fredman
12 años hace
BioMimetic Therapeutics, Inc. Initiates Enrollment in Augment™ Chronic Tendinopathy Clinical Trial
Product Candidate Aimed at Large Tendinosis Market
FRANKLIN, Tenn.--(BUSINESS WIRE)-- BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) today announced it initiated enrollment in a Phase II clinical trial to assess the safety and efficacy of Augment™ Chronic Tendinopathy (ACT) as a treatment for lateral epicondylitis, commonly known as tennis elbow. The randomized, controlled trial is expected to enroll up to 100 patients at seven clinical sites in the U.S. and will evaluate the safety and therapeutic potential of escalating doses of a one-time injection of pure recombinant human platelet-derived growth factor (rhPDGF-BB) homodimer solution into the extensor carpi radialis brevis (ECRB), the tendon in the elbow that is generally the source of pain in tennis elbow. The product candidate is aimed at the large tendinosis market for which there is significant unmet clinical need with limited effective long-term treatments currently available.
“We have seen promising pre-clinical data with ACT and believe the initiation of this Phase II dose finding clinical trial is the logical next step in the development of our sports medicine program,” said Dr. Samuel Lynch, BioMimetic president and CEO. “ACT has the potential to help millions of patients suffering from painful inflammation of the tendon at the outer border of the elbow resulting from overuse of lower arm muscles or trauma.”
Study Design
The Phase II trial is designed as a randomized, ascending dose, double-blinded, placebo controlled, multi-center study. The trial is expected to enroll up to 100 patients ranging from 21 – 80 years of age, who will receive a single injection into the ECRB. The injection will consist of either a placebo or one of four different doses of rhPDGF-BB.
The primary efficacy endpoints will be derived from a combination of pain and disability assessments as measured by the Visual Analog Scale (VAS), Disabilities of the Arm, Shoulder and Hand (DASH) Score and the Patient Rated Tennis Elbow Evaluation (PRTEE), along with sincerity of effort measured by grip strength testing. These clinical outcome measures will be used to detect changes in pain and function up to 24 weeks from baseline. Adverse event reporting, including incidence, relationship with treatment and severity will be recorded throughout the study to evaluate safety of the drug. The product candidate will be reviewed by the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), which regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs.
The study is currently open for enrollment, and more information can be found at www.clinicaltrials.gov. The Company anticipates completing enrollment around year end 2013.
Lateral Epicondylitis
Augment Chronic Tendinopathy (ACT) is being developed to treat chronic tendon injuries, or tendinosis. The target indication for this clinical trial is lateral epicondylitis, commonly referred to as tennis elbow. Lateral Epicondylitis is an inflammation of the tendons that join the forearm muscles on the outside of the elbow. The forearm muscles and tendons become damaged from overuse, or in some cases trauma, leading to pain and tenderness on the outside of the elbow. It is estimated that lateral epicondylitis currently affects one to three percent of the total U.S. population (or approximately three to nine million people), and there is no decisive effective standard of care. Various conservative treatment options are available and include topical and oral non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroid injections, and autologous blood injection (PRP). These conservative treatment options may be effective in short term pain relief and return to function, but studies have shown that a significant portion of patients treated with conservative therapies continue to have recurrent symptoms. Additionally, none of the currently available therapies address the fundamental need to enhance healing at the tendon-to-bone interface and improve long-term outcomes. Thus, lateral epicondylitis is an indication that not only represents a large market opportunity, but it is also one with a significant unmet clinical need. The Company believes there is an opportunity for rhPDGF-BB to fulfill this unmet clinical need and is currently testing this hypothesis in the clinic.
About BioMimetic Therapeutics
BioMimetic Therapeutics (NASDAQ: BMTI) is a biotechnology company specializing in the development and commercialization of clinically proven products to promote the healing of musculoskeletal injuries and diseases, including therapies for orthopedics, sports medicine and spine applications. All Augment® branded products are based upon recombinant human platelet-derived growth factor (rhPDGF-BB), which is a bio-engineered form of PDGF, one of the body's principal agents to stimulate and direct healing and regeneration. Through the commercialization of this patented technology, BioMimetic seeks to become the leading company in the field of regenerative medicine by providing new treatment options for the repair of bone, cartilage, tendons and ligaments.
BioMimetic has received regulatory approvals to market Augment® Bone Graft in Canada, Australia and New Zealand for use in hindfoot and ankle fusion indications. Augment is pending regulatory decisions in the U.S. and European Union for similar indications. The Company also markets a bone graft substitute line of products for orthopedic indications called AugmatrixTM Biocomposite Bone Graft.
On November 19, 2012, BioMimetic and Wright Medical Group, Inc. entered into a definitive agreement for a business combination of the two companies. The transaction will combine BioMimetic’s breakthrough biologics platform and pipeline with Wright’s established sales force and product portfolio to further accelerate growth opportunities in Wright’s Extremities business. The merger is subject to a vote by BioMimetic shareholders, and, if approved, is expected to close in the first quarter of 2013.
