Insmed Receives Approvable Letter for iPlex(TM) Tuesday September 27, 6:55 pm ET Conference Call Tomorrow at 8:00am EST
RICHMOND, Va.--(BUSINESS WIRE)--Sept. 27, 2005--Insmed Incorporated (NASDAQ-NMS: INSM - News; NASDAQ: INSM - News) announced today the receipt of an Approvable Letter from United States Food and Drug Administration (FDA) for iPlex(TM) (rhIGF-I/rhIGFBP-3) (Mecasermin rinfibate), for the treatment of children with growth failure who suffer from Severe Primary IGF-1 deficiency (Primary IGFD). Previously Insmed referred to its primary indication as Growth Hormone Insensitivity Syndrome (GHIS). Based on FDA input GHIS is now referred to as Severe Primary IGFD. iPlex is the new worldwide trade name for Insmed's proprietary combination of rhIGF-I/rhIGFBP-3 which was previously called SomatoKine.
ADVERTISEMENT The Approvable Letter Insmed received is an official notification that the FDA has completed the review of the iPlex New Drug Application (NDA) and has found the application to be sufficiently complete for full approval pending the submission of additional information primarily regarding the Chemistry, Manufacturing and Controls (CMC) section of the application. FDA is not requiring the Company to conduct additional preclinical or clinical trials. FDA has informed Insmed that they are still considering iPlex's orphan exclusivity status.
"The Company plans to rapidly respond to these questions and work with the Agency to resolve all outstanding issues. I look forward to the completion of our work with the FDA so that we may bring this product to the clinic, and provide caregivers with this important therapeutic option for their patients", added Geoffrey Allan, Ph.D., President and Chief Executive Officer of Insmed.
"Based on my experience with therapies for a variety of growth disorders, it is clear that the pediatric endocrine community will welcome this alternative therapy. Throughout the clinical development program, iPlex therapy has demonstrated a very favorable safety profile, in addition to the robust growth response," commented Kenneth Attie, M.D. Chief Medical Officer for Insmed.
Conference Call at 8:00am
Insmed management will host a conference call at 8:00am ET, September 28, 2005. To participate in the conference call, dial 800-811-8824 (domestic) or 913-981-4903 (international). The call will be webcast live through Insmed's corporate website: www.insmed.com. A telephonic replay of the call will be available for one week at 888-203-1112 (domestic) or 719-457-0820 (international) Passcode: 2242133 A web replay of the call will be available through the corporate website beginning at 10:00 a.m.
About Insmed Incorporated
Insmed is a biopharmaceutical company focused on the discovery and development of drug candidates for the treatment of metabolic diseases and endocrine disorders with unmet medical needs. For more information, please visit www.insmed.com.
Statements included within this press release, which are not historical in nature, may constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include, but are not limited to, statements regarding planned clinical trial design, our regulatory and business strategies, plans and objectives of management and growth opportunities for existing or proposed products. Such forward-looking statements are subject to numerous risks and uncertainties, including risks that product candidates may fail in the clinic or may not be successfully marketed or manufactured, the company may lack financial resources to complete development of product candidates, the FDA may interpret the results of our studies differently than we have, competing products may be more successful, demand for new pharmaceutical products may decrease, the biopharmaceutical industry may experience negative market trends and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission. As a result of these and other risks and uncertainties, actual results may differ materially from those described in this press release. For further information with respect to factors that could cause actual results to differ from expectations, reference is made to reports filed by the Company with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended. The forward-looking statements made in this release are made only as of the date hereof and Insmed disclaims any intention or responsibility for updating predictions or financial guidance contained in this release.
Posts: 1421 | From: USA | Registered: Dec 2004
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Up tp $1.50 or 37% after hours by 8 eastern time.....the news is spreading.....
