biotech news

French biotechs optimistic about investment, pipelines

Calisha Myers — Tue, 07 Oct 2008 12:44:22 -0400

France Biotech, the country's life sciences association, has released its report detailing the results of its annual survey. The trends? According to survey results, we can expect several deals or mergers between French biotechs and pharma companies within the coming months. And despite the global financial crisis, industry execs are optimistic that there will also be more acquisitions, investments and IPOs. "My bet is that next spring we will see a rally of investments turning to companies that can create a future, are truly innovative," France Biotech chairman Philippe Pouletty said.

In the first half of this year, venture capitalists injected $98 million into the biotech industry. Only one company--Ipsogen--managed an IPO. There were 15 in 2007.

Pouletty, who also heads venture capital company Truffle Capital, expects Sanofi-Aventis to be among the drugmakers pulling in biotechs to help expand its pipeline and make up for revenue lost to patent expirations and generic competition.

Speaking of pipelines, the survey results indicate that French biotechs have 73 products entering the research phase and 98 experimental drugs in mid and late-stage in clinical development phases. Ten biotech products are awaiting marketing approval, including BioAlliance Pharma's Loramyc and Addmedica's Siklos, with four currently available to patients.

- check out the France Biotech release
- get more on the survey results from the Guardian

ALSO: The French pharmaceutical industry seems to be in the throes of huge changes as global pressures hit home. French pharma appears to be seeking the best of both worlds: new, internationally trained management, while maintaining as much family/French control as practically possible. We'll see how they fare. Report

Top 10 mistakes biotechs make (and how to avoid them)

Maureen Martino — Thu, 18 Sep 2008 08:07:49 -0400

As biotechs navigate the always-tricky drug development and approval world, mistakes are inevitable. From IP to marketing, there are endless ways a small, inexperienced company can run into problems. At the very least, these errors cost time and money; at worst, they can lead to the demise of a promising drug or even an entire company.

In his 18 years as an attorney, Stephen Ferruolo (right) has seen plenty of mistakes. He's a partner in the Business Law Department at Goodwin Procter, an 850-person firm that has helped large and small companies alike negotiate the development process. Ferruolo has worked on public and private financings, acquisitions, joint ventures, strategic partnerships and technology licenses. In the course of his work he has witnessed the same mistakes repeated time and again, giving him insight into the best ways for companies to minimize risk, as well as save time and money. From the mismanagement of IP to not knowing when to partner, Ferruolo discusses the blunders he regularly sees small drug development companies make--and what you can do to avoid them.

1. Not thinking strategically about IP

Intellectual property and licenses are at the core of everything a biotech company does. But too often, biotechs don't think strategically about their licenses and patents--both what they own and what they'll have to license from others. In order to be successful, a company needs to think about the IP relating o its drug candidates on a variety of levels early on. How strong is the patent protection? Will the company have freedom to operate? How will a buyer or partner view the terms and conditions of your licenses? How well will the patents hold up against challenges from generic companies?"Think globally," encourages Ferruolo. What plans are in place to develop and commercialize the drug in the U.S., Europe, Asia and emerging markets? Companies need to think strategically about IP and spend their money wisely. "The key is to have the right advisors internally or externally who think long term." So what can you do to avoid an IP nightmare? Instructs Ferruolo, "Ask yourself this: If I were a buyer or partner doing IP due diligence, where would I poke holes and see issues? Identify the and fix them now."

2. Not understanding the target market

Before investing millions of dollars and many years into a drug, biotechs should think about the commercial viability of the end product. "Don't treat your R&D process as just a research project," advises Ferruolo. Not only should your company assess the drug's activity, management must also determine if there's a reasonable and timely path to approval. As for its market potential, ask yourself this: Can the drug be differentiated? Will it be reimbursed? Study Medicare and Medicaid and find out how drugs or other products like yours are being reimbursed in the current market. Have realistic expectations, because healthcare costs are on the rise and there's less tolerance for expensive meds. A super-expensive drug--even an effective one--may not be worth pursuing if there are alternatives on the market.

