NEXMED INC (WKN: 914164 / NEXM) / Nasdaq
http://www.nexmed.com/index.php
SEC-FILINGS:
http://www.sec.gov/cgi-bin/...e=&SIC=&owner=include&action=getcompany
NEWS/INFO's:
http://www.finanznachrichten.de/nachrichten-aktien/nexmed.asp
http://finance.yahoo.com/q?s=nexm
http://www.nexmed.com/investors/annualReport.php
BÖRSENPLÄTZE:
http://www.ariva.de/quote/simple.m?secu=5340
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letzter Quartalsbericht:
http://www.sec.gov/Archives/edgar/data/1017491/...244/v131191_10q.htm
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BUSINESS:
NexMed, Inc., a pharmaceutical and medical technology company, engages in the development of transdermal products based on its proprietary NexACT drug delivery technology. The NexACT transdermal drug delivery technology is designed to enhance the absorption of an active drug through the skin and enabling concentrations of the active drug to penetrate the desired site of the skin or extremity. The company�s products under development include NM100060, a nail lacquer treatment for onychomycosis; Femprox, which is an alprostadil-based cream product intended for the treatment of female sexual arousal disorder; and ED Product, which is an alprostadil-based cream treatment intended for patients with erectile dysfunction. It has a licensing agreement with Novartis International Pharmaceutical, Ltd. for the development, manufacture, and commercialization of NM100060. The company was founded in 1987 and is based in East Windsor, New Jersey. NexMed Inc. operates as a subsidiary of Alphatec Spine, Inc.
nexm.png (verkleinert auf 84%)
PS: Hoffnung auf heutige NEWS (Kontrakt-Verlängerung) mit/durch http://www.wcrx.com/
(siehe auch: http://finance.google.ca/finance?q=NASDAQ:NEXM )
...
On January 12, 2009, NexMed, Inc. (the “Company”) and Warner Chilcott Company, Inc. (“Warner”) entered into an amendment (the “Amendment”) to the exclusive United States licensing agreement dated November 1, 2007, as amended by amendment entered into on November 24, 2008, by and between the Company and Warner (as amended, the “Agreement”), for NexMed’s proprietary topical alprostadil-based cream treatment for erectile dysfunction (“Vitaros®”).
Pursuant to the Amendment, Warner has been granted an additional 20 days, or until February 2, 2009, to review the results of the October 15, 2008 meeting (the “Meeting”) with the Food and Drug Administration (FDA). The purpose of the Meeting was to gain clarification on the major deficiencies cited by the FDA in their July 21, 2008 action letter regarding the New Drug Application (NDA) for Vitaros®. As such, on or before February 2, 2009, Warner must decide whether or not it wishes to continue with the development of Vitaros®. If Warner decides that it does not wish to continue with Vitaros® then the Agreement would terminate and all rights would revert back to the Company. Warner was previously granted an additional 45 days, or until January 13, 2009, to review such regulatory concerns.
Warner Chilcott Announces Agreement to Acquire Topical Alprostadil Treatment for Erectile Dysfunction
* Tuesday February 3, 2009, 9:00 am EST
FAJARDO, Puerto Rico and EAST WINDSOR, N.J., Feb. 3 /PRNewswire-FirstCall/
-- Warner Chilcott Company, Inc. (a subsidiary of Warner Chilcott, Ltd., [Nasdaq: WCRX]) announced today that it has entered into an agreement with NexMed, Inc. [Nasdaq: NEXM] to acquire the U.S. rights of NexMed's topically applied alprostadil cream for the treatment of erectile dysfunction (ED). As a result, the previous license agreement between Warner Chilcott and NexMed related to this product has been terminated.
Under the terms of the agreement, NexMed received an up-front payment of $2.5 million and is eligible to receive an additional payment of $2.5 million upon Warner Chilcott's receipt of a New Drug Application approval from the Food and Drug Administration. In addition, Warner Chilcott will pay a total of $350,000 for the manufacturing equipment for the product.
About the ED Market
According to IMS data, the U.S. ED market in 2007 was about $1.5 billion -- dominated by oral PDE5 treatments. Despite the availability of today's oral and other therapies, there is still a need for new, safe and effective treatments, especially for those patients who cannot or do not respond well to oral medication. Alprostadil, well-recognized as a safe and effective drug for the treatment of ED, is currently marketed as both an injectable and intra-urethral pellet. NexMed's topical product provides a more patient-friendly alternative due to its non-invasive ease of administration.
