Biomaryland Forum

Latest Biotech news

Human Genome Sciences and BioInvent International have inked a deal to discover, develop and commercialize therapeutic monoclonal antibodies that specifically target antigens discovered by HGS. BioInvent will use its antibody discovery technology to generate and develop monoclonal antibody candidates, with a focus on the field of inflammation. Financial terms were not disclosed. Release

MiddleBrook plots major job cuts as CEO exits

MiddleBrook Pharmaceuticals' downward slide continues. In its full-year results release, the Westlake, TX-based company says it's eliminating its field sales force and significantly reducing its corporate staff to preserve money as it explores its options. As part of the cut-backs, CEO John Thievon will resign effective Monday, March 15, and CFO David Becker will become the acting CEO. Today's announcement follows two rounds of layoffs at MiddleBrook last year; at that time the developer had 145 employees.

MiddleBrook's recurring operating losses and management's substantial doubt about the company's ability to continue as a going concern for at least 12 months following the balance sheet date of Dec. 31, 2009 have led auditors to include a going concern warning in their audit opinion. MiddleBrook has engaged Broadpoint Gleacher Securities Group to help its board of directors to identify strategic alternatives, which could include a possible merger or sale of the company.

With its sales force gone, MiddleBrook says it will rely on its partnership with DoctorDirectory.com to commercialize Moxatag, an antibiotic for strep throat. Moxatag is the company's only marketed drug.

- here's the Wall Street Journal report
- read the Reuters article for more

Arena will launch lorcaserin with or without partner

Arena Pharmaceuticals expects to launch its weight loss drug lorcaserin within 12 weeks of FDA approval--with or without a partner, according to the company. The agency's deadline for review of the drug is Oct. 22.

"We are pleased with the timely execution and significant progress made in our lorcaserin program," Jack Lief, Arena's president and CEO, says in a statement detailing the company's 2009 financial results. "As we continue efforts to reach a commercial agreement for lorcaserin, we are building a strong foundation for a successful launch upon potential approval."

Lief tells Reuters Arena aims to secure a commercial partner for the drug, but is prepared to hire a contract sales team on its own if needed. "We will certainly be ready to launch either with a commercialization organization or on our own within 12 weeks of hitting the go button," he adds.

The lorcaserin NDA is based on a data package from a development program that includes 18 clinical trials totaling 8,576 patients. The pivotal Phase III clinical trial program, BLOOM and BLOSSOM, evaluated nearly 7,200 patients treated for up to two years. In both trials, lorcaserin produced statistically significant weight loss with excellent safety and tolerability, according to the company.

Arena and rivals Vivus and Orexigen Therapeutics are all trying to develop the first new prescription weight loss drug in a decade. Vivus announced March 1 that the FDA accepted its NDA for its obesity treatment Qnexa. The target date for the FDA to complete its review of the Qnexa NDA is Oct. 28. And Orexigen has a couple of obesity candidates: Contrave and Empatic.

- read the Arena release
- see the Reuters coverage

Pfizer stops another figitumumab trial

Pfizer has discontinued another trial of its monoclonal antibody figitumumab. The drug was in a Phase III trial in combination with Tarceva as a second/third-line treatment for patients with previously treated advanced non-adenocarcinoma non-small cell lung cancer (NSCLC). An independent data safety monitoring committee recommended that Pfizer stop the study after it became apparent that figitumumab was unlikely to prove superior to Tarceva in the study population.

Last year, Pfizer shuttered a late-stage trial of the drug in lung cancer after investigators found a higher rate of adverse events in figitumumab patients compared with those receiving a placebo. Pfizer is continuing to study figitumumab to treat prostate, breast and lung cancers, as well as Ewing's sarcoma.

"This outcome is disappointing to us and to patients with NSCLC. Pfizer is working to thoroughly analyze all available data from the figitumumab program to better understand the compound and the IGF-1R (insulin growth factor-1 receptor) pathway," says Mace Rothenberg, senior vice president of clinical development and medical affairs for Pfizer's Oncology Business Unit, in a statement.

