Replidyne (MM) (RDYN) News

Replidyne Announces Second Quarter 2008 Results From Operations
Tuesday August 5, 4:15 pm ET

LOUISVILLE, Colo., Aug. 5 /PRNewswire-FirstCall/ -- Replidyne, Inc. (Nasdaq: RDYN - News) today announced its financial results for the second quarter and six months ended June 30, 2008.

Replidyne reported a net loss of $18.7 million for the quarter ended June 30, 2008, or a net loss per basic and diluted common share of $0.69 per share, compared to net income of $45.5 million, or $1.71 per basic common share or $1.65 per common share on a fully diluted basis, for the second quarter ended June 30, 2007. Replidyne reported a net loss of $27.7 million for the six months ended June 30, 2008, or a net loss per basic and diluted common share of $1.02 per share, compared to net income of $36.9 million, or $1.39 per basic common share or $1.34 per common share on a fully diluted basis, for the six months ended June 30, 2007. Net income for the second quarter and six months ended June 30, 2007 was due to revenue recognized upon termination of the Company's former commercialization and collaboration agreement for faropenem medoxomil (faropenem) with Forest Laboratories that ended in May 2007 resulting in the one-time recognition of previously deferred revenue. Cash, cash equivalents and short-term investments at June 30, 2008 totaled $64.7 million.

"This second quarter we have taken several direct actions to structure our operations to conserve our cash position," said Kenneth J. Collins, Replidyne's President and CEO. "These actions have included the difficult decisions to return the faropenem license to the licensor, conclude our development efforts on the faropenem program and restructure our workforce. We believe these actions were important steps in our effort to conclude our ongoing strategic alternatives process."

During the second quarter of 2008, Replidyne announced that it had decided to terminate its license agreement with Asubio Pharma Co., Ltd. (Asubio Pharma) for faropenem. In conjunction with this decision, Replidyne also announced that it had terminated its supply agreement with Asubio Pharma and Nippon Soda Co., Ltd. (Nippon Soda) for production of faropenem. As a result, the Company recorded research and development expense of $4.2 million in the quarter, comprising a license termination fee of $3.6 million to Asubio Pharma and reimbursement of engineering costs of $0.6 million to Nippon Soda in accordance with the terms of the agreements. Replidyne also paid Nippon Soda $0.9 million for delay compensation under the supply agreement, which had been recorded in 2007.

In April 2008, Replidyne announced it had discontinued enrollment in a placebo-controlled phase III clinical trial testing faropenem in patients with acute exacerbation of chronic bronchitis (AECB) and restructured its operations. In June 2008, Replidyne further restructured its operations. As a result of these actions the Company has reduced its headcount by 23 employees and incurred approximately $2.5 million of related expense, comprising $2.1 million of employee severance expenses and $0.4 million of expenses related to closure of its facility in Milford, Connecticut.

Research and development expenses in the second quarter of 2008 were $14.4 million compared to $8.4 million in the corresponding quarter of 2007. Faropenem related expense in the quarter totaled $10.5 including $4.2 million for the termination of the faropenem license with Asubio Pharma and related reimbursement of engineering costs to Nippon Soda and costs for patient monitoring and data base analysis required for the Phase III study testing faropenem in patients with AECB that was discontinued in April 2008. Replidyne will incur further expense related to this clinical trial to complete required patient monitoring and data base analysis until the final clinical report is filed with the U.S. Food and Drug Administration, which is expected during the third quarter of 2008. Also related to faropenem, Replidyne recorded $2.7 million of research and development expense related to future decontamination of the MEDA Manufacturing GmbH (MEDA Manufacturing) facility in Germany that had previously manufactured 300 mg tablets of faropenem based on MEDA Manufacturing's communicated intention to decontaminate the facility. Replidyne believes that following receipt of documented decontamination expenses from MEDA Manufacturing these expenses are to be reimbursed by Forest Laboratories under the terms of its former collaboration agreement. Additionally, research and development expense included increased costs for preclinical activities associated with Replidyne's discovery research programs, primarily the C. difficile and DNA replication inhibition programs, offset by decreased expense related to the REP8839 program that was suspended in December 2007.

Sales, general and administrative expenses for the second quarter of 2008 were $4.7 million compared to $3.3 million in the second quarter of 2007. Replidyne recorded $1.7 million in the second quarter of 2008 as the estimate of the outcome, within a range of possible outcomes, from its pending arbitration with MEDA Manufacturing. This increase was partially offset by decreases in expenses following restructuring actions implemented in the fourth quarter of 2007 to reduce commercial and general and administrative headcount.

Investment income and other net for the second quarter of 2008 was $0.4 million compared to $1.5 million for the second quarter of 2007, primarily reflecting lower cash balances available for investment in the 2008 period.

Replidyne did not report any revenue in the second quarter of 2008. Revenue for the second quarter of 2007 was $55.6 million. Under a February 2006 commercialization and collaboration agreement with Forest Laboratories that terminated on May 7, 2007, Replidyne received non-refundable upfront and milestone payments totaling $60 million that were being recognized as revenue on a straight-line basis over approximately 15 years in accordance with Replidyne's revenue recognition policy. Upon termination, the balance of unamortized upfront and milestone payments of $55.2 million was fully recognized as revenue in the second quarter of 2007. In addition, during the second quarter of 2007 the Company recognized $0.4 million in contract revenue for funded activity through May 7, 2007 under the agreement.

Failure Sets Replidyne Back
Wednesday June 25, 3:57 pm ET
By Grant Zeng, CFA

Replidyne, Inc. (NasdaqGM: RDYN - News) discontinued the development of its lead clinical candidate, antibiotic Orapem, after failing to find a suitable partner for the drug. Additionally, discontinuation of the development program for anti-infective REP8839 and weak pipeline keep us on the sidelines.

The company had found the going tough ever since filing the new drug application for Orapem in January 2006. Issuance of an 'approvable' letter for Orapem led to the termination of the development deal with Forest (NYSE: FRX - News).

Replidyne's strategy is to develop and commercialize anti-infective compounds that address unmet medical needs. The largest commercial opportunity for Orapem is in the community pediatric setting and approval of the drug will grant Replidyne five years of marketing exclusivity in the U.S. and ten years in Europe.

The company announced a restructuring program in last December to conserve cash and suspended all development activities associated with its phase II candidate, REP8839, and reduce headcount by 35 percent. While the company's current cash balance may last through 2009, we do not expect Replidyne to get any product on the market before 2013 at the latest.

Post the restructuring program and discontinuation of the development program of Orapem, the company has only anti-infective REP3123 in preclinical development. We maintain our Hold rating on the stock with a target price of $1.60 (with an expected market cap of $43.4 million).





surf's up......crikey

Replidyne ends deal with Asubio, expects charge
Monday June 23, 5:55 pm ET
Replidyne ends deal with Asubio Pharma over lead drug candidate; expects $4.1 million charge

LOUISVILLE, Colo. (AP) -- Biotechnology company Replidyne Inc. on Monday said it ended a licensing deal with Asubio Pharma Co. for its lead drug candidate and expects a charge of about $4.1 million.

In May, Replidyne discontinued enrollment in a late-stage study testing its faropenem medoxomil oral antibiotic as a treatment for patients with acute exacerbation of chronic bronchitis. The company made the decision to terminate the deal Monday because it was unable to secure a partner for the clinical program.

It also ended a supply agreement with Nippon Soda Co.

Replidyne said the charges will include about $3.5 million in termination fees for Asubio and $600,000 in engineering costs for Nippon. Other payments going to Nippon include $900,000 for delay compensation.

"We are clearly disappointed that we have been unable to identify a partner for the faropenem program," said Kenneth J. Collins, president and chief executive of Replidyne. "We have decided to terminate this program in order to preserve cash and focus our attention on our previously discussed strategic initiatives and our C. difficile Infection (CDI) program and novel anti-infective programs based on DNA replication inhibition technology."

As of May 31, the company had cash and short term investments totaling $71.5 million.

Shares of Replidyne fell 14 cents, or 10.2 percent, to $1.23 in after-hours trading, after rising 2 cents to close at $1.37 during the regular trading session.

RDYN seems to have held on to most of the fund companies that have been in the stock. The stock is selling for half of cash and should be around for another couple of years after looking at the cash burn. Current prices and the why the chart has finally bottomed, I am looking to take a large position in the stock. Is anyone out there still following RDYN? Any additional info would be helpful.

surf

http://www.nasdaq.com/asp/holdings.asp?mode=&kind=&timeframe=&intraday=&charttype==RDYN&symbol&FormType=Institutional&mkttype=&pathname=&page=holdings&selected=RDYN

Replidyne Announces First Quarter 2008 Earnings Results
Wednesday May 7, 4:00 pm ET

LOUISVILLE, Colo., May 7 /PRNewswire-FirstCall/ -- Replidyne, Inc. (Nasdaq: RDYN - News) today announced its financial results for the first quarter ended March 31, 2008.

Replidyne reported a net loss of $9.0 million for the first quarter ended March 31, 2008, or a net loss per basic and diluted common share of $0.33 per share, compared to a net loss of $8.6 million, or $0.32 per basic and diluted common share, for the first quarter ended March 31, 2007. Cash, cash equivalents and short-term investments at March 31, 2008 totaled $78.1 million.