About Warner Chilcott
Warner Chilcott is a leading specialty pharmaceutical company currently focused on the women's healthcare and dermatology segments of the U.S. pharmaceuticals market. The Company is a fully integrated company with internal resources dedicated to the development, manufacturing and promotion of its products. (WCRX-G)
Read more on www.warnerchilcott.com.
About NexMed
NexMed, Inc. leverages its proprietary NexACT drug delivery technology to develop innovative topical pharmaceutical products that address unmet medical needs. NexMed's novel onychomycosis treatment is licensed to Novartis for global development. NexMed's pipeline also includes a Phase 2 treatment for female sexual arousal disorder, and an early stage treatment for psoriasis. For further information about NexMed, go to www.nexmed.com.
Read more on www.nexmed.com
Warner Chilcott's Forward-Looking Statements
This press release contains forward-looking statements, including statements concerning our operations, economic performance, financial condition, business plans, growth strategy and product development efforts. These statements constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The words "may," "might," "will," "should," "estimate," "project," "plan," "anticipate," "expect," intend," "outlook," "believe" and other similar expressions are intended to identify forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of their dates. These forward-looking statements are based on estimates and assumptions by our management that, although we believe to be reasonable, are inherently uncertain and subject to a number of risks and uncertainties.
The following represent some, but not necessarily all, of the factors that could cause actual results to differ from historical results or those anticipated or predicted by our forward-looking statements: our substantial indebtedness; competitive factors in the industry in which we operate (including the approval and introduction of generic or branded products that compete with our products); our ability to protect our intellectual property; a delay in qualifying our manufacturing facility to produce our products or production or regulatory problems with either third party manufacturers upon whom we may rely for some of our products or our own manufacturing facility; pricing pressures from reimbursement policies of private managed care organizations and other third party payors, government sponsored health systems, the continued consolidation of the distribution network through which we sell our products, including wholesale drug distributors and the growth of large retail drug store chains; the loss of key senior management or scientific staff; adverse outcomes in our outstanding litigation or an increase in the number of litigation matters to which we are subject; government regulation affecting the development, manufacture, marketing and sale of pharmaceutical products, including our ability and the ability of companies with whom we do business to obtain necessary regulatory approvals; our ability to manage the growth of our business by successfully identifying, developing, acquiring or licensing new products at favorable prices and marketing such new products; our ability to obtain regulatory approval and customer acceptance of new products, and continued customer acceptance of our existing products; changes in tax laws or interpretations that could increase our consolidated tax liabilities; the other risks identified in our Annual Report on Form 10-K for the year ended December 31, 2007; and other risks detailed from time-to-time in our public filings, financial statements and other investor communications.
We caution you that the foregoing list of important factors is not exclusive. In addition, in light of these risks and uncertainties, the matters referred to in our forward-looking statements may not occur. We undertake no obligation to publicly update or revise any forward-looking statement as a result of new information, future events or otherwise, except as may be required by law.
NexMed's Forward Looking Statements:
Statements under the Private Securities Litigation Reform Act: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described, including, but not limited to, obtaining regulatory approval for its products under development, entering into partnering agreements, pursuing growth opportunities, and/or other factors, some of which are outside the control of NexMed, Inc.
03.02.2009 15:40
NexMed Announces Sale of U.S. Rights for Topical Erectile Dysfunction Treatment
-Management to Hold Conference Call Today at 10:00AM EST-
NexMed, (News) Inc. (Nasdaq: NEXM), a developer of products based on the NexACT® drug delivery technology, today announced that it has sold the U.S. rights for its topical alprostadil erectile dysfunction treatment to partner, Warner Chilcott Company, Inc., (a subsidiary of Warner Chilcott, Ltd., [Nasdaq: WCRX]). Under the terms of the agreement, NexMed has received an up-front payment of $2.5 million and is eligible to receive an additional payment of $2.5 million upon Warner Chilcott’s receipt of a New Drug Application (NDA) approval from the U.S. Food and Drug Administration. In addition, Warner Chilcott will pay a total of $350,000 for the manufacturing equipment for the product.
Vivian Liu, NexMed’s Chief Executive Officer commented, ”We firmly believe that selling the U.S. rights of the product to Warner Chilcott is in the best interest of NexMed given the significant expenditures necessary before resubmission of the NDA can take place. The cash infusion received, along with the significant reduction in expenditures that we have implemented, will help ensure the viability of NexMed and continued pipeline development during these challenging economic times.”