- here's Pfizer's release

PLUS: Pfizer also announced today that two Phase III studies of Sutent (sunitinib malate) in advanced breast cancer did not meet their primary endpoints. Report

Aveo proves investors still lack appetite for biotech IPOs

Anthera, Ironwood and Aveo. What do these developers have in common? With their debuts, they've all proven that despite hope for a resurgence of biotech IPOs after a ghastly 2009, investors still aren't eager to invest in risky companies.

After delaying its debut two days, Aveo unloaded its initial public shares for $9, far less than the $13 to $15 range it had hoped for. That means the developer raised $81 million and has a market value of $267 million. The cancer drug company is currently in Phase III trials for tivozanib for renal cell carcinoma. It also has a Phase II program for lung cancer drug AV-299 and a host of Phase I programs. Additionally, the company has partnerships in place with Merck, OSI and others. But it has no marketed products, and, like most biotechs, has burned through oodles of cash in its existence.

Anthera went public earlier this month, pricing its shares at half of what it had originally hoped for. And when Ironwood went public in February, it ended up selling 16.7 million shares at $11.25 each--well below its $14 to $16 target. Biotech may not be in the valley of death experienced in 2009, but investors are still hesitant to part with their cash.

- read the Xconomy write-up

Genetix raises $35M to advance gene therapies

Cambridge, MA-based Genetix Pharmaceuticals has completed a $35 million Series B financing with new investors Third Rock Ventures and Genzyme Ventures joining TVM Capital, Forbion and Easton Capital. The company was founded in 1993, but in 2004 Genetix was re-started and recapitalized in a Series A investment by TVM, Forbion, and Easton, and has raised a total of $23 million in Series A and bridge funding since then. "The whole point of this financing is to (1) advance the programs in the clinic, (2) expand and broaden the platform of the company, and (3) expand the team," explained Genetix President Nick Leschly (also of Third Rock Ventures) in an interview with FierceBiotech. He said this round will give the company a cash runway of three or more years.

Genetix has two lead programs in the Phase II trials. Lenti-D is an experimental therapy for Adrenoleukodystrophy (ALD), a severe neurodegenerative disorder that affects one in 17,000 males. Its other program is Lentiglobin for beta-Thalassemia, one of the most prevalent human genetic disorders. Both therapies use Genetix's gene therapy platform to re-engineer patient's own cells to treat the rare and potentially fatal diseases. And Leschly notes that its technology is being explored for other genetic conditions. The funding will be used to immediately move both lead programs into pivotal trials.

Genetix currently has 15 employees but expects to double over the next 12 to 18 months. And it's already getting that process under way. In addition to today's financing, the company has announced that it named Mitchell Finer, Ph.D. as chief scientific officer. Finer is a former Novocell exec with years of experience in gene therapy and regenerative medicine. As Genetix news CSO, he'll help guide the company's existing programs while exploring other applications for its technology.

"The intent of the company is to create a collaborative networks with both disease foundations, academic institutions, and industry," explained Leschly. "We're in ongoing discussions with a number of folks who are interested in our programs." And with a disease-altering technology platform, you can bet Big Pharma will take notice. Leschly wouldn't give specifics on any companies that would be interested in Genetix technology, but he did point out that developers like Biomarin, GlaxoSmithKline, Shire and Novartis have all expressed interested in pursuing treatments for rare genetic diseases or severe diseases. And investor Genzyme Ventures is the VC arm of Genzyme, which has built its business on treating rare diseases.