On April 23, 2008, subsequent to the conclusion of the first quarter, Replidyne announced it had discontinued enrollment in a placebo-controlled Phase III clinical trial testing faropenem medoxomil (faropenem) in patients with acute exacerbation of chronic bronchitis (AECB) and restructured its operations. As a result, the Company will incur approximately $1.8 million of expense, including $1.4 million of future employee severance related expense. Replidyne took these actions to conserve cash assets and support ongoing strategic initiatives.

"We have made difficult decisions and taken significant action this year," said Kenneth J. Collins, Replidyne's President and CEO. "By discontinuing enrollment in the AECB study and restructuring our workforce, we are limiting spending to conserve our strong financial base. We believe these actions will enable us to act opportunistically in pursuing a strategic transaction."

Research and development expenses in the first quarter of 2008 were $7.6 million compared to $9.4 million in the corresponding quarter of 2007. Faropenem related expense represented approximately 47% of total research and development expense, primarily associated with costs to support the Phase III study testing faropenem in patients with AECB. With this trial discontinued, Replidyne will incur future clinical trial expense necessary to complete patient monitoring and database analysis, including safety reporting. Additionally, research and development expense included increased costs for preclinical activities associated with Replidyne's discovery research programs, primarily the C. difficile and DNA replication inhibition programs, offset by decreased expense related to the REP8839 program that was suspended in December 2007.

Selling, general and administrative expenses for the first quarter of 2008 were $2.0 million compared to $3.5 million in the first quarter of 2007 reflecting lower compensation expense following a restructuring implemented in December 2007 and reduced market monitoring expenses in the first quarter of 2008.

Investment income and other for the first quarter of 2008 was $0.6 million compared to $1.5 million for the first quarter of 2007, primarily reflecting lower cash balances available for investment in the 2008 period.

Replidyne did not report any revenue in the first quarter of 2008. Revenue reported in the first quarter of 2007 of $2.9 million was related to the commercialization and development agreement with Forest Laboratories that concluded on May 7, 2007.

Conference Call Information

Replidyne will host a conference call and webcast today, May 7, 2008, at 4:45 P.M. ET to discuss first quarter 2008 earnings results. Callers may participate in the conference call by dialing 866-770-7125 (domestic) or 617-213-8066 (international), and providing the passcode 79991920. To access the live webcast, please log on to the Company's website at http://www.Replidyne.com and go to the Investor Relations section.

A replay of the conference call will be available approximately one hour after completion of the call through Wednesday, May 21, 2008 at midnight. Callers may access the replay by dialing 888-286-8010 (U.S. participants) or 617-801-6888 (international participants). The audio replay passcode is 81984297. To access a replay of the webcast, visit the Investor Relations section of the Company's website at http://www.Replidyne.com.

Five Cheapest Stocks by Multiple Measures(RDYN)

http://seekingalpha.com/article/74608-five-cheapest-stocks-by-multiple-measures?source=yahoo

Replidyne is a biotech company focused on anti-infective drugs. Its lead candidate is Orapem, a Phase III oral antibiotic, and it's also working on a Phase I topical antibiotic that will treat staph infections in hospitals. The good news is that growing bacterial resistance has created a demand for stronger anti-infective drugs, and that if Orapem is approved it will be the first U.S. beta-lactam stronger than penicillin, and that beta-lactams comprise 70% of the pediatric antibiotic market. The bad news is that Orapem hasn't been approved and that's cost Replidyne its partner, Forest Labs (FRX), which was planning to provide both development and marketing for the drug. As with so many biotechs, this one looks like a crapshoot on FDA approval.

Replidyne Discontinues Phase III Trial
Wednesday April 23, 7:30 am ET

LOUISVILLE, Colo., April 23 /PRNewswire-FirstCall/ -- Replidyne, Inc. (Nasdaq: RDYN - News) announced today that it has discontinued enrollment in a placebo-controlled Phase III clinical trial testing faropenem medoxomil (faropenem) in patients with acute exacerbation of chronic bronchitis (AECB). Replidyne took this action to conserve its cash assets and support initiatives that include pursuing strategic transactions and maintaining its research programs.

The AECB study is one in a package of four clinical trials, including two in community-acquired pneumonia and one in acute bacterial sinusitis, recommended as a way forward by the U.S. Food and Drug Administration for a new drug application submission for faropenem to treat these three adult community respiratory tract infections. Replidyne has not initiated the other three trials, and consistent with prior guidance, further faropenem development will depend on Replidyne securing a partner for the program.

"In the interest of conserving our financial position, we have made a difficult decision to discontinue enrollment in this faropenem trial," said Kenneth J. Collins, Replidyne's President and CEO. "This decision reflects our sense of urgency and the belief that in today's environment available cash assets broaden the scope of potential partnering and strategic options."

As of March 31, 2008, Replidyne had cash assets of approximately $78 million.

About Replidyne, Inc.

Replidyne is a biopharmaceutical company focused on discovering, developing, in-licensing and commercializing innovative anti-infective products. Replidyne's most advanced product candidate, faropenem medoxomil, is a novel oral community antibiotic, expected to be appropriate for use as a first-line antibiotic for treatment of respiratory and skin infections in adult and pediatric patients. Replidyne's investigational antibacterial agent REP3123 targets Gram-positive C. difficile bacteria and C. difficile- associated disease (CDAD). Replidyne is pursuing the development of other novel anti-infective programs based on its DNA replication inhibition technology and its in-house discovery research.

1-Apr-2008 Change in Directors or Principal Officers

Item 5.02 Departure of Directors or Principal Officers; Election of Directors;
Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
(e) On March 31, 2008, Replidyne, Inc. (the "Company") entered into retention bonus agreements with each of Donald Morrissey and Mark Smith (the "Retention Bonus Agreements"). The Retention Bonus Agreements provide that Messrs. Morrissey and Smith are each eligible to earn both (i) a cash bonus in the amount of $100,000 (the "September Bonus"), provided that such employee remains employed by the Company through September 30, 2008, and (ii) a cash bonus in an amount of not less than $100,000 and not greater than $150,000, which final amount will be determined by the Board of Directors of the Company in its sole discretion, provided that such employee remains employed by the Company through the consummation of a strategic transaction. For purposes of the Retention Bonus Agreements, a strategic transaction is defined as, subject to the sole discretion of the Board of Directors of the Company, (i) a strategic alliance or partnership with an unaffiliated third party that relates to the development and commercialization of faropenem medoxomil or (ii) another strategic transaction to which the Company is a party. In the event that the employment of Messrs. Morrissey or Smith with the Company is terminated by the Company without cause (as defined in such employee's employment agreement with the Company) or by such employee for good reason (as defined in such employee's employment agreement with the Company) prior to September 30, 2008, such employee will become entitled to the September Bonus. The term of the Retention Bonus Agreements extends until the later to occur of
(i) September 30, 2008 and (ii) ten days following the consummation of a strategic transaction, provided that the Company has made all required payments thereunder. The Retention Bonus Agreements do not affect the terms of the employment agreements that the Company has entered into with each of Messrs. Morrissey and Smith, which remain in full force and effect. Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.


Exhibit Description

10.1 Retention Bonus Agreement dated March 31, 2008 by and between the
Company and Mark Smith

10.2 Retention Bonus Agreement dated March 31, 2008 by and between the
Company and Donald Morrissey

Great Progress in Replidyne’s Pipeline

http://seekingalpha.com/article/66685-great-progress-in-replidynes-pipeline

Replidyne Announces 2007 Fourth Quarter and Full Year Results
Tuesday February 26, 4:00 pm ET

LOUISVILLE, Colo., Feb. 26 /PRNewswire-FirstCall/ -- Replidyne, Inc. (Nasdaq: RDYN - News) today announced its financial results for the fourth quarter and full year ended December 31, 2007.

Replidyne reported a net loss of $16.9 million for the fourth quarter ended December 31, 2007, or a net loss per basic and diluted common share of $0.63 per share, compared to a net loss of $9.6 million, or $0.36 per basic and diluted common share, for the quarter ended December 31, 2006. For the year ended December 31, 2007, Replidyne reported net income of $7.7 million, or $0.29 per share basic common share and $0.28 per diluted common share, compared to a net loss of $29.2 million, or $2.49 per basic and diluted common share, for the year ended December 31, 2006. Net income for the current year was due to revenue recognized upon termination of the company's commercialization and development agreement for faropenem medoxomil (faropenem) with Forest Laboratories (Forest) in May 2007. Cash, cash equivalents and short-term investments at December 31, 2007 totaled $90.3 million.

"At the end of 2007, we streamlined our operations by restructuring the organization and re-prioritizing our research and development pipeline. In 2008, we continue to focus on our main objectives," said Kenneth J. Collins, Replidyne's President and CEO. "Securing a partner for the faropenem program remains a top priority. We intend to advance our Clostridium difficile program and file an IND by the end of the year. Also by the end of the year, we expect to identify an IND candidate from our DNA replication inhibition program. Finally, we will continue to seek strategic alternatives that augment our pipeline and add value."

Revenue for the year ended December 31, 2007 was $58.6 million. Upon termination of the commercialization and development agreement with Forest, all unamortized upfront and milestone payments as well as contract revenue for funded activities were fully recognized as revenue in the period ended May 7, 2007. Replidyne will not report any revenue under this agreement for future reporting periods.