NexMed management will host a conference call and provide an investor update today, Tuesday, February 3, 2009 at 10:00am EST. The call can be accessed in the U.S. by dialing 877-407-9205 and outside of the U.S. by dialing 201-689-8054 and asking the conference operator for the NexMed Conference Call. The teleconference replay is available for one week by dialing in the U.S. 877-660-6853 and outside of the U.S. by dialing 201-612-7415. Replay pass codes 286 and 312198 are both required for playback. The conference call will also be Webcast live at URL http://www.investorcalendar.com/IC/CEPage.asp?ID=140732. The Webcast replay will be available for three months.
About NexMed:
NexMed, Inc. leverages its proprietary NexACT drug delivery technology to develop innovative topical pharmaceutical products that address unmet medical needs. NexMed’s novel onychomycosis treatment is licensed to Novartis for global development. NexMed’s pipeline also includes its late stage alprostadil treatment for erectile dysfunction, licensed to Warner Chilcott, a Phase 2 treatment for female sexual arousal disorder, and an early stage treatment for psoriasis. For further information about NexMed, go to www.nexmed.com.
Forward Looking Statements:
During the course of the call, NexMed Management will make forward looking statements regarding future events or the future financial performance of the Company that involve risks and uncertainties that may individually or mutually impact the matters herein described, including, but not limited to, generating positive clinical results, obtaining regulatory approval for its products under development, entering into partnering agreements, pursuing growth opportunities, and/or other factors, some of which are outside the control of the Company. Such statements are predictions based on current expectations and actual results could differ materially.
Contacts:
NexMed, Inc.
Mark Westgate, CFO, 609-371-8123, ext: 159
mwestgate@nexmed.com
or
Investor Relations:
Rx Communications Group, LLC
Paula Schwartz, 917-322-2216
pschwartz@rxir.com
03.02.2009 19:17
NexMed to Present at the 11th Annual BIO CEO & Investor Conference
NexMed, (News) Inc. (Nasdaq: NEXM), a developer of products based on the NexACT® drug delivery technology, today announced that Vivian Liu, Chief Executive Officer, will present an overview of the company at the BIO CEO&Investor Conference on Tuesday, February 10, 2009 at 11 am (ET) at the Waldorf Astoria Hotel in New York City.
BIO CEO is the largest independent investor conference focused on leading publicly traded biotech companies, and is designed to appeal to public market investors as well as the sell-side investment community, in addition to business development executives from global pharmaceutical and biotechnology companies.
Interested parties may access the live webcast of NexMed’s presentation on the Company’s website (Investors: News&Events) at http://www.nexmed.com.
About NexMed
NexMed, Inc. leverages its proprietary NexACT drug delivery technology to develop innovative topical pharmaceutical products that address unmet medical needs. NexMed’s novel onychomycosis treatment is licensed to Novartis for global development. NexMed’s pipeline also includes its late stage alprostadil treatment for erectile dysfunction, a Phase 2 treatment for female sexual arousal disorder, and an early stage treatment for psoriasis. For further information about NexMed, go to www.nexmed.com.
Contacts:
NexMed, Inc.
Mark Westgate, CFO
609-371-8123, ext: 159
mwestgate@nexmed.com
or
Investor Relations:
Rx Communications Group, LLC
Paula Schwartz
917-322-2216
pschwartz@rxir.com
24.03.2009 21:16
NexMed Receives Nasdaq Delisting Warning Letter
NexMed, (News) Inc. (Nasdaq: NEXM), a developer of innovative transdermal products based on the Company’s proprietary NexACT® drug delivery technology, today announced that it has received a notice from Nasdaq indicating that it does not comply with the minimum $2.5 million in stockholders’ equity requirement for continued listing on the Nasdaq Capital Market set forth in Marketplace Rule 4310(c)(3). Additionally, the Company does not comply with the alternative Marketplace Rule which requires total market value of listed securities of $35 million or $500,000 of net income from continuing operations for the most recently completed fiscal year or two of the three most recently completed fiscal years. Further, the company remains on notice for maintaining the minimum $1 bid requirement as set forth in Marketplace Rule 4310(c)(8)(D). However, because Nasdaq has suspended enforcement of this requirement until July 20, 2009, as of its announcement on March 23, 2009, the Company now has until January 9, 2010 to meet that requirement.
...(weiter siehe LINK)
Dies wird natürlich (negativ) den Kurs beeinflussen, jedoch am Unternehmen selber hat sich nichts verändert...
