03-18-2007 products in development · 2013-03-26 · inhibits the epidermal growth factor receptor...

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03-18-2007

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Products in Development

Preclinical

Export Company: Aida Pharmaceuticals

HQ Location: Hangzhou, China

Product: Vasostatin-Apo2L

Dosage Form: Unknown

Nature of API: Biologic - Recombinant protein

Therapeutic Area: Oncology - Chemotherapy

Comment:

Aida initiates preclinical trials of the potential anticancer treatment Vasostatin-Apo2L. Vasostatin-Apo2L is a recombinant fusion protein with the potential to inhibit tumor growth.

Corporate: Jin Biao

Corporate: Lin Hui

Corporate: Huang Daofei

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Export Company: Curis Inc.

HQ Location: Cambridge, MA

Product: CUDC-101


Nature of API: Chemical - Normal potency

Therapeutic Area: Oncology - Other

Comment:

Curis selects CUDC-101 for preclinical studies as a treatment for cancer. CUDC101 is a multi-target small molecule which

inhibits the epidermal growth factor receptor and a second undisclosed target. Curis plans to initiate preclinical drug development activities shortly and expects to file an IND in late 2007 or early 2008.

Clinical research contact: Changgeng Qian, PhD, MD

Corporate: Mark Noel


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Export Company: Exelixis, Inc.

HQ Location: S. San Francisco, CA

Product: XL147

Dosage Form: Oral – Unspecified



Comment:

Exelixis submits an IND for XL147, a novel anticancer compound. XL147 is an inhibitor of phosphoinositide-3 kinase, activation of which can promote tumor cell growth, survival, and resistance to chemotherapy and radiotherapy.

Research contact: Michael Morrissey, PhD

Clinical research contact: Gisela M. Schwab, MD


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Phase I

Export Company: Diffusion Pharmaceuticals

HQ Location: Charlottesville, VA

Product: Trans sodium crocetinate (TSC)

Dosage Form: Oral solid Parenteral - Unspecified Inhaled - Metered dose inhaler


Therapeutic Area:

Other Oncology - Other Stroke Pulmonary - Other

Comment: Diffusion initiates Phase I trials of trans sodium crocetinate (TSC). TSC increases the rate of oxygen

delivery to oxygen-deprived tissues, and will be developed as a radiation sensitizer in the treatment of tumors, stroke and respiratory disorders. The company also plans to develop it for the treatment of hemorrhagic shock. TSC can be administered intravenously, through inhalation and orally.

Research contact: James Edward John

Research contact: Chris Dvergsten, PhD

Research contact: Robert Murray, PhD


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Export Company: Pain Therapeutics Inc.

HQ Location: South San Francisco, CA

Product: Monoclonal antibody


Nature of API: Biologic - Monoclonal antibody Radioactive/radiolabeled product

Therapeutic Area: Oncology - Immunotherapy

Comment:

Pain receives approval to initiate a Phase I trial with a radio-labeled monoclonal antibody in patients with metastatic melanoma. The company expects to initiate this trial in Q2 of 2007 in Israel.

Research contact: Grant L. Schoenhard, PhD

Clinical research contact: Peter Butera


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Export Company: Potentia Pharmaceuticals

HQ Location: Louisville, KY

Product: POT-4


Nature of API: Peptide - Chemical

Therapeutic Area: Ophthalmic Anti-inflammatory

Comment:

Potentia initiates Phase I trials of POT-4, its lead drug candidate, for the treatment of age-related macular degeneration (AMD). POT-4 is a synthetic peptide that

binds tightly to complement component C3, preventing its participation in the complement activation cascade involved in AMD.

Research contact: Pascal Deschatelets, Ph.D.

Research contact: Paul Olson, Ph.D


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Phase II

Export Company: ACADIA Pharmaceuticals Inc.

HQ Location: Multiple

Product: ACP-103

Dosage Form: Oral solid


Therapeutic Area: Neurology Psychiatric - Other

Comment:

ACADIA reports positive results from a Phase II trial of ACP-103 used together with other antipsychotic drugs as therapy for schizophrenia patients. The product is a small molecule 5-HT2A inverse agonist. An earlier trial involved patients with Parkinson's disease suffering from treatment-induced psychosis.

