Biomaryland Forum

Latest Biotech news

John Carroll, FierceBiotech Editor-in-Chief When we ran the 2009 Fierce 15 report at the beginning of this week, we expected a big response. But even the optimists among the editorial crew here were surprised by the hard numbers. Monday provided the biggest single daily haul of page views in FierceBiotech's history. And Tuesday offered another bumper crop of readers. It all helped us make June the single biggest month ever for Web traffic.

It's always a lot of fun to go out and select a list of developers doing exciting things in the world of biotechnology, and we appreciate your clear interest in the project. As I mentioned earlier in the week, I start a new Fierce 15 once the report is posted. I've already received a number of suggestions and I encourage you to add your voice to the process.

On another note, we're preparing for the July 4th weekend and won't be publishing on Friday. We'll see you again on Monday. Enjoy the holiday. - John Carroll

Eisai creates jobs, readies Aricept NDA

Japan's Eisai has completed construction of a European Knowledge Centre in the UK, which could bring up to 250 jobs to the region. It's part of a £100 million effort to launch a strategic base giving Eisai it's first manufacturing facilities in Europe.

In addition to the manufacturing capabilities, the project includes a research laboratory and offices. Eisai will move its R&D activities, drug production and marketing to the new headquarters, where 500 people are expected to be employed. Half of those will be newly-created positions.

In a separate announcement, Eisai said that it's planning to submit an NDA for a new formulation of it's Alzheimer's drug Aricept in August or September. The existing version of Aricept makes up 40 percent of the company's sales, and will be going off-patent next year.

- read the Business Weekly report
- see this report on Aricept

King, Acura get FDA response letter

The FDA has issued a Complete Response Letter to King Pharmaceuticals and Acura Pharmaceuticals regarding their NDA for the pain drug Acurox. The agency has questions about the potential abuse deterrent benefits of Acurox, which the two companies say they can address without having to conduct additional clinical trials. Report

J&J to invest $1B in Elan, scoops up drug program

After months of rumors regarding potential deals, Ireland's Elan Pharmaceuticals announced this morning that Johnson & Johnson will invest a billion dollars into the company while taking control of Elan's rights in a key Alzheimer's drug program.

J&J is taking over Elan's rights to the Alzheimer's program, which is partnered with Wyeth, through a newly formed company, initially committing $500 million into the development of the drug. And Elan will keep 49.9 percent of the new company, with a share of the profits and the royalties.

"This transaction will leverage Elan's unique scientific and clinical work and leadership in bringing treatments to market that potentially slow the progression of Alzheimer's disease," said Elan CEO Kelly Martin in a statement. "The Elan commitment to scientific innovation and patients remains absolute and we will continue to build upon and expand our leadership in the fields of neuroscience and immunology."

"Johnson & Johnson's development capabilities, commercial experience and global reach will provide the foundation to accelerate the AIP Program development, and increase its potential availability for patients globally," said Sheri McCoy, worldwide chairman, pharmaceuticals, Johnson & Johnson.

- check out J&J's release

Sanofi-Aventis wins big with Multaq approval

After a long, dry spell, Sanofi-Aventis' pipeline has finally produced a winner. The FDA has approved its blockbuster heart therapy Multaq.

While expected, the news Thursday morning raised a swift cheer from the ranks of stock analysts. Sanofi has estimated Multaq's earnings potential at more than €1 billion a year. And some of the analysts' estimates go higher than that.

"The drug is now approved, ending Sanofi's streak of pipeline futility," Gbola Amusa, an analyst with UBS, tells Dow Jones. Amusa believes that Multaq can earn €1.4 billion annually.

While the road to an approval has been a long one, the news also bolsters Chris Viehbacher, who was recently brought in to help shake up the pharma giant and make it more productive. And he's already announced a major reorganization in its R&D arm. "The FDA approval of Multaq is an important milestone in the management of atrial fibrillation or atrial flutter that demonstrates the commitment of Sanofi-Aventis to provide patients and physicians with important new medicines," said Viehbacher.

