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FDA Requests More Erbitux Data

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Monday, 02 March 2009 21:38
NEW YORK (AP) -- Bristol-Myers Squibb Co. and Eli Lilly and Co. said Monday the Food and Drug Administration delayed a new marketing approval for their cancer drug Erbitux, asking for additional study data.

The companies are seeking approval to market Erbitux as a first-line, or primary, treatment for squamous cell carcinoma of the head and neck. But they said the FDA wants a new pharmacokinetic study, or one that evaluates how the body processes the drug. The FDA wants to confirm that clinical studies of Erbitux match the way it is marketed.

Erbitux is currently approved as a treatment for locally advanced squamous cell carcinomas of the head and neck in patients who are undergoing radiation therapy, or for patients whose disease has returned or progressed after chemotherapy. It is also approved to treat colorectal cancer.

The two companies market Erbitux through a partnership. Eli Lilly gained a stake in the arrangement after buying ImClone Systems Inc. in November.

Last month, the companies decided to withdraw an application asking to market Erbitux for advanced non-small cell lung cancer.

Eli Lilly shares fell to a 12-year low in Monday and closed at $27.75. Shares of Bristol-Myers Squibb lost 67 cents, or 3.6 percent, to $17.74 during the day. They fell 4 cents to $17.70 in aftermarket trading.

 

FDA Apporoval Delayed for Genzyme's Lumizyme

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Monday, 02 March 2009 21:34
CAMBRIDGE, Mass. (AP) -- Genzyme Corp. said the Food and Drug Administration is not yet willing to approve its drug Lumizyme, a treatment for the genetic disorder Pompe disease.

The FDA wants Genzyme to correct problems at a manufacturing plant before it will approve the drug, Genzyme said. The biotechnology company also needs to reach an agreement on the design of a study to test the drug's effectiveness after it is approved, and to finalize a strategy to evaluate Lumizyme's risks.

Genzyme said it worked closely with the FDA and was making progress toward those requirements, but was not able to complete them before the FDA was due to rule on Lumizyme.

The company said it is assuming a six-month delay before Lumizyme will be approved, trimming 2009 adjusted profit by about 12 cents per share. It now expects $370 million to $380 million in 2009 sales of its Pompe disease treatments, down from $430 million to $440 million.

Last month, Genzyme forecast profit of $3.50 per share for this year, or $4.70 per share excluding one-time items. Analysts have projected earnings of $4.72 per share, according to a Thomson Reuters poll.

Lumizyme and an older Genzyme drug, Myozyme, are both intended to treat Pompe, a disorder which interferes with muscle development and can cause deadly respiratory problems.

Myozyme is made in 160-liter bioreactors, and Lumizyme is made in 2,000-liter bioreactors. The FDA ruled the drugs were different enough that they required separate clinical trials to gain approval, and Genzyme decided to market Lumizyme under a separate name.

In aftermarket electronic trading, Genzyme shares sank $3.37, or 6 percent, to $53.15, having closed earlier down more than 7 percent at $56.52. During intraday trading, shares fell to $56.11, their lowest price since March 2005.

 

A Stem Cell Deal

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Monday, 02 March 2009 07:48

PALO ALTO, Calif. & LONDON--(BUSINESS WIRE)--StemCells, Inc. (NASDAQ:STEM - News) and Stem Cell Sciences plc (AIM:STEM) (ASX:STC - News) announced today that they have entered into a definitive agreement pursuant to which StemCells will acquire the operating subsidiaries and certain related assets of Stem Cell Sciences (SCS) for 2,650,000 shares of StemCells common stock and approximately $715,000 in cash. Stem Cell Sciences is a UK-based company focused on commercializing applications of stem cell technologies for drug discovery and regenerative medicine research.

 

StemCells, which is focused on the discovery and development of tissue-derived cellular products for therapeutic uses, will acquire upon completion of the acquisition: proprietary cell technologies relating to embryonic stem cells, induced pluripotent stem (iPS) cells, and tissue-derived (adult) stem cells; expertise and infrastructure for providing cell-based assays for drug discovery and screening, including automated robotic production and manipulation of stem and progenitor cells; patented gene insertion technology, with broad utility in drug screening and for applications in cell and gene therapy; the SC Proven® media formulation and reagent business, including the iSTEM®, 2i, 3i, Passaid™, HEScGRO™, and EScGRO™ proprietary media; a portfolio of over twenty patent families claiming a range of technologies relevant to cell processing, reprogramming and manipulation and gene targeting; and existing business and license relationships respecting SCS technologies entered into by several major life science companies, such as Merck and Millipore, among others.

 

“The industrial logic of this acquisition is compelling,” said Martin McGlynn, President and CEO of StemCells. “StemCells has established itself as a world leader in tissue-derived stem and progenitor cells for therapeutic uses, while Stem Cell Sciences has focused on non-therapeutic applications for embryonic and tissue derived stem cells, such as cell-based assays for drug discovery and screening. This proposed acquisition will combine three distinct stem cell platforms, adult, embryonic and iPS cells, for both therapeutic and drug discovery applications, and will position StemCells to diversify and pursue near-term commercialization opportunities while continuing to develop our cell-based therapeutic products.”

