EastCoastCdn
14 years ago
http://www.prnewswire.com/news-releases/nuvo-research-announces-us-availability-of-pennsaid-92168094.html
Nuvo Research announces U.S. availability of PENNSAID
PENNSAID - a topical NSAID - is indicated for the treatment of the signs and symptoms of osteoarthritis of the knee(s)
MISSISSAUGA, ON, April 27 /PRNewswire-FirstCall/ - Nuvo Research Inc. (TSX: NRI), a drug development company focused on the research and development of drug products that are delivered to and through the skin using its topical and transdermal drug delivery technologies, and on the development of its immune modulating drug candidate WF10, today announced that PENNSAID(R) (diclofenac sodium topical solution) 1.5% w/w, is now available by prescription in U.S. pharmacies.
PENNSAID is a non-steroidal anti-inflammatory drug (NSAID) indicated for the treatment of the signs and symptoms of osteoarthritis of the knee(s). Nuvo's U.S. licensee, Mallinckrodt Inc., a Covidien ( COV) company, has now commenced U.S. commercialization activities for PENNSAID. Nuvo will receive royalties on net U.S. sales of PENNSAID at rates that are consistent with industry standards. Nuvo will also be eligible to receive sales milestone payments totaling up to US$100 million as U.S. annual sales levels are achieved.
Nuvo develops drug products delivered to and through the skin using its topical and transdermal drug delivery technologies. Covidien is the largest supplier of controlled pain medications in the United States based on number of prescriptions.
"Physicians in the United States now have a new alternative to help patients manage their signs and symptoms of osteoarthritis of the knee," said Dr. Brad Galer, President of Nuvo Research's Pain Group. "Covidien's commercial launch of PENNSAID in the U.S. is the culmination of our attainment of U.S. Food and Drug Administration approval, and the establishment of a strong collaboration with an exceptional sales and marketing organization in Covidien. The launch of PENNSAID in the U.S. should further strengthen Nuvo financially and support the Company's continued growth as a leader in the development of new pain medications."
About Nuvo Research Inc.
Nuvo is primarily focused on the research and development of drug products delivered to and through the skin using its topical and transdermal drug delivery technologies, and on the development of its immune modulating drug candidate WF10. Nuvo's lead product is PENNSAID, a topical non-steroidal anti-inflammatory drug (NSAID), which is sold in Canada, several European countries and now the United States. PENNSAID was approved for marketing in the U.S. by the FDA on November 4, 2009. Nuvo intends to leverage its skin-penetrating technologies to create a portfolio of topical and transdermal products targeting a variety of indications. Nuvo is a publicly traded, Canadian pharmaceutical company headquartered in Mississauga, Ontario. Nuvo's Pain Group is located in West Chester, Pennsylvania. Its manufacturing facilities are located in Varennes, Québec and Wanzleben, Germany, and its research and development centers are located in San Diego, California and Leipzig, Germany. For more information, please visit www.nuvoresearch.com.
IMPORTANT RISK INFORMATION ABOUT PENNSAID
-------------------------------------------------------------------------
Cardiovascular Risk
- Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased
risk of serious cardiovascular thrombotic events, myocardial
infarction, and stroke, which can be fatal. This risk may increase
with duration of use. Patients with cardiovascular disease or risk
factors for cardiovascular disease may be at greater risk.
- PENNSAID is contraindicated in the perioperative setting of coronary
artery bypass graft (CABG) surgery.
Gastrointestinal Risk
- NSAIDs cause an increased risk of serious gastrointestinal adverse
events including bleeding, ulceration, and perforation of the stomach
or intestines, which can be fatal. These events can occur at any time
during use and without warning symptoms. Elderly patients are at
greater risk for serious gastrointestinal events.
-------------------------------------------------------------------------
PENNSAID is contraindicated in patients:
- with a known hypersensitivity to diclofenac sodium or any other
component of PENNSAID.
