Key Developments: BioMimetic Therapeutics, Inc. (BMTI.O)
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9 Feb 2010
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$11.86
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Latest Key Developments
BioMimetic Therapeutics, Inc. Strengthens Patent Portfolio
BioMimetic Therapeutics, Inc. announced the European Patent Office (EPO) intends to grant patent application No. 05803356 titled 'Platelet-Derived Growth Factor Compositions and Methods of Use Thereof'. The allowed claims cover compositions of platelet derived growth factor (PDGF) combined with matrix materials having defined characteristics, which cover the Company`s novel recombinant protein-device combination product candidates, including AugmentBone Graft and Augment Injectable Bone Graft, as well as GEMESIS, which the Company previously sold to Luitpold Pharmaceuticals, Inc. The new patent, which expires in 2025, will provide protection against the marketing of similar or generic versions of Augment, Augment Injectable, and GEMESIS in Europe. This notice from the EPO enhances the Company`s existing, strong patent portfolio, which includes a similar patent in the United States effective through 2025.
BioMimetic Therapeutics, Inc. Reaffirms FY 2009 Earnings Outlook
BioMimetic Therapeutics, Inc. announced that for fiscal 2009 it expects loss before income taxes to be in the range of $31.0 to $38.0 million. According to Reuters Estimates, analysts on an average are expecting the Company to report operating loss of $35.6 million for the same period.
BioMimetic Therapeutics, Inc. Receives First Orthopedic Marketing Approval For Augment Bone Graft
BioMimetic Therapeutics, Inc. announced that it has received approval from Health Canada to begin the marketing of its lead orthopedic product, Augment Bone Graft, as an alternative to the use of autograft in midfoot, hindfoot and ankle fusion indications in Canada.
BioMimetic Therapeutics, Inc. Announces Positive Data From Augment Bone Graft North American Pivotal Trial
BioMimetic Therapeutics, Inc. announced positive top-line results from its North American pivotal (Phase III) randomized controlled trial comparing its fully synthetic, off-the-shelf bone growth factor product, Augment Bone Graft (Augment), to autograft for use in hindfoot and ankle fusion surgery. The primary study goal was to establish non-inferiority of Augment compared to autograft. Autograft is the historical standard of care but has the limitation that it must be obtained and transplanted from another bone in the patient's body, often requiring a second surgical procedure. These positive top-line results indicate that, with the use of Augment, patients can expect a comparable treatment outcome while being spared the pain and potential morbidity associated with traditional autograft bone harvesting and transplantation. For the primary endpoint, the percent of subjects achieving fusion as defined by 50% or greater bone bridging on CT scans at 24 weeks, patients treated with Augment experienced a similar fusion rate (61.2%) compared with those receiving autograft (62.0%), which met non-inferiority (p=0.037; n=397 patients). Since many patients had multiple joints treated, analysis was also performed on a per joint basis. Non-inferiority was also established on a per joint basis, with 66.5% of joints treated with Augment fused on CT scans compared to 62.6% of joints treated with autograft (p=<0.001; n=597 joints). In the key clinical
BioMimetic Therapeutics, Inc. Reaffirms FY 2009 Earnings Outlook
BioMimetic Therapeutics, Inc. announced that for fiscal 2009 it expects loss before income taxes to be in the range of $31.0 to $38.0 million.
BioMimetic Therapeutics, Inc. Announces Completion of Rights Offering and Sale of Shares in Standby Purchase
BioMimetic Therapeutics, Inc. announced that it has closed its previously announced rights offering. The Company received valid subscriptions for all of shares purchasable in the rights offering, including shares subscribed for by certain of the Company`s stockholders in the exercise of their over-subscription rights, at a subscription price of $8.50 per share. The Company issued the shares purchased in the rights offering to the purchasers on June 25, 2009. After the closing of the rights offering, the Company sold 343,406 shares of its common stock to Novo A/S, a stockholder of the Company, in a private placement. The purchase price of such shares was $8.50 per share, the same purchase price of the shares sold in the rights offering. The Company received total gross proceeds of approximately $17.0 million from the rights offering and the transaction with Novo A/S. The Company intends to use the proceeds, after payment of fees and expenses incurred in connection therewith, for general corporate purposes, including to fund additional product development and potential commercialization activities. Subscription rights that were not exercised by June 22, 2009 have expired.
BioMimetic Therapeutics, Inc. Announces Preliminary Results of Rights Offering
BioMimetic Therapeutics, Inc. announced that on June 22, 2009, the offering period of its previously announced rights offering expired. In connection with the rights offering, the Company previously offered to its stockholders as of April 21, 2009, non-transferable rights to purchase 2,000,000 shares of its common stock for a purchase price of $8.50 per share. The preliminary results indicate that the offering has been over-subscribed and, accordingly, the Company will issue a total of 2,000,000 shares to stockholders that exercised their basic subscription privileges and their over-subscription privileges. As the number of over-subscription requests exceeds the number of shares available for sale in the rights offering, the Company will allocate the shares of common stock that are available for sale pursuant to over-subscription requests on a pro rata basis. Novo A/S, a stockholder of the Company, had committed to participate in the rights offering as a standby purchaser; however, due to the over-subscription by the Company`s other stockholders, Novo A/S will participate only to the extent of its pro rata interest. . The Company will receive gross proceeds of approximately $17.0 million in the rights offering. The Company intends to use the proceeds to fund additional product development and potential commercialization activities. Subscription rights that were not exercised by June 22, 2009 have expired.
BioMimetic Therapeutics, Inc. Submits First Two PMA Modules To FDA
BioMimetic Therapeutics, Inc. announced that it has submitted both the pre-clinical pharmacology/toxicology and quality/manufacturing modules of its Premarket Approval (PMA) application for marketing of Augment Bone Graft in the U.S. These are two of the three parts, or modules, required for a complete PMA application to the FDA. The Company intends to file the third and final module, containing the clinical data, in the fourth quarter of 2009.
BioMimetic Therapeutics, Inc. Announces Extension of Rights Offering
BioMimetic Therapeutics, Inc. announced that it has approved a seven-day extension of the Company`s pending subscription rights offering to 5:00 p.m., New York City time, on June 22, 2009, unless further extended by the Company. Pursuant to the subscription rights offering, each holder of record of the Company`s common stock as of April 21, 2009 received one non-transferable subscription right for each share of common stock owned by such holder on such date, except with respect to shares of common stock held by the BioMimetic 401K Plan. Each subscription right represents the right to purchase 0.1017 shares of the Company`s common stock at a price of $8.50 per share. The rights offering originally was scheduled to expire on June 15, 2009.
BioMimetic Therapeutics, Inc. Announces Launch Of Rights Offering
BioMimetic Therapeutics, Inc. announced that the Securities and Exchange Commission (SEC) has declared effective the Registration Statement on Form S-3 filed by the Company in connection with the rights offering previously announced by the Company. Accordingly, the Company has launched the $17 million rights offering pursuant to which holders of its common stock, except with respect to shares of common stock held by the BioMimetic 401K Plan, will be entitled to purchase additional shares of its common stock at a price of $8.50 per share. The proceeds from the rights offering are expected to be used for general corporate purposes, including to fund additional product development and potential commercialization activities. Pursuant to the rights offering, the Company will distribute subscription rights, at no charge, to each record holder of its common stock as of April 21, 2009, the record date for the rights offering, except with respect to shares of common stock held by the BioMimetic 401K Plan.
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