darmstadt germany

Struengmanns to invest in German biotech firms

John Carroll — Thu, 21 Aug 2008 10:57:43 -0400

Twin brothers Thomas and Andreas Struengmann made a fortune selling their generic drug business back in 2005. Now they plan to invest a good bit of their money in Germany's biotech industry. In an interview with a German magazine, manager magazin, the Struengmanns outlined plans to invest 500 million euros in the country's biotech businesses. And they made it clear that they favor strong, family-owned companies to invest in. The twins already own stakes in 10 German biotechs that concentrate on new cancer therapies.

"We want to create something new, as we did with Hexal," says Thomas Struengmann.

--read the AFX report

Novartis, MorphoSys ink $1B antibody deal

Mon, 03 Dec 2007 06:59:58 -0500

There's fresh evidence this morning that antibodies remain one of the hottest commodities in biotechnology. Novartis has extended its antibody development deal with Germany's MorphoSys, agreeing to pay $60 million a year in R&D support along with technology access fees and up to $400 million in milestone payments. Investors loved the major league endorsement of MorphoSys, sending its shares up 32 percent. Novartis gains access to MorphoSys' library of antibodies, expanding a pact that was originally signed three years ago. The pharma giant also gains an option to extend the deal by another two years. Analysts applauded the deal and seemed particularly enthusiastic about the length of Novartis' commitment.

- see the release on the deal
- check out the AFX report for more

ALSO: MorphoSys used the attention garnered by the announcement to say that much of the money it gains from Novartis will go into developing its own pipeline. Report

PLUS: Read more about Novartis' pipeline. Report

Related Articles:
Novartis bankrolls a drug manufacturing revolution. Report
Novartis makes the "Biggest Splash." Report
Lagging sales spur Novartis layoffs. Report
Novartis plots $700M biotech plant. Report

Troubled GPC cuts staff, looks for M&A deals

Thu, 15 Nov 2007 06:59:58 -0500

The failure of GPC Biotech's cancer drug satraplatin in a Phase III trial is being paid for with the jobs of 44 percent of its workforce. PC announced late last week that it needed to significantly cut back to account for the setback. Now the company says it will concentrate "internal efforts on a limited number of development-stage oncology projects, significantly increasing our licensing efforts and actively exploring M&A opportunities." Sixty workers in Germany and 43 more in Princeton are getting pink slips. The remaining staff of 114 will be about evenly split between Germany and Princeton after GPC's Waltham, MA facility is closed.

"Our goal of having approximately two years of operating cash on hand at the end of 2007 has sadly necessitated very significant staff reductions on both sides of the Atlantic," says CEO Bernd R. Seizinger.

- see this release
- read the AFX report for more

Related Articles:
GPC Biotech reports Q3 results, layoffs. Report
GPC shares crater on Phase III cancer failure. Report
FDA delay forces cutbacks at GPC Biotech. Report
GPC yanks FDA application for satraplatin. Report
FDA questions satraplatin. Report
Top 5 layoffs of 2007. Report

ALSO NOTED: Ventana and Roche forge confidentiality agreement; Rigel wins $3M payment; and much more...

Wed, 14 Nov 2007 06:59:50 -0500

> Ventana Medical Systems and Roche have made nice over a confidentiality agreement, raising the prospects of a takeover. One analyst says that Ventana would likely fetch more than $87 a share. Report

> Rigel Pharmaceuticals will pocket a $3 million payment with the announcement that Merck Serono has exercised its option to add the Japanese territory to its current Aurora kinase collaboration that includes the lead product, R763/AS703569. Release

> ThromboGenics has launched pre-clinical trials on its cancer antibody VPAC. Report

> A team of researchers from the U.S. and Germany has found that community associated MRSA, a particularly virulent strain of staph infection, creates a peptide that causes immune cells to burst. Report

> Sanofi-Aventis just got slapped with a class-action lawsuit on behalf of an institutional investor over Acomplia's FDA rejection. Report

> A synthetic compound developed in the lab at UT Southwestern Medical Center mimics the cellular protein Smac, broadcasting a message to cancer cells that triggers their destruction. Report

> One foundation isn't please with a spoof of Glaxo's restless leg syndrome ad. Report

And Finally... Scientists at the Oregon National Primate Research Center are on the verge of announcing that they have developed a new technique for cloning embryos from adult monkeys. Report

Antisense Pharma lands $38M in VC

Fri, 09 Nov 2007 06:59:56 -0500

Germany's Antisense Pharma has landed €27 million ($38 million) from the VC-funds of MIG Fonds, a fund initiator of closed-end venture capital funds that raises capital for and invests in private companies. Antisense said it will use the round to further development of its lead compound AP 12009, which is currently in Phase II. Preparations for a 2008 Phase III trial are under way.

