Selective PDE4 inhibitor is aimed at patients with severe COPD associated with chronic bronchitis.

The European Commission granted Nycomed marketing authorization for Daxas® (roflumilast). The drug is indicated as an add-on to bronchodilator therapy for maintenance treatment of severe COPD (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations.

Daxas reportedly represents the first new class of treatment for COPD in more than a decade. It is a selective phosphodiesterase 4 (PDE4) enzyme inhibitor. It is taken as an oral tablet once a day and is expected to be launched in European countries, starting with Germany and the U.K.

On April 26, Nycomed and Merck & Co. signed an agreement to co-promote Daxas in France, Germany, Italy, Spain, Portugal, and Canada. Nycomed will manufacture and distribute the finished product in all these countries. In addition, the two companies entered into an exclusive distribution arrangement for the commercialization of Daxas in the U.K. Nycomed will supply finished product and has retained a co-promotion option. For the U.S. the company signed a collaboration and distribution agreement with Forest Laboratories in August 2009. The NDA for Daxas was submitted in July 2009.

“Daxas is a novel therapy that improves lung function and most importantly reduces exacerbations,” says Klaus F. Rabe, M.D., lead author on various Daxas clinical trials from the University Medical Centre in Leiden, The Netherlands. “It has a unique mode of action that targets the underlying inflammation in COPD and is an important addition to the current options available to doctors and patients.”

Neil Barnes, M.D., professor of respiratory medicine at Barts and the London Hospital and Nycomed consultant, notes, “We have a large number of patients who remain symptomatic and have frequent exacerbations despite existing treatments, and for that more severe end of the spectrum we need new therapeutic options. The main additional benefit of Daxas on top of what is already achieved with bronchodilators is to reduce the number of exacerbations, or flare ups.”

The application to the EMEA was based on four Phase III trials in symptomatic COPD patients. In two placebo-controlled, 12-month studies involving over 3,000 patients, Daxas demonstrated statistically significant improvements on both co-primary endpoints: moderate-to-severe exacerbations and prebronchodilator FEV1.

The effect of Daxas was independent of concomitant use of long-acting beta2-agonist, according to Nycomed. In two supportive studies the drug also showed a statistically significant improvement compared to placebo on lung function over a six-month period when added to the bronchodilators tiotropium or salmeterol. Full data from all four studies was published in The Lancet in August 2009.

Source: GEN

Popularity: 3% [?]

When you’re trying to sell drugs in Russia these days, it pays to be a local. That’s because the government is trying to boost local companies’ share of the pharma market to 50 percent by 2020, stairstepping upward along the way. So, international drugmakers that don’t already produce drugs–or at least package them–in Russia are planning to change that.

Indeed, foreign pharma is pouring money into the Russian market –at least $1 billion, by one estimate–as companies set up local production, Reuters reports. “Certainly companies have to be loyal to the government, try to build at least packaging facilities to show that they have a long-term commitment to the market,” market researcher David Melik-Guseinov told the news service.

One attendant bonus to producing drugs in Russia for sale in Russia is a reduced risk of detrimental currency-price changes. “The more stages of production [a drugmaker] has [in Russia], the less the forex risk is,” Julia Fedorova, a lawyer with CMS, told Reuters.

So, who’s in the lead with Russian manufacturing? Helpfully, Reuters has compiled a list of drugmakers and their investments in the country. They include Novo Nordisk, which recently announced plans for its first production facility there, at a cost of up to $100 million. Sanofi-Aventis bought a controlling stake in a Russian insulin plant. Nycomed is plotting a liquid sterile products and solid medicines production facility, projected to cost up to €75 million, or $93 million. And there’s more. Check it out.

Source: FiercePharma

Popularity: 2% [?]

U.S. health officials have started releasing summaries of safety reviews for recently approved medicines as part of their efforts to inform doctors and consumers about potential side effects.

The information comes in part from post-approval reports of health problems from consumers, doctors and companies, Food and Drug Administration officials said as they unveiled the program on Tuesday. Agency reviewers also look at medical literature and ongoing studies.

The FDA and companies track potential problems after a drug reaches the market as some side effects do not emerge in the smaller groups of people who take part in pre-approval testing.

A 2007 law required the FDA to prepare a safety summary for certain prescription drugs 18 months after approval or after they have been used by 10,000 people, whichever comes later. Those summaries will now be posted on the FDA website.

On Tuesday, the agency released summaries for 24 medicines and two vaccines for hypertension, allergies, HIV and other conditions. It included details on what action the agency was taking.

In the list, the FDA said it had reviewed reports of cases where Alvesco, an asthma drug sold by Dainippon Sumitomo Pharma unit Sepracor Inc, was ineffective. The reports “described problems with drug delivery (possible device malfunction) after a period of use,” the FDA said.