3. Not raising enough money

Too often, biotechs don't raise as much money as they could because management wants to avoid dilution. Often, the decision is made to raise just enough money to the next development milestone, with the assumption that the company will then be able to raise a new round at a higher valuation and thinks the company has enough cash to get by. "That is just plain dumb," Ferruolo says bluntly. Drug development inevitably takes more money and time than anticipated, so biotechs should raise as much money as they can, when they can. "Alex Zaffaroni use to say, "It's not the size of your slice of the pie; it's the size of the pie that matters,'" notes Ferruolo. Too often founders and investors fight over the relative size of their slice of the pie. "Even in this environment, people continue to have unrealistic expectations about valuation." As a result, a lot of money is sitting on the sidelines and not being put to work in the industry.

In addition to raising as much money as possible, biotechs need to pick their VCs wisely. It's important to pick an experienced VC with deep pockets to lead, one that will be able to syndicate of similar investors. Those are the investors you want on your board to support subsequent rounds, even if they grind you down some on the initial valuation.

Developers tout protein manufacturing breakthrough

John Carroll — Mon, 16 Jun 2008 07:14:21 -0400

A joint venture between Crucell and DSM Biologics--Percivia--has produced a new, more efficient approach to manufacturing monoclonal antibodies and proteins. By relying on human cell lines rather than a traditional chemical approach, officials for the two companies say they can significantly cut the cost of manufacturing. And researchers for the joint venture say they achieved fermentation yields in human cells of 27 grams a liter--a record.

"This new achievement surpasses all other reported titer levels to date with any mammalian system and clearly demonstrates the robustness and power of the PER.C6 platform," said Marco Cacciuttolo, CEO and President of Percivia. "We are particularly enthused with the user-friendliness of the platform and pleased to be able to provide this to our licensees. We strive to revolutionize the pharmaceutical industry in protein production."

Less expensive manufacturing, they add, will allow developers to advance some new products to the market that would not have been able to generate a profit before.

- read the release

Massachusetts closer on biotech bill

John Carroll — Thu, 12 Jun 2008 11:20:58 -0400

Lawmakers in Massachusetts are edging ever closer to approving the state's ambitious $1 billion incentives program to help foster its thriving biotech industry. That gives Governor Deval Patrick just enough time to sign a new bill before flying off to the BIO meeting in San Diego. Report

Canadian biotech may face funding crisis

Tue, 20 May 2008 06:59:57 -0400

Every country's biotech industry is different. And E&Y's report notes that Canada in particular is "facing a real funding crisis," says Rod Budd, Ernst & Young's Canadian biotech industry leader.

"In Canada, the industry market cap dropped 26 percent in 2007, funding to public companies dropped by almost US$900 million and the number of companies shrunk by 14 percent reflecting the long-awaited consolidation. It's getting harder and harder to attract investors to this area," says Budd.

- check out the Canadian release

Are Mass. lawmakers 'anti-biopharmaceutical'?

Mon, 12 May 2008 06:59:56 -0400

After coming up with a billion-dollar program to encourage the growth of the state's biotech industry, you'd think that BIO and the biopharma biz would be giving great bear hugs to Massachusetts lawmakers. Instead, GSK wrote a letter to the governor castigating the bill for demonstrating "a strong anti-biopharmaceutical streak." And BIO complained that the bill included a provision that threatened research as well as patient treatment.

The target of all this ire? A provision that bans any and all gifts from a drug company to a physician. That's any and all, as in free lunches, trips to swanky resorts or even cheap pens with company logos on them.

Nonsense, replied state senator Mark Montigny. Lawmakers felt that the gifts--which don't include drug samples--encouraged the use of expensive branded drugs without really benefiting patients.