"We are concentrating our research and development activities on cancer indications with particularly high unmet medical need. The lead compound AP 12009 has exceeded by far our expectations in the international Phase II clinical trial," explained Dr. Karl-Hermann Schlingensiepen.

- check out the release for more

GPC shares crater on Phase III cancer failure

Wed, 31 Oct 2007 07:59:58 -0400

Germany's GPC Biotech saw its already battered stock price crater this morning after announcing that its experimental prostate cancer drug, satraplatin, failed to help patients live longer in a critical late-stage trial. GPC announced it was cutting its workforce by 15 percent to account for the trial disaster, which sliced 65 percent off of its remaining stock value.

The vultures had already been gathering around satraplatin after GPC and its partner, Pharmion, announced that they were withdrawing their FDA application until survival data was in. The data is also expected to have an impact on their European regulatory filing. In the trial, patients taking the therapy in combination with prednisone lived an average of 61.3 weeks compared to 61.4 weeks for the control group. That kind of survival response would not pass muster with regulators. Researchers say they will evaluate how they plan to proceed with the cancer program.

"We are extremely disappointed with the findings,'' said GPC Chief Executive Officer Bernd Seizinger in an understatement of the week. One analyst noted that the company's business model is somewhat "unclear" after the results were announced.

- see this release from GPC
- here's the report from MarketWatch

Related Articles:
FDA delay forces cutbacks at GPC Biotech. Report
GPC yanks FDA application for satraplatin. Report
FDA questions satraplatin. Report
Shares surge as satraplatin succeeds in Phase III. Report
Pharmion signs $270M licensing deal for GPC's satraplatin. Report

Direvo pockets $17M in investment round

Thu, 18 Oct 2007 06:59:55 -0400

Germany's Direvo Biotech, a protein engineering company, has raised $16.8 million in its third round. Part of that money is being earmarked for its collaboration and research programs in therapeutic proteases and antibodies. A big group of investors participated in the round, including Danisco Venture A/S, Copenhagen, S-Equity Partner, Cologne, Mulligan BioCapital, Hamburg and funds managed by New York based Signet Healthcare Partners, as well as private investors such as Nobel laureate Prof. Manfred Eigen.

- see this release for more info

ALSO: Ikonisys has raised $30 million to advance its work in diagnostics. Release

Read more on: Venture capital news

Evotec adds drugs in Renovis buyout

Wed, 19 Sep 2007 06:59:58 -0400

Germany's Evotec is boosting its pipeline to five compounds with the acquisition of Renovis for $152 million in an all-stock transaction. An insomnia drug is slated to begin a human clinical trial by the end of next year. Evotec says it will seek a NASDAQ listing for the merged operation, which should help it buy out more drug developers.

"By combining Evotec's drug discovery and development know-how with Renovis' medicinal chemistry and target validation expertise, we expect to form a global biopharmaceutical company with world-class discovery capabilities," said Evotec Chief Executive Jorn Aldag.

- see the release on the buyout
- read the report from the International Herald Tribune

Related Articles:
Evotec shutters Alzheimer's development program. Report
Evotec touts early data. Report
Renovis pares work force in restructuring. Report
Renovis, Pfizer to collaborate on pain research. Report

