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                 April 3, 2001                                     No. 1229

*     The European Medicines Evaluation Agency's Committee on Proprietary Medicinal Products (CPMP) recommended approval of Skyepharma plc's (London, U.K.) Depocyte (liposomal cytarabine) for the treatment of lymphomatous meningitis. The sustaine d-release drug, formulated with the company's Depofoam drug delivery technology, is administered intrathecally every two weeks, compared to the twice-weekly administration of standard intrathecal chemotherapy. Skyepharma is seeking a European marketing partner for the drug, which is already approved in the U.S. and Canada. Contact: Michael Ashton, CEO. Ph: 44 2074 911777. *     Pain Therapeutics Inc. (PTI) (South San Francisco, CA) has added a fifth drug candidate, PTI-801, to its pipeline of pain management drugs. PTI-801 consists of low-dose naltrexone and immediate-release oxycodone, an opioid used to treat patients with bone cancer, osteoarthritis, lower back pain and other forms of moderate to severe pain. PTI has submitted an investigational new drug application for PTI-801 and plans to test the treatment in patients with chronic pain due to cancer or osteoarthritis. Contact: Christi Waarich. Ph: (650) 825-3324.

   *     Titan Pharmaceuticals Inc. (South San Francisco, CA) initiated a controlled, multicenter, 58-patient, Phase II study of gallium maltolate in metastatic prostate cancer and refractory multiple myeloma. The agent is an oral form of the semimetallic element gallium that inhibits ribonucleotide reductase, an enzyme involved in tumor growth. It had a good safety and pharmacokinetic profile in Phase I trials. Intravenous gallium nitrate is indicated for treating hypercalcemia of malignancy. Contact: Louis Bucalo, pres. & CEO. Ph: (650) 244-4990.     *     Novartis Generics (Basel, Switzerland) has entered the British generic drug market with the acquisition of Lagap Pharmaceuticals Ltd. (Bordon, Hampshire, U.K.), which markets generic drugs in the U.K. Lagap had Euro43 million in sales last year and employs about 70 people. Novartis bought the company from Adcock Ingram Ltd. (Bryanston, South Africa); financial terms of the deal were not disclosed. Novartis Generics has made five acquisitions over the last 12 months. Contact: Felix Raber, Novartis. Ph: 41 61 324 2200.

*     Pharmagenesis Inc. (Palo Alto, CA) is conducting preclinical studies of PG490-88, an apoptosis-inducing anticancer compound, and hopes to file an investigational new drug (IND) application with the FDA by the end of the year. Research to date has found the compound, alone and in combination with conventional chemotherapy drugs, to be effective in animal cancer models. A similar compound Pharmagenesis is developing, PG2-2000, has just completed clinical studies in China. The firm plans to file an IND for that compound by early 2002. Contact: Julie Johnson. Ph: (310) 785-0515.     *     Noven Pharmaceuticals Inc. (Miami, FL) will delay submitting a new drug application for its methylphenidate patch for about six to 12 months. It had expected to submit the NDA to the FDA in the second quarter of this year. One aspect of a recently completed Phase III study was unsuccessful, although the company is not disclosing which aspect, and will require Noven to conduct another study. The product is under development for treating attention deficit hyperactivity disorder. In other company news, Novogyne, Noven's joint venture with Novartis Pharmaceuticals Corp. (East Hanover, NJ), has acquired the U.S. rights to Noven's Combipatch (estrogen/progestin) for $25 million upfront and $40 million in installments. Contact: Joseph Jones, Noven. Ph: (305) 253-1916.

    *     Medimmune Inc. (Gaithersburg, MD) has begun dosing psoriasis patients in its first North American Phase II trial of Medi-507. The study is being conducted at 25 U.S. and Canadian sites with about 100 patients with plaque psoriasis affecting at least 10% of the body.   Medi-507 is a humanized monoclonal antibody that binds to the CD2 receptor and suppresses the function of T cells and natural killer cells. The firm is also recruiting patients for a European Phase II study and plans to begin two more Phase II trials later this year. Contact: Lori Weiman, dir. inv. rel. Ph: (301) 527-4321. *     Researchers at Cypress Biosciences Inc. (San Diego, CA) and Georgetown University Medical School (Washington, D.C.) are collaborating to develop therapies for fibromyalgia syndrome, a rheumatological disorder characterized by pain, stiffness, fatigue, insomnia and headache. Cypress also intends to gain access to other candidates and products for treating fibromyalgia through additional collaborations. Contact: Jay Kranzler, CEO, Cypress. Ph: (858) 452-2323.

