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[schwi105]

Covidien Announces License Agreement with Nuvo Research Inc. - FierceBiotech

Covidien Announces License Agreement with Nuvo Research Inc.
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Posted June 16, 2009
Covidien Announces License Agreement with Nuvo Research Inc.
Goal to Expand Covidien's Entry into Branded Pain Management Market

ST. LOUIS--(BUSINESS WIRE)--Jun. 16, 2009-- Covidien (NYSE:COV), a leading global provider of healthcare products, today announced that its Pharmaceutical Products business unit has entered into a license and development collaboration with Nuvo Research Inc. (TSX:NRI), a Canadian drug development company. The agreement is aimed at expanding Covidien's entry into the branded pain management market.

Covidien is the largest supplier of controlled pain medications in the United States based on number of prescriptions. Nuvo develops transdermal and topical therapeutic products designed to reduce side effects.

The companies' collaboration encompasses two topical formulations of diclofenac, a non-steroidal anti-inflammatory drug (NSAID), the first of which is currently under U.S. Food and Drug Administration (FDA) review. In February 2009, the FDA accepted Nuvo's resubmission of its application for approval of the first formulation as a complete response to a December 28, 2006, approvable letter from the FDA. The FDA is scheduled to advise Nuvo of its decision on the application by August 5, 2009. The second formulation is currently in development.

The first topical formulation combines a transdermal carrier, dimethyl sulfoxide, with diclofenac sodium, a leading NSAID. It is the subject of a research article appearing in the June 2009, edition of PAIN, the journal published by the International Association for the Study of Pain.

Under the license agreement between Nuvo and Mallinckrodt, Inc., a subsidiary of Covidien, Nuvo will receive a one-time upfront payment and could receive additional development and sales milestone payments over the next several years. The one-time upfront payment will be expensed in Covidien's fiscal third quarter. In addition, Covidien will pay Nuvo a royalty on sales of products developed and commercialized under this license agreement. Covidien anticipates launch of the first product from this agreement in the first half of calendar 2010.

Covidien will be responsible for all commercialization activities, including marketing, selling and medical education. Nuvo will own and maintain the intellectual property and will be responsible for manufacturing.

"Building on more than a century of pain treatment experience, Covidien focuses on providing patients with access to advanced medications that expand the limits of pain therapy by combining proven drugs with innovative delivery systems. We are pleased to be collaborating with Nuvo Research on topical formulations of diclofenac and the opportunity to expand our branded pharmaceutical portfolio," said Timothy R. Wright, President, Pharmaceutical Products and Imaging Solutions, Covidien. "While we face difficult comparisons in 2010 in our Pharmaceutical business, we are excited about the potential of these products to accelerate our performance in 2011 and beyond."

About Covidien

Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading product lines in four segments: Medical Devices, Imaging Solutions, Pharmaceutical Products and Medical Supplies. With 2008 revenue of nearly $10 billion, Covidien has more than 41,000 employees worldwide in 59 countries, and its products are sold in over 140 countries. Please visit Welcome to Covidien to learn more about our business.

Forward-Looking Statements

Any statements contained in this communication that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on our management's current beliefs and expectations, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or Company actions to differ materially from what is expressed or implied by these statements. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, our ability to effectively introduce and market new products or keep pace with advances in technology, the reimbursement practices of a small number of large public and private insurers, cost-containment efforts of customers, purchasing groups, third-party payers and governmental organizations, intellectual property rights disputes, complex and costly regulation, including healthcare fraud and abuse regulations, manufacturing or supply chain problems or disruptions, rising commodity costs, recalls or safety alerts and negative publicity relating to Covidien or its products, product liability losses and other litigation liability, including legacy Tyco-related litigation, divestitures of some of our businesses or product lines, our ability to execute strategic acquisitions of, investments in or alliances with other companies and businesses, competition, risks associated with doing business outside of the United States, foreign currency exchange rates, issues related to our existing material weakness in accounting for income taxes or potential environmental liabilities. These and other factors are identified and described in more detail in our filings with the SEC. We disclaim any obligation to update these forward-looking statements other than as required by law.





http://www.reuters.com/article/rbssHealthcareNews/idUSN1626047120090616

* Covidien gains rights to Pennsaid

* Nuvo gets $10 mln payment up front

NEW YORK, June 16 (Reuters) - Medical products maker Covidien Plc (COV.N) will license rights to two Nuvo Research Inc (NRI.TO) topical anti-inflammatory medicines as it expands into the branded pain market, the companies said on Tuesday.