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Nasdaq will provide written notice that the Company’s common stock will be delisted from the Nasdaq National Market at the opening of business on August 27, 2009
NexMed Receives Nasdaq Delisting Warning Letter
Date : 08/14/2009 @ 12:45PM
Source : Business Wire
http://ih.advfn.com/...0268785&article=39055611&symbol=N^NEXM
27.08.2009 16:05
NexMed Submits Compliance Plan to Nasdaq
NexMed, Inc. (Nasdaq: NEXM), a developer of innovative topical products based on the NexACT® technology, today announced that it has submitted to Nasdaq its plan to achieve and sustain compliance with Marketplace Rule 4310(c)(3). The plan will be reviewed by Nasdaq and, if deemed to be acceptable, the Company would be granted up to 105 calendar days from the date of Nasdaq’s notice to the company, or November 25, 2009, to evidence compliance with Marketplace Rule 4310(c)(3).
On August 14, 2009, the Company announced that it had received a notice from Nasdaq indicating that it did not comply with the minimum $2.5 million in stockholders’ equity requirement for continued listing on the Nasdaq Capital Market set forth in Marketplace Rule 4310(c)(3). There can be no assurance that Nasdaq’s Listing Qualifications Panel will decide to allow the Company to remain listed. If the Company’s plan is not acceptable to Nasdaq, then the Company will be notified of its delisting. The Company also remains on notice for maintaining the minimum $1 bid requirement as set forth in Marketplace Rule 4310(c)(8)(D). However, because Nasdaq had suspended enforcement of this requirement until August 3, 2009, as of its most recent announcement on July 13, 2009, the Company now has until January 25, 2010 to meet that requirement.
...(weiter siehe LINK)
Date : 11/23/2009 @ 8:00AM
Source : Business Wire
Stock : NexMed, Inc. (NEXM)
http://ih.advfn.com/...8982157&article=40471999&symbol=N^NEXM
NexMed, Inc. (Nasdaq: NEXM), a developer of products based on the NexACT® technology, today announced that it has entered into a definitive agreement to acquire Bio-Quant, Inc., a revenue generating privately-held leading research organization for in vitro and in vivo contract drug discovery and pre-clinical development services, headquartered in San Diego, CA. Upon closing of the transaction, which is expected before the end of the year, Bio-Quant will become a wholly-owned subsidiary of NexMed. Bassam Damaj, Ph.D., co-founder, current Chief Executive Officer and Chief Scientific Officer of Bio-Quant, will become Chief Executive Officer of NexMed, replacing Vivian Liu, who will transition to the role of Executive Vice President and, in that capacity, Ms. Liu will continue to be responsible for leading the business development and licensing efforts for NexMed’s clinical programs. Mark Westgate will remain as NexMed’s Chief Financial Officer. The Board will be composed of three Bio-Quant nominees and four NexMed nominees, and Ms. Liu is expected to be appointed as Chairman of the Board.
The agreement provides for NexMed’s issuance of 4,000,000 unregistered shares of its common stock to the Bio-Quant shareholders and a promissory note (the “Note”) in the amount of approximately $12.1 million due on December 31, 2010. NexMed can elect to pay all or any portion of the Note by issuing its common stock. Such repayment in common stock is contingent upon NexMed shareholder approval. As a condition to closing, there will be a Bio-Quant shareholders meeting. Certain key shareholders of Bio-Quant have agreed to vote in favor of the transaction.
Commenting on today’s news, Ms. Liu stated, “We look forward to welcoming the Bio-Quant team as a NexMed subsidiary. Through this transaction, NexMed acquires a revenue generating, cash flow positive business which has grown over 250% in the past five years and is continuing to grow at present. Moreover, we will gain preclinical capabilities, add valuable licensing expertise and be able to leverage Bio-Quant’s existing relationships with key pharmaceutical companies – all of which will aid in the continued development and the ultimate commercialization of our products under development.”
Dr. Damaj, noted, “We are delighted to become part of NexMed, a company with a novel technology and innovative products which we believe can be better monetized and generate value for our shareholders. While continuing our normal course of business as a leading CRO, we will be adding Our established and growing business, resources, and expertise to NexMed, which should allow NexMed to continue its business development in a more rapid and efficient manner.”
Mark Westgate added, “The acquisition of Bio-Quant was an integral part of our compliance plan presented to the NASDAQ Listing Qualification Panel (the “Panel”) on Thursday, November 12, 2009. We are hopeful that the signing of this agreement will give the Panel further confidence that we will regain and maintain compliance with all applicable continued listing requirements. While we have yet to receive a decision from the Panel, we are optimistic that the Panel will continue our listing pending the implementation of our plan.”
FTN Equity Capital Markets Corp., in New York City, has served as NexMed’s financial advisor in the structuring and negotiations of this transaction.