- read the AP report

Enzon spins off biotech ops into $150M enterprise

Wed, 07 May 2008 06:59:57 -0400

Enzon Pharmaceuticals has decided to spin off its biotech operations into a new company, adopting a suggestion floated by none other than Carl Icahn. Icahn has been making quite a name for himself as a mover and shaker-upper in the biotech industry. Unlike Biogen Idec, which is now barricading the doors against Icahn's campaign to push a sale, Enzon appears to have quickly changed game plans under pressure from Icahn--separating its business into specialty pharma and biotechnology.

Icahn reported a 6.9 percent stake in the company last March, according to the Wall Street Journal, and swiftly suggested either a spin-off or sale of the company.

"The separation will enable the two businesses to compete more effectively in their respective markets and optimize their business goals, research initiatives and capital requirements," says Chief Executive Jeffrey H. Buchalter. Enzon CFO Craig Tooman will become president and CEO of the new company, which will start off with $150 million in the bank to fund R&D efforts. That's enough to fund operations for two to three years.

- see Enzon's release
- check out the article in the Wall Street Journal

SPOTLIGHT: Colorado passes $26.5M biotech incentive bill

Fri, 25 Apr 2008 06:59:53 -0400

Like so many other regions, Colorado is hoping to get its own slice of the biotech industry pie with the passage of a $26.5 million incentive bill. The bill "provides grants for five years to Colorado startup companies and research institutions seeking to commercialize new biotech drugs, biofuels, medical devices and nanotechnology," reports the Colorado Business Journal. Thirty percent of the funds will go to university and research institution technology transfer offices, thirty percent will go to start-up bioscience companies, and forty percent will be used to support the development of public-private infrastructure that will help commercialize Colorado's bioscience research. Release | Report

Biotech's next big opportunity: Follow-ons?

Thu, 24 Apr 2008 06:59:56 -0400

Follow-on biologics are often cited as major long-term threat to the biotech industry, which so far has not had to face a future where generic therapies are allowed to slice and dice the market for approved therapies. But new analysis from the RPM Report notes that biotech companies--along with the Big Pharma companies--may be much better positioned than generic drug developers to capitalize on the market.

The rationale is that developing follow-on proteins will demand exactly the kind of expertise that the biotech industry has on staff. Teva, meanwhile, has been on a buying spree and may be the only big generic developer that can compete in this space. Of course, before anyone produces follow-ons in the U.S. market, lawmakers have to agree on new legislation. And some proposals are calling for lengthy periods of exclusivity for biologics.

- read the analysis in the RPM Report

Stromedix gets $25M for mAb work

Mon, 21 Apr 2008 06:59:56 -0400

Cambridge, MA-based Stromedix has landed $25 million in a Series B round of venture capital. The company's lead drug is STX-100, a humanized monoclonal antibody which Stromedix is developing for chronic allograft dysfunction, a fibrotic condition that is a leading cause of graft loss in kidney transplant patients. There are no approved therapies for the condition. A Phase I trial of the drug kicked off earlier this year. The round was led by New Leaf Venture Partners; Bessemer Venture Partners, Red Abbey Venture Partners, Atlas Venture, Frazier Healthcare Ventures also participated.

- check out this press release

Related Article:
MAbs are hottest segment of biotech industry. Report

Big Biotech emerges as a shelter in economic storm

Thu, 10 Apr 2008 06:59:57 -0400

Veteran investors have long taken different views of biotechnology, sometimes in the course of a single day. And share prices regularly go on a roller coaster ride driven by hope and fear. During one particularly dour period at the beginning of this decade, biotech stocks lost their allure--along with 50 percent of their collective value. But analysts tell The Wall Street Journal that there are distinct signs that all that may be changing. While just about every category of stocks has been hammered in recent months, biotech has edged up. Investors have been betting that the biotech business model, which relies on breakthrough technologies and long-term contracts, could well weather the economic storm in the U.S. And Big Biotech companies with their big pipelines have been doing the best. Genentech shares are up 16 percent for the year to date.