DEALS: Isis, Alnylam form RNAi company

Thu, 13 Sep 2007 06:59:52 -0400

Isis, Alnylam form RNAi company

DEALS
WHO	WITH	WHAT	SCOOP
Alpharma	IDEA	$202 licensing deal	Alpharma has agreed to pay Germany's IDEA up to $202 million in upfront fees and milestones for the U.S. rights to the late-stage pain drug Diractin, a prescription topical NSAID.
Nabi Biopharmaceuticals	Biotest	$185M sale	Nabi Biopharmaceuticals plans to sell its biologics unit to Germany's Biotest for $185 million.
Boehringer Ingelheim	Ablynx	$103.5M partnership	Boehringer has signed a second agreement with Ablynx to develop and commercialize up to 10 different Nanobody therapeutics.
Medivation	Azimuth Opportunity	$100M stock deal	VC firm Azimuth Opportunity will purchase $100 million of Medivation's stock over the next 18 months as the drug developer pushes through a late-stage trial of an experimental Alzheimer's drug.
Meda	BioDelivery Sciences	$90M licensing deal	Meda will pay BioDelivery up to $90 million in exchange for a licensing deal covering the North American rights to BEMA Fentanyl, a new pain patch for cancer patients.
Ventana Medical Systems	Spring BioScience	$31M acquisition	Ventana Medical Systems has inked a deal to acquire Spring BioScience, which makes rabbit monoclonal antibodies and other reagents.
Isis Pharmaceuticals	Alnylam Pharmaceuticals	Company formation	Isis and Alnylam have teamed up to form Regulus Therapeutics, a company that will focus on developing new drugs based on micro-RNA.

Nabi sells unit for $185M, plans Maryland move

Tue, 11 Sep 2007 06:59:55 -0400

Nabi Biopharmaceuticals plans to sell its biologics unit to Germany's Biotest for $185 million. Biotest gains a headquarters facility in Boca Raton, a plasma protein plant, Nabi-HB Hepatitis B immune globulin, and nine plasma centers. Nabi plans to move its headquarters to Rockville, MD, which is bound to draw cheers from Maryland's economic development officials.

- check out this release from Nabi

Related Articles:
Nabi CEO walks after hedge fund balks. Report
Nabi vows to push ahead with vaccine work. Report
Nabi's StaphVax fails late-stage study for infections. Report
Despite company losses, Maryland CEOs enjoy a payday. Report

FDA delay forces cutbacks at GPC Biotech

Thu, 23 Aug 2007 06:59:58 -0400

Struggling to overcome FDA hurdles for its cancer drug satraplatin, Germany's GPC Biotech says it will slash its staff by 15 percent and ratchet down research and development costs. An FDA advisory committee opted to delay approval until the company can deliver final data on patient survival, which GPC has estimated would take six months. To survive the delay, the biotech is handing out 46 pink slips among its 316 employees. GPC licensed satraplatin five years ago, agreeing to take on development and regulatory costs. As part of the restructuring, GPC says it will slow down--for a while anyway--its work on its 1D09C3 monoclonal antibody and cell cycle inhibitors.

As part of a planned succession, Dr. Martine George is succeeding Dr. Marcel Rozencweig as senior vice president of drug development and chief medical officer. Dr. Rozencweig will remain with the company in the new role of senior vice president, clinical science and drug evaluation.

- check out the release

Related Articles:
GPC yanks FDA application for satraplatin. Report
FDA questions satraplatin. Report
Shares surge as satraplatin succeeds in Phase III. Report
Pharmion signs $270M licensing deal for GPC's satraplatin. Report

SPOTLIGHT: Sonic buys Bioscientia

Mon, 13 Aug 2007 06:59:53 -0400

Bioscientia, one of the largest diagnostics companies in Germany, has been acquired by Sonic Healthcare, which valued the company at €190 million. BioScientia operates 15 regional labs in Germany and other hospital-based facilities. The company was spun off by Ingelheim in 1995. Sonic Healthcare says the deal greatly enhances the company's global reach. Report

Pevion gains $30.2M in first round

Fri, 10 Aug 2007 06:59:55 -0400

Germany's Pevion Biotech has landed a $30.2 million Series A private financing round. The round was led by the new investor BZ Bank Aktiengesellschaft. BB Biotech Ventures II, CC Private Equity Partners and Bachem Holding also participated. Pevion has three of its vaccines in clinical testing. The company said it will use the funds to push a hepatitis C and breast cancer vaccines into Phase II. It will also fund preclinical vaccine candidates against RSV and Candida infections into clinical development.