In that case, the agency said it had requested more information on the issue but decided no changes to the drug’s prescribing instructions are required at this point.

Sepracor spokeswoman Susan Adler said the company and its distribution partner, privately held Nycomed, have been working with the FDA throughout its review of the matter.

“This review has not resulted in any changes to the labeling or manufacturing process for Alvesco,” she said.

For most of the drugs, the FDA said no new issues were identified or problems had been investigated and determined to be unrelated to the medicine.

The findings show “for the most part, we know a lot from (pre-market) clinical development,” said Dr. Robert Boucher, an official in the FDA office that reviews post-approval drug risks.

The FDA will provide summaries for drugs approved after September 2007, when the law that required them took effect. New summaries will be released quarterly.

Serious issues that arise before the 18-month mark could be disclosed earlier, Boucher said.

A drug industry group said it believed the FDA should continue to monitor risks and benefits after a product’s approval.

“A medicine’s FDA-approved labeling should contain the most authoritative summary of its benefits and risks, and this is reflected in FDA’s new website” listing the safety summaries, said Ken Johnson, a spokesman for the Pharmaceutical Research and Manufacturers of America.

The FDA has moved to make public more information about drug risks since running into criticism for its handling of problems with medicines including Merck & Co’s pain reliever Vioxx, which was pulled from the market in 2004 after it was linked to heart attacks and strokes.

The agency now alerts the public to early investigations of problems before scientists have determined if a drug is responsible.

Source: Reuters

Popularity: 3% [?]

Nycomed’s COPD drug Daxas may be in deep trouble in the U.S., but a thumb’s up from the European Medicines Agency last week set the stage for a new co-promotion deal with Merck covering the continent and Canada.

An FDA panel voted not to recommend the therapy for approval a little more than two weeks ago. That was a heavy blow for Switzerland’s Nycomed–which has been grooming itself for an IPO–and its U.S. partner Forest Laboratories. The developer, though, gets an undisclosed upfront payment in the deal to co-promote in France, Germany, Italy, Spain, Portugal and Canada.

“This builds upon Merck’s leadership in the asthma and allergy marketplace and positions the company to leverage our well-trained sales force to target the rapidly growing unmet medical need of COPD,” said Kevin Ali, a senior VP at Merck.

Nycomed’s crucial presentation to an FDA expert panel earlier this month foundered on a belief by a majority of the panel that the data on Daxas demonstrated too few benefits and too many potential safety issues to warrant an approval. A company spokesperson told Reuters that Nycomed is still planning an IPO “sooner or later,” which sheds as little light on those plans as the co-promotion announcement did on the financials in the Merck deal.

Source: FIerceBiotech

Popularity: 2% [?]

Nycomed is in luck. The European Medicines Agency today recommended approval of Daxas, the company’s once-a-day pill for patients with severe COPD. The approval follows an expert FDA panel’s decision earlier this month not to recommend the drug for approval. In a 10-5 vote, panelists determined the side effects of Daxas outweighed the limited improvement in lung function. The ruling was a blow to Nycomed’s partner Forest Labs, which has U.S. rights to Daxas. A final FDA decision is due in May.

Nycomed says it will launch Daxas later this year once it obtains a formal approval from the European Commission. The drug’s approval there could lead to an IPO for Nycomed, which has planned to go public but never provided a timetable for doing so. “Nycomed is excited about the positive opinion of the CHMP recommending approval of Daxas in the European Union. Daxas is the first in a new class of oral agents to treat this life-threatening condition, offering clinicians and patients a much needed new treatment option alongside existing inhaled therapies,” said Anders Ullman, Nycomed executive vice president of R&D.

Source: FierceBiotech

Popularity: 2% [?]

In a 10-5 decision, an FDA expert panel voted against approval Daxas, Forest Laboratories and Nycomed’s drug for chronic obstructive pulmonary disorder (COPD). The panel did vote 9-6 that the drug is safe and effective. “The benefit of this drug, although it’s there, it’s meager,” noted one panelist. That benefit obviously wasn’t enough to warrant the panel’s backing, as many thought the side effects of Daxas outweighed the limited improvement in lung function. An FDA decision is due in May, and although the agency doesn’t have to follow the panel’s recommendations, it generally does.

Forest could gain approval of the the drug for a narrower group of patients, rather than the broad COPD indication. “We believe there is still room for us to begin and go forward with negotiations with the agency,” said Forest President and COO Lawrence Olanoff.

Nycomed, which developed the drug, conducted four Phase III trials of Daxas and got a $100 million upfront payment from Forest for the licensing deal last year. The company stood to gain an additional $500 million in milestones for the drug, which has blockbuster potential if it can compete with GSK’s mega-seller Advair.

Source: FierceBiotech

Popularity: 6% [?]