Research contact: Bo-Ragnar Tolf, PhD

Corporate: Brian Lundstrom

Clinical research contact: Roger C. Mills


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Export Company: Amicus Therapeutics

HQ Location: Cranbury, NJ

Product: Amigal (AT1001)



Therapeutic Area: Metabolic - Other

Comment:

Amicus completes patient enrollment of Phase II trials of Amigal for potential treatment of Fabry's disease. Fabry's disease

is a lysosomal storage disease caused by a deficiency of alpha-galactosidase A. Amigal is designed to enhance the patient's own alpha-galactosidase A activity.

Research contact: David Palling, PhD

Research contact: Gregory P. Licholai


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Export Company: Avexa

HQ Location: Richmond, Victoria, Australia

Product: AVX754 (SPD-754)

Dosage Form: Parenteral - Unspecified


Therapeutic Area: Anti-viral

Comment:

Avexa reports positive results from a Phase IIb clinical trial with AVX754 for HIV/AIDS. The product is a reverse transcriptase inhibitor that was acquired from Shire Pharmaceuticals.

Research contact: Jonathan Coates, Ph.D.

Research contact: John Deadman, Ph.D.


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Export Company: Avigen Inc.

HQ Location: Alameda, CA

Product: AV650 (tolperison)



Therapeutic Area: Neurology

Comment:

Avigen receives approval to initiate Phase II trials in the US with AV650. AV650 is a small molecule that treats neuromuscular spasm and spasticity resulting from muscle injuries and serious neurological diseases.

Preclinical contact: Kirk Johnson, PhD

Corporate: Christina Thomson, JD

Corporate: Michael Coffee


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Export Company: Gilead Sciences Inc.

HQ Location: Foster City, CA

Product: GS 9137



Therapeutic Area: Anti-viral

Comment:

Gilead reports positive results from a Phase II trial of GS 9137 for the treatment of HIV. GS 9137 is an HIV integrase inhibitor which was licensed from Japan Tobacco.

Manufacturing and packaging contact: Anthony D. Caracciolo

Clinical research contact: John J. Toole, PhD, MD

Manufacturing and packaging contact: Taiyin Yang, PhD

Research contact: William A. Lee


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Export Company: Neose Technologies Inc.

HQ Location: Horsham, PA

Product: NE-180


Nature of API: Biologic - Protein Hormone

Therapeutic Area: Coagulation and Blood Formation Oncology - Chemotherapy

Comment:

Neose Technologies receives clearance to initiate clinical trials of NE-180 in the US. NE-180 is a long-acting GlycoPEGylated erythropoietin for the treatment of chemotherapy-induced anemia. NE-180 is currently in a Phase II trial for oncology-related anemia in Switzerland.

Research contact: David A. Zopf

Manufacturing and packaging contact: Valerie Mulligan

Research contact: Shawn DeFrees, PhD


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Export Company:

Nymox Pharmaceutical Corporation


Product: NX1207



Therapeutic Area: Renal - Urologic

Comment:

Nymox reports positive results for its Phase II trial for NX1207, an investigational new drug for benign prostatic hyperplasia. In earlier Phase I/II trials, NX1207 showed statistically significant overall symptom improvement and shrinkage in prostate size.

Corporate: Paul Averback, MD

Corporate: Jack Gemmell


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Export Company: Pervasis Therapeutics


Product: Vascugel


Nature of API: Biologic - Manipulated/transplanted cells

Therapeutic Area: Cardiovascular Other

Comment:

Pervasis initiates enrollment in two Phase II trials with Vascugel, a novel allogeneic cell therapy, for maintaining vascular potency in patients with surgical arteriovenous access grafts and fistulas. Vascugel is placed around the treated vessels and is continuously released to promote blood vessel repair.

Clinical research contact: John L. Wilson

Research contact: Helen Marie Nugent, PhD

Manufacturing and packaging contact: Jack Harvey


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Export Company: Radius, Inc.


Product: BA058


Nature of API: Biologic - Protein

Therapeutic Area: Bone metabolism

Comment:

Radius commences patient enrollment for Phase II trials of BA058, a human parathyroid hormone-related protein for the treatment of osteoporosis in menopausal women. BA058 is a critical cytokine for promoting new bone formation and regulates calcium homeostasis and bone resorption.

