drug developer

Daiichi Sankyo acquires Ranbaxy in $4.6B deal

John Carroll — Wed, 11 Jun 2008 11:12:29 -0400

Ranbaxy's drive to become a research-based drug developer and major manufacturer has led it straight into the welcoming arms of Japan's Daiichi Sankyo, which announced it is buying a majority stake in the Indian pharma company. After Sankyo completes a buyout of the founding Singh family's stake in the company, Ranbaxy will become a subsidiary operation. The deal is valued at $4.6 billion and will create a combined company worth about $30 billion.

That move positions Daiichi Sankyo to become a major supplier of low-priced generics to Japan's aging population and accelerates a trend by Japanese pharma companies to enter emerging Asian markets, where they see much of their future growth. The acquisition stunned investors and analysts alike, who were caught off guard by a bold move from a conservative player in the industry.

- check out this release for more on the deal
- read the report from The Times

BrainCells launches IIa trial after $50M VC round

Fri, 18 Apr 2008 06:59:57 -0400

San Diego-based BrainCells is moving its lead program into a Phase IIa trial after boosting its second venture round with a second tranche. The new money brings its second round to $50 million. BrainCells says it's developing compounds that promote the growth of new neurons for CNS diseases. Its lead product candidate, BCI-540, is designed to treat patients suffering from depression with anxiety.

"Current therapies directly impact serotonin levels causing many unpleasant side effects, however we have shown that BCI-540 directly impacts neurogenesis without affecting serotonin levels," says Carrolee Barlow, M.D., Ph.D., the CSI at BCI.

- check out the press release

Related Article:
Emerging Drug Developer: BrainCells. Report

Pfizer, Avant ink $440M cancer vax deal

Thu, 17 Apr 2008 06:59:57 -0400

Avant Immunotherapeutics is pocketing a $40 million upfront fee and a $10 million equity stake from Pfizer in exchange for the worldwide rights to Avant's experimental brain cancer vaccine. And Avant could pocket $390 million in milestone paydays if all goes well with the drug's development. Avant gained control of CDX-110 after completing a merger with Celldex Therapeutics earlier this year.

CDX-110 is in a mid-stage trial designed to demonstrate its efficacy against a defective protein that promotes brain cancer. Pfizer has agreed to take over all development activities and pay out a double-digit royalty to Avant on an approved therapy. Pfizer also gains exclusive rights to EGFRvIII vaccines for other uses.

The Avant deal is just one more in a string of recent Pfizer biotech acquisitions. As Forbes points out, the world's largest drug developer has been bargain hunting: it purchased publicly-traded Coley Pharmaceuticals and Encysive Pharmaceuticals for $164 million and $195 million respectively. It also snapped up two privately-held biotechs: Serenex and CovX. The deals are designed to bolster Pfizer's biotech and oncology pipeline as it faces the loss of some of its biggest drugs to patent expirations over the next several years.

- here's the release
- read the article from Forbes on Pfizer's cancer strategy

Related Articles:
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Feds ok Iomai Phase II adjuvant patch study

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

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

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

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

- here's the press release

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

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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

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Panacos surges on HIV response data

Thu, 06 Mar 2008 06:59:56 -0500

Shares of Panacos shot up yesterday when the drug developer reported that it discovered factors that predict response to bevirimat, its lead HIV maturation inhibitor. Patients who had few mutations on the HIV Gag protein were more likely to respond to bevirimat. When researchers analyzed data from a recent Phase II trial, they found that about 50 percent of the 100 patients studied have these specific changes in Gag. "In a very short period of time we have made a number of significant discoveries with regard to bevirimat. We can specifically target the patients who will respond well to bevirimat in advance. In that population, we have seen a dramatic treatment response," noted Alan W. Dunton, Panacos' President and CEO. Simple genotype test will help determine which patients benefit from bevirimat; additional trials will be needed to test the drug in this group.

