La Merie R&D Pipeline News Technology Edition Sample

Part A

Product Type	Category	No. of news	Page	Frequent abbreviations
Pharmaceuticals	Small molecule	36	3	Ol	Open-label
	Antibody	5	9	Rx	Randomized
	Protein	6	10	Db	Double-blind
	Peptide	5	11	Pc	Placebo-controlled
	RNA	5	12	Pts	Patients
	DNA	2	13	PK	Pharmacokinetic
	Cells	5	14	PD	Pharmacodynamic
	Vaccine	5	15	PoC	Proof-of-concept
	Natural Source	3	16	NCE	New chemical entity
	Generics	5	17	Co	Cross-over
	Drug Delivery	8	18	GRAS	Generally recognized as safe
Radiotherapy & Radiopharmaceuticals		2	19	NDI	New dietary ingredient
NutraCeuticals, Dietary Supplements & Cosmeceuticals		-	-	ANDA	Abbreviated new drug application
Biomaterials, Medical Devices, Combination & NanoTechnology Products		7	20	BLA	Biologics License Application

Part B

Company Profiles	-		IDE	Investigational device exemption
Technology & BioManufacturing Sites	6	21	NDA	New drug application
R&D Collaborations	6	22	MAA	Marketing authorization application
R&D Licensing Agreements	7	23	SPA	Special protocol assessment