- who have experienced asthma, urticaria, or allergic-type reactions
after taking aspirin or other NSAIDs. Severe, rarely fatal
anaphylactic-like reactions to NSAIDs have been reported in such
patients.
Elevation of one or more liver tests may occur during therapy with NSAIDs. PENNSAID should be discontinued immediately if abnormal liver tests persist or worsen.
Use with caution in patients with fluid retention or heart failure. Hypertension can occur with NSAID treatment. Monitor blood pressure closely with PENNSAID treatment.
Long-term administration of NSAIDs can result in renal papillary necrosis and other renal injury. Use PENNSAID with caution in patients at greatest risk of this reaction, including the elderly, those with impaired renal function, heart failure, liver dysfunction, and those taking diuretics and ACE-inhibitors.
Should not be used in pregnant or lactating women and is not approved for use in pediatric patients.
Anaphylactoid reactions may occur in patients without prior exposure to PENNSAID. NSAIDs can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal.
The most common treatment-related adverse events in patients receiving PENNSAID were application site skin reactions including dry skin (32%), contact dermatitis characterized by skin erythema and induration (9%), contact dermatitis with vesicles (2%) and pruritus (4%). In a long term safety study, contact dermatitis occurred in 13% and contact dermatitis with vesicles in 10% of patients, generally within the first 6 months of exposure, leading to a withdrawal rate for an application site event of 14%. Other common adverse events greater than placebo include: dyspepsia (9%), abdominal pain (6%), flatulence (4%), diarrhea (4%) and nausea (4%).
Do not apply to open wounds. Protect treated knee(s) from natural or artificial sunlight. Topicals such as sunscreen and bug repellant may be applied after PENNSAID treated knee(s) are completely dry. Avoid contact of PENNSAID with eyes and mucous membranes. Wash and dry hands after use.
Concurrent use with oral NSAIDs should be avoided unless benefit outweighs risk and periodic laboratory evaluations are conducted.
Please click the link below for Full Prescribing Information and additional Important Risk Information.
http://www.pennsaid.com/attachments/PENNSAID_Prescribing_Information.pdf
Forward-Looking Statements
This document contains forward-looking statements. Some forward-looking statements may be identified by words like "expects", "anticipates", "plans", "intends", "indicates" or similar expressions. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Nuvo considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared, but caution that these assumptions regarding future events, many of which are beyond the control of the Company, may ultimately prove to be incorrect. Factors and risks, which could cause actual results to differ materially from current expectations, are discussed in the annual report, as well as in Nuvo's Annual Information Form for the year ended December 31, 2009. Nuvo disclaims any intention or obligation to update or revise any forward-looking statements whether a result of new information or future events, except as required by law. For additional information on risks and uncertainties relating to these forward looking statements, investors should consult the Company's ongoing quarterly filings, annual report and Annual Information Form and other filings found on SEDAR at www.sedar.com
SOURCE Nuvo Research Inc.
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EastCoastCdn
14 years ago
Nuvo Research completes redemption of 5% convertible debentures
http://www.prnewswire.com/news-releases/nuvo-research-completes-redemption-of-5-convertible-debentures-88247872.html
MISSISSAUGA, ON, March 17 /PRNewswire-FirstCall/ - Nuvo Research Inc. (TSX: NRI), a Canadian drug development company focused on the research and development of drug products that are delivered to and through the skin using its topical and transdermal drug delivery technologies, and on the development of its immune modulating drug candidate WF10, today announced that 100 per cent of eligible convertible debentures were converted into common shares pursuant to the Company's notice of redemption to holders of its 5% convertible debentures (the Debentures).
Nuvo announced a notice of early redemption for its Debentures on February 4, 2010, stating that it would redeem the outstanding $3,486,000 principal amount of Debentures for $3.61 million in cash. The Debentures would otherwise have matured on November 16, 2010. As of March 12, 2010, all debenture holders elected to convert their outstanding principal amount into 25.3 million shares of common stock at $0.138 per share. All shares received upon conversion of the Debentures are freely tradable.