For further information contact Kearstin Patterson, senior director of corporate communications, at 615-236-4419.
Important Additional Information Regarding the Transaction
In connection with the proposed transaction, Wright filed a registration statement on Form S-4 (the “Form S-4”) with the Securities and Exchange Commission (“SEC”) on December 20, 2012, but such registration statement has not been declared effective by the SEC. BioMimetic will be mailing a proxy statement/prospectus for its stockholders and each will be filing other documents regarding the proposed transaction with the SEC. BEFORE MAKING ANY VOTING OR INVESTMENT DECISION, BIOMIMETIC STOCKHOLDERS AND INVESTORS ARE URGED TO READ THE PROXY STATEMENT AND OTHER RELEVANT MATERIALS CAREFULLY IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THE DOCUMENTS WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND BIOMIMETIC. Investors and stockholders may obtain copies of the proxy statement and other relevant documents filed with the SEC by BioMimetic free of charge at the SEC’s web site at www.sec.gov. In addition, investors and stockholders may obtain copies of the proxy statement and other relevant documents filed with the SEC by BioMimetic (when they are available) by going to BioMimetic’s Investor Relations page on its corporate website at www.biomimetics.com.
BioMimetic, Wright and their respective directors and executive officers and other persons may be deemed to be participants in the solicitation of proxies in respect of the proposed transaction. Information regarding BioMimetic’s executive officers and directors, and their beneficial ownership of BioMimetic’s common stock as of April 12, 2012 is available in BioMimetic’s proxy statement for its 2012 annual meeting of stockholders, which was filed with the SEC on April 27, 2012. Information regarding Wright’s executive officers and directors is available in Wright’s proxy statement for its 2012 annual meeting of stockholders and its current reports on Form 8-K, which were filed with the SEC on March 27, 2012, August 3, 2012 and November 6, 2012, respectively. Other information regarding the interests of such potential participants in the proxy solicitation are included in the Form S-4 and will be contained in the proxy statement and other relevant materials to be filed with the SEC when they become available.
Forward-looking Statements
This press release contains forward-looking statements about our future results of operations and financial position, product development programs, business strategy, plans and objectives of management for future operations that are not historical facts. The words “may,” “continue,” “estimate,” “intend,” “plan,” “will,” “believe,” “project,” “expect,” “anticipate,” “optimistic” and similar expressions may identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. There are many important factors that could cause actual results to differ materially from those indicated in the forward-looking statements, including that: (i) the Food and Drug Administration may not approve Augment Chronic Tendinopathy and (ii) despite the Company’s future marketing and commercialization efforts, Augment Chronic Tendinopathy may not achieve broad market acceptance. Further, BioMimetic’s actual results and the timing and outcome of events may differ materially from those expressed in or implied by the forward-looking statements because of risks detailed in BioMimetic’s recent annual and quarterly reports filed with the Securities and Exchange Commission (SEC), including those factors discussed under the caption "Risk Factors" in the Company’s Annual Report on Form 10-K filed with the SEC on March 13, 2012, which are incorporated in this press release by this reference. Except as required by law, BioMimetic undertakes no responsibility for updating the information contained in this press release beyond the published date, whether as a result of new information, future events or otherwise, and has no policy of doing so.
BioMimetic Therapeutics, Inc.
Kearstin Patterson
Senior Director of Corporate Communications
615-236-4419 (office)
615-517-6112 (mobile)
kpatterson@biomimetics.com
Source: BioMimetic Therapeutics, Inc.
fredman
12 años hace
BioMimetic Therapeutics, Inc. (NASDAQ:BMTI) Investor Files Lawsuit to Halt Buyout
A lawsuit was filed by an investor in shares of BioMimetic Therapeutics, Inc. (NASDAQ:BMTI) in effort to block the proposed takeover and current NASDAQ:BMTI stockholders should contact the Shareholders Foundation.
San Diego, CA -- (SBWIRE) -- 11/28/2012 -- An investor in shares of BioMimetic Therapeutics, Inc. (NASDAQ:BMTI) filed a lawsuit against directors of BioMimetic Therapeutics in effort to stop the proposed buyout of BioMimetic Therapeutics by Wright Medical Group.
Investors who purchased shares of BioMimetic Therapeutics, Inc. (NASDAQ:BMTI) prior to November 19, 2012, and currently hold any of those NASDAQ:BMTI shares have certain options and should contact the Shareholders Foundation at mail(at)shareholdersfoundation.com or call +1(858) 779 - 1554.
The plaintiff alleges that the defendants breached their fiduciary duties owed NASDAQ:BMTI stockholders by agreeing to sell the company too cheaply via an unfair process to Wright Medical Group, Inc.