Conference Call
The Company will hold a conference call to discuss this announcement, today, Monday, November 23, 2009 at 9:00 am EST. The call can be accessed in the U.S. by dialing 877-407-9205 and outside of the U.S. by dialing 201-689-8054 and asking the conference operator for the NexMed Conference Call. The teleconference replay is available for one week by dialing in the U.S. 877-660-6853 and outside of the U.S. by dialing 201-612-7415. Replay pass codes 286 and 338281 are both required for playback. The conference call will also be Webcast live at URL http://www.investorcalendar.com/IC/CEPage.asp?ID=152583. The Webcast replay will be available for three months.
About NexMed
NexMed’s pipeline includes a late stage terbinafine treatment for onychomycosis, a late stage alprostadil treatment for erectile dysfunction, a Phase 2 alprostadil treatment for female sexual arousal disorder, and an early stage treatment for psoriasis. For further information, go to www.nexmed.com.
About Bio-Quant
Founded in 1999, Bio-Quant is the largest specialty CRO based in San Diego and is one of the industry's most experienced CROs for in vitro and in vivo pharmacology services and research models specializing in oncology, inflammation, immunology, and metabolic diseases, including diabetes. For further information, go to www.bio-quant.com.
Statements under the Private Securities Litigation Reform Act: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described, including, but not limited to, maintaining NexMed’s listing on NASDAQ, closing of the Bio-Quant acquisition, entering into licensing agreements for products under development, obtaining regulatory approval for its products under development, entering into a strategic transaction for the company, pursuing growth opportunities, and/or other factors, some of which are outside the control of the Company.
NexMed Receives Cash Infusion of $750,000
Date : 11/11/2009 @ 8:30AM
Source : Business Wire
Stock : NexMed, Inc. (NEXM)
ih.advfn.com/p.php
NexMed, Inc. (Nasdaq: NEXM), a developer of innovative transdermal products based on the NexACT® drug delivery technology, today announced that it raised $750,000 in gross proceeds from the issuance of new convertible notes due December 31, 2011 (the “Notes”), which are secured by a mortgage on NexMed’s facility in East Windsor, New Jersey. The Notes were purchased by two investors, including The Tail Wind Fund Ltd., a long term investor in NexMed.
The Notes are convertible into shares of NexMed common stock at $2 per share with a coupon rate of 7% per annum. The shares underlying the Notes will not be registered with the Securities and Exchange Commission.
About NexMed
NexMed’s pipeline includes a late stage terbinafine treatment for onychomycosis, a late stage alprostadil treatment for erectile dysfunction, a P 2 alprostadil treatment for female sexual arousal disorder, and an early stage treatment for psoriasis. For further information about NexMed, go to www.nexmed.com.
http://www.finanznachrichten.de/...s-acquisition-of-bio-quant-004.htm
NexMed Closes Acquisition of Bio-Quant
Acquisition May Enable Continued NASDAQ Listing
Conference Call to Be Held at 3:30 pm EST Tomorrow
NexMed, Inc. (Nasdaq: NEXM), a developer of products based on the NexACT® technology, today announced the closing of its acquisition of Bio-Quant, Inc., a privately-held leading research organization for in vitro and in vivo contract drug discovery and pre-clinical development services, headquartered in San Diego, CA. Upon closing, Bio-Quant became a wholly-owned subsidiary of NexMed. Bassam Damaj, Ph.D., co-founder and former Chief Executive Officer and Chief Scientific Officer of Bio-Quant, was named President and Chief Executive Officer of NexMed, replacing Vivian Liu, who has assumed the role of Executive Vice President and was appointed Chairman of the Board of Directors. The Board of Directors is now composed of three Bio-Quant nominees and four NexMed nominees.
Commenting on today's news, Dr. Damaj stated, "The synergistic combination of NexMed's novel NexACT® technology and existing clinical assets with Bio-Quant's revenue generating business, will enable us to offer both our existing and potential pharmaceutical customers a broader array of products and services. I look forward to working closely with Vivian on our integration efforts, as well as on business development and licensing activities for NexMed's product pipeline."
Mark Westgate, Chief Financial Officer of NexMed, added, "The acquisition of Bio-Quant was an integral part of our compliance plan which we presented during our November 12, 2009 meeting with the NASDAQ Listing Qualification Panel. We remain hopeful that the closing of this transaction will give the NASDAQ Panel sufficient confidence in NexMed's ability to regain and maintain compliance with all applicable listing requirements going forward."