Covidien gains rights to sell Pennsaid, a cream version of the older pain medicine diclofenac which U.S. regulators are reviewing, and a follow-on product in development. The U.S. Food and Drug Administration is expected to respond to the Pennsaid application by Aug. 5.

Nuvo said it will receive $10 million up front from Covidien and $15 million or $20 million for FDA approval of Pennsaid, depending on the drug's labeling. It could receive up to $100 million more should the two drugs reach various sales milestones.

Covidien is the largest U.S. supplier of controlled pain medications, based on number of prescriptions, but those have all been generics. (Reporting by Lewis Krauskopf; Editing by Derek Caney)

[AdamJ]

I'm in for 100k. Been watching this set new support levels but, with this news it should step forward consistently for the next month. If it pulls back to 0.30 then I'll consider buying another 100k.

Probably will holding 25% minimum for the long considering the jumps that should occur with milestones.

[Spinner]

The NRI pumping seems to have started in earnest all over the interwebs this week so I think we're safe in the one-month timeframe into the decision run-up.

Cheers, Spinner

[Nauth]

Yes I have heard it's been trying to be pumped up by stockheaven in an article on June 16th on the google forums. Here is the link to the article for those that are interested. This stock has the potential to see the .60-.70 very soon comparied to later becuase of the pumping that might start today.

Third Time's A Charm For Nuvo Research (TSE:NRI) |

I'm already in on this stock because the product is already being used in canada. So i see this getting approval by the fda in about 2 months.

[xGriMx]

this looks like a solid company. Anyone have any idea where the pps is headed? still a good buy in at .34 ?

[Dognamedabu]

Check out other Bio stocks and see how they tend to ramp up as they near their FDA date..This one is Aug 5, I think. If you buy you might want to buy enough to play the ramp up, sell to get free shares and then let the rest ride. .34 is where it has been sitting for nearly a month so I don't see it going down to much between now and Aug 5 but MM do strange things so BBW.

[AdamJ]

Keep in mind that not much will most likely happen until after the warrants expiry in a week or two. That for the most part is the only major issue but, most of them were already exercised a couple months back.

Although I'd like to exit in August IMHO this should be a ten bagger in a year and fits my criteria for a long position. My best advice is if you are fence sitting to make your decision/investment before that expiry date.

[stock926]

OK GUYS WE NEED TO START LOOKING AT THIS BEAUTY ONCE AGAIN...

I Don't know why no one is posting about NRI but this company is hot right now

anyone who has been following it for the past 2 weeks will know what i'm talking about. today it hit a high of $0.465/share and only a two weeks ago was it down in the range of .34-.36

Nuvo Research's star drug is Pennsaid and is currently in the spotlight. Their anticipated FDA decision date is still Aug 5th 2009(unchanged/no delays)

This drug looks pretty good so far as it is safe, proven, approved and sold in both Canada and Europe. There is nothing new about this drug except that they are now looking to expand their market reach into the US.

I see no reason why the FDA would reject this application unless some issue not relating to the actually drug came up.

The FDA approval seems very probable but you never know with the FDA right?

Again this is all only MY OPINION but i am pretty confident in the company as i have a long position in the stock.

Tell me what you guys think about this company... I'd like to hear some more opinions on the last 2 weeks of movement.

[mobgma]

Just a thought, should this get approved, will it still be a "ten bagger" even though it is a Canadian company?

I am not sure what experience tells us but I am assuming the jumps are smaller on FDA approvals when compard to an American owned and operated company.

I have 5000 shared in this at 0.36 so I am always hoping fore a substantial jump but is it being "over-hyped"?

[bilinz]

when is the FDA's approval coming? this stock is still looking pretty good but im not sure if i should go for it or not. any opinions?