On November 19, 2012, the Wright Medical Group, Inc. (NASDAQ: WMGI) and BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) announced that they have entered into an agreement for a business combination of Wright Medical Group and BioMimetic Therapeutics. Under the terms of the agreement, the transaction has a total potential value for BioMimetic shareholders of approximately $380 million, or $12.97 per share, based on Wright’s closing stock price on Friday, November 16, 2012. Each share of BioMimetic common stock will be converted into the right to receive an upfront payment of $1.50 in cash and 0.2482 shares of Wright common stock. The upfront payment values BioMimetic at approximately $190 million, or $6.47 per share, based on Wright’s closing stock price on November 16, 2012. Each BioMimetic share will also receive one tradable Contingent Value Right (CVR), which entitles its holder to receive additional cash payments of up to $6.50 per share, which are payable upon receipt of FDA approval of Augment® Bone Graft and upon achieving certain revenue milestones.
The CVR payments to BioMimetic shareholders are structured as follows:
- $3.50 per share upon FDA approval of Augment® Bone Graft;
- $1.50 per share upon the achievement of $40 million in trailing twelve month sales for all products contributed by BioMimetic;
- $1.50 per share upon the achievement of $70 million in trailing twelve month sales for all products contributed by BioMimetic.
However, the plaintiff alleges that the offer is unfair to NASDAQ:BMTI stockholders and undervalues BioMimetic Therapeutics, Inc. Indeed shares of BioMimetic Therapeutics, Inc. (NASDAQ:BMTI) traded as high as $14.07 per share in April 2011 and at least one analyst has set the high target price of NASDAQ:BMTI shares at $7.50 per share. Furthermore, so the plaintiff, BioMimetic Therapeutics, Inc. on the verge of a major breakthrough.
Those who are current investors in BioMimetic Therapeutics, Inc. (NASDAQ:BMTI), have certain options and should contact the Shareholders Foundation.
Contact:
Shareholders Foundation, Inc.
Joelle Day
3111 Camino Del Rio North - Suite 423
92108 San Diego
Phone: +1-(858)-779-1554
Fax: +1-(858)-605-5739
mail@shareholdersfoundation.com
Source: http://www.sbwire.com/press-releases/biomimetic-therapeutics-inc-nasdaqbmti-investor-files-lawsuit-to-halt-buyout-183410.htm
fredman
12 años hace
Wright Medical Group, Inc. and BioMimetic Therapeutics, Inc. Enter into Agreement to Combine Businesses
Transaction Will Add Breakthrough Biologics Platform and Pipeline to Further Accelerate Growth Opportunities in Wright’s Extremities Business
Upfront Purchase Price Payment of $190 Million in Cash and Stock Plus Contingent Payments of up to $190 Million
Wright to Host Conference Call Today at 10:00 a.m. Central Time
Press Release: Wright Medical Group, Inc. and BioMimetic Therapeutics, Inc
ARLINGTON, Tenn. & FRANKLIN, Tenn.--(BUSINESS WIRE)--
Wright Medical Group, Inc. (WMGI) and BioMimetic Therapeutics, Inc. (BMTI) announced today that they have entered into a definitive agreement for a business combination of Wright and BioMimetic, both publicly traded, Tennessee-based companies. Wright is an orthopedics company with a market-leading lower extremities franchise. BioMimetic is focused on developing regenerative medicine products to promote the healing of musculoskeletal injuries and diseases with a novel protein therapeutic product, Augment® Bone Graft, under late stage FDA review as a replacement for autologous bone graft in foot and ankle fusions. The transaction will combine BioMimetic’s breakthrough biologics platform and pipeline with Wright’s established sales force and product portfolio, to further accelerate growth opportunities in Wright’s Extremities business.
Under the terms of the agreement, the transaction has a total potential value for BioMimetic shareholders of approximately $380 million, or $12.97 per share, based on Wright’s closing stock price on Friday, November 16, 2012. Each share of BioMimetic common stock will be converted into the right to receive an upfront payment of $1.50 in cash and 0.2482 shares of Wright common stock. The upfront payment values BioMimetic at approximately $190 million, or $6.47 per share, based on Wright’s closing stock price on November 16, 2012. Each BioMimetic share will also receive one tradable Contingent Value Right (CVR), which entitles its holder to receive additional cash payments of up to $6.50 per share, which are payable upon receipt of FDA approval of Augment® Bone Graft and upon achieving certain revenue milestones.
Any contingent milestone payments will be paid in cash. The CVR payments to BioMimetic shareholders are structured as follows:
$3.50 per share upon FDA approval of Augment® Bone Graft;
$1.50 per share upon the achievement of $40 million in trailing twelve month sales for all products contributed by BioMimetic;
$1.50 per share upon the achievement of $70 million in trailing twelve month sales for all products contributed by BioMimetic.
The latter two sales milestone payments cannot be made sooner than 24 and 36 months post-closing of the transaction, respectively.