"As anticipated all of these deep-in-the-money debentures were converted into common shares," said Jim Moulds, Executive Vice President and CFO of Nuvo Research. "Their early conversion removes substantially all debt from Nuvo's balance sheet and eliminates the obligation to make future interest payments."
EastCoastCdn
14 years ago
Nuvo Research enrolls first patient in Phase 2 WF10 allergic rhinitis trial
http://www.prnewswire.com/news-releases/nuvo-research-enrolls-first-patient-in-phase-2-wf10-allergic-rhinitis-trial-87689872.html
MISSISSAUGA, ON, March 15 /PRNewswire-FirstCall/ - Nuvo Research Inc. (TSX: NRI), a Canadian drug development company focused on the research and development of drug products that are delivered to and through the skin using its topical and transdermal drug delivery technologies, and on the development of its immune modulating drug candidate WF10, today announced that it has enrolled the first patient in its European Phase 2 clinical trial evaluating WF10 as a treatment for allergic rhinitis.
The randomized, double-blind, placebo-controlled, single-centre trial will assess the efficacy and safety of WF10 infusions for the treatment of patients with severe persistent allergic rhinitis. The trial will enroll 50 patients who have at least a two-year history of persistent allergic rhinitis, and who have a positive allergen skin test. The trial's primary endpoint will be the change from patient baseline to final Total Nasal Symptom Score, an established scale to measure the aggregation of symptoms consistent in allergic rhinitis. Furthermore, patients will undergo rhinometric examinations and spirometric tests at baseline and during the assessment period to further evaluate WF10's efficacy.
At the first treatment visit, patients who meet the inclusion and exclusion criteria will be randomized into one of two treatment groups: WF10, or placebo. Treatment will be administered once daily for five consecutive days. Patients will be assessed over a three-month period. Nuvo intends to complete the trial in late 2010 or early 2011.
"Positive Phase 2 data from this trial would substantiate WF10 as an important therapeutic asset," said Dr. Henrich Guntermann, President, Europe and Immunology Group. "We are hopeful that this carefully designed and well controlled clinical study will provide us with the scientific evidence to confirm our long-held belief that WF10 can effectively treat patients with certain autoimmune conditions, such as severe allergic rhinitis."
As previously disclosed, Nuvo is co-developing WF10 as a treatment for allergic rhinitis with the Fraunhofer Institute for Cell Therapy and Immunology IZI in Leipzig, Germany. The Development Bank of Saxony in Germany is providing financial support for this co-operative project that will be conducted in Germany through Nuvo Research GmbH, a Nuvo subsidiary.
Allergic rhinitis, also known as Hay Fever, causes cold-like symptoms such as a runny nose, congestion and sneezing. Unlike a cold, allergic rhinitis isn't caused by a virus; it is caused by an allergic response to airborne allergens such as pollen, pet dander or dust mites. The condition affects about one in five people according to the Mayo Clinic.
EastCoastCdn
14 years ago
Nuvo Research announces early redemption of 5% convertible debentures
MISSISSAUGA, ON, Feb. 4 /PRNewswire-FirstCall/ - Nuvo Research Inc. (TSX: NRI), a Canadian drug development company focused on the research and development of drug products that are delivered to and through the skin using its topical and transdermal drug delivery technologies, and on the development of its immune modulating drug candidate WF10, today announced that it has issued a notice of redemption to holders of its 5% convertible debentures due November 16, 2010 (the "Debentures"), stating that it will redeem the outstanding $3,486,000 principal amount of Debentures for cash on March 12, 2010 ("the Redemption Date"). A redemption amount of $1,035.75 (the "Redemption Price") will be paid for each $1,000 of principal amount of Debentures, being an amount equal to the aggregate of i) $1,020 for each $1,000 principal amount of Debentures plus ii) all accrued and unpaid interest up to but excluding the Redemption Date.