Research and development expenses in the fourth quarter of 2007 were $14.9 million compared to $13 million in the corresponding quarter of 2006. Faropenem related expense represented approximately 77% of total research and development expense in the quarter, primarily for costs to prepare for patient enrollment in three planned Phase III clinical trials of faropenem, one for treatment of acute bacterial sinusitis and two for treatment of community acquired pneumonia, as well as costs to support the ongoing placebo-controlled Phase III clinical trial of faropenem for treatment of acute exacerbation of chronic bronchitis. Fourth quarter 2007 expense also included $1.7 million related to contingent supply agreement costs related to the delayed development program for faropenem. Additionally, research and development expense included increased costs for preclinical activities targeted to Replidyne's discovery research programs, primarily its C. difficile and inhibition of DNA replication programs offset by decreased expense related to the REP8839 program that was suspended in December 2007. Research and development expense was $43.3 million for the full year 2007 compared to $38.3 million in 2006. The increase in full year research and development expense reflected increased costs to prepare for future clinical trials of faropenem and ongoing execution of the placebo-controlled Phase III clinical trial for treatment of acute exacerbations of chronic bronchitis as well as increased preclinical activities within the C. difficile and inhibition of DNA replication programs. These increases were partially offset by lower full year contingent supply agreement costs related to the faropenem program and $1.5 million of product acquisition cost in 2006 to complete the purchase of tRNA synthetase technology from GlaxoSmithKline which includes Replidyne's C. difficile program and REP8839.

Sales, general and administrative expenses for the fourth quarter of 2007 were $3.2 million compared to $3.5 million in the fourth quarter of 2006 reflecting lower marketing study expenses in the 2007 quarter. Included in the 2007 quarter result was $0.6 million related to the organizational restructuring implemented on December 10, 2007. Full year 2007 selling, general and administrative expenses were $13 million compared to $12.2 million in 2006 reflecting increased full year compensation costs, restructuring expense, and increased professional fees related to public company compliance.

Investment income for the fourth quarter of 2007 was $1.2 million compared to $1.7 million for the fourth quarter of 2006, primarily reflecting lower cash balances available for investment in the 2007 period. Full year 2007 investment income was $5.5 million compared to $6.0 million 2006.

As reported in its 2006 results, through July 3, 2006 Replidyne recorded dividends due to preferred shareholders of $5.4 million. All outstanding preferred stock and accumulated dividends were converted into common stock upon closing of the initial public offering on July 3, 2006 and no preferred stock or accrued dividends were outstanding after that date.

I'm not sure how to value it currently except for cash, the report on the 26th should open the door for that. A big reason for the drop is that it's a very thin stock, but that will be good when it moves back up.

close to 100 m cash enough to survive 2 fiscal years; 34 % head count cut; get rid of antibiotics research in pipe line; priorty for promising candidates in pipeline; seek partner for its important drugg.. Am i missing anything?
What is fair book value?

I bought a small amount this morning just to keep a closer eye on it, waiting for the 26th to see why this is so cheap.

what is range for entry? tia

surf thnx.. very good info..
'Faropenem, from Replidyne (RDYN), is in early-stage tests for MRSA. An antibiotic from privately held Paratek Pharmaceuticals is in early-stage tests for community and hospital infections. And Cubist's (CBST) fast-growing antibiotic Cubicin, which is already on the market, is being tested for a variety of other infections.'
ADLS IS MENTIONED TOO.. Two of stocks under my radar..
Getting back to RDYN .. what did u mean when you said "trading at nothing"?

Super drugs for 'superbugs'

http://money.cnn.com/2008/02/13/news/companies/antibiotic/index.htm?source=yahoo_quote

RDYN has bottomed and you should get a nice bounce into CC: (buy on any further weakness)

Replidyne to Report 2007 Fourth Quarter and Year-End Earnings
Tuesday February 5, 7:30 am ET
Presenting at BIO CEO & Investor Conference

LOUISVILLE, Colo., Feb. 5 /PRNewswire-FirstCall/ -- Replidyne, Inc. (Nasdaq: RDYN - News) announced today that it will host a conference call on Tuesday, February 26, 2008 at 4:45 P.M. ET to report 2007 fourth quarter and year-end earnings. Additionally, Replidyne will present at an upcoming investor conference in February 2008.

Earnings conference call information is as follows:

Kenneth J. Collins, President and CEO, and other members of Replidyne's
senior management team will provide a company update and discuss
earnings results via conference call and webcast on Tuesday, February 26,
2008, at 4:45 P.M. ET. Callers may participate in the conference call by
dialing 866-510-0707 (domestic) or 617-597-5376 (international), and
providing the passcode 33794809. To access the live webcast, please log
on to the company's website at http://www.Replidyne.com and go to the
Investor Relations section.

A replay of the conference call will be available approximately one hour
after completion of the call through Tuesday, March 11, 2008 at midnight.
Callers may access the replay by dialing 888-286-8010 (U.S.
participants) or 617-801-6888 (international participants). The audio
replay passcode is 92464480. To access a replay of the webcast, visit
the Investor Relations section of the company's website at
http://www.Replidyne.com.


Investor conference presentation information is as follows:

-- Mr. Collins will present on Tuesday, February 12, 2008 at 2:45 P.M. ET
at the BIO CEO & Investor Conference, to be held at the Waldorf-Astoria
in New York City. A live audio webcast of this presentation will be
available on the investor relations section of the company's website at
http://www.Replidyne.com. The webcast will be archived and available on
Replidyne's website after the event for a period of 30 days.
-- At the same conference, Replidyne's Chief Commercial Officer Peter
Letendre, Pharm.D. will participate on antibiotics panel "Super Drugs
Against Super Bugs" on Wednesday, February 13, 2008 at 9:30 A.M.

Form 8-K for REPLIDYNE INC

28-Jan-2008

Other Events


Item 8.01. Other Events.

On January 22, 2008, Replidyne, Inc. (the "Company") received a Warning Letter (the "Letter") from the U.S. Food and Drug Administration (the "FDA") pursuant to the completion of the FDA's review of clinical trials performed in connection with the December 2005 new drug application ("NDA") filed by the Company in support of faropenem medoxomil 300 mg tablets twice per day dose, in respect of which the FDA issued a non-approvable letter in October 2006. The clinical trials that supported this NDA were conducted by Bayer Corporation as a previous licensee of faropenem medoxomil. The Company intends to respond timely to the issues raised by the FDA.

Replidyne Provides Strategic Update
Monday December 10, 4:00 pm ET
- Initiatives include restructuring and pipeline prioritization -


LOUISVILLE, Colo., Dec. 10 /PRNewswire-FirstCall/ -- Replidyne, Inc. (Nasdaq: RDYN - News) today announced an operational restructuring to align critical resources with strategic priorities. These priorities include identifying a partner for Replidyne's late-stage antibiotic, faropenem medoxomil (faropenem), advancing and expanding its infectious disease pipeline, and exploring additional corporate development opportunities.
The key elements of the Company's operating strategy going forward are as follows:


-- Corporate restructuring. To better align the organization with its
strategic and operations priorities, Replidyne has reduced headcount by
approximately 35 percent, primarily in the administrative, clinical,
regulatory, and commercial functions.

-- Pipeline programs. Replidyne will retain key research and development
expertise to progress its most promising preclinical programs,
including REP3123, its investigational antibacterial for the treatment
of C. difficile-associated disease (CDAD), and its DNA replication
inhibition program. As a result of prioritizing these preclinical
programs, Replidyne has suspended the development of topical antibiotic
REP8839 due to the additional investment required to optimize the
formulation and the niche market opportunity.

-- Development strategy for faropenem. Replidyne will continue its ongoing
placebo-controlled Phase III trial for faropenem in acute exacerbation
of chronic bronchitis (AECB). This clinical trial is approaching
50 percent enrollment and results are expected in 2008. Consistent with
prior guidance, Replidyne will not initiate enrollment in clinical
trials for faropenem in acute bacterial sinusitis (ABS) and
community-acquired pneumonia (CAP) until a partner is identified.

-- Business development. Replidyne will retain a strong business
development capability that, in addition to seeking a partner for
faropenem, will pursue opportunities to augment Replidyne's pipeline.


"We have re-sized Replidyne to align the organization with our near-term strategic interests and financial responsibilities," stated Kenneth J. Collins, Replidyne's President and CEO. "By retaining our key scientific assets and our experienced management team, we maintain our core value as an infectious disease company. While Replidyne continues to build on our most promising research and development programs, we will also focus on pursuing strategic alternatives that bring value to Replidyne shareholders."

