SUPPLEMENTARY INFORMATION In format provided by Czerepak and Ryser (MARCH 2008)

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1 Table S1 US FDA drug approvals from January 2006 December 2007 Quarter Proprietary name Generic name Indication* Industry origin, innovation level 4Q 2007 Bystolic Nebivolol # Hypertension Erbitux Cetuximab Metastatic colorectal 2b cancer after failure of irinotecan and oxaliplatin, as a monotherapy Doribax Doripenem Complicated intraabdominal and complicated urinary tract infections Isentress Raltegravir HIV infection, in other antiretroviral therapies Ixempra Ixabepilone Metastatic or locally advanced breast cancer resistant to treatment with anthracycline, taxanes or capecitabine, as monotherapy or in capecitabine Kuvan Sapropterin # Phenylketonuria Mircera Methoxy Anaemia associated with polyethylene glycolepoetin beta chronic renal failure Nexavar Sorafenib Hepatocellular carcinoma 2b Omnaris Ciclesonide nasal Seasonal allergic rhinitis spray in 6 11 years old Renvela Sevelamer carbonate Control serum phosphorus in dialysis patients with chronic kidney disease (CKD) Tasigna Nilotinib Philadelphia chromosome-positive chronic myelogenous leukemia in patients who are resistant or intolerant to prior therapies Stavzor Valproic acid Seizures and manic episodes associated with bipolar disorder and to prevent migraines Voluven Hydroxyethyl Blood volume loss starch # following surgery 3Q 2007 ACAM 2000 Smallpox vaccine Vaccine for use in subjects at high risk of exposure

2 Afluria Influenza vaccine Prevent influenza types A and B in adults 18 years and older Azor Fixed-dose Hypertension combination of olmesartan and amlodipine EvaMist Estradiol Moderate to severe vasomotor symptoms due to menopause Evista Raloxifene Reduce risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk for breast cancer Evithrom Human thrombin General haemostasis in Exelon Patch Rivastigmine surgery Mild to moderate Alzheimer s disease (AD) Exelon Rivastigmine Mild to moderate Parkinson s disease dementia LCP Fenofibrate Hyperlipidaemia and FenoChol hypertriglyceridaemia Sanctura XR Trospium chloride Overactive bladder Selzentry Maraviroc Treatment-experienced adult patients infected with CC chemokine receptor 5 (CCR5)-tropic HIV-1 Somatuline Lanreotide, depot Acromegaly Totect Dexrazoxane Accidental extravasation of anthracycline chemotherapeutics Zelnorm Tegaserod Women with irritable bowel syndrome with constipation or chronic idiopathic constipation Zingo Lidocaine powder, needle-free injection Pain associated with venous access procedures in children ages Q 2007 Altabax Retapamulin Impetigo AzaSite Azithromycin Bacterial conjunctivitis ophthalmic solution Extina Ketoconazole, topical Seborrheic dermatitis in immunocompetent H5N1 influenza virus vaccine H5N1 pandemic influenza vaccine patients Prevent influenza

3 HepaGam B Human hepatitis B immune globulin Prevent hepatitis B virus (HBV) reinfection in HBsAg-positive liver transplant patients Letairis Ambrisentan Pulmonary arterial hypertension Neupro Rotigotine Early stage Parkinson s disease Nuvigil Armodafinil Excessive sleepiness associated narcolepsy, obstructive sleep apnea/hypopnea syndrome and shift work sleep disorder Perforomist Formoterol fumarate Chronic obstructive pulmonary disease (COPD) Supprelin- LA Subcutaneous histrelin acetate implant Central precocious puberty Torisel Temsirolimus Advanced renal cell carcinoma Xyzal Levocetirizine dihydrochloride Seasonal and perennial allergic rhinitis and uncomplicated skin manifestations of chronic idiopathic urticaria Zyflo CR Zileuton Prevent and treat asthma 2a Prevent influenza in individuals 5-49 years of age 1Q 2007 CAIV-T Live attenuated cold-adapted trivalent influenza vaccine Exforge Combination of amlodipine and valsartan Hypertension Humira Adalimumab Moderate to severe Crohn s disease in patients not responding to conventional therapy Keppra Levetiracetam Adjunctive therapy, primary generalized tonic-clonic seizures in patients Lialda Mesalamine Induction of remission in patients with active, mild to moderate ulcerative colitis Olux-E Clobetasol propionate foam Inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients ages 12 and older Soliris Eculizumab Paroxysmal nocturnal haemoglobinuria 2a

4 Sutent Sunitinib malate Advanced renal cell carcinoma, first-line treatment Tekturna Aliskiren Hypertension, monotherapy or in other anti-hypertensive agents Tykerb Lapatinib Advanced metastatic HER2-positive breast cancer in patients who have received prior therapy, in combination with capecitabine Vidaza Azacitidine Myelodysplastic syndromes (MDS) Vyvanse Lisdexamfetamine Paediatric attentiondeficit/hyperactivity disorder (ADHD) Yaz Ethinyl estradiol/ drospirenone Moderate acne in women who want an oral contraceptive for birth control 4Q 2006 Avastin Bevacizumab Unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC), in carboplatin and paclitaxel as first-line treatment Byetta Exenatide Adjunctive therapy to improve blood sugar control in patients with type 2 diabetes who have not achieved adequate control on a thiazolidinedione Coreg CR Carvedilol Mild to severe heart failure Elestrin Estradiol gel Moderate to severe vasomotor symptoms associated with menopause Invanz Ertapenem Prevent surgical site infection following elective colorectal surgery in adults Invega Paliperidone, extended-release Januvia Sitagliptin phosphate Schizophrenia Adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes, 4 2a 2b 2b

