Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : Sepracor-Looks very promising -- Ignore unavailable to you. Want to Upgrade?

To: Icebrg who wrote (7334)	1/26/2004 11:05:11 AM
From: bio_kruncher	Read Replies (1) \| Respond to of 10280

Are "marketing" trial expenses accounted for as R&D? Pharma/biotech companies spend considerable amounts of money funding clinical trials which are really just intended for marketing purposes(i.e. not to fulfill any regulatory requirements for approval or conditions set at approval). I realize there are some grey areas when pursuing label expansion. In light of recent discussions about total SEPR R&D spending, I have been wondering if anybody knows if these marketing type trials are expensed as R&D or Sales&Marketing?

To: Icebrg who wrote (7334)	1/26/2004 11:46:29 AM
From: Biomaven	Read Replies (1) \| Respond to of 10280

Details of the trial (free full text) at January issue of: sciencedirect.com Abstract This was a prospective, open-label, nonrandomized pilot study to evaluate efficacy and tolerability of levalbuterol (LEV) in acute asthma. Asthmatics (forced expiratory volume in 1 second [FEV1], 20?55% predicted) were sequentially enrolled into cohorts of 12 to 14 and received 0.63, 1.25, 2.5, 3.75, or 5.0 mg LEV or 2.5 or 5.0 mg racemic albuterol (RAC) every 20 minutes × 3. After the first dose, FEV1 changes were 56% (0.6 L) for 1.25 mg LEV and 6% (0.07 L) and 14% (0.21 L) for 2.5 and 5 mg RAC respectively. After three doses, FEV1 changes were 74% (0.9 L), 39% (0.5 L), and 37% (0.6 L) for 1.25 mg, LEV 2.5 mg, RAC and 0.63 mg LEV respectively. LEV doses greater than 1.25 mg did not further improve bronchodilation. Baseline plasma (S)-albuterol levels were negatively correlated with baseline FEV1 (R = - 0.3, P = .004) and percent change in FEV1 (R = -0.3, P = .006). LEV at a dose of 1.25 mg produced effective bronchodilation that was greater than both RAC doses. The negative correlation between (S)-albuterol levels and FEV1 could suggest a deleterious effect of (S)-albuterol. Larger comparative studies are warranted. From the text: Among all patients and in the subset with baseline FEV1 35% of predicted, 1.25 mg levalbuterol produced a greater degree of bronchodilation after the first dose than both racemic albuterol doses and 0.63 mg levalbuterol. In the subset with more respiratory compromise, the median percent change in FEV1 was more than 10-fold greater than both racemic albuterol doses (75%, compared with 7.5% and 3.2% for 2.5 and 5.0 mg racemic albuterol, respectively). They should really do a proper trial and nail down this improvement. If they can conclusively demonstrate this, then they should get close to 100% of the hospital market. Peter

To: Icebrg who wrote (7334)	2/3/2004 7:57:46 AM
From: Icebrg	Read Replies (1) \| Respond to of 10280

King Pharmaceuticals' Investigational New Drug Application for an Extended Release Formulation of Sonata(R) Now Active Tuesday February 3, 7:48 am ET Phase II Clinical Trial Program Planned to Begin Before the End of April 2004 BRISTOL, Tenn., Feb. 3 /PRNewswire-FirstCall/ -- King Pharmaceuticals, Inc. (NYSE: KG - News) announced today that the Company's Investigational New Drug ("IND") Application for an extended release formulation of Sonata® (zaleplon), a nonbenzodiazepine treatment for insomnia, has been allowed by the U.S. Food and Drug Administration ("FDA"). The Phase II clinical trial program, designed to select the most effective extended release formulation of Sonata® utilizing the commercially proven drug delivery technology of Elan Corporation plc, is anticipated to begin before the end of April 2004. Jefferson J. Gregory, Chairman and Chief Executive Officer of King, stated, "This is an important step forward for King Pharmaceuticals. The successful development of an extended release formulation of Sonata®, along with the new promotional campaign planned for our immediate release formulation of this product, should well-position the Sonata® brand within the growing insomnia market." Mr. Gregory explained, "The immediate release formulation of Sonata® is currently a very effective treatment for insomnia, particularly in those patients who experience difficulty with sleep onset. We believe that the extended release formulation of Sonata®, once approved, will enable us to significantly expand upon our opportunities within the insomnia market. With U.S. patent coverage that extends to 2018, the extended release formulation should position Sonata® as a long-term cornerstone product for our Company. Moreover, this development program should provide us with the opportunity to procure additional patents potentially covering, among other things, unique biopharmaceutical characteristics and methods-of-use related to the extended release formulation of Sonata®." Mr. Gregory added, "The FDA's allowance of this IND and the planned commencement of the Sonata® extended release Phase II clinical trial program are evidence of our ability to work productively with Elan for the purpose of achieving our shared goals for this project. We are very eager to grow our participation in this large market and believe we currently offer one of the best products for patients who suffer from insomnia." The prescription insomnia market equaled approximately $2.0 billion in the U.S. during 2003 and is expected to grow to over $3.5 billion by 2008. Wallace B. Mendelson, M.D., Professor of Psychiatry and Clinical Pharmacology and former Director of the Sleep Research Laboratory at the University of Chicago, commented, "This is a very exciting advance for future treatment options for patients that suffer from insomnia. A product that maintains the quick onset of action and safety of the immediate release formulation of Sonata®, while extending the efficacy of the drug to a broader range of patients with insomnia, should be very well received by the medical community." Michael K. Jolly, Pharm. D., Executive Vice President, Research and Development, of King, said, "We are very pleased with the allowance of the IND and excited to begin the Sonata® Phase II clinical trial program. The goal of the Phase II trial is to determine which new formulation is the most efficacious for the purpose of increasing total sleep time and reducing any potential for premature awakenings, while continuing to build upon the quick onset profile currently available in the immediate release formulation of Sonata®." Dr. Jolly continued, "In connection with our acquisition of Elan's primary care business last year, which included Sonata®, King and Elan entered into an agreement whereby Elan agreed to work with our Company to continue Elan's ongoing development of new formulations of Sonata®, which included an extended release formulation. After evaluating several drug delivery technologies, we have selected Elan's Spheroidal Oral Drug Absorption System ("SODAS") technology as the most promising for the purpose of developing a safe and effective extended release formulation of Sonata®. The SODAS technology, which incorporates Elan's proprietary multiparticulate pulsatile system, will utilize uniform spherical beads containing zaleplon, the active ingredient in Sonata®, plus excipients coated with product-specific modified-release polymers." Dr. Jolly further emphasized, "This versatile delivery technology applied to zaleplon should provide a unique biopharmaceutical profile leading to a wide variety of additional potential patents covering the extended release formulation of Sonata®."