Conference Call
The Company will hold a conference call to discuss the closing of the Bio-Quant acquisition tomorrow, Tuesday, December 15, 2009 at 3:30 pm EST. The call can be accessed in the U.S. by dialing 877-407-0778 and outside of the U.S. by dialing 201-689-8565 and asking the conference operator for the NexMed Conference Call. The teleconference replay is available for one week in the U.S. by dialing 877-660-6853 and outside of the U.S. by dialing 201-612-7415. Replay pass codes 286 and 339648 are both required for playback. The conference call will also be Webcast live at URL http://www.investorcalendar.com/IC/CEPage.asp?ID=153616. The Webcast replay will be available for three months.
About NexMed
NexMed's pipeline includes a late stage terbinafine treatment for onychomycosis, a late stage alprostadil treatment for erectile dysfunction, a Phase 2 alprostadil treatment for female sexual arousal disorder, and an early stage treatment for psoriasis. For further information, go to www.nexmed.com.
About Bio-Quant
Founded in 1999, Bio-Quant is the largest specialty CRO based in San Diego and is one of the industry's most experienced CROs for in vitro and in vivo pharmacology services and research models specializing in oncology, inflammation, immunology, and metabolic diseases, including diabetes. For further information, go to www.bio-quant.com.
Statements under the Private Securities Litigation Reform Act: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described, including, but not limited to, maintaining NexMed's listing on NASDAQ, entering into licensing agreements for products under development, obtaining regulatory approval for its products under development, pursuing growth opportunities, and/or other factors, some of which are outside the control of the Company.
Contacts:
NexMed, Inc.
Mark Westgate, CFO, 609-371-8123, ext: 159
mwestgate@nexmed.com
or
NexMed, Inc.
Edward M. Cox, 858-222-8041
V.P. Investor Relations& Corporate Development
ecox@bio-quant.com
or
NexMed Investor Relations:
Rx Communications Group, LLC
Paula Schwartz, 917-322-2216
pschwartz@rxir.com
© 2009 Business Wire
Date : 12/17/2009 @ 9:00AM
Source : Business Wire
Stock : NexMed, Inc. (NEXM)
http://ih.advfn.com/...69261&article=40804024&symbol=N%5ENEXM
NexMed, Inc. (Nasdaq: NEXM), a specialty CRO and a developer of products based on the NexACT® technology, today announced that it has signed an agreement to lease its facility in East Windsor, NJ, commencing February 1, 2010. The lease agreement also contains an option to purchase the facility during the term of the lease
Commenting on today’s news, NexMed’s Chief Financial Officer, Mark Westgate, said, “In light of our announcement earlier this week regarding the closing of the Bio-Quant acquisition, the timing is ideal, as we move our headquarters from New Jersey to San Diego. Additionally, the monthly rental payment will more than cover the existing debt service on our mortgage, thus making this a cash positive transaction. Further, the initial purchase option price which we have negotiated, of $4.4 million, is approximately $1.4 million above the existing debt on our building.”
About NexMed NexMed, due to its recent acquisition of Bio-Quant, is the largest specialty CRO based in San Diego, CA and is one of the industry’s most experienced CROs for in vitro and in vivo pharmacology services and research models. NexMed is also developing a proprietary product pipeline based on its NexACT® drug delivery technology, including a late stage terbinafine treatment for onychomycosis, a late stage alprostadil treatment for erectile dysfunction, a Phase 2 alprostadil treatment for female sexual arousal disorder and an early stage treatment for psoriasis. For further information, go to www.nexmed.com and www.bio-quant.com
http://www.finanznachrichten.de/...ontinued-listing-on-nasdaq-004.htm
NexMed Granted Continued Listing on NASDAQ
NexMed must evidence minimum stockholders' equity of $2.5 million or minimum market capitalization of $35 million by March 31, 2010
NexMed, Inc. (Nasdaq: NEXM), a specialty CRO and a developer of products based on the NexACT® technology, today announced that it received a letter from the NASDAQ Listing Qualifications Panel (the "Panel") on December 17, 2009, informing the Company that the Panel had granted the Company's request to remain listed on the NASDAQ Stock Market, subject to the condition that, on or before March 31, 2010, the Company evidence stockholders' equity of at least $2.5 million or a market value of listed securities of at least $35 million, which are the applicable minimum requirements for the continued listing of the Company's securities on The NASDAQ Capital Market.
The Panel's determination follows the Company's hearing before the Panel on November 12, 2009, at which the Panel considered the Company's plan to regain compliance with the continued listing requirements, including through the recent acquisition of Bio-Quant, Inc. While the Company is working to satisfy the requirements set forth in the Panel's decision, there can be no assurance that it will be able to do so.