- see this release
- read the BusinessWeek article for more

Related Articles:
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Vernalis may be in play after dramatic reorg

Wed, 20 Feb 2008 06:59:56 -0500

The UK's Vernalis saw its shares shoot up after the drug developer announced a dramatic restructuring that will eliminate more than half of its work force and put significant parts of its business up for sale. Out the door goes CEO Simon Sturge as Vernalis' U.S. operations and lead drug Apokyn go on the sales block. Analysts immediately began to speculate that the restructuring may put the company in play, with a buyer moving in to take control. New money is needed to meet its obligations to Endo Pharmaceuticals on the migraine drug Frova. Last October the FDA dealt a major blow to Vernalis when it rejected the company's application for another indication on Frova. Vernalis is contesting the decision. Vernalis' executive chairman Peter Fellner told Thomson Financial that the company has enough cash to continue operations for two years and was selling off further assets to beef up its cash stake.

- here's the release
- read the report in Hemscott

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Rumor Mill: Sanofi to buy Oxford BioMedica

Mon, 11 Feb 2008 06:59:56 -0500

Rumors are swirling that Sanofi-Aventis may be making a bid for Oxford BioMedica, a U.K.-based developer of gene-based medicines. Oxford's shares have surged in response to a report published in The Mail claiming that a Sanofi bid for the company is imminent. Neither side is sharing details, however; spokespeople for both Sanofi and Oxford declined to comment.

A takeover by Sanofi isn't out of the question, as the drug developer has indicated in recent months that it's looking to acquire a biotech. Additionally, last year Sanofi hopped on the cancer vaccine bandwagon when it inked a $690 million licensing deal for Oxford BioMedica's TroVax. However, another news source reported that the rumors are false and that Sanofi doesn't have plans to change its relationship with the company.

- read this CNN report

Related Articles:
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Lilly sees pipeline hope in MS drug

Mon, 11 Feb 2008 06:59:54 -0500

An article in the Indianapolis Star details Lilly's development program for MBP9289, a multiple sclerosis drug offering hope to both patients and a drug developer that hasn't launched a new drug for humans since 2005. MBP9289 is currently in Phase II and III trials and has shown promise in delaying progression and worsening of MS. The opportunity here for Lilly is huge--roughly 2.5 million people worldwide have the disease, and MS-related drugs did $6 billion in sales last year. Moreover, those who treat the MS say the disease is under-served by current treatments.

"Given Lilly's prominence in neurosciences, an expansion into multiple sclerosis makes strategic sense," said Linda Bannister, a drug analyst at Edward Jones in St. Louis. "But whether this compound is the answer, it's too soon to say."

- read this IndyStar article

ALSO: Take a look at Lilly's pipeline. Report

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Neurogen cuts 70 jobs in restructuring

Wed, 06 Feb 2008 06:59:56 -0500

Neurogen is slashing 70 jobs in a restructuring that will focus company assets around its clinical programs. The drug developer is focused on insomnia, Parkinson's disease, restless legs syndrome and pain. Neurogen announced Monday that its president, Stephen R. Davis, had been appointed chief executive officer at the biotechnology company.

"As our clinical portfolio advances, we must allocate our resources to facilitate this growth," said Davis. "Our insomnia program holds the potential for significant differentiation and increased value as we seek to expand on the clinical profile we have seen thus far, suggesting improved objective and subjective measures of efficacy over currently available insomnia drugs. Aplindore remains on track for the commencement of Phase 2 studies in both Parkinson's disease and Restless Legs Syndrome."

- check out the release

Emerging Drug Developer: Sonexa Therapeutics

Mon, 04 Feb 2008 06:59:59 -0500

Emerging Drug Developer: Sonexa Therapeutics

Sonexa Therapeutics is just the latest biotech start-up that Eckard Weber has added to his entrepreneurial resume as a partner at Domain Associates. The biotech expert isn't saying much, but he's got great expectations for an early-stage drug Sonexa has in-licensed for Alzheimer's. With $30 million and a few skilled hands in charge of the "semi-virtual" company, Weber believes that Sonexa has the potential to become another winner for Domain--following a business model that has been pursued by more than a dozen companies started under Weber's wing.

