Summary

• Page properties (1 modified, 0 added, 0 removed)

Details

Page properties

Content

...	...	@@ -2,8 +2,10 @@
2	2	{{toc/}}
3	3	{{/box}}
4	4
5		-= Overview =
	5	+= Paragraph 1 =
6	6
	7	+==== Overview ====
	8	+
7	7	Titan Pharmaceuticals is a pharmaceutical company developing proprietary therapeutics for the treatment of serious medical disorders. The company's product development programs utilize its proprietary long-term drug delivery platform, ProNeura™, and focus primarily on innovative treatments for select chronic diseases for which steady state delivery of a drug provides an efficacy and/or safety benefit.
8	8
9	9	Probuphine®, its first product candidate based on the ProNeura platform, was approved by the FDA in May 2016 for the maintenance treatment of opioid dependence in patients who are stable on low to moderate doses of daily sublingual buprenorphine treatment. The company licensed development and commercialization rights of Probuphine for the U.S. and Canadian markets to Braeburn Pharmaceuticals, Inc., or Braeburn.
...	...	@@ -56,7 +56,7 @@
56	56
57	57	In February 2016, Braeburn informed it that it has entered in a sublicense agreement with Knight Therapeutics, Inc., or Knight, a specialty pharmaceutical company, whereby Braeburn has granted to Knight the rights to commercialize Probuphine in Canada.
58	58
59		-= Intellectual Property =
	61	+==== Intellectual Property ====
60	60
61	61	The company's goal is to obtain, maintain and enforce patent protection for its product candidates, formulations, processes, methods and any other proprietary technologies, preserve its trade secrets, and operate without infringing on the proprietary rights of other parties, both in the United States and in other countries. The company's policy is to actively seek to obtain, where appropriate, the broadest intellectual property protection possible for its current product candidates and any future product candidates, proprietary information and proprietary technology through a combination of contractual arrangements and patents, both in the United States and abroad. However, patent protection may not afford it with complete protection against competitors who seek to circumvent its patents.
62	62
...	...	@@ -68,7 +68,7 @@
68	68
69	69	Future court decisions or changes in patent law might materially affect the patents or patent applications, including, but not limited to, their expiration dates.
70	70
71		-= Competition =
	73	+==== Competition ====
72	72
73	73	The pharmaceutical and biotechnology industries are characterized by rapidly evolving technology and intense competition. Many companies of all sizes, including major pharmaceutical companies and specialized biotechnology companies, are engaged in the development and commercialization of therapeutic agents designed for the treatment of the same diseases and disorders that the company target. Many of its competitors have substantially greater financial and other resources, larger research and development staff and more experience in the regulatory approval process. Moreover, potential competitors have or may have patents or other rights that conflict with patents covering its technologies.
74	74
...	...	@@ -76,14 +76,14 @@
76	76
77	77	If successfully developed and approved for commercialization, its ProNeura ropinirole product for PD will face competition primarily from numerous daily dose dopamine agonist treatments currently in use that provide symptom relief from disease related immobility, as well as the complications associated with long-term levodopa therapy (e.g. dyskinesias, tolerance). Approved products in the U.S. in addition to Requip XL®, which is marketed by GlaxoSmithKline, include Apokyn® (US WorldMeds LLC), Parlodel® (Novartis Pharmaceuticals Inc.), Mirapex ER® (Boehringer Ingelheim Pharmaceuticals Inc.) and Neupro® (UCB Inc.). There is a strong need for products providing continuous, stable, long term delivery of dopamine and dopamine agonists and the FDA recently approved a product called Duodopa®, the first and only treatment delivered via catheters directly into the duodenum that is capable of providing 16 continuous hours of carbidopa and levodopa for treatment of motor fluctuations in advanced PD. Duodopa is marketed globally by Abbvie. Also, Titan Pharmaceuticals is aware of products in mid-stage clinical development that are capable of short to medium-term subcutaneous and subdermal delivery of levodopa/carbidopa using pumps.
78	78
79		-= Manufacturing =
	81	+==== Manufacturing ====
80	80
81	81	The manufacturing of Probuphine has primarily been conducted at DPT Laboratories, Inc., or DPT, and Titan Pharmaceuticals has expanded the manufacturing facility at this contract manufacturer to establish commercial scale capability to support the market launch of Probuphine and ongoing demand. Titan Pharmaceuticals has entered into a commercial manufacturing agreement with DPT that governs the terms of the production and supply of Probuphine. During a part of 2017, the company continued to supply and support Braeburn while an agreement between Braeburn and DPT for the supply of Probuphine was being finalized. Pursuant to the Purchase Agreement, Titan Pharmaceuticals is responsible for the manufacture and supply of Probuphine as needed for the Molteni Territory.
82	82
83	83	To date, Titan Pharmaceuticals has obtained the supply of bupenorphine from Teva Pharmaceuticals, Inc. under a commercial supply agreement similar to the one with DPT.
84	84
85		-= Sales and Marketing =
	87	+==== Sales and Marketing ====
86	86
87	87	The company do not currently have any sales and marketing capability. As its licensee, Braeburn has sole responsibility for sales and marketing of Probuphine within the United States and, through its sublicensee, Knight Pharmaceuticals, Inc., in Canada. Molteni has sole responsibility for the commercialization of Probuphine in the Molteni Territory. The company's current plans are to make similar arrangements for the commercialization of any additional products the company may successfully develop based on its ProNeura technology.
88	88
89		-= References =
	91	+