- here's Genetix's release on the funding
- and take a look at the announcement on Finer's appointment

Related Article:
Top 20 Biotech VC Deals of 2009

Merck joins consortium on vax plant

Merck, IBM and Battelle have signed up to partner with GE Healthcare on a new vaccine plant that has been proposed by the University of Pittsburgh Medical Center. The vaccine facility backers want to build a state-of-the-art facility that can respond on an emergency basis to bioterror attacks. Merck would contribute its drug-development expertise, with IBM handling IT and Battelle doing the pre-clinical work and research. Story

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

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

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

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

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

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

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

EKR names interim president, CEO

> EKR Therapeutics has announced that its executive chairman John Bailye has been appointed interim president and CEO replacing Howard Weisman, who is no longer with the company. Weisman will also no longer serve on EKR's board of directors. Release

> Human Genome Sciences has named David Southwell as CFO and EVP. Release

> Robert Shepard has been appointed CMO of Cornerstone Pharmaceuticals. Release

> Shengtai Pharmaceutical has appointed Hu Ye as its new CFO. Release

> Talaris Advisors has named Derek Lee as CFO and corporate development officer. Release

> Sandoz announced the appointment of Don DeGolyer as president of the company's U.S. operations and head of commercial operations for North America.

> Phillip Frost will serve as the new chairman of the board of Teva Pharmaceutical Industries after Eli Hurvitz indicated he wishes to be released from his duties. Moshe Many has stepped down from his role as interim chairman and has been appointed vice chairman. Release

> Protalix BioTherapeutics has reported that Eli Hurvitz is relinquishing his position as chairman and member of the board of directors. The board has unanimously appointed longstanding member Zeev Bronfeld to serve as interim chairman. Release

> Charles Lannon has been named vice-chairman of the board at Kinex Pharmaceuticals. Release

> China Yongxin Pharmaceutical has announced that Hal Lieberman, Laura Philips, Bing Li and Jingang Wang were appointed to its board of directors as independent directors. Release

> 3SBio has announced changes to its board of directors. Liping Xu, company founder, executive director and VP, will retire from the board and her position as a company officer. Peiguo Cong will join the board and serve as an independent, non-executive director.

Novartis offers $955M deal to snare Transgene drug option

Novartis has put up $10 million and promised up to €700 million more in milestones in exchange for an option on Transgene's promising, late-stage cancer immunotherapy.

France's Transgene will hold on to control of the upcoming Phase IIb/III pivotal trial of TG4010 that is slated to get under way by the end of this year after enrolling about a thousand patients with non-small cell lung cancer. Once Novartis gets its hands on the IIb portion of the data, the pharma giant will have 90 days to decide whether it will exercise its option on the program. The data is scheduled to arrive in early 2012.

If Novartis decides to pull the trigger on the option--a deal structure that is growing increasingly common in drug development--Transgene will get a fee plus milestones along with co-promotion rights in a list of countries that includes France and China. Novartis will gain control of the program and take responsibility for further costs.

"We believe this agreement represents the best way to accelerate development and create long term value for our shareholders," says Transgene CEO Philippe Archinard. "It is also consistent with the company's goal of becoming a fully integrated biopharmaceutical company as under this agreement Transgene will maintain certain commercialization and manufacturing rights."

However, not everyone was impressed with the optional, uncertain terms of the agreement, andshares in the French biotechnology company went down 12 percent. "We view today's option announcement as slightly underwhelming, given that the ongoing burden of funding remains with Transgene for another two years," says Nomura Code analyst Gary Waanders.

Because Novartis wants to see the outcome of a mid-stage Phase IIb clinical trial before exercising its option, Waanders said he was reviewing his "neutral" rating and fair value estimate of 21.80 euros a share.

- check out the Transgene press release
- here's the Reuters story

Biotech VCs, Big Pharma stepping outside the comfort zone

BARCELONA - On Monday evening I moderated a panel on corporate venture financing at BIO-Europe Spring, joined by Roel Bulthuis, the head of Merck Serono Ventures, Anja (it's pronounced Anya) König, managing director of Novartis Venture Fund, Patrick Krol, a partner with Aescap and Malcolm Weir, the CEO at Heptares. I'd spoken with Weir before about his U.K. biotech company and knew that he and König went back. Novartis is an investor in Heptares, which we featured last year as a Fierce 15 company.