Clinical research contact: Louis O'Dea, FRCP

Corporate: Mick Harvey


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Export Company:

Valeant Pharmaceuticals International

HQ Location: Aliso Viejo , CA

Product: Taribavirin


Nature of API: Nucleic Acid - DNA

Therapeutic Area: Anti-viral Liver Disease

Comment:

Valeant initiates a Phase IIb trial with taribavirin for the treatment of chronic Hepatitis C. The product is an oral nucleoside (guanosine) analog. The results from this trial will be released by the end of 2007.

Corporate: Bary G. Bailey

Corporate: Wesley P. Wheeler

Corporate: Martin Mercer


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Phase III

Export Company: Advanced Life Sciences, Inc.

HQ Location: Woodridge, IL

Product: Cethromycin


Nature of API: Chemical - Antibiotic

Therapeutic Area: Anti-bacterial Pulmonary - Other Biodefense/Security

Comment:

Advanced Life Sciences reports that Cethromycin has received orphan drug designation for anthrax. Cethromycin is a novel ketolide antibiotic in Phase III clinical development for the treatment of community-acquired pneumonia and other respiratory tract infections.

Research contact: David A. Eiznhamer, Ph.D.

Research contact: Ze-Qi Xu, Ph.D.


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Export Company: Advanced Magnetics Inc.


Product: Ferumoxytol



Therapeutic Area: Coagulation and Blood Formation Medical imaging Renal - Urologic

Comment:

Advanced Magnetics completes patient enrollment for Phase III trials of ferumoxytol as an iron-replacement therapeutic in patients with chronic kidney disease. The company plans to submit a NDA during Q4 of 2007.

Clinical research contact: Terri Clark

Research contact: Jerome M. Lewis, PhD

Manufacturing and packaging contact: Dennis R. Lawler


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Export Company: Lev Pharmaceuticals

HQ Location: New York, NY

Product: C1-INH


Nature of API: Biologic - Blood derivative Biologic - Protein

Therapeutic Area: Anti-inflammatory

Comment:

Lev reports positive results for Phase III trials of C1-INH. C1-INH is a human plasma protein product that mediates inflammation; Lev is investigating it for hereditary angioedema. The company anticipates filing a BLA in Q2 of 2007.

Corporate: Judson Cooper

Regulatory: Jason Bablak


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Export Company: MGI Pharma Inc.

HQ Location: Bloomington, MN

Product: AQUAVAN



Therapeutic Area: Anesthetic

Comment:

MGI reports positive results from a Phase III trial of AQUAVAN injection for minimal to moderate sedation of patients undergoing short surgical or diagnostic procedures. The product is a water-soluble prodrug of propofol that, when administered intravenously, is converted to active propofol, a short-acting anesthetic agent. The company plans to file a NDA in Q3 of 2007.

Research contact: Mary Lynne Hedley, PhD

Corporate: Eric P. Loukas, Esq


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Export Company: Myriad Genetics Inc.

HQ Location: Salt Lake City, UT

Product: Flurizan (MPC-7869)



Therapeutic Area: Alzheimer Disease and Dementia

Comment:

Myriad completes enrollment in a second Phase III trial with Flurizan in patients with Alzheimer's disease. Flurizan is the R-enantiomer of flurbiprofen

and selectively lowers levels of amyloid beta 42, a toxic peptide, implicated in the onset of Alzheimer's disease.

Research contact: Mark H. Skolnick, PhD

Research contact: Jerry Lanchbury, PhD


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Export Company: Napo Pharmaceuticals, Inc.

HQ Location: South San Francisco, CA

Product: Crofelemer


Nature of API: Botanical

Therapeutic Area: Gastrointestinal

Comment:

Napo initiates Phase III trials of Crofelemer, an oligometric proanthocyanidin derived from the Croton lecheri tree, to treat HIV-associated diarrhea. The product normalizes water flow in the gut via an anti secretory mechanism that blocks chloride ion secretion through the CFTR channel.

Corporate: Lisa A. Conte

Regulatory: Kimberly J. Manhard


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Export Company: Optimer Pharmaceuticals, Inc.