Product Type: Pharmaceutical			Category: Small molecule
ID No.	Product Name	Target / Mechanism of Action	Class of Compound	Company	Therapeutic Area	Indication	R&D Stage	Message
S 333	Aliskiren; SPP100	Renin inhibition	Oral small molecule	Novartis & Speedel	Cardio-vascular & renal	Hypertension: monotherapy; combination	III II	Released positive phase III results from monotherapy and HCTZ-combination studies and plan filing in 2006 HTUread moreUTH
S 346	MC-1	Purinergic receptor agonist	Naturally occurring small molecule	Medicure	Cardio-vascular	Prevention of cardio- + cerebrovascular events after PCI, CABG and ACS	II/III	FDA granted Fast Track Designation HTUread moreUTH
S 046	ISA247	Immuno-suppressive	Trans-isomer of cyclospo-rine analog	Isotechnika	Dermatology	Stable moderate to severe psoriasis	III	Announced that phase III study met all primary and secondary endpoints HTUread moreUTH
S 348	Aplaviroc; GW873140; ONO-4128	CCR5 chemokine antagonism	Oral small molecule	GSK	Infectious	Treatment naive HIV Treatment experienced HIV	II III	GSK halted all clinical trials with the CCR5 inhibitor after two pts developed severe liver toxicity in the phase II study HTUread moreUTH
S 343	Vildagliptin LAF237	DPP-IV inhibition	Oral small molecule	Novartis	Metabolism & endocrine	Type 2 diabetes	III	New study results show sustained efficacy (after 12 wks) in lowering HbA1c and excellent tolerability without weight gain; plans to file in 2006 HTUread moreUTH
S 331	Parecoxib	COX-2 selective antagonism	Non-narcotic injectable small molecule	Pfizer	Neurology & psychiatry & pain	Acute pain in post-surgical setting	NDA	Received non-approvable letter from FDA for parecoxib which is approved in many countries and marketed in the EU as Dynastat HTUread moreUTH
S 191	Neurodex; AVP 923	NMDA R antagonism + sigma-1 agonism	Combination of dextro-methorphan + quinidine sulfate	Avanir	Neurology & psychiatry	Pseudobulbar affect	NDA	FDA requested more analyses to better support the electronic data submission guideline HTUread moreUTH
S 010	Phenserine tartrate	Acetycholin-esterase synthesis of beta-amyloid	Small molecule	Axonyx	Neurology & psychiatry	Mild to moderate Alzheimer’s disease	III	12-wk treatment did not achieve significant improvement over placebo as measured by scales HTUread moreUTH
S 335	Silenor™ Doxepin hydro-chloride	Presumably via influence on adrenergic activity	Oral small molecule (tricyclic compound)	Somaxon Pharma-ceuticals	Neurology & psychiatry	Sleep maintenance insomnia	III	Announced that enrollment has begun in the second phase III trial with 3-mth dosing HTUread moreUTH
S 351	ACP-104	Partial ago-nism of D2 + D3 dopamine R, muscarinic M1 agonism, 5-HT2A inver-se agoninsm	Small molecule (major metabolite of clozapine)	Acadia Pharma-ceuticals	Neurology & psychiatry	Schizophrenia	II	Published results of preclinical investigation in the JPET about molecular mechanisms of new schizophrenia drug candidate HTUread moreUTH
S 080	arimoclomol	Induces heat shock protein expression	Oral small molecule: L-hydroxylamine derivative	CytRx	Neurology & psychiatry	Amyotrophic lateral sclerosis (Lou-Gehrig’s diseaes)	II	Initiated phase II study which plans to enroll n=80 pts in the db, pc study in the US to evaluate safety and tolerability HTUread moreUTH
S 352	NG2-73	GABA-A receptor modulation	Oral small molecule	Neurogen	Neurology & psychiatry	Insomnia	I	Induction of deep sleep was “dose-limiting” effect in phase I trial with healthy volunteers, single doess of drug were well tolerated HTUread moreUTH
S 034	Flurizan; MCP-7869	Selective amyloid beta lowering (Abeta42 inhibition)	Oral small molecule (R-enantiomer of flurbiprofen)	Myriad Genetics	Neurology & psychiatry	Mild Alzheimer’s disease	III	Follow-on study results suggest that pts appear to stabilize from months 12 to 15 with continued medication HTUread moreUTH
S 116	Taxotere® docetaxel	Tubulin	Semisyn-thetic small molecule	Sanofi-Aventis	Oncology	Various cancers Early stage Her2+ breast cancer	Mar-ket III	Interim results of phase III study of taxotere-including chemotherapy plus trastuzumab show significantly improved disease free survival HTUread moreUTH
S 296	Xinlay™ atrasentan	Selective endothelin A receptor antagonism	Oral small molecule	Abbott	Oncology	Hormone-refractory prostate cancer with bone metastases	NDA	HTUread briefing docsUTH FDA Advisory Committee did not recommend the drug for approval, phase III study with earlier stage HRPC is ongoing HTUread moreUTH
S 285	Sorafenib; BAY43-9006	Multi-kinase: RAF, VEGF-R2, VEGF-R3, KIT, FLT-3, RET	Oral small molecule inhibitor	Bayer & Onyx	Oncology	Advanced renal cell carcinoma	MAA; NDA	Bayer submitted to the EMEA a MAA for sorafenib in kidney cancer HTUread moreUTH FDA accepted submission and granted priority review HTUread moreUTH
S 309	Arranon® nelarabine injection	DNA synthesis inhibition (cytotoxic)	Small mole-cule chemo-therapeutic, a prodrug of ara-G (arabinosid)	GSK	Oncology	Refractory T-cell acute lymphoblastic leukemia and lymphoblastic lymphoma	NDA	FDA Oncology Advisory Committee recommended accelerated approval of Arranon pediatric pts HTUread moreUTH
