Executives

Medivation hands out big bonuses after Pfizer deal

Calisha Myers — Thu, 06 Nov 2008 10:09:31 -0500

San Francisco-based biotech Medivation will pay its top executives $1 million in bonuses for individual performance, achieving company goals and landing a partnership deal with Pfizer. Here's the breakdown according to the company's Securities and Exchange Commission report filed Wednesday: CEO David Hung will receive $413,435, which includes an "extraordinary bonus" of $100,100 for the Pfizer deal; CFO Patrick Machado and Chief Medical Officer Dr. Lynn Seely will each get $290,000, which also includes the same $100,000 for the Pfizer partnership.

The SEC filing also revealed exec salaries for the 2009 fiscal year. Effective January 1, 2009, Hung will receive $570,000; Machado and Seely will both receive $365,000.

Medivation and Pfizer inked a $725 million partnership in early September. The development and commercialization deal is for Dimebon, a late-stage treatment for Alzheimer's and Huntington's disease. Pfizer will pay $225 million upfront and up to $500 million more in milestones. The two companies will share development and commercialization costs in the U.S., with Pfizer assuming a larger portion of the expenses and profits in a 60-40 split.

Medivation stock jumped 31 percent to a high of $34.40 on news of the Pfizer deal back in September. It closed Wednesday at 18.45 a share.

- check out the San Francisco Business Times article

Shareholders stymie VaxGen, Raven merger

Fri, 28 Mar 2008 07:59:57 -0400

VaxGen and Raven Biotechnologies are backing out of their proposed merger after "stronger than anticipated opposition" from shareholders. The companies say that while they initially thought shareholders would go for the deal, it became apparent that they'd reject the plan. VaxGen develops drugs for the treatment and prevention of infectious disease, and Raven develops monoclonal antibody (MAb) therapeutics for cancer. Company officials hoped that the merger would put them at the forefront of the market for MAb cancer treatments.

"We are obviously very disappointed that the proposed merger with Raven was not approved by our stockholders," said James P. Panek, VaxGen President and CEO. "...[I]t has become quite clear that there is sufficient opposition, such that this merger will not be approved." The merger rejection is more bad news for VaxGen, which has been through three rounds of layoffs since the federal government canceled its $877 million anthrax vaccine contract.

- check out this release

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SGX shares slide on report of early-stage toxicity

Thu, 27 Mar 2008 07:59:58 -0400

Shares of SGX Pharmaceuticals were sliding this morning on the news that its lead cancer therapy produced unexpected dose-limiting levels of toxicity in early-stage trials. The company said that it was surprised by the toxicity in SGX523 after a careful evaluation of animal data revealed no such tendency. And company officials carefully noted that they're examining other dosing regimens while pursuing the development of additional cancer therapies in its pipeline.

Patients in a low-dose trial of SGX523 involving solid tumors continue to be treated while no further dosing is being provided in an interrupted dosing trial--a repeating 21 day cycle of 14 days on therapy followed by 7 days off.

"From the initial clinical data, the profile of SGX523 appears to be different than the preclinical data would suggest," said Mike Grey, president and chief executive officer of SGX Pharmaceuticals. "We may explore whether alternative doses and schedules are safe and efficacious. We continue the preclinical development of the BCR-ABL inhibitor SGX393 and the second MET inhibitor SGX126. In addition, we are targeting the identification of two development candidates this year from our drug discovery programs to further enhance our pipeline."

- check out the press release

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Novo Nordisk shelves inhaled insulin, axes staffers

Tue, 15 Jan 2008 06:59:58 -0500

There's another big loser in the inhaled insulin game. Shares of Novo Nordisk were trimmed more than four percent after the Danish developer announced it was dropping its short-acting AERx insulin inhaler after coming to the conclusion that it had little commercial value and was no better than injectable insulin. The AERx inhaler was in late-stage trials.

Company officials said they would trim hundreds of jobs and write off $260 million as a result of the move. Pfizer dropped Exubera last fall after the inhaled diabetes product failed to live up to, or even get close to, a much heralded blockbuster status. Novo says it will continue to develop other experimental inhaled diabetes therapies. That's not likely to be any consolation to Novo's workers at its Hayward, CA facility, where about 300 employees face the axe.

