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):
June 9, 2014
Titan Pharmaceuticals, Inc.
(Exact Name of Registrant as Specified in
Charter)
Delaware |
0-27436 |
94-3171940 |
(State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
400 Oyster
Point Blvd., Suite 505, South San Francisco, CA |
94080 |
(Address of Principal Executive Offices) |
(Zip Code) |
Registrant’s telephone number, including
area code: 650-244-4990
____________________________________
(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.
On June 9, 2014, Titan Pharmaceuticals, Inc. (the “Company”
or “Titan”) announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for a patent
application covering the sustained release of dopamine agonists utilizing ProNeura™, Titan’s proprietary long-term
drug delivery technology. The patent provides intellectual property protection for the Company’s development program of ProNeura
for Parkinson’s disease and carries a patent term to at least 2024
A copy of the press release issued by the
Company is attached hereto as Exhibit 99.1 and is incorporated herein by reference,
Item 9.01. Financial Statements
and Exhibits.
(d)
Exhibits
Exhibit No. |
Description |
99.1 |
Press Release, dated June 9, 2014. |
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.
Dated: June 9, 2014 |
TITAN PHARMACEUTICALS, INC. |
|
|
|
|
By: |
/s/ Sunil Bhonsle |
|
|
Name: Sunil Bhonsle |
|
|
Title: President |
Exhibit Index
Exhibit No. |
Description |
99.1 |
Press Release, dated June 9, 2014. |
Titan Pharmaceuticals Receives Notice
of Allowance for Patent of Implantable Polymeric Device for Sustained Release of Dopamine Agonists
New patent to provide intellectual
property protection for
ProNeura for Parkinson’s disease
South San Francisco, CA – June 9, 2014 - Titan
Pharmaceuticals, Inc. (TTNP.OB), a specialty pharmaceutical company developing proprietary therapeutics for the treatment
of opioid dependence and other serious medical disorders, announced today that it has received
a Notice of Allowance from the U.S. Patent and Trademark Office for a patent application covering the sustained release of dopamine
agonists utilizing ProNeura™, Titan’s
proprietary long-term drug delivery technology. The patent, titled “Implantable
Polymeric Device for Sustained Release of a Dopamine Agonist,”
provides intellectual property protection for the company’s
development program of ProNeura for Parkinson’s disease and
carries a patent term to at least 2024. Similar patents have been issued in Europe, Australia, Canada, Japan, Korea, Mexico, New
Zealand, South Africa and Hong Kong, and patent applications are pending in Israel, India and China.
“This
patent allowance is a significant milestone for Titan, as we advance our ProNeura for Parkinson’s
development program,” said Titan President Sunil Bhonsle.
“The ability to maintain stable, non-fluctuating, around-the-clock
blood levels of dopamine agonists has the potential to improve the health of the estimated seven to 10 million people who are suffering
from Parkinson’s disease worldwide today, and we are pleased
to receive this IP protection.”
Titan
is actively engaged in the early stages of product development, while simultaneously consulting with scientific advisors and key
opinion leaders on the ProNeura for Parkinson’s disease program.
The company anticipates filing an investigational new drug application for ProNeura for Parkinson’s
disease in 2015. In 2012, Titan successfully completed a preclinical investigation into the feasibility of utilizing the ProNeura
platform for the continuous delivery of ropinirole in a nonhuman primate model commonly used to study medications for Parkinson’s
disease.
About the ProNeura Technology Platform
The ProNeura technology platform is Titan’s
proprietary, long-term drug delivery technology utilized in the development of products for the treatment of chronic conditions
that may benefit from the continuous delivery of certain medications over an extended period of time. The ProNeura drug delivery
system consists of a small, solid rod made from a mixture of ethylene-vinyl acetate (“EVA”)
and a drug substance. The resulting product is a solid matrix that is placed subdermally, normally in the inner part of the upper
arm, during a simple office procedure, and is removed in a similar manner at the end of treatment. The drug substance is released
continuously through the process of dissolution, resulting in a stable, non-fluctuating blood level similar to that seen with
intravenous administration. These long-term, linear-release characteristics are medically desirable to avoid the peak and trough
swings from oral dosing that pose problems in the current treatments for many diseases, especially diseases of the central nervous
system. Titan has issued patents as well as patent applications covering the use of the ProNeura platform technology for the formulation
of specific products for the treatment of certain chronic diseases, such as opioid dependence, Parkinson’s
disease, and others.
Probuphine®,
an investigational subdermal implant designed to deliver around-the-clock blood levels of buprenorphine for the long-term maintenance
treatment of opioid dependence, is Titan’s first product
in development employing the ProNeura technology platform.
About Titan Pharmaceuticals
Titan Pharmaceuticals Inc. (TTNP.OB), based in South San Francisco,
CA, is a specialty pharmaceutical company developing proprietary therapeutics primarily for the treatment of serious medical disorders.
The company’s lead product candidate is Probuphine®,
a novel and long-acting formulation of buprenorphine for the long-term maintenance treatment of opioid dependence. Probuphine employs
Titan’s proprietary drug delivery system ProNeura™,
which is capable of delivering sustained, consistent levels of medication for six months or longer. Titan has granted North American
commercial rights for Probuphine to Braeburn Pharmaceuticals. If approved, Probuphine would be the first and only commercialized
treatment of opioid dependence to provide continuous, round-the-clock blood levels of buprenorphine for six months following a
single procedure. The ProNeura technology has the potential to be used in developing products for treating other chronic conditions,
such as Parkinson’s disease, where maintaining consistent
blood levels of a dopamine agonist may benefit the patient and improve medical outcomes. For more information about Titan, please
visit www.titanpharm.com.
This press release may contain "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 statements
include, but are not limited to, any statements relating to our product development programs and any other statements that are
not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results,
financial condition and stock price. Factors that could cause actual results to differ materially from management's current expectations
include those risks and uncertainties relating to the regulatory approval process, the development, testing, production and marketing
of our drug candidates, patent and intellectual property matters and strategic agreements and relationships.
We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements
contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such
statement is based, except as required by law.
CONTACT:
Titan Pharmaceuticals, Inc. |
Media |
Sunil Bhonsle, 650-244-4990 |
Susan Thomas, 619-540-9195 |
President |
stcommunications@aol.com
|
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