- check out the report from Dow Jones

Sepracor depression drug flunks a mid-stage test

Sepracor ran into an unexpected setback on a mid-stage therapeutic for depression. Researchers say that the drug--SEP-225289--failed to deliver positive data in a trial that dosed 514 patients over eight weeks.

The developer says that the drug levels that reached patients' bloodstreams were lower than they had seen in earlier studies and that the side effect profile that emerged was different as well. And on top of that, U.S. regulators ordered a halt to two trials of the insomnia drug Lunesta in children. Regulators have concerns about non-clinical data that could be relevant in pediatrics. The double whammy cost Sepracor about 15 percent of its share price.

Sepracor says it's evaluating the mid-stage drug program before deciding how to proceed. SEP-225289 is a triple reuptake inhibitor based on its activities at the serotonin, norepinephrine and dopamine transporters.

"While we are clearly disappointed with the findings from the analysis of the preliminary study results, we are in the process of further analysis of the dose response and secondary endpoints to determine how or if we will take this novel mechanistic approach forward," Mark Corrigan, Sepracor's executive vice president of research and development.

- read the Sepracor release
- read the report from Reuters

Discovery Labs shares pummeled on new Surfaxin roadblock

Discovery Laboratories lost more than half of its stock value yesterday afternoon, plunging to 52 cents a share after investors got news of a new roadblock at the FDA for its respiratory drug Surfaxin.

After a four-year quest to gain an approval on the drug, Discovery Labs said that regulators had changed course in a meeting in early June, saying the developer had not offered enough data to gain an approval for the therapy - designed to treat respiratory distress in premature babies. And that would make it unlikely to get an approval with existing data. The FDA had declined to approve Surfaxin in April, but added that it felt it had supplied the agency with the necessary data to address its concerns.

"At the recent June 2 meeting," the company stated, "Discovery Labs learned that the FDA will now apply a newly defined standard to determine whether Discovery Labs has adequately demonstrated comparability of Surfaxin clinical to commercial drug product. This new standard represents a significant hurdle for approval of Surfaxin." The agency suggested that a new limited clinical trial would help its chances for gaining an approval.

In the short term Discovery Labs plans to focus on its other programs and will wait to further analyze a full record of its discussions with the agency before deciding on its next step.

- check out the report from Dow Jones
- read the press release

Discovery Labs: Surfaxin approval unlikely

Following an end of review meeting with the FDA, Discovery Labs said yesterday that it is unlikely that its lung drug Surfaxin will gain the agency's approval anytime soon. The company was dealt a blow in April when the FDA rejected it's application for the drug, saying that certain aspects of a Surfaxin biological activity test (a quality control stability and release test) had to be resolved before the Surfaxin can win approval. The drug is intended to treat premature infants with Respiratory Distress Syndrome.

At a follow-up meeting in early June, the FDA said it was applying a newly-defined standard to determine whether Discovery Labs had adequately demonstrated comparability of Surfaxin to commercial drug product. In a statement, the company said the FDA's new standard represents a "significant hurdle" in their quest for Surfaxin's approval, adding that it is unlikely that Discovery will be able to satisfy this requirement with existing preclinical comparability data. That virtually ends the drug's chances of near-term approval.

Discovery may appeal the FDA's decision, but in the meantime it will focus on two pipeline programs--Surfaxin LS and Aerosurf. According to the company's CEO Robert Capetola, the issues raised by the FDA regarding Surfaxin do not apply to the company's other programs.

- here's Discovery's release
- see the Reuters report

FDA wants more info on Novartis' Menveo vax

The FDA has asked Novartis for more information on its meningitis vaccine Menveo, which is likely to push back any approval date to late this year or early in 2010. And the manufacturer was quick to note that the agency is focused on questions regarding production, not safety or efficacy. That means no new clinical trials are needed to satisfy the agency's request.

It's a setback for Novartis, but not a serious obstacle. "While the financial impact is small, the setback is nevertheless a disappointment," said Vontobel analyst Andrew Weiss. But with prospective annual sales of $650 million, any delay is likely to sting. Menveo has demonstrated it can guard against the four most common types of meningitis.

- read the report from the Wall Street Journal

Are biotech CEO's worth what they're paid?

