Aveo Pharma delays IPO, at least briefly

Aveo Pharmaceuticals kept the biotech investment community on pins and needles this morning. The cancer drug developer was supposed to price its shares for a $105 million IPO yesterday, but reportedly pushed that back to today in the face of shareholder resistance to the share price.

The Wall Street Journal reported the resistance at the end of a lengthy piece today on the bullish investor response to Sensata, a venture-backed company that was able to hold on to its price range and trade higher on the first day--a first for the year.

After a brief surge of hope that 2010 would see a big surge of biotech IPOs after a lengthy dry spell, the first developers to make it into the market all stumbled badly. Ironwood seriously overreached on its projected share price and Anthera raised $42 million in an IPO recently after chopping its share price in half.

- here's the report from the Wall Street Journal, with the Aveo news mentioned at the end

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Bay Area biotech blueprints $100M China biologics hub

Santa Clara, CA-based AutekBio says it has joined a pair of venture capital firms to hatch plans to invest $100 million into a new R&D and contract manufacturing operation for biologics in southern Beijing.

AutekBio signed up with SUMA Ventures and Beijing E-Town Harvest International Capital Management Corporation, a venture capital group operated by the Beijing Municipal Government, in orchestrating the research and manufacturing project. AutekBio has kept a low profile, at least in the U.S. Li's resume includes stints at Hoffmann La-Roche and Asterand. Back in 2007 the Beijing/Bay Area hybrid reported raising $1.1 million to help build its business growing cell lines for drug companies. China has become a hotbed of biopharma activity in recent years, with some of the world's biggest players making ambitious plans to develop and manufacture therapeutics in the country.

"I am extremely pleased with this joint investment. This will allow us to build one of the largest biologic CMOs in Asia," said Julius Li, the CEO of AutekBio, in a statement. "The newly established facility and company will provide, for the first time, manufacturing services in China fully conforming to the FDA,EMEA (and) cGMP standards for the global biopharmaceutical needs."

- check out the AutekBio release

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BioSante shares surge as cancer vax performs in small study

Shares of BioSante Pharmaceuticals surged this morning in pre-market trading after the developer said that a 19-patient study demonstrated the promise of its GVAX leukemia vaccine to mop up the stubbornly lingering cancer cells of CML patients taking Gleevec.

Researchers said that the 19 patients selected for the study had measurable levels of cancer cells even though they had been on Gleevec for at least a year. After a median of 17 months, 13 of the patients saw their number of cancer cells decline and seven emerged with undetectable levels. The study was financed by the NCI and handled by scientists at Johns Hopkins.

Despite the small size of the trial, lead investigator Hyam Levitsky says it demonstrates a promising potential treatment tactic: using cancer vaccines to go in after powerful cancer therapies are used to help eradicate any remaining cancer cells.

BioSante announced just two days ago that it had raised $17.5 million through a sale of 10.4 million shares to Great Point Partners LLC and Deerfield Management Company. The shares were sold for $1.73 each. Most of that money is earmarked for LibiGel, a treatment for female sexual dysfunction. Its shares were up 15 percent by mid-morning.

- check out the BioSante's release
- here's the Reuters story

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Basilea mounts last-ditch effort to gain quick ceftobiprole OK

The ceftobiprole saga isn't finished yet. Basilea Pharmaceutica said this morning that J&J subsidiary Janssen-Cilag International has asked European regulators to re-examine their rejection of a marketing application for the superbug antibiotic ceftobiprole, a troubled program that has endured despite bickering partners and a cloud now hovering over its clinical trial process.

Last month the European Committee for Medicinal Products for Human Use rejected the application to market the treatment for complicated skin and soft tissue infections. Regulators at the EMA had pulled an earlier recommendation after concluding that good clinical practices weren't followed at some of the sites. And late last year U.S. regulators had also questioned the data submitted for the antibiotic.

J&J, which had been fending off accusations by Basilea that it was responsible for a delay in gaining an approval, had responded by handing the rights to the program back to Basilea. And Basilea CEO Anthony Man said that the company was reviewing all its options in light of J&J's decision to terminate its license. One of those options evidently included a new pitch to regulators, even with low odds of any quick success. Basilea says that a final opinion could arrive in four or five months.