As of November 30, 2007, Replidyne had cash assets of approximately $93 million. Based on currently planned clinical trials and development activities, as well as the restructuring announced today, the Company believes it has internal cash resources to support operations for at least the next two fiscal years. In connection with the restructuring, Replidyne expects to include a restructuring expense of approximately $1.5 million primarily related to employee severance payments.

http://biz.yahoo.com/prnews/071210/lam092.html?.v=101

Oversold with an Improving RSI (RDYN)

Bullish MACD Crossovers (RDYN)

10/01/07 ECHOLS ROGER M Sold 5,000 $6.48 32,375.00
09/04/07 ECHOLS ROGER M Sold 5,000 $6.78 33,900.00
08/22/07 ECHOLS ROGER M Sold 6,541 $6.00 39,246.00
08/21/07 ECHOLS ROGER M Sold 3,459 $6.00 20,754.00
06/15/07 ECHOLS ROGER M Sold 7,555 $6.00 45,330.00
05/23/07 ECHOLS ROGER M Sold 7,445 $6.00 44,670.00
03/01/07 ECHOLS ROGER M Sold 10,000 $6.00 60,000.00
03/01/07 ECHOLS ROGER M* Sold 15,000 $6.00 90,000.00
03/01/07 MORRISSEY DONALD JAMES JR Sold 25,000 $6.00 150,000.00
01/17/07 MORRISSEY DONALD JAMES JR Sold 20,000 $5.04 100,800.00
01/03/07 MORRISSEY DONALD JAMES JR Sold 11,895 $5.68 67,563.60

http://moneycentral.msn.com/investor/invsub/insider/trans.asp?Symbol=rdyn

Parabolic SAR Buy Signals (RDYN)

RDYN also turned out to be a nice reversal buy, sold half of position at the close today, hopefully it has some more swing through this week.

surf

Replidyne's Investigational Antibacterial Agent REP3123 Prevents Sporulation in Clostridium difficile
Poster to be Presented at the 47th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy

LOUISVILLE, Colo., Sept. 19 /PRNewswire-FirstCall/ -- Replidyne, Inc. (Nasdaq: RDYN) announced today that in preclinical studies, its antibacterial candidate REP3123 is shown to inhibit growth and prevent spore-forming of the Gram-positive Clostridium difficile (C. difficile) bacterium without inhibiting other key organisms that are essential for normal intestinal functioning. C. difficile-associated disease (CDAD), a major cause of morbidity among the elderly and hospitalized patients, is acquired by ingesting spores present in the environment that then grow and multiply in the gut. In preclinical studies, REP3123 was superior to two agents widely used to treat C. difficile infections, vancomycin and metronidazole, in preventing the organism from forming spores. The study results suggest that REP3123 has the potential to reduce the presence of spores in the intestine, subsequently preventing dissemination into the environment, thereby potentially reducing outbreak and relapse rates.

These results will be presented on Thursday, September 20, 2007 at 10:00 AM in Room E253D by Ian A. Critchley, Ph.D., Executive Director, Microbiology at Replidyne during poster session 229 titled, 'New Agents Active Against Clostridium difficile' at the 47th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy held at the McCormick Place conference center in Chicago.

REP3123 is a new narrow spectrum antibacterial agent that in vitro prevents the growth of C. difficile by inhibiting an essential enzyme in the bacterial cell called methionyl tRNA synthetase, which blocks the organism from synthesizing proteins. Methionyl tRNA synthetase is a novel target that has not been previously exploited by antibiotics and REP3123 shows no cross-resistance to currently marketed antibacterial agents. To determine the ability of REP3123 to prevent sporulation of C. difficile, four clinical isolates were studied including two epidemic BI/NAP1/027 strains identified in recent outbreaks in Quebec, Canada. The BI/NAP1/027 outbreak strains produce greater amounts of toxins A and B, have increased sporulation capacity, and cause more severe disease and increased morbidity and mortality. All bacterial strains were grown in the presence of low concentrations (sub-minimum inhibitory concentrations or MICs) of either REP3123, vancomycin or metronidazole. Spores were quantified after 96 hours of drug exposure. All four strains of C. difficile varied in their ability to produce spores under the conditions evaluated in this study. At 0.5 times the MIC, REP3123 was the most effective agent at preventing the production of spores in all strains (equal to or less than 1% of spores after 96 hours of treatment). In contrast, sub-MICs of metronidazole promoted spore formation in three strains and vancomycin promoted sporulation in two strains. The ability of REP3123 to inhibit sporulation was concentration-dependent, with no spores detected at concentrations of 0.5 times the MIC. The FDA has not approved REP3123 for marketing in this or any other indication.

'CDAD is a challenging disease for many reasons, including the difficulty associated with eradication of Clostridium difficile and its spores from the environment,' explained Stuart Johnson, M.D., Associate Professor of Medicine, Stritch School of Medicine, Loyola University and the Hines VA Medical Center in Chicago. 'These results demonstrating that REP3123 has a direct impact on inhibiting spore-formation of C. difficile bacteria are highly promising and clinically relevant.'

'Through a novel mechanism of action that inhibits growth and targets both sporulation and toxin production, REP3123 could be a future treatment option that tackles the main challenges associated with treating CDAD: high rates of relapse and new outbreaks,' stated Kenneth J. Collins, Replidyne's President & CEO. 'We are excited by the potential of REP3123 and look forward to its further development.'

About Clostridium difficile

C. difficile is a Gram-positive anaerobic bacterium that causes C. difficile-associated disease (CDAD). According to the Centers for Disease Control and Prevention, CDAD is on the rise worldwide, both in terms of number of cases and severity of the disease. Most cases of CDAD occur in a hospital setting due to increased use of antibiotics and other chemotherapeutics that disrupt normal intestinal flora, an ageing population, and difficulty of eradicating C. difficile spores. However, more recently, CDAD has been acquired in the community setting where several outbreaks with increased mortality have occurred. The emergence of an epidemic, hypervirulent C. difficile strain (BI/NAP1, 027) that produces high levels of toxins poses a real threat to public health and demands improved infection control as well as novel treatment options.

Replidyne's Investigational Antibacterial Agent REP3123 Prevents Toxin Production in Clostridium difficile
Poster to be Presented at the 47th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy

LOUISVILLE, Colo., Sept. 19 /PRNewswire-FirstCall/ -- Replidyne, Inc. (Nasdaq: RDYN) announced today that in preclinical studies, its antibacterial candidate REP3123 is shown to stop the production of destructive intestinal toxins caused by Clostridium difficile (C. difficile) bacteria. C. difficile-associated disease (CDAD), an inflammatory condition caused by potentially lethal toxins that enter and then kill healthy cells in the gut, is a major cause of morbidity among elderly and hospitalized patients. The study results suggest that REP3123 inhibits growth and blocks the production of these disease-causing toxins potentially reducing the severity of, and even preventing, CDAD.

These results will be presented on Thursday, September 20, 2007 at 10:00 AM in Room E253D by Urs Ochsner, Ph.D., Principal Scientist, Microbiology at Replidyne during poster session 229 titled, 'New Agents Active Against Clostridium difficile' at the 47th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy held at the McCormick Place conference center in Chicago.

REP3123 is a new narrow spectrum antibacterial agent that in vitro prevents the growth of C. difficile by inhibiting an essential enzyme in the bacterial cell called methionyl tRNA synthetase, which blocks the organism from synthesizing proteins. Methionyl tRNA synthetase is a novel target that has not been previously exploited by antibiotics and REP3123 shows no cross-resistance to currently marketed antibacterial agents. When tested in high density cultures, REP3123 inhibited toxin production at low concentrations (< 1 ug/mL) for all C. difficile strains tested. In contrast, widely used agents such as vancomycin and metronidazole did not reduce toxin production in these high density cultures even at drug concentrations well above those required to inhibit growth of the bacteria. The levels of toxins were monitored by immunoassays using antibodies that specifically recognize two disease-causing factors, toxin A and toxin B. The dramatic reduction in the deleterious effects of the toxins was directly demonstrated by the gold standard cytotoxicity assay, which uses human fibroblasts to confirm the ability of REP3123 to block toxin production. The FDA has not approved REP3123 for marketing in this or any other indication.

'CDAD is a challenging disease because of the difficulty in managing patients with severe manifestations as well as the problem of recurrence in those patients who recover from the initial episode. As the disease is primarily toxin-mediated, new therapies that act by means other than simply eradicating the bacteria may be very helpful and should be studied,' stated Stuart Johnson, M.D., Associate Professor of Medicine, Stritch School of Medicine, Loyola University and the Hines VA Medical Center in Chicago. 'The finding that REP3123 has a direct impact on inhibiting toxin production of C. difficile bacteria is very important and equally as exciting.'

'C. difficile-associated diseases have become a serious health matter in both the hospital and community settings,' stated Kenneth J. Collins, Replidyne President & CEO. 'These results, along with the sporulation-inhibition findings also reported today, are very encouraging and we look forward to the further development of REP3123.'

About Clostridium difficile

C. difficile is a Gram-positive anaerobic bacterium that causes C. difficile-associated disease (CDAD). CDAD is on the rise worldwide, both in terms of number of cases and severity of the disease. Most cases of CDAD occur in a hospital setting due to increased use of antibiotics and other chemotherapeutics that disrupt normal intestinal flora, an ageing population, and difficulty of eradicating C. difficile spores. However, more recently, CDAD has been acquired in the community setting where several outbreaks with increased mortality have occurred. The emergence of an epidemic, hypervirulent C. difficile strain (BI/NAP1, 027) that produces high levels of toxins poses a real threat to public health and demands improved infection control as well as novel treatment options.

