Backed up with some impressive mid-stage data, Targacept has inked a $1.24 billion licensing deal with AstraZeneca for its promising new depression therapy.

The Winston-Salem, NC-based developer landed a $200 million upfront payment for TC-5214, with more than a billion dollars in development and sales milestones up for grabs. Targacept also gets "significant" double-digit royalties from any approved product from AstraZeneca, which is already partnered with the developer on two other programs. And the two companies are planning to launch a jointly designed Phase III next year as they map out plans to file for approval in 2012.

The size and scope of the worldwide collaboration deal underscore the impressive set of data Targacept reported on the drug-a nicotinic channel blocker. Targacept shares shot up to a record high on that report. And shares spiked 13 percent this morning as investors responded to the news of the pact.

"The opportunity to improve treatment in depression is a large one, both commercially and in terms of benefits for patients," said AstraZeneca Chief Executive Officer David Brennan in a statement. "It's an area both AstraZeneca and Targacept know well and I'm pleased to be adding another late stage project to our pipeline."

- check out Targacept's release
- here's the report from LocalTechWire
- and here's the story from the AP

Related Articles:
Targacept touts mid-stage depression drug results
Targacept lands $10M AZ payday for ADHD success
Targacept dumps pain drug after trial failure
Targacept, AZ nix schizophrenia drug

Life science CEOs made an average base salary of $273,000, up 3.2 percent from 2008 levels. That's according to the 10th annual Compensation and Entrepreneurship study, released by J. Robert Scott and Ernst & Young. The study authors polled more than 200 emerging, private life sciences firms, and found that the life science industry fared better in 2009 compared with executives in other technology sectors. C-suite execs polled at 500 technology firms reported that their compensation remained relatively flat at $231,000, compared with $230,000 last year.

The news wasn't all good for life sciences, however. Biotech and Pharma CEOs received average bonuses of $48,000 in 2008--or 44 percent of their target bonus--down from 73 percent in 2007.

"This is the first time in 10 years of conducting the study that we have seen anything other than an increase in technology executive total cash compensation. In fact, the average increase over the past nine years has been five percent annually," said Aaron Lapat, managing director, J. Robert Scott. "In terms of private life sciences companies, these executives may have experienced an increase in base salary because their compensation tends to be based more on clinical milestones. Clearly, the economy is driving change at these organizations."

- here's the release

Related Articles:
Are biotech CEO's worth what they're paid?
CEO pay of 2008: Who makes what in Big Biotech?

Shares of Endo Pharmaceuticals (ENDP) slid this morning after investors got wind of the news that the FDA stiff-armed the company's application to market its new drug for low testosterone. Low testosterone is associated with a variety of ailments, including fatigue and loss of libido.

Regulators want more information on rare but serious incidents of anaphylactic reactions and pulmonary oil microembolism among patients taking Aveed (known as Nebido outside the U.S.). And the FDA said in its complete response letter that Endo's risk mitigation program for the drug is inadequate. Endo stock was down nine percent in premarket trading.

The FDA's rejection marks a setback for Endo CEO David Holveck, who recently signaled his interest in a new round of deals to help the company expand beyond pain into new therapeutic areas like cancer. Earlier this year Endo bought out Indevus for $370 million, winning Aveed in the deal. Holveck is now looking for new licensing pacts, acquisitions and development deals. In a terse release, the developer says that it's evaluating the FDA's letter.

- check out the release from Endo
- here's the Reuters piece

Related Articles:
Endo Pharma CEO plots new round of deals
Endo inks $210M deal for testosterone therapy
Endo licenses cancer drug for $20M up front
Endo Pharma, Jubilant in oncology pact

Cubist Pharmaceuticals slammed the brakes on enrollment for two mid-stage studies of ecallantide after the safety monitoring board noted a higher death rate among patients taking a high dose of the therapy to reduce bleeding during on-pump cardiac surgery. The move came one day after the FDA approved Dyax's ecallantide--to be marketed as Kalbitor--for hereditary angioedema. Cubist had in-licensed the drug.

The safety board raised the red flag for Cubist's CONSERV-2 trial, which is evaluating a high dose of the drug. Initial review shows mortality observed in the trial was due to a variety of causes typically expected in a high-risk-for-bleed population undergoing cardiac surgery, said the company in a statement. There was no such imbalance detected in the CONSERV-1 trial, also being monitored by the DSMB.

"When we designed Phase II to study ecallantide as therapy to reduce blood loss in on-pump cardiac surgery, we intentionally made it a robust program," said Cubist CEO Mike Bonney. "The CONSERV-2 trial in particular was intended to provide insight on all-cause outcomes in a higher risk cardiac surgery patient population. We will move as quickly as is prudent to analyze all the data from both CONSERV- 1 and CONSERV-2 in the first quarter."

