SoCalBiowww.socalbio.org 1SYNERGIESSoCalBio

� Fall/Winter 2006

SYNERGIES

Volume III, Issue 1 . Fall - Winter 2006

SoCalBio

The Voice of the Life Sciences Community in the Greater Los Angeles Region

Southern California

BiomedicalCouncil

C-LAB Fosters Collaboration

“California Style”CSU Program Addresses

Biotech Workforce Education &

Training Needs in L.A.

By James Rosser, Ph.D.

President

California State University, Los Angeles

Icons of Modern Dentistry:Dental implants represent awatershed innovation in moderndentistry. They are titaniumreplacements for dental rootsimplanted directly into a patient’sjawbone. They fuse with the jawbonethrough osseointegration,(2) aprocess discovered accidentally in1952 by the Swedish orthopedicsurgeon, Dr. Per-Ingvar Brånemark,who was the first to implant titaniumroots in a human in 1965. His workled to the 1981 formation ofNobelPharma – one of the firstcommercial providers of dentalimplants. The company was

James Mazzo

Chairman, President & CEO

Advanced Medical Optics

is Santa Ana-based Advanced Medical Optics (AMO).Spun-off in 2002 from Irvine-based Allergan, Inc., thepublicly-traded AMO (NYSE: EYE) employs nearly 4,000in operations located in 24 countries. The company isunique in that it provides a wide range of products toaddress what it describes as the “vision care life cycle.”Notwithstanding recent stock performance hickups and avoluntary product recall, the company is expectinghealthy growth in 2007 and beyond.

Jim Mazzo, AMO’s chairman, president and CEO,recently spoke with SoCalBio Synergies about hiscompany’s product development efforts.

--------------------

Why did Allergan form AMO as a spin-off venture?

I had been with Allergan for 22 years and was part of itsexecutive team when we came to the realization thatmanagement had been operating two distinct businessesunder the Allergan umbrella. One was engaged inspecialty pharma, while the other was focused onmedical devices. Since Allergan was a publicly tradedcompany, the question for management involved whatstrategy would be best for shareholders. It was clear thatthe answer was a tax-free spin off. This strategy wouldallow both companies to run independently, build theirown management teams, and have their own board ofdirectors.

The spin-off occurred just as many industry observers

were touting the benefits of device-drug convergence.

Do you think potential synergies may have been lost as

a result of parting with Allergan?

Specialty pharma and medical devices are distinctlydifferent businesses, and one does not necessarilyleverage the other. In effect we had two companiesoperating under one roof. It was very difficult to developa cohesive strategy when we were under the Allerganumbrella because we had to be pharma specialists oneday and a medical device specialists the next. As bothsides of Allergan’s business gained in size, we started to

The Greater Los Angeles region has developed awell earned reputation as a hotbed for eye careproduct development and manufacturing.Locally spawned innovations include many

advances in the cataract and refractive surgery that nowdominate a significant share of the worldwide eye caremarket. This rich tradition began in the ‘70s and ‘80s,when companies such as Cavitron of Irvine, Iolab ofClaremont, Ioptex of Irwindale, STAAR Surgical ofMonrovia, Optical Radiation Corp. of Asuza, andPharmacia Ophthalmic of Monrovia helped develop thetools that transformed cataracts from a disabling diseaseinto a manageable condition.

While industry restructuring and technological changehastened the demise of many first-generation firms, themanagerial class they left behind helped sprout a newcrop of companies that are now re-inventing the eye-carebusiness. The list includes implantable lens makers suchas Eyeonics of Aliso Viejo, ReVision Optics of LakeForest, and Calhoun Vision of Pasadena, LASIK devicefirms such as IntraLase of Irvine, and Second Sight ofSylmar, which specializes in back-of-the-eye implants torestore vision to the blind.

Topping the region’s impressive list of ophthalmic firms

SoCalBio Profile: Advanced Medical OpticsGlobal Leader in Eye Care Technology Tops Greater L.A.

Region’s Burgeoning Ophthalmic Industry Cluster

renamed Nobel Biocare in 1996, and isnow the dominant player in implantdentistry.

Dr. Brånemark introduced the results ofhis research on osseointegration to askeptical North American scientificcommunity during the Toronto Conferencein 1982. His data on the success ofimplants at the Brånemark Clinic helpedgalvanize support for the use of dentalimplants in the U.S.

If Dr. Brånemark’s research demonstratedthe validity of osseointegration and,therefore, the clinical potential of implantdentistry, Dr. Niznick’s inventions helpedmake this potential a commercial reality inthe U.S.

Historically, dental implants were made intwo parts: an anchor (screw) to provide

the replacement root, and a post (abutment) to supportor retain an artificial tooth. The most commonly usedinterface between these two parts was Brånemark’sexternal hexagonal design. Although considered theindustry standard and used by Nobel Biocare in itsBrånemark line of implants, articles in implant journalsreported that this design had numerous deficienciesmaking it prone to chronic screw loosening and failure.