Separately, and as previously announced, the Company remains subject to a grace period through January 25, 2010 to evidence compliance with the $1.00 bid price requirement for continued listing on NASDAQ. If at any time during the grace period the bid price of the Company's common stock closes at $1.00 per share or more for a minimum of ten consecutive business days, the Company will have evidenced compliance with the minimum bid price requirement. In the event it does not evidence compliance with the bid price requirement by January 25, 2010, the Company expects that it will be provided with formal notice of the deficiency and an opportunity to request an extension from the Panel to evidence compliance with the minimum bid price requirement.
About NexMed
NexMed, due to its recent acquisition of Bio-Quant, is the largest specialty contract research organization ("CRO") based in San Diego, CA and is one of the industry's most experienced CROs for in vitro and in vivo pharmacology services and research models. NexMed is also developing a proprietary product pipeline based on its NexACT® drug delivery technology, including a late stage terbinafine treatment for onychomycosis, a late stage alprostadil treatment for erectile dysfunction, a Phase 2 alprostadil treatment for female sexual arousal disorder and an early stage treatment for psoriasis. For further information, go to www.nexmed.com and www.bio-quant.com.
Forward-Looking Statement Safe Harbor
Statements under the Private Securities Litigation Reform Act: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described, including, but not limited to the Company's ability to satisfy NASDAQ continued listing standards, and other matters that are outside the control of the Company.
Contacts:
NexMed, Inc.
Mark Westgate, CFO, 609-371-8123, ext: 159
mwestgate@nexmed.com
or
Edward Cox, 858-222-8041
V.P. Investor Relations&Corporate Development
ecox@nexmed.com
or
NexMed Investor Relations:
Rx Communications Group, LLC
Paula Schwartz, 917-322-2216
pschwartz@rxir.com
© 2009 Business Wire
NexMed Provides Corporate Update
Date : 01/08/2010 @ 12:00PM
Source : Business Wire
Stock : NexMed, Inc. (NEXM)
http://ih.advfn.com/...2970500&article=41031116&symbol=N^NEXM
NexMed, Inc. (Nasdaq: NEXM), a specialty CRO and a developer of products based on the NexACT® technology, today provided an update on ongoing corporate activities and the status of the Company’s NASDAQ listing
Product Pipeline Topical Alprostadil Treatments NexMed expects to hear from Health Canada concerning the approvability of its New Drug Submission (NDS) for Vitaros®, its topical treatment for erectile dysfunction, sometime in February 2010. As such, management has postponed negotiations with its potential partner until an approval decision from Health Canada is received, as partnering negotiations with a marketing approval would be expected to yield more favorable terms for the Company
In the U.S., NexMed is awaiting a response from the Food and Drug Administration (FDA) regarding the carcinogenicity (CAC) assessment package, which it expects to occur within the next two months. Partnering efforts for Femprox®, NexMed’s topical treatment for female sexual dysfunction, are on hold pending the final decision by the FDA
Outside of North America, NexMed is awaiting Health Canada or the FDA’s response to accelerate partnering efforts and/or filing for marketing approvals. To date, NexMed has received multiple indications of interest from international pharmaceutical companies that might be interested in partnering with NexMed
In addition, through its Bio-Quant research and development team, NexMed is running new efficacy studies on the Vitaros formulation to assess the potential of the compound for other indications such as wound healing and Raynaud’s Syndrome. NexMed’s strategy is to take advantage of the development work already completed for Vitaros and bolster the existing database with new data and apply it to potentially shorten the path of approval. The goal includes commencing partnering discussions in mid-2010 for the new indications, if the pre-clinical data are positive
NM100060 Onychomycosis Treatment NexMed is actively engaged in efforts to re-license this product for the treatment of nail fungus. In the meantime, Novartis continues to transfer the clinical and regulatory dossiers to the Company and the data are being shared with potential partners
Topical Psoriasis Treatment NexMed’s Bio-Quant R&D team is also proceeding with extensive pre-clinical efficacy studies to strengthen its psoriasis candidate while actively engaging in partnering discussions
Topical NSAID Program NexMed is also exploring the opportunity to license an early stage NSAID program, which includes an issued U.S. patent. This program was not pursued when NexMed chose to focus its resources on its sexual dysfunction programs. Preclinical data of the NexACT-based ketoprofen cream has shown more rapid and efficient delivery of the drug as compared to the currently marketed products
NexACT technology, Partnering as a Service NexMed has initiated discussions with potential partners regarding the application of its NexACT technology to drugs that will soon be going off-patent to help create a second-generation drug that has patent protection through the mechanism of delivery. The NexACT platform technology has demonstrated the potential to improve the topical absorption of active therapeutic ingredients and/or to develop new patient-friendlier routes of administration. Incorporating older drugs with the NexACT proprietary delivery system can create new products that not only provide patients with added therapeutic benefits, but can also extend the product life for up to an additional 20 years. As such, the Company intends to aggressively pursue these types of potential partnering arrangements going forward