The transaction is expected to close in the first quarter of 2013 and is subject to customary closing conditions, including BioMimetic shareholder approval. The transaction received the unanimous approval of the board of directors of both Wright and BioMimetic. In addition, several key shareholders of BioMimetic have evidenced their support of the transaction by entering into agreements to vote in favor of the transaction.
Robert Palmisano, President and Chief Executive Officer of Wright, commented, “We believe this transaction will significantly accelerate the continued transformation of our business as well as our strategy of building a world-class biologics platform and growing our foot and ankle business at well above market growth rates. BioMimetic’s products complement our existing biologics product portfolio, and, if approved by the FDA as we expect, Augment® Bone Graft will provide us with a unique solution for the U.S. hindfoot and ankle fusion market that leverages the distribution capabilities of Wright’s dedicated foot and ankle sales organization and our physician training capabilities.”
Dr. Samuel Lynch, President and Chief Executive Officer of BioMimetic Therapeutics, added, “BioMimetic is delighted to partner with a company that shares our commitment to building a world-class biologics platform. We believe that Augment® Bone Graft will become an important new therapeutics option to improve patient outcomes in hindfoot and ankle fusion procedures, and that Wright Medical with its leadership position in the foot and ankle market is the ideal partner to accelerate the rapid adoption of our products around the world.”
BioMimetic’s Augment® product line is based on recombinant human platelet-derived growth factor (rhPDGF-BB), a synthetic copy of one of the body’s principal healing agents. In May 2011, the FDA’s Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee voted favorably on Augment® Bone Graft’s safety, efficacy and benefit to risk profile for its use as an alternative to autograft in hindfoot and ankle fusions. In January 2012, BioMimetic announced receipt of a post-panel non-approvable letter requesting additional information in a PMA amendment. In June 2012, BioMimetic submitted a responsive PMA amendment, and the product is currently pending a final FDA regulatory decision. If approved, Augment® Bone Graft will be the first clinically proven protein therapeutic to come to the orthopedics market in a decade, offering the potential to reinforce surgical bone repair in hindfoot and ankle fusion procedures effectively, which translates into an estimated market opportunity believed to be approximately $300 million annually in the U.S. Augment® Bone Graft is currently available for sale as an alternative to autograft in Canada for foot and ankle fusion indications and in Australia and New Zealand for hindfoot and ankle fusion indications.
Although Wright cannot finalize the purchase price allocation and fair value assessment of the contingent consideration until the closing, and thus cannot yet assess the exact impact on its future GAAP earnings, Wright anticipates that the transaction will be dilutive to adjusted EBITDA until the second full-year post-FDA approval of Augment® Bone Graft and accretive thereafter. Wright will provide additional information on the financial impact of this transaction after the closing.
In connection with this transaction, J.P. Morgan Securities LLC and Wilson Sonsini Goodrich & Rosati, a Professional Corporation advised Wright Medical, and Goldman, Sachs & Co. and Ropes & Gray LLP advised BioMimetic Therapeutics.
Conference Call and Webcast
Wright Medical will host a conference call today, November 19, 2012, beginning at 10:00 a.m. Central Time (11:00 a.m. Eastern Time) to discuss the BioMimetic transaction, followed by a question and answer session.
The conference call will be available to interested parties through a live audio webcast at www.wmt.com, where it will be archived and accessible for approximately 12 months. The live dial-in number for the call is 800-591-6930 (U.S.) or 617-614-4908 (International). The participant passcode is “Wright.”
If you do not have access to the Internet and want to listen to an audio replay of the conference call, dial 888-286-8010 (U.S.) or 617-801-6888 (International) and enter passcode 47252247. The audio replay will be available beginning at 12:00 p.m. Central Time on Monday, November 19, 2012 until Monday, November 27, 2012.
About Wright Medical
Wright Medical Group, Inc. (WMGI) is a global orthopaedic medical device company and a leading provider of surgical solutions for the foot and ankle market. Wright Medical specializes in the design, manufacture and marketing of devices and biologic products for extremity, hip and knee repair and reconstruction. Wright Medical has been in business for more than 60 years and markets its products in over 60 countries worldwide. For more information about Wright Medical, visit the Wright Medical’s website at www.wmt.com.
About BioMimetic Therapeutics, Inc.
BioMimetic Therapeutics, Inc. (BMTI) is a biotechnology company specializing in the development and commercialization of clinically proven products to promote the healing of musculoskeletal injuries and diseases, including therapies for orthopedics, sports medicine and spine applications. All Augment® branded products are based upon recombinant human platelet-derived growth factor (rhPDGF-BB), which is an engineered form of PDGF, one of the body’s principal agents to stimulate and direct healing and regeneration. Through the commercialization of this patented technology, BioMimetic seeks to become the leading company in the field of regenerative medicine by providing new treatment options for the repair of bone, cartilage, tendons and ligaments.
