 2.4 mln shares are priced at $25

      PALO ALTO, Calif., July 31 (Reuters) - Coulter Pharmaceutical Inc. said
      Friday its public offering of 2.4 million shares was priced at $25 a share.

      All of the shares were sold by the company, Coulter said in a statement.
      The offering was managed by the investment firms BT Alex. Brown Inc.,
      Hambrecht & Quist LLC, Pacific Growth Equities Inc., and Piper Jaffray
      Inc., the company said.

      Coulter had about 13.4 million shares outstanding at the end of the second
      quarter.

      The company anticipates that proceeds of the offering will be used to
      support the potential commercialization of Bexxar, including costs
      associated with establishing sales and marketing capabilities and
      pre-launch inventory in anticipation of potential product launch, as well
      as to support clinical and manufacturing development costs.

      Bexxar is in Phase III clinical trials for the treatment of non-Hodgkin's
      lymphoma, Coulter said.

      The balance of the net proceeds of the offering is expected to be used
      primarily in the company's other research and development programs and for
      general corporate purposes.

      ---8<----8<---

      Friday July 31, 7:35 am Eastern Time

      Company Press Release

      Coulter Pharmaceutical Reports Second Quarter Results

      PALO ALTO, Calif.--(BW HealthWire)--July 31, 1998--Coulter Pharmaceutical
      Inc. (NASDAQ:CLTR - news) today reported a net loss of $8,348,000, or $0.62
      per share, for its second quarter ended June 30, 1998, compared to a net
      loss of $4,994,000, or $0.50 per share, for the quarter ended June 30, 1997.

      The company reported a net loss of $18,613,000, or $1.39 per share, for the
      six months ended June 30, 1998. For the same period in 1997, the company
      reported a net loss of $8,800,000, or $1.05 per share.

      The increase in net loss for both the second quarter and year-to-date 1998
      periods was primarily due to an increase in operating expenses to reflect
      the company's ongoing support of significant clinical and commercialization
      development activities for the potential launch of Bexxar(TM) (iodine I 131
      tositumomab), its lead investigational cancer therapy for the treatment of
      non-Hodgkin's lymphoma. Cash, cash equivalents and short-term investments
      were approximately $56 million at June 30, 1998.

      Coulter Pharmaceutical Inc. is engaged in the development of novel drugs
      and therapies for the treatment of people with cancer. The company is
      developing a family of cancer therapeutics based upon two drug discovery
      programs: therapeutic antibodies and targeted oncologics.

      The company's most advanced investigational product candidate, Bexxar(TM)
      (iodine I 131 tositumomab), consists of a monoclonal antibody conjugated
      with a radioisotope. The company is gathering data from a Phase III
      investigational trial for the treatment of non-Hodgkin's lymphoma and
      intends to file a Biologic License Application for Bexxar by the end of 1998.

      The company currently is developing a tumor-activated peptide pro-drug
      version of doxorubicin to treat certain solid tumor cancers.

      Except for the historical information contained herein, the matters
      discussed in this news release are forward-looking statements that involve
      risks and uncertainties, including uncertainties related to product
      development, uncertainties related to the need for regulatory and other
      government approvals, dependence on proprietary technology, uncertainty of
      market acceptance of Bexxar(TM) or the company's other product candidates
      and other risks detailed from time to time in the company's filings with
      the Securities and Exchange Commission (SEC). In particular, see ``Risk
      Factors'' in the company's Registration Statement on Form S-3, as amended,
      filed with the SEC on July 10, 1998.
    Your message has been successfully submitted and would be delivered to recipients shortly.