One of Dr. Niznick’s early inventions provided analternative via an implant design launched in 1986 thatincorporated the “internal hexagonal connection.”Protected by U.S. Patent # 4,960,381 issued on Oct.2nd, 1990, this design provided a stable mechanism forattaching the screw to the abutment and, as a result,

Implant Dentistry Pioneer Dr. Jerry Niznick

Takes Aim at Industry Heavyweights

On September 26, Implant Direct LLC --a medical device startup based in the City ofCalabasas, a suburb of Los Angeles --received 510(k) clearance from the FDA (#

K061319) to market its Spectra-System dentalimplants. To a casual observer, the system (see page 3)may look like just another substantially-equivalentdental product. But once you know the identity of theman behind Implant Direct, this 510(k) decision takeson a whole new meaning, as it signals the return to themarketplace of Jerry Niznick, D.M.D., M.S.D., aprosthodontist and longtime Los Angeles entrepreneurdescribed by a recent article in Barron’s as “thegodfather of American implant dentistry.”(1)

@ A Glance

By Ahmed Enany

Editor-in-Chief

continued on page 3

Workforce Development

continued on page 4

continued on page 3

Interview

Honor Roll

Collaboration is a key ingredient in just aboutevery major scientific endeavor. Nowhere isthis truer than in the field of biotechnology,where scores of companies are developing

wonders such as new gene therapies to fight diseasesand new microbial cleansers to remediate hazardouswastes. Converting the results of this promisingresearch into commercial reality, and doing so quicklyand effectively, requires a strong intellectual and humancapital.

There is no denying the fact that California, thebirthplace of commercial biotechnology, hasmaintained its leadership in this field because itcontains the intellectual and human assets required tosupport biocommerce. However, this leadershipposition shouldn’t lull us into a false sense ofcomplacency. As each advance in biotechnologygenerates a new wave of commercial opportunities, itshould also sound a renewed call for continuedcollaboration between educational institutions andindustry to ensure that the State’s supply of humancapital is always replenished.

compete for resources. In addition, we always hadseparate sales forces — one for surgical and one forpharma. The spin-off has been nothing but positive forboth companies because it has enabled each to focus onits strengths.

How do you describe AMO’s product development

strategy?

AMO’s strategy is guided by the patient “vision care lifecycle” model, which is based on providing products tomeet the patient’s eye-care needs throughout his or herlifetime. We’re also focused on providing a “completerefractive solution” for surgeons. AMO has grown tobecome a fully-integrated, multinational company with3,800 employees - about 600 in the U.S., and the rest inmanufacturing outside the U.S., mostly in Puerto Rico,China, Spain and Sweden.

Which products target the fast-growing youth market?

The majority of contact lens users are under the age of35, with the fastest growing demographic between the

Interview by Ahmed Enany, Editor-in-Chief &

Erik Deutsch, Managing Editor

Nobel’s external hex

connection

CoreVent’s internal

hex connection

Dr. Jerry Niznick

President & CEO

Implant Direct LLC

An icon of dentistry who, along

with Dr. Brånemark of Sweden,

helped jumpstart the dental

implant industry more than 25

years ago.

Who Raised the MostCapital in 2006?

It’s been a bumper year for fundraising by GreaterL.A. device and biotech firms. The top firms --including several alumni of the SoCalBio InvestorConference -- have collectively secured more than

$300 million in various forms of private financingduring 2006. And the year isn’t over yet.

Here are the top five companies that raised the mostcapital from institutional investors and other sources.

Cougar BiotechnologyWestwood-based Cougar tops the list with $47.5million raised last Spring in private placement funds.The list of investors includes Brookside Capital, fundsmanaged by T. Rowe Price Associates, Merlin BiomedGroup, RA Capital Management, and Tavistock LifeSciences. Cougar, which filed to go public via a reversemerger, focuses on novel oncology therapies, andcurrently has three lead compounds targeting prostatecancer and hematological malignancies in the clinicalphase. �

AMO’s Verisyse™ phakic IOL (left) and multifocal

ReZoom™ lens for cataract patients

SoCalBio Roundup............ 2Inside

�

continued on page 4

Keith Leonard of Kythera Biopharma shares his

company’s successful fundraising experience during the

August ‘06 SoCalBio Networking Forum held at UCLA

1

By Ahmed Enany

Editor-in-Chief

Coming in 2007

Organized by the Southern California Biomedical Council, this annualconference showcases emerging growth life-science companies andtechnologies. It engages leading investors, technologists and policy makersin a dialogue focused on bringing life-science innovations to the marketplacefor wealth and job creation, and improving the human condition.

A p r i l 4 , 2 0 0 7Wilshire Grand Hotel

Los Angeles, CA

Company PresentationsPoster Show Company Exhibits

Panel Discussions Keynote Presentations

For presentation, exhibit and sponsorship opportunities, contact the SCBC at 213-236-4890 or scbc@socalbio.org

Southern CaliforniaBiomed ica l Counc i l

9thS o C a l B i o

I n v e s t o r

Conference

S o C a l B i o

I n v e s t o r

Conference

For presentation, exhibit and sponsorship opportunities, contact the SCBC at 213-236-4890 or scbc@socalbio.org

SoCalBiowww.socalbio.org2 Fall/Winter 2006SYNERGIES

SoCalBio�

RESEARCH GRANTS

New NIH SBIR/STTR Grants to Greater Los Angeles CompaniesApr-Oct 2006

ROUNDUPSoCalBio

By Ahmed A. EnanyEditor-in-Chief

enany@socalbio.org

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Obagi Files for IPOOn September 13th, Obagi Medical Products -- a Long Beach maker of prescription skincare products to treatphotodamage, hyperpigmentation, wrinkles, and other skin imperfections -- filed for an IPO to raise $86 million.The company will trade on NASDAQ under ticker OMPI. Its stock is priced in the range of $13-$15 and expected tocommence trading during the second week of December. Obagi employs 132 people and generate $70 million inrevenues from sales. �

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MERGERS & ACQUISITIONS

Beckman Buys Lumigen for $185 MillionOn October 2nd, Beckman Coulter announced its plan to acquire Lumigen Inc. (Southfield, MI) for $185 million incash. Lumigen develops detection chemistries for testing in clinical diagnostics and research. �

Amgen Acquires AvidiaOn Sept 29th, Amgen announced its acquisition of Avidia, a privately held biotech company in Monutain View, CA.Avidia’s lead product is a compound that inhibits a protein involved in inflammation known as interleukin 6. Thedeal is valued at $290 million upfront in cash. �

Precision Dynamics Buys Hollister’s Patient ID BusinessOn Sep 13th, San Fernando-based Precision Dynamics Corp. (PDC) announced its acquisition of Hollister’s Ident-A-Band

and WrisTicket, wristband identification product lines. Financial terms were not disclosed. PDC is the

world leader and pioneer in identification wristband systems for healthcare and other markets. �

HemaCare Completes Acquisition of TeragenixOn August 29th, Woodland Hill-based HemaCare -- a founding member of the Southern California BiomedicalCouncil and a leading provider of blood products and hemapheresis services -- announced the completion of itsacquisition of Teragenix (Fort Lauderdale, Fl). Teragenix provides human biological samples, quality controlproducts, and clinical trial management services. The acquisition is expected to enable HemaCare to expandproduct and service offerings to biotechnology, pharmaceutical and other research-focused organizations. �

CLINICAL STUDIES

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Pre-Market ApprovalsJan-Oct 2006

510(K) DecisionsJan-Oct 2006

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Spectrum’s Ozarelix Meets Phase II GoalsOn October 3rd, Irvine-based Spectrum Pharmaceuticals (Nasdaq: SPPI) announced that its Phase 2 trial of Ozarelixin patients suffering from Benign Prostatic Hypertrophy (BPH) met the primary endpoint. In its press release, thecompany reported that the trial established Ozarelix’s safety profile. The results were highly statistically significantin improving clinical symptoms of BPH as measured by the International Prostate Symptom Score (IPSS), thestandard method of assessing BPH symptoms and the primary endpoint of the study. �

MannKind Announces More Positive Results for Technosphereand Files to Raise $500 Million

On September 16th, Valencia-based MannKind Corp. (Nasdaq: MNKD) announced positive results from its Phase IIIclinical study of inhaled insulin in patients with Type 2 diabetes. The results were unveiled during the 42nd AnnualMeeting of the European Association for the Study of Diabetes (EASD) in Copenhagen. MannKind indicated that itsTechnosphere Insulin System showed similar safety and efficacy compared to injected rapid-acting insulin analogs.On November 2nd, MannKind announced that it filed to sell up to $500 million in common stock, warrants and debtsecurities. Proceeds from the offering will be used to cover clinical trial costs, R&D activities, manufacturingexpansion, and general corporate purposes. �

Abraxis Drug Gets FDA NodOn November 28th, West-L.A.-based Abraxis announced that it obtained FDA approval for its generic equivalent ofPfizer’s anti-infection drug Unasyn. This marks the 10th approval that Abraxis received this year. The FDA iscurrently reviewing an additional 26 drug applications from the company. �

Amgen Wins Approval of VectibixOn Sep 27th, the FDA approved Amgen’s Vectibix (panitumumab) for treating patients with colorectal cancer.Panitumumab is Abgenix’s first entirely human monoclonal antibody for treating cancer. Abgenix was acquired byAmgen late last year.�

COLLABORATIONS

DEVICE APPROVAL DECISIONS

PUBLIC OFFERINGS

LABORATORY REAL ESTATE

C3 Scientific Finds Home Near LAXLast October, biotech startup, C3 Scientific, leased a facility for its headquarters near LAX. The Goodglick Companyacted as a broker. C3 seeks to commercialize target-specific antimicrobial protein drugs based on researchconducted by Dr. Wenyuan Shi at the UCLA School of Dentistry. �

DRUG APPROVALS

SoCalBiowww.socalbio.org 3SYNERGIESSoCalBio

� Fall/Winter 2006

Dr. Niznickcontinued from page 1

became one of the cornerstones of modern implant dentistry.(3) It was thenlicensed to 10 companies, and helped fuel the growth of implant dentistryinto a $2.2 billion industry by 2006 figures.(4)

In addition to the internal hexagonal connection, Dr. Niznick introducednumerous innovations, receiving 23 patents by 2000. His formerCalabasas-based companies -- Core-Vent Bio-Engineering founded in 1982to make implants, and Paragon formed in 1997 as Core-Vent’s soledistribution agent -- were the commercial vehicles for turning theseinnovations into a prolific product portfolio.(5)

Dr. Niznick’s companies helped drive the evolution of implant dentistry inthe U.S. from an exotic practice focused on functional rehabilitation of fullyedentulous elders to single-tooth restorations and aesthetic applicationstargeting younger patients. In fact, the evolution of the dental implantindustry in the U.S. mirrors the progression of his product line.(6)

Sulzer Acquires Niznick’s Business:Technological advances along with the growing awareness of the clinicalbenefits of dental implants, the rise in number of dentists trained in implantsurgery, and coverage of implant procedures by government or insuranceproviders, particularly in Europe, helped grow the global market for implantdentistry to $590 million in 2000. As a result, companies such as Core-Vent/Paragon that controlled enabling innovations became attractive targetsfor acquisition by established players eager to enter the market orstrengthen competitive positions.(7)