 

“StemCells, Inc. is the logical home for our businesses,” said Alastair Riddell, Chief Executive Officer of Stem Cell Sciences. “Our respective technologies and capabilities are highly complementary, and the Stem Cell Sciences Board is confident StemCells has the knowledge and resources to fully leverage these assets and realize their potential value.”

 

Terms of the Transaction

 

The transaction has been unanimously approved by the board of directors of each of the companies and is subject to customary closing conditions, including the approval of the shareholders of SCS in general meeting. Members of the SCS Board and other significant stockholders representing over 30% of the SCS shares outstanding have irrevocably agreed to vote in favor of the transaction. Approval by StemCells’ stockholders is not required.

 

Under the terms of the asset purchase agreement, StemCells will acquire substantially all of the operating assets and liabilities of SCS, including its research and development operations in Cambridge, UK and near Melbourne, Australia, and substantially all of its intellectual property portfolio. It is expected that most of SCS’ approximately 20 full-time current staff will remain with StemCells upon completion of the transaction.

 

As consideration for these assets, StemCells will, except as provided below, issue 2,650,000 shares of common stock to SCS. In addition, upon completion, StemCells will waive certain loan obligations of SCS to repay approximately $715,000 in cash made available by StemCells to SCS for its working capital purposes. The actual number of shares delivered to SCS at completion will depend on the acquired subsidiaries having at least an agreed-upon target amount of working capital. A portion of the consideration shares will be held in escrow for release in 12 months, subject to any claims for indemnification StemCells may make under the terms of the agreement.

 

The transaction is expected to close within two months, after which SCS expects to wind down its operations and distribute proceeds from the sale of the acquisition shares, less its transaction and wind-down expenses, to its stockholders.

 

About StemCells, Inc.

 

StemCells, Inc. is a clinical-stage biotechnology company focused on the discovery, development and commercialization of cell-based therapeutics to treat diseases of the central nervous system and liver. StemCells’ product development programs seek to repair or repopulate CNS and liver tissue that has been damaged or lost as a result of disease or injury. StemCells has pioneered the discovery and development of HuCNS-SC® cells, its highly purified, expandable population of human neural stem cells. In January 2009, StemCells completed a six patient Phase I clinical trial of its proprietary HuCNS-SC product candidate as a treatment for neuronal ceroid lipofuscinosis (NCL), a rare and fatal neurodegenerative disease that affects infants and young children. StemCells has also received approval from the US Food and Drug Administration (FDA) to initiate a Phase I clinical trial of the HuCNS-SC cells to treat Pelizaeus-Merzbacher Disease (PMD), also a rare and fatal brain disorder that mainly affects young children. StemCells owns or has exclusive rights to approximately 50 issued or allowed U.S. patents and more than 150 granted or allowed non-U.S. patents. Further information about StemCells is available on its web site at: www.stemcellsinc.com.

 

About Stem Cell Sciences plc

 

Stem Cell Sciences plc (SCS) is an international research and development company focusing on the commercial application of stem cell biology technologies for drug discovery and regenerative medicine research. SCS is now focusing on building revenues through the sale of products, collaborative research and licensing deals with international biotechnology and pharmaceutical companies. SCS has a substantial portfolio of patents and patent applications in both adult and embryonic stem cell fields. SCS has been active in the stem cell research field since 1994, principally focused on technologies to grow, differentiate, and purify adult and embryonic stem cells. These include technologies to permit the generation of highly purified stem cells and their differentiated progeny (specialized tissue cell types) for use in genetic, pharmacological and toxicological screens. Moreover, these technologies may be able to provide pure populations of appropriate cell types for transplantation therapies in the future. SCS has its main research base and headquarters in Cambridge, UK with a second research base in Monash near Melbourne, Australia.

 

Contact:

StemCells, Inc.

Rodney Young, 650-475-3100 ext. 105

Chief Financial Officer

irpr@stemcellsinc.com

Source: StemCells, Inc.

 

Big Pharma Goes Generic: Is Biotech Next?

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Friday, 27 February 2009 21:13
Sanofi-Aventis (SNY) is now the 11th largest generic drug maker in the world following its successful acquisition of Czech generic drug company Zentiva. As $70B in brand drug patents are set to expire through 2012, big pharma companies are hedging their bets through generic drug divisions, including Pfizer (PFE) - Greenstone, Novartis (NVS) - Sandoz, and the recently announced Merck (MRK) BioVentures which will specialize in bio-generics.
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Caraco Pharma Awaits FDA Inspection in May

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Friday, 27 February 2009 21:11

I spoke with the investor relations representative for Caraco Pharma (CPD) earlier this week and received some clarity on the expected timeline for resolving the major overhang on the stock price related to the FDA warning letter over Form 483 concerns by the agency stemming from quality control issues raised during an inspection of manufacturing facilities last year.

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Drugmakers' push boosts 'murky' ailment

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Monday, 09 February 2009 03:00

 
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