HQ Location: San Diego, CA

Product: Difimicin (OPT-80)


Nature of API: Chemical - Antibiotic

Therapeutic Area: Gastrointestinal Anti-bacterial

Comment:

Optimer initiates Phase III trials with its lead antibiotic, Difimicin. The product candidate has shown efficacy in the treatment of Clostridium difficile-associated diarrhea. Optimer is working on this product with its partner, Par Pharmacetuicals.

Research contact: Pam Sears, Ph.D.

Research contact: Yoshi Ichikawa, PhD

Clinical research contact: Youe-Kong Shue, Ph.D.


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Export Company: Pharmexa A/S

HQ Location: Hørsholm, Denmark

Product: GV1001


Nature of API: Peptide - Chemical

Therapeutic Area: Oncology - Immunotherapy

Comment:

Pharmexa initiates a Phase III trial with GV1001 in the UK. The trial will involve patients with inoperable pancreatic cancer. GV1001 is a peptide vaccine against telomerase being developed to recognize and kill cancer cells.

Research contact: Iben Dalum, PhD

Research contact: Torsten Skov


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Terminated in Phase II or III

Export Company: Hollis-Eden Pharmaceuticals, Inc.


Product: NEUMUNE (HE2100)


Nature of API: Chemical - Steroid Hormone

Therapeutic Area: Immunomodulator Oncology - Immunotherapy Biodefense/Security

Comment:

Hollis-Eden halts further development of NEUMUNE after the U.S. Department of Health and Human Services (HHS) rejected a contract proposal involving the drug. NEUMUNE was in a Phase I/II trial for treatment of patients at risk of developing hospital-acquired infections. NEUMUNE was also being studied in the biodefense industry for acute radiation syndrome, which arises from

high levels of radiation exposure.

Research contact: James M. Frincke

Research contact: Christopher Reading, PhD

Research contact: Steven Gordziel, PhD

Clinical research contact: Dwight R. Stickney, MD


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Approved

Export Company: Adams Respiratory Therapeutics

HQ Location: Chester, NJ

Product: Guaifenesin combination


Nature of API: Chemical - Normal potency Unknown

Therapeutic Area: Cough & Cold

Comment:

Adams receives FDA approval for a guaifenesin combination for the treatment of cough. The compound is an orally taken extended-release tablet designed to supress coughs and will be available via prescription.

Research contact: Helmut Albrecht

Corporate: William H. Howard, PhD


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Export Company: Alexion Pharmaceuticals, Inc.

HQ Location: Cheshire, CT

Product: Soliris (eculizumab)


Nature of API: Biologic - Monoclonal antibody

Therapeutic Area: Anti-inflammatory Coagulation and Blood Formation Renal - Urologic

Comment:

Alexion receives FDA approval for Soliris, a C5 cleavage inhibitor for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). The product has received orphan drug status for PNH in both the US and Europe and is also being studied for rheumatoid arthritis, membranous nephritis and lupus

nephritis.

Clinical research contact: Christopher F. Mojcik, MD, PhD

Research contact: Scott A. Rollins, PhD

Manufacturing and packaging contact: M. Stacy Hooks, PhD


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Export Company: GlaxoSmithKline


Product: Tykerb (lapatinib ditosylate)




Comment:

GSK receives FDA approval for Tykerb in women with advanced or metastatic HER2-positive breast cancer. The drug, known as a dual-kinase inhibitor, blocks the EGFR and ErbB-2 receptors, whose stimulation is involved in tumor proliferation.

Manufacturing and packaging contact: Dr. David Pulman

Research contact: Moncef Slaoui


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Product Acquisitions & Alliances

Export Buyer: TRACON Pharmaceuticals, Inc.

Seller: Micromet, Inc.

Transaction Type: License

Product: D93


Nature of API: Biologic - Monoclonal antibody

Threapeutic Area: Oncology - Immunotherapy

Development Phase: Preclinical

Comment:

Micromet grants TRACON the worldwide right to develop and commercialize D93, an antibody for the treatment of cancer. D93 is a recombinant humanized IgG1 monoclonal antibody that inhibits angiogenesis, tumor cell growth and metastasis. Under the terms of agreement, TRACON will be responsible for all development

and commercialization. TRACON plans to initiate Phase I trials in H2 of 2007.

Annual Sales: $0.00

Clinical research contact: Carsten Reinhardt, MD, PhD

Research contact: Patrick A. Baeuerle, PhD


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Corporate Finance, Alliances, and Acquisitions

Corporate Finance

Export Company: Alpharma Inc.


