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Biotech / Medical : Biotech Lock-Up Expiration Hell Portfolio -- Ignore unavailable to you. Want to Upgrade?

To: Biomaven who wrote (714)	10/1/2002 10:34:34 AM
From: tuck	Read Replies (1) \| Respond to of 1005

>>SOUTH SAN FRANCISCO, Calif., Oct. 1 /PRNewswire-FirstCall/ -- Pain Therapeutics, Inc. (Nasdaq: PTIE - News), a medical research company, today announced that it has completed two safety studies using multi-doses of OxyTrex(TM) and MorViva(TM), its two lead candidates. The Company believes OxyTrex(TM) and MorViva(TM) could represent a new generation of safer, more efficacious narcotic painkillers. "The completion of these two clinical studies marks an important milestone for Pain Therapeutics," said Remi Barbier, president and chief executive officer. "We believe the results of these two studies allow us to continue executing our clinical plan on-time and on-budget. Our next step is to announce the initiation of a large multi-dose safety study with OxyTrex(TM) in the fourth quarter of 2002, followed by the initiation of a pivotal efficacy study in the second quarter of 2003." The Company's two clinical studies were randomized, double-blind and designed to assess the occurrence of adverse safety events in patients after multi-dose OxyTrex(TM) or MorViva(TM) treatment was initiated, while tracking patients' analgesic response. As expected, most patients experienced mild to moderate clinical events commonly associated with oxycodone or morphine use, while reporting excellent pain relief. OxyTrex(TM) Study Forty-nine (49) patients with chronic pain due to severe osteoarthritis were recruited to participate in a clinical study comparing the safety and efficacy of multiple doses of OxyTrex(TM) to oxycodone. Prior to entering the study, all patients stopped taking all pain medications for several days. Immediately following this washout period, 49 patients were assigned to five different treatment groups. Each group received OxyTrex(TM) or immediate release oxycodone either two or four times a day for fourteen (14) days. Safety, pharmacokinetics and efficacy parameters were then assessed at various times during the two week treatment period. The preliminary results of this safety study indicate that no serious health consequences resulted from the use of various dose levels of OxyTrex(TM). MorViva(TM) Study One hundred sixty (160) patients with post-operative pain participated in a clinical study comparing the safety and efficacy of a continuous intravenous infusion of MorViva(TM) to morphine sulfate. Immediately following major surgery, the study design allowed all patients to receive discretionary amounts of intravenous fentanyl. Several hours after reaching a state of comfort using fentanyl alone, patients were then randomly assigned to four different treatment groups. Each group received a continuous infusion of MorViva(TM) or morphine sulfate over a 48-hour treatment period. In addition to study medication, all patients had concurrent access to intravenous morphine via a patient controlled analgesia (PCA) pump. Safety, pharmacokinetics and efficacy parameters were then assessed at various times during the treatment period. The preliminary results of this safety study indicate that no serious health consequences resulted from the use of three different dose levels of MorViva(TM). "The assessment of a novel drug's safety plays a key role in our drug development programs," said Nadav Friedmann, PhD, MD, Pain Therapeutics' chief operating officer. "Based on the results of these two safety studies, combined with our animal data and previously announced clinical data, we continue to believe OxyTrex(TM) and MorViva(TM) could represent important new treatment paradigms for patients with pain." As previously announced, Pain Therapeutics has approximately $58 million of cash and cash equivalents as of June 30, 2002 and expects its net cash burn for 2002 to be under $20 million. About Opioid Drugs Opioid drugs (sometimes called 'narcotic painkillers') are derived from the opium poppy plant. These drugs are widely used throughout the world to treat severe forms of clinical pain. In the United States, for example, opioid drugs represent a $3 billion market and account for over five percent of all drug prescription sales. Despite widespread use, opioid drugs have debilitating side-effects that limit their usefulness at all doses. In addition, chronic use may lead to tolerance, dependence, abuse, or, more rarely, addiction. As a result, some patients prefer to suffer through pain rather than endure the ill effects of opioid drugs. The under-treatment of pain is a serious and growing problem in the U.S. For example, according to the National Institutes of Health, over 40 million Americans are unable to find relief from their pain.<< snip Stock not moving at all. Results expected? Or is the one of those times when maybe we get a delayed reaction to good news, and could actually trade this? Cheers, Tuck

To: Biomaven who wrote (714)	7/22/2003 3:16:13 PM
From: tuck	Read Replies (1) \| Respond to of 1005

Peter, I remember you saying you were of two minds about PTIE on the Valuation thread a while back. Feel better about POZN? This deal is interesting because they talk of expanding into areas beyond migraine . . . >>CHAPEL HILL, N.C. & ROSKILDE, Denmark--(BUSINESS WIRE)--July 22, 2003--POZEN Inc. (NASDAQ: POZN - News), and Nycomed announced today that they signed an exclusive option agreement, under which POZEN may acquire from Nycomed a license to certain rights related to lornoxicam, a non-steroidal anti-inflammatory drug (NSAID). POZEN paid an upfront fee of $50,000 to Nycomed upon signing the option agreement. During the term of the option agreement, POZEN will explore the development of novel product candidates containing lornoxicam alone or in combination with other active ingredients for pain or other indications. Depending upon the achievement of certain milestones, up to an additional $450,000 is payable under the option agreement. In the event that POZEN elects to exercise the option, it will pay Nycomed additional fees, including certain license fees, regulatory approval milestones and royalties on sales of any products developed using the licensed rights. Additionally, POZEN will fund product development and retain exclusive commercialization rights in the U.S. and Canada and semi-exclusive rights in select European countries. Nycomed will have a right of first negotiation for commercialization rights in the Nordic countries for any future products developed by POZEN combining lornoxicam with another active ingredient. Nycomed's lornoxicam is approved and marketed in most European countries, and in several countries in the Middle East, South America and Asia, including Japan and China (brandnames Xefo, Xafon, Acabel, Lorcam). "Lornoxicam is a potent analgesic pain reliever, which makes it an attractive candidate for combination therapy," said John R. Plachetka, Pharm.D., chairman, president, and chief executive officer of POZEN. "This option agreement serves as an important first step for POZEN to expand into new therapeutic areas." "Nycomed has continuously developed new formulations of lornoxicam, most recently a Quick Release formulation, which is under approval in several countries. The option agreement with POZEN is an endorsement of the continuing value of lornoxicam in pain treatment. Nycomed is looking forward to follow POZEN's work with the compound in order to further exploit lornoxicam's potential," said Hakan Bjorklund, chief executive officer of Nycomed. << snip Cheers, Tuck