Chiron rejects Novartis bid, leaves door open to higher offer
Chiron has rejected Novartis' takeover offer of $40 per share, setting the stage for what analysts believe is likely to be a sweetened bid package. Some analysts pegged the next likely bid at $45 per share for all shares Novartis doesn't already own. That would raise the value of the offer to more than $5 billion. Novartis has already shelled out more than $8 billion for two generic drug makers this year. A Chiron takeover would make it a big player in the global vaccine …
PDL touts mid-stage data for new heart drug
Protein Design Labs says that a mid-stage trial of its experimental drug ularitide -- one of its leading drug candidates -- helped patients with severe heart disease by easing symptoms and cutting mortality rates. In particular, the new drug helped without causing kidney toxicity, a major health issue for patients with acute decompensated congestive heart failure, a condition that can reduce kidney function.
"We are very pleased with the results of the SIRIUS II trial and are …
Andrx applications put on hold as feds review manufacturing
The federal government has put Andrx's new drug applications on hold after raising issues with its manufacturing operations following a federal inspection last May. The generic drug maker said in a release that the agency may sanction the company, which could include product recalls or the suspension of production. Andrx said it had filed a plan to correct the problems found during the inspection. Trading of Andrx's stock was halted before the announcement.
- read this AP story for more
EpiCept to buy Maxim for $136M
Xigen raises $21M in first round
Switzerland's Xigen garnered $21 million in its first round, with Tilocor Life Sciences, Venture Incubator and Initiative Capital joining as investors. Xigen has been researching a new class of peptide therapeutics for the treatment of stroke, myocardial infarction and cancer.
- read this press release for more
PLUS: Switzerland's …
SPOTLIGHT: Cephalon files NDA
Cephalon has filed an NDA for a new pain medication for cancer patients. Cephalon plans to market OraVescent fentanyl in multiple dosages. Release
ALSO NOTED: New Ambien drug approved; Amgen's two new facilities approved; Barr, Teva to partner on generic Allegra; and much m
> Sanofi-Aventis has received approval to sell a new, extended release version of its insomnia drug Ambien in the US. The drug maker has been developing the new version to compete with a host of new insomnia drugs entering the market. Release
> The federal government has approved Amgen's two new manufacturing facilities in Rhode Island and Puerto Rico. …
Editor's Corner
Dr. Susan Wood's decision to resign as the FDA's top official for women's health should be a warning sign to the entire drug development industry. As she noted, FDA Commissioner Dr. Lester Crawford's decision to indefinitely delay any decision on pushing the morning-after contraceptive to OTC is purely the result of abortion politics, and partisanship should have no role to play in …
Feds ask for more data on Dacogen
Shares of MGI Pharma and SuperGen slid this morning after they announced that the FDA issued an "approvable" letter for Dacogen -- their new treatment for bone marrow disorders -- but would need more data before the agency could give it a green light. MGI Pharma bought the treatment from SuperGen last year, leaving SuperGen with a 30 percent royalty deal. The FDA's letter, though, did state that the drug could be approved after an analysis to determine how many patients currently in a …
Metric: 4.4M children in US diagnosed with ADHD
Researchers analyzing government data have concluded that 4.4 million children age four to 17, 7.8 percent of the total, have been diagnosed with ADHD and more than half of them are being medicated for the condition. The report from the Centers for Disease Control in Atlanta noted that this is the first time there has been a careful estimate of the number of children on drugs for the disorder, which is characterized by an inability to pay attention and hyperactivity. Boys are …
GSK to use new technology, invest $100M in vaccine plant
GlaxoSmithKline has acquired a shuttered vaccine plant in the Philadelphia area and plans to invest $100 million in the 90-acre site. GSK says it will hire 300 people to reopen the plant, which will help solidify Philadelphia's reputation as the vaccine capital of the nation. GSK bought the vaccine facility from Wyeth. GSK plans to use the site to begin work with a new technology that makes vaccines from cell cultures, a faster approach than using chicken eggs in the traditional method of …
Drug makers to supply US with up to 97M doses of flu vaccine
Up to 97 million doses of flu vaccine should be available in the coming season. The bigger supply marks a substantial turnaround from last year, when regulators shut down Chiron's Liverpool facility and cut off half of the nation's vaccine supply. The CDC estimates that Chiron will deliver 18 million to 26 million doses; Sanofi Pasteur will produce 60 million shots; GlaxoSmithKline will ship 8 million doses of its new vaccine; and MedImmune expects to sell 3 million doses of its nasal …
SGX out to raise $80.5M in IPO
SGX Pharmaceuticals has filed for an IPO designed to raise $80.5 million. The drug developer says it will use much of the money to fund the development of Troxatyl and other research efforts. SGX lost about $13 million in the first half of the year, up from $7.1 million for the same period the year before.
- read this story from Dow Jones for more
SPOTLIGHT: Novogen expanding US subsidiary
Australia's Novogen said that it will expand its US subsidiary, Glycotex, and that board member Dr. Graham Kelly had resigned in order to devote his attention to the US expansion. Release
FEATURE: Medicare Part D: The Perfect Storm In Healthcare Communications?
Medicare Part D: The Perfect Storm In Healthcare Communications?
Silverlink CEO Stan Nowak examines the confusion surrounding the new prescription drug benefit.
Talk to someone inside the managed care world right now, and things seem somewhat frantic about Medicare Part D. Those accountable for launching their companies' Part D programs say the task …
ALSO NOTED: Intarcia sets IPO terms; VaxGen touts new study; Sinha named CFO at Alexion; and much more...
> Intarcia Therapeutics set the terms of their IPO at 5 million shares priced from $12 to $14 each. Story
> SkinMedica set its IPO terms today, with plans to sell 5.25 million shares at $11 to $13 each. Report
> VaxGen is touting a new study in the Journal of Virology which shows that a single …
Novartis bids $4.5B for remaining shares of Chiron
Novartis has offered $4.5 billion to acquire all the remaining shares of Chiron it doesn't already own. To be successful, about half of the outstanding shareholders in Chiron have to agree to accept Novartis' offer of $40 per share. Novartis already owns 42 percent of the company. Novartis officials said they decided to pursue the takeover after completing due diligence on the company. According to a spokesman, Novartis plans to use the takeover to create a vaccine platform for the drug …
Agency OKs Fluarix, opening spigot of vaccine supplies
The FDA has approved GlaxoSmithKline's Fluarix, opening up a supply of 8 million doses of vaccine for the coming flu season. GSK provided about half that much vaccine last season as the FDA allowed emergency shipments to flow into the US following the sudden closure of Chiron's Liverpool facility. Yesterday, the FDA gave that manufacturing site a green light to start production again, another move likely to insure easy availability of vaccine this year.
While Fluarix does not …
FDA chief of women's health resigns over Plan B inaction
Criticizing the influence of "abortion politics" in the FDA's decision to indefinitely delay any decision on allowing the controversial morning-after pill to be sold over-the-counter, the agency's top official for women's health turned in her resignation yesterday. In an email to her colleagues, Dr. Susan F. Wood said she could no longer remain at the FDA when scientific evidence and the recommendations of professional staff were being ignored. The morning-after pill, she noted, was aimed …
MDS slashing jobs, narrows focus to life sciences
Toronto-based MDS is cutting its core business down to three units from six, eliminating about 500 jobs and restructuring its pharma unit as it narrows its focus to the life sciences arena. As part of the restructuring, MDS, which employs 9,000 people in 27 countries, will consider selling its laboratory services arm. Sites in Geneva, Taiwan and Munich are being shuttered. The moves come a month after Stephen DeFalco took over as CEO and after years of poor financial performance. The …
