exhibit991.htm

EX-99.1 CHARTER 2 exhibit991.htm PRESENTATION exhibit991.htm

Analyst & Investor Day

January 28, 2010

Specialty Pharmaceuticals for
Women’s Healthcare Needs

Except for historical information contained herein, certain statements of Columbia Laboratories,

Inc.’s expectations made in this presentation constitute forward-looking statements within the

meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange

Act of 1934. Such forward-looking statements involve certain risks and uncertainties. Those

statements include statements regarding the intent, belief or current expectations of Columbia

Laboratories and its management team. Investors are cautioned that any such forward-looking

statements are not guarantees of future performance and involve risks and uncertainties, and that

actual results may differ materially from those projected in the forward-looking statements. Given

these uncertainties, investors should not place undue reliance on these forward-looking

statements. Factors that might cause future results to differ include, but are not limited to, the

following: the successful marketing of CRINONE® 8% (progesterone gel) and STRIANT® (testosterone

buccal system) in the U.S.; the successful marketing of CRINONE 8% by Merck Serono; the timely and

Successful completion of clinical studies, including the Phase III study of PROCHIEVE 8% to reduce the

risk of preterm birth in women with a short cervix in mid-pregnancy; success in obtaining acceptance

and approval of new products and indications for current products by the FDA and international

regulatory agencies; the timely and successful development of products, including PROCHIEVE 8%

in short cervix patients; the impact of competitive products and pricing; our ability to obtain financing

in order to fund our operations and repay our debt as it becomes due; the timely and

successful negotiation of partnerships or other transactions; competitive economic and

regulatory factors in the pharmaceutical and healthcare industry; general economic conditions;

and other risks and uncertainties that may be detailed, from time-to-time, in Columbia’s reports filed

with the Securities and Exchange Commission. Columbia Laboratories undertakes no obligation to

publicly update any forward-looking statements.

Under The Private Securities Litigation Reform Act Of 1995

Columbia Laboratories

Frank Condella

Interim Chief Executive Officer

} Introduction

} The Current Market for Crinone: Infertility

◦ Crinone is the Patient-Friendly Alternative

} Ongoing Crinone Development:
Preventing the Tragedy of Preterm Birth

◦ Changing the Practice of Medicine

} Life Cycle Management & IP

} Financial Update

} The Plan Going Forward

} Q&A

Crinone: The Patient-
Friendly Progesterone
in Infertility

Frank Condella

Interim CEO

} Elena Yanushpolsky MD

◦ Asst. Professor - Harvard Medical School

} Brian Berger MD

◦ Asst. Clinical Professor - Harvard Medical School

} David Keefe MD

◦ Professor and Chairman - NYU Medical Center

} Kaylen Silverberg MD

◦ Medical Director - Texas Fertility Center

} Tina Straseske - Patient

} Crinone 8% vaginal progesterone

◦ The only once-daily vaginal progesterone

◦ As effective as progesterone intramuscular injections

◦ The only vaginal progesterone approved for donor
and frozen cycles

◦ The only vaginal progesterone with demonstrated
efficacy in women age 35 and over

◦ Better tolerated than intramuscular injections

} Infertility

◦ the inability to conceive after one year of
unprotected intercourse (6 months if the woman is
over age 35)

} Affects

◦ about 5.3 million Americans,

◦ 9% of the reproductive age population

} Treatment

◦ 85-90% drug therapy or surgery

◦ <3% IVF

• At 30, a healthy
woman has about a
20% chance per month
of conceiving.

• By the time a woman
reaches 40, her
chances drop to about
5% per month.

$300+ Million Total Market Opportunity

$160+ million
market potential

Infertility Business

$140+ million

market potential

2 weeks x $83 per week =
$166 per patient

10 weeks x $83 per week =
$830 per patient

Fertility Assistance
(1.0 million cycles)

Pregnancy Support

22% success rate

Strengths

} Vaginal Delivery System vs IM

} Once daily delivery vs other vaginal options

} Strong/Superior clinical data profile

} Bioadhesive gel format - continuous progesterone
delivery

} Fertility Centers of Illinois

} University of Pennsylvania

} Atlanta Center for
Reproductive Medicine

} Reproductive Biology
Associates

} Reproductive
Endocrinology Associates
of Charlotte

} CNY Fertility Center

} Conceptions Reproductive
Associates

} Fertility Centers of Las
Vegas

} Brigham & Women’s

} Boston IVF

} Cleveland Clinic Fertility
Center

} Huntington Reproductive
Center

} Texas Fertility Center

} NYU School of Medicine

} Yale University IVF

} Duke Fertility Center

} Cooper Institute for
Reproductive Hormonal
Disorders

Assistant Professor of Obstetrics,
Gynecology and Reproductive Biology,
Harvard Medical School, Waltham,
Massachusetts