On January 8th, 2001, Sulzer AG of Switzerland sought to double its dentalimplant business, named Sulzer Medica, by acquiring Dr. Niznick’scompany, which was then renamed Paragon Implant Company, for $102million. At that time, Paragon was garnering $35 million in sales, or about25% and 4.5% of the U.S. and global dental implant market respectively.(8)

In 2002, Sulzer Medica was spun out of its parent company and changedits name to Centerpulse. A year later, Centerpulse was purchased byZimmer of Warsaw, IN. The latter’s dental business is currentlyheadquartered in Carlsbad, CA and named Zimmer Dental. With 2005revenues of $148 million, the company is ranked fourth in implant dentistryby virtue of a product portfolio acquired primarily from Dr. Niznick.(9)

Plotting Reentry:Following the sale of his business, Dr. Niznick retired from the dentalimplant industry and agreed, as a condition of the sale, to a non-competeagreement effective until January 8th, 2006. But after trying his hand atnonmedical device activities including investing in aerospace venturessuch as Acromil Aerospace Manufacturing, he decided to once again investin what he knows best: implant dentistry.

During the five years that Dr. Niznick pursued other ventures, the dentalimplant industry became more concentrated, with two European players,Nobel Biocare and Straumann, and two U.S. companies, Biomet andZimmer, collectively controlling more than 78% of the market in 2005.(10)

To establish a footing and compete with these much larger players, Dr.Niznick formed a new company -- Implant Direct -- and planned his reentryaround a new product line to be launched commercially when his non-compete agreement with Zimmer expired.

To differentiate Implant Direct from the competition, Dr. Niznick plotted anInternet-centered marketing strategy that would avoid the industry’s costlysales and marketing practices, and in turn offer heavily discounted implantsand accessories for purchase directly online. Such a strategy wouldcapitalize on his high name recognition in the implantology community.

Launching Implant Direct:Implant Direct was formed in 2004, and took back CoreVent/Paragon’sCalabasas-based 40,000 sq. ft. implant factory abandoned by Zimmer.Although the latter assumed the lease as part of the acquisition of Paragonby Sulzer Medica, it was put on the market when Zimmer decided not torenew the lease in order to consolidate its dental business in Carlsbad.

Zimmer took issue with the formation of Implant Direct, and considered thenew company as a violation of Dr. Niznick’s agreement not to compete. Butafter a period of lengthy arbitration, “it was ruled that preparing to competewas not actual competition,” Dr. Niznick commented.

This ruling paved the way for Implant Direct to prepare for entry and growrapidly. Today, the company employs 90 people and has expanded itsproduction capacity to 26 CNC machines. Each machine has beenupgraded to allow lights-out 24/7 manufacturing, a first in the dentalimplant industry and, according to Dr. Niznick, “the key to Implant Direct’sability to produce very high precision products at a lower cost than itscompetitors.”

Unveiling the Spectra System:Implant Direct’s new Spectra System line of dental implants cleared lastSeptember for marketing by the FDA is described by Dr. Niznick as “anintegrated system of application specific implants ... five implants for

different clinical applications, each having the same body capable of beinginserted with the same drill.”

In addition to design features that minimize bone loss and maximizeosseointegration, the Spectra-System features “all-in-one” packaging inwhich the five implants are packaged with specific additional components(e.g., abutments, transfers, healing collars). According to Dr. Niznick, thisallows implantation to be completed without requiring the surgeon to orderadditional items, which in turn saves money and simplifies ordering.

Implant Direct’s product offering expanded with the addition of Legacy,RePlant and RePlus which compete directly with popular implants byleading manufacturers.

Investing in Image-Guided Implantation:In addition to his new line of implants, Dr. Niznick acquired a 60% interestin Tactile Technologies, an Israeli developer of computerized systems forprecisely placing dental implants.(11) The company’s technology allows formapping the jawbone electronically by 3-D CT scans to guide theplacement of implants. This system will be marketed in 2007.

Internet-Centered Marketing:While incremental product innovations may win Dr. Niznick a few convertsin a mature market that increasingly lacks product differentiation, his plan tomarket directly to surgeons and therefore cut the price of implants iscreating significant buzz, particularly among investment analysts followingthe leading pure-play dental implant companies -- Nobel Biocare andStraumann -- whose high valuations are quite rich, leaving them vulnerableto any market disruptions even at the margins.(12)

The linchpin of Dr. Niznick’s strategy is to use Internet marketing to selldirectly to experienced implant surgeons and dental laboratories at pricesmuch lower than those charged by the big four suppliers. By focusing saleson experienced clinicians and selling only through the Internet, ImplantDirect hopes to reduce the cost of marketing, education, and accounting.This in turn will enable the company to “cut implant prices by 60%-70%and still make a significant profit,” Dr. Niznick explained. “In an industrywhere price competition among the major players has been nonexistent,this strategy gives Implant Direct the edge it needs.”

The doctor is counting on his marketing strategy to pay dividends,especially in the cost-sensitive U.S. market, where implant dentistryprocedures are neither fully reimbursed by government, nor adequatelycovered by insurers.