- see Novo's release
- read the report from Dow Jones

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China launches drug recall system

Wed, 12 Dec 2007 06:59:54 -0500

Lately, not a week passes without China's trumpeting a new drug-safety initiative, and this week is no exception. Now, the country says it's launching a nationwide drug recall system. The news comes on the heels of a drug-and-device safety pact with the U.S., signed into being just yesterday. The recall plan will force pharma companies to withdraw problem products within 24 hours if they pose major safety concerns. If companies voluntarily recall bad drugs, they may escape fines and other punishments.

Meanwhile, China has also cracked down on the manufacturer of a tainted leukemia drug by pulling its production license. Shanghai Hualian Pharmaceutical also saw revenues from the drug seized, and company officials were taken into custody.

- check out the AP article
- read more on Shanghai Hualian's punishment

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Pfizer's future rests with biotech

Maureen Martino — Thu, 13 Sep 2007 11:00:07 -0400

At this week’s Bear Stearns Healthcare Conference, Pfizer discussed its plans for the future with analysts. As we all know, Pfizer is facing a major loss of sales when its best-selling drug Lipitor goes off patent in 2010. This wasn’t a major cause for concern until January, when Pfizer abandoned development of Torcetrapib due to concerns about mortality and cardiovascular events. Torcetrapib was slated to replace Lipitor, and the stunning loss of the progam left a gaping hole in Pfizer’s pipeline. In addition to concerns about Lipitor, both Viagra and Geodon, a schizophrenia therapy, will be faced with generic competitors by 2014. All told, Pfizer has to find a way to replace an annual $19 billion in sales when these drugs go off patent.

So how is Pfizer planning to deal with this loss? Company officials told analysts that Pfizer would increase its focus on biologics, which are much more difficult to make generic copies of. Lawmakers and healthcare professionals both here and abroad have embraced generic pharmaceuticals, which are relatively easy for generic drugmakers to produce. But Congress and the FDA have been slow to greenlight a faster approval process for generic biologics (on the other hand, the EMEA has had a regulatory pathway in place for almost three years). Pfizer has already announced a plan to invest $10 million a year for the next five years to help start-up biotechs in San Diego. Expect to see Pfizer snapping up biologics from smaller drug developers and investing more money in biotech companies in the months and years to come.

- read the Motley Fool article for more

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Pharming steps up marketing plans on Phase III data

Thu, 30 Aug 2007 06:59:58 -0400

Pharming says that its Phase III trial for Rhucin--a human protein developed to treat acute attacks of hereditary angieoedema--has hit its targets, opening the way to European and U.S. markets as the company pursues regulatory approvals on both sides of the Atlantic. With experts at the EMEA expected to give a thumb's up to Rhucin late this year, company officials reportedly believe that they are hot on the trial of a U.S. partnership deal that should include a substantial upfront payment. If all goes according to plan, Pharming tells the wire services, it will launch its therapy--derived from rabbit's milk--in Europe in the first half of '08. And FDA marketing application is expected later this year with an approval coming soon enough to launch in the U.S. soon after the therapy is introduced in Europe. Rhucin would be the second transgenic therapy to hit the market, and Pharming believes it has the potential to earn up to $820 million a year.

- check out the release on Pharming's Phase III

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IDM shares plunge on FDA's rejection

Mon, 27 Aug 2007 06:59:57 -0400

The FDA has turned thumbs down on IDM Pharma's mifamurtide, which was developed to treat a rare form of bone cancer. The agency is looking for more clinical data, says IDM, adding that company officials anticipated that move last July. Of course, IDM got a strong signal on their chances in May, when an advisory committee voted the drug down, saying the application was light on efficacy data. The company adds they'll be able to respond to the agency's demands by the first quarter of next year. It expects that the supplemental information and an amended NDA will prevent any demands for a new trial.

That wasn't enough to assuage many investors, who saw the value of IDM shares drop 25 percent on the news. The drug, formerly called Junovan, targets the often fatal non-metastatic osteosarcoma, which primarily afflicts children and young adults.

- see this release
- here's the report from RTT News

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Ception Therapeutics pockets $63M in third round

Mon, 29 Jan 2007 19:01:37 -0500

Ception Therapeutics has rounded up $63 million in its third round of venture capital, with Essex Woodlands Health Ventures leading the way. Ception, which is based in Malvern Hill, PA, says that much of that money will be used to advance a late-stage biologic compound in clinical development for multiple inflammatory conditions, a small molecule anti-TNF program and other discovery programs. Investor Growth Capital, MDS Life Sciences Technology Fund II, New Science Ventures and Aperture Venture Partners all participated as investors.