Holders of the Debentures have the right to convert their Debentures into common shares at a conversion price of $0.138 at any time prior to the close of business on the business day immediately preceding the Redemption Date by duly completing the required notice of conversion and delivering same at the place of business of Computershare Trust Company of Canada, such that approximately 7,246.377 common shares shall be issued for each $1,000 principal amount of Debentures so converted. Holders converting their Debentures shall be entitled to receive, in addition to the applicable number of shares, accrued and unpaid interest for the period up to but excluding the date of conversion from the day immediately following the latest interest payment date, all in accordance with the trust indenture and supplemental indentures.
The maximum amount payable would be $3.61 million if all Debentures are redeemed. If all outstanding Debentures are converted 25.3 million common shares would be issued.
Further details concerning the Debentures including the rights of redemption and conversion are described in the trust indenture dated November 16, 2004 and supplemental indentures dated January 1, 2007 and September 17, 2008 made between the Company and Computershare Trust Company of Canada, as Trustee. Copies of the indenture and supplemental indentures can be found on SEDAR and hard copies can be obtained from the Trustee.
"We believe that our strong cash position allows us to make this prudent move that simplifies our capital structure and supports the long-term growth of Nuvo Research," said Jim Moulds, Executive Vice President and CFO of Nuvo.
About Nuvo Research Inc.
Nuvo is primarily focused on the research and development of drug products delivered to and through the skin using its topical and transdermal drug delivery technologies, and on the development of its immune modulating drug candidate WF10. Nuvo's lead product is Pennsaid, a topical non-steroidal anti-inflammatory drug (NSAID), which is currently sold in Canada and several European countries. Pennsaid was approved for marketing in the U.S. by the FDA on November 4, 2009. The commercial launch of Pennsaid in the U.S. by Nuvo's licensee, Covidien (COV), is scheduled for the first half of 2010. Nuvo intends to leverage its skin-penetrating technologies to create a portfolio of topical and transdermal products targeting a variety of indications. Nuvo is a publicly traded, Canadian pharmaceutical company headquartered in Mississauga, Ontario, with manufacturing facilities in Varennes, Québec and Wanzleben, Germany, and research and development centers in San Diego, California and Leipzig, Germany. For more information, please visit www.nuvoresearch.com.
Forward-Looking Statements
This document contains forward-looking statements. Some forward-looking statements may be identified by words like "expects", "anticipates", "plans", "intends", "indicates" or similar expressions. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Nuvo considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared, but caution that these assumptions regarding future events, many of which are beyond the control of the Company, may ultimately prove to be incorrect. Factors and risks, which could cause actual results to differ materially from current expectations, are discussed in the annual report, as well as in Nuvo's Annual Information Form for the year ended December 31, 2008. Nuvo disclaims any intention or obligation to update or revise any forward-looking statements whether a result of new information or future events, except as required by law. For additional information on risks and uncertainties relating to these forward looking statements, investors should consult the Company's ongoing quarterly filings, annual report and Annual Information Form and other filings found on SEDAR at www.sedar.com.
SOURCE Nuvo Research Inc.
http://www.prnewswire.com/news-releases/nuvo-research-announces-early-redemption-of-5-convertible-debentures-83580892.html
EastCoastCdn
15 years ago
http://www.newswire.ca/en/releases/archive/November2009/11/c8235.html
Nuvo research provides WF10 licensing and development update
MISSISSAUGA, ON, Nov. 11 /CNW/ - Nuvo Research Inc. (TSX: NRI), a Canadian drug development company focused on the research and development of drug products that are delivered to and through the skin using its topical and transdermal drug delivery technologies, and on the development of its immune modulating drug candidate WF10, today announced a new licensing agreement for Oxoferin(TM), its topical wound healing agent, and additional details of the funding assistance to be provided by the Development Bank of Saxony for the development of WF10.