BioMimetic has received regulatory approvals to market Augment® Bone Graft in Canada, Australia and New Zealand for use in hindfoot and ankle fusion indications. Augment® is pending regulatory decisions in the U.S. and European Union for similar indications. BioMimetic also markets a bone graft substitute line of products for orthopedic indications called Augmatrix™ Biocomposite Bone Graft. For more information about BioMimetic, visit BioMimetic’s website at www.biomimetics.com.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This press release may contain “forward-looking statements” as defined under U.S. federal securities laws. These statements reflect management’s current knowledge, assumptions, beliefs, estimates, and expectations and express management’s current view of future performance, results, and trends. Forward looking statements may be identified by their use of terms such as anticipate, believe, could, estimate, expect, intend, may, plan, predict, project, will, and other similar terms. Forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. In addition to those described below, forward looking statements contained in this press release include, without limitation, statements concerning the possibility of FDA approval of Augment Bone Graft, statements regarding market acceptance of, and expected annual market demand for Augment Bone Graft, statements regarding the expected impact of the transaction with BioMimetic on Wright’s adjusted EBITDA and other financial results, and statements about the timing and expected benefits of the transaction. The reader should not place undue reliance on forward-looking statements. Such statements are made as of the date of this press release, and we undertake no obligation to update such statements after this date. In addition to those described above, risks and uncertainties that could cause our actual results to materially differ from those described in forward-looking statements are discussed in our filings with the Securities and Exchange Commission (including those described in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2011 and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2012, in each case under the heading “Risk Factors” and elsewhere in such filings). By way of example and without implied limitation, such risks and uncertainties include: the failure of BioMimetic stockholders to adopt the merger agreement or the failure of either Wright or BioMimetic to meet any of the other conditions to the closing of the transaction, the failure to realize the anticipated benefits from the transaction or delay in realization thereof, future actions of the United States Attorney’s office, the FDA, the Department of Health and Human Services or other U.S. or foreign government authorities that could delay, limit or suspend our development, manufacturing, commercialization and sale of products, or result in seizures, injunctions, monetary sanctions or criminal or civil liabilities; any actual or alleged breach of the Corporate Integrity Agreement to which we are subject through September 2015 which could expose us to significant liability including exclusion from Medicare, Medicaid and other federal healthcare programs, potential criminal prosecution, and civil and criminal fines or penalties; adverse outcomes in existing product liability litigation; new product liability claims; inadequate insurance coverage; the possibility of private securities litigation or shareholder derivative suits; demand for and market acceptance of our new and existing products; potentially burdensome tax measures; lack of suitable business development opportunities; product quality or patient safety issues; challenges to our intellectual property rights; geographic and product mix impact on our sales; our inability to retain key sales representatives, independent distributors and other personnel or to attract new talent; inventory reductions or fluctuations in buying patterns by wholesalers or distributors; inability to realize the anticipated benefits of restructuring initiatives; negative impact of the commercial and credit environment on us, our customers and our suppliers; and the potentially negative effect of our ongoing compliance enhancements on our relationships with customers, and on our ability to deliver timely and effective medical education, clinical studies, and new products.
ADDITIONAL INFORMATION ABOUT THIS TRANSACTION
This press release may be deemed to be solicitation material regarding the proposed business combination of Wright and BioMimetic. In connection with the proposed transaction, Wright intends to file with the SEC a registration statement on Form S-4, which will include a proxy statement/prospectus and other relevant materials in connection with the proposed transaction, and each of Wright and BioMimetic intend to file with the SEC other documents regarding the proposed transaction. The proxy statement/prospectus and this press release are not offers to sell Wright securities and are not soliciting an offer to buy Wright securities in any state where the offer and sale is not permitted. The final proxy statement/prospectus will be mailed to the stockholders of BioMimetic. INVESTORS AND SECURITY HOLDERS OF BIOMIMETIC ARE URGED TO READ THE PROXY STATEMENT/PROSPECTUS (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO) AND THE OTHER RELEVANT MATERIAL CAREFULLY IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT WRIGHT AND BIOMIMETIC AND THE PROPOSED TRANSACTION.
The proxy statement/prospectus and other relevant materials (when they become available), and any and all documents filed with the SEC, may be obtained free of charge at the SEC’s web site at www.sec.gov. In addition, investors and security holders may obtain free copies of the documents filed with the SEC by Wright by directing a written request to Wright Medical Group, Inc, 5677 Airline Road, Arlington, TN 38002, Attention: Investor Relations, and by BioMimetic by directing a written request to BioMimetic Therapeutics, Inc., 389 Nichol Mill Lane, Franklin, TN 37067, Attention: Investor Relations.