With a number of UK biotechs struggling to find cash to stay afloat, investors are raising some sharp questions about the pay packages that executives in the industry earn. A recent survey by Nature Biotechnology concluded that the average CEO in the UK earned close to half a million dollars in annual compensation, modest compared to many U.S. salaries.

But that figure doesn't sit well with many of the investors being asked to bail out shaky developers. The pay doesn't live up to actual performance, critics say.

"There are quite a number of companies paying really quite substantial sums to CEOs and board members when they have very poor prospects. It cannot be helpful for the companies to have people draining cash out of them in this way," William Bains, associate faculty member at the Institute of Biotechnology, University of Cambridge, tells the Wall Street Journal.

"We can't allow the industry to just disappear, and then say that part of the problem was executive pay," Robin Davison, an analyst at Edison Investment Research in London, says.

- read the report in the Wall Street Journal

Related Article:
CEO pay: Who makes what in Big Biotech?

Repros drops top dose for late-stage study

Repros Therapeutics is recalibrating clinical studies of its lead drug, dropping a 50 mg dose after researchers found that a small percentage of women in the studies of Proellex as a treatment for endometriosis demonstrated a dose-dependent increase in liver enzymes, a key marker of toxicity.

But Repros also noted that there was no difference in efficacy between patients taking a 25 mg dose and another group given a 50 mg dose in a clinical trial. Late-stage studies of a 12.5 mg dose and 25 mg dose are scheduled to launch later this year and in the first quarter of 2010 in Europe and the United States.

Repros shares were dinged by the news, sliding five percent. The developer says it will sit down with the FDA in September to review plans for a late-stage trial. It is also planning additional placebo-controlled studies of the 12.5 mg dose. But Repros adds that it does not expect that the new trial plans will delay a planned NDA in the second half of next year.

- check out the Repros release
- read the story from Reuters

AZ wins European approval for Iressa

It's been a long time coming, but AstraZeneca says that the European Commission has approved its oral cancer drug Iressa. AZ withdrew its EU app in 2005 and resubmitted it in early 2008. In a sign of the growing importance of personalized therapies, the approval is for adults with locally advanced or metastatic non-small cell lung cancer whose tumors have an EGFR mutation. The drug scrambles cellular communications required for tumor growth. Once seen as a potential blockbuster, Iressa stumbled badly when a late-stage trial failed to demonstrate positive results in 2004. Now, though, the therapy could start a comeback. Report

CombinatoRx and Neuromed forge merger deal

CombinatoRx and Canada's Neuromed have agreed to merge in an all-stock deal that starts out with a 50-50 split of the combined company followed by a recalibration of ownership based on the FDA's decision--and timing--regarding Neuromed's pain drug Exalgo. CombinatoRx will issue 36 million shares of common stock to complete the deal.

Investors in both companies will be left waiting to hear how the agency rules on Exalgo, a late-stage pain drug recently licensed to a subsidiary of Covidien for $15 million upfront, $16 million for development funding and up to $40 million for an approval. The FDA has a November 22 PDUFA date on the drug, and there's a lot riding on the agency's timetable. Pre-merger CombinatoRx shareholders will gain a greater ownership percentage of the combined company the longer it takes to gain an approval.

"This is a unique merger structure, with a contingent valuation element providing downside protection and upside participation for shareholders," said Robert Forrester, interim president and CEO of CombinatoRx. "This merger with Neuromed will leverage the operational efficiencies created by CombinatoRx's recent restructuring, including workforce reductions and divestiture of our Singapore subsidiary, to focus on our core technology, simplification of our balance sheet and reduced cash burn going forward. As a result, we expect to have sufficient cash to continue operations into 2012."

- check out the press release

Acorda lands $110M upfront in new Biogen pact

Acorda Therapeutics has forged a $510 million licensing pact for its multiple sclerosis drug Fampridine-SR with Biogen Idec. And Biogen has agreed to pay a hefty $110 million of that in an upfront fee for the late-stage program.