S 61	Tarceva; erlotinib	EGF-R1 tyrosine kinase	Oral small molecule	OSI Pharma-ceuticals	Oncology	Treatment naive advanced pancreatic cancer + gemcitabine	sNDA	HTUbriefing docsUTH were published; FDA staff question new use of Tarceva HTUread moreUTH; FDA Oncology Drug Advisory Committee recommended approval of pancreatic cancer label HTUread moreUTH
S 61	Tarceva; erlotinib	EGF-R1 tyrosine kinase	Oral small molecule	OSI Pharma-ceuticals & Roche	Oncology	Advanced non-small cell lung cancer (NSCLC)	Approved	Roche received approval from the European Commission to market the drug in the EU HTUread moreUTH
S 334	Arimidex® anastrozole	Aromatase inhibition	Small molecule	AstraZeneca	Oncology	Adjuvant treat-ment of hormo-ne-receptor positive early breast cancer in postmenopausal women	Approved	Gained full approval from FDA for its aromatase inhibitor, the only with 5-yr full data set and superior disease free survival over tamoxifen, holds accelerated approval since September 2002 HTUread moreUTH
S 252	Acapodene® toremifene citrate	Selective estrogen receptor modulation	Small molecule	GTx	Oncology	High grade prostatic intraepithelial neoplasia (PIN)	III	Received FDA response under SPA protocol on design of phase III trials HTUread moreUTH
S 61	Tarceva; erlotinib	EGF-R1 tyrosine kinase	Oral small molecule	OSI Pharma-ceuticals & Roche	Oncology	First line treatment of advanced NSCLC	II	Uncontrolled phase II study in elderly pts reveiled benefits of Tarceva as first line treatment in NSCLC pts > 70 yrs HTUread moreUTH
S 128	Combre-statin A4 phoshate, CA4P	Microtubules	Synthetic drug derived from root bark of Combretum caffrum tree	Oxigene	Oncology	Advanced, relapsed, platinum-resistant ovarian cancer in triple combination	II	Initiated phase II triple combination therapy with carboplatin and paclitaxel HTUread moreUTH
S 347	Teverelix LA (long acting)	Gonadotropin-releasing hormone antagonism	Small molecule	Ardana	Oncology	Prostate cancer and benign prostate hyperplasia	II	Reported acceleration of clinical development by 2 yrs after pre-IND meeting with FDA; launch now planned for 2010 HTUread moreUTH
S 332	cloretazine®	DNA-alkylation	Small molecule	Vion Pharma-ceuticals	Oncology	Advanced small cell lung cancer	II	Initiated phase II clinical study to determine the response rate and toxicity in up to n=90 pts HTUread moreUTH
353	Perifosine	Signal trans-duction (AKT, MAPK, JNK) inhibition	Oral small molecule	Aeterna Zentaris & Keryx Biophar-maceuticals	Oncology	NSCLC in combination with radiotherapy	II	Initiated an European exploratory phase II study in n=160 pts with once daily dosing HTUread moreUTH
S 015	Cloretazine; VNP40101M	DNA alkylation; AGT + GST inhibition	Sulfonyl hydrazine prodrug	Vion Pharma-ceuticals	Oncology	Relapsed SCLC	II	Started phase II trial in up to n=90 pts HTUread moreUTH
S 354	RP101; INOC001;	STAT3 and APEX down-regulation	“well known antiviral drug for herpes zoster”	Avantogen & Innovate (from RESprotect)	Oncology	Pancreatic cancer in combination with standard chemotherapy	II	Reported survival results from extended observation of pts from clinical study: median survival of 447 d which is higher than historical controls HTUread moreUTH
S 340	XL844	Chk1 and 2 protein kinases	Oral small molecule	Exelixis	Oncology	CLL	I	Initiated phase I clinical trial to study safety, tolerability and PK profile HTUread moreUTH
S 341	XL184	Hepatocyte growth factor receptor (Met) + VEGF-R2 + other RTKs	Oral small molecule	Exelixis	Oncology	Solid tumors	I	Initiated phase I clinical trial to study safety, tolerability and PK profile HTUread moreUTH
S 338	Trp-p8 agonists	Trp-p8 trans-membrane ion channel	Oral small molecules	Dendreon & Genentech	Oncology	Tumors	Leads	Identified several lead candidates which were effective in animal models HTUread moreUTH
344	Visudyne® verteporfin	Oxygen radicals generated after laser light activation	Small molecule in photo-dynamic therapy setting	QLT Inc & Novartis Ophthtalmics	Ophthal-mology	Wet AMD with predominantly occult neo-vascularization	Mar-ket	Primary endpoint not achieved after 2 yr follow up in clinical study HTUread moreUTH
S 339	Lomucin™ talniflumate	hCLCA1 chloride channel blocking	Small molecule	Genaera	Pulmonary	Cystic fibrosis	II	Started phase II trial with support of the CF Foundation Therapeutics in n=200 pts over 1 yr HTUread moreUTH
S 342	Indacaterol QAB149	Beta2-receptor agonism	Oral small molecule	Novartis	Pulmonary	Asthma and chronic obstructive pulmonary disease	II	Study results show that once-daily indacaterol is effective over 24 h and well tolerated HTUread moreUTH
S 350	Altace® ramipril	Angiotensin converting enzyme inhibition	Oral small molecule	King Pharmaceutical & Wyeth	Renal	Delay of progreesion of chronic kidney disease in hypertensive, non-diabetic pts	sNDA	FDA accepted a supplemental NDA filing for new indication of the ACE inhibitor HTUread moreUTH
S 098	XL784	ADAM-10 matrixmetalloproteinase	Oral small molecule	Exelixis	Renal	Renal failure	I	A repeat dose phase I study has been initiated in healthy volunteers HTUread moreUTH