Replidyne Pipeline Featured at 47th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy
~ Presentations Include 1 Oral Session and 21 Poster Sessions ~
~ Replidyne Debuts New Clostridium difficile Program ~

LOUISVILLE, Colo., Sept. 17 /PRNewswire-FirstCall/ -- Replidyne, Inc. (Nasdaq: RDYN) announced today that it will be presenting 21 posters highlighting three major pipeline programs at the 47th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) held at the McCormick Place conference center in Chicago. The posters will showcase previously unpublished data related to faropenem medoxomil (faropenem), Replidyne's Phase III clinical program for the treatment of community-acquired respiratory tract infections in adults and children; REP8839, Replidyne's Phase II topical antibiotic initially targeted for the treatment of impetigo, the most common bacterial skin infection in children; and REP3123, Replidyne's newly disclosed lead product candidate to treat Clostridium difficile (C. difficile) related diseases, a major cause of morbidity among the elderly and hospitalized patients.

'We are excited to be presenting a wealth of information on our novel anti-infective pipeline at the premier scientific conference in this field. The presentation and posters showcase the depth of our pipeline and the productivity of our research and development organization,' commented Kenneth J. Collins, Replidyne President and CEO. 'In particular, we will be presenting data highlighting the scientific promise of our preclinical C. difficile program.'

REP3123 Presentations

Today at the All New Antimicrobial Agents session, Replidyne's Chief Scientific Officer and company co-founder, Nebojsa Janjic, Ph.D., unveiled highly-anticipated details of Replidyne's C. difficile program. The presentation introduced REP3123, highlighting key preclinical findings including its ability to inhibit growth, halt toxin production and prevent spore-formation of the Gram-positive C. difficile bacterium without inhibiting other key organisms that are essential for normal intestinal functioning.

Replidyne will present the following C. difficile posters on Thursday, September 20 at 10:00 AM, Room E253D:

-- Poster F1-2112, titled 'Novel Inhibitors of Methionyl tRNA Synthestase
from Clostridium difficile: Identification and Synthesis of REP3123.'
-- Poster F1-2113, titled 'REP3123 is a Potent and Selective Inhibitor of
Methionyl tRNA Synthetase from Clostridium difficile.'
-- Poster F1-2114, titled 'Co-crystal Structure of REP3123 Bound to
Clostridium difficile Methionyl tRNA Synthetase.'
-- Poster F1-2115, titled 'Spectrum of Activity of REP3123 against
Aerobic Bacterial Pathogens.'
-- Poster F1-2117, titled 'In vitro Activity of REP3123 against
Clostridium difficile and Other Anaerobic Intestinal Bacteria.'
-- Poster F1-2118, titled 'REP3123: A Narrow Spectrum Antibacterial Agent
that Inhibits Growth and Prevents Sporulation in Clostridium
difficile.'
-- Poster F1-2119, titled 'REP3123 Inhibits Toxin Production in C.
difficile.'
-- Poster F1-2120, titled 'Efficacy of Novel MetRS Inhibitors in a C.
difficile Hamster Model.'


Faropenem Presentations
Monday, September 17 at 12:00 PM, Hall D:
-- Poster E-256, titled 'Comparison of the Bactericidal Activities of
Faropenem, Ertapenem, Amoxicillin, Cefixime, Cefuroxime and
Moxifloxacin against Streptococcus pneumoniae.'
-- Poster E-257, titled 'Comparative Ability of Faropenem to Select for
Resistant Mutants of S. pneumoniae.'
-- Poster E-258, titled 'Comparative Ability of Faropenem to Select for
Resistant Mutants in H. influenzae.'
-- Poster C2-200, titled 'Antimicrobial Resistance Patterns among
Streptococcus pneumoniae Isolated from Children in the U.S. 2005-2006
Faropenem Surveillance Study.'
-- Poster D-238, titled 'An Evaluation of Dried MIC Susceptibility Plate
Compared to the CLSI (M7) Reference Broth Microdilution Method with
the New Antimicrobial Agent, Faropenem.'
-- Poster C2-214, titled 'Comparative Affinity of Faropenem to Penicillin
Binding Proteins (PBPs) of Pneumococci with Varying Beta-Lactam
Susceptibilities.'


Monday, September 17 at 1:00 PM, Hall D:
-- Poster L-480, titled 'A Double-Blind, Randomized, Dose Ranging Study
to Evaluate the Safety of Faropenem Medoxomil (FM) at 300 or 600 mg
BID for Seven Days in Healthy Volunteers.'
-- Poster L-481, titled 'A Phase II Double-Blind, Randomized Trial
Comparing Faropenem Medoxomil at 300 mg BID for Seven Days and 600 mg
BID for Five Days in Subjects with Acute Maxillary Sinusitis Diagnosed
by Antral Tap.'


Tuesday, September 18 at 11:15 AM, Hall D:
-- Poster G-980, titled 'Monitoring Changes in Susceptibility of Middle
Ear Fluid (MEF), Nasopharyngeal (NP) and Oropharyngeal (OP) Pathogens
to Faropenem in a Phase II Acute Otitis Media (AOM) Study.'
-- Poster G-983, titled 'Use of Parent-reported Outcome Measure in Acute
Otitis Media Clinical Trials.'
-- Poster G-987, titled 'Dose-effect of Faropenem Medoxomil (FM) in the
Treatment of Acute Otitis Media.'


Wednesday, September 19 at 11:15 AM, Hall D:
-- Poster A-1435, titled 'Pharmacokinetic-Pharmacodynamic (PK-PD)
Assessment of Faropenem (FAR) in a Lethal Murine-Bacillus anthracis
(BA) Inhalation Post-Exposure Prophylaxis Model.'


REP8839 Presentation
Thursday, September 20 at 10:00 AM, Room E253D:
-- Poster F1-2116, titled 'In vitro Activity of REP8839 against
Pasteurella species and Other Fastidious Bacteria Isolated from
Infected Animal Bites in Humans.'


About Clostridium difficile

C. difficile is a Gram-positive anaerobic bacterium that causes C. difficile-associated disease (CDAD). CDAD is on the rise worldwide, both in terms of number of cases and severity of the disease. Most cases of CDAD occur in a hospital setting due to increased use of antibiotics and other chemotherapeutics that disrupt normal intestinal flora, an ageing population, and difficulty of eradicating C. difficile spores. However, more recently, CDAD has been acquired in the community setting where several outbreaks with increased mortality have occurred. The emergence of an epidemic, hypervirulent C. difficile strain (BI/NAP1, 027) that produces high levels of toxins poses a real threat to public health and demands improved infection control as well as novel treatment options.

About Replidyne, Inc.

Replidyne is a biopharmaceutical company focused on discovering, developing, in-licensing and commercializing innovative anti-infective products. Replidyne's lead product, faropenem medoxomil, is a novel oral, community antibiotic, expected to be appropriate for use as a first-line antibiotic for treatment of respiratory and skin infections in adult and pediatric patients. Replidyne's second drug candidate, REP8839, is a topical anti-infective product candidate in development for the treatment of skin and wound infections, including methicillin-resistant S. aureus (MRSA) infections. Replidyne's investigational antibacterial agent REP3123 targets Gram-positive C. difficile bacteria and related diseases. In preclinical studies, REP3123 has been show to inhibit growth, toxin production and spore-forming in C. difficile bacteria. Replidyne is also pursuing the development of other novel anti-infective programs based on its in-house discovery research.

http://biz.yahoo.com/e/070917/rdyn8-k.html

Form 8-K for REPLIDYNE INC

17-Sep-2007

Regulation FD Disclosure


Item 7.01 Regulation FD Disclosure.
Replidyne, Inc. (the "Company") announced today that it will be presenting 21 posters relating to three of its research pipeline programs at the 47th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy ("ICAAC") held at the McCormick Place conference center in Chicago, Illinois. The posters will describe previously unpublished data related to faropenem medoxomil, the Company's Phase III clinical program for community-acquired respiratory tract infections; REP8839, the Company's Phase II topical antibiotic initially targeted for the treatment of impetigo, the most common bacterial skin infection in children; and REP3123, the Company's product candidate to treat Clostridium difficile ("C. difficile") related diseases, a major cause of morbidity among the elderly and hospitalized patients.
REP3123 Presentations
On September 17, 2007 at the All New Antimicrobial Agents session of the ICAAC, the Company's Chief Scientific Officer, Nebojsa Janjic, described details of the Company's C. difficile program. The presentation introduced REP3123, highlighting key preclinical findings, including its ability to inhibit growth, halt toxin production and prevent spore-formation of the Gram-positive C. difficilebacterium without inhibiting other key organisms that are essential for normal intestinal functioning.
The Company will present the following C. difficile posters on Thursday, September 20, 2007 at 10:00 AM, Room E253D:
• Poster F1-2112, titled "Novel Inhibitors of Methionyl tRNA Synthestase from Clostridium difficile: Identification and Synthesis of REP3123."

REP3123 is a novel antibacterial agent that inhibits growth of C. difficile by inhibiting an essential enzyme called methionyl t-RNA synthetase ("MetRS") that prevents the organism from synthesizing proteins. The research work shows that REP3123 has an in vitro microbiological profile that is competitive with vancomycin and metronidazole currently used to treat C. difficileassociated disease ("CDAD").
• Poster F2113, titled "REP3123 is a Potent and Selective Inhibitor of Methionyl tRNA Synthetase from Clostridium difficile."