- here's Basilea's release for more info

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Pioneering personal sequencing projects unveil disease triggers

Taking advantage of lower cost genome sequencing technology, two independent teams of researchers have sequenced the genomes of sick patients to determine the precise genetic trigger to their disease and help point the way to a cure. And in the process, they may help revolutionize the way that sequencing research is being done to guide new treatments.

While a massive amount of work has been done to find common genetic triggers to diseases like cancer and diabetes, some scientists believe that individual cases are typically spurred by rare rather than common mutations. And now that sequencing costs have fallen to about $50,000 or less, scientists have begun to explore what they can learn about the genetic triggers in a single patient.

"We need a way of assessing rare variants better than the genomewide association studies can do, and whole-genome sequencing is the only way to do that," Dr. James Lupski, a medical geneticist with a rare nerve disease, tells the New York Times' Nicholas Wade. Colleagues sequenced his genome to find the gene that caused his ailment--an "obscure" gene dubbed SH3TC2.

A separate team in Seattle sequenced the genomes of two children and their parents to find the causative genes behind their single-gene diseases. Complete Genomics sequenced their genes at a cost of $25,000 each. The company is one of several that believe they can reap a fortune from the coming tidal wave of genome sequencing that will reshape medical research.

- here's the article from the New York Times

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Amylin, Lilly gear up for big FDA ruling

Eli Lilly, Amylin and Alkermes will be holding their collective breath this Friday when the FDA will reveal whether it will approve Byetta LAR, the long-acting form of the bestselling diabetes drug Byetta. Thanks to technology from Alkermes that helps the drug stay in the patient's bloodstream, Byetta LAR can be administered just once a week rather than requiring twice-daily injections.

What's at stake for these companies? Amylin has the most invested. An approval could provide the drugmaker with billions in revenues for years to come. According to the Wall Street Journal, one analyst projected $2.1 billion in sales for the drug by 2015, while another industry watcher predicts $3 billion in U.S. sales. For Lilly, Byetta LAR would boost a product lineup that's facing one of the steepest patent cliffs in the coming years. And Alkermes is set to reap 7.5 percent royalty on worldwide sales.

Xconomy's Luke Timmerman maps out the four possible outcomes from the FDA's decision Friday:

• The FDA approves Byetta LAR with only a standard warning, though JP Morgan analyst Cory Kasimov says there's not much chance of that happening.


• Byetta LAR could be approved, but with a severe black box warning about the possibility of patients developing thyroid cancer.


• Third--most likely, according to Kasimov--the FDA will delay its response and ask for additional, but minor, data on the drug. In that case, the companies could still have an approval in hand by the end of 2010.


• Finally, the worst-case scenario: FDA could issue a "complete response" letter asking for major new set of data that would severely delay the drug's approval. If that happens, look for Amylin stock to lose half its value and Alkermes to dive about 33 percent.

Needless to say, the stakes are high for all involved.

- here's the Wall Street Journal report
- read more from Xconomy

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Cytokinetics gets orphan drug status for ALS drug

Cytokinetics announced today that its drug CK-2017357 has been granted orphan-drug designation by FDA. The drug is in trials for amyotrophic lateral sclerosis (ALS, or Lou Gehrig's Disease), a condition that affects about 20,000 to 30,000 people in the U.S. Cytokinetics plans to initiate a Phase II trial for CK-2017357 in ALS patients in the first half of 2010. Cytokinetics release

Neuropharm mulls voluntary liquidation as it waits for deal

Shares of U.K.'s Neuropharm shot up 33 percent this morning when the developer announced that its board will explore the possibility of a return of cash to shareholders. The company is still hoping to pull off a deal for its lead autism candidate NPL-2008, which it put up for sale in November of last year. "The company is continuing talks with a potentially interested party, which is in the advanced stages of due diligence, but no indicative offer has yet been received from that party," Neuropharm says in a statement.

Neuropharm's shares took a beating early last year after the biotech reported that its late-stage trial for an experimental autism therapy flunked its primary endpoint. But its stock was revived upon rumors that it was getting close to a deal for NPL-2008. In its release, the company notes it has significantly reduced its cash burn and had £6.18 million ($9.2 million) on hand as of Dec. 31, 2009. 

- here's Neuropharm's release
- read this Reuters report for more

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