R&D Pipeline News - Technology Edition Sample September 2005

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Product Type: Pharmaceutical			Category: Antibody
ID No.	Product Name	Target / Mechanism of Action	Class of Compound	Company	Therapeutic Area	Indication	R&D Stage	Message
318	Tysabri / antegren; natalizumab	Alpha4 / beta1/7 integrin	Rec humanized mab	Elan & Biogen Idec	Neurology / gastro-intestinal	Multiple sclerosis Crohn’s disease	Off mar-ket	Expect to complete the safety evaulation in a few weeks and to file a sBLA for Tysabri in multiple sclerosis HTUread moreUTH
071	Eculizumab ; H5G1.1	Complement C5	Rec humanized full mab	Alexion Pharma-ceuticals	Cardio-vascular & blood	Paroxysmal nocturnal hemoglobinuria	III	Completed enrollment of the phase III trial with n=95 in the orphan drug indication HTUread moreUTH
460	Avastin® Bevacizumab R435	VEGF	Rec humanized mab	Genentech & Roche	Oncology	Platinum-refractory ovarian cancer	II	Discontinued enrollment of a phase II study due to occurrence of 5 cases of gastrointestinal perforation in the first 44 pts HTUread moreUTH
117	Altastaph™	Capsular polysaccharides from S. Aureus types 5+8	Purified immunoglobulin from humans immunized with StaphVAX®	Nabi Biopharma-ceuticals	Infectious	S aureus infections in very low birth weight infants & hospitalized adults	II	Received a favorable opinion from the COMP of the EMEA for desi-gnation as orphan drug in treatment of Staphylococcus aureus bacteremia HTUread moreUTH
467	Proxinium™ VB-845	EpCAM	immunotoxinscFv + pseu-domonas exotoxin	Viventia Biotech	Oncology	Recurrent, refractory head & neck cancer	Pre II	Received FDA clearance to start phase II trial HTUread moreUTH