5 Omnaris Ciclesonide Seasonal and allergic rhinitis in patients 12 years of age and older Polyphenon Clindamycin External genital and E Ointment perianal warts Tyzeka Telbivudine Chronic HBV infection Veregen Kunecatechins, External genital and topical perianal warts Zolinza Vorinostat Cutaneous T-cell lymphoma, third-line therapy 3Q 2006 Atripla Fixed-dose HIV-1 infection combination of emtricitabine, tenofovir and efavirenz Elaprase Idursulfase Mucopolysaccharidosis II, Hunter syndrome Fentora Fentanyl Breakthrough cancer pain Noxafil Posaconazole Prevent invasive Aspergillus and Candida infections in immunocompromised patients at high risk for infection Pylera Triple-combination of biskalcitrate potassium, metronidazole and tetracycline Helicobacter pylori infection Vectibix Panitumumab Metastatic colorectal cancer in patients who have failed chemotherapy Verdeso Desonide, topical Mild to moderate atopic dermatitis Xolegel Ketoconazole, Seborrheic dermatitis topical Vivitrol Naltrexone Alcohol dependence 2Q 2006 Chantix Varenicline Smoking cessation Cubicin Daptomycin Bacteremia caused by Staphylococcus aureus, endocarditis caused by methicillin-susceptible S. aureus (MSSA) and methicillin-resistant S. aureus (MRSA) Dacogen Decitabine MDS Daytrana Methyl-phenidate Paediatric ADHD 2b Exelon Rivastigmine Mild to moderate dementia associated with Parkinson s disease Lucentis Ranibizumab Wet age-related macular degeneration 2a

6 Myozyme Alglucosidase alfa Pompe s disease Opana Oxymorphone Pain Oracea Doxycycline Rosacea Orapred Prednisolone Paediatric asthma and reduce inflammation from various inflammatory conditions Prezista Darunavir HIV infection, 4 Revlimid Lenalidomide Newly diagnosed multiple myeloma, in dexamethasone Sprycel Dasatinib Chronic myelogenous leukaemia and Philadelphia chromosome-positive acute lymphoblastic leukaemia in patients with resistance or intolerance to prior therapy Thalomid Thalidomide Newly diagnosed multiple myeloma, in dexamethasone Tysabri Natalizumab Monotherapy, relapsing 2a forms of multiple sclerosis (MS) 1Q 2006 Amitizia Lubiprostone Chronic idiopathic constipation in adults Aranesp Darbepoietin alfa Chemotherapy-induced anaemia in patients with non-myeloid malignancies Azilect Rasagiline mesylate Parkinson s disease, as monotherapy and adjunct therapy to levodopa Eraxis Anidulafungin Esophageal candidiasis Erbitux Cetuximab Squamous cell carcinoma of the head and neck Exubera Inhaled insulin Type 1 and type 2 diabetes Ranexa Ranolazine Chronic angina Ralenza Zanamivir Prevent influenza in, 4 adults and children age five years or older Rituxan Rituximab Diffuse large B cell, CD20 positive, non- Hodgkin s lymphoma in anthracycline-based chemotherapy, as firstline treatment

7 Rituxan Rituximab Moderately to severely active rheumatoid arthritis in patients who have had an inadequate response to anti-tnf therapies, in combination with methotrexate Sutent Sunitinib malate Advanced renal cell carcinoma and gastrointestinal stromal tumors Vusion Miconazole, topical Candida-associated diaper dermatitis Zegerid Omeprazole Heartburn and other symptoms associated with gastroesophageal reflux disease (GERD), erosive esophagitis, duodenal ulcers and gastric ulcers, 4 * For full information of clinical indications, please refer to FDA approvals and/or company information. 1=biotech companies; 2=biotech/pharma alliances; 3=pharmaceutical companies; 4=acquired /licensed product from a biotech company; a=novel drug, new chemical structure; b=line extension; c=me-too. New Molecular Entities or New Biologics, not including imaging agents (21 in 2006; anticipated to be 18 in 2007). # An NME designation has not yet been given to nebivolol, hydroxyethyl starch and sapropterin by the FDA according to the FDA website, but is anticipated to be by some. Source: BioCentury reports (REFS 1 8) and 1. No Author listed. 1Q Stock Wrap-Up. BioCentury 14, No.15, 9 11 (2006). 2. No Author listed. 2Q Stock Wrap-Up. BioCentury 14, No. 29, (2006). 3. No Author listed. 3Q Stock Wrap Up. BioCentury 14, No. 43, (2006). 4. Edelson, S. 4Q Stock Wrap-Up. BioCentury 15, No. 1, 8 12 (2007). 5. No Author listed. 1Q Stock Wrap-Up. BioCentury 15, No. 15, 9 12 (2007). 6. Lawrence S. 2Q Stock Wrap-Up. BioCentury 15, No. 29, (2007). 7. Lawrence, S. 3Q Stock-Wrap-Up. BioCentury 15 No. 43, 9 12 (2007). 8. Lawrence, S. 4Q Stock Wrap-Up. BioCentury 16 No. 2, (2008).

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