Today's Top Stories As if drugmakers didn't have enough pressure on sales from the upcoming patent cliff, they're now facing the threat of a pharmacy benefits merger that would turn two 900-pound gorillas into one King Kong of pricing power. As Dow Jones reports, pharma companies aren't cringing in fear just yet--at least not in public--but they might soon grab some burning torches and make a run at antitrust regulators, to see if that can keep the monster away. Since Express Scripts announced last week that it planned to buy Medco Health Solutions for $29-plus billion, drugmakers have been taciturn about the possible threat to U.S. drug prices. Those who have spoken have tended to downplay the risk. Eli Lilly CFO Derica Rice, for instance, said the company could keep its negotiating power simply through the advantages its products offer over generics. (Never mind that the company's recent earnings clearly suffered from generic competition; that's another story.) But industry experts and analysts have a different story to tell. BioPharma Alliance's Michael Luby, for instance, told Dow Jones that the Express/Medco combo would offer "extraordinary purchasing power for the combined company to leverage with pharmaceutical companies." And Morningstar analyst Damien Conover said the companies might raise antitrust concerns with regulators; that wouldn't be much of a stretch, given that the word "antitrust" was already all over the media coverage when Express and Medco announced the deal. Price cuts in European countries such as Germany and Spain have already been dogging Big Pharma. In the U.S., drugmakers have escaped government price negotiation, at least so far, though companies have discounted their drugs for Medicare and are subject to mandatory Medicaid rebates. Pharma has, of course, spent lots of time, money and effort lobbying against U.S. government pricing pressure. Now, the threat comes from the private sector. Besides the obvious danger of sheer size, the planned PBM merger involves at least one company, Medco, that hasn't been shy about subjecting drugs to its own comparative-effectiveness research--something the federal government has had difficulty embracing for political reasons. Pharma isn't wild about the idea. So, if the FTC doesn't start getting letters from drug CEOs, we'd be surprised. - read the Dow Jones story Related Articles:
Express Scripts strikes $29B deal for Medco
Medco digs deeper into diagnostics for drugs
Report: U.S. specialty-med spending on the rise Read more about: Express Scripts, Medco Health Solutions, drug prices
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 | An Expert Briefing: Biotechnology 101- An Industry Overview for the Non-Scientist - Tuesday, July 26th, 1 pm ET / 10 am PT
Join us as we define biotechnology and briefly explore the various biotechnology sectors. We will also focus on the healthcare sector and explain how basic science and technology are used during the drug discovery process.
Topics include: DNA, Proteins, Recombinant DNA, Small and Large Molecule Drugs, and more Register today. |
Forest Laboratories is stepping up its fight on behalf of CEO Howard Solomon. In the face of threats that Solomon would be barred from doing business with the federal government, the company has tapped former Sen. John Breaux for help. A Democrat from Louisiana, Breaux co-headlines a lobbying firm with former Senate Majority Leader Trent Lott, and one of his specialties is healthcare issues. Several months ago, the Department of Health and Human Services notified Solomon that he might be excluded from government business, a move that would prevent Forest from capturing Medicare and Veterans Administration sales so long as Solomon is associated with the company. Forest immediately pledged its support in Solomon's fight against exclusion, noting that, while the company had pleaded guilty to marketing an unapproved drug and settled an off-label marketing investigation with the U.S. Justice Department, Solomon himself had never been accused of wrongdoing. In going after Solomon personally, HHS is making good on threats to hold pharma executives accountable for their companies' misdeeds, perhaps even if those executives weren't directly involved in wrongdoing. In spite of several Justice Department settlements in the hundreds of millions of dollars--as well as a couple in the billions--federal officials have worried that such deals aren't enough to deter bad corporate behavior. Solomon's problems with HHS have spawned problems for Forest, most notably a proxy fight with Carl Icahn and his investment funds. Icahn's group has nominated new members for the company's board, and it has sued the company for more information about Solomon's status. Clearly, Forest thinks it needs help fighting off the dragons, or it wouldn't have hired Breaux. - read the news from The Hill
- get more from Pharmalot Related Articles:
Forest proxy battle heats up as meeting nears
Icahn sues Forest for info on Solomon's woes
Feds target Forest again with Justice subpoena
HHS move to bar Solomon raises pharma fears Read more about: Forest Laboratories, Howard Solomon
