California Biomedical Industry - California Healthcare Institute

••Ella (ulipirstal acetate) approvedin August 2010 from French HRAPharma and Corona, California’sWatson. Ella was developed forthe the prevention of pregnancyfor up to 120 hours (five days)post-unprotected intercourse orcontraceptive failure. Waston holdsthe U.S. commercialization rightsto Ulipristal acetate, a selectiveprogesterone receptor modulator,and plans to launch the agentunder the trade name ELLA infourth quarter 2010. The agent ismarketed in the EU as an emergencycontraceptive under the trade nameellaOne.••Fanapt (iloperidone) marketedin January 2010 by Novartis hada California connection for abouta year back in 1997 when SanFrancisco company Titan bought therights from Sanofi-Aventis after theyhad discontinued research. Laterthat year, Novartis acquired therights from Titan, then licensed themto Vanda of Maryland in 2004 whichtook the compound to approval, andthen Novartis reacquired the U.S.and Canada rights to the drug. Ameandering journey to be sure, butnot unusual. Fanapt (iloperidone)is an atypical antipsychotic withmixed dopamine-D2/5HT2 receptorantagonist properties indicated inschizophrenia. The product also haspotential use in bipolar disorder.••Vibativ (telavancin) marketedin November 2009 by Astellaswas developed by San Francisco’sTheravance. VIBATIV(telavancin) isa glycopeptide injectable antibioticfor the treatment of Gram positivebacterial infections and is a potentialnew treatment for methicillinresistantStaphylococcus aureus(MRSA). Originally developedby Theravance, its FDA approvalindicates it for complicated skinand soft tissue infections (cSSTI)in adults. It has also been filed forapproval in the U.S. in the indicationof hospital-acquired pneumonia ornosocomial pneumonia.••Bepreve (bepotastine)marketed in October 2009 by ISTAPharmaceuticals of Irvine, is anophthalmic formulation of a secondgenerationhistamine H1 receptorantagonist that was first developedand launched by Tanabe in Japanin 2000 for allergic rhinitis. Thenew indication for the formulationISTA developed is for the treatmentof ocular itching associated withallergic conjunctivitis in patientsaged two years and older.••Savella (milnacipran) marketedin April 2009 from CypressBioscience of San Diego and comarketedwith Forest Labs is anantidepressant (dual 5-HT andnorepinephrine reuptake inhibitor),approved for the management offibromyalgia.••California companies and researchinstitutions are also waiting forapproval for drugs to treat diseaseswith narrower patient populations:••Lucinactant from The ScrippsResearch Institute for respiratorydistress syndrome••Pharmacyclics’ motexafingadolinium to treat metastasis innon-Hodgkin’s lymphoma and othertypes of cancer.InterMune Inc.’s drug to treat idiopathicpulmonary fibrosis, a fatal lungscarringdisease, received a positiverecommendation from the EuropeanMedicines Agency’s Committee forMedicinal Products for Human Use.The European Commission could acton the recommendation in early 2011which could enable the drug, calledpirfenidone and branded as Esbriet,to be sold in the 27 countries of theEuropean Union.No drug in the United States or Europeis currently approved to treat thedisease, which has no known causeand slowly scars the lungs and makesit increasingly difficult for patients tobreathe. IPF patients typically have twoto five years to live after diagnosis.California’s early start in nurturingand developing the biotech industryis bearing fruit. California has leadingcompanies of all types from largemultinational biotechs like Amgenand Genentech to technology anddevice companies, as well as one of thelargest and best respected collectionsof academic institutions in the world.With the world’s largest, most diverseand most successful biopharmaceuticalecosystem, California benefitsimmeasurably from the contributions ofthe scientists and researchers tacklingour toughest diseases.26 | California Biomedical Industry 2011 Report