Progesterone For
The 21st Century

Brian M. Berger, MD

Assistant Clinical Professor

Boston IVF/Harvard Medical School

Progesterone Therapy:
Supplementation Versus Replacement

Progesterone can be administered for two indications:

1. Supplementation - patient is given progesterone to
supplement her own progesterone production (which
is reduced due to fertility treatment)

– Examples: medicated fertility cycles; in vitro
fertilization or “test-tube” baby (IVF)

2. Replacement - fertility treatment in which patient
does not make any progesterone; i.e.100% of
progesterone is external

– Examples: Donor Egg IVF (eggs from donor are
used to create embryos/pregnancy); frozen
embryo transfers (FET) - frozen embryos are
thawed and placed in the womb

1. Donor Egg IVF

2. Frozen Embryo Transfers

Crinone 8% For Progesterone Replacement:
Updating the Evidence

Pregnancy Outcomes in Recipients of Donor Oocytes:
Crinone 8% (progesterone gel) vs IM Progesterone

Berger B, Phillips JA. Presented at: 56th Annual Meeting of the Pacific Coast Reproductive Society; April 11-13, 2008; Rancho
Mirage, California.

Objective	Compare the efficacy of Crinone 8% with IM progesterone for luteal support in women undergoing donor oocyte cycles
Trial design	Retrospective data analysis January 2002 through December 2006
No. of patients	225 recipients of oocytes from anonymous donors (<32 years old)
Dosing	Crinone (90 mg; BID n=105) IM progesterone (50 mg; QD n=120)

Results

P=NS

Berger B, Phillips JA. Presented at: 56th Annual Meeting of the Pacific Coast Reproductive Society; April 11-13, 2008; Rancho
Mirage, California.

A Retrospective Analysis of Pregnancy Outcomes in Recipients of
FET From Donated Oocytes at a Large ART Center

Objective	To compare pregnancy outcomes between IM vs vaginal progesterone support regimens in recipients of FET
Trial design	Retrospective analysis
Timeframe	January 2002 through December 2006
No. of patients	279 patients receiving FET
Dosing	IM progesterone (50 mg QD) n=71 Crinone® 8% (progesterone gel) (90 mg BID) n=208

Berger B, Philips JA. 64th Annual Meeting of the American Society for Reproductive Medicine;
November 8-12, 2008; San Francisco, California.

Comparable Pregnancy and Delivery
Outcomes

Berger B, Philips JA. 64th Annual Meeting of the American Society for Reproductive
Medicine; November 8-12, 2008; San Francisco, California.

Endometrin: The Ferring Trial Examined

• Ferring Pharmaceuticals released Endometrin
100 mg Vaginal Tablets for progesterone
supplementation in June, 2007.

• They then published the results of largest
prospective fertility trial ever

– Compared Endometrin to Crinone (the “Gold
Standard”) in October, 2007.

Ongoing Pregnancy Rate

1. Doody K et al. Fertil Steril. 2008; DOI 10.1016 / j.fertnstert.2008.01.069 [epub ahead of print].

2. Endometrin Package Insert

Crinone® 8%

(90 mg progesterone

Gel QD) (n=403)

Endometrin®

(100 mg BID)

(n=404)

Endometrin®

(100 mg TID)

(n=404)

42.2%

38.6%

42.3%

[-10.3, 3.2]

[-6.7, 6.9]

Non-inferiority lower limit for the 95% CI was -10%2

Ongoing Pregnancy: Women ≥ 35

1. Doody K et al. Fertil Steril. 2008; DOI 10.1016 / j.fertnstert.2008.01.069 [epub ahead of print].

2. Endometrin Package Insert

Crinone® 8%

(90 mg progesterone

gel QD)

Endometrin®

(100 mg BID)

Endometrin®

(100 mg TID)

38.7%

N=160

28%

N=157

34%

N=157

[-20.3, 0.3]

[-14.9, 6.3]

