Sicor Gets Nod on New Generic; Watson Pursuing Bladder Therapy
For some time, Orange County health officials have wanted to expand local services for people with severe mental illnesses. The county’s Health Care Agency unveiled one of those efforts earlier this month.
The agency joined with Royale Health Care Center to open an 80-bed psychiatric health and mental health rehabilitation facility in a building off Los Alisos Boulevard in Mission Viejo previously owned by Charter Behavioral Health System. Royale Mission Viejo was set to admit its first patients last week.
“We’ve been involved in trying to acquire a facility for several years,” said Juliette Poulson, the Health Care Agency’s director.
The agency is leasing the facility from Royale, paying a fixed monthly cost of $58,229 over a 20-year lease. The business relationship also calls for a $21.6 million, three-year contract for services, including a staff of approximately 60 people. Tobacco settlement proceeds are funding the new facility, Poulson said.
“This will add to the continuum of care,” Poulson said. “It’s important for individuals with long-term mental illnesses.”
Having Royale complements existing acute care and sub-acute services, she said. Additionally, she noted that the facility could bring back some of the approximately 300 OC residents who are receiving mental health services in Los Angeles and Riverside counties.
Royale Mission Viejo plans to provide therapeutic treatment of initial or chronic mental illness with a focus on helping its patients develop skills necessary for an independent lifestyle. “The program itself will have a heavy emphasis on pre-employment skills and vocational training,” Poulson said. “Having this for rehabilitation, we’re better able to manage the care.”
Poulson acknowledged, however, that Royale Mission Viejo isn’t the be-all, end-all when it comes to mental healthcare services. “By no means does this fully meet our needs,” she said.
When it comes to payment, Poulson said the agency’s “residents”,its preferred term for patients,almost all receive MediCal.
As for patient load, the Health Care Agency treated 35,500 mentally ill adults on an outpatient basis in 1998-99, the last year for which figures were available. Comparable figures weren’t available for inpatients, but an agency spokeswoman said inpatient adult mental health admissions are running approximately 3,000 a year.
On the FDA Front
Gensia Sicor Pharmaceuticals Inc., a subsidiary of Sicor Inc., Irvine, received approval of an abbreviated new drug application from the Food and Drug Administration for its Thiotepa injectable pharmaceutical. Thiotepa, a generic of Seattle-based Immunex Corp.’s Thioplex, is intended for treating breast and ovarian cancers, superficial papillary carcinoma of the bladder and various lymphomas, such as Hodgkin’s disease.
Figures from IMS, a pharmaceutical market research firm, showed that sales of branded Thiotepa totaled $19 million last year. An abbreviated new drug application means that a company marketing and selling generic pharmaceuticals are generally not required to include animal and human study data to establish safety and efficacy.
In other FDA-related news, Refractec Inc., an Irvine medical technology and research firm, said the agency accepted its clinical module for pre-market approval. Refractec is asking regulators to approve conductive keratoplasty, or CK, to treat farsightedness.
Refractec touts CK as a less invasive and less expensive alternative to LASIK laser eye surgery for treating farsightedness. It works by inserting a hair-thin probe inside the cornea. That probe is then heated by radio frequency energy, which shrinks collagen around the cornea’s edge,causing it to rise. That allows the cornea to be reshaped.
Also, Watson Pharmaceuticals Inc., Corona, filed a new drug application with the FDA for an oxybutynin transdermal system to treat overactive bladders. The application was based on clinical results obtained by a placebo-controlled Phase III trial in more than 500 patients.
Bits and Pieces:
TriZetto Group Inc., Newport Beach, signed an application service provider contract with Potomac Physicians, P.A., an affiliate of CareFirst BlueCross BlueShield. Potomac Physicians has 11 offices in the Baltimore-Washington, D.C. area Fountain View Inc., the Burbank-based owner of Carehouse Care Center, Santa Ana, said the U.S. Health Care Financing Administration appealed a federal administrative law judge’s decision that reversed the de-certification of Carehouse from Medicare and Medicaid funding BC Life and Health Insurance Co., Thousand Oaks, signed a software licensing agreement with StrataCare, Newport Beach. The deal covers workers’ compensation bill review software I-Flow Corp., Lake Forest, said it signed an international distribution agreement with Ruesch Group, a German company, to distribute I-Flow’s PainBuster and Soaker pain management systems Children’s Hospital of Orange County, Orange, recently hosted a forum on children and young adults’ athletic injuries BioBid.com, Newport Beach, said it was collaborating with EinsteinsGarage, a Pittsburgh company, to create an Internet site for buying and selling equipment, supplies and services to biotechnology, pharmaceutical and academic life science research markets Houston-based Sharps Compliance Inc. introduced a mail-back disposal system for needles and syringes at a recent meeting of the Orange County Diabetic Educators Arrowhead Standard Inc., Dana Point, and BesTech Consulting Services, Laguna Niguel, said they started offering regulatory compliance assistance for medical device and instrument manufacturers.