"One of the things we do at Domain is that we look at therapeutic areas which we think are of a particular interest for potential investment and then we go out proactively to look for investment opportunities," Weber tells FierceBiotech. "That includes going out and looking for product opportunities all over the world. And if we find one, we buy or license the product and create a company around the product and make an investment." Article

Cell Therapeutics reorganizes, scales back R&D

Thu, 31 Jan 2008 06:59:58 -0500

Cell Therapeutics is scaling back its research plans for Xyotax and pixantrone, cutting one group of staffers and beefing up on the sales side as it concentrates on marketing its recently-acquired Zevalin cancer therapy. The move--designed to reduce operating expenses by 35 percent--leaves 31 staffers out of jobs, reducing its headcount to 133 after it fills 13 sales and marketing posts. The biotech says that they are still on track to file for European approval of Xyotax and evaluate pivotal data for pizantrone.

"We believe the best way to maximize shareholder value now is to focus our resources on our marketed and late-stage products," said James Bianco, president and CEO. "It is with great disappointment that we must reduce head count elsewhere in order to meet these goals."

- see this release
- read the report from the Seattle Times

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Phenomix outlines its shot at an IPO

Mon, 28 Jan 2008 06:59:57 -0500

Phenomix says now is the time to go public. The San Diego-based drug developer has filed papers with the SEC that outline an initial public offering designed to raise $86 million. Phenomix has development programs for type 2 diabetes as well as hepatitis C. Its lead program is a mid-stage DPP4 inhibitor. Its long list of venture backers include JP Morgan FUnds, Nomura Phase4 Ventures, Delphi Funds, Alta Partners Funds, Sofinnova Funds, Novartis Funds. Morgan Stanley, Credit Suisse, Oppenheimer & Co. and Pacific Growth Equities will underwrite. Phenomix was a 2007 Fierce 15 company.

- see this release
- here's the report from SoCalTech

Biocon CEO plans acquisition, spin-off

Thu, 17 Jan 2008 06:59:55 -0500

Biocon chief Kiran Mazumdar-Shaw says the Indian drug developer is close to completing a multimillion-dollar acquisition to push its products in North American and Europe and plans to spin off its clinical research group--Syngene--into a separately listed company. Shaw added that the spin-off should be completed this year.

"We believe Syngene has attained critical mass that can be leveraged to deliver a strong growth trajectory," says Shaw. "As one of Asia's largest and most profitable contract research companies, Syngene's public float can deliver superior shareholder value."

- read the article in the Hindustan Times

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UK biotechs feeling the chill from investors

Thu, 10 Jan 2008 06:59:58 -0500

One of the analysts at Seymour Pierce has been pondering the ice-cold attitude of investors to biotech stocks in the UK. Despite some big licensing news for the likes of Renovo, Antisoma and Oxford BioMedica in '07, Zhining Xu remarks that the British biotechs have dramatically underperformed. Other analysts note that while a host of biotechs are trading at a discount, they're likely to face some strong headwinds as they go back out this year to raise more money. It could be that investors just aren't patient enough to stick with a drug developer in the long dry spells between big announcements. Only nine of the 47 biotechs on the UK index made gains last year. Big losers: Vernalis, down 90 percent, and CeNeS, down 70 percent.

Still, says Xu, companies like Renovo, Antisoma and Oxford BioMedica may not be performing well, but they are positioned for a comeback. "All three of these companies have a solid cash position and have their lead programs covered by their partners so they are in a position to push ahead with early stage drug development projects," adds Xu.

- read the report from the Financial Times

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Europe moves to reclaim center stage

Fri, 21 Dec 2007 06:59:55 -0500

In Europe, venture money is typically harder to come by than in the U.S., but the continent still has some of the best scientific talent on the planet, often working at academic institutions that make groundbreaking discoveries a routine performance.