- here's the release on the round

ALSO: Canada's Osprey Pharmaceuticals has garnered $9 million in financing, including $3 million in venture debt. Much of that is earmarked for early clinical trials of its lead product candidate, OPL-CCL2-LPM, for patients with chronic kidney disease. Release

PLUS: Abingworth has announced the closing of its $587 million life sciences fund, Abingworth Bioventures V. Company officials say the fund is the largest ever raised in Europe for the life sciences field. Release

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Astellas faces FDA delay on reformulated Prograf

Tue, 23 Jan 2007 19:01:36 -0500

The FDA has issued a nonapprovable letter to Japan's Astellas Pharma for a new formulation of its drug Prograf for heart transplant patients. But the agency also said that the drug was approvable for liver and kidney patients while asking for additional information before a final decision is made. That delay sent shares of Astellas down more than five percent, although company officials said they had not given up hope of an approval. The patent on Prograf, which earned $1.4 billion last year, expires in 2008. One analyst noted that if Astellas ended up with an approval for kidney and liver patients the company would be able to protect its market share.

- here's the release on Prograf from Astellas

ALSO: Kirin Brewery and Astellas have inked a deal to collaborate on the development of an anti-CD40 antagonistic monoclonal antibody. Release (.pdf)

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Genaera cans AMD therapy, slashes staff

Wed, 03 Jan 2007 19:01:38 -0500

Genaera will cut its staff by 30 percent as it shutters its development program for Evizon, an experimental therapy that has been in mid-stage trials for wet age-related macular degeneration. Genaera reported disappointing results from the most recent mid-stage study. Company officials announced that Genaera now plans to shift its focus to trodusquemine (MSI-1436), a new obesity drug in Phase I as Banc of America Securities is brought on to explore "strategic alternatives."

"This restructuring is a fundamental shift in direction for Genaera, but represents the best match of our development programs to the new realities of the marketplace," said Zola Horovitz, the board's lead director. "By re-focusing resources from the Evizon development program, Genaera has the opportunity to bring trodusquemine forward and address a significant market opportunity in the treatment of obesity."

- check out the company's press release on the decision
- here's the UPI report on Genaera

Acambis shares plunge after U.S. nixes contract

Mon, 13 Nov 2006 19:01:38 -0500

Shares of Acambis took a beating after the company announced it was no longer in the competition for a U.S. contract to provide smallpox vaccine. Its stock plunged 39 percent after company officials said it was no longer being considered. Acambis said that it would arrange a meeting with government officials to "seek clarification." "We are surprised that the U.S. government would eliminate Acambis," CEO Gordon Cameron said. "We believe that our proposal would have met the requirements."

- here's the International Herald Tribune report on Acambis

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Tm Bioscience posts "for sale" sign

Mon, 13 Nov 2006 19:01:34 -0500

Tm Bioscience, a Toronto-based developer of DNA-based genetic tests, is exploring a possible sale or merger. Company officials say they've been approached by interested parties, making it an "ideal time" to explore its options. They're showing every sign of looking for the best terms they can get, touting their revenue from existing tests and a pipeline of new products.

- read the report from The Globe and Mail for more

Avanir slashes jobs, puts Zenvia on ice

Thu, 09 Nov 2006 19:01:35 -0500

Hammered by the FDA's demand for more data on Zenvia, an experimental drug for involuntary emotional expression disorder (IEED), Avanir Pharmaceuticals has halted commercial development of the drug and cut its workforce by 16 percent. Avanir's stock price has plunged about 80 percent this year, and company officials said they were cutting their burn rate to $10 million a quarter.

"These cost reduction actions and the recently announced financing will provide financial flexibility for the company while determining the future opportunity for Zenvia," said Eric K. Brandt, CEO of Avanir. "We believe in the therapeutic potential of Zenvia to provide relief for this unmet medical condition. I have personally had the pleasure of talking to IEED patients and their caregivers about the life-changing effect the drug candidate Zenvia has had on patients' lives in our clinical trials. We will provide an update on this program once we process the feedback from our planned meeting with the FDA."