The objective of the study was to characterize the interaction of REP3123 with the isolated MetRS enzyme from C. difficile, define its potency of inhibition under standard conditions and compare its ability to inhibit MetRS enzymes from other bacteria and humans. REP3123 is an inhibitor of the MetRS enzyme from C. difficile and most Gram-positive bacteria, which is consistent with its narrow spectrum of inhibition of bacterial growth. It is a limited inhibitor of the human MetRS enzyme from both cellular mitochondria and cytoplasm. These data help establish that MetRS is the target enzyme for REP3123 inhibition of bacterial growth. The limited inhibition of human MetRS predicts little protein synthesis inhibition in the bacterial host.
• Poster F1-2114, titled "Co-Crystal Structure of REP3123 Bound to Clostridium difficileMethionyl tRNA Synthetase."

This study determined the three-dimensional structure of C. difficile MetRS (CDMetRS) in combination with REP3123 by X-ray crystallography. Knowing the three-dimensional structure of REP3123 bound to CDMetRS will allow further study related to how REP3123 inhibits CDMetRS. This understanding will also facilitate design of the next generation of MetRS inhibitors.
• Poster F1-2115, titled "Spectrum of Activity of REP3123 against Aerobic Bacterial Pathogens."

REP3123 is a narrow spectrum antibacterial agent with activity against Gram-positive aerobes, including resistant strains, but limited or no activity against Gram-negative aerobes. The limited activity against enteric Gram-negative organisms suggests that REP3123 is unlikely to disturb the ecological balance of intestinal aerobes. The potent activity of REP3123 against vancomycin-resistant enterococci suggests that the agent is unlikely to promote intestinal colonization with these organisms. Based on the outcome of studies conducted to date, further studies are believed to be warranted to evaluate REP3123 as a novel agent for the treatment of CDAD.
• Poster F1-2117, titled "In vitro Activity of REP3123 against Clostridium difficile and Other Anaerobic Intestinal Bacteria."

The objective of the study was to evaluate the activity of REP3123 and comparator agents against 50 strains of C. difficile and 233 other common Gram-positive and Gram-negative intestinal anaerobic bacterial organisms. REP3123 demonstrated activity against C. difficile and limited activity against other "friendly" intestinal strains and warrants further clinical evaluation for treatment of CDAD.
• Poster F1-2118, titled "REP3123: A Narrow Spectrum Antibacterial Agent that Inhibits Growth and Prevents Sporulation in Clostridium difficile."

In contrast to vancomycin and metronidazole at sub-minimum inhibitory concentrations, REP3123 was effective in preventing vegetative cells of C. difficile from producing spores. Because C. difficile infection is thought to be initiated via ingestion of spores, REP3123 may be a useful agent in treating CDAD and reducing outbreaks and relapse rates. REP3123 is a novel agent with antibacterial activity against C. difficile and further studies will be needed to evaluate its ability to treat CDAD in a clinical setting.
• Poster F1-2119, titled "REP3123 Inhibits Toxin Production in C. difficile."

REP3123 inhibited growth and toxin production in C. difficile broth cultures. REP3123 was found to be more potent against C. difficile broth cultures compared to vancomycin and metronidazole. REP3123 inhibited de novo toxin production in high cell density, stationary phase cultures of C. difficile. REP3123 has the potential to be a superior therapeutic agent compared to currently used antibiotics against CDAD with the added benefit of quickly disarming the disease-causing bacteria.
• Poster F1-2120, titled "Efficacy of Novel MetRS Inhibitors in a C. difficile Hamster Model."

In a hamster model, REP3123 exhibited superior efficacy to vancomycin for the treatment of CDAD. Unlike vancomycin, the hamster survived for the duration of the study suggesting that REP3123 may provide protection from relapse or re-infection. REP3123-treated animals had a healthy gastrointestinal appearance at study termination. These data suggest that REP3123 is a promising new agent for the treatment of CDAD and superior to current standard therapy based upon efficacy results in this animal (hamster) model. Faropenem Presentations
The Company will present the following Faropenem posters on Monday, September 17, 2007 at 12:00 PM, Hall D:
• Poster E-256, titled "Comparison of the Bactericidal Activities of Faropenem, Ertapenem, Amoxicillin, Cefixime, Cefuroxime and Moxifloxacin against Streptococcus pneumoniae."

In this study, both experimental and mathematical models were used to evaluate differences between time and concentration dependent killing properties of faropenem medoxomil and other agents against two strains of S. pneumoniae. Faropenem medoxomil exhibited the most pronounced bactericidal effects against S. penumoniae when compared with moxifloxacin, amoxicillin, cefuroxime, cefixime and ertapenem, even at the minimum inhibitory concentration ("MIC"). In the mathematical model the maximal kill rates (k-max, h-1) were 2.4 for faropenem medoxomil, 1.4 for ertapenem, amoxicillin, cefuroxime and moxifloxacin, and 0.7 for cefixime. Much lower concentrations of faropenem medoxomil were required for 3log kill within six hours when compared with the other agents. These results suggest that faropenem medoxomil should be an effective agent for the treatment of infections caused by S. pneumoniae.

• Poster E-257, titled "Comparative Ability of Faropenem to Select for Resistant Mutants of S. pneumoniae."

The objective of the study was to evaluate the ability of faropenem medoxomil and other agents to select for resistant strains of S. pneumoniae in the laboratory. Faropenem medoxomil had low MICs for all strains of S. pneumoniae isolates tested, including strains resistant to penicillin and macrolides. Faropenem medoxomil failed to select for resistant mutants of S. pneumoniae even after 50 daily subcultures in contrast to the macrolides and quinolones that selected for mutants with higher MICs. Development of resistance following the launch of a new antibacterial agent is always a concern. Some antibiotics seem to select for resistant bacteria more quickly than others. These in vitro study results suggest that faropenem medoxomil is unlikely to select for resistant isolates of S. pneumoniae in the clinical setting.
• Poster E-258, titled "Comparative Ability of Faropenem to Select for Resistant Mutants in H. influenzae."

The aim of the study was to evaluate the ability of faropenem medoxomil and other agents to select for resistant strains H. influenzae in the laboratory. Faropenem medoxomil, unlike the macrolides and quinolones, did not select for resistant mutants in any of the six strains of H. influenzaetested in this study even after 50 days. Development of resistance following the launch of a new antibacterial agent is always a concern. Some antibiotics seem to select for resistant bacteria more quickly than others. These in vitro study results suggest that faropenem has a low likelihood of resistance selection when the drug is introduced into the clinical setting.
• Poster C2-200, titled "Antimicrobial Resistance Patterns among Streptococcus pneumoniaeIsolated from Children in the U.S. 2005-2006 Faropenem Surveillance Study."

The objective of the study was to determine the prevalence of resistant strains of S. penumoniaecollected from U.S. children during the 2005-2006 respiratory season and determine the activity of faropenem medoxomil and other agents against recent clinical isolates. Penicillin-resistant and multi-drug resistant strains of S. pneumoniae remain prevalent among U.S. isolates from children aged 14 years or less during 2005-2006 despite widespread use of the pneumococcal vaccine. The highest resistance rates were seen in S. pneumoniae isolated from the youngest children aged two years or less. Faropenem medoxomil was the most active oral b-lactam based on in vitro susceptibility test results suggesting that further studies are warranted to determine clinical efficacy against pediatric respiratory tract infections. In light of the continued prevalence of antibiotic-resistance among U.S. pediatric respiratory tract isolates of S. pneumoniae, these data suggest that there is an unmet need for new and safe oral agents that are active against both penicillin-resistant and multi-drug-resistant strains.
• Poster D-238, titled "An Evaluation of Dried MIC Susceptibility Plate Compared to the CLSI (M7) Reference Broth Microdilution Method with the New Antimicrobial Agent, Faropenem."

The aim of the study was to show that a Sensititre® 18-24 hour dried susceptibility plate containing faropenem medoxomil was an accurate and reproducible method for testing bacterial isolates when compared with the CLSI (M7) reference broth microdilution method. Dried MIC panels provide a more convenient method for clinical laboratories to test faropenem medoxomil since they have a longer shelf life, are easier to transport to sites participating in clinical trials and can be used to test many different types of bacteria regardless of their growth medium requirements. Also, if clinical isolates are tested with a dried panel in clinical trials it is a regulatory requirement for a sponsor to demonstrate equivalency to the CLSI (M7) reference broth microdilution method.
• Poster C2-214, titled "Comparative Affinity of Faropenem to Penicillin Binding Proteins (PBPs) of Pneumococci with Varying Beta-Lactam Susceptibilities."

The objective of the study was to compare the affinities of faropenem medoxomil and other b-lactam agents (penicillin G, amoxicillin, cefuroxime and imipenem) for the PBPs of clinical isolates of S. pneumoniae with varying resistance profile (strains that were penicillin-susceptible, penicillin-intermediate, penicillin-resistant, macrolide-resistant and fluoroquinolone-resistant). Faropenem medoxomil exhibited the highest affinities for most of the PBPs (except PBP2X) from the different resistant strains when compared with the other b-lactam antibiotics. b-Lactam antibiotics with high affinity for selected PBPs are generally more rapidly bactericidal which generally means they can kill the bacterial cell more quickly. The potent antibacterial activity of faropenem medoxomil and

high-affinity for all PBPs (except PBP2X) suggests that faropenem medoxomil will retain important killing properties (bactericidal activity) against strains of S. pneumoniae that are both susceptible and resistant to currently marketed antibacterial agents.
The Company will present the following Faropenem posters on Monday, September 17, 2007 at 1:00 PM, Hall D:
• Poster L-480, titled "A Double-Blind, Randomized, Dose Ranging Study to Evaluate the Safety of Faropenem Medoxomil (FM) at 300 or 600 mg BID for Seven Days in Healthy Volunteers."