- see the release

SPOTLIGHT: GPC hit by high R&D costs

Wed, 08 Aug 2007 06:59:53 -0400

Germany's GPC Biotech announced wider losses as a result of the expense of developing its prostate cancer therapy Satraplatin. A recent delay in gaining FDA approval of the drug sent GPC shares tumbling. Release

SPOTLIGHT: Hikma buying Ribosepharm

Tue, 23 Jan 2007 19:01:33 -0500

Hikma Pharmaceuticals is buying Germany's Ribosepharm for $45 million in cash. Ribosepharm markets injectable generic oncology drugs. Report

Press Release: Archemix Corporation And Merck KGaA To Collaborate On Aptamer-Based Cancer Therapeutics

Maureen Martino — Thu, 18 Jan 2007 09:10:01 -0500

Archemix Corporation And Merck KGaA To Collaborate On Aptamer-Based Cancer Therapeutics; Archemix Will Receive As Much As $10 Million

CAMBRIDGE, Mass., Jan. 17 -- Archemix announced today that it has signed a multi-year, multi-target agreement with Merck KGaA of Darmstadt, Germany, that focuses on the discovery, development, and commercialization of first-in-class aptamer-based therapeutics to treat cancer.

Under terms of the agreement, Archemix will receive an upfront payment and committed research funding of as much as $10 million. Archemix also could receive milestones and royalty payments for products successfully commercialized under the collaboration. In addition, Archemix may participate in the co-promotion of products that result from the collaboration. Other financial terms were not disclosed.

Dr. Errol De Souza, President and Chief Executive Officer of Archemix, commented: "Merck is a recognized global leader in oncology drug development and marketing, and we are excited to be working with them to apply our scientific expertise in developing novel aptamer therapeutics for cancer. This alliance is the fourth major partnership we have formed over the past six months and is consistent with our strategy to enable partners to leverage aptamers as drugs on a target-by-target basis."

"Archemix is the leader in the field of aptamers, a new class of drugs that has tremendous potential in the battle against cancer," said Dr. Bernhard Kirschbaum, Executive Senior Vice President and Director of Research for Merck Serono. "We hope this collaboration will further our efforts to provide physicians and oncology patients with innovative, targeted cancer treatments."

About Aptamers

Aptamers are single-stranded nucleic acids that form well-defined three dimensional shapes, allowing them to bind target molecules in a manner that is conceptually similar to antibodies. Aptamers combine the optimal characteristics of small molecules and antibodies, including high specificity and affinity, chemical stability, low immunogenicity and the ability to target protein-protein interactions. In contrast to monoclonal antibodies, aptamers are chemically synthesized rather than biologically expressed, offering a significant cost advantage.

About Archemix Corp.

Archemix Corp. is a privately-held biopharmaceutical company based in Cambridge, Massachusetts. The company's mission is to develop aptamers as a class of directed therapeutics for the prevention and treatment of human disease. Because of their unique properties and proven efficacy, aptamers offer an alternative to biologics and small molecules in numerous applications and offer the potential to be a major class of drugs for the treatment of unmet medical needs.

Archemix's aptamer expertise is complemented by a robust patent estate comprised of over 220 issued and 230 pending patents covering the identification, composition, and use of therapeutic aptamers. In addition to the company's core aptamer generation technology, Archemix possesses strong expertise in both pre-clinical and clinical drug development. Further information on Archemix can be found at http://www.archemix.com.

About Merck

Merck is a global pharmaceutical and chemical company with sales of EUR 5.9 billion in 2005, a history that began in 1668, and a future shaped by about 35,000 employees in 56 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds a 73% interest and free shareholders own the remaining 27%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.

For more information about Archemix or aptamers, or to speak with Dr. De Souza, please contact Davia Temin of Temin and Company at 212-588-8788 or news@teminandco.com.