The pact was announced just hours after Biogen Idec and UCB announced that they were shelving a mid-stage MS drug, CDP323, after reaching the conclusion that the drug failed to demonstrate any clinical benefit when compared to a placebo.

Biogen Idec gains marketing rights to the drug outside the United States, adding to its considerable MS franchise. The biotech company also takes over regulatory and clinical work outside the United States, committing to $400 million in milestones and a royalty package. Acorda in turn will share a portion of its revenue from the drug with Elan, which holds a licensing pact of its own on Fampridine and manufactures the drug.

"We are delighted to be working with (Biogen Idec) to make Fampridine-SR, if approved, available to people living with MS in Europe, Canada, Australia and other areas of the world," said Ron Cohen, M.D., president and CEO of Acorda. "We believe that Biogen Idec's international expertise in MS and neurology also will help us optimize future development of Fampridine-SR and maximize its value in markets outside the U.S."

Fampridine-SR has posted positive data in two late-stage trials which tested the oral drug's ability to improve patients' ability to walk. An FDA approval could come this fall and the EMEA has already notified Acorda that the drug is eligible for a marketing submission.

- read the press release
- check out the story from Dow Jones on the failed MS program

Novavax stock soars on deal with ROVI, Spain

Vaccine developer Novavax announced a new deal with Spain's health ministry and drugmaker ROVI Pharmaceuticals Tuesday afternoon, sending its stock soaring 35 percent in afternoon trading. Spanish officials have committed €60 million to develop vaccines and establish the country's first vaccine plant to be built in Granada. Under agreements currently being negotiated, Rockville, MD-based Novavax will license its proprietary virus-like-particle vaccine technology to Spain's ROVI, which will use the technology to produce pandemic and seasonal flu vaccines.

The Spanish government will fund the development and provide the capital needed to get the vaccines through the regulatory process. The parties hope to have the manufacturing plant completed and the vaccines approved in 2012. ROVI will have exclusive rights to market the vaccines in Spain and Portugal, but Novavax will retain the rights to all other markets. Novavax President and CEO Rahul Singhvi seemed excited about the arrangement as he explained that the deal provides a funding pathway to get the company's products approved worldwide, while only giving up exclusive rights in two markets. "We were aggressive [in developing our vaccines] to begin with but [this] gives us a pathway to finance without doing a partnership deal which could be a lot less attractive," he tells FierceBiotech.

For its part, Novavax will receive much needed capital. In the short term, the company will get a $3 million equity investment from ROVI, a 10 percent premium over Monday's closing price. The developer is also in line for an undetermined future royalty and milestone payments, which could reach the tens of millions, a spokesperson told the Associated Press. Singhvi says there was mutual interest between the company and Spain officials, which--like a number of other countries--has shown interest in the company's VLP technology and the prospect of having an efficient and low cost vaccine manufacturing production within the country. "The idea that you can have that capacity in your borders is very attractive," said Singhvi.

The CEO says the company will set up operations in Spain through ROVI and he expects to hire new staff across the board.

- here's the Novavax release

Teva, Optimata to 'rescue' failed cancer drugs

Israel's Optimata and Teva Pharmaceutical Industries have teamed up to develop cancer drugs. The two say they will "efficiently rescue" failed advanced stage clinical trials. Teva will purchase the rights to drug candidates that other companies have shelved, Reuters reports, which the two will then co-develop using Optimata's bio-simulation technology. For its part, Optimata will receive an upfront payment, milestone payments and royalties, though further financial details were not disclosed. Teva has also agreed to make an undisclosed equity investment in Optimata.

"Having Teva Pharmaceutical Industries as a partner is clearly a transforming event in the history of our company," Dr. Pini Orbach, COO of Optimata, said in a statement. "With this new collaboration we continue to fulfill Optimata's goal of accelerating the oncology drug development process."

The Virtual Patient toolkit is a predictive software that, among other things, allows developers to conduct trials, track dosing and timing and monitor the interaction of drugs in patients, enabling drugmakers to create an optimal dosing schedule, as well as drug and safety profiles.

