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Form 8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported) September 19, 2011

A.P. Pharma, Inc.

(Exact name of registrant as specified in its charter)


Delaware	001-33221	94-2875566
(State or other jurisdiction of incorporation)	(Commission File Number)	(I.R.S. Employer Identification No.)

123 Saginaw Drive Redwood City CA		94063
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code (650) 366-2626

N/A

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

¨	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

ITEM 8.01

Other Events.

A.P. Pharma, Inc. (the “Company”) updated its corporate presentation on September 19, 2011. The slides from the presentation are attached hereto as Exhibit 99.1. The attached materials have also been posted on the Company’s website at www.appharma.com. The Company does not undertake to update this presentation.

ITEM 9.01

Financial Statements and Exhibits.

(d) Exhibits.


Exhibit No.		Description

99.1		Corporate Presentation, dated September 2011

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.


				A.P. Pharma, Inc.

Date: September 19, 2011				/s/ John B. Whelan
				John B. Whelan
				President and Chief Executive Officer

Corporate Presentation, dated September 2011

Company Overview

OTCQB: APPA.PK

September 2011

Exhibit 99.1

Legal Disclaimer

September 2011

This presentation contains "forward-looking statements" as defined by the Private

Securities Litigation Reform Act of 1995. These forward-looking statements

involve risks and uncertainties, including uncertainties associated with timely

development, approval, launch and acceptance of new products, satisfactory

completion of clinical studies, establishment of new corporate alliances, progress

in research and development programs and other risks and uncertainties identified

in the Company's filings with the Securities and Exchange Commission. Actual

results may differ materially from the results expected in our forward looking

statements. We caution investors that forward-looking statements reflect our

analysis only on their stated date. We do not intend to update them except as

required by law.

Company:

A.P. Pharma, Inc.

Ticker:

OTCQB: APPA.PK

Stock Price:

$0.25 (9/16/11)

Market Capitalization:

$98.1 million

Cash:

$23.6

million

Debt:

$1.5 million

Stock Summary

September 2011

Based on 392.5 million as-converted common shares assuming the full conversion of

convertible debt outstanding or subject to purchase rights, and 80 million warrants; not

including options and 4M warrants with an exercise price of $0.88/share

Pro forma as of June 30, 2011 including net proceeds from July 1, 2011 PIPE funding

As of June 30, 2011

John B. Whelan

President, CEO & CFO

Raven Biotechnologies

Eos Biotechnology

Hewlett Packard/Agilent

Michael A. Adam,

Ph.D.

Senior Vice President &

Chief Operating Officer

Spectrum Pharmaceuticals

Pfizer

Bristol-Myers Squibb

John Barr, Ph.D.

Senior Vice President,

Research and Development

Cortech

Kristin Ficks

Head of Commercial Operations

Gemini Healthcare

Celgene

Eisai/MGI Pharma

Management

September 2011

A.P. Pharma Highlights

Lead product candidate, APF530, is long-acting, injectable

product for chemotherapy-induced nausea and vomiting (CINV)

Incorporates

widely

used

5HT3

anatgonist

granisetron

(Kytril

)

5-day delivery profile

Reduces both acute-

and delayed-onset CINV with single injection

APF530

shown

non-inferior

market

leader

Aloxi

1,341-patient, randomized, controlled, Phase 3 study

Presented at ASCO 2009

Company is addressing issues raised in Complete Response

Letter

End-of-review meetings held in 1Q 2011

Resubmission planned for 1H 2012

APF530 targets a $900 million market opportunity in US alone

Could be second, long-acting, injectable product on market

A.P. Pharma has pipeline of additional products based on its

Biochronomer™

drug delivery technology

September 2011

Product Pipeline

Product

Candidate

Potential

Indication

Drug

Target

Duration

Preclinical

Phase 1

Phase 2

Phase 3

NDA

APF530

Chemotherapy-

induced nausea

and vomiting

Granisetron

5 days

APF112

Post-surgical

pain relief

(opiate-sparing)

Mepivacaine

3 days

APF580

Sustained pain

relief

Buprenorphine

7 days

APF328

Post-surgical

pain and

inflammation

(orthopedic

surgery)