- see the release on Avanir's restructuring

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New trial for CytoFab as investors urge action

Thu, 02 Nov 2006 19:01:38 -0500

AstraZeneca is planning a new mid-stage trial of CytoFab for severe sepsis which will take 21 months to complete. The prospect of a delay for CytoFab hammered the share price of the UK's Protherics, which licensed the drug to AstraZeneca 11 months ago in a deal valued at up to $372 million. The move could delay AstraZeneca's plans to launch a Phase III trial in 2007, which would delay a potential market launch. But company officials cautioned that a successful new mid-stage trial could significantly reduce the amount of time it would take to complete final testing. Analysts were cautious about this latest news from AstraZeneca, which has had a string of disappointing trials and faces a difficult task in proving the effectiveness of a new therapy for severe sepsis.

- here's the AFX report on AstraZeneca

ALSO: Big shareholders in AstraZeneca say that its recent clinical trial failures will require the UK-based developer to start investing its $4 billion in cash reserves in new acquisitions to rebuild a severely depleted pipeline. CEO David Brennan is reportedly set to meet with stockholders to review the company's plans and get their advice, according to The Times of London. If they do decide to go on the acquisition trail, they'll likely run into some heavyweight competition. Merck's $1.1 billion Sirna buyout--which includes a hefty premium for shareholders--has spurred talk that valuations in biotechnology have soared. That will leave AstraZeneca in a bidding war with other drug developers equally determined to gain control of promising new therapeutics. Article

Related Article:
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Cephalon shares tank after Sparlon rejection

Wed, 09 Aug 2006 20:01:39 -0400

Cephalon's last bid to gain approval for its ADHD drug Sparlon was rejected by the FDA and the news helped push its shares down 12 percent in early trading. The FDA's formal rejection was heavily influenced by its concern that the drug may have caused a case of Stevens Johnson syndrome, a rare and deadly skin disorder. That same link was enough for an FDA expert committee, which had rejected Sparlon by a vote of 12 to 1. Sparlon is marketed as a therapy for narcolepsy under the brand name of Provigil. Company officials said they were disappointed by the FDA's position, noting that their own experts disagreed with the regulators' conclusion.

- read the article on Cephalon from MarketWatch

FBI agents raid BMS office in deal probe

Thu, 27 Jul 2006 20:01:38 -0400

FBI agents raided the office of Bristol-Myers Squibb CEO Peter Dolan as part of its investigation into a $40 million deal to stave off generic competition to the blood thinner Plavix. Bristol-Myers and Sanofi-Aventis, which both hold marketing rights on Plavix, agreed to give Apotex $40 million in exchange for its agreement to hold off on a generic competitor until 2011. Plavix, with nearly $6 billion in revenue last year, is the world's second-highest selling therapeutic. It was not immediately clear what caused the Federal Trade Commission to launch the probe. There is no prohibition against deals such as this, though company officials would have to steer clear of sharing pricing information or other confidential data. Dolan said the company is cooperating.

- here's the article on the probe from The Wall Street Journal (sub. req.)

Schwarz wins approvable letter for Parkinson's

Tue, 28 Feb 2006 19:01:36 -0500

Germany's Schwarz Pharma has earned an "approvable" letter from the FDA for its Neupro patch to treat early-stage Parkinson's. Schwarz will have six months to respond to the letter, which outlines additional data being sought for a treatment. That letter, though, hasn't dampened Schwarz's enthusiasm for Neupro, which won European approval last week. Company officials say they expect a U.S. launch, but evidently not this year as they had hoped. The patch delivers a steady dose of rotigotine throughout the day.

- read this AFX report for more information

FDA asks for new Phase III trial of Genelabs' Prestara

Thu, 12 Jan 2006 19:01:38 -0500

The FDA has told Genelabs Technologies that it will have to mount a new Phase III trial of its lupus drug Prestara before it can be approved, spurring the biotech company to signal its need for a collaborator to finance the work. Genelabs said it doesn't have the money needed to mount a new pivotal trial of the drug, which earned an "approvable" letter in 2002. As a result, company officials announced that they would either need a partner to sign on or would consider discontinuing or delaying further research into Prestara. Genelabs had been seeking FDA approval for the drug as a therapy used to prevent the loss of bone mineral density in women with the disease. It now says that seeking FDA approval as a therapy for the signs and symptoms of the disease would be more viable.

- read this release for more

Glycotex withdraws IPO

Tue, 10 Jan 2006 19:01:37 -0500

Glycotex, the U.S. subsidiary of Novogen, has withdrawn its initial public offering. Company officials say that they want Glycotex to push its wound healing and tissue repair drugs further along before proceeding with an IPO.

- read this release for more

ALSO: Altus Pharmaceuticals has priced its IPO of 6 million shares at $14 to $16 a share. Report