- read the release
- here's more from Reuters

Catalyst bags potential $500M deal with Wyeth

South San Francisco-based Catalyst Biosciences and Wyeth Pharmaceuticals announced that the companies have entered into a worldwide collaboration valued at potentially more than $500M for the discovery, development and commercialization of recombinant Factor VIIa products for patients with hemophilia and other bleeding conditions.*

The deal covers Catalyst's Factor VIIa products, which could treat hemophilia and other bleeding conditions. Wyeth will fund the discovery, research and preclinical development of Factor VIIa products, including CB 813, Catalyst's drug for the treatment and prevention of bleeding in hemophilia patients. The funds will support up to twelve full time employees at the biotech company. After Catalyst has completed preclinical development, Wyeth will take over development, manufacturing and commercialization of any products resulting from the partnership.

"This collaboration serves as an excellent fit with our recombinant Factor VIII and Factor IX hemophilia products and provides us with an opportunity to expand Wyeth's hemophilia franchise," says Mikael Dolsten, President, Wyeth Research. "We have been impressed by the caliber of Catalyst's therapeutic protein engineering skills used in the Factor VIIa program and the lead candidate CB 813. We look forward to a highly productive collaboration."

- here's the release

*Correction: The original version of this story confused Catalyst Biosciences with Catalyst Pharmaceutical Partners. It incorrectly stated that Catalyst Biosciences was in need of the funding that it received from Wyeth, and that the company had halted a mid-stage trial in March. That information refered to Catalyst Pharmaceutical Partners. Catalyst Biosciences has not halted any trials and in fact landed one of the top 20 VC deals of 2008.

Geron shares jump on GE stem cell pact

This morning the share price of Geron shot up 23 percent after the biotech company announced that it is teaming up with GE Healthcare to develop embryonic stem cell products that researchers can use in drug discovery work and tox screening. No terms were announced, but the new partners said that they would be using cell lines available through the National Institutes of Health's Human Pluripotent Stem Cell Registry. Geron report

Hyperion lands $60M VC round

San Francisco-based Hyperion Therapeutics has raised a whopping $60 million in a Series C financing round. New investors Bay City Capital and Panorama Capital co-led the financing, while existing investors Highland Capital Partners, NEA, and Sofinnova Ventures also participated.

Hyperion recently announced positive Phase II results and an orphan drug designation for HPN-100, a potential treatment for urea cycle disorders (UCT). This new round of funding will help fund Phase III trials of the drug for UCT, as well as a Phase II study in low grade hepatic encephalopathy.

"Considerable unmet needs remain in the treatment of both urea cycle disorders and hepatic encephalopathy," said Daniel Perez of Bay City Capital. "We believe the Hyperion management team, with their extensive drug development and regulatory expertise, is well positioned to lead a clinical development program focused on potential treatment options for these

- here's Hyperion's release

Related Article:
Hyperion garners $40M in second VC round

Abbott loses $1.67B patent fight with J&J; Jerini cuts preclinical ops;

> It's the patent judgment to end all patent judgments. A federal jury in Texas said Abbott Laboratories should pay some $1.7 billion to Johnson & Johnson for copycatting its blockbuster rheumatoid arthritis drug Remicade. Report

> After failing to find a buyer for its preclinical assets, Jerini announced that it will cut 45 workers. Report

> Alameda, CA-based Celera is licensing five cancer-related targets that Bayer Schering will use to detect and identify tumors. Specific financial terms of the deal, which includes in vivo diagnostic imaging developed by Celera, were not disclosed. Report

> Paladin Labs agreed to buy a bundle of products currently marketed in Canada by U.S. drugmaker Wyeth to boost its over-the-counter portfolio. Report

Research News

> An animal study is shedding new light on the complicated chemistry of the brain, and how a drug intended to do one thing can have entirely unintended consequences. Report

> A group of researchers at Children's Hospital of Pittsburgh have been developing a novel approach to preventing the onset of Type 1 diabetes. Diabetes report

> A key protein that plays a critical role in nicotine addiction--the alpha-7 receptor--could also be a key player in the fight against obesity, Alzheimer's, schizophrenia and a long list of other such ailments. Report