Financing Type: Private debt placement

Amount Raised: $200.00 million

Description:

Alpharma offers $200 million in convertible senior notes. Earnings will be used to fund future business development transactions and for general corporate purposes, including working capital.

Strategy:

Alpharma is a global specialty pharmaceutical company with products for humans and animals.

CMC R&D Contact: Dr. Ronald N. Warner

CMC R&D Contact: Carl-Åke Carlsson


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Export Company: Chelsea Therapeutics, Inc.

HQ Location: Charlotte, NC

Financing Type: Private equity placement


Description:

Chelsea raises approximately $12.5 million in a private placement. The proceeds will be used for the clinical development of CH-1504, including Phase II and Phase III trials.

Strategy:

Chelsea Therapeutics is developing drugs for treatments of arthritis, psoriasis and some cancers.

Research contact: L. Arthur Hewitt, PhD

Research contact: Cameron B. Szakacs, PhD


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Export Company: Cleveland BioLabs Inc.

HQ Location: Cleveland, OH



Description:

Cleveland BioLabs closes a private placement raising approximately $30 million. The funding will be used to advance the company's pipeline.

Strategy:

Cleveland BioLabs is a biotechnology company that is involved in drug development for cancer treatments and radiation protection.

Research contact: Andrei Gudkov, PhD

Research contact: Farrel Fort, PhD


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Export Company: Epiphany Biosciences

HQ Location: San Francisco, CA



Description:

Epiphany raises $36 million in a Series A financing. The funding will be used to advance the company's programs, which include the antiviral drug candidate Valomaciclovir (EPB-348) through Phase IIb clinical trials against shingles.

Strategy: Epiphany Biosciences develops drugs that focus on systematic diseases of viral origin.

Clinical research contact: Brian Murphy

Clinical research contact: Michael Houghton, PhD


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Export Company: Genta Inc.

HQ Location: Berkeley Heights, NJ

Financing Type: Secondary public offering


Description:

Genta reports a common stock offering for an estimated $11 million. Allocation of funds was not disclosed.

Strategy:

Genta is developing oligonucleotides (RNA and DNA-based medicines) and small molecules for the treatment of patients with cancer.

Manufacturing and packaging contact: Bharat Mehta

Research contact: Bob D. Brown, PhD


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Export Company: Intarcia Therapeutics, Inc.

HQ Location: Emeryville, CA, Canada

Financing Type: Venture capital investment


Description:

Intarcia receives $50 million through venture investment funding. Funds will be used for the clinical development of the company's chronic Hepatitis C and diabetes development program.

Strategy:

Intarcia Therapeutics is developing therapies for the treatment of cancer and immunological and infectious diseases.

Research contact: Janice Dahms

Research contact: Thomas Alessi, PhD


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Export Company: La Jolla Pharmaceutical Company


Financing Type: Secondary public offering


Description:

La Jolla offers 5 million shares of common stock in a public offering. At current market price this would raise approximately $34.25 million. Allocation of funds was not disclosed.

Strategy:

La Jolla is developing therapeutics for antibody-mediated autoimmune diseases including lupus and antibody-

mediated thrombosis.

Research contact: Matthew D. Linnik, PhD

Manufacturing and packaging contact: Josefina Elchico

Manufacturing and packaging contact: Luke Seikkula


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Export Company: Memory Pharmaceuticals

HQ Location: Montvale, NJ



Description:

Memory closes a $10 million term loan agreement. The company will use the funds to increase its efforts on achieving near-term milestones and advancing its clinical, preclinical and exploratory research programs.

Strategy:

Memory Pharmaceuticals develops drugs to treat central nervous system disorders, including neurological diseases such as Alzheimer's, vascular dementia and schizophrenia.

Research contact: David A. Lowe, PhD

Corporate: Michael P. Smith

Clinical research contact: Stephen Murray, MD, PhD


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Export Company: NeuralStem, Inc.

HQ Location: Rockville, MD



Description:

NeuralStem raises approximately $5.1 million in a private placement. The proceeds will be used for the company's first human trial, working capital and other general corporate purposes.