Nuvo's German subsidiary Dimethaid GmbH entered into an exclusive license agreement with Ranbaxy Laboratories Limited ("Ranbaxy") for the supply and distribution of Oxoferin in Malaysia, Cambodia, Philippines, Vietnam, Myanmar and Singapore. Under the terms of the agreement, Nuvo will manufacture and supply Oxoferin to Ranbaxy, India's largest pharmaceutical company. Ranbaxy will be responsible for obtaining regulatory approval in the licensed territories and has committed to minimum annual purchase quantities once approved.
As previously disclosed, the Development Bank of Saxony in Germany ("SAB") expanded its financial support for Nuvo's co-operative drug development project with the Fraunhofer Institute of Cell Therapy and Immunology IZI to include pre-clinical and early clinical development of WF10 as a treatment for Rheumatoid Arthritis. This support is in addition to the SAB's financial support for the ongoing pre-clinical and clinical development of WF10 as a treatment for Allergic Rhinitis.
In aggregate, the SAB has now committed to provide funding over a three-year period of approximately $3.5 million towards the $6 million estimated cost of these two development projects that are being conducted in Leipzig, Germany by Nuvo Research GmbH, a Nuvo subsidiary.
"These agreements provide further evidence of the potential for WF10," said Henrich Guntermann, President and Chief Executive Officer of Nuvo Research. "Additionally, the financial support allows us to move our drug development pipeline forward more expeditiously."
About WF10
The immune system provides an essential defense to micro organisms, cancer and substances it sees as foreign and potentially harmful. WF10 focuses on supporting the immune system by targeting the macrophage, a type of white blood cell that coordinates much of the immune system, to regulate normal immune function. In conditions such as Allergic Rhinitis, the body's immune system inappropriately responds to the presence of foreign allergens. Research suggests that in some cases, WF10 may rebalance improperly functioning immune systems.
About Oxoferin
Oxoferin, a topical wound healing agent, is a diluted form of WF10. Nuvo believes that research to date indicates that Oxoferin has a positive impact on wound healing leading to contraction, closure and faster healing of wounds. Chronic, hard-to-heal wounds are a serious problem with an increasing incidence. Chronic wounds can be caused by such conditions as burns, pressure sores and poor circulation in the lower extremities. Co-morbid conditions such as diabetes and atherosclerosis reduce blood flow to the extremities and also increase the likelihood of developing chronic wounds such as diabetic foot ulcers and venous ulcers. Oxoferin is marketed by Dimethaid Gmbh and its partners in parts of Europe, Asia and South America under several trade names including Oxoferin and Oxovasin(TM) and it is currently in the process of obtaining marketing approval in Russia.
About Ranbaxy
Ranbaxy Laboratories Limited, India's largest pharmaceutical company, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies. Ranbaxy's continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. The Company's foray into Novel Drug Delivery Systems has led to proprietary "platform technologies," resulting in a number of products under development. The Company is serving its customers in over 125 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 49 countries and manufacturing operations in 11 countries.
About Fraunhofer Institute
The Fraunhofer Institute for Cell Therapy and Immunology IZI is a member of the Fraunhofer Group for Life Sciences. Its objective is to find solutions for specific problems at the interfaces of medicine, life sciences and engineering. It supports partners active in medicine-related industries and businesses.
About Development Bank of Saxony
SAB is the hub at the center of the many activities that traditionally comprise regional development in Saxony, a federal state that enjoys a unique position in both Germany and Central Europe.
SAB is a stand-alone development bank, with no commercial banking activities. Its business lines are recognized by the European Commission as purely development-oriented. They support both general and highly specific economic and social development initiatives. Working closely together with Saxony's state government, banks and savings banks as well as the KfW banking group, the primary objective of SAB is to develop commercial foundations and general infrastructure, thereby securing and improving living conditions throughout Saxony as a whole.
SAB also advises clients on supplementary development aid available from the German federal government, European Union and other sources, assisting them in making their applications or developing tailor-made solutions that bundle together resources from multiple providers. SAB acts as a single specialized point of contact for individuals, entrepreneurs, researchers, associations, local authorities and other institutions and organizations operating or planning to operate in Saxony.