NexACT technology, New Applications In addition to developing innovative topical treatments, NexMed’s new scientific team is evaluating the ability of the NexACT technology to deliver biologics, such as humanized or fully human antibodies, via transdermal application. The delivery of such biologics through the skin represents a novel approach to delivering antibodies to specific areas of the body with limited systemic exposure – potentially reducing side effects and toxicity. We are also evaluating the ability of the NexACT technology to deliver drugs orally, including various first-line oral chemotherapeutics, which currently have poor bioavailability and thus require high doses and result in certain toxic side effects
NASDAQ Listing On January 4, 2010, NexMed received an expected notice of non-compliance from The NASDAQ Stock Market LLC based upon its failure to solicit proxies and hold an annual meeting for fiscal 2008 by December 31, 2009, as required by NASDAQ Listing Rules 5620(a) and 5620(b), which could serve as an additional basis for the delisting of the Company’s securities from The NASDAQ Capital Market. NexMed had discussed this matter with the NASDAQ Listing Qualifications Panel (the “Panel”) at the hearing on November 12, 2009, and explained that it planned to postpone the 2008 annual meeting due to the ongoing acquisition of Bio-Quant and would not be able to incorporate all of the relevant acquisition related materials in the meeting proxy in a timely manner
As NexMed previously announced on December 18, 2009, the Panel granted its request to remain listed on The NASDAQ Capital Market, subject to the condition that it evidence stockholders’ equity of at least $2.5 million or a market value of listed securities of at least $35 million on or before March 31, 2010. The determination followed the hearing before the Panel on November 12, 2009, at which time NexMed presented its plan to evidence compliance with all requirements for continued listing on The NASDAQ Capital Market, including the proxy solicitation/annual meeting and bid price requirements (notwithstanding the fact that NexMed was not yet deficient with respect to those standards)
As provided by NASDAQ’s most recent notice, NexMed plans to timely make a formal written submission to the Panel presenting its plan to evidence compliance with the proxy solicitation and annual meeting requirements. While it intends to file a proxy statement for a special meeting of shareholders to be held within the next sixty days to consider amending its Articles of Incorporation to authorize more common stock for issuance, that meeting may not be conducted as an annual meeting since the proxy statement will not incorporate audited financial statements for the fiscal year ended December 31, 2009. As a result, in order to satisfy NASDAQ’s annual meeting requirement, NexMed plans to file a proxy statement for a joint 2008/2009 annual meeting promptly following the filing of its Annual Report on Form 10-K for fiscal 2009 in March 2010. Accordingly, the Company is asking the Panel to modify its previously issued decision in accordance with the Company’s revised plan of compliance. However, there can be no assurance that the Panel will grant the Company’s request
Also as previously announced, NexMed remains subject to a grace period through January 25, 2010 to evidence compliance with the $1.00 bid price requirement for continued listing on NASDAQ. In the event NexMed does not evidence compliance with the bid price requirement by that date, NexMed expects to receive an additional formal notice of non-compliance and to be afforded an opportunity to request an exception from the Panel to evidence compliance with the minimum bid price requirement. In that regard, NexMed will implement a reverse stock split, if necessary, to evidence compliance with NASDAQ’s minimum bid price requirement, which action may be taken at any time at the discretion of the NexMed Board of Directors
Corporate Integration Subsequent to the December 17, 2009 announcement of the lease of its manufacturing building in New Jersey, NexMed has completed the relocation of its headquarters to 6330 Nancy Ridge Drive, San Diego, CA 92121. NexMed now has 34 full time employees, of whom eight employees hold either Ph.D or MD degrees. NexMed will include the pro forma financial statements for the combined entity in an amendment to its December 17, 2009 Current Report on Form 8-K, to be filed on or before February 26, 2010
About NexMed NexMed, due to its recent acquisition of Bio-Quant, is the largest specialty contract research organization (“CRO”) based in San Diego, CA and is one of the industry’s most experienced CROs for in vitro and in vivo pharmacology services and research models. NexMed has a proprietary product pipeline based on its NexACT drug delivery technology, including a late stage terbinafine treatment for onychomycosis, a late stage alprostadil treatment for erectile dysfunction, a Phase 2 alprostadil treatment for female sexual arousal disorder, and an early stage treatment for psoriasis. For further information, go to www.nexmed.com and www.bio-quant.com