Strategy:

Neuralstem, Inc. uses its patented Human Neural Stem Cell technology to create cures for diseases of the central nervous system.

Corporate: Richard Garr

Research contact: Karl Johe


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Export Company: Neuromed Pharmaceuticals Ltd.

HQ Location: Vancouver, BC, Canada

Financing Type: Milestone payment


Description:

Neuromed receives a $2 million milestone payment under its collaboration and license agreement with Merck & Co.

Strategy:

NeuroMed is developing chronic pain drugs with pipeline programs in anxiety and epilepsy.

Research contact: Terrance P. Snutch

Clinical research contact: Barry Sachais, PhD

Preclinical contact: Dr. Stephen Arneric


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Export Company: Viragen Inc.

HQ Location: Plantation, FL



Description:

Viragen announces a debt restructuring in a financing of $9.2 million in convertible notes. Allocation of the funds was not disclosed.

Strategy:

Viragen focuses on the research and development of natural and recombinant protein-based drugs designed for a broad range of viral and malignant diseases.

Corporate: Charles A. Rice

Clinical research contact: Patrick Yeramian


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Export Company: ViroPharma Inc.

HQ Location: Exton, PA



Description: ViroPharma offers $200 million in convertible senior notes.

ViroPharma plans to use the proceeds of the offering for general corporate purposes, investments, or acquisitions.

Strategy: ViroPharma develops antiviral pharmaceuticals.

Research contact: Colin Broom, MD

Clinical research contact: Stephen Villano, MD


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Corporate Alliances

Export Alliance Partners:

Chromos Molecular Systems Inc. Pain Therapeutics Inc.

Description:

Chromos enters into an agreement with Pain Therapeutics to engineer cell lines for the expression of a monoclonal antibody. Financial terms were not disclosed.

Research contact: Grant L. Schoenhard, PhD

Clinical research contact: Nadav Friedmann, MD, PhD

Corporate: Alistair Duncan Jr.

Research contact: Harry C. Ledebur, Jr., PhD

Clinical research contact: Peter Butera


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Export Alliance Partners:

Evotec AG Boehringer Ingelheim

Description:

Evotec reports a research collaboration agreement with Boehringer Ingelheim to develop new targets as potential treatments for Alzheimer's disease. Evotec is eligible for milestone payments of up to $26.6 million plus royalties.

Research contact: John Kemp, PhD

Clinical research contact: Tim Tasker, MD

Sourcing and Supply Chain contact: Stephan Gotthardt


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Other Sponsor Events

Export Sponsor: MedImmune Inc.

HQ Location: Gaithersburg, MD

Location: Rockville, MD

Strategy:

MedImmune strives to provide medicines in the areas of infectious and inflammatory diseases and cancer.

Description:

MedImmune and Human Genome Sciences enter an agreement under which MedImmune will lease a portion of an HGS facility located in Rockville, MD, for the development and manufacturing of clinical trial material for influenza vaccines.

Corporate: Lota S. Zoth


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Export Sponsor: Neose Technologies Inc.

HQ Location: Horsham, PA

Location: Horsham, PA

Strategy:

Neose focuses on the improvement of protein therapeutics through the application of its proprietary technologies.

Description:

Neose will cut its work force by about 40 percent as part of a restructuring plan, largely attributable to increased clinical development costs.

Research contact: Bruce A. Wallin, MD


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Export Sponsor: InterMune Inc.

HQ Location: Brisbane, CA

Location: Brisbane, CA

Strategy:

InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology.

Description:

InterMune plans to reduce annual operating expenses by approximately $40 to $50 million by reducing staffing levels by 50 percent, or 116 full-time and

contract positions affecting all departments.

Corporate: John Hodgman


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Key Appointments

Export Company: Alexza Pharmaceuticals

Appointee: Jeffrey S. Williams

Position: SVP, Operations and Manufacturing


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Export Company: Novavax, Inc.

Appointee: James Robinson

Position: VP, Technical & Quality Operations


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Export Company: Allos Therapeutics Inc.

Appointee: Pablo Cagnoni, MD

Position: CMO & SVP


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Export Company: Anthera Pharmaceuticals, Inc.

Appointee: James Pennington, MD

Position: EVP & CMO


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03-18-2007 products in development · 2013-03-26 · inhibits the epidermal growth factor receptor...

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