From a drug developer's perspective, Europe's single-payer systems have cast a constant shadow over earnings potential. But the pall hasn't stopped the industry in its tracks. If anything, the market obstacles have been spurring innovators to become more creative. That could be seen in the recent deal by Johnson & Johnson to guarantee the effectiveness of Velcade. And more recently there was a pact to include cost effectiveness in a late-stage trial for UK regulators. Given the focus on value-based medicine, where payers on both sides of the Atlantic are stepping up their demands on these expensive new therapies, this is one trend that won't be going away anytime soon. In fact, you can expect payers in the U.S. to pay particularly close attention and start issuing their own demands.

Anxious to revive drug development work in the continent, the industry has successfully pushed through one of the largest public/private initiatives the world has seen in drug discovery. Europeans are on the verge of authorizing a €2 billion partnership with pharma designed to fuel academic and industry research over the next seven years. The Innovative Medicines Initiative is expected to speed testing on safety and efficacy, the Holy Grail of goals among developers. This partnership could help open the tap of funds that would fuel the swift advance of the European biotechnology industry.

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Emerging Drug Developer: Ambit Biosciences

Fri, 14 Dec 2007 06:59:59 -0500

Emerging Drug Developer: Ambit Biosciences

Ambit Biosciences has taken another important step forward. In the middle of last month, CEO Scott Salka announced that it had garnered about $50 million in its fourth round. That money should be enough to get the company through 2009, a key transition period for Ambit. "We're expecting at least clinical proof of concept and completion of that milestone with one compound by the end of '09." Salka tells FierceBiotech, which named Ambit a Fierce 15 company in 2006. Article

Nabi explores "strategic alternatives"

Thu, 06 Dec 2007 06:59:56 -0500

Nabi Biopharmaceuticals has approved the repurchase of up to $65 million of the company's outstanding common shares in the open market or in privately negotiated transactions. The company said its pursuing the action in order to benefit shareholders.

What else is it doing to benefit shareholders? Exploring strategic alternatives, according to a release. "These future alternatives may include, but are not limited to, licensing or development arrangements; joint ventures or strategic alliances; the sale or merger of all or part of the company; and additional share repurchase programs or other distributions to our shareholders." Earlier this week the drug developer closed a $185 million sale of its biologics unit to Biotest. Times have been turbulent at Nabi. This year er the company cut 33 jobs and CEO Thomas McLain resigned shortly after reportedly working out a deal to accommodate a hedge fund investor that had been harshly critical of his performance.

- see Nabi's release

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Wyeth takes another look at antibody pact

Thu, 06 Dec 2007 06:59:54 -0500

In yet another sign of monoclonal antibodies' popularity among big drug developers, Wyeth has extend its evaluation of selected Raven Biotechnologies MAb antibodies. Raven, which signed a pact with Wyeth earlier this year, will receive an undisclosed milestone payment.

2007 hasn't been a pretty year for Wyeth. A string of woeful developments has left the company stripped of three of its leading drug candidates, and the drug developer could certainly use MAb technology to revive its pipeline. A new Datamonitor report projects 14 percent annual growth in the market for the antibody drugs, which mimic the body's own immune system. Raven was a 2003 Fierce 15 company.

- see this release for more

ALSO: Take a look at Wyeth's pipeline. Report

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Struggling GPC looking for merger or acquisition

Wed, 28 Nov 2007 06:59:58 -0500

Wanted: Private drug developer interested in partnering with struggling biotech specializing in cancer therapies. GPC Biotech essentially posted that message when its CEO announced that he is looking to partner up with a private biopharma player that would see extra value in the drug developer's listings in the U.S. and German markets. CEO Bernd Seizinger tells Financial Time Deutschland that he plans to stay on with the company as it tries to survive the late-stage failure of satraplatin. In recent days GPC has laid off almost half of its staff. Any alliance the company makes would focus exclusively on cancer therapies, he says. And Seizinger denies that he ignored warnings from the FDA when he pushed ahead with satraplatin. GPC has about $90 million in cash reserves.

- read the report from Thomson Financial

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