BioMimetic and its respective executive officers and directors and other persons, including Wright and its respective executive officers and directors, may be deemed to be participants in the solicitation of proxies from its stockholders in connection with the proposed transaction. Information about the executive officers and directors of BioMimetic and their ownership of BioMimetic common stock is set forth in its annual report on Form 10-K for the year ended December 31, 2011, filed with the SEC on March 13, 2012 and the proxy statement for BioMimetic’s 2012 annual meeting of stockholders, filed with the SEC on April 27, 2012. Information about the executive officers and directors of Wright Medical Group is set forth in its annual report on Form 10-K for the year ended December 31, 2011, filed with the SEC on February 24, 2012 and the proxy statement for Wright Medical Group’s 2012 annual meeting of stockholders, filed with the SEC on March 27, 2012. Certain directors and executive officers of BioMimetic and other persons may have direct or indirect interests in the merger due to securities holdings, pre-existing or future indemnification arrangements and rights to severance payments if their employment is terminated prior to or following the transaction. If and to the extent that any of the BioMimetic participants will receive any additional benefits in connection with the transaction, the details of those benefits will be described in the proxy statement/prospectus relating to the transaction. Investors and security holders may obtain additional information regarding the direct and indirect interests of BioMimetic and its executive officers and directors in the transaction by reading the proxy statement/prospectus regarding the transaction when it becomes available.
Contact:
Wright Medical Group, Inc.
Julie D. Tracy, 901-290-5817 (office)
Sr. Vice President, Chief Communications Officer
julie.tracy@wmt.com
or
BioMimetic Therapeutics, Inc.
Kearstin Patterson, 615-236-4419 (office)
mobile: 615-517-6112
Sr. Director of Corporate Communications
kpatterson@biomimetics.com
Source: http://finance.yahoo.com/news/wright-medical-group-inc-biomimetic-113000874.html
surf1944
13 años hace
Brower Piven Encourages Investors Who Have Losses in Excess of $300,000 From Investment in BioMimetic Therapeutics, Inc. to Inquire About the Lead Plaintiff Position in Securities Fraud Class Action Lawsuit Before the September 6, 2011 Lead Plaintiff Deadline
Press Release Source: Brower Piven, A Professional Corporation On Wednesday July 13, 2011, 5:50 pm EDT
STEVENSON, MD--(Marketwire - 07/13/11) - Brower Piven, A Professional Corporation announces that a class action lawsuit has been commenced in the United States District Court for the Middle District of Tennessee on behalf of purchasers of the securities of BioMimetic Therapeutics, Inc. ("BioMimetic" or the "Company") (NASDAQ:BMTI - News) during the period between October 14, 2009 and May 11, 2011, inclusive (the "Class Period").
No class has yet been certified in the above action. Members of the Class will be represented by the lead plaintiff and counsel chosen by the lead plaintiff. If you wish to choose counsel to represent you and the Class, you must apply to be appointed lead plaintiff no later than September 6, 2011 and be selected by the Court. The lead plaintiff will direct the litigation and participate in important decisions including whether to accept a settlement and how much of a settlement to accept for the Class in the action. The lead plaintiff will be selected from among applicants claiming the largest loss from investment in the Company during the Class Period. You are not required to have sold your shares to seek damages or to serve as a Lead Plaintiff.
The complaint accuses the defendants of violations of the Securities Exchange Act of 1934 by virtue of the Company's failure to disclose during the Class Period full and accurate information regarding the status of ongoing clinical studies status of Augment™ Bone Graft ("Augment") and regarding the safety and efficacy of Augment. According to the complaint, after, on May 10, 2011, the FDA published briefing documents that were a scathing assessment of the conduct of the Augment clinical trial, the value of BioMimetic shares declined significantly.
If you have suffered a net loss for all transactions in BioMimetic Therapeutics, Inc. securities during the Class Period (including shares or possibly calls purchased during, but not sold until after the end of the Class Period or possibly put options sold but not covered until after the end of the Class Period), you may obtain additional information about this lawsuit and your ability to become a lead plaintiff by contacting Brower Piven at www.browerpiven.com, by email at hoffman@browerpiven.com, by calling 410/415-6616, or at Brower Piven, A Professional Corporation, 1925 Old Valley Road, Stevenson, Maryland 21153. Attorneys at Brower Piven have combined experience litigating securities and class action cases of over 60 years. If you choose to retain counsel, you may retain Brower Piven without financial obligation or cost to you, or you may retain other counsel of your choice. You need take no action at this time to be a member of the class.
surf1944
13 años hace
Mannkind and BioMimetic Suffer From Poor Management
As I previously showed, often times the stock market cycles through similar patterns. This time I will detail how two healthcare companies have recently faced similar ill fates. The first is Mannkind Corporation (MNKD) and the second is BioMimetic Therapeutics (BMTI). Both companies have faltered beyond investors' worst imagination and both have faced a heavy load of class action lawsuits from several law firms. These suits may not have any bearing on the share price, but it does indicate the share price has declined very fast due to, arguably, management flaws.
With that said, both companies have fallen for different reasons. Mannkind crumbled due to a CRL for the companies leading product Afrezza and a 40% cut in employment. BioMimetic's share price fell due to a not-so-strong recommendation by an FDA Advisory Committee followed by statements that make it seem clear BioMimetic's leading product, Augment Bone Graft, will need further trials.