Meloxicam

Up to two

weeks

APF505

Chronic pain

and

inflammation

(osteoarthritis)

Meloxicam

Up to six

weeks

All leverage same polymer technology used in APF530

September 2011

APF530 Milestones 2011 -

2012

1Q 2012

2Q 2012

2H 2012

September 2011

Complete validation activities

FDA approval decision

Complete thorough QT and

metabolism study

Complete human factors study

Complete CMC activities

Resubmit APF530 NDA

Clinical Summary

September 2011

APF530 Pivotal Phase 3 Study Overview

Randomized, controlled, multi-center study

1,341 patients in primary efficacy population

Two doses of APF530 (5 mg and 10 mg granisetron)

compared to the approved dose of Aloxi

Patients stratified by type of chemotherapy regimen

(moderately or highly emetogenic)

Primary end point compared complete response between

groups in both the acute (day 1) and delayed (days 2-5)

phase

Complete response defined as no emesis and no rescue medications

A ±15% margin was used to establish non-inferiority

September 2011

APF530 Phase 3 Study Design

Cycle 1

Cycles

2 to 4

Patient Stratification

(n = 1,341)

Moderately Emetogenic

(n = 634)

Highly Emetogenic

(n = 707)

September 2011

Aloxi

APF530

(5mg)

APF530

(10mg)

Aloxi

APF530

(5mg)

APF530

(10mg)

APF530

(5mg)

APF530

(10mg)

APF530

(5mg)

APF530

(10mg)

Primary Efficacy Results: Complete Response

Patients Receiving Moderately Emetogenic Chemotherapy

Acute

Delayed

APF530 5mg

APF530 10mg

Acute

Delayed

Acute

Delayed

Difference in Complete Response

APF530-Aloxi (97.5% CI)

-15

-10

-5

September 2011

74.8

76.9

57.7

51.4

59.0

Primary Efficacy Results: Complete Response

Difference in Complete Response

APF530-Aloxi (98.33% CI)

Acute

Delayed

APF530 5mg

APF530 10mg

Patients Receiving Highly Emetogenic Chemotherapy

Acute

Delayed

September 2011

80.7

77.7

81.3

66.4

64.6

68.3

Safety Summary

* >90% of injection site reactions were reported as mild; one patient discontinued due to

injection site reaction

Reported in Cycle 1

September 2011

Nervous System

Bruising

Erythema (redness)

Nodule (lump)

Pain

Injection Site*

Headache

Serious Adverse Events

Discontinued Due to Adverse Event

Frequent Adverse Events

Constipation

Nausea

Diarrhea

Abdominal pain

Gastrointestinal disorders

APF530 5 mg

APF530 10 mg

0.2

13.4

12.1

10.6

4.5

15.4

12.8

9.4

2.8

13.4

8.9

8.4

6.0

6.7

10.0

9.7

16.8

7.1

4.7

3.4

19.9

10.9

10.7

7.1

8.9

3.0

0.6

1.1

Placebo (NaCl)

Aloxi 0.25 mg

APF530’s Efficacy with Difficult Chemo Regimens

Treatment

Chemotherapeutic Regimen

APF530 10 mg

Aloxi 0.25 mg

Moderately

Emetogenic

Acute

Cyclophosphamide/Doxorubicin

70.7%

65.7%

All other regimens

84.4%

85.0%

Delayed

Cyclophosphamide/Doxorubicin

47.4%

46.3%

All other regimens

72.9%

70.0%

Highly

Emetogenic

Acute

Cisplatin regimens

81.1%

75.5%

Carboplatin/Paclitaxel

85.4%

89.8%

All other regimens

75.4%

67.6%

Delayed

Cisplatin regimens

66.0%

60.4%

Carboplatin/Paclitaxel

70.8%

71.4%

All other regimens

65.2%

57.4%

September 2011

APF530’s Sustained Efficacy in Cycles 2-4

* Sakai et al (Annals of Oncology, Vol. 19 Sept. 2008)

