Biotech IPO

Analysts predict more M&A as capital shrinks

John Carroll — Thu, 03 Jul 2008 10:07:13 -0400

A shortage of new money is likely to drive more and more life sciences companies into mergers and acquisitions, say some of the industry's top analysts. Money raised from IPOs, venture capital companies and stock sales dropped to a meager $6.5 billion in the first half of this year, less than a third of the amount posted in the first half of last year. And they cited Invitrogen's acquisition of Applied Biosystems as a prime example of what lies ahead.

Two bright spots: Expanding markets in China and India will help the field as the U.S. economy softens and federal funding of the NIH will grow regardless of who is elected.

- check out the AP report

Alimera Sciences files $75M IPO

John Carroll — Wed, 02 Jul 2008 10:56:32 -0400

Alimera Sciences is braving a badly roiled public market with plans to push a $75 million IPO. The Atlanta-based biotech is developing ophthalmic drugs. Credit Suisse, Citi, Cowen and Co. and Leerink Swann are underwriting the IPO. Alimera has raised more than $71 million from a group of venture capital groups that include Scale Venture Partners, Domain Associates, Intersouth Partners and Polaris Venture Partners. In addition to developing new therapies, Alimera also markets OTC ophthalmic products. Report

Emergent adds new space for biotech start-ups

John Carroll — Mon, 16 Jun 2008 07:24:42 -0400

Emergent Technologies (ETI) has doubled its office space, taking new digs in Austin that includes new laboratory space for the biotech companies that it helps foster. ETI specializes in creating new companies that are engaged in commercializing research pioneered at regional universities.

Thomas Harlan, president and CEO of ETI, told the Austin Business Journal that the company had just run out of room. ETI moved from 12,000 square feet into 23,000 square feet of space. ETI closed a $27 million fund in the spring of 2007 and used the money to launch three companies: Mimetic Solutions, Beacon Sciences and AeonClad Coatings.

"The biotech sector is a limitless one," Harlan told the newspaper. "We're delighted to be sitting in a region where there's abundant deal flow, in terms of the science coming from the university."

- read the report in the Austin Business Journal

Peplin joins list of developers to drop IPO

John Carroll — Tue, 10 Jun 2008 11:57:33 -0400

You can count Peplin on the growing roster of developers that couldn't make a go of an IPO. The Emeryville, CA-based company cited "unfavorable market conditions" as its reason for dropping the IPO, which was filed with the SEC last year. A string of biotechs have made a similar move as investors have proved difficult to win over at a time public markets are badly roiled. Peplin had planned to use the IPO money to fund development of dermatology therapies. The company has a special focus on treating skin cancers. Shares of Peplin trade on the Australian exchange.

- read the AP story

Vertex shares rise on positive data for telaprevir

John Carroll — Mon, 09 Jun 2008 11:52:41 -0400

Vertex Pharmaceuticals saw a significant bump in its share price this morning after researchers released new, mid-stage interim data backing telaprevir for hepatitis C. The company is now penciling in the start of a new late-stage trial for the closely watched drug--enrolling patients who had failed standard therapy--in the third quarter. The new data is from a Phase IIb involving patients who had failed a standard therapy.

In the study, patients received telaprevir in combination with interferon/ribavirin for 12 weeks, then the combination therapy for the next 12 weeks followed by 12 weeks of neither therapy. The control arm received the combination therapy for 36 weeks. Slightly more than half of the telaprevir group had undetectable levels of the virus after 36 weeks compared to 30 percent in the control group. A late stage trial for the hep C drug began in spring with patients who had received no prior therapy.

- check out the press release
- read the AP report

SPOTLIGHT: Talecris may be sold

Mon, 02 Jun 2008 06:59:53 -0400

Almost a year after filing plans for a $1 billion IPO for Talecris Biotherapeutics, Cerberus and partner Ampersand Ventures may instead pursue a sale of the blood plasma product business. And Australia's CSL may be in the running. The blood plasma product business has been rapidly consolidating. Talecris said last year that three companies controlled 82 percent of the U.S. market. Report

Sonus, OncoGenex to merge

Wed, 28 May 2008 06:59:58 -0400

Bothell, WA-based Sonus Pharmaceuticals is merging with Canada's OncoGenex Technologies and will operate under the name OncoGenex Pharmaceuticals. OncoGenex's CEO Scott Cormack will head up the new company.