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* The European Medicines Evaluation Agency's Committee on Proprietary Medicinal Products (CPMP) recommended approval of Skyepharma plc's (London, U.K.) Depocyte (liposomal cytarabine) for the treatment of lymphomatous meningitis. The sustaine d-release drug, formulated with the company's Depofoam drug delivery technology, is administered intrathecally every two weeks, compared to the twice-weekly administration of standard intrathecal chemotherapy. Skyepharma is seeking a European marketing partner for the drug, which is already approved in the U.S. and Canada. Contact: Michael Ashton, CEO. Ph: 44 2074 911777.	* Pain Therapeutics Inc. (PTI) (South San Francisco, CA) has added a fifth drug candidate, PTI-801, to its pipeline of pain management drugs. PTI-801 consists of low-dose naltrexone and immediate-release oxycodone, an opioid used to treat patients with bone cancer, osteoarthritis, lower back pain and other forms of moderate to severe pain. PTI has submitted an investigational new drug application for PTI-801 and plans to test the treatment in patients with chronic pain due to cancer or osteoarthritis. Contact: Christi Waarich. Ph: (650) 825-3324.
* Titan Pharmaceuticals Inc. (South San Francisco, CA) initiated a controlled, multicenter, 58-patient, Phase II study of gallium maltolate in metastatic prostate cancer and refractory multiple myeloma. The agent is an oral form of the semimetallic element gallium that inhibits ribonucleotide reductase, an enzyme involved in tumor growth. It had a good safety and pharmacokinetic profile in Phase I trials. Intravenous gallium nitrate is indicated for treating hypercalcemia of malignancy. Contact: Louis Bucalo, pres. & CEO. Ph: (650) 244-4990.	* Novartis Generics (Basel, Switzerland) has entered the British generic drug market with the acquisition of Lagap Pharmaceuticals Ltd. (Bordon, Hampshire, U.K.), which markets generic drugs in the U.K. Lagap had Euro43 million in sales last year and employs about 70 people. Novartis bought the company from Adcock Ingram Ltd. (Bryanston, South Africa); financial terms of the deal were not disclosed. Novartis Generics has made five acquisitions over the last 12 months. Contact: Felix Raber, Novartis. Ph: 41 61 324 2200.
* Pharmagenesis Inc. (Palo Alto, CA) is conducting preclinical studies of PG490-88, an apoptosis-inducing anticancer compound, and hopes to file an investigational new drug (IND) application with the FDA by the end of the year. Research to date has found the compound, alone and in combination with conventional chemotherapy drugs, to be effective in animal cancer models. A similar compound Pharmagenesis is developing, PG2-2000, has just completed clinical studies in China. The firm plans to file an IND for that compound by early 2002. Contact: Julie Johnson. Ph: (310) 785-0515.	* Noven Pharmaceuticals Inc. (Miami, FL) will delay submitting a new drug application for its methylphenidate patch for about six to 12 months. It had expected to submit the NDA to the FDA in the second quarter of this year. One aspect of a recently completed Phase III study was unsuccessful, although the company is not disclosing which aspect, and will require Noven to conduct another study. The product is under development for treating attention deficit hyperactivity disorder. In other company news, Novogyne, Noven's joint venture with Novartis Pharmaceuticals Corp. (East Hanover, NJ), has acquired the U.S. rights to Noven's Combipatch (estrogen/progestin) for $25 million upfront and $40 million in installments. Contact: Joseph Jones, Noven. Ph: (305) 253-1916.
* Medimmune Inc. (Gaithersburg, MD) has begun dosing psoriasis patients in its first North American Phase II trial of Medi-507. The study is being conducted at 25 U.S. and Canadian sites with about 100 patients with plaque psoriasis affecting at least 10% of the body. Medi-507 is a humanized monoclonal antibody that binds to the CD2 receptor and suppresses the function of T cells and natural killer cells. The firm is also recruiting patients for a European Phase II study and plans to begin two more Phase II trials later this year. Contact: Lori Weiman, dir. inv. rel. Ph: (301) 527-4321.	* Researchers at Cypress Biosciences Inc. (San Diego, CA) and Georgetown University Medical School (Washington, D.C.) are collaborating to develop therapies for fibromyalgia syndrome, a rheumatological disorder characterized by pain, stiffness, fatigue, insomnia and headache. Cypress also intends to gain access to other candidates and products for treating fibromyalgia through additional collaborations. Contact: Jay Kranzler, CEO, Cypress. Ph: (858) 452-2323.