König's fund has a history of getting in early at a developer. And as she emphatically hammered home during the rather informal hour-long exchange about corporate VC goals and objectives, Novartis' venture arm is on the lookout for game-changing technologies. An incremental, short-yardage health gain isn't the objective.

Over the last year, König's longstanding interest in the cutting-edge has become an increasingly common feature in the drug development scene. As Big Pharma companies apply shock therapy to their R&D empires, it's clear that the top CEOs are focused on getting their organizations to think more like biotech organizations. If they can't become more efficient at development and shed some of the bureaucracy that has grown around their empires even as they grow bolder in their scientific objectives, then they won't be nimble enough to get out from under the avalanche of patent expirations that is tumbling their way. That process won't ever be pretty, but it is understandable.

That's a lesson, though, that more biotech execs need to take to heart as well. Safety is great. Low risk is great--if you can find it, and I'm not sure you can. But if you aren't trying to change the game of health, it's going to be very difficult to find a licensing partner when you need one. Getting backing from a venture group that thinks that way is the best kind of validation you can hope for as you're going into the clinic.

Thanks to everyone on the panel for a lively discussion. And we appreciated a big, receptive audience. Moving from the world of virtual, online news production to the world of face-to-face communication helps make simple truths come alive. - John Carroll twitter | email

In 9-3 vote, expert panel backs InterMune's pirfenidone

An FDA expert panel voted 9-3 Tuesday in favor of InterMune's Esbriet (pirfenidone), a treatment for idiopathic pulmonary fibrosis. IPF is a rare and fatal lung disease that affects approximately 200,000 people in the U.S. and Europe. If approved, Esbriet would be the first treatment for U.S. IPF sufferers. The treatment has already received approval in Japan on the condition that there will be a post-marketing period during which the drug won't be widely available until further data are available.

Not all the panelists were convinced of the drug's efficacy; however, most voted that the potential benefits of the drug outweighed these concerns. "I voted yes because I've been straight down the middle the entire time. I didn't see substantive evidence of efficacy per the FDA regulations but there was clinical meaningful effect on the disease. You need to offer patients hope. If this offers a smidgen of hope, then it is worth approving," one panelist said, according to TheStreet's Adam Feuerstein. Added another, "I voted yes, opposite of my vote on the question of substantial efficacy because I don't believe there is substantial evidence of efficacy; but if I got this disease, I'd be on the next Delta flight to Japan."

The FDA doesn't have to follow the panel's recommendations, but it usually does. In a conference call, CEO Dan Welch said that if the drug is approved, it may take the company some time to ramp up production. "We chose not to make certain investments in commercial or other areas of the company until we had visibility from this meeting. So one should not expect that Esbriet would be available immediately after the approval."

During the call, analysts also attempted to suss out how InterMune would price the biologic if approved. InterMune also manufactures Actimmune, a treatment for chronic granulomatous disease that's been used off-label for the treatment of IPF. On-label, Actimmune runs in the range of $8,000 to $20,000 per year. When used off-label for IPF patients, the annual cost price per year shoots up to $50,000. "I don't know what you draw from that," noted Welch, unwilling to reveal the possible price of Esbriet. A final decision is expected May 4.

- check out InterMune's release
- read TheStreet's live blog on the panel meeting

Abbott buys Facet Biotech for $450M

Abbott has succeeded where Biogen Idec once failed. The company announced late Tuesday that it's purchasing Facet Biotech for $450 million, or $27 a share. That's 67 percent premium over the biotech's closing price of $16.21 earlier today.

Abbott says the acquisition will boost its early- and mid-stage pharmaceutical pipeline. The developer has its eyes on two primary therapeutic areas--immunology and oncology. The highest-priority program is daclizumab, a Phase II biologic for multiple sclerosis that will move into Phase III trials in Q2 of 2010. Facet is already partnered with Biogen Idec on the compound. The biotech also has oncology compounds for multiple myeloma and chronic lymphocytic leukemia in early to mid-stage trials.