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In the wake of a recall in Hong Kong, GlaxoSmithKline's ($GSK) antibiotic Augmentin is now facing testing by regulators in Vietnam. The Drug Administration of Vietnam says it will collect samples of the drug to test for plasticizers, the chemicals found in trace amounts by Hong Kong officials. Vietnam has also asked GSK to work with distributors to collect samples. Hong Kong has pulled two Augmentin products: a powdered form that's reconstituted into a liquid for dosing and a 375 mg pill version. Authorities there said they had found plasticizers in both products; the pill version contained di-2-ethyl hexyl phthalate (DEHP) and diisodecyl phthalate (DIDP). The 375 mg pill is no longer imported into Vietnam, authorities there said, although other pill strengths and powdered versions are. At the time of the Hong Kong recall, GSK and health officials there emphasized that the amounts of plasticizer found weren't likely to cause harm to humans if they were taken at the proper doses. But Hong Kong is still mulling legal action against the drugmaker. Meanwhile, GSK is conducting an internal investigation to determine the source of the chemicals, because they are not used to manufacture the antibiotic products. - read the story in Thanh Nien News Related Articles
Hong Kong forces second GSK recall
Hong Kong yanks GSK drug on phthalate levels Read more about: Augmentin, Vietnam, GlaxoSmithKline, drug recall
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Roche and Novartis both got a boost from European authorities, who are recommending new uses for their targeted cancer drugs. Roche got the nod from European Medicines Agency to market Tarceva for patients with a particular genetic strain of non-small cell lung cancer, while Novartis' Afinitor won backing for use in patients with advanced pancreatic neuroendocrine tumors. Both new indications will need a final OK from the European Commission, but as Reuters points out, the EC typically follows through on these recommendations within a couple of months. Tarceva already is a big seller for Roche, with $1.58 billion in 2010 revenues, but the new use promises to broaden its marketing appeal further. The new indication would cover Tarceva as a first-line treatment for NSCLC that has tested positive for a genetic mutation affecting the advanced epidermal growth factor receptor. It's already approved as a second- and third-line treatment for lung cancer with or without the mutation. Afinitor, on the other hand, is still a sub-$1 billion drug, but Novartis ($NVS) hopes that building up new indications for the drug will eventually push it into blockbuster territory. As Reuters notes, the drug targets a protein that regulates cell division and metabolism, as well as blood-vessel growth. The new indication would allow Afinitor to be marketed for NET tumors that are inoperable or have metastasized. It's already approved for kidney disesase, and recent data have raised hopes that it could win a nod for use in breast cancer. Novartis plans to file for that indication by year's end. - read the Reuters news
- get more from InPharm Related Articles:
Study: Tarceva delays lung cancer twice as long
Another study-data boost for Novartis' Afinitor
Study boosts Roche bid for first-line Tarceva use
Novartis drug gets CHMP nod for new use Read more about: Novartis, Roche, lung cancer, Tarceva
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Johnson & Johnson ($JNJ) saw its stable of new drugs strengthened at last week's meeting of European regulators. The European Medicines Agency's drug-approval panel backed its new prostate cancer drug Zytiga and its new hepatitis C treatment Incivo. As Bloomberg notes, both are presumed blockbusters that could help give J&J sales a multibillion-dollar boost. Zytiga won approval in the U.S. earlier this year, as did Incivo, which is sold in that market by Vertex Pharmaceuticals ($VRTX) under the brand name Incivek. Citigroup's Matthew Dodds has tagged peak sales of Zytiga at $1.1 billion by 2015, while Incivo could hit $1.4 billion by the same year, Bloomberg notes. The final European approval will have to come from the European Commission, but J&J is expected to be able to launch the drugs on the continent by the end of this year. In fact, J&J's Janssen Pharmaceutical is raring to go; Incivo medical leader Jim Witek told Bloomberg that Incivo could be on the market within days of the EC's blessing. - read the Bloomberg story ALSO: Johnson & Johnson (JNJ)'s Simponi, a treatment for rheumatoid arthritis, wasn't approved by U.S. regulators as a way to inhibit the progression of damage from the disease. Report Related Articles:
With Incivek approval, hep C drug battle begins
Blockbuster expectations for new J&J prostate drug
Merck gets Roche to sell HCV drug in EU, elsewhere
Novartis, Roche blockbusters shine at ASCO Read more about: European Medicines Agency, Prostate Cancer, Zytiga, Incivek
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@FiercePharma: Merck amps up in China with Simcere JV. 
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