About Nuvo Research Inc.
Nuvo is primarily focused on the research and development of drug products delivered to and through the skin using its topical and transdermal drug delivery technologies. Nuvo's lead product is Pennsaid, a topical non-steroidal anti-inflammatory drug (NSAID) which is currently sold in Canada and several European countries. Pennsaid was approved for marketing in the U.S. by the FDA on November 4, 2009. The commercial launch of Pennsaid in the U.S. by Nuvo's licensee, Covidien (NYSE:COV), is scheduled for the first half of 2010. Nuvo intends to leverage its skin-penetrating technologies to create a portfolio of topical and transdermal products targeting a variety of indications.
Nuvo is a publicly traded, Canadian pharmaceutical company headquartered in Mississauga, Ontario, with manufacturing facilities in Varennes, Québec and Wanzleben, Germany, and research and development centers in San Diego, California and Leipzig, Germany. For more information, please visit www.nuvoresearch.com.
This document contains forward-looking statements. Some forward-looking statements may be identified by words like "expects", "anticipates", "plans", "intends", "indicates" or similar expressions. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Nuvo considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared, but caution that these assumptions regarding future events, many of which are beyond the control of the Company, may ultimately prove to be incorrect. Factors and risks, which could cause actual results to differ materially from current expectations, are discussed in the annual report, as well as in Nuvo's Annual Information Form for the year ended December 31, 2008. Nuvo disclaims any intention or obligation to update or revise any forward-looking statements whether a result of new information or future events, except as required by law. For additional information on risks and uncertainties relating to these forward looking statements, investors should consult the Company's ongoing quarterly filings, annual report and Annual Information Form and other filings found on SEDAR at www.sedar.com.
For further information: about Nuvo, please contact: Adam Peeler, Media and Investor Relations, The Equicom Group Inc., Tel: (416) 815-0700 x225, email: apeeler@equicomgroup.com
EastCoastCdn
15 years ago
Apparently they cut it short on the link.
Here is the full article:
"
TORONTO (Dow Jones)--It's taken the better part of a decade, but Nuvo Research Inc. (NRI.T) has finally landed U.S. approval of its topical pain medicine, Pennsaid.
Earlier Thursday, the Canadian biotech - formerly known as Dimethaid - said the U.S. Food and Drug Administration approved Pennsaid for the treatment of "the signs and symptoms of osteoarthritis of the knee." The approval triggers a $15 million milestone payment from marketing partner Covidien PLC (COV), and Nuvo will receive royalties on sales "consistent with industry standards," estimated at about 20%.
In a release, Nuvo Chairman Dan Chicoine said he is "thrilled" with the result, and that the product's launch will support development of its pipeline products. The main product it has in development is a follow-on to Pennsaid, Pennsaid Plus, a gel formulation that could be more efficacious using less medication.
In Toronto Thursday, Nuvo is up 6 Canadian cents to 41 Canadian cents on 29.7 million shares. It traded as high as 54 Canadian cents earlier in the session.
Nuvo's road to U.S. approval was long and difficult and dilutive for the company, which has a whopping 391 million shares outstanding, plus a host of unexercised options and warrants. Approval was denied twice by the FDA -- in 2002 and 2006 -- and the agency was originally to have ruled a third time in August but needed more time to analyze all the data.
In a report, Dundee Securities analyst David Martin said he believes the substantial safety data Nuvo collected since 2006, coupled with no changes in "direction" at the FDA's pain division, gave Pennsaid better odds of approval this time.
He said a peak sales estimate for Pennsaid of $100 million is reasonable based on the current market size for drugs in this class and potentially stronger efficacy and improved patient convenience compared to its key competitor, Voltaren gel.
Company Web Site: http://www.nuvoresearch.com
-By Andy Georgiades, Dow Jones Newswires; 416-306-2031; andy.georgiades@dowjones.com "
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