The primary objective of this trial was to evaluate the safety and tolerability of two doses of faropenem medoxomil, 300 mg BID and 600 mg BID. A secondary objective was to evaluate oral faropenem medoxomil pharmacokinetics. The results suggest that both faropenem medoxomil 300 mg and faropenem medoxomil 600 mg are safe and well tolerated. Faropenem medoxomil is active against the major pathogens responsible for community-acquired respiratory tract infections. These safety and pharmacokinetics data in healthy volunteers suggest that faropenem at a dose of 600 mg BID would be an appropriate candidate for further clinical development in adult patients.
• Poster L-481, titled "A Phase II Double-Blind, Randomized Trial Comparing Faropenem Medoxomil at 300 mg BID for Seven Days and 600 mg BID for Five Days in Subjects with Acute Maxillary Sinusitis Diagnosed by Antral Tap."

The focus of the tolerability assessment was on gastrointestinal adverse events of faropenem medoxomil 300 mg BID and faropenem medoxomil 600 mg BID. Clinical efficacy was a secondary endpoint. Gastrointestinal adverse events were similar in the two groups, 300 mg and 600 mg (14.9% and 14.7%, respectively). No unexpected adverse events were identified with the higher faropenem medoxomil dose. Clinical cure rates achieved with the faropenem medoxomil 600 mg dose were comparable to those achieved with the faropenem medoxomil 300 mg dose; however, the study was not powered for efficacy comparison. In this population of subjects with acute bacterial sinusitis ("ABS"), the two dosing regimens had similar safety and tolerability profiles. Combined with the Phase I comparison of the two dosing regimens (poster L-480), the higher 600 mg dosing regimen appears similar to the 300 mg dosing regimen. The higher dose will be used in future faropenem medoxomil Phase III clinical trials.
The Company will present the following Faropenem posters on Tuesday, September 18, 2007 at 11:15 AM, Hall D:
• Poster G-980, titled "Monitoring Changes in Susceptibility of Middle Ear Fluid (MEF), Nasopharyngeal (NP) and Oropharyngeal (OP) Pathogens to Faropenem in a Phase II Acute Otitis Media (AOM) Study."

The objective of the study was to monitor changes in the susceptibility of bacteria collected at visit 1 by comparing them with susceptibility results obtained on isolates collected at visit 2 and other subsequent visits to faropenem medoxomil. No differences in the susceptibility of middle ear fluid, nasopharyngeal or oropharyngeal isolates to faropenem medoxomil was detected in organisms persisting after days 4-6 in any subjects treated with any of the four doses. These data suggest faropenem medoxomil therapy did not appear to lead to any resistance development pressure on nasopharyngeal/oropharyngeal flora that may relocate to the middle ear causing recurrent Acute Otitis Media ("AOM") with resistant organisms.
• Poster G-983, titled "Use of Parent-reported Outcome Measure in Acute Otitis Media Clinical Trials."

The objective of this study was to compare the rate of symptom resolution in children in two studies (one with tympanocentesis and one without) to examine the association between the AOM-Severity of Symptom scale and clinician assessment. A total of 328 subjects were included in the randomized study and 70 in the observational study. In the first 12 hours, there was reduction in the average score from 8.5 to 4.9 in the randomized trial and 6.4 to 4.8 in the observational study. The large early reduction in clinical score in the randomized study coincided with tympanocentesis. Differences in scores between clinical failures and clinical cures diagnosed by physician assessment appeared later and were smaller in the randomized study than the observational study. This study indicates that tympanocentesis has an immediate effect on AOM symptoms and alters the natural history of AOM. The utility of a PRO as a primary outcome in a study with tympanocentesis is limited.
• Poster G-987, titled "Dose-effect of Faropenem Medoxomil (FM) in the Treatment of Acute Otitis Media."

A total of 328 subjects were randomized to four treatments (7.5 mg/kg, 15, 30, 40) of faropenem medoxomil. The bacteriological response rates ranged from 55% in patients treated with 7.5 mg/kg to 94% in patients treated with 40 mg/kg. Differences in bacteriological eradication were most evident with H. influenzae infections. Eradication was 0 of 9 in subjects treated with 7.5 mg/kg, and 16 of
19 (84%) in subjects treated with 40 mg/kg. This study demonstrates the bacteriological and clinical effectiveness of faropenem medoxomil in the treatment of AOM. The study will provide critical data for dose selection in Phase III. The Company will present the following Faropenem poster on Wednesday, September 19, 2007 at 11:15 AM, Hall D:
• Poster A-1435, titled "Pharmacokinetic-Pharmacodynamic (PK-PD) Assessment of Faropenem (FAR) in a Lethal Murine-Bacillus anthracis (BA) Inhalation Post-Exposure Prophylaxis Model."

Faropenem medoxomil has shown activity against anthrax disease development in the mouse model. In addition, a strong relationship was observed between dose and dose schedule and corresponding plasma concentrations of faropenem medoxomil with efficacy. This study demonstrates that faropenem medoxomil, currently being developed for community respiratory infections in adult and pediatric subjects, may be useful for prevention of anthrax disease development in the event of a bioterrorist attack. In addition, the relationship established between faropenem medoxomil plasma concentrations and efficacy provides an estimate for dose selection.
REP8839 Presentation
The Company will present the following REP8839 poster on Thursday, September 20, 2007 at 10:00 AM, Room E253D:
• Poster F1-2116, titled "In vitro Activity of REP8839 against Pasteurella species and Other Fastidious Bacteria Isolated from Infected Animal Bites in Humans."

The aim of the study was to further define the spectrum of activity of REP8839 against a collection of 101 fastidious Gram-negative organisms and Streptococcus species plus 117 anaerobic isolated from dog and cat bite wounds. REP8839 was active against some of the Gram-positive organisms such as the anaerobic peptostreptococci. Among the Gram-negative bacteria, Bacteroides ureolyticus and Fusobacterium species were quite susceptible. These results suggest that REP8839 may provide some additional coverage against some but not all pathogens isolated from animal bites in humans.
In accordance with General Instruction B.2. of Form 8-K, the information presented under this Item 7.01 shall not be deemed "filed" for purposes of
Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such a filing.
Safe Harbor
The presentations discussed herein contain plans, intentions, objectives, estimates and expectations that constitute forward-looking statements about Replidyne, Inc. that involve significant risks and uncertainties. Actual results could differ materially from those discussed due to a number of factors including, the success and timing of pre-clinical studies and clinical trials; the Company's ability to obtain and maintain regulatory approval of product candidates and the labeling under any approval that may be obtained; plans to develop and commercialize product candidates; the loss of key scientific or management personnel; the size and growth of the potential markets for the Company's product candidates and the Company's ability to serve those markets; regulatory developments in the U.S. and foreign countries; the rate and degree of market acceptance of any future products; the accuracy of Company estimates regarding expenses, future revenues and capital requirements; the Company's ability to obtain and

maintain intellectual property protection for our product candidates; the successful development of the Company's sales and marketing capabilities; the success of competing drugs that are or become available; and the performance of third party manufacturers. These and additional risks and uncertainties are described more fully in the Company's Form S-1 and most recent periodic report filed with the SEC under the Securities Exchange Act of 1934. Copies of filings made with the SEC are available through the SEC's electronic data gather analysis and retrieval system (EDGAR) atwww.sec.gov. All forward-looking statements made in the presentations discussed herein are made as of the date hereof and the Company assumes no obligation to update the forward-looking statements in the document.

I'm just buying now because it had a run that was just as big as this current drop, but selling has had half the volume.

RDYN is actually making money! just read their july 30 earnings report.. Despite termination of one researh contract with Forest Lab..
What is your take surf?

Stocks in a New Uptrend (ADX) (RDYN)

Moved Above Upper Bollinger Band (RDYN)

CCI Buy Signals (RDYN)

Parabolic SAR Buy Signals (RDYN)

Strong Volume Gainers (RDYN)

Replidyne Announces Second Quarter 2007 Earnings

LOUISVILLE, Colo., July 31 /PRNewswire-FirstCall/ -- Replidyne, Inc. (Nasdaq: RDYN) today announced its financial results for the second quarter and cumulative six months ended June 30, 2007.

Replidyne reported net income of $45.5 million for the second quarter ended June 30, 2007 compared to a net loss of $6.2 million for the quarter ended June 30, 2006. Net income for the second quarter of 2007 included license and contract revenue totaling $55.6 million recognized on May 7, 2007, the effective termination date of Replidyne's collaboration and commercialization agreement with Forest Laboratories (Forest). For the six month period ended June 30, 2007, Replidyne reported net income of $36.9 million compared to a net loss of $13.9 million for the six month period ended June 30, 2006. Cash, cash equivalents and short-term investments on hand at June 30, 2007 totaled $112.1 million.

'This quarter we continued to focus on defining the approval path for faropenem,' said Kenneth J. Collins, Replidyne's President and CEO. 'We are now actively engaged in identifying a new collaboration and development partner for faropenem and, in anticipation of a partnership, we are conducting all preparations to allow us to commence further Phase III clinical trials in community-acquired pneumonia and acute bacterial sinusitis by the end of this year. In the second half of this year other milestones to expect from Replidyne include presenting highly-anticipated research on our C. difficile program at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in September and initiating Phase II clinical trials for REP8839.'