Posts: 11304 | From: Fort Worth, Texas | Registered: Mar 2005
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moving up strong on Dec. 12th FDA approval anticipation
-------------------- Choosing individual stocks without any idea of what you're looking for (or without reliable information) is like running through a dynamite factory with a burning match. You may live, but your still an idiot. Posts: 5320 | From: Syracuse, NY | Registered: Apr 2005
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BRISBANE, Calif.--(BUSINESS WIRE)--Dec. 6, 2005--Tercica, Inc. (Nasdaq:TRCA - News) today announced the filing, in the United States District Court for the Northern District of California, of a complaint against Insmed Incorporated (Nasdaq:INSM - News) for false and misleading promotional statements and unfair business practices made in anticipation of Insmed receiving U.S. Food and Drug Administration (FDA) approval for a product to compete with Increlex(TM) (Tercica's FDA-approved product for the long-term treatment of severe primary IGF-1 deficiency). The suit asserts that Insmed has engaged in numerous unlawful, unfair, deceptive, false, misleading and fraudulent acts, practices, and promotions, including the public dissemination of false statements that Increlex(TM) is unsafe; false, misleading and deceptive statements that iPlex(TM) (Insmed's product under FDA review for the treatment of the same condition) is safer than Increlex(TM); and that tests, trials or studies show that iPlex(TM) is safer than Increlex(TM). The complaint alleges that Insmed has violated and continues to violate Sections 17500 and 17200, et seq., of the California Business and Professions Code and the Federal Lanham Act. Through the litigation, Tercica is requesting the Court to stop Insmed from making these false and/or misleading statements and to order Insmed to publicly correct its prior representations and misleading comparisons. Tercica is also seeking disgorgement of any profits by Insmed earned as a result of its false, unlawful, unfair, and fraudulent business practices. About Tercica Tercica, Inc. is a biopharmaceutical company focused on the development and commercialization of products to improve endocrine health. The company's first product, Increlex(TM), or recombinant human insulin-like growth factor-1 (rhIGF-1), is approved by the FDA for the treatment of severe Primary IGFD. For further information on Tercica, please visit www.tercica.com
-------------------- Choosing individual stocks without any idea of what you're looking for (or without reliable information) is like running through a dynamite factory with a burning match. You may live, but your still an idiot. Posts: 5320 | From: Syracuse, NY | Registered: Apr 2005
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i agree. something good has happened. Tercica is nervous. Pick up more on the dip today. I am sure there will be seller today.
Posts: 1421 | From: USA | Registered: Dec 2004
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I have a hunch that an approval PR comes later today.
-------------------- Choosing individual stocks without any idea of what you're looking for (or without reliable information) is like running through a dynamite factory with a burning match. You may live, but your still an idiot. Posts: 5320 | From: Syracuse, NY | Registered: Apr 2005
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due for approval/denial tomorrow, should be interesting both for longs and daytraders :-)
-------------------- Choosing individual stocks without any idea of what you're looking for (or without reliable information) is like running through a dynamite factory with a burning match. You may live, but your still an idiot. Posts: 5320 | From: Syracuse, NY | Registered: Apr 2005
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haha holy smokes news came about 4.8 million volume so far, I hope all brought in today and didnt miss out, not to mention watch this one for the markets tomorrow
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Holding 5,000 shares at 1.31 :-) I would think 3-4.00 is a good estimate, could spike above 5.00 intraday if things really heat up
-------------------- Choosing individual stocks without any idea of what you're looking for (or without reliable information) is like running through a dynamite factory with a burning match. You may live, but your still an idiot. Posts: 5320 | From: Syracuse, NY | Registered: Apr 2005
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Not sure yet Cruz...There are so many cheap Pharmas with great potential, it's really tuff to hit him right.
Posts: 10729 | From: oregon | Registered: Feb 2005
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Lets see, bought 2500 shares at 1.92 earlier this week, sold today at 2.38..lets do the math..oops my mistake i made over a grand..lol..let me correct myself I made 1150 to be exact..geez, sorry Dust...Not bad ya think?
Need to make allowances for wrinkled old f-rts like Dust...
Then, considering he makes allowance for us frisky dudes, and offers good advise, 'tain't no difficult procedure....
Posts: 11304 | From: Fort Worth, Texas | Registered: Mar 2005
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