Sonus has been struggling since September when it pulled the plug on its lead therapy for breast cancer. Since then the company said it has been looking for ways to rebuild shareholder value. A merger with OncoGenex was the best way to do that, CEO Michael Martino said in a release.

The combined company has a strong oncology pipeline with three candidates in various stages of clinical development. Its lead candidate, OGX-011 for prostate cancer, is being evaluated in five Phase II clinical trials.

- see the merger release

Emergent BioSolutions buys flu vaccine maker

Tue, 27 May 2008 06:59:56 -0400

Emergent BioSolutions has inked a deal to acquire the Protein Sciences Corporation assets for up to $75 million. The move is part of Emergent's strategy to expand its product portfolio with a drug candidate focused on infectious disease. Currently, most of Emergent's business comes from government contracts for biodefense. Emergent will acquire PSC's ongoing operations, including FluBlok, a Phase III recombinant influenza vaccine candidate, and certain other assets. "The acquisition of FluBlok is consistent with Emergent's strategy of expanding its product portfolio with a vaccine candidate focused on a major infectious disease," said Fuad El-Hibri, Emergent's CEO. The company recently bought rival VaxGen's anthrax vaccine business.

- check out Emergent's release
- read the Washington Post article

Early IPO at Aldagen leaves analysts wondering

Mon, 19 May 2008 06:59:54 -0400

A pair of analysts has taken a cautious attitude toward Aldagen's plans for an $80 million IPO. The stem-cell company has no products on the market, makes no profit and is attempting to pioneer an FDA approval in an emerging field. None of that exactly breeds confidence, especially given the arctic chill that has afflicted biotech IPOs recently.

"These are the worst capital markets for biotech in the last five years," says Steve Brozak, an analyst at WBB Securities. "Their technology is good, but it's a tough equity market."

- read the report from the New York Times

Elixir drops IPO, Aldagen launches IPO

Mon, 12 May 2008 06:59:55 -0400

Elixir Pharmaceuticals has dropped its bid for an $86 million IPO, saying that market conditions aren't right. At the same time, Aldagen, a small biotech company with 18 employees, is making a bid to raise $80 million in an IPO. Aldagen is developing adult stem cell therapies.

The News & Observer notes that if Aldagen is successful, it will raise new funds for research while setting up an exit for its investors. The developer was set up in 2000 to exploit new research at Duke.

- check out the report on Elixir
- see Aldagen's release and read the story for more

Talecris' antibody drug gets priority review

Fri, 09 May 2008 06:59:54 -0400

The FDA has granted priority review to Talecris' drug Gamunex, meaning the FDA will review its application in six months rather than the standard 10. Gamunex is an IGIV therapy that contains antibodies purified from the donated blood plasma of thousands of people. It's already approved to treat one autoimmune disease, and bring in about $650 million a year. The company is now pursuing an indication for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), a rare neurological disorder in which patients suffer from weakness and impaired sensory function in the legs and arms. Gamunex previously received fast track and orphan drug status.

- here's the Talecris release
- read this report for more

Related Article:
Talecris backers design a $1 billion IPO

Feds ok Iomai Phase II adjuvant patch study

Wed, 16 Apr 2008 06:59:54 -0400

Health and Human Services is giving Iomai the green light to do a mid-stage dose ranging study of its adjuvant patch for bird flu vaccine. HHS provided a $128 million contract backing Iomai's effort last year, and was rewarded with dramatic Phase I/II data on its ability to boost the effectiveness of bird flu vaccine.

The U.S. government, like other governments around the world, has been stockpiling vaccine to fight a potential pandemic. Iomai's patch worked well enough to provide protection to many people after a single dose, rather than the two usually required. That would allow physicians to stretch available vaccines over a much larger population on a much quicker basis.