Non-inferiority lower limit for the 95% CI was -10%2

Crinone vs. Progesterone Capsules
vs. Progesterone in Oil

Berger BM, et al. Fertility and Sterility, September 2009 (Vol. 92, Issue 3, Page
S23)

Background

• Progesterone can be administered orally, vaginally, or by IM
injections

• The Endometrin Trial compared Crinone 8% to Endometrin
Tablets BID/TID only1

• There have been no data comparing Crinone with either
intramuscular progesterone in oil (PIO) or vaginal
micronized progesterone 200 mg in capsular form (PC) in
patients > age 35 undergoing IVF

1Kevin J. Doody, et al. Fertility and Sterility, April 2009 (Vol. 91, Issue 4, Pages 1012-1017)

Crinone vs. Progesterone Capsules vs.
Progesterone in Oil

• We performed a retrospective analysis on the efficacy of
three progesterone preparations in 1525 women > age 35
undergoing IVF-ET:

1. Vaginal gel containing 90 mg micronized progesterone
in a polycarbophil base (PG) administered once daily

2. Vaginal micronized progesterone 200 mg in capsular
form (PC) administered three times daily

3. Intramuscular progesterone 50 mg in oil (PIO) given
once daily

Berger BM, et al. Fertility and Sterility, September 2009 (Vol. 92, Issue 3, Page S23)

Clinical Results

p=ns

Summary

1. Crinone® 8% (progesterone gel) is the only once-daily
FDA-approved progesterone for ART

Ø Novel bioadhesive vaginal preparation allows for
steady release of progesterone throughout the day

2. Progesterone is delivered locally to the endometrium

Ø Targeted delivery allows for high endometrial
concentrations while systemic levels remain low

3. Crinone has comparable efficacy to IM progesterone in
patients < 35 and ≥ 35 years old

4. Patients prefer Crinone

Kaplan Professor & Chair

NYU Langone Medical Center

Crinone Vaginal Dosing is Patient Friendly

Kaylen Silverberg, M.D.

Medical Director

Texas Fertility Centers, LLP

¨ Critical for successful implantation

¨ Natural Cycles: Rarely needed

¨ Clomiphene Cycles: Rarely used

¡ Limited data, other studies underway

¨ COH/IUI: Growing use

¡ 2009 Prospective, randomized study driving
adoption

¨ IVF: Standard of care

¨ FET, Donor Oocyte: Standard of care

¨ Intramuscular

¡ Old standard; compounded; painful; inconvenient;
no self administration

¨ Vaginal suppositories

¡ Compounded; inconvenient; messy; inconsistent
delivery

¨ Vaginal capsules

¡ BID/TID administration; messy; discharge

¨ Vaginal tablets

¡ BID/TID administration; fizz; residue/discharge

¨ Crinone

¨ IVF

¡ Multiple studies demonstrating equal to superior
efficacy

¨ FET

¡ 2-3 studies demonstrating equal efficacy

¨ Donor

¡ 2 studies demonstrating equal to superior efficacy

¨ COH/IUI

¡ New study demonstrating doubling (18-36%) of live
birth rate

¨ Crinone vs:

¡ IM: 84:16%

¡ Suppository: 87:13%

¡ Capsules: 85:15%

¨ Initial poor experience in small Serono
sponsored trial

¡ Old formulation, applicator

¨ A large prospective, randomized trial

¡ Higher pregnancy rates with Crinone

¨ Data driven decisions

¨ Patient Preference

¨ Internal Study

¨ Dynamics of TFC transition

¨ ART volume down 15-20% 2009:2008

¨ Volumes should resume upward trend with
rebounding economy

¨ Crinone opportunities:

¡ ART: Increase market share

¡ Gonadotropin/IUI: Lead drive for P4 adoption

ú Existing data

¡ Clomiphene: Lead drive for P4 adoption

ú Data needed

¡ Broader indications:

ú Progesterone withdrawal (GYN), HRT

ú OB indications

Tina Straseske

The Patient Perspective

} Crinone 8% vaginal progesterone

◦ The only once-daily vaginal progesterone

◦ As effective as progesterone intramuscular injections

◦ The only vaginal progesterone approved for Donor
and Frozen cycles

◦ The only vaginal progesterone with demonstrated
efficacy in women age 35 and over

