Plx Pharma Withdraws Ipo

Plx pharma withdraws ipo

As filed with the Securities and Exchange Commission on January 15, 2016

Registration No. 333-207297

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C.

Plx pharma withdraws ipo

20549



 

Amendment No. 3 to
FORM S-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933



 

8285 El Rio Street, Suite 130
Houston, Texas 77054
(713) 842-1249

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)



 

Natasha Giordano
President and Chief Executive Officer
PLx Pharma Inc.


8285 El Rio Street, Suite 130
Houston, Texas 77054
(713) 842-1249

(Name, address, including zip code, and telephone number, including area code, of agent for service)



 


 

Approximate date of commencement of proposed sale to the public: As soon as practicable after the effective date of this Registration Statement.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box.

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.

PLx Pharma withdraws IPO

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

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(Check one):

The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until this Registration Statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.

 

 


 

 

TABLE OF CONTENTS

The information in this preliminary prospectus is not complete and may be changed. These securities may not be sold until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell nor does it seek an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.

In This Story



 

 


 

 

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We believe our PLxGuard TM delivery system has the potential to improve many already-approved drugs and drugs in development because it may:

enhance the efficacy of the drug using our technology;
improve the GI safety of the drug;
provide new or extended patent protection for an already-approved or development-stage drug: and
utilize the 505(b)(2) New Drug Application (NDA) regulatory path, which may provide a faster and lower-cost FDA approval route when used with already-approved drugs.

The PLxGuard TM delivery system has clinically proven these benefits with our novel formulations using aspirin and ibuprofen and has preclinical evidence supporting the potential for a GI-safer oral diclofenac and intravenous indomethacin products.

Other existing or new drugs in development that may benefit from the PLxGuard TM delivery system will be evaluated either by us or through collaboration agreements with other companies.

Product Pipeline

Our lead product, PL2200 Aspirin 325 mg, is approved by the FDA for OTC distribution and is the first-ever FDA-approved liquid-fill aspirin capsule.

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All the clinical trials necessary for product launch have been completed. In clinical trials in diabetic patients at risk for cardiovascular disease, PL2200 Aspirin 325 mg demonstrated better antiplatelet efficacy compared with enteric coated aspirin, which is the current standard of care for cardiovascular disease prevention and treatment. PL2200 325 mg delivers faster antiplatelet efficacy than enteric coated aspirin with a median time to 99% inhibition of serum Thromboxane B2 of two hours compared with 48 hours for enteric coated aspirin.

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Serum Thromboxane B2 is a clinically accepted marker for antiplatelet efficacy (sometimes referred to as “aspirin response”).

PL2200 Aspirin 325 mg provides more reliable, predictable and sustained antiplatelet benefits than enteric coated aspirin with a 3 – 5 times greater chance of a complete aspirin antiplatelet effect than enteric coated aspirin.

PL2200 Aspirin 325 mg has demonstrated a statistically significant 65% reduction in the risk of acute ulcers compared with immediate release aspirin in healthy subjects with an age associated risk for cardiovascular disease.

Plx pharma withdraws ipo

This acute GI safety benefit may also be important for acute coronary syndrome (ACS) patients. Moreover, we believe ACS patients who are also diabetics and suffer from gastroparesis, or a lack of digestive stomach motility, could also benefit from PL2200 Aspirin due to its more predictable absorption when compared to enteric coated aspirin.

The acute GI safety benefit may also be used to differentiate PL2200 Aspirin 325 mg from products intended for use in conditions associated with pain and inflammation, including other aspirin and NSAID products.

PL2200 Aspirin 81 mg is our lower-dose companion product for PL2200 Aspirin 325 mg (the two dose forms are often referred to in this prospectus collectively as “PL2200 Aspirin”).

Plx pharma withdraws ipo

This product utilizes exactly the same formulation as the 325 mg product (except delivered in a capsule one quarter the size) and will be the subject of an sNDA, which we expect to file with the FDA early in the second half of 2016. We will rely on the clinical results for PL2200 Aspirin 325 mg for the PL2200 81 mg sNDA and do not anticipate any additional clinical trials will be required, effectively positioning this product as an end of Phase 3 status.

(For a more detailed explanation of clinical trial phases, see the discussion below under “Business — Government regulation —  Clinical trials.”)

We believe our technology may be used with other selected NSAIDs, such as ibuprofen. For the U.S. OTC market, we have used the PLxGuard TM delivery system to create a lipid-based formulation of ibuprofen, PL1200 Ibuprofen 200 mg and a 400 mg product for prescription doses of ibuprofen.

We have OTC and prescription (Rx) Investigational New Drug applications (IND) active with the FDA and have demonstrated bioequivalence with the OTC 200 mg dose ibuprofen to support a 505(b)(2) NDA in fasted-state clinical trials at three different doses, 200 mg, 400 mg and

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800 mg.

Using the PL1200 formulation at prescription doses, we demonstrated better GI safety in osteoarthritic patients with equivalent analgesic and anti-inflammatory efficacy, when compared with prescription ibuprofen in a six-week endoscopy pilot clinical trial.

PL1200 and PL1100 Ibuprofen may be considered as being in Phase 1 in the FDA process and may qualify for the 505(b)(2) NDA path.

PLXP PLx Pharma Inc.

The following table summarizes information regarding our product candidates and development program:

The Market

Cardiovascular/Aspirin Market

Aspirin, also known as acetylsalicylic acid (ASA), is a foundational medicine for the treatment and prevention of cardiovascular disease (CVD) — a collective term for chest pain, coronary artery disease, heart attack, heart failure, high blood pressure and stroke — which is the leading cause of death in the United States.