Pharma News

> Don't panic about Tamiflu, Roche says--and the CDC agrees. Both the drugmaker and the agency say they still consider the antiviral med effective against the H1N1 flu circulating the globe, despite news that a Danish patient proved resistant to the drug. Tamiflu report

> Are expensive cancer drugs a contemporary version of the emperor's new clothes? The Journal of the National Cancer Institute says they just might be. After analyzing data from existing studies, researchers found that some of the costliest drugs in medicine only prolong patient's lives by months, or even weeks. Report

> Analysts are increasingly skeptical of Biogen Idec, as each weekly Tysabri update turns up another patient with the potentially deadly brain infection PML. Report

And Finally... Researchers for Australia's EnGeneIC have outlined a strikingly successful new approach to conquering cancer. In several preclinical studies the scientists injected minicells into animals which are designed to deliver a payload of toxins and gene inhibitors and are coated with an antibody that latches on to tumor cells. In one recent study all the mice implanted with a tumor were free of tumor cells after a 70-day treatment period. Report

Former Genentech CFO heads to Facebook

Former Genentech CFO David Ebersman has found a new home as the first CFO of Facebook. The biotech veteran, who spent 15 years with Genentech, was promoted as the company's CFO in 2006. He departed the biotech in April as Genentech was officially absorbed into the Roche fold. In his new position he will be in charge of Facebook's finance, accounting, investor relations and real estate functions. He also becomes a part of the company's executive management team. Ebersman will assume the CFO roll in September 2009.

"We received a lot of interest in the CFO position and had the opportunity to meet with many impressive candidates," said Facebook CEO Mark Zuckerberg. "We quickly recognized that David was the right person for Facebook. He was Genentech's CFO while revenue tripled, and his success in scaling the finance organization of a fast growing company will be important to Facebook."

- here's Facebook's release
- see the WSJ report

BioSante, Cell Genesys merge in $38M deals

Cell Genesys has put an end to its financial woes through a $38 million merger with BioSante. The two companies will merge in an all-stock deal; BioSante will be the surviving company.

Cell Genesys stockholders will receive 0.1615 of a share of BioSante common stock for each share of Cell Genesys common stock they own. Based on the companies' closing stock prices on June 29, 2009, this represents $0.347 per share of consideration to be received by the Cell Genesys stockholders, or a total consideration of approximately $38 million. BioSante stockholders prior to the merger are expected to own approximately 60.4 percent of the outstanding shares of the combined company and the former Cell Genesys stockholders are expected to own 39.6 percent.

The new company will focus on BioSante's LibiGel, a female sexual dysfunction treatment currently in Phase III trials. It will also examine options for the future of Cell Genesys' GVAX Immunotherapies, including potential combination with BioVant, BioSante's vaccine adjuvant, as well as possible external collaborations. The combined entity will also try to outlicense other Cell Genesys technologies.

Last year Cell Genesys shelved a late-stage trial of GVAX immunotherapy in patients with prostate cancer after its independent monitoring board concluded that the trial had less than a 30 percent chance of success. Since that time, the company has gone into survival mode, shrinking its workforce down to just nine employees.

"This merger allows BioSante to secure additional funding required for the continued Phase III development of LibiGel for FSD and offers the potential to expand our product development portfolio with the addition of GVAX Immunotherapies," said Stephen M. Simes, BioSante's president and CEO. "...In addition, our company has had a long-standing interest in immunotherapy based on our proprietary vaccine adjuvant, BioVant, and we look forward to future value-creating opportunities for our stockholders based on Cell Genesys' technologies and other assets."

- check out this release

ALSO: BioSante Pharmaceuticals says a study of 631 women over 18 years showed that testosterone has no effect on the incidence of invasive breast cancer among menopausal women who use testosterone to improve sexual function. The drug developer is evaluating its testosterone treatment LibiGel for the treatment of hypoactive sexual desire disorder (HSDD) in women. Release

Sanofi unveils R&D makeover

As promised, Sanofi-Aventis announced today that it's overhauling its R&D operations in a bid to boost productivity. Noting its "social responsibility," the company is not planning layoffs, but says it will restructure through "voluntary staff departures."