- read Cubist's release
- here's the Reuters story

Related Articles:
Forma inks tech deal with Cubist
Alnylam, Cubist form RNAi partnership

Genzyme's development program for Lumizyme, a therapy to treat Pompe disease, appears to be back on track. The FDA had rejected Genzyme's BLA for Lumizyme in November, saying that the biotech company needed to fix problems at its Allston plant before it could make the therapy in Massachusetts. Based on follow-up talks with the FDA, Genzyme will now seek approval of the product produced at a larger 4000 L bioreactor scale produced at Genzyme's manufacturing plant in Geel, Belgium. Genzyme says it will resubmit its BLA this month.

Genzyme also says that it is reopening its temporary access program to provide the therapy to patients ahead of an approval. "The U.S. patient community has been very supportive," says CEO Henri A. Termeer, "and we will continue to work closely with the FDA to finalize our efforts and to bring this important therapy to the Pompe community." The company has provided the therapy free of charge to approximately 170 patients since 2007, and will work with the 81 active study sites in the U.S. to enroll additional patients into the program. The ATAP program will remain open until commercial approval of Lumizyme, says Genzyme.

Production at the Allston plant had been halted after regulators discovered it had been contaminated, triggering a staggering set of problems for Genzyme. But on Tuesday morning the biotech announced that it had resumed some shipments of Cerezyme from the facility.

- here's the Genzyme release

Related Articles:
FDA delays Lumizyme approval as woes mount at troubled Genzyme
More plant problems for Genzyme to fix
Genzyme: partly cloudy, chance of regulators

Vertex Pharmaceuticals has scooped up $442.8 million from a secondary stock offering as it fattens its cash reserves ahead of the expected launch of telaprevir for hepatitis C. Some of the money is also earmarked for the development of VX-770 drug for cystic fibrosis. Vertex had already raised $573 million from earlier financing arrangements and a licensing deal for Japan. Vertex is capitalizing on a hot market for its shares, which are up 30 percent this year. This latest stock sale will take its cash reserves past the $1 billion mark. Vertex release

> Novartis has won E.U. approval of OnBrez, a new COPD therapy that some analysts say may eventually emerge as a new blockbuster for the pharma company. A number of analysts expect the FDA to follow up with a U.S. approval of QAB149 sometime next year. Article

> Shares of Keryx Biopharmaceuticals (KERX) jumped this morning after the biotech announced that the FDA provided fast track status for a new cancer therapy. Keryx release

> Dutch biotech arGEN-X BV added $4.5 million in a second closing of its Series A equity financing round. Credit Agricole Private Equity and VIB provided the cash. Release

> Belgian drugmaker Movetis priced its IPO at €12.25, hitting its mark. Story

> AlphaRx has selected locations in Hong Kong and Shanghai for its corporate headquarters and a new R&D facility. AlphaRx release

> Galapagos has earned €10.2 million in milestones from its collaboration deal with Janssen Pharmaceutica NV for rheumatoid arthritis. Story

Pharma News

> Now that eyecare company Alcon has seen its shares recover--rising almost 6 percent just yesterday--Novartis is more likely to buy that majority stake from Nestle. Report

> As some big-name hospitals and drugmakers back away from industry-funded medical education, the Canadian Medical Association has anted up. The CMA has teamed up with Pfizer on a nationwide educational campaign, backed by $780,000 in Pfizer funding. Article

> Drug marketing is always under someone's microscope. Does DTC work? Are consumer ads misleading? Is spending on marketing delivering the kind of returns we need? DTC article

> If you're not an eternal optimist, don't read A.T. Kearney's new report on the pharmaceutical industry. The management consulting firm takes a hard look at current trends, concluding that much of the work drugmakers have done to combat their well-known woes is just rearranging deck chairs on the Titanic. Report

Vaccine News

> Novavax reported a pair of key milestones this week in its quest to introduce a new vaccine technology to the world. Novavax report

> Researchers have now had a chance to track the experiences of a large group of girls in New Mexico who had been injected with the Cervarix HPV vaccine more than six years ago. And they say that the vaccine continues to protect them from cervical cancer with no indication yet that a booster shot is needed. Article

> The swine flu pandemic is likely to have a long-term impact on the U.S. government's strategy for dealing with outbreaks. HHS Secretary Kathleen Sebelius is vowing to make sure that the next pandemic will be fought with vaccines that can be produced in vast quantities far faster than we've seen this year. Report

> Novartis' vaccine division is booming as demand spikes. Report

Special Report: The 2009 Biotech Graveyard

And Finally... A sham website offering swine flu vaccinations is actually designed to help spread a virus rather than stop one. Emails for the site are contaminated with a vicious computer virus. Story