Press Release: 4-Antibody Closes CHF $18.5 Million Series A Financing

Maureen Martino — Tue, 16 Jan 2007 11:56:51 -0500

4-Antibody Closes CHF 17 Million Series A Financing, Bringing the Total Series A Financing to CHF 23 Million ($18.5 Million)

BASEL, Switzerland | Jan 15, 2006 | Advent Venture Partners, Life Science Partners (LSP) and BioMedinvest today announced the completion of a CHF 17 Million Series A financing of 4-Antibody AG. This closing was led by new investor Advent Venture Partners (UK), together with existing lead investors Life Sciences Partners (LSP, The Netherlands) and BioMedinvest AG (Switzerland). All other existing investors; Grazia Equity (Germany), Mulligan Biocapital (Germany) and several private investors also participated

4-Antibody AG is focused on exploiting its 4mAb(TM) proprietary platform to improve existing antibodies and to discover de- novo fully human antibodies. Proceeds will be used to accelerate the discovery and development of novel therapeutic monoclonal antibodies.

"The success of our Series A financing is a recognition of the potential of our proprietary 4mAb(TM) platform to generate novel fully human antibodies against a broad range of disease targets. We are very pleased to be able to attract Advent Venture Partners, a top tier Life Sciences investor, complementing our existing investor syndicate. We are now well positioned to build on our product pipeline and to accelerate our fast follower monoclonal antibody programs" said Sijmen de Vries, CEO of 4-Antibody AG.

Raj Parekh, General Partner at Advent Venture Partners commented:

"The 4mAb(TM) technology has the potential to become an industry standard to increase the potency and specificity of human monoclonal antibodies designed for therapeutic use. We are very pleased to support the company."

About 4-Antibody AG

4-Antibody AG is a Basel-based privately owned company, with a wholly owned subsidiary in Jena, Germany. 4-Antibody owns a novel and proprietary technology platform (4mAb(TM)) for the development and/or optimization of fully human antibodies. For more information about 4-Antibody, please visit our website at http://www.4-antibody.com.

About Advent Ventures

Advent Ventures is one of the most experienced technology venture capital firms in the UK. Established in 1981 it invests in both the Life Science and Information and Communications Technology sectors. Advent Ventures has over GBP500 million (US$ 900m) under management from institutional investors across Europe and the USA. It has backed around 60 life science companies of which, to date, 19 have obtained public listings. Recent investments by the Advent Life Sciences team include Norwegian radiopharmaceuticals company, Algeta; the US speciality pharma company, CardioKine Inc; the US medical services company NeoGuide and UK-based Thiakis which develops hormone-based treatments for obesity. For additional information please visit: www.adventventures.com

Press Release: Erbitux Phase III Study Meets Primary Endpoint In First-Line Treatment Of Metastatic Colorectal Cancer

Maureen Martino — Wed, 10 Jan 2007 10:45:27 -0500

ImClone Systems Incorporated And Bristol-Myers Squibb Company Release: ERBITUX Phase III Study Meets Primary Endpoint In First-Line Treatment Of Metastatic Colorectal Cancer

NEW YORK, Jan. 10 -- ImClone Systems Incorporated and Bristol-Myers Squibb Company today announced that a Phase III study of ERBITUX (cetuximab) plus FOLFIRI (an irinotecan- based chemotherapy) met the primary endpoint of increasing median duration of progression-free survival over FOLFIRI alone in patients with previously untreated metastatic colorectal cancer (mCRC). More than 1,000 patients were recruited from around the world to participate in the study, known as the CRYSTAL(1) study.

"Despite advancements, metastatic disease remains difficult to treat. This study demonstrates the potential benefit of adding ERBITUX to first-line treatment of metastatic colorectal cancer," said Eric Rowinsky, M.D., Chief Medical Officer and Senior Vice President of ImClone Systems.

"These results provide important new information for patients with metastatic colorectal cancer, and are part of a comprehensive clinical development program designed to fully understand the potential uses of ERBITUX for cancer patients," said Martin Birkhofer, M.D., Vice President, Oncology Global Medical Affairs, Bristol-Myers Squibb.

The study was conducted by Merck KGaA, Darmstadt, Germany, ImClone Systems' ERBITUX partner outside of North America. Results have been submitted for presentation at the 2007 American Society of Clinical Oncology Annual Meeting in Chicago in June.