The France-based pharma will reorganize some of its world-wide operations, which includes consolidating its R&D activities in France. The reorganization will affect preclinical activities at some sites of Spain, the United Kingdom, the United States and Japan where divestment or reconversion solutions will be sought for certain activities.

Sanofi's restructuring includes plans to strengthen 'exploratory structures' that work in close collaboration with outside entities. It will pursue partnerships with public and private research entities, academic institutions and biotechnology companies, and bring new skills to the company via the recruitment of promising researchers.

"We are living through radical times of change for Research," explained Dr. Marc Cluzel, Senior Vice President, Research and Development. "Given the increasing complexity of the world of science, we need to change our approach to the patient, make use of novel technologies and create new concepts,' he continued. 'Tomorrow's research will be carried out through networks. We will be open to knowledge from outside sources, becoming a key partner. We need to reinvent R&D."

Last week CEO Chris Viehbacher said the company would pursue a shift toward generics and away from in-house research, including a greater push into emerging markets. The company is facing generic competition of its best-selling drug Plavix in 2011.

- here's Sanofi's release
- read the WSJ report

FierceBiotech's 2009 Fierce 15

At the beginning of this year, I was just a little nervous about how the Fierce 15 would come together for 2009. The biotech industry was headed into the Valley of Death, after all, not a pleasant-sounding place to go looking for up-and-coming companies boldly pursuing their destinies.

In truth, this year turned out to be remarkably easy to find star players. The weak developers are in survival mode, unable to attract new money and playing for time. With venture backers more selective, the cream was more readily visible at the top. And this year's Fierce 15 help prove that if you have vision, good science and solid management, the money is still there to execute growth strategies.

Most of these companies are following a familiar path. Often starting with a university lab project, many are out to prove that they can fight disease with a new product that works a lot better than what patients have to rely on today. But there are some exceptions as well, pursuing some groundbreaking technologies. Either way, they typically face years of tests and trials, a complex and expensive regulatory review process and an incredibly risky business model. But of course a big appetite for risk helps to qualify for the Fierce 15.

I would like to thank the readers of FierceBiotech who suggested nominees for this year's list. This year more than any other you offered up a slate of candidates for the Fierce 15 that included some real winners. And keep the e-mails coming. Once one year's list is finished, I start compiling a list of possibilities for the coming review. On to 2010! Click here to see this year's winners

Juvaris strikes collaboration deal on new vaccines

Juvaris has taken a significant new step in its development as a vaccine company. Originally focused primarily on its experimental vaccine adjuvant JVRS-100, Juvaris will announce later today that it has inked a collaboration deal with Antigen Discovery to identify antigen targets for new vaccines. While Juvaris has in-licensed antigens for use in new vaccines, the pact announced today gives Juvaris a path toward identifying a slate of new vaccine candidates.

"We've got clear reach into the antigen arena to continue to create attractive, proprietary vaccines," Juvaris CEO Grant Pickering tells FierceBiotech. "This is really a transformational event for Juvaris. We'll be nominating a series of additional infectious disease targets for Antigen Discovery to run their process."

The deal includes upfront payments and milestones, which are not being revealed. But Pickering is optimistic that the pact creates the foundation for building a successful company in the vaccine arena. "A great adjuvant and a great antigen discovery engine give you the key building blocks for building a great vaccine company."

The pact also helps push the company at a critical point in its development. Pickering says that Juvaris is now in the "final stages" of raising a new round of venture capital. The vaccine company has already gained the backing of Kleiner Perkins. Juvaris announced positive results for a Phase I study involving JVRS-100 in April, A Phase II study will get underway soon with a group of elderly subject and should wrap in the early fall.