Product Type: Pharmaceutical			Category: Protein
ID No.	Product Name	Target / Mechanism of Action	Class of Compound	Company	Therapeutic Area	Indication	R&D Stage	Message
009	Increlex rhIGF1	IGF1 receptor	Rec human insulin growth factor 1	Tercica	Metabolism & endocrine	Severe primary IGF1 deficiency	Mar-ket	Presented results of 6 children treated until they have received adult height (gaining 16 cm); and further biochemical and PK data HTUread moreUTH
330	Procrit® Epoetin alfa	Erythropoietin receptor	Rec hu ery-thropoietin	Ortho Biotech	Oncology	Chemotherapy-induced anemia	Mar-ket	Procrit® was superior to Aranesp® in increasing hemoglobin after 4 wks of treatment with standard doses HTUread moreUTH
474	MM-093	AFP receptor	Rec hu alpha fetoprotein produced in transgenic goats	Merrimack Pharmaceuticals	Rheumatoid	Rheumatoid arthritis	II	Contracted out further manufacturing to GTC Biotherapeutics, ongoing pilot phase II study HTUread moreUTH
481	rEV131	Immuno-suppressive via histamine receptor	Recombinant tick protein	Evolutec	Pulmonary & respiratory	Allergic rhinitis (hay fever)	II	The intranasally administered protein achieved its primary endpoint of symptoms scores in a n=112 pts study HTUread moreUTH
483	V10153	Thrombin	Modified rec human plasminogen	Vernalis	Neurology & psychiatry	Acute ischemic stroke	II	Currently being studied in stroke pts; signed process development and manufacturing agreement for phase III material with Diosynth Biotechnology HTUread moreUTH
476	sPHEX Metallo peptidase	Enzyme substitution	Rec enzyme	Enobia	Metabolism & endocrine	X-linked hypophosphatemia	Precl	Contracted out process development and cGMP batch manufacturing for phase I study scheduled for Q3/06 HTUread moreUTH

Product Type: Pharmaceutical			Category: Peptide
ID No.	Product Name	Target / Mechanism of Action	Class of Compound	Company	Therapeutic Area	Indication	R&D Stage	Message
048	Chrysalin® TP508	High-affinity thrombin receptor	23-aa synthetic peptide	OrthoLogic	Metabolism & endocrine	Bone fracture repair	III	Preclinical study showed neovas-cularization effects in support of bone repair and growth HTUread moreUTH
150	Xerecept®; Corticorelin acetate	Corticotropin release	Synthetic human CRF peptide	Neurobiological Technologies & Celtic Pharma	Oncology	Peritumoral brain edema	III	Celtic Pharma acquired ww licen-sing rights for Xerecept HTUread moreUTH
008	Hematide™	Erythropoietin receptor	Synthetic pegylated peptide	Affymax	Renal	Chronic kidney disease with pts not on dialysis	II	Initiated third phase II study in Europe with sc injection to evaluate safety, PD and PK HTUread moreUTH
469	PCK3145	Survival mechanism: signal transduction inhibition	Synthetic 15-mer peptide from PSP94	Procyon Biopharma	Oncology	Advanced prostate cancer	IIa	Filed IND to start clinical phase II development in USA following prior clinical experience abroad and published various preclinical papers on mechanism of action HTUread moreUTH
206	LAB CGRP	CGRP receptor	37 aa neuro-peptide (calcitonin gene related peptide)	LAB International	Pulmonary	Asthma	I	Completed phase I trial in healthy volunteers with inhalation of siingle ascending doses; showed safety and tolerability HTUread moreUTH

Product Type: Pharmaceutical			Category: RNA
ID No.	Product Name	Target / Mechanism of Action	Class of Compound	Company	Therapeutic Area	Indication	R&D Stage	Message
029	Genasense® Oblimersen sodium	Bcl-2	Antisense oligo-nucleotide	Genta	Oncology	Relapsed/refrac-tory CLL + chemotherapy	NDA	Announced results from extended follow-up of phase III pts showing longer remission duration and less relapse HTUread moreUTH
303	Isis 301012	apoB-100	2P^ndP generation antisense	Isis Pharma-ceuticals	Metabolism	High cholesterol	II	Initiated phase II development and plans to start with optimization of dose and frequency of dosing HTUread moreUTH
475	ARC183	Direct thrombin inhibition	Aptamer	Archemix & Nuvelo	Cardio-vascular	Acute cardiovascular settings	I	Clinical results showed sub-optimal dosing profiles due to amounts needed; project terminated in favor of 2P^ndP generation molecule HTUread moreUTH
135	AEG35156	Inhibition of X-linked inhibitor of apoptosis protein (XIAP)	2P^ndP generation antisense	Aegera Therapeutics	Oncology	Solid tumors in combination with docetaxel	I	Announced start of second phase I trial of XIAP antisense in combination with docetaxel HTUread moreUTH
473	ALN-RSV01	RSV	RNAi intranasal	Alnylam Phar-maceuticals	Infectious	RSV infection	Precl	Expects to file IND by end of 2005; dropped its ALN-VEG01 project in AMD due to competitive reasons HTUread moreUTH

