OncoMed offers $115M IPO bet on cancer stem cell work

Posted under Bayer, Biotech IPO, Blog, cancer stem cells, Companies, Diagnostics, Funding, GlaxoSmithKline, Medical Devices, Medical Supply, OncoMed Pharmaceuticals, Pharmaceuticals, Pipeline, Startups, Universities, Verastem, Videos, Wnt pathway by john

A year after scoring a $20 million milestone from Bayer, OncoMed Pharmaceuticals is preparing to see if it can generate enough excitement from investors for its cancer stem cell work to support a $115 million IPO.

Jefferies, Leerink Swann, Piper Jaffray and BMO Capital Markets are listed as underwriters.

Redwood City, CA-based OncoMed has some of the biggest partners in the business, which has helped fund the company since it was founded in 2004. In its filing with the SEC, the biotech says it has raised $187 million in equity financing and $112 million in collaboration cash.

Bayer's payday arrived less than a year after the pharma giant struck a $387 million development deal for each new cancer stem cell and protein therapeutic program targeting the Wnt pathway. The antibody OMP-18R5 was the first of these programs to make it into the clinic. OncoMed also struck a partnership deal with GlaxoSmithKline ($GSK) back in 2007 on anti-cancer stem cell treatments. 

OncoMed may find a cool reception among investors. Like a lot of developers, OncoMed has no products. And it doesn't have any pivotal trials to whet investors' interest. It is, though, focused on a hot field in cancer drug development; a story line that has buoyed startups like Verastem ($VSTM), one of a few successful IPOs this year.

One point in OncoMed's favor: Several biotech IPOs have managed to hold their own with investors in the first few months of 2012, with prices edging upward. For some developers, that's a good enough reason to take their IPO plans off hold and push ahead after three years of near dormant IPO activity.

- here's the S-1
- read the Reuters story

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Indian gov’t probes drug regulator after scathing review

Posted under Bayer, Blog, Central Drugs Standard Control Organization, Companies, Diagnostics, Emerging Markets, Funding, GlaxoSmithKline, india, Medical Devices, Medical Supply, Novartis, Pharmaceuticals, Regulatory, Sanofi, Startups, Universities, Videos by rmcbride

India's drug regulators are ensnared in a scandalous fix. Days after a parliamentary report noted shoddy oversight of approvals, the Indian government has mounted an investigation into the alleged misdeeds. Meanwhile, big names in biopharma have surfaced in the sea of allegations.

As The Wall Street Journal reports, India's ministry said Friday it has created a special group to probe the long list of grievances in the report, with an eye toward repairing the infrastructure in place for approving drugs in the country. If the allegations in the parliamentary review are true, the Indian government believes that laws were broken and drugs arrived in pharmacies without undergoing required clinical studies.

Drugs from several of the largest drug companies--including Bayer, GlaxoSmithKline ($GSK), Novartis ($NVS) and Sanofi ($SNY)--were listed among those that were approved without standard clinical evaluation. Many of the drug manufacturers have professed their innocence after the report cited alleged collusion between pharma groups and India's drug regulator, Central Drugs Standard Control Organization.

- read the WSJ's article (sub. req.)
- see Reuters' report

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Buzz: Is Bayer looking to buy Onyx Pharma?

Posted under Bayer, Blog, carfilzomib, Companies, Diagnostics, Funding, M&A, Medical Devices, Medical Supply, Nexavar, Onyx Pharmaceuticals, Pharmaceuticals, regorafenib, Startups, Universities, Videos by john

Reuters reported today that Bayer is looking to close a multibillion-euro acquisition deal, quoting sources who say that an announcement could be "imminent." And investors took one look at the news and started to bid up the share price of Onyx Pharmaceuticals--a close partner of Bayer's on Nexavar with a big stake in some promising late-stage cancer drugs.

San Francisco-based Onyx ($ONXX) has been at the center of persistent buyout rumors since last fall, when it reportedly brought in bankers to scout a strategic deal. And it would be a perfect fit for Bayer, which would like to have carfilzomib in its portfolio when the FDA hits the July 27 PDUFA date on the potential blockbuster multiple myeloma drug. Bayer also was forced to settle up with Onyx on regorafenib, a close cousin to Nexavar that Onyx now has a 20% stake in.

It's pure speculation, of course, but it's a sensible enough theory to investors, who bid up Onyx shares 8.5% today.

Bayer CEO Marijn Dekkers has done nothing to squelch the buyout rumors in recent months. "Every company of our size is looking for acquisition opportunities," he told reporters recently. "You have to do it to remain competitive."

M&A has been a key theme in the past few weeks, with GlaxoSmithKline ($GSK) looking to acquire Human Genome Sciences ($HGSI), Roche ($RHHBY) wrestling with a frustrated bid for Illumina ($ILMN), a much discussed but never confirmed attempt by Bristol-Myers Squibb to acquire Amylin and AstraZeneca's ($AZN) move to snap up Ardea Biosciences ($RDEA) in a scramble for new drug programs. There's no sign of the wave evaporating anytime soon.

Carfilzomib has an interesting history. Originally developed at Proteolix, a biotech run by Susan Molineaux, Onyx acquired it in an $851 million deal. Onyx also lists PD 0332991, a mid-stage drug, in its pipeline. 

- here's the story from Reuters

Special Report: Carfilzomib – Top 10 Late-Stage Cancer Drugs – 2012

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Piramal lays claim to a late-stage imaging rival for Lilly’s Alzheimer’s agent

Posted under Alzheimer's, Amyvid, Bayer, Blog, Companies, Diagnostics, florbetaben, Funding, imaging, M&A, Medical Devices, Medical Supply, Pharmaceuticals, Pipeline, Piramal Healthcare, Startups, Universities, Videos by john

Bayer has sold off its portfolio of molecular imaging agents to India's Piramal Healthcare in a package deal that includes a late-stage agent that could eventually rival Eli Lilly's ($LLY) newly approved Amyvid for detecting Alzheimer's-related brain plaque. Piramal wasn't saying just how much it paid for the portfolio, but rather breezily claimed that the market for such Alzheimer's imaging agents could amount to $1.5 billion.

Right now, though, it's hard to say exactly what these agents could be worth. Amyvid was approved for ruling out Alzheimer's, giving doctors one more tool to use to evaluate patients. But with no proven therapy on the market and an as-yet undeciphered link between beta amyloid and Alzheimer's, the initial use seems largely restricted to the clinical trial field as developers study new drugs.

None of those concerns were apparent in Piramal's release, though, as it outlined ambitious plans for florbetaben as a diagnostic tool for Alzheimer's, giving physicians another method for mapping beta amyloid with a PET scan. The company touted the late-stage success of the agent, with data slated to be reviewed later this month.

"This is the second acquisition of late stage assets after our acquisition of assets of BioSyntech in 2011, where we have recently received the European CE mark approval for an innovative bio-orthopaedic product for cartilage repair, BST-CarGel, which enables the company to commercialize BST-CarGel in all of the countries in the European Union," said Piramal Chairman Ajay Piramal. "We plan to build a promising portfolio in the pharma space, including our newly acquired Molecular Imaging assets, which will help us create a global branded pharma business."

Piramal boasts that it's building a business on novel treatments after selling its generics operation to Abbott ($ABT) in 2010. 

- here's the press release
- here's the story from The Wall Street Journal

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