Following the CRL, Mannkind's share price declined roughly 41% over four trading sessions, followed by a separate 40% slide over the next 24 days. This means Mannkind's share price declined about 64% in less than four weeks. Comparatively, BioMimetic's share price tumbled over 35% on May 9th after the FDA reported concerns with Augment Bone Graft. Over the next six days the company fell another 13% after the FDA Advisory Committee gave a positive vote for the treatment. Despite the positive vote, the advisory committee pointed out the fact that Augment may need new trials because the previous trial had too few people and it did not prove Augment Bone Graft works better than autologous grafts.
When comparing the two companies it is possible to see several similar characteristics. The most obvious is the share price drop. From Mannkind's peak to bottom the share price fell 64.5% while BioMimetic slid roughly 66.7%. However, I must say I would not be surprised to see BioMimetic fall to the $4.00-$4.15 range before finding long term stability.
Another similarity is the wording in which both companies' management described the two respective treatments. Prior to the delayed PDUFA for Mannkind, Alfred Mann gave an interview in which he stated the December delay was expected due to an audit on the bioequivelancy group that studied the data. This should have been a red flag as the FDA must have seen something was wrong with the data. This did not bother Mr. Mann in any way. In my opinion an audit like this should have been a concerning action.
Similarly BioMimetic's management did not release to the full extent the concerns the FDA had with Augment Bone Graft until much later. Also, the company stated problems with the trials existed, but management continued to irresponsibly promote the treatment as if nothing was wrong. However it must be noted until the verdict from the FDA about the NDA is released, the treatment is not guaranteed to be rejected; but it can be assumed at this point a CRL will be sent to BioMimetic. And if the FDA does irresponsibly approve Augment Bone Graft, the share price will rise over 100%.
Another similarity between the two companies is the mass amount of lawsuits thrown at each company. The basis for the class action suits is that each respective company withheld truth from investors about their respective drugs. The lawsuits for Mannkind can be found here (as well as I and II). While several of BioMimetic's lawsuits can be found here (as well as I, II, III, IV, V, VI). From a legal standpoint, these lawsuits seem futile as proving someone purposely withheld information is nearly impossible to prove. Also, it will be nearly impossible to prove the company knew the FDA was going to hand down negative news about the treatments. However, in the case of Mannkind we did see some insider selling that brings to mind maybe Mannkind knew the drug was going to be rejected before the company announced it publicly. Of course this is all speculation and would be nearly impossible to prove as well.
This shows the way in which many companies, particularly small biotechnology companies, follow similar cycles. Some very recent examples of this are Durect (DRRX), Pain Therapeutics (PTIE), and Transcept (TSPT). Companies in other sectors face this same fate as well. Off the top of my head, JDS Uniphase (JDSU) comes to mind as the share price fell almost 50% due to terrible outlook and negative news earlier this year. These are not the only companies that follow this pattern, but Mannkind and BioMimetic are perfect examples.
An important point to take from this note is companies that fall hard and fast tend to continue to fall several days or weeks later. Therefore it is imperative for investors to keep these trends in mind and avoid hoping for a "dead cat bounce" after a large 20-30% drop because the share price may drop another 20% before catching resistance. However one important fact to remember is after an extreme drop, these companies fall into oversold territory and always move up a little bit before settling down into a lower more stable level.
http://seekingalpha.com/article/279862-mannkind-and-biomimetic-suffer-from-poor-management?source=yahoo
fredman
13 años hace
BioMimetic Therapeutics Completes Enrollment in Augment(TM) Rotator Cuff Graft Pilot Trial
Company Receives Patent Allowance for Treatment of Distraction Osteogenesis Until 2029
-
BioMimetic Therapeutics, Inc. (NASDAQ: BMTI), a biotechnology company specializing in the development and commercialization of innovative bioactive products to promote the healing of musculoskeletal injuries and diseases, reported today that, ahead of previously announced guidance, the Company completed enrollment of 30 patients in a pilot clinical trial to assess the safety and clinical utility of AugmentTM Rotator Cuff Graft for the repair of large rotator cuff tears. The study's objective is to determine the safety and performance of Augment Rotator Cuff for primary surgical treatment of full thickness rotator cuff tears. To date there have been no product related serious adverse events (SAEs) attributed to Augment Rotator Cuff in the study. The Company expects to release data from the trial in the first half of 2012.
"The efficient enrollment of patients in this trial demonstrates both our commitment to our sports medicine program and the support and enthusiasm of the Augment Rotator Cuff trial's investigators and patient community," said Dr. Samuel Lynch, president and CEO of BioMimetic Therapeutics. "Data generated from this study will provide valuable information regarding Augment Rotator Cuff's performance and should be instrumental in designing a successful pivotal trial in this indication. We appreciate the collaboration of the investigators and patients involved in this important effort, and we hope to develop this new treatment as expeditiously as possible."