About ERBITUX® (Cetuximab)

ERBITUX is a monoclonal antibody (IgG1 Mab) designed to inhibit the function of a molecular structure expressed on the surface of normal and tumor cells called the epidermal growth factor receptor (EGFR, HER1, c-ErbB-1). In vitro assays and in vivo animal studies have shown that binding of ERBITUX to the EGFR blocks phosphorylation and activation of receptor-associated kinases, resulting in inhibition of cell growth, induction of apoptosis, and decreased matrix metalloproteinase and vascular endothelial growth factor production. In vitro, ERBITUX can mediate antibody-dependent cellular cytotoxicity (ADCC) against certain human tumor types. While the mechanism of ERBITUX' anti-tumor effect(s) in vivo is unknown, all of these processes may contribute to the overall therapeutic effect of ERBITUX. EGFR is part of a signaling pathway that is linked to the growth and development of many human cancers, including those of the head and neck, colon and rectum.

ERBITUX (Cetuximab), in combination with radiation therapy, is indicated for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck. ERBITUX as a single agent is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck for whom prior platinum-based therapy has failed.

ERBITUX is indicated for the treatment of EGFR-expressing, metastatic colorectal carcinoma (mCRC) in combination with irinotecan for patients who are refractory to irinotecan-based chemotherapy, and as a single agent for patients who are intolerant to irinotecan-based therapy. The effectiveness of ERBITUX for the treatment of EGFR-expressing mCRC cancer is based on objective response rates. Currently, no data are available that demonstrate an improvement in disease-related symptoms or increased survival with ERBITUX for the treatment of EGFR-expressing mCRC.

For full prescribing information, including boxed WARNINGS regarding infusion reactions and cardiopulmonary arrest, visit http://www.ERBITUX.com.

Important Safety Information

Grade 3/4 infusion reactions, rarely with fatal outcome, occurred in approximately 3% (46/1485) of patients receiving ERBITUX (Cetuximab) therapy. These reactions are characterized by rapid onset of airway obstruction (bronchospasm, stridor, hoarseness), urticaria, hypotension, and/or cardiac arrest. Severe infusion reactions require immediate and permanent discontinuation of ERBITUX therapy.

Most reactions (90%) were associated with the first infusion of ERBITUX despite the use of prophylactic antihistamines. Caution must be exercised with every ERBITUX infusion as there were patients who experienced their first severe infusion reaction during later infusions. A 1-hour observation period is recommended following the ERBITUX infusion. Longer observation periods may be required in patients who experience infusion reactions.

Cardiopulmonary arrest and/or sudden death occurred in 2% (4/208) of patients with squamous cell carcinoma of the head and neck treated with radiation therapy and ERBITUX as compared to none of 212 patients treated with radiation therapy alone. Fatal events occurred within 1 to 43 days after the last ERBITUX treatment. ERBITUX in combination with radiation therapy should be used with caution in patients with known coronary artery disease, congestive heart failure and arrhythmias. Close monitoring of serum electrolytes, including serum magnesium, potassium, and calcium during and after ERBITUX therapy is recommended.

Severe cases of interstitial lung disease (ILD), which was fatal in one case, occurred in less than 0.5% of 774 patients with advanced colorectal cancer (mCRC) receiving ERBITUX. There was one case of ILD reported in 796 patients with head and neck cancer receiving ERBITUX in clinical studies.

In clinical studies of ERBITUX, dermatologic toxicities, including acneform rash, skin drying and fissuring, and inflammatory and infectious sequelae (eg, blepharitis, cheilitis, cellulitis, cyst) were reported. In 208 patients receiving ERBITUX + RT, acneform rash was reported in 87% (17% severe) as compared to 10% in 212 patients treated with radiation therapy alone (1% severe). In patients receiving ERBITUX alone, 76% (N=103) experienced acneform rash (1% severe). In patients with mCRC, acneform rash was reported in 89% (686/774) of all treated patients, and was severe in 11% (84/774). Subsequent to the development of severe dermatologic toxicities, complications including S. aureus sepsis and abscesses requiring incision and drainage were reported. Sun exposure may exacerbate these effects. A related nail disorder, occurring in 12% (0.4% Grade 3) of patients, was characterized as a paronychial inflammation.

The safety of ERBITUX in combination with radiation therapy and cisplatin has not been established. Death and serious cardiotoxicity were observed in a single-am trial with ERBITUX, delayed, accelerated (concomitant boost) fractionation radiation therapy, and cisplatin (100 mg/m2) conducted in patients with locally advanced squamous cell carcinoma of the head and neck. Two of 21 patients died, one as a result of pneumonia and one of an unknown cause. Four patients discontinued treatment due to adverse events. Two of these discontinuations were due to cardiac events (myocardial infarction in one patient and arrhythmia, diminished cardiac output, and hypotension in the other patient).