Last year Biogen attempted to purchase Facet, eventually making a "best and final offer" of $430 million after its initial $356 million bid was deemed hopelessly unrealistic based on the developer's cash position and pipeline. But with the support of two major investors, Facet was able to fend Biogen off, while at the same time noting that it would be open to more substantial bids from other companies. Biogen will owe Facet a big milestone on the launch of a late-stage study for daclizumab.

"This acquisition will further strengthen Abbott's biologics capabilities and pharmaceutical pipeline," says John Leonard, M.D., senior vice president, global pharmaceutical research and development, Abbott. "Daclizumab is a promising treatment for multiple sclerosis, a disease that has a significant unmet medical need, and has the potential to become an important treatment option for patients. We continue to explore multiple mechanisms to treat autoimmune diseases and cancer with both biologic and small molecule approaches."

Abbott has been on a buying spree as of late. It spent $10 billion on new acquisitions last year, paying $3 billion for Advanced Medical Optics and $6.6 billion for the prescription drug business of Solvay.

- here's Abbott's release
- read the BusinessWeek article for more

Tocagen raises $7.8M; ISTA gets PDUFA date;

@FierceBiotech: Between 4Q07 and 4Q09, 25 percent of US public biotechs disappeared (half via M&A), says BIO. | Follow @FierceBiotech

@JohnCFierce: For sale: Ark Therapeutics. Willing to consider any serious offer. Buyer must be willing to mount new Ph3 for lead drug. Follow @JohnCFierce

> San Diego-based Tocagen has raised almost $7.8 million from 75 investors in a Series D round of financing. Article

> The FDA has granted ISTA Pharmaceuticals NDA for XiDay a PDUFA date of October 16, 2010. The company's request for a shorter, six-month priority review is still under consideration by the agency. ISTA release

> INSYS Therapeutics announced positive results from the pivotal phase III efficacy trial for patients utilizing the Fentanyl Sublingual Spray (SL Spray) technology to treat breakthrough cancer pain. INSYS release

> Amgen plans to sell $1 billion of senior notes in a two-part sale, reported IFR, a Thomson Reuters service. Report

> Stirling Pharma, an Australian group, has taken over North Sydney-based Keata Pharma for about $3.6 million. Report

And Finally... More than 100 researchers teamed up over two years pieced together a genetic blueprint of the bacteria that's found in the human digestive tract. Article

AutoImmune calls it quits

After considering all of its options, Pasadena, CA-based AutoImmune has decided to liquidate its assets and to dissolve the company. The developer had been working on products to treat autoimmune and other cell-mediated inflammatory conditions. The company ran into trouble after the Phase III failure of multiple sclerosis drug dirucotide, a treatment it had been developing with BioMS. In October, AutoImmune retained Junewicz & Co. to explore its strategic options. Shuttering its operations proved to be the best course, and the company plans to distribute all available cash to stockholders.

"After evaluating the Company's strategic options, the Board of Directors reached the conclusion that it is in the best interest of stockholders to liquidate and dissolve the Company," says CEO Robert Bishop in a statement. "In connection with the Company's plans to liquidate, we have begun the orderly wind down of the Company's operations, including seeking purchasers for the Company's intellectual property and other tangible and intangible assets and providing for the Company's outstanding and potential liabilities."

- here's AutoImmune's release

Cellzome partners with GSK on inflammatory diseases

Germany's Cellzome has inked a second drug discovery pact with GlaxoSmithKline in the field of inflammatory disease. Under the terms of the agreement, Cellzome will receive about $44.79 million in upfront payments.

The companies will use Cellzome's Episphere technology to identify small molecule candidates against targets from four different epigenetic classes. After they identify candidates, GSK will take over all preclinical and clinical development, as well as commercialization. If all programs under the alliance are successfully developed and commercialized, additional milestone payments could exceed $645 million, according to GSK.