As noted above, revenue for the second quarter of 2007 was $55.6 million compared to $4.0 million for the second quarter of 2006. Since entering the agreement with Forest in February 2006, non-refundable upfront and milestone payments totaling $60 million were recognized as revenue on a straight-line basis over approximately 15 years in accordance with Replidyne's revenue recognition policy. Upon termination, the balance of unamortized upfront and milestone payments of $55.2 million was fully recognized as revenue in the second quarter of 2007. In addition, the Company recognized $0.4 million in contract revenue for funded activity through May 7, 2007 under the agreement. Funded activities represent Forest's majority share of certain direct costs incurred to develop faropenem during the agreement term. Based on termination of this agreement, Replidyne will not report any revenue under the agreement in future reporting periods.

Research and development expenses in the second quarter of 2007 were $8.4 million compared to $9.1 million in the corresponding quarter of 2006 and were substantially faropenem-related. Faropenem related research and development expense this quarter included costs to replace the contract research organization conducting the acute exacerbation of chronic bronchitis study. The new contract research organization is expected to oversee all planned faropenem Phase III registration studies. Additionally, research and development expense included costs to prepare for REP8839 Phase II clinical trials and preclinical activities targeted to Replidyne's discovery research programs, primarily C. difficile and inhibition of DNA replication. Research and development expense in the second quarter of 2006 included $1.5 million paid to GlaxoSmithKline as final payment for the acquisition of REP8839 and its related technology.

Sales, general and administrative expenses for the second quarter of 2007 were $3.3 million compared to $2.9 million in the second quarter of 2006. Replidyne reported net income attributable to common stockholders for the second quarter of 2007 of $45.5 million or, $1.71 per basic common share. On a diluted basis, earnings per share were $1.65 per common share for the second quarter of 2007. This result compared to a net loss attributable to common stockholders of $8.9 million, or a net loss of $5.79 per basic and diluted common share in the second quarter of 2006.

Conference Call Information

Replidyne will host a conference call and webcast today, July 31, 2007, at 4:45 P.M. ET to discuss 2007 second quarter financial results and recent corporate developments. Callers may participate in the conference call by dialing 888-680-0890 (U.S. participants) or 617-213-4857 (international participants) and providing the passcode 27796470. To access the live webcast, log on to the Company's website at www.Replidyne.com and go to the Investor Relations section.

A replay of the conference call will be available approximately one hour after the completion of the call through Tuesday, August 14, 2007 at midnight. Callers may access the replay by dialing 888-286-8010 (U.S. participants) or 617-801-6888 (international participants). The audio replay passcode is 31540010. To access a replay of the webcast, visit the Investor Relations section of the Company's website at www.Replidyne.com.

About Replidyne, Inc.

Replidyne is a biopharmaceutical company focused on discovering, developing, in-licensing and commercializing innovative anti-infective products. Replidyne's lead product, faropenem medoxomil, is a novel oral, community antibiotic, expected to be appropriate for use as a first-line antibiotic for treatment of respiratory and skin infections in adult and pediatric patients. Replidyne's second drug candidate, REP8839, is a topical anti-infective product candidate in development for the treatment of skin and wound infections, including methicillin-resistant S. aureus (MRSA) infections. Replidyne is also pursuing the development of other novel anti-infective products based on its in-house discovery research.

Safe Harbor

This press release contains plans, intentions, objectives, estimates and expectations that constitute forward-looking statements about Replidyne, Inc. that involve significant risks and uncertainties. Actual results could differ materially from those discussed due to a number of factors including, the success and timing of pre-clinical studies and clinical trials; the Company's ability to obtain a new partner for faropenem on acceptable terms; the Company's ability to obtain and maintain regulatory approval of product candidates and the labeling under any approval that may be obtained; plans to develop and commercialize product candidates; the loss of key scientific or management personnel; the size and growth of the potential markets for the Company's product candidates and the Company's ability to serve those markets; regulatory developments in the U.S. and foreign countries; the rate and degree of market acceptance of any future products; the accuracy of Company estimates regarding expenses, future revenues and capital requirements; the Company's ability to obtain and maintain intellectual property protection for our product candidates; the successful development of the Company's sales and marketing capabilities; the success of competing drugs that are or become available; and the performance of third party manufacturers. These and additional risks and uncertainties are described more fully in the Company's most recent Form 10-Q filed with the SEC under the Securities Exchange Act of 1934. Copies of filings made with the SEC are available through the SEC's electronic data gather analysis and retrieval system (EDGAR) at www.sec.gov. All forward-looking statements made in the press release are made as of the date hereof and the Company assumes no obligation to update the forward- looking statements in the document.


REPLIDYNE, INC.

CONDENSED BALANCE SHEETS
(In thousands, except for share and per share amounts)
(Unaudited)

June 30, December 31,
2007 2006
ASSETS
Current assets:
Cash and cash equivalents $56,841 $24,091
Short-term investments 55,257 101,476
Receivable from Forest Laboratories -- 4,634
Prepaid expenses and other current assets 1,981 2,079
Total current assets 114,079 132,280
Property and equipment, net 2,503 3,170
Other assets 121 111
Total assets $116,703 $135,561

LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable and accrued expenses $6,643 $7,957
Current portion of deferred revenue -- 56,176
Total current liabilities 6,643 64,133
Other long-term liabilities 44 56
Total liabilities 6,687 64,189

Commitments and contingencies


Stockholders' equity 110,016 71,372
Total liabilities and stockholders' equity $116,703 $135,561



REPLIDYNE, INC.

CONDENSED STATEMENTS OF OPERATIONS
(In thousands, except share and per share amounts)
(Unaudited)

Three Months Ended June 30, Six Months Ended June 30,
2007 2006 2007 2006

Revenue $55,647 $4,045 $58,571 $6,922

Costs and expenses:

Research and
development 8,364 9,141 17,811 18,110

Sales, general
and administrative 3,280 2,859 6,815 4,812

Total costs and
expenses 11,644 12,000 24,626 22,922

Income (loss) from
operations 44,003 (7,955) 33,945 (16,000)

Investment income
and other, net 1,487 1,747 2,993 2,090

Net income (loss) 45,490 (6,208) 36,938 (13,910)

Preferred stock
dividends and
accretion -- (2,654) -- (5,306)

Net income (loss)
attributable to
common stockholders $45,490 $(8,862) $36,938 $(19,216)

Net income (loss)
attributable to
common stockholders
per share - basic $1.71 $(5.79) $1.39 $(12.98)

Net income (loss)
attributable to
common stockholders
per share - diluted $1.65 $(5.79) $1.34 $(12.98)

Weighted average
common shares
outstanding -
basic 26,676,886 1,530,965 26,649,042 1,480,407

Weighted average
common shares
outstanding -
diluted 27,650,814 1,530,965 27,611,733 1,480,407


SOURCE Replidyne, Inc.

Source: PR Newswire (July 31, 2007 - 3:00 PM EST)

News by QuoteMedia
www.quotemedia.com

Now @ 5.50 was around 4.75 when I started this board.

Another nice vol relative spike today. Thin volume between trades as usual. Could be a good time to take some off the table, assuming anybody bought around 4.75

One of the few green stocks today, who woulda thunk it <g>

Vol spike today

24k down

224k shares on uptick

Short covering and/or somebody wants some (alot)?

Interesting.

Phase III Trial OK

I just looked at the last title and and first glance it seems to indicate the misinterpretation I was conjecturing about, so making a better heading for this msg.

The other thing is that I recall reading somewhere that a type of staph has some medical people more worried about staph than bird flu because it apprantly attacks the lungs. One scenerio medical people are keen to avoid is people getting deathly ill from visiting a hospital. Here again, this company seems to have something that could prove timely in addressing the staph issue.

Actually I just stumbled on this stock noticing a bit of a volume spike on the ups, though stock currently looks depressed. It seemed a bit interesting, so thought would pass on.

When a dev biotech passes a late stage trial they can often spike impressively.

Also there was no other board so what the hey....<g>

Faropenem Phase III Clinical Trial Stopped to Consider Exclusion of Ketek Comparator

http://news.moneycentral.msn.com/ticker/article.aspx?Symbol=US:RDYN&Feed=PR&Date=20061226&am....

My impression is that this one may be on to something in regard to an improved treatment for staph. My impression is that the Phase III was interrupted due to the comparison/competitor (approved) drug causing problems. "..Committee recommended to the FDA that the risks of Ketek outweigh the benefits of using the drug for the treatment of patients with AECB in a 17 to 2 vote." (Competitor "approved" drug = KETEK)

Which implies that their new drug faropenem medoxomil is better.
And approval should be a shoo-in considering the inferior drug got previously approved...

I'm certainly not an expert on biotechs but it seems that their product market is similar to Staph drug /hospital market targetted by VPHM. I beleive that VPHM has done well with their product in the past, so, it seems possible that RDYN may be in a good position.

PPS is likely low and volume is sparse because RDYN seems to be completely unknown in the investment community (no other boards found so far) and it may be that people read the headline about Phase III stopped without noticing that it was stopped because of the competitor product, not, RDYN's...