Complete Response Rates for Delayed-onset CINV in Patients Receiving

Highly Emetogenic Chemotherapy

351

315

254

117

100%

90%

72%

33%

240

169

129

100%

70%

54%

39%

N =

% of Cycle 1

APF530 10mg

Aloxi 0.75mg*

September 2011

Summary of APF530 Phase 3 Results

Non-inferiority to Aloxi was demonstrated

For both acute-

and delayed-onset CINV

With both moderately and highly emetogenic chemotherapy

APF530 was safe and well-tolerated

Incidence of adverse events comparable to Aloxi

High response rates were observed in difficult

chemotherapy regimens

A high level of efficacy was maintained through multiple

cycles of chemotherapy

September 2011

Regulatory Status and Strategy

September 2011

APF530 NDA Status

Submitted NDA in May 2009

Received Complete Response Letter in March 2010

FDA raised issues in three main areas:

Dosing system

Two-syringe system

Chemistry, Manufacturing, and Controls (CMC)

Sterilization

Characterization

Clinical/statistical

Specific studies

Presentation of data

Held end-of-review meetings with FDA in 1Q 2011

Implementing plan to resubmit NDA in 1H 2012

September 2011

Outcome of FDA Meetings

Dosing System

Changed to single-syringe system

Single glass syringe for storage and administration

Smaller needle: switch from 1”

x 16 gauge to 5/8”

x 18 gauge thin-wall

Enhanced dosing instructions

Overall, simpler and more convenient

Non-clinical human factors study planned

Chemistry, Manufacturing, and Controls

Changed from bulk to terminal irradiation

Additional specifications and assays for raw materials, polymer and drug

product

Clinical/Statistical

Thorough QT study –

Initiated in August 2011

Metabolism study

Revised presentation format for Phase 3 data

No additional clinical efficacy studies requested

September 2011

Commercial Opportunity

September 2011

U.S. Market Opportunity for APF530

More than 7 million cycles of chemotherapy administered

each year

~27% are highly emetogenic

~46% are moderately emetogenic

Significant unmet medical need for additional therapies to

address delayed-onset CINV

5HT3 antagonists are standard-of-care for CINV

Recommended in treatment guidelines –

NCCN, ASCO, ONS

An injectable 5HT3 antagonist is co-administered with more than 90% of

moderately and highly emetogenic regimens

APF530 targets a $900

million market opportunity in the

US alone

In 2010, there were 5.14 million vials of injectable 5HT3 antagonists

administered for CINV

The average selling price for market leader Aloxi is $179

Sources: Company-sponsored survey and analysis and Wolters Kluwer

September 2011

Generation 5HT3 Antagonists Study Results

Moderately

Emetogenic

Chemotherapy

Ondansetron

Gralla

Eisenberg

50%

34%

Highly Emetogenic Chemotherapy

Ondansetron

Granisetron

Aapro

Emend Label Studies

Emend

Label

Saito

25%

43%

52%

43%

33%

40%

Average Overall Complete Response* rates

*Overall Complete Response defined as no emesis and no rescue

medications during 0 to 120 hours following chemotherapy

September 2011

Moderately Emetogenic Chemotherapy ~ 42%

Highly Emetogenic Chemotherapy ~ 39%

Overall Complete Response rates by study:

Aloxi Study Results

Moderately Emetogenic Chemotherapy

Eisenberg

Gralla

Grunberg

Hajdenberg

APPA Ph 3

46%

69%

59%

52%

Highly Emetogenic Chemotherapy

Aapro

APPA Ph 3

41%

62%

Average Overall Complete Response rates

Moderately Emetogenic Chemotherapy ~ 57%

Highly Emetogenic Chemotherapy ~ 51%

Overall Complete Response rates by study:

September 2011

Antiemetic Treatment Patterns

September 2011

Most chemotherapy patients will undergo 4 to 15 cycles of

chemotherapy

Doctors prefer to administer antiemetics on-site for

moderately and highly emetogenic chemotherapy

Patient compliance is a significant concern

Average cost per CINV event ranges from $4,000 to $5,300

Issues controlling CINV typically appear during the first few

cycles

If the initial prevention regimen is not effective, drugs are

added and/or changed to address CINV in subsequent

cycles

No long-acting injectable alternative to Aloxi is available to prevent

delayed-onset CINV

LOGO

CINV Market Dynamics

Injectable Drugs for the Prevention of CINV

Number of Package Units Sold by Quarter

800,000

700,000

600,000

500,000

400,000

300,000

200,000

100,000

Q2’06 Q3’06 Q4’06 Q1’07 Q2’07 Q3’07 Q4’07 Q1’08 Q2’08 Q3’08 Q4’08 Q1’09 Q2’09 Q3’09 Q4’09 Q1’10 Q2’10 Q3’10 Q4’10 Q1’11 Q2’11