"The Iomai immunostimulant patch has the potential to change how we react to an influenza pandemic, and we will move ahead quickly with the development of this technology," said Iomai CEO Stanley C. Erck. "Based on the data from this new Phase II study, Iomai and HHS will evaluate whether to proceed next with a pivotal Phase III trial."

- here's the press release

ALSO: South Korea has mobilized troops to help fight the spread of H5N1 in poultry. Report

Related Articles:
Emerging Drug Developer: Iomai. Report
Iomai gets boost in bird flu vaccine adjuvant study. Vaccine report
Iomai vax patch guards against traveler's diarrhea. Iomai report
Vaccine-maker Iomai files $83M IPO. Report

CellCyte in 'precarious' shape after shares collapse

Tue, 15 Apr 2008 06:59:57 -0400

After a brief period as a high-flying stem cell company, CellCyte Genetics' share price has fallen back to earth, wiping out much of the $440 million market valuation achieved last fall and leaving it in "precarious" financial shape. The Seattle Times is reporting that CellCyte has about five months worth of working capital on hand with shares trading at 45 cents each, down from a high of $10.01 hit last year after an intense period of stock promotion. The stem cell company now faces shareholder lawsuits and an investigation by German regulators of its stock promotion work. Documents filed with regulators on Monday say the company has raised $400,000 from investors since the end of the year. CellCyte had discussed plans of starting clinical trials of stem cell therapies this year at a cost of $7 million in 2008.

- read the report in the Seattle Times

Related Articles:
Report: CellCyte stock up after promoter touts shares. Cellcyte Report
Falling dollar, falling drugmaker prices. Stock report

Codexis blueprints $100 million IPO

Mon, 14 Apr 2008 06:59:54 -0400

Codexis has decided to wade into frigid market waters with an IPO that may be used to raise upwards of $100 million. The company makes biocatalysts: enzymes or microbes that cause chemical reactions. Those biocatalysts have been used by drug companies like Bristol-Myers Squibb, Merck and Pfizer. Proceeds will go to general working capital. And the money is needed, it appears. Codexis lost $39 million last year even as its earnings jumped to $25.3 million.

- read the AP story

Related Articles:
Codexis garners $37M in fourth round. Codexis report
M&A activity heats up as biotech IPOs struggle. IPO report
Big Biotech emerges as a shelter in economic storm. Report

Vertex shares jump on positive telaprevir data

Tue, 01 Apr 2008 07:59:56 -0400

Vertex Pharmaceuticals got a much-needed boost to its share price after investors responded positively to the latest data analysis on its closely-watched hepatitis C therapy. Vertex stock jumped 28 percent after researchers noted that patients responded to telaprevir in a mid-stage study. The data will be featured in a late-breaker poster presentation during the 43rd Annual Meeting of the European Association for the Study of the Liver in Milan, April 23-27. There's a $3 billion market for hep C drugs in the U.S. and Europe. Schering-Plough is also developing a hep C drug--boceprevir.

- check out the press release
- read the AP report

Related Articles:
Investors disappointed in Vertex despite strong data. Report
Vertex hep C drug impresses in Phase IIb. Report
Vertex inks rich pact with J&J. Report

Insulin retreats blamed for Generex stock drop

Tue, 11 Mar 2008 07:59:58 -0400

Generex is firmly in the camp that sees the glass as half full. After seeing its share price slide 16 percent yesterday, the developer attributed the sudden setback to decisions by Eli Lilly, Pfizer and Novo Nordisk to pull out of programs to develop other inhaled insulin products.

Worried? No, says Generex, happy to extol its late-stage drug's safety profile. The company says its Oral-lyn insulin doesn't leave a deposit in the lungs. And there's reason for cheer; the departure of the big companies removes some heavyweight competitors, says Generex.

Generex's stock woes followed a recent announcement from Alkermes that Eli Lilly is dropping out of their collaboration on an inhaled insulin therapy. Novo Nordisk and Pfizer have already pulled out of their respective programs. MannKind, meanwhile, reiterated its plans to forge ahead in the field.