Product Type: Pharmaceutical			Category: DNA
ID No.	Product Name	Target / Mechanism of Action	Class of Compound	Company	Therapeutic Area	Indication	R&D Stage	Message
477	CERE-120	Neurturin (NTN)	NTN gene via AAV type 2 vector	Ceregene	Neurology	Parkinson’s disease	I	Initiated patient treatment in the phase I study with NTN gene therapy to maintain survival of dopamine producing nerve cells HTUread moreUTH
478	CERE-100; AAV-NGF	NGF	NGF gene via AAV vector	Ceregene	Neurology	Alzheimer’s disease	I	Recently completed enrollment in phase I study in Chicago HTUread moreUTH

Product Type: Pharmaceutical			Category: Cells
ID No.	Product Name	Target / Mechanism of Action	Class of Compound	Company	Therapeutic Area	Indication	R&D Stage	Message
325	CB001	Transplantation of stem cells	Cord blood stem cells	ViaCell	Oncology	Hematopoietic stem cell transplantation in cancer	I	Suspended enrollment into clinical study due to acute graft-versus-host disease grade IV in 2/8 pts HTUread moreUTH and HTUeven moreUTH
472	CVA 21 virus	Oncolytic action of virus	Oncolytic Coxsackie-virus produced in rec cell line	Psiron	Oncology	Melanoma stage IV	I	Announced delay in clinical study completion due to supply problems and changes in the production cell line of the virus; material from the new cell line will be used for further phase I studies HTUread moreUTH
470	HuCNS-SC	Regeneration	Human fetal neural stem cells	StemCells	Neurology & psychiatry	Batten disease (neuronal ceroid lipofuscinosis)	IND	Phase I trial on hold since Feb 2005; company filed an amendment of its initial IND HTUread moreUTH
406	Adult mes-enchymal precursor cells	Tissue regeneration	Adult mes-enchymal precursor cells (aMPC)	Mesoblast Ltd	Orthopedic	Non-union or long bone fractures	Ethics comm approval	Received approval from Ethics Committee to study stem cell treatment in up to 10 pts HTUread moreUTH
482	ReN001	Tissue repair and regeneration	c-mycER technology based genetically stable neural stem cells	ReNeuron	Neurology & psychiatry	Chronic disability after stroke	Pre-IND	Held pre-IND meeeting and based upon agreed preclinical develop-ment program expects to file IND by mid 2006 HTUread moreUTH