ALOXI ANZEMET KYTRIL KYTRIL Generic (GRANISETRON) ZOFRAN ZOFRAN Generic (ONDANSETRON) EMEND

* US Oncology data added starting Q1’09.

Source: Wolters Kluwer

Usage in CINV estimated based on vial size

a.p.pharma

Aloxi Market Performance

September 2011

Zofran went

generic

Pricing

Average Selling Price = $179

Medicare Reimbursement = $189

Wholesale

Acquisition

Cost

$300

$330

Orange Book Patent Exclusivity

One patent expires April 2015

Three patents expire January 2024

CINV Market Dynamics: Conclusions

Aloxi has gained market share over last 3 years despite

availability of generics for acute-onset CINV

From 48% in 2008 to 56% in 2Q 2011

Kytril was widely used prior to Zofran

going generic

High physician acceptance of granisetron

Aloxi dipped 30% when Zofran went generic but then

regained 100% of its lost share two quarters later

NK1 antagonists typically are only used as an adjunct to

5HT3 antatgonists

Injectable Emend

units sold less than 10% of injectable units sold for

CINV prevention

September 2011

Competitive Landscape

September 2011

APF530 would be one of two injectable products approved

for preventing delayed-onset CINV

5HT3 antagonists are standard-of-care

1 generation products have limited effectiveness in preventing

delayed-

onset CINV

Patients continue to experience CINV despite currently available

products

Most chemotherapy patients will undergo 4 to 15 cycles of chemotherapy

Large Phase III study supporting APF530’s use

Non-inferior efficacy to Aloxi

Similar safety profile to granisetron and Aloxi

High response rates were observed in difficult chemotherapy regimens

A high level of efficacy was maintained through multiple cycles of

chemotherapy

APF530 Commercialization Strategy

A.P. Pharma owns worldwide rights to APF530

APF530 can be commercialized with a compact

commercial infrastructure targeting oncologists

Company to evaluate partnering opportunities before and

after FDA approval

September 2011

Financial Summary

September 2011

Completed $24MM PIPE in July 2011

Current resources expected to fund company into 2013

Summary Statement of Operations

(In thousands, except per share data)

Six Months Ended

June 30, 2011

Revenue

$ 646

Operating expenses

3,501

Other

income

(expenses)

(496)

Net loss

$ (3,351)

Net

loss

per

$ (0.08)

Condensed Balance Sheet Data

(In thousands)

June 30, 2011

Dec 31, 2010

Cash and cash equivalents

$ 21,331

$ 2,109

Working capital

$ 18,626

$ 941

Total assets

$ 22,121

$ 2,911

Total stockholders’

equity

$ 18,892

$ 1,316

Includes discontinued operations

Based on 40.1 million weighted average common shares outstanding

Includes $20.3 million in advance proceeds received in June 2011

A.P. Pharma Highlights

Lead product candidate, APF530, is long-acting, injectable

product for chemotherapy-induced nausea and vomiting (CINV)

Incorporates

widely

used

5HT3

antagonist

granisetron

(Kytril

)

5-day delivery profile

Reduces both acute-

and delayed-onset CINV with single injection

APF530 shown

non-inferior

market

leader

Aloxi

1,341-patient, randomized, controlled, Phase 3 study

Presented at ASCO 2009

Company is addressing issues raised in Complete Response

Letter

End-of-review meetings held in 1Q 2011

Resubmission planned for 1H 2012

APF530 targets a $900 million market opportunity in US alone

Could be second, long-acting, injectable product on market

A.P. Pharma has pipeline of additional products based on its

Biochronomer™

drug delivery technology

Thank You

A.P. Pharma, Inc.

OTCQB: APPA.PK

September 2011