Cellzome and GSK signed their first inflammatory disease collaboration in September 2008. Through this partnership, the companies hope to identify and develop selective kinase inhibitors using Cellzome's Kinobeads technology. Cellzome also has partnered with Ortho-McNeil Pharmaceutical, Bayer HealthCare and Novartis on various projects.

- read more in this report

Related Article:
GSK signs $1.5 drug dev deal with Cellzome

Publisher's Note: This article was based on an embargoed press release posted on Genetic Engineering News' site, and has since been removed. The embargo will be lifted at 12:01am on Wednesday, March 10. - Arsalan Arif

Who's the next biotech buyout target?

With Astellas Pharma and OSI Pharmaceuticals haggling over price, BNet Pharma wonders which biotechs could be next on the buyout menu. Mega-mergers might have been all the rage in 2009; however, with few targets left, the focus will shift to smaller acquisitions. Big Biotechs Biogen Idec and Gezyme could be on the menu, given Carl Icahn's involvement in the companies.

So which smaller developers could be targets? Here's BNet's list:

Vertex Pharmaceuticals' promising hepatitis c drug telaprevir is in Phase III trials, and the company has a pipeline of drugs that features treatments for cystic fibrosis, epilepsy and inflammatory diseases
GlaxoSmithKline is already partnered with Human Genome Sciences on its lupus drug Benlysta, which analysts predict could lead to $4 billion in sales.
Alexion Pharmaceuticals boasts Soliris, the world's most expensive drug, which pulls in about $400 million a year. The developer has four Phase II trials for other indications of the drug, which is currently approved for a rare blood disorder.
Sales of pulmonary arterial hypertension drugs Remodulin and Tyvaso have led United Therapeutics to $370 million in annual revenues.
With $844 million in sales last year, Bayer and Onyx Pharmaceuticals' kidney and liver cancer drug Nexavar came close to the blockbuster mark. Four Phase III trials are testing the drug for additional indications
Auxilium Pharmaceuticals is looking for more uses for its Testim testosterone gel and Xiaflex, a drug for hand contracture disease.
Allos Therapeutics won approval last year for Folotyn as a treatment for peripheral T-cell lymphoma; trials for cutaneous T-cell lymphoma are under way.

- read the BNet article for more details

InterMune trading halted on panel review

The Pulmonary-Allergy Drugs Advisory Committee is meeting today to review InterMune's NDA for pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis. As a result, trading of the company's stock has been halted. InterMune release

'Externalization' takes center stage at Bio-Europe Spring

BARCELONA - The emphasis in the European biopharma scene is squarely on finding a new equation for drug discovery that relies less on internal R&D operations and more on external drug discovery work. And the balancing act has created a lively amount of new partnering discussions here at BIO-Europe Spring.

Just in case anyone might have missed that point, AstraZeneca's Geoff Collett, a business development executive, took a moment during a presentation this morning and highlighted a quote from his boss, David Brennan, that made it crystal clear: "Externalization will be a way of life going forward."

Got it?

The reason is simple, says Morgan Stanley's Andrew Baum. He tells the Financial Times that partnering on a drug program is less risky than relying on in-house projects and mid-stage programs Big Pharma companies collaborate on are likely to have a rate of return three times higher than the companies can earn on their own.

But even as AstraZeneca joins a long list of big companies that are reengineering their whole approach to drug development, Brennan is also cautious about how much can be cut. "You still need to have sufficient in-house staff," he tells the FT, "to scrutinize external projects."

These are lean times in the European biotech industry, but it was hard to see that in the packed presentation rooms at Bio-Europe Spring. On Tuesday morning a slate of big and small developers were on hand to provide a snapshot look at their partnering plans, and there was no shortage of would-be collaborators in the audience.

In a form of biopharma speed dating, a host of companies including Novartis, AstraZeneca and Merck offered some highlights of their partnering interests. And there's a highly ecumenical approach to deal-making these days.