Sizing Up the Threat:Industry observers agree that Dr. Niznick’s reentry into the dental implantbusiness shouldn’t be taken lightly. A recent article in Barron’s advisedinvestors in implant dentistry “to pay close attention to Niznick, generallyrecognized for his pioneering work in the field and his numerous patents.”The article went on to proclaim, “He is a particularly serious industry rival,but one unknown to many investors.”(13)

Although his Internet-centered approach to marketing is not considered amajor threat to the structure of the implant dentistry industry, Dr. Niznick isexpected to make gains that may eventually enable Implant Direct toestablish a firm footing in the market.

According to a recent market analysis by the Swiss investment bank andbrokerage firm Lombard Odier Darier Hentsch, some of Implant Direct’santicipated gains are likely to come at the expense of small nichediscounters whose customers may switch due to Dr. Niznick’s reputation.Also, these niche companies may not have the resources to outbid Dr.Niznick or mount a counteroffensive. (14)

But the doctor also has his crosshairs locked on established players suchas Zimmer and Noble Biocare. This is why his new product portfolio ismade compatible with many widely-marketed implants offered by thecompetition. This strategy helps minimize the practitioner’s cost ofswitching.

“I filed eight new patents incorporating the best ideas from my old productswith the best ideas of the competitors, and then designed products withcross-compatibility to the most popular implant systems,” Dr. Niznickobserved.

Cross-compatibility -- defined as the ability of dentists to insert onecompany’s implants using drills and surgical tools developed by anothercompany -- may win Dr. Niznick market shares from established players,particularly Zimmer.

Aiming at Zimmer:Analysts following the dental implant industry at both Lombard Odier DarierHentsch(16) and Merrill Lynch(17) agree that Zimmer seems the mostvulnerable to Implant Direct’s market entry. Cost-conscious dentists may beswayed by the low prices of its Spectra-System implants at $150 includingthe abutment and related components, in contrast to Zimmer’s main line ofimplants, the Screw-Vent, also developed by Dr. Niznick and being offeredat $512 for comparable components.

Implant Direct is also offering an implant named Legacy, whichincorporates the internal hex connection platform, first introduced in 1986,

and is still used with ZimmerDental’s main Screw-Vent line onimplants. Legacy will be introducedin the U.S. when the patent on theinternal hex connection expires inOctober 2007.

Implant Direct is counting on its lowprice to entice cost-consciousdentists to switch. Legacy will alsobe offered at $150 including theabutment and other components.

Targeting the Industry

Leader:Other established players, includingmarket leader Nobel Biocare, are nottotally shielded from Implant Direct’sassault. For example, ImplantDirect’s RePlant device is advertisedas a cheap alternative to Nobel’sReplace tapered implant. TheRePlant is priced at $150, about

continued on page 4

Implant Direct employees 90 people and has expanded its production capacity to 26

CNC machines. Each machine has been upgraded to allow lights-out 24/7

manufacturing, a first in the dental implant industry.

Implant Direct’s New Spectra-SystemCleared Last September for Marketing by the FDA

ScrewPlant ScrewPlant InDirect ScrewDirect Redirect

Source: Implant Direct

For nearly two decades, the 23-campus, 400,000 student California StateUniversity (CSU) system -- the most diverse and comprehensive universitysystem in the nation -- has quietly laid the foundation for such acollaborative framework statewide through its CSU Program for Educationand Research in Biotechnology (CSUPERB). Founded in 1987, thisprogram has developed in sync with the growth of the State’sbiotechnology industry, which now accounts for half of the country’srevenues from biocommerce. CSUPERB has been able to contribute to thisgrowth via its various activities in biotechnology education and industry-focused training.

As a founding member of the Southern California Biomedical Council(SCBC), CSUPERB has supported the emergence of biotechnology in theGreater Los Angeles region, encompassing Los Angeles and Orangecounties, the Inland Empire, and Ventura/Santa Barbara Gold Coast. Onerecently launched initiative seeking to strengthen the collaboration betweenthe CSU system and industry is the formation of CSUPERB-Los AngelesBasin (C-LAB).

Encouraged by Ahmed A. Enany, President and CEO of SCBC, and withleadership provided by Dr. A. Stephen Dahms, former Executive Director ofCSUPERB, C-LAB is launched in response to the growing realization thatCalifornia’s biotech clusters -- San Francisco Bay Area, Greater LosAngeles, and San Diego -- are evolving differently in terms of the mix ofbiocommerce activities and the speed of development. These regionalvariations translate into different combinations of workforce skill sets indemand by firms in each region.

To be able to meet such demand, the CSU system has adopted a regionalapproach to partnering with industry. C-LAB is a manifestation of this newthinking. As the first of three regional centers to nurture the collaborationbetween the CSU campuses and nearby industry partners, it is charged withthe task of coordinating workforce training activities in the Greater LosAngeles region in collaboration with SCBC.

As the life-science trade association of the Greater Los Angeles region,SCBC is positioned to articulate the industry’s workforce skill needs. C-LAB will be able to provide a mechanism to pool resources needed to meetthis demand from the region’s eight CSU campuses -- Channel Islands,Dominguez Hills, Fullerton, Long Beach, Los Angeles, Northridge, Pomonaand San Bernardino -- community colleges -- such as Pasadena CityCollege, Pierce College, and the College of the Canyons -- and localworkforce investment boards at the city and county levels.

C-LAB envisions itself as a flexible, on-demand, one-stop-shop forcoordinating training and education, not just in biotechnology, but also inthe medical device industry, and other components of the region’s life-science cluster. This is reflected in its mission statement, which reads asfollows:

“C-LAB, working with its partner organizations in the life sciences andbiocommerce, is an innovative, central provider and clearing house thatanticipates and then flexibly responds to workforce education, training andinnovation needs of the Greater Los Angeles Basin. C-LAB meets theseneeds through quality training within the industry’s critical time frame.”

C-LAB and its partners will enable the industry to fill positions withgraduates already experienced in areas such as proteomics, genomics, bioand health informatics, stem cell biology, photonics, engineering, qualitycontrol, biomaterials and bioprocessing. Of equal importance, is meetingthe life-science industry’s demand for upgrading workforce skills throughcontinued education and non-degreed training programs. In all of theseareas, the C-LAB campuses and community college partners will strive topromote access, diversity and excellence in bioscience education andtraining through an array of externally funded programs.

With its first-year startup funding just provided by the CSU’s Commissionon Extended Education, C-LAB is now poised to help the life-scienceindustry fulfill its potential in the Los Angeles region, providing yet anotherdemonstration of how the CSU system is “working for California.” �

---------------

Dr. James Rosser can be reached at 323-343-3030 or

jrosser@cslanet.calstatela.edu.

C-LABcontinued from page 1

60% less than Nobel’s implant. Similarly, Implant Direct’s RePlus Implant -- marketed as an alternative to Nobel’s smaller diameter Replace implants -- will sell for $200 including the abutment and related components, incontrast to $622 for similar items from Nobel Biocare.

The RePlant and RePlus implants embody design innovations (U.S. patent# 7,108,510 issued on September 19, 2006) to ensure crosscompatibility. The two implants use a new double tri-lobe internal

SoCalBiowww.socalbio.org4 Fall/Winter 2006SYNERGIES

SoCalBio�

Chairman:Alfred E. Mann, MannKind Corp.

Vice Chairman:Walter Mosher, Jr., Ph.D.Precision Dynamics Corp.

Treasurer:Robert Berliner, Berliner &Associates

Secretary:

Michael Wise, Perkins Coie

Board Members at Large:

George Ayoub, One Lambda

Bruce Blomstrom, Pasadena

Angels

Kenneth Charhut, Orqis Medical

Gary Fujii, Ph.D., MolecularExpressRobert Greenberg, M.D., Ph.D.Second SightAya Jakobovits, Ph.D., AgensysJolene Koester, Ph.D., CaliforniaState University NorthridgeMichael Ross, HGA Architects &EngineersMichael Smith, Perkins & Will

Kenneth Trevett, Los Angeles

Biomedical Research Institute

Allan Wolfe, M.D., UV Partners

Michael Ziering, Diagnostic

Products Corporation

Executive Officer:

Ahmed A. Enany

SYNERGIESSoCalBio

SYNERGIES is a publication of the Southern California

Biomedical Council (SCBC or SoCalBio).

Editor-in-Chief, Ahmed A. Enany

enany@socalbio.org

Managing Editor, Erik Deutscherik@socalbio.org

Contact Information

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Biomedical Council

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ages of 14 and 24. Contact lens patients are the mostprofitable to an ophthalmic practice. AMO’s contact lenscare line includes disinfecting solutions, daily cleaners,enzymatic cleaners and lens rewetting drops. Among thecontact lens care product brands the company promotesare COMPLETE® Moisture PLUS™, COMPLETE® Blink-N-Clean®, Consept® 1 Step, Oxysept® 1 Step, andblink™.

What about LASIK products?

The LASIK market has matured in recent years, withconsumers willing to pay for each new innovation. Whenit comes to custom LASIK, our WaveScan WaveFront®

System sets the industry standard for wavefrontacquisition. The system provides fast and efficientcapture of the patient’s wavefront data required for laservision correction with lasers such as AMO’s STAR S4IR™ Excimer Laser System. We’re also at the forefront ofLASIK flap creation with the Amadeus™ IImicrokeratome.

What are some of AMO’s new products for older

consumers?

Today’s cataract patient maintains an active lifestyle andincreasingly expects technology to provide him with thevision of a 20-year-old. In addition to traditionalmonofocal IOLs, AMO has new products in its refractiveportfolio such as the ReZoom™ IOL. This acrylic,multifocal lens helps patients greatly reduce their needfor glasses for near, intermediate and distance vision.Clearly, the need for crisp intermediate vision is a mustfor a large segment of the active cataract-age population,and growth in the refractive market shows they’re willingto pay for it. Our popular Verisyse lens is used widely totreat myopia in adults with vision ranging from -5.0 to -20.0 diopters.

How are AMO’s revenues spread across market

segments?

We anticipate 2006 revenues to exceed $1 billion.Contact lenses and lens-care products should accountfor 24% of that figure, the cataract and implant marketwill account for 50%, and LASIK for the remaining 26%.

Which market segments

are poised for the most

growth?

The greatest growth isprojected in lensimplants. By 2010, AMOwill introduce a trulyaccommodating lens thatwill leapfrog currentlyavailable accommodatingIOL technology. Our laservision correction businessoutside the U.S. will alsocontinue to grow steadily, as it is still a fairly embryonicmodel. The more mature eyecare business will grow insingle digits, aided by the launch of our dry eye productnext year.

AMO’s stock took a big hit in September, when the

company reported slower than expected sales of

certain products, such as LASIK devices. How do you

respond to those who argue that Wall Street and your

investors currently take a dim view of AMO’s future

prospects?

AMO’s strategy is sound and I am more confident thanever in our prospects. We operate three complementarybut distinct businesses with excellent growthpotential. We’ve made significant investments todevelop new innovations, and plan to launch a series ofpromising new products in 2007. Our balance sheet ishealthy and cash flow is strong.

What is the key ingredient for success in executing

your “Vision-for-Life” product development strategy?

The key is providing support for the eyecare professional,who is the key decision maker when it comes to apatient’s ocular health. We understand this marketdynamic, and focus our sales, educational and marketingefforts on the practitioner rather than the consumer.

Executing the “Vision-for-Life” product development

strategy places a heavy emphasis on your R&D

pipeline because you are competing in many

technology-driven market segments. What is AMO’s

strategy for introducing new products and platforms?

Since the spin off, we worked hard to invigorate newproduct development and stay at the forefront of

technological change. This iswhy we devote significantresources to internal R&D.The company currentlyspends 6.5-7.0% ofrevenues on R&D [vs. 5% attime of spin-off]. Most of ourR&D is performed at ourcorporate headquarters inSanta Ana. We’re alsostrengthening the company’sproduct offering viaacquisitions, as in the caseof VISX in the Bay Area. As aresult of the VISXacquisition, we have becomea leader in the design anddevelopment of proprietarysystems for laser vision

AMO Interviewcontinued from page 1

correction.

What new products should we expect from AMO?

We’re globally launching a new consumer product fortreating dry eye that will be push-marketed by doctors.It’s our only new drug product in the pipeline, and istargeted at the $500 million dry eye market. Of coursewe’re also looking at ways to address the big opportunityin glaucoma devices. The idea is to reduce glaucomadrug dependence by focusing on “back of the eye”devices and better drug delivery. As I mentioned earlier,we will also introduce a truly accommodating lens thatwill leapfrog currently available accommodating IOLtechnology.

What is AMO’s main challenge as a California-based

business?

There’s no denying that our ability to compete is partiallya function of attracting talent. The cost of living inCalifornia is a persistent issue. There are greateducational institutions here, such as UCI, which supportthe industry’s entry-level engineering and life-scienceneeds. But if you need people with medical deviceexperience, you have to recruit them from other placessuch as Minnesota.

In which, if any, job category does AMO encounter

shortages, and how do you attract talent?

The greatest struggle is finding regulatory talent – thereare never enough people with such skills. We also needmore optical engineers and patent attorneys with medicaldevice experience. To attract this talent, it is important tocompensate people very well. We also think that trainingemployees and investing in their careers is critical.

Overall, how do you view the future of the medical

device industry?

Device companies will have significant opportunitiesover the next 10 years. Due to their inherent “wow”factor, I believe medical devices will be more popularthan drugs as the population ages. Geographically, we’revery optimistic about the U.S. market. But some keyforeign markets may prove problematic. Japan, Franceand Germany come to mind because their healthcaresystems are stressed and heavily regulated. �

connection that accepts Nobel Biocare’s abutments.This design effectively circumvents Nobel’s patentprotection on its single tri-lobe connection. Accordingto Merrill Lynch’s market analysis, this new implant“gives customers for the first time the choice of using amore cost effective abutment.”(18)

Field of Dreams?Although industry observers are intrigued by Dr.Niznick’s entrepreneurial spirit and bold approach tomarketing, some caution that “dentists actconservatively when it comes to the health of theirpatients and the outcome of dental treatments affectingthe dentist’s reputation. Switching from one dentalimplant system to another is therefore uncommon.”(19)

This is one of the reasons why the Lombard OdierDarier Hentsch study concludes that, under the best ofcircumstances, the combination of incrementalinnovations, cross compatibility, and aggressivediscounting may help Implant Direct – given its outputcapacity – only garner $50 million in revenues fromsales by 2008, or a market share of about 2%.(20)

Although a significant accomplishment for a startup,this hardly poses a challenge to the industry’soligopolistic structure or the dominance of the leadplayer, Nobel Biocare, which controlled 32% of themarket in 2005.

Dr. Niznick thinks the above-mentioned studyunderestimates Implant Direct’s potential.(21) He isconfidant that his marketing strategy will appeal to animplant community that is now more open to switching,particularly in the cost-sensitive American market.

Dr. Niznick noted that historically, 80% of the dentalimplants are placed by 20% of the more experienceddentists. “These surgical specialists stand to gain themost from low prices because of their volume usage.They neither want nor need to be bothered by implantsalespeople trying to fill their monthly quotas,” heexplained.

Although traditionally loyal, these specialists now havea strong incentive to switch. As established players

Xencor CorporationMonrovia-based protein therapeutics firm Xencorcomes in second, with a $45 million round of fundingthat closed last October. Participants included returnbacker Zen Investments and new investors such asMedImmune Ventures, Novo Nordisk, and HealthcareVentures. This brings the total raised by the companyduring the period from Oct ‘05 to Oct ‘06 to $65million, or about half the total funds raised since itsfounding. �

Calhoun VisionThe company comes in third place to prove thatinstitutional capital is not the only source of fundingtapped by L.A. firms. Like many of the region’s life-science companies, Calhoun opted for non-institutionalmoney, and was able to raise $31 million during 2006from angel investors and a Japanese strategic partner. .Calhoun is developing a new type of intraocular lenswith power that can be adjusted noninvasively afterimplantation. �

Kythera BiopahramaceuticalsThe fourth spot goes to Kythera Biopharmaceuticals ofWoodland Hills. This startup is focused on aestheticand restorative dermatology, and succeeded in raising$30 million last summer in a series B round offinancing. Participants included notable VC firms suchas Prospect Venture Partners and ARCH Ventures. �

CytRx CorporationFinally, patient advocates are emerging as an importantsource of non-dilutive funding. Last August, CytRx ofBrentwood secured $24.5 million in a royaltyagreement with the ALS Charitable Remainder Trust.The funds will be used to continue development ofCytRx’s drug candidate -- arimoclomol -- for thetreatment of amyotrophic lateral sclerosis (ALS or LouGehrig’s disease). �

Dr. Niznickcontinued from page 3

Who Raised Capitalcontinued from page 1

Cougar Biotechnology’s CEO Alan Auerbach

presents his company’s future plans following its

successful private placement that netted $47.5

million. Presentation was made during the August

‘06 SoCalBio Networking Forum held at UCLA.

3

4

5

2

attempt to expand the market by training generalpractitioners (GPs) to perform implant surgery, theability of these specialists to charge premium pricesfrom their customers will be reduced. With itsaggressive discounting, Implant Direct is positioningitself to benefit from the resulting backlash as these“surgical specialists start questioning their traditionalties with the large companies that are courting theirreferring doctors,” Dr. Niznick commented.

Even GPs placing implants have a stronger incentive toswitch. They are more cost-conscious “because theygenerally do not command the high prices charged bysurgical specialists,” he added.

Dr. Niznick is also counting on his high namerecognition to help both specialists and GPs make theswitch to his product portfolio. “If there is someonewho can pull it off, it’s Dr. Niznick because he is well-regarded among implant surgeons, many of whom builtpractices benefiting from his breakthrough contributionsto the American implant dentistry,” said Dr. LionellGreenberg, a West Los Angeles periodontist andimplant surgeon.

In the End:Only time will tell if Implant Direct is able to fullyrealize Dr. Niznick’s ambitious plans. The fact remainsthat his reentry has already energized the dental implantmarket. If nothing else, it has helped jumpstart thedebate on the virtues of price vs. technology-basedcompetition in a market expected to grow by 10-15% ayear. It has also raised questions about the establishedplayers’ marketing practices, which -- as in the case ofimplants sold by market leaders Nobel Biocare andStraumann -- account for 48-54% of the price,compared with 26-29% for cost of goods and 5-9% forR&D.(22) �

Footnotes

(1) Vito J. Racanelli, “Impacted Industry,” Barron’s,February 15, 2005.

(2) On osseointegration, see: Rickard Brånemark, M.D.et al, “Osseointegration in skeletal reconstructionand rehabilitation,” Journal of Rehabilitation

Research and Development, Vol. 38, No. 2, 2001.(3) On the internal vs external hex connection, see:

Paul P. Binon, “The Evolution and Evaluation of TwoInterference-Fit Implant Interfaces,” Postgraduate

Dentistry, Vol. 3, No. 1, 1996.(4) The most recent estimate of the size and growth of

implant dentistry is offered by Michael Jüngling andAlex Surla, “The Changing World of DentalImplantology,” Merrill Lynch, October 12, 2006.

(5) On Dr. Niznick and his ventures, see: Walter Eisner,“The Dramatic Return of Dr. Niznick,” Orthopedics

This Week, August 15, 2006.(6) For a brief but concise account of the evolution of

implant dentistry, see: Robert L. Holt, “Theevolution of dental implant design and application,”Dental Equipment and Materials, September, 2005.

(7) Jennie Tsai, “The Worldwide Dental ImplantMarket, Gabelli & Company, September 11, 2003,P. 4.

(8) It is estimated that the size of the US dental implantmarket was $132 million and $150 million in 2001and 2002 respectively. See Millennium ResearchGroup, “U.S. Market for Dental Implants: ExecutiveSummary,” Implant Dentistry, Vol. 12, No. 2, P. 109.

(9) See: Christoph Gubler and Mark Browne, “NiznickRejoins the Dental Implant Party,” Lombard Odier

Darier Hentsch, Feb. 2006, P. 13.(10) Ibid., p. 12.(11) See http://www.tactile-tech.com.(12) Vito J. Racanelli, Op. Cit.(13) Loc. Cit.(14) Christoph Gubler and Mark Browne, Op. Cit., P. 15.(15) Michael Jüngling and Alex Surla, “Niznick

Announces New Dental Implant Portfolio,” Merrill

Lynch, Jan 26, 2006, P. 1.(16) Christoph Gubler and Mark Browne, Op. Cit., P. 15.(17) Michael Jüngling and Alex Surla, “Niznick

Announces New Dental Implant Portfolio,” Op. Cit.,P. 3.

(18) Ibid, p. 1.(19) Christoph Gubler and Mark Browne, Op. Cit., P. 15.(20) Ibid, p. 3 & 13(21) In their most recent report on implant dentistry,

Jüngling and Surla, conclude that industry analystsmay have underestimated the gains made by newmarket entrants who compete on price and theirability to erode market positions of big players,including Nobel Biocare. See: “The Changing Worldof Dental Implantology,” Op. Cit. P. 1.

(22) Michael Jüngling and Alex Surla, “NiznickAnnounces New Dental Implant Portfolio,” Op. Cit.,P. 2.

AMO’s excimer laser system is designed by its VISX Division for surgery to correct

vision problems such as nearsightedness, farsightedness, and astigmatism.

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The Southern California Biomedical Council (SCBC or

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