Providing additional support for the product candidate's use in rotator cuff tears, results of a pre-clinical study demonstrating that rhPDGF-BB promotes healing in tendon-bone injuries has been accepted for publication in The American Journal of Sports Medicine (AJSM). The published study was conducted in collaboration with investigators from the Hospital for Special Surgery and Colorado State University and evaluated the effects of rhPDGF-BB, in combination with a type I collagen matrix, on rotator cuff repair in a sheep model and demonstrated a significant 63% increase in the load at failure of the repair compared to fixation alone at 12 weeks post-repair. The paper, entitled "Augmentation of a Rotator Cuff Suture Repair Using rhPDGF-BB and a Type I Bovine Collagen Matrix in an Ovine Model," is currently available online ahead of the print edition and can be accessed on PubMed (http://www.ncbi.nlm.nih.gov/pubmed/21555508).
"Rotator cuff tears are a painful and debilitating condition in which the rotator cuff tendon no longer fully attaches to the head of the humerus and results in prolonged weakness and pain in the shoulder and an overall impaired quality of life," said Robert Litchfield, MD, principle investigator for the Augment Rotator Cuff pilot study. "Rotator cuff tears are one of the most common problems encountered by orthopedic surgeons, and their repair is among the most commonly performed procedures in orthopedic soft tissue indications. The rapid enrollment of patients in this pilot study speaks to the surgeons' desire to improve the outcomes of this frequent and difficult-to-treat condition. Biologic enhancement of cuff repairs is undoubtedly the next major advancement in the management of these challenging cases, and as principle investigator I am delighted by the ease of use and the absence of any adverse events associated with the application of this product. Additionally, the clinicians involved in this study are very enthusiastic about the potential benefits and safety of this product."
About Augment Rotator Cuff Graft and Clinical Study
Augment Rotator Cuff Graft is an interpositional graft consisting of a collagen matrix hydrated with recombinant human Platelet-Derived Growth Factor-BB (rhPDGF-BB), one of the principal wound healing stimulators in the body. The graft is positioned between the humerus and torn rotator cuff tendon(s) during standard surgical suture repair. BioMimetic is leveraging the same rhPDGF-BB technology around the world for orthopedic applications.
The trial is designed as a multi-center, randomized (2:1), controlled, blinded study to evaluate safety and performance of Augment Rotator Cuff for primary surgical treatment of full thickness (greater-than or equal to 2 cm to < 5 cm) rotator cuff tears. The Canadian study enrolled 30 patients with 20 patients receiving Augment Rotator Cuff plus standard suture repair and 10 patients receiving standard suture repair alone. The primary endpoint of the trial is safety, which will be evaluated by a comparison of adverse events between the two groups. MRIs will also be reviewed to evaluate the safety and durability of the device.
Rotator Cuff Anatomy, Tears and Repair
The rotator cuff is made up of four muscles and their tendons. These combine to form a "cuff" over the upper end of the arm (head of the humerus). The rotator cuff holds the humerus in place in the shoulder joint, enables the arm to rotate, helps to lift and rotate the arm, and stabilizes the ball of the shoulder within the joint. Rotator cuff tear is a common cause of pain and disability among adults. Most tears occur in the supraspinatus tendon, but other parts of the cuff may be involved. Rotator cuff tears are among the most common shoulder injuries, and rotator cuff repair is one of the most commonly performed orthopedic soft tissue procedures performed in the United States.
Operative repair of rotator cuff tears may reduce pain and function, however previous studies have demonstrated that a significant percentage of these repairs fail to heal when evaluated radiologically. Integrity of repair has been correlated with improvements in functional outcomes and results of revision surgeries are less than optimal, reinforcing the notion that prevention of retears with a quality repair is critical for the long term outcome of the patient. There are approximately 450,000 rotator cuff repair procedures annually in the U.S. and the Company estimates an additional 275,000 in other parts of the world. These numbers are expected to increase at a rate of 6.5% annually due to the increasingly active aging population suffering acute sports-related injuries and various degenerative overuse conditions that ultimately require surgical repair.
United States Patent Allowance
Additionally, U.S. Patent Number 7,943,573 entitled "Treatment of Distraction Osteogenesis Using PDGF" was issued by the U.S. Patent and Trademark Office and will remain in force until February 2029. The allowed claims within this patent application cover methods of stimulating osteogenesis (i.e., formation and development of bone) in a bone distraction procedure and certain platelet derived growth factor (PDGF) compositions that are applied to the distraction site to stimulate bone formation. This patent will prohibit the marketing of similar or generic versions of Augment, Augment Injectable, or GEM 21S for use in distraction osteogenesis procedures.
Source: http://investor.biomimetics.com/phoenix.zhtml?c=196896&p=irol-newsArticle&ID=1571488&highlight=
Regístrate para obtener gráficos en tiempo real, herramientas de análisis y precios.
Seshet
12 años hace
MissionIR
12 años hace
Penny Roger$
13 años hace
Hot Features
Premium