- read the Juvaris release

Roche recasts itself as a Big Biotech

Think Roche is a Big Pharma company? Think again. From now on, Roche--which just completed a buyout of Genentech--is a Big Biotech company. And to help signal the switch Roche is dropping out of PhRMA and is taking up Genentech's top position in BIO. "Genentech and Roche believe BIO's purpose is closely aligned with the direction of the new company and, therefore, can represent the company's interest in Washington,'' spokeswoman Darian Wilson said. The switch came despite an 11th-hour appeal by PhRMA, which sent AstraZeneca CEO David Brennan to discuss the matter directly with Roche CEO Severin Schwann. Report

FDA throws up roadblock for Takeda's diabetes drug

Takeda confirmed today that the FDA won't approve its critically important diabetes drug alogliptin without a new clinical trial that fully explores the drug's cardiovascular effects. A spokesman for the company told Bloomberg that the application for the Type 2 diabetes therapy could be resubmitted in two years, after a new trial is completed.

While a number of analysts had predicted a lengthy delay, noting the agency's new and tougher safety standards for diabetes drugs, the decision was a heavy blow for Takeda. The Japanese company had hoped to start marketing the once daily alogliptin, or SYR-322, as its existing drug, Actos, lost patent protection. Earlier this month Takeda announced that it was delaying its European application for alogliptin as it pursues new studies. A new application for Europe is expected in 2012.

"SYR-322 is the most important drug development agenda for Takeda," company spokesman Hisashi Tokinoya told Bloomberg. "We expect to lose patent protection on Actos, and with the decision by the FDA it's difficult to have the drug in time for the patent expiration.''

- read the report from Bloomberg
- read the story from the Chicago Tribune

Alizyme makes last-ditch effort to raise new funds

The UK's Alizyme is mounting an 11th-hour effort to stay alive. In a statement released today the developer said that its cash reserves would only carry the company through August and that it would be forced into bankruptcy or liquidation unless it raised fresh cash.

A strategic review is underway and the company is signaling that 'significant' layoffs are coming. Investors saw the blood in the water and bailed out as fast as possible, sending the company's already battered share price down 63 percent to two pence.

Alizyme funds itself from the milestones due on its program for Colal-Pred, but "material uncertainty" has developed over the receipt of money due from the pact. Alizyme has one drug candidate that has completed a Phase III clinical trial, according to its web site, one candidate in Phase III development and a further candidate with Phase II ‘proof of concept' data in its development portfolio.

- check out the Alizyme release
- read the report from Reuters

Sources: Novartis in talks to buy Elan assets

Novartis appears ready to cherry pick some of Elan's prime assets, if it can come to terms on the details. Citing sources, The Sunday Times in London reported that the pharma giant is in talks to buy Elan's interest in Tysabri--which it markets with Biogen Idec--as well as its development programs for Alzheimer's.

The Irish biopharma company has been seeking a partner for months now, with reports of its on-and-off merger talks capturing headlines periodically. In Sunday's report, the source said that the complexity of a negotiation over buying specific assets would likely push any prospective deal signing "some way off."

Citigroup Global Markets was brought in at the beginning of the year to see if it could help arrange a merger, alliance or some minority investment. And Elan said earlier this month that a strategic transaction was in the offing. At one time or another, however, Elan has reportedly been in talks with BMS, Pfizer and Lundbeck, but no deal was ever finalized with any of them.

- read the report from RTT News
- read the story in the Guardian

Swine flu cases spike as vax stockpile is readied

The number of suspected swine flu cases in the U.S. spiked to 6,300 last week, with health care officials across the country confirming that virtually all newly diagnosed flu cases are being caused by the H1N1 virus. Altogether more than 27,000 probable and confirmed cases have been recorded at the CDC.

The rising volume of cases is likely to fuel the debate over the need for a national vaccination campaign this fall. Manufacturers and agencies are readying 600 million doses of new vaccine in development--enough to protect the entire population. And the first 60 million doses may be available for use in September. But so far officials have yet to determine if they will roll out a national vaccination campaign.

Scientists at the CDC have been scrambling to try to understand the new H1N1 virus. In a study with ferrets, the researchers concluded that the new flu can be slightly more severe than seasonal H1N1. It also doesn't spread as easily. But the scientists are tracking outbreaks in Australia, Chile and Argentina in the southern hemisphere to determine if the virus is becoming more virulent as it spreads around the globe. And fears persist that a second-wave of the virus in the fall could prove more deadly.

- read the report from the Wall Street Journal