- see the statement from Generex
- read the MarketWatch report

Related Articles:
Analyst gives bullish assessment of Generex program. Report
Generex initiates Phase II Trial in breast cancer patients. Report
MannKind bets the farm on inhaled insulin. Report
Pfizer kills off Exubera, hunts for deals. Report
Novo Nordisk shelves inhaled insulin, axes staffers. Report

PDL axes 260 and takes itself off the market

Wed, 05 Mar 2008 06:59:57 -0500

With no "firm" buyout offers coming in, PDL BioPharma has decided to axe 260 workers--on top of the 320 layoffs already announced--and take itself off the market. The latest restructuring round follows the sale of a half billion dollars worth of assets. And after the new pink slips are delivered, PDL will have about 300 workers, a fraction of its peak of 1,100. PDL put itself up for sale last fall after coming under withering fire from investors for its financial performance. To help win back the favor of investors, who drove down the company's share price 28 percent this morning, a four-year low, PDL is considering giving shareholders 50 percent of the royalties coming from approved products.

- see this release
- here's the AP report

Related Articles:
PDL sells off drugs as it counters harsh criticism. Report
PDL BioPharma puts out 'for sale' sign. Report
In last act, PDL chief takes out the axe. Report
PDL chief resigns in wake of investor wrangle. Report
Biotech CEOs face rising fury of angry investors. Report
PDL BioPharma rises on shareholder complaint. Report

SPOTLIGHT: Bioheart stumbles out of the IPO gate

Wed, 20 Feb 2008 06:59:53 -0500

Going public wasn't easy for Bioheart. After delaying its IPO twice and slashing its prospective share price from a range of $14 to $16 to $6 to $8, the Sunrise, FL-based biotech saw its share price quickly slip from its $5.25 a share offering on its first day of trading on Tuesday. The biotech raised about $5.8 million in a tough market. Much of that money will go to funding clinical trials of its cell therapy for heart damage. Release | Report

OncoGenex, Isis report Phase II success

Fri, 15 Feb 2008 06:59:57 -0500

OncoGenex and collaborator Isis Pharmaceuticals say that in a Phase II trial, OGX-011, in combination with either docetaxel or mitoxantrone, was well-tolerated as a second-line treatment for patients with prostate cancer. In addition, the trials demonstrated ongoing survival rates better than results published with chemotherapy alone.

"These data show that the combination of OGX-011 with docetaxel or mitoxantrone may improve treatment outcomes in second-line prostate cancer," said Dr. Fred Saad, the primary investigator in the study. "The data also suggests that re-treatment with docetaxel when combined with OGX-011 may reverse chemotherapy resistance in second-line docetaxel re-treatment." The results were presented at the 2008 Genitourinary Cancers Symposium. Planning is underway for a Phase III study utilizing chemotherapy plus OGX-011 as second-line therapy in patients progressing after a first-line docetaxel regimen.

- see OncoGenex's release for more

Related Articles:
OncoGenex outlines plans for $48 million IPO. Report

Italy's Newron buys U.K.-based developer

Mon, 11 Feb 2008 06:59:57 -0500

Italy's Newron Pharmaceuticals has U.K.-based Hunter-Fleming, a company that's developing therapies for neurodegenerative and inflammatory disorders. Newron gains several clinical-stage compounds, including:

HF0220, a Phase II drug for Alzheimer's disease and rheumatoid arthritis;
HF0420, a Phase I therapy for prevention of anti-cancer therapy induced neuropathy;
and HF0299, a potential neuropathic pain treatment in Phase I

Hunter-Fleming also has a neuroprotective compound series in the discovery phase. Newron will make an upfront payment of €8 million, minus net debt, for the fully diluted share capital of Hunter-Fleming, in newly issued Newron shares. In addition, Hunter-Fleming programs could earn up to €17 million in success-based milestones.

"Hunter-Fleming represents an excellent opportunity for Newron to expand its late-stage development pipeline, a key element of our strategy for growth. It also enables us to expand our CNS expertise into the area of neuro-inflammation thus broadening our overall CNS knowledge," said Dr. Luca Benatti, Newron's CEO.

- here's the release

Related Articles:
Newron reports positive mid-stage pain data. Report
FDA OKs Newron trials. Report
Italy's Newron gains $99 million in IPO. Report
Newron launches a Phase III trial on eve of IPO. Report