Product Type: Pharmaceutical			Category: Vaccine
ID No.	Product Name	Target / Mechanism of Action	Class of Compound	Company	Therapeutic Area	Indication	R&D Stage	Message
471	Hexavac	Active immunization	Combination of 6 existing vaccines	Sanofi-Aventis	Infectious	Prevention of diphtheria, teta-nus, whooping cough, hepatitis B, polio and haemophilus influenzae B	Mar-ket	EMEA suspended sales of Hexavac due to concerns on efficacy of the vaccine ragarding hepatitis B immunogenicity possibly related to manufacturing changes performed at Merck HTUread moreUTH and HTUread FaQsUTH
047	FluMist® CAIV-T; influenza vaccine live, intranasal	Active immunization with influenza virus	Cold adapted live influenza vaccine, trivalent	MedImmune	Infectious	Prevention of influenza in healthy individuals 5-49 yrs of age	sBLA	Submitted sBLA for its refrigerator-stable formulation HTUread moreUTH
480	Proquad		Combination of vaccines	Sanofi-Pasteur	Infectious	Measle, mumps, rubella, varicella	MAA	The CHMP of the EMEA adopted a positive opinion on Proquad HTUread moreUTH
190	StaphVax®	Outer coating polysaccharide of Staph aureus types 5+8	S. aureus polysaccharide linked to large carrier molecule	Nabi Biopharma-ceuticals	Infectious	Pts at high chronic risk for Staph. Aureus infection, e.g. ESRD	III	Initiated repeat dose clinicl study in high chronic risk pts HTUread moreUTH
079	L-BLP25	MUC1	Liposomal synthetic peptide vaccine	Biomira & Merck KGaA	Oncology	Advanced NSCLC	IIb	Paper on phase IIb study was published in J Clin Oncol HTUread moreUTH; announced delay in start of phase III study due to accelerated stability problems HTUread moreUTH

R&D Pipeline News - Technology Edition Sample September 2005

Return to introduction ~ Request a 3 week FREE trial ~ Purchase

Product Type: Pharmaceutical			Category: Natural Source
ID No.	Product Name	Target / Mechanism of Action	Class of Compound	Company	Therapeutic Area	Indication	R&D Stage	Message
468	Hyalgan® hyaluronate	Substitution of hyaluronic acid/hyaluronate	HMW fraction of purified hyaluronate form rooster combs	Sanofi-Aventis	Metabolism	Pain due to osetoerthritis (knee)	sPMA	FDA accepted filing of supplemental Pre-Market Approval application to include shoulder pain due to osteoarthritis HTUread moreUTH
207	Miraxion®; LAX-101	Phospholipase A2 and caspases	Semi-syn-thetic highly purified eico-sapentaenoic acid (EPA)	Amarin	Neurology & psychiatry	Huntington’s disease	III	Announced patient enrollment and fist patient dosing in the US phase III trial conducted under SPA by the FDA HTUread moreUTH
485	Betulinol derivative	Cell division	Derivative from outer layer of the bark of the white birch tree	Marc Pharma-ceuticals	Oncology	Prostate cancer	Res-earch	Water soluble drug candidate slowed prostate tumor progression in mice by influencing tumor cell division HTUread moreUTH

Product Type: Pharmaceutical			Category: Generic
ID No.	Product Name	Target / Mechanism of Action	Class of Compound	Company	Product Category	Indication	R&D Stage	Message
S 355	SMT Sulfameth-oxazole + trimetoprim	antibiotic	Generic equivalent of Bactrim®	Interpharm Holdings	Small molecule	Urinary tract infections, bronchitis, otitis, traveler’s diarrhea et al.	Mar-ket	Announced the launch of the generic antibiotic HTUread moreUTH
S 326	Tretinoin cream USP, 0.05 %	Unclear (retinoid irritation)	Generic equivalent of J&J’s Renova®	Spear Pharma-ceuticals	Small molecule	Mitigation of fine wrinkles, mottl-ed hyperpigmen-tation, tactile roughness of facial skin	ANDA	Received approval on Sept 15, is looking for strategic alternatives in commercializing the cosmetic product HTUread moreUTH
S 330	Ziduvidine Tbls. USP 300 mg	HIV reverse transcriptase inhibition	Generic equivalent to GSK’s Retrovir®	Ranbaxy Laboratories	Small molecule	Treatment of HIV infection	ANDA	Received approval from FDA to market the generic antiretroviral AZT agent with a total oral zidovudine market of US$ 34 mln. HTUread moreUTH
S 336	Ziduvidine Tbls. and oral solution	HIV reverse transcriptase inhibition	Generic equivalent to GSK’s Retrovir®	Aurobindo Pharma (India)	Small molecule	Treatment of HIV infection	ANDA	Received approval from FDA to market the generic antiretroviral HTUread moreUTH
S 337	Ziduvidine Tbls.	HIV reverse transcriptase inhibition	Generic equivalent to GSK’s Retrovir®	Roxane Laboratories	Small molecule	Treatment of HIV infection	ANDA	Received approval from FDA to market the generic antiretroviral HTUread moreUTH