"Everyone looked at big pharma as both defensive and growth plays," says Ned Davis analyst John LaForge. "That's what they consider big biotech now."

- read the story in the Wall Street Journal

Related Articles:
Big Biotech's Stock Report
Best and Worst Pharma stocks of 2007
Rocky market puts freeze on biotech deal-making
Investors remain leery of the biotech industry
Biotech stocks surge as investors anticipate buyouts

Sanofi makes moves in China

Fri, 04 Apr 2008 07:59:55 -0400

In the Wall Street Journal, Sanofi's R&D chief Marc Cluzel (photo) discusses the company's plans for expanding in China. Back in September Sanofi signed a deal to collaborate with the Chinese Academy of Medical Sciences on stem cell research. As many as five more deals will follow, though Cluzel declined to say which partners Sanofi has approached and how much money the company intends to invest in China. The company is hoping to work with universities and state-funded research institutions.

Despite recent concerns about the quality of Chinese-made medical products, the country is actively pursuing an increased role in biotech R&D. Cluzel says the talent pool and entrepreneurial spirit of Chinese researchers will help the country become a leader in the biotech industry. "I think the amount of people with a master's [degree] in biology in China is now bigger than the number of people with a master's in biology in the U.S. The number of people with a Ph.D. in biology in the U.S. is still higher than in China, but it's getting closer and closer," Dr. Cluzel said. "And they are doing some good fundamental science. One day or another there will be a payback."

- read the WSJ article for more

Related Articles:
Sanofi signs stem cell pact in China. Report
Sanofi to build vaccine plant in China. Report
China pushes drug development as R&D soars. Report

ALSO NOTED: Pharmaxis reports Phase II CF data; New Zealand publishes biotech industry stats; and much more...

Fri, 04 Apr 2008 07:59:50 -0400

> Pharmaxis announced today that a Phase II clinical trial in children with cystic fibrosis demonstrated excellent lung function improvement following three months treatment with Bronchitol that matched that achieved by the current marketed product, Genentech's rhDNase. Release

> New Zealand has release new statistics on the country's biotech industry. Release

> Malaysian officials say the country is on track to become a biotech hub by 2020. Report

> The FDA has allowed Eisai to resume a Phase I clinical trial of E2012, an Alzheimer's treatment. Release

> Big Pharma looks more and more like a big ostrich these days, Forbes suggests. The brouhaha over Vytorin and Zetia this week is a case in point. Report

Most popular this week: Lilly readies Phase III Alzheimer's trial. Report

And Finally... Researchers are pushing ahead with the first human trials of an ebola vaccine. Report

SPOTLIGHT: Biotech sector poised for growth

Tue, 01 Apr 2008 07:59:53 -0400

Investment analysts say that Israel's biotech industry should see a significant hike in the amount of VC funds invested in the country. Any downturn triggered by the ongoing uproar in global financial circles isn't likely to arrive for at least two quarters. Report

SBA looks to boost grants to small biotechs

Mon, 31 Mar 2008 07:59:55 -0400

In a possible boon to the biotech industry, the SBA is looking to hike research grants to small U.S. businesses. And regulators are considering new rules that would allow grants to go to businesses owned by venture capital firms. Current laws require the grants to go to companies that are majority owned by American citizens or permanent alien residents. And the House appears to be ready to take a second look at new legislation that would allow the grants to go to companies so long as no single VC group owns more than 50 percent of the company. BIO has been actively pressing for the new legislation.