"We're not married to one particular deal structure," says Collett. In this climate, it helps to keep an open mind. - John Carroll twitter | email

More from BIO-Europe:
The biotech spring arrives in Barcelona

Ark in sales talks after regulators demand new trial

London-based Ark Therapeutics' efforts to pioneer a gene-based brain cancer therapy in Europe hit a new hurdle today as European regulators demanded a new trial of Cerepro ahead of any approval. Ark pulled its marketing application, which had been rejected last December, and says it's considering selling the company.

An expert advisory panel for the European Medicines Agency decided at the end of last year that Cerepro failed to measure up to its efficacy standards. The therapy is Ark's lead program, and this new setback drove its shares down 15 percent, leaving the developer studying its options.

"Ark has initiated a full review of its substantial portfolio of assets, their potential and alternative strategies and options to optimise shareholder value," the company says in a statement. A number of approaches have been made to the company, it added, but there's no guarantee of an offer.

- here's the press release
- here's the story from Reuters

Related Article:
Ark shares soar on gene therapy data

Exelixis chops 270 jobs in restructuring

South San Francisco-based Exelixis is axing 270 jobs--40 percent of its workforce--as it circles its wagons around its top three cancer programs.

Citing SEC documents, the San Francisco Business Times reports that the axe will fall hardest on the company's drug discovery unit. And the developer says that slashing its budget for salaries, lab supplies and clinical trial costs will help the company save $90 million through 2011.

The spotlight now will primarily focus on three cancer programs--for XL184, XL147 and XL765--while its preclinical development program has been scaled to produce one new IND per year. Exelixis will continue development of XL888, an orally available small molecule inhibitor of HSP90 currently in Phase I, XL139 and XL413, compounds co-developed with BMS, as well as its preclinical program focused on PI3K delta

"Our priority is to see ourselves through to the anticipated filing of our first NDA for XL184 in the second half of 2011," said George A. Scangos, president and CEO of Exelixis.

- check out the Exelixis release for more information
- here's the report from the San Francisco Business Times

ExonHit, bioMerieux nix colon cancer program

French drugmakers ExonHit Therapeutics and bioMérieux have decided against pursuing their collaboration in colon cancer after a recent review of data by a scientific committee. Both companies say they will continue to collaborate in the field of prostate cancer.

"ExonHit's technology was able to produce a robust and reproducible test however, the final results from the colon cancer program did not reach the level of performance we were aiming to achieve. Therefore, we have decided together with bioMérieux to focus our efforts on the prostate cancer program," Loïc Maurel, president of the management board of ExonHit, says in a statement.

In European trading, ExonHit lost 4.9 percent to €3.32 ($4.53), but BioMerieux, which makes tests for HIV and hepatitis, jumped 4.1 percent to €83.61 ($114.15), according to the Financial Times.

- check out the press release
- read the Financial Times article

Related Article:
BMS inks $413M pain pact with Allergan

FDA OKs Cell Therapeutics' manufacturing plant

The FDA has approved Cell Therapeutics' facility to manufacture Pixuvri (pixantrone), an experimental cancer drug that is currently under review. The NerPharMa facility, which belongs to Nerviano Medical Sciences, is based in Nerviano, Italy. "FDA approval of the NerPharMa facility to manufacture our drug product is a major milestone in the drug approval process and we are pleased that our manufacturing partner is prepared to provide commercial supplies when pixantrone is approved," says Craig Philips, president of CTIC.

Cell Therapeutics' closely-watched pixantrone is a potential treatment for relapsed/refractory aggressive non-Hodgkin's lymphoma. The FDA's decision will be a make-or-break moment for the struggling developer, with many analysts expecting the FDA to rule against the drug. FDA staffers have raised questions about the treatment, expressing concerns about both the drug's effectiveness, as well as its safety profile. An ODAC meeting is scheduled for March 22, and the FDA is expected to make a final decision on approval of the NDA for pixantrone by April 23.

- see CTIC's release
- here's the Reuters Article