Product Type: Pharmaceutical			Category: Drug Delivery
ID No.	Product Name	Target / Mechanism of Action	Class of Compound	Delivery System	Company	Indication	R&D Stage	Message
S 345	Vivitrex® naltrexone long-acting injection	Opioid receptor	Small molecule	ER Medisorb technology with polylacti-de co-glycolide microspheres	Cephalon & Alkermes	Alcohol dependence	NDA	FDA notifed about extension of action date by 90 days HTUread moreUTH
S 349	Symbicort® budesonide + formoterol	Corticosteroid receptor + beta 2 recep-tor agonism	Combination of inhaled budesonide + formoterol	Dry powder inhaler device Turbuhaler®	AstraZeneca	Maintenance treatment of asthma	NDA	Submitted an NDA to the FDA based on 27 clinical trials HTUread moreUTH
354	Junovan™ L-MTP-PE; MEPACT	Macrophage targeting and activation	Synthetic tripeptide derived from muramyl dipeptide	Liposomal formulation	IDM Pharma	High-grade, non-metastatic osteosarcoma	III	Produced first lot of commercial production process via CMOs which appears to be comparable with previous phase III material HTUread moreUTH
S 328	SABER™-Bupivacaine	Blocks gener-ation and con-duction of ne- rve impulses	Amino amid class of local anesthetics	SABER™-depot injectable DD technology	Durect Corp	Post-operative pain relief	II	Completed dosing in last cohort of phase II study in hernia pts with local administration HTUread moreUTH
352	PYY 3-36	Appetite regulation	Hormone peptide	Intranasal with spray	Nastech Pharmaceutical	Obesity	II	Announced publication in J Obesity about preclinical study results showing PoC in weight reduction HTUread moreUTH
484	IFN-alpha-XL	IFN-alpha 2b receptor	Rec interferon alpha 2b	Medusa® nanoparticle technology	Flamel Bio-technologies	Chronic hepatitis C virus infection	I/II	Phase I/II results show safety, tolerability and long-acting activity HTUread moreUTH
S 329	Zolmitriptan + Actyve™	Selective 5-hydroxytryptamine 1B/1D receptor agonism	Zolmitriptan (NCE)	Actyve™ transdermal iontophoretic delivery	Vyteris	Migraine	I	Showed clinical PoC of its transdermal iontophoretic delivery in comparison with oral zolmitriptan HTUread moreUTH
S 327	Oral heparin capsule	Indirect thrombin inhibition	Heparin	Eligen® oral DD technology with carriers	Emisphere Technologies	Anticoagulation	Clin	Completed dosing in a trial comparing oral heparin with iv and sc heparin HTUread moreUTH

Product Type: Radiotherapy & Radiopharmaceuticals
ID No.	Product Name	Target / Mechanism of Action	Class of Compound	Company	Therapeutic Area	Indication	R&D Stage	Message
X 005	Y-90 Yttrium 90 sterile solution	radiation	Isotope	MDS Nordion	Oncology	NHL	Mar-ket	MDS Nordion will supply Berlex Canada with sterile Yttrium 90 to be used for its radioimmunotherapy with Zevalin
479	^P131PI-labeled Labetuzu-mab	CEA	^P131PI-radio-labeled rec humanized mab	Immuno-medics	Oncology	Colorectal cancer	II	Results of a 5-yr follow up study with n=23 pts were published in the J Clin Oncol showing twice as long survival as historical and con-temporaneous controls HTUread moreUTH

Product Type: Biomaterials, Medical Devices, Combination & NanoTechnology Products