Aspirin is widely used to treat patients exhibiting signs and symptoms of heart attack or stroke (collectively referred to as ACS), and is commonly prescribed or recommended by physicians, in addition to other drugs such as cholesterol or blood pressure medications, as the standard of care for treating ACS and preventing recurrent ACS for the duration of a patient’s life.

The 325 mg dose is generally prescribed:

in an acute setting for the treatment of ACS;
following an interventional procedure (such as placement of a stent); and
for preventing heart attack or stroke during the high-risk period following an event or intervention.

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Eventually, most patients move to the 81 mg dose for secondary prevention applications and for high-risk primary prevention, as they are typically directed to take aspirin every day for the rest of their life.

The 81 mg aspirin dose is the most prevalent, representing approximately 70% to 80% of aspirin sales in the United States, followed by the 325 mg dose and then several other dose forms including powdered and effervescent aspirin products.

In the United States, the primary use for aspirin is for the prevention and treatment of cardiovascular disease as evidenced by the predominance of the 81 mg dose.

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Aspirin is also used for pain relief and fever reduction. The most widely used dose for pain is 325 mg. A GI-safer PL2200 Aspirin 325 mg may be able to capture market share from other aspirin and NSAID products in the large pain and inflammation market.

Annual global aspirin sales in 2013 were estimated to be $1.6 billion (Euromonitor), including branded products such as Bayer®, Ecotrin® and St.

Joseph®, together with numerous private label or store brands.

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Because of the known GI toxicity issues associated with immediate release (or “regular”) aspirin, enteric coated aspirin has evolved to become the leading aspirin dose form, representing over 90% of U.S. aspirin sales in 2013. This success is largely based on early clinical studies suggesting that enteric coated aspirin showed a reduction in superficial gastric lesions as compared with regular aspirin.

However, when measured using contemporary clinical procedures, enteric coated aspirin has not continued to demonstrate such reductions. These deficiencies create a significant opportunity for the demonstrated efficacy of PL2200 Aspirin.

Pain & Inflammation/Ibuprofen

The global OTC pain market for NSAIDs was over $12 billion in annual sales in 2013 (Evaluate Pharma).

Other Topics

Ibuprofen in the United States alone represents $1.6 billion. This class of drugs is one of the most widely used drugs worldwide. Increasing concerns over liver toxicity associated with acetaminophen products coupled with known ibuprofen analgesic superiority over acetaminophen, indicate there is a substantial global opportunity for a GI safer ibuprofen product. While we do not believe our technology will work with the entire NSAIDs class, it is possible that our technology may be successfully applied to other NSAIDs beyond aspirin and ibuprofen.

For example, we have preclinical data suggesting that diclofenac — a leading NSAID for pain and inflammation outside the United States — is a viable product candidate.

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Our Key Competitive Strengths

Our lead product, PL2200 Aspirin 325 mg, has been approved by the FDA under a traditional NDA process.

  We intend to leverage clinical studies and market research to launch PL2200 Aspirin 325 mg on a commercial scale using a combined prescription and OTC strategy that takes advantage of the existing OTC distribution channels for aspirin while leveraging the FDA approval of PL2200 Aspirin 325 mg for prescription and recommendation by physicians for cardiovascular disease treatment and prevention. We will be seeking approval of the companion PL2200 Aspirin 81 mg dose via an sNDA that should benefit from the prior approval of PL2200 Aspirin 325 mg.

Our management team has extensive experience in development and commercialization of OTC products.

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  Mr. Valentino, our Executive Chairman of the Board, brings over 30 years of experience in the healthcare industry. Mr. Valentino successfully built Adams Respiratory Therapeutics into a fully integrated specialty pharmaceutical company with more than $490 million in annual revenue and leading OTC brands such as Mucinex® and Delsym®.

In December 2007, Adams Respiratory Therapeutics sold to Reckitt Benckiser for approximately $2.3 billion.

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Ms. Giordano, our President and Chief Executive Officer, has over 20 years in the life science industry and has successfully developed commercialization plans for several new product launches across various therapeutic areas, specifically building physician directed sales teams, including with one of the most successful products in the cardiology sector, Lipitor.

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PL2200 Aspirin 325 mg has demonstrated clinically superior antiplatelet efficacy in diabetic patients when compared to enteric coated aspirin, the current standard of care for cardiovascular disease prevention.

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  PL2200 Aspirin 325 mg delivers faster and more reliable, predictable and sustained antiplatelet benefits than enteric coated aspirin as clinically demonstrated in diabetic patients at risk for cardiovascular disease with a median time to 99% inhibition of serum Thromboxane B2 of two hours compared with 48 hours and with a 3 – 5 times greater chance of a complete aspirin antiplatelet effect than enteric coated aspirin.(Serum Thromboxane B2 is an accepted clinical marker of anti-platelet efficacy.)

PL2200 Aspirin 325 mg has demonstrated clinically superior GI safety when compared to regular aspirin.

  PL2200 Aspirin 325 mg has demonstrated a statistically significant 65% reduction in the risk of acute ulcers compared with regular aspirin in healthy subjects with an age associated risk for cardiovascular disease. Based on physician market research, we believe that our clinical data supporting superior acute GI safety as compared to aspirin is important for physicians who are having difficulty keeping high-risk patients on sustained aspirin use due to lack of tolerability.

Our PLxGuard TM delivery system is a platform technology that may improve the GI safety and efficacy when applied to already approved drugs.

Plx pharma withdraws ipo

  Our PLxGuard TM delivery system is a platform technology that we believe could improve the GI safety of selected NSAIDs that meet specific criteria. According to a report by Evaluate Pharma, the global OTC pain market for NSAIDs was over $12 billion in 2013. We intend to explore new development opportunities and utilize the 505(b)(2) NDA regulatory pathway to decrease the time and costs associated with obtaining FDA approval for new products.