- read the article in the Dallas Business Journal

Related Articles:
Bill could improve funding for small biotechs. Report
NIH joins campaign to ease SBA grant restrictions. Report

In Austin, VC is booming for biotechs

Fri, 28 Mar 2008 07:59:55 -0400

Further evidence of Texas' growing power in the biotech industry: the Austin Business Journal reports that in recent months, central Texas-based life science outfits have attracted about $500 million in VC. "The 'we can't do bio in Austin' attitude is no longer true," said Isaac Barchas, director of the University of Texas' IC2 Institute. "Taken together, it feels like this is the moment when things are happening in bio. I think in two years we'd point to this moment and say, 'that was when things started to happen.'" Texas' biotech efforts--particularly its $3 billion bond program for cancer research--propelled it to first place on FierceBiotech's annual list of the top five regions attracting biotech business.

- see the Austin Business Journal piece
- read FierceBiotech's special report on Texas. Report

Related Articles:
Texas' $3B cancer program draws controversy. Report
Texas touts $3B plan for cancer research. Report
Venture group targets tech transfer deals in Texas. Report

NJ officials want to expand biopharma biz

Wed, 26 Mar 2008 07:59:54 -0400

A state economist for New Jersey has spelled out some of the biggest threats to the Garden State's biopharma industry. In a recent address, James Hughes underscored that New Jersey is losing its reputation as the country's "medicine chest," reports Gannett. Its high concentration of pharma jobs has slid badly during this decade while states like Texas have come up with major new programs to back research into cancer drugs.

Former Pennsylvania Gov. Mark S. Schweiker told the group that the best way to expand biopharma was to adopt a regional approach, with south New Jersey, southeastern Pennsylvania and Delaware joining forces to promote a "Greater Philadelphia" approach. Schweiker, it should be noted, is now president and CEO of the Greater Philadelphia Chamber.

- read the article from Gannett

Related Articles:
Top 5 Regions Targeting Biotech--2008. Report
NJ stem cell initiative shot down at the polls. Report
NJ lawmakers back $270M stem cell program. Report
In New Jersey, biotech industry is booming. Report

Market volatility spurs M&A talks at UK biotechs

Tue, 25 Mar 2008 07:59:56 -0400

Up until last week, Renovo was the poster child for success in the UK's biotech industry. Then after one of its therapies failed a drug trial for one indication, investors bailed and cut its stock price in half. And the analysts say the cutthroat response has raised fears about the sudden swings in stock price that can afflict any emerging drug developer.

"We need a success," Cannacord's Karl Keegan told the Financial Times. "I was hoping that Renovo would be a straightforward success story that would attract the more general small-cap investor but those have now been turned away."

The volatility in the market has opened the doors to M&A talks at a growing number of biotech companies. The FT notes that Ardana has announced plans to sell or merge and CeNeS Pharmaceuticals has confirmed that it is in takeover talks.

- read the story in the Financial Times

Related Articles:
Renovo shares plunge even after 'buy' signals. Report
Mixed data for Renovo's scarring therapy. Report
Renovo inks $875M deal for scarring drug. Report
Dealmaking stays big even as the markets tremble. Report

India moves to back up emerging biotech industry

Mon, 24 Mar 2008 07:59:55 -0400

The Times of India lauds new efforts in the subcontinent to encourage the growth of its biotech industry. Under new legislation, the country's department of biotechnology is now setting aside 30 percent of its annual budget to fund public/private collaborations on new drug development. A new council has been created to help coordinate efforts between academics and biotech companies and a new regulatory body has been created. India has a shortage of trained regulators, but the Times editorial suggests that the FDA may step in to help train personnel.

- read the editorial in the Times of India

Related Articles:
India emerging as big drug market. Report
China surges past India in drug discovery work. Report
China now leads India in ongoing clinical trials. Report
Bangalore Bio: India's biotech future is bright. Report

SPOTLIGHT: Patent bill bogs down

Mon, 24 Mar 2008 07:59:53 -0400

A patent reform bill being argued in Congress has drawn a significant amount of protest from the biotech industry. But with a wide array of groups looking to influence the legislation, including the White House, the bill appears to have stalled in a Senate committee. High-tech companies, meanwhile, have been actively pushing for its passage. Report