The incidence of hypomagnesemia (both overall and severe [NCI CTC Grades 3 & 4]) was increased in patients receiving ERBITUX alone or in combination with chemotherapy as compared to those receiving best supportive care or chemotherapy alone based on ongoing, controlled clinical trials in 244 patients. Approximately one-half of these patients receiving ERBITUX experienced hypomagnesemia and 10-15% experienced severe hypomagnesemia. Electrolyte repletion was necessary in some patients and in severe cases, intravenous replacement was required. Patients receiving ERBITUX therapy should be periodically monitored for hypomagnesemia, and accompanying hypocalcemia and hypokalemia during, and up to 8 weeks following the completion of, ERBITUX therapy.

The most serious adverse reactions associated with ERBITUX in combination with radiation therapy in 208 patients with head and neck cancer were infusion reaction (3%), cardiopulmonary arrest (2%), dermatologic toxicity (2.5%), mucositis (6%), radiation dermatitis (3%), confusion (2%), and diarrhea (2%).

The most serious adverse reactions associated with ERBITUX in mCRC clinical trials (N=774) were infusion reaction (3%), dermatologic toxicity (1%), interstitial lung disease (0.4%), fever (5%), sepsis (3%), kidney failure (2%), pulmonary embolus (1%), dehydration (5% in patients receiving ERBITUX with irinotecan, 2% in patients receiving ERBITUX as a single agent) and diarrhea (6% in patients receiving ERBITUX with irinotecan, 0.2% in patients receiving ERBITUX as a single agent).

The overall incidence of late radiation toxicities (any grade) was higher with ERBITUX in combination with radiation therapy compared with radiation therapy alone. The following sites were affected: salivary glands (65%/56%), larynx (52%/36%), subcutaneous tissue (49%/45%), mucous membranes (48%/39%), esophagus (44%/35%), skin (42%/33%), brain (11%/9%), lung (11%/8%), spinal cord (4%/3%), and bone (4%/5%) in the ERBITUX and radiation versus radiation alone arms, respectively.

The incidence of Grade 3 or 4 late radiation toxicities were generally similar between the radiation therapy alone and the ERBITUX plus radiation therapy arms.

The most common adverse events seen in patients with carcinomas of the head and neck receiving ERBITUX in combination with radiation therapy (n=208) versus radiation alone (n=212) were mucositis-stomatitis (93%/94%), acneform rash (87%/10%), radiation dermatitis (86%/90%), weight loss (84%/72%), xerostomia (72%/71%), dysphagia (65%/63%), asthenia (56%/49%), nausea (49%/37%), constipation (35%/30%) and vomiting (29%/23%). The most common adverse events seen in patients with carcinomas of the head and neck receiving ERBITUX as a single agent (N=103) were acneform rash (76%), asthenia (45%), pain (28%), fever (27%) and weight loss (27%).

The most common adverse events seen in patients with mCRC receiving ERBITUX with irinotecan (n=354) or ERBITUX as a single agent (n=420) were acneform rash (88%/90%), asthenia/malaise (73%/48%), diarrhea (72%/25%), nausea (55%/29%), abdominal pain (45%/26%), vomiting (41%/25%), fever (34%/27%), constipation (30%/26%), and headache (14%/26%).

About Colorectal Cancer

In the U.S., approximately 149,000 people will be diagnosed with cancer of the colon or rectum this year. Half of these patients have metastatic disease, or cancer that has spread to other organs, at the time of diagnosis. EGFR is expressed in up to 77.7% of colorectal cancer tumors. Colorectal cancer is the third most common cancer in both men and women.(2)

About ImClone Systems

ImClone Systems Incorporated is committed to advancing oncology care by developing a portfolio of targeted biologic treatments designed to address the medical needs of patients with a variety of cancers. The Company's research and development programs include growth factor blockers and angiogenesis inhibitors. ImClone Systems' strategy is to become a fully integrated biopharmaceutical company, taking its development programs from the research stage to the market. ImClone Systems' headquarters and research operations are located in New York City, with additional administration and manufacturing facilities in Branchburg, New Jersey.