◦ Better tolerated than intramuscular injections

Preventing the Tragedy of
Preterm Birth by Changing
the Practice of Medicine

George W. Creasy MD FACOG

Vice President

Clinical Research & Development

} Sonia Hassan MD -

◦ Associate Professor OB GYN - Wayne State University

◦ Director of Research - Perinatology Research Branch,
NIH

} Michael Ross MD -

◦ Professor and Chair OB GYN - Harbor UCLA

} Lee Shulman MD -

◦ Professor of OB GYN - Northwestern University

◦ Chief of Reproductive Genetics

} A Short Cervix is the Most Powerful Predictor of Preterm
Birth

} Cervical Length Should be Measured in All Women in Mid-
Pregnancy

} Progesterone is the Most Promising Treatment to Improve
Infant Outcomes in Women with a Short Cervix

} The Prematurity Rate is Increasing

} The Consequences of Prematurity are Severe

} Effective Treatments Will have a Huge Economic Impact

Iams et al. NEJM 1996

• 2915 patients screened

• 24 week TVU

• Multiple studies confirm this
association of CL and PTB

• At least 25% of pregnant
women are at risk for PTB
due to Short Cervical Length

Iams JD et al. N Engl J Med. 1996;334(9):567-572.

progesterone

placebo

33 investigators

n=116 (58 Prochieve, 58 Placebo)

As Cervical Length Decreases, The Benefit Of
Treatment Increases

Baseline Cervical Length ≤ 3.0 cm

Baseline Cervical Length < 2.8 cm

progesterone

placebo

22 Investigators

N=46 (19 Prochieve, 27 Placebo)

Fishers Exact Test
at <32 weeks*:

(p = 0.014)

At ≤ 32 Weeks No Preterm Births Were Seen With Prochieve® Vs. 29.6% On Placebo

The Kaplan-Meier method was
used for calculation; (Wilcoxon
P = 0.043).

DeFranco et al, Ultrasound Obstet Gynecol 2007; 30: 697-705

p=0.026

p=0.05

p=0.013

DeFranco et al, Ultrasound Obstet Gynecol 2007; 30: 697-705

} Ongoing Phase III Study

◦ Double blind, placebo controlled

◦ 450 women with cervical length between 1.0 -
2.0 cm

◦ ~ 40 centers (domestic & international)

◦ Primary endpoint: a reduction in preterm births ≤
32 6/7 weeks vs. placebo

◦ Improved infant outcomes important secondary
endpoint

} NIH

◦ Validated the science and design of trial

The Risk of Preterm Birth in
Patients with a Sonographic
Short Cervix

Sonia S. Hassan, M.D.
Perinatology Research Branch, NICHD, NIH, DHHS, Bethesda, Maryland
Wayne State University, Department of Obstetrics and Gynecology, Detroit,
Michigan

Internal

Cx Os

External

Cx Os

Canal Length

Funnel

Length

Canal

Length

A short cervix is the most
powerful predictor of
spontaneous preterm
birth

Anderson et al, 1990

Kushnir et al, 1990

Okitsu et al, 1992

Iams et al, 1994, 1995,1996

Hasegawa et al, 1996

Berghella et al 1997

Goldenberg et al, 1998

Guzman et al, 1998

Heath et al, 1998

Taipale et al, 1998

Watson et al, 1999

Andrews et al 2000

Hibbard et al, 2000

Hassan et al, 2000

To et al, 2001

Owen et al, 2001

Durnwald et al 2005

Matijevic et al 2006

Celik et al 2008

Risk for Spontaneous Delivery at <32 Weeks According to

Cervical Length at 23 Weeks of Gestation

Heath VCF et al. Ultrasound Obstet Gynecol 1998;12:301-3.

Cervical length (mm)

100

Iams et al NEJM 1996;334:567-72.

Cervical length (mm)

Anderson et al. AJOG;2990:163-859

Hassan S, ,et al. AJOG 2000;182:1458

Cervical length (mm)

What is a

“short cervix?”