Shares of Forest Laboratories slid this morning after investors got a chance to look over some of the FDA staff’s skeptical questions for Daxas, a potential new blockbuster for smoker’s lung that goes before an expert advisory panel on Wednesday.

A staff summary concluded that the COPD drug’s ability to spur better lung function relative to a placebo was really “quite modest,” while a slate of potential safety issues–gastrointestinal problems, potential carcinogenicity, pancreatitis and weight loss–could pose a hurdle for Forest, which is seeking an approval for Daxas alongside its partner, Nycomed. And the FDA raised another red flag, noting that there were three completed suicides in the drug group as well as two attempted suicides.

Forest shares had slipped three percent on the staff review, which typically takes a fairly skeptical view of all the new drugs that come its way. Nycomed completed four Phase III trials of Daxas and picked up a $100 million upfront from Forest for the licensing pact last summer. Forest also agreed to pay up to $500 million in milestones for the drug, which has the potential to earn blockbuster revenue if it can go on to compete with Advair–a drug that earned $6 billion in 2006.

Source: FierceBiotech

Popularity: 2% [?]

Whatever last-minute flurry of Solvay Pharmaceuticals (SVYSY) bidding there was–or wasn’t–it’s over now. The winner? Abbott Laboratories, which has agreed to buy the drugs unit of the Belgian company Solvay. Price: about $7.6 billion, or €5.2 billion.

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Talking heads are hailing the Abbott buy for a variety of reasons. It will beef up Abbott’s (ABT [4]) emerging-markets sales, for one. It gives Abbott full control of the TriCor cholesterol pill it’s been co-marketing with Solvay Pharma, plus solo rights to the Trilipix follow-up med. Plus, Abbott gets access to a variety of other desirable products, including drugs for hypertension and Parkinson’s disease, hormone treatments, and flu vaccine. And that diversification will help curb Abbott’s reliance on Humira, though not enough to make some analysts happy.

The purchase price includes a €4.5 billion ($6.6 billion) up-front payment, plus an additional €300 million ($437 million) in payments contingent on product performance, payable in 2011 and 2013. The deal also includes assumptions of liabilities valued at €400 million ($583 million). Solvay had been looking for up to €5 billion for the pharma unit, so Abbott beat its asking price.

The Abbott buyout leaves a couple of other Solvay-chasers in the dust, particularly Nycomed, which until recently was said to be the sole company to lodge an actual bid. Belgium’s UCB also was looking at the company, news reports say, along with Takeda Pharmaceuticals.

Source: FierceBiotech

Popularity: 4% [?]

Suddenly there’s a surge of interest in Solvay Pharmaceuticals. The Belgian drugmaker, a division of conglomerate Solvay, has been on the block for months [1], generating a flurry of interest at first but generating only one actual offer, from Nycomed. Now, though, Abbott Labs has joined the hunt with its own offer, the Wall Street Journal reports. And fellow Belgian drugmaker UCB is also mulling a bid.

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Abbott is already in business with Solvay, partnering on the marketing of Tricor and Trilipix. And UCB and Solvay have common ownership ties, with the Janssen family holding sizable stakes in both firms.

Analysts tag Solvay’s drugs unit with a price anywhere from $5.9 billion to $7 billion; word is that Nycomed’s bid is on the lower end of that range. Now that other companies have emerged as bidding rivals to Nycomed, Solvay could command a price on the higher end. And a higher price would make an actual sale more likely, as Solvay officially is weighing all options for the pharma unit, including hanging onto it as is. Analysts expect the company to sell.

The Solvay board is set to meet Friday, with a deal potentially following soon after, sources told the WSJ. Solvay, Abbott, Nycomed and UCB all refused to comment.

Source: FiercePharma

Popularity: 4% [?]

Reuters is reporting that Switzerland’s Nycomed has made a €4 to 4.5 billion ($5.88 to $6.62 billion) bid for Solvay’s drug unit, which has been on the market since May. Nycomed would draw on European “junk” bonds, $1 billion from Nycomed’s owners and existing funds to finance the deal. The resulting company would have $6 billion in annual sales. Solvay’s drug unit features treatments for cholesterol, hypertension, Parkinson’s disease and hormone replacement therapies for men and women.

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Previously, Nycomed and an unnamed Japanese firm were rumored to be eyeing the drug unit. Reuters’ sources say the company has had several proposals and it’s unknown whether Nycomed will face competition for the unit. Abbott Labs–Solvay’s partner on its drug TriCor–and Takeda Pharmaceuticals have already publicly stated that they would not be interested in a deal. A source told Bloomberg that Nycomed’s bid is part of a plan to set the company up for an IPO in 2011. A spokesperson for Nycomed declined to comment on the report, while Solvay said that no decisions have been made as of yet.

Source: FierceBiotech

Popularity: 3% [?]