Certain matters discussed in this news release may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws. Although the company believes that the expectations reflected in such forward-looking statements are based upon reasonable assumptions it can give no assurance that its expectations will be achieved. Forward-looking information is subject to certain risks, trends and uncertainties that could cause actual results to differ materially from those projected. Many of these factors are beyond the company's ability to control or predict. Important factors that may cause actual results to differ materially and could impact the company and the statements contained in this news release can be found in the company's filings with the Securities and Exchange Commission, including quarterly reports on Form 10-Q, current reports on Form 8-K and annual reports on Form 10-K. For forward-looking statements in this news release, the company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The company assumes no obligation to update or supplement any forward-looking statements whether as a result of new information, future events or otherwise.

About Bristol-Myers Squibb

Bristol-Myers Squibb is dedicated to the discovery, development and exhaustive exploration of innovative cancer fighting therapies designed to extend and enhance the lives of patients living with cancer. More than 40 years ago, Bristol-Myers Squibb built a unified vision for the future of cancer treatment. With expertise, dedication and resolve, that vision led to the development of a diverse global portfolio of anti-cancer therapies that are an important cornerstone of care today. Hundreds of scientists at Bristol- Myers Squibb's Pharmaceutical Research Institute are studying ways to improve current cancer treatments and identify better, more effective medicines for the future.

Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life.

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding product development. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2005 and in our Quarterly Reports on Form 10-Q. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

(1) Cetuximab combined with iRinotecan in first line therapY for metaSTatic colorectAL cancer (2) American Cancer Society: Cancer Facts and Figures 2006. http://www.cancer.org/downloads/STT/CAFF2006PWSecured.pdf. Accessed 5/16/06.

Source: ImClone Systems Incorporated; Bristol-Myers Squibb Company

Press Release: Merck KGaA to Explore Divestiture of Its Generics Business

Maureen Martino — Fri, 05 Jan 2007 11:50:29 -0500

Merck KGaA to Explore Divestiture of Its Generics Business

Darmstadt, Germany, January 5, 2007 – Merck KGaA confirmed, that it is evaluating the divestiture of its Generics division (Merck Generics) as one strategic option. Merck is not engaged in initial discussions with any potential buyers. Irrespective of this strategic evaluation Merck still plans to make a capital increase of EUR 2 billion to EUR 2.5 billion within the first quarter of 2007.

Merck Generics has sales in more than 90 countries and is the number 3 ranked generics business in the world. In 2005 Merck Generics reported sales of
EUR 1.8 billion and an operating result of EUR 238 million. The division employs approximately 5,000 people worldwide.

“Merck Generics has a strong business with excellent leadership and good growth prospects for the future. However it will need continued investment to fully realize its potential and strengthen its market presence,” said Dr. Michael Roemer, Chairman of the Executive Board of Merck KGaA. “In light of the far-reaching changes occurring in the market we are considering as an option the divestiture of Merck Generics to a qualified buyer.”

Important Information
This document does not constitute an offer of securities for sale or a solicitation of an offer to purchase securities in the United States. The shares referred to herein have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the “Securities Act”), and may not be offered or sold in the United States absent registration under the Securities Act or an available exemption from such registration. The issuer of the shares does not intend to register any portion of the offering in the United States or to conduct any public offering of the shares in the United States.

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Merck is a global pharmaceutical and chemical enterprise with sales of € 5.9 billion in 2005, a history that began in 1668, and a future shaped by 30,158 employees in 56 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds a 73 % interest and free shareholders own the remaining 27 %. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.

Merck KGaA reportedly considering generics sale

Wed, 03 Jan 2007 19:01:37 -0500

Germany's Merck KGaA is mulling the possible sale of its generics drug business, according to a news report. The unit could be worth about €4 billion and the money would help fund its acquisition of Switzerland's Serono as it focuses on developing new therapies. Any sale would likely be to financial investors, analysts note. The European drug company declined to comment on the report.

- here's the AFX report on Merck's plans

Related Articles:
Merck KGaA buying control of Serono. Report
Merck KGaA inks deal with China's Chi-Med. Report