Cervical length (mm)	% <32 wks	% <36 wks
< 10	50	61
< 15	48	64
< 20	41	61
< 25	32	50
< 30	9.6	19
< 40	4	11

Frequency of Preterm Delivery According

To Sonographic Cervical Length

Hassan S, Romero R, Berry S,et al. AJOG 2000;182:1458

• To assess the risk of preterm delivery:

- Calculate the exact probability

• To intervene:

- Low-risk with <15 mm Cx (50% PTB)

- High-risk with <25 mm Cx (50 - 70% PTB)

Why Measure Cervical Length

Summary

• Cervical length is the most powerful predictor of
preterm birth

• Risk is function of length and obstetrical history

• many women do not deliver preterm

• a short cervix is not a ripened cervix

• Standardization and certification of the transvaginal
sonographic evaluation of the cervix in trials and
practice is needed

• An effective treatment for a short cervix has not
been proven

Randomized Clinical Trial
of vaginal progesterone in
women with a short cervix

Multi-Center Trial

Co-sponsors: Columbia Laboratories and
the Perinatology Research Branch,
Intramural Division, NICHD, NIH

• The Effect of Vaginal Progesterone Administration in
the Prevention of Preterm Birth in Women with a
Short Cervix

• The NIH network has 9 sites worldwide

• Wayne State University is one of the highest
enrolling sites in the trial

Columbia / NIH Collaboration

The Effect of Vaginal Progesterone Administration in the
Prevention of Preterm Birth in Women with a Short Cervix

1. 19 - 23 6/7 weeks gestation

2. Cervical length: 10 - 20 mm

3. Vaginal bioadhesive gel vs. placebo

4. Endpoint: preterm delivery at 32 6/7 weeks or less

5. Part of United States Food and Drug Administration
application

6. Co-sponsors: Perinatology Research Branch and
Columbia Laboratories

Detroit

PRB/NIH Collaborative
Network

Italy

New York

Chile

Israel

Pontiac

Grand

Rapids

Measuring
Cervical Length to
Prevent Preterm
Birth

Michael G. Ross, MD, MPH

Harbor-UCLA Medical Ctr

Los Angeles CA

Cervilenz Inc,

Founder and Medical
Director

Cervical Length Measurement

• Short Cervix Diagnosis:

– Gold Standard: transvaginal ultrasound (TVU)

• Cervical Length Screening:

– Proposed Screens every 2 weeks from 16-24 weeks

– TVU costly, logistical challenge

– Need for low cost screening method

NICHD, National Institute of Child Health and Human Development.

1. Grimes-Dennis J, Berghella V. Curr Opin Obstet Gynecol. 2007;19(2):191-195. 2. Berghella V et al. Obstet
Gynecol. 2005;106(1):181-189.

Cervilenz

Low Cost

Performed by Nursing,

Nurse-Midwife or Physician

In office, immediate result

FDA approved

Cervical Portio length measurement
performed under direct visualization with a
speculum

Measuring probe advanced along the
outer aspect of the body of the cervix until
examiner perceives gentle resistance of
the vaginal apex

Cervical flange placed against the cervix,
Cervilenz locked

Measurements at the left and right
quadrants of the cervix

Cervilenz Measurements
Correlate to TVU

Left and right lateral Cervilenz measures were highly correlated to each
other (r=0.95)

Cervilenz mean lateral measurement of <30mm predicted short cervix
(<30 mm) by transvaginal ultrasound

Sensitivity 88%

Specificity 92%

Cervilenz represents potential screening tool for patients who may benefit
from transvaginal ultrasound

J Reprod Med. 2007 May;52(5):385-9.

Cervilenz Measurements are
More Accurate than Digital Exam

Blinded comparison of objective Cervilenz measurement and digital exam
cervical length in patients presenting with signs and symptoms of preterm
labor

Digital cervical length was significantly less than Cervilenz (2.88 vs 3.40
cm; P < .001), and in 36% of subjects, this difference exceeded 1 cm.

Digital assessment underestimates cervical length, whereas the
Cervilenz device permits a visualized and objective cervical length
measure in patients with preterm labor.

Am J Obstet Gynecol. 2009 May;200(5):e37-9.

Efficacy of Progesterone for
Patients with Short Cervical
Length

Natural Progesterone Efficacy:
Cervical Length ≤15 mm: Fonesca et al 2007

Fonseca EB et al, for the Fetal Medical Foundation Second Trimester Screening Group. N Engl J Med.
2007;357(5):462-469.

•Progesterone
reduces the risk of
spontaneous
delivery before 34
weeks by 44.2%

Kaplan-Meier Plot of the
Probability of Continued
Pregnancy Without Delivery
Among Patients Receiving
Vaginal Progesterone as
Compared With Placebo

P=.02

Placebo

Progesterone

No. at Risk for Spontaneous Birth
Progesterone	125	125	122	118	114	112	107	103	99
Placebo	125	121	119	115	109	105	98	87	80

160

100

Gestational Age (d)

240

230

220

210

200

190

180

170

Vaginal Progesterone Gel: Decrease in Risk
for Early PTB in Patients With a Short Cervix
De Franco et al

Planned secondary
analysis evaluating
efficacy of daily vaginal
progesterone gel in
patients with midtrimester
short cervix

Frequency of PTB in
patients with
short cervix (£28
mm) at baseline

DeFranco EA et al. Ultrasound Obstet Gynecol. 2007;30(5):697-705.

0.8

0.0

0.4

0.6

0.2

1.0

Placebo (n=27)

Progesterone (n=19)

Time (wk)

• Fonseca trial demonstrated vaginal
progesterone effective in patients with
cervical length ≤15 mm

• DeFranco trial suggests vaginal
progesterone may work in patients with
longer cervical length (<28 mm)

Implications of Fonseca and
DeFranco Trials

The Ongoing Short Cervix Trial

• Our center (Harbor-UCLA) participated in
both of the Columbia Trials of Vaginal
Progesterone

• Cervilenz Inc is performing several studies
examining the determination of cervical
length and preterm birth outcomes

• Promising prospects for prevention of
preterm birth via cervical length screening
and progesterone therapy for patients
with short cervix

Lee P. Shulman, MD

Anna Ross Lapham Professor

Chief, Division of Reproductive Genetics

Feinberg School of Medicine

Department of Obstetrics and Gynecology

Northwestern University

Chicago, Illinois

35.1% increase since 1981

PTB, preterm birth.

1. Martin JA et al. Natl Vital Stat Rep. 2006;55(1):1-101.

2. Hamilton BE. http://www.cdc.gov/nchs/products/pubs/pubd/hestats/prelimbirths05/prelimbirths05.htm.
Accessed November 19, 2008.

3. Healthy People et al. http://www.healthypeople.gov/document/html/objectives/16-11.htm. Accessed November 19, 2008.

¨ Mortality

¡ Markedly increased risk compared with
term infants1,2

ú 16-fold higher for infants born at 28 to
31 weeks

¨ Morbidity

¡ Acute respiratory, GI, immunologic, and
CNS complications1,3

¨ Significant economic and emotional
costs1,3

GI, gastrointestinal; CNS, central nervous system.

• Kramer MS et al JAMA. 2000;284(7):843-849.

• Callaghan WM et al. Pediatrics. 2006;118(4):1566-1573.

• Institute of Medicine. Preterm Birth: Causes, Consequences, and Prevention. http://books.nap.edu/catalog.php?record_id=11622#toc.
Accessed November 19, 2008

¨ Neurodevelopmental
disabilities

¨ Altered pulmonary
function

¨ Metabolic and
cardiovascular risk

1. Institute of Medicine. Preterm Birth: Causes, Consequences, and Prevention. http://books.nap.edu/catalog.php?record_id=11622#toc.
Accessed November 19, 2008

¨ Prior history of SPTB1

¨ Multiple gestation1

¨ Cervical insufficiency, uterine
abnormalities2

¨ African American ethnicity1,3

¨ Low prepregnancy weight1,3

¨ Maternal age <17 and >35 years1,3

¨ Low socioeconomic status1,3

¨ Maternal stress1

¨ Cigarette smoking,1,3 drug abuse1

¨ Vaginal bleeding in more than 1
trimester1

¨ Anemia1

1. Iams JD. Clin Perinatol. 2003;30(4):651-664.

2. Goldenberg RL et al. Am J Public Health. 1998;88(2):233-238.

3. ACOG Committee on Practice Bulletins—Obstetrics. Number 31, October 2001. Obstet Gynecol. 2001;98(4):709-716.

>50% of women who deliver preterm
do not have identifiable risk factors

Kramer MS. Bull World Health Organ. 1987;65(5):663-737.

“Improved methods for the
identification of women at
increased risk of preterm labor
both before pregnancy and
in the first and second
trimesters are needed.”

Institute of Medicine. Preterm Birth: Causes, Consequences, and Prevention. http://books.nap.edu/catalog.php?record_id=11622#toc.
Accessed November 19, 2008

Preterm Delivery <35 Weeks

CL (mm)*

*CL was measured at 24 weeks..

Iams JD et al. N Engl J Med. 1996;334(9):567-572.

¨ Estimated annual societal economic burden in the
United States: >$26.2 billion ($51,600 for every infant
born preterm)

¨ Average hospital length of stay

Term infant	1.5 days
Preterm infant	13 days

Term infant	$3325
Preterm infant	$32,325

March of Dimes. http://www.marchofdimes.com/prematurity/21198_10734.asp. Accessed November 19, 2008.

Time of Delivery (wk)	Prochieve® 8%	Placebo
<32	7%	19%
32-34	19%	22%
35-36	12%	14%
≥37	62%	45%

*Nine patients did not have a prior PTB.

Time of Delivery (wk)	Neonatal ($)	Maternal ($)	Total ($)
<32	69,026	7,216	76,242
32-34	10,373	4,251	14,625
35-36	3,197	3,212	6,409
≥37	1,295	2,565	3,860

Gilbert WM et al. Obstet Gynecol. 2003;102(3):488-492.

¨ The Consequences of PTB are

¡ Severe for the Family

¡ Costly for Healthcare, and

¡ The trend is worrisome

¨ Preliminary Data suggests that identification
and treatment of short cervix may improve
outcomes and decrease cost

Frank Condella

Interim CEO

Behrman RE et al. In: Behrman RE, Butler AS, eds. Preterm Birth: Causes, Consequences, and
Prevention. Washington, DC: The National Academies Press; 2006:329-354.

Lost household and
market productivity

$5.7 billion

Maternal delivery costs

$1.9 billion

Children’s early intervention
services

$611 million

Infant Costs

Special education services

$1.1 billion

Medical care services

$16.9 billion

~$51,600 Per Preterm Infant

Strengths

} Conclusive secondary analysis with statistically significant patient outcomes

} Reduce significant healthcare cost

} Impact devastating effects on otherwise helpless infants, mothers and
families

} Policy & PR support, with positive trial results from powerful government &
lobby groups

◦ March of Dimes

◦ NIH

◦ Office of the Surgeon General

◦ ACOG

} Fonseca positive short cervix trial data at 1.5 cm

} 12 year safety record developed in ART

$1.7+ Billion Total Market Opportunity

$225+ million
market potential

4.3 Million Births Annually

>2.5 - 3.0 cm
(20%)

$1.1+ billion

market potential

> 2.0 - 2.5 cm
(6%)

1.0 - 2.0 cm
(4%)

$340+ million
market potential

16 weeks X $83.31 week =

$1,333 per patient

} A Short Cervix is the Most Powerful Predictor of Preterm
Birth

} Cervical Length Should be Measured in All Women in Mid-
Pregnancy

} Progesterone is the Most Promising Treatment to Improve
Infant Outcomes in Women with a Short Cervix

} The Prematurity Rate is Increasing

} The Consequences of Prematurity are Severe

} Effective Treatments Will have a Huge Economic Impact

Life Cycle Management
& Intellectual Property

Michael McGrane

Senior Vice President & General Counsel

} Progesterone delivery patent à Sept. 2013

◦ U.S. Patent No. 5,543,150

} Maintain FDA Exclusivity

◦ Petition FDA to convince the agency that:

– Clinical endpoints, not blood levels, are required to
demonstrate bio-equivalence for a generic gel

– A clinical endpoint requires a non-inferiority study in
hard to treat infertility subjects

– Clinical trials in infertility take significant time and
money

} Convert market to patented next generation
Crinone

} Progesterone delivery patent à 2013

◦ Patent No. 5,543,150

} Progressive hydration patent à 2019

◦ Patent No. 6,248,358

} Non-inferiority clinical study in approved
indications to support approval

} Promote next generation to replace gel

} Progesterone delivery patent à 2013

◦ Patent No. 5,543,150

} Progressive hydration technology à 2019

◦ Patent No. 6,248,358

} PTB/Short Cervix (patent pending) à 2028

◦ Patent Application No. US-2008/0188829
-A1

} PTB/Short Cervix (patent pending)

◦ Priority date February 2007

◦ US patent filed February 2008

◦ If granted, patent protection to February 2028

◦ Claims a method to:

– Identify pregnant women with a short cervix

– Prevent preterm birth by administering progesterone to
minimize the shortening or effacing of the cervix

– Administer progesterone by any route

– Deliver in a broad range of doses

– Include both natural progesterone and synthetic progestins

◦ Patent applications filed worldwide

Financial Update

Lawrence Gyenes

Senior Vice President & Chief Financial Officer

Recent market price (1/21/10)	$1.24
Market capitalization	$ 81.4 million
Cash and equivalents (12/31/09)	$ 14.7 million
Long-term Obligations: • PharmaBio royalty loan due 11/30/10 - extendable one year • Subordinated 8% convertible notes due 12/31/11 - convertible @ $5.25	$16.4 million $40.0 million

The Plan Going Forward

Frank Condella

} U.S. Commercial Organization successfully growing
Crinone 8% in infertility

+ New clinical data should continue to drive switch from
injectable forms

− Single product offering vs broader product portfolio by
larger, competitive companies

} Good royalty stream from Crinone international
sales through Merck Serono

} Small contribution from Striant

} Large PTB opportunity if positive results from
PREGNANT trial

} R&D spend focused on PTB opportunity

} Drug delivery technologies are relevant and
have other potential applications

} Scarce financial resources inhibit ability to
acquire additional products or develop
pipeline

} Process ongoing for several months

} Contacted large universe of potential partners
(50+)

} 10 companies entered CDA to gain additional
information

} Six term sheets received

} Three viable opportunities

} Active negotiation ongoing

} Strengthen balance sheet immediately

} Preserve upside of PTB for shareholders

} Partner would bring:

◦ Financial Strength

◦ Strong marketing capability

◦ Synergistic development & regulatory capabilities

} Allow aggressive lifecycle management activities

} Provide resources to expand product
development capabilities

} Grow Crinone U.S. Sales

} Conclude partnership negotiations

} Continue international sales growth of
Crinone with Merck Serono

} Complete PREGNANT trial

} Pursue FDA approval of
Crinone/Prochieve for PTB

} Partner Striant to grow sales and expand
labeling

} Focus on maximizing PTB opportunity and
return on investment for shareholders

} Utilize proven proprietary drug delivery
systems to develop new products to address
health needs of women

} Selectively pursue other development
opportunities outside women’s health utilizing
platform technologies

◦ Expand use of progressive hydration technology for
extended release products

◦ Pursue label expansion on Striant

} Technology that uses bioadhesion to
administer medication to patients in a
targeted fashion

} Polycarbophil-based, non-
immunogenic (hypo-allergenic)
polymer

} Adheres to mucosal surface and
discharged upon normal cell turnover

◦ Oral mucosa for up to 24 hours

◦ Vaginal epithelium for 72+ hours

} Enables controlled and sustained
drug release

} Able to deliver broad range of
compounds to address numerous
therapeutic areas

Polycarbophil: a water-
swellable, water-
insoluble polymer with
numerous negative
charges that

permit hydrogen
bonding with the cell
surface

Active entrapped in
the cross-linked
polymer polycarbophil

Sustained release of
active to tissue

Product	Indication	Clinical	Market Potential/ Current Market Size
Crinone/Prochieve 8% Vaginal Gel	Reduce risk of preterm birth in women with a short cervix in mid- pregnancy	Pivotal Phase III	$1.7 billion (US)
Crinone/Prochieve 8% Next generation	Life Cycle Management Program in ART	Non-inferiority Trials versus Vaginal Gel	$300 + million (US)
Crinone/Prochieve 8% Next Generation	Life Cycle Management Program in Prevention of Preterm Birth	Non-inferiority Trial versus Vaginal Gel	$2.5 billion1 (US & ex- US)
Carbamide Peroxide Vaginal Tablet	Treatment and prevention of bacterial vaginosis	Preclinical Work Complete	$200+ million (US)
Infertility Product Sub-cutaneous	Non-progesterone ART	In-process	$500 million (US)
Testosterone Vaginal delivery	Fibroid reduction	Phase I Work In Progress	$1.2 billion (US)
Anesthetic Vaginal Gel	Treatment of Chronic Pelvic Pain (CPP)	Pilot Clinical Work Complete	$1.5 billion (US)

1. Figure includes $1.7 billion in US & $0.8 billion is ex-US

2. All products but the infertility product utilize the Columbia bioadhesive technology

Therapeutic Area	Indication
Hormone Replacement Therapy	Prevent endometrial hyperplasia associated with estrogen use in menopausal women
Osteoporosis	Three potential drugs identified
Smoking Cessation	One potential drug identified
Oncology	Three potential drugs identified
Deep Vein Thrombosis	Three potential drugs identified
Coagulation